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Because the stipend is less than $5,000 and from a U.S. institution, this does not need to be disclosed for conflict of interest review.  This may, however, need to be disclosed for conflict of commitment review if it is an Outside Commitment, which can include fee-for-service activity and Research.

The Outside Commitment Decision Tree on our Disclosure Requirements webpage are available to assist individuals in determining what needs to be disclosed. Individuals can also contact OROI at coi@arizona.edu.

COI:  Income received from the University of Arizona is exempt from the COI disclosure requirements

COC:  Please work with your college/unit leadership to determine if they consider this to be an Outside Commitment.  Pursuant to policy, Outside Commitments (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment.  Here, the teaching commitment is not for the benefit of an external entity or individual. With that said, an individual’s supervisor/department/college could require submission of a COC form for review and approval to ensure the individual’s institutional duties and responsibilities are properly covered if they desired to do so.

Outside Commitments require prior approval.

If you will be participating in research under the auspices of the University, you are required to complete the Required COI Disclosure Training through Edge Learning and submit a disclosure via via eDisclosure. These requirements apply to anyone who is an “Investigator” on a research project at the University (whether or not externally funded).  “Investigator” is a defined term in the Conflicts of Interest and Commitment policy, and generally means “any person who shares the responsibility for the design, conduct, or reporting of Research” and may include students, postdocs and trainees.

More details can be found on the Conflict of Interest Requirements for Students, Postdocs and Trainees webpage.

Yes, since UArizona receives federal funding, all University Employees are expected to follow federal regulations as embodied in the Conflicts of Interest & Commitment Policy.

If you are an Investigator, this activity should be disclosed for conflict of interest review if it meets the definition of a Significant Personnel Interest.  Significant Personal Interests are any managerial, professional, or Fiduciary Position you (or a Family Member) hold in any outside entity, whether or not you or your family is compensated. This can include officer, director, and board positions.

Fiduciary Position means one's legal and/or ethical obligation to act in the best interests (e.g., the financial and/or operating success) of another person or entity, regardless of whether such role is compensated. Examples of Fiduciary Positions include but are not limited to membership on a board of directors or board of advisors, or a management role in an entity (e.g., as a corporate officer, LLC member, general partner, and governing board member of a professional association).

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.  Individuals can also contact OROI at coi@arizona.edu.

Please work with your college to determine if this is outside of your institutional duties and responsibilities.  If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, receipt of remuneration (includes stipends and honorariums) in the amount of $5,000 or more will make this a Significant Financial Interest that needs to be disclosed.

If you are an Investigator and receive remuneration (includes stipends and honorariums) of any amount from a foreign entity, this must be disclosed as a Foreign Interest for conflict of interest review.

There is not enough information to determine whether this should be disclosed for conflict of interest review.  (e.g., Is it a UArizona grant?  Are you funded by a PHS agency or the Dept of Energy?)  Please contact OROI at coi@arizona.edu or visit our office hours (1st & 3rd Thursday, 2 pm – 3 pm; Connect via Zoom) for assistance.

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, this activity should be disclosed for conflict of interest review if it meets the definition of a Significant Personnel Interest.  Significant Personal Interests are any managerial, professional, or Fiduciary Position you (or a Family Member) hold in any outside entity, whether or not you or your family is compensated. This can include officer, director, and board positions.

Fiduciary Position means one's legal and/or ethical obligation to act in the best interests (e.g., the financial and/or operating success) of another person or entity, regardless of whether such role is compensated. Examples of Fiduciary Positions include but are not limited to membership on a board of directors or board of advisors, or a management role in an entity (e.g., as a corporate officer, LLC member, general partner, and governing board member of a professional association).

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.  Individuals can also contact OROI at coi@arizona.edu.

Investigators, as defined in the Conflicts of Interest & Commitment policy, are required to submit a Research Certification for each Research Project, both non-sponsored and sponsored.  OROI relies on the PI to make this determination.  “Who is an Investigator?” can be used to help determine if you are an Investigator.

For IRB protocols, the Human Subjects Protection Program has guidelines for who needs to submit a Research Certification - Investigator Roles & COI Disclosures in eIRB.  OROI happy to assist you in contacting them or you can reach out to them via email - vpr-irb@email.arizona.edu.

An up-to-date COI disclosure (either an Annual Disclosure or Research Certification submitted within the last 364 days) is required at the time of proposal to a federal funding agency.

Additionally, Federal regulations prohibit expenditures on Awards until after the COI review process is complete. Our office desires to see all funded research go forward without delay.

Therefore, to avoid Award Holds, you are asked to submit Research Certifications early. Generally, Research Certifications are available in eDisclosure 60 days prior to the project start date listed in the Institutional Proposal. (For certain clinical trials, it may be fewer than 60 days) eDisclosure will send a notification to the Investigator as part of the UAccess Research/Sponsored Projects integration. If at any time you have been informed that any given project was not funded  you would then advise sponsor@arizona.edu as soon as possible that the specific project will not be funded and no action is required for the Research Certification.
 

Please work with your college to determine if this is outside of your institutional duties and responsibilities.  If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, receipt of remuneration (includes stipends and honorariums) in the amount of $5,000 or more will make this a Significant Financial Interest that needs to be disclosed.

If the Outside Commitment is not approved, the individual cannot engage in the Outside Commitment.

OROI is available to work with college/department approvers to discuss concerns and develop a COC management plan.  More details about the COC review process are available on our COC & COI Review Processes webpage. 

This depends on your UA role (whether an Employee, Administrator and/or Investigator – An complete overview of UA roles and Disclosure requirements can be found here)  

• If you are an Investigator, receiving remuneration/income in any amount from Intellectual Property rights, such as patents or copyrights will make this a Significant Financial Interest that needs to be disclosed via eDisclosure. Additionally,

• If you are a UA employee whose FTE is 0.5 or greater, the definition of Outside Employment and Outside Commitment is included below for your review. The Outside Commitment Decision Tree may be of assistance when making the determination as to whether an activity requires disclosure. Additionally, the Disclosure Table resources provide an overview of the disclosure requirements.  

Outside Employment refers to any employment relationship outside of the University requiring a time commitment.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

Also, please refer to the University’s TLA-100 The Intellectual Property Policy in case applicable.

Both.  Outside Commitments must be disclosed in eDisclosure, at which time OROI will initiate the review process.  

More details about the COC review process are available on our COC & COI Review Processes webpage. 

Generally speaking, this often falls within one’s institutional duties and responsibilities.  If this is outside of an individual’s institutional duties and responsibilities and meets the definition of an Outside Commitment, it will need to be disclosed for conflict of commitment review.

This activity falls under the following exemption for conflict of interest disclosure: Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by (i) a government agency (federal, state, or local); or (ii) an institution of higher education as defined at 20 USC § 1001(a); or (iii) an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education.

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

If you are an Investigator, receipt of remuneration (includes stipends and honorariums) in the amount of $5,000 or more will make this a Significant Financial Interest that needs to be disclosed.

Disclosures must be submitted in eDisclosure.  If you experience any issues in eDisclosure, please contact OROI at coi@arizona.edu.

University Employees are asked to disclose their Outside Interests (Significant Financial Interests, Significant Personal Interests, Foreign Interests), Outside Commitments and Substantial Interests so that determinations of what is and is not a conflict can made through OROI. The review processes are available on our COC & COI Review Processes webpage. 

The Disclosure Tables and Outside Commitment Decision Tree on our Disclosure Requirements webpage are available to assist individuals in determining what needs to be disclosed. Individuals can also contact OROI at coi@arizona.edu.

Financial Conflict of Interest means an Outside Interest is Related to, or can be perceived to be Related to, an individual’s institutional responsibilities.  Relatedness is a defined term that means it may reasonably appear that decisions made by the Investigator in the performance of his/her institutional responsibilities could directly and significantly affect the value of his/her Significant Financial Interests or be in conflict with Significant Personal Interests or Foreign Interests.  More information can be found here: Relatedness.

Outside Commitments require prior approval.  In an ideal world, the COC form would be submitted in eDisclosure 4 weeks prior to the start date to ensure college and department reviewers have an opportunity to review the form, resolve concerns and/or implement a management plan.  Realizing that submission 4 weeks prior to the start date is not always possible, we ask that individuals email us to flag a fast-approaching start date so that we can work with the approvers to ensure all questions are answered, etc. 

A foreign entity is:

1. A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance; or
2. A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public; or
3. A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or
4. An organization located in a country other than the United States not recognized as a Foreign Public Entity.  A Foreign Public Entity is (1) A foreign government or foreign governmental entity; (2) A public international organization, which is an organization entitled to enjoy privileges, exemptions, and immunities as an international organization under the International Organizations Immunities Act (22 U.S.C. 288f); (3) An entity owned (in whole or in part) or controlled by a foreign government; or (4) Any other entity consisting wholly or partially of one or more foreign governments or foreign governmental entities.

Please work with your college to determine what is and is not considered to be part of your UArizona duties and responsibilities.  The following disclosure scenarios may be helpful:

• An Investigator receives personal compensation or an honorarium of $5,000 or more for editing journal articles. In this instance, the editing work must be disclosed as a Significant Financial Interest for conflict of interest (COI) review even though it is part of the individual’s professional service requirement.  The Investigator would not need to submit a COC form for approval if the activity is part of their professional service.

• An Investigator serves on the Scientific Advisory Board for a professional society but does not receive any remuneration.  The Investigator must disclose this board membership as a Significant Personal Interest for conflict of interest (COI) review.  The Investigator would not need to submit a COC form for approval if the activity is part of their professional service.

• An Investigator receives an honorarium of $300 from a foreign funding agency to review research proposals. In this instance, the Investigator must disclose the review work as a Foreign Interest for conflict of interest (COI) even though the remuneration is less than $5,000 and the work may be part of the individual’s professional service.  The Investigator would not need to submit a COC form for approval if the activity is part of their professional service.

Research and Research Project mean any organized program of scientific inquiry that involves a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge that is performed at or under the auspices of the University. Research includes non-sponsored research, research fellowship and training programs, and research-related activities in undergraduate, graduate, and postdoctoral education.  It also includes some educational activities that are supported by a research sponsor.

Federal funding agencies indicate that Research can be thought of as:

1. "a process to discover new knowledge,"
2. "a scientific study of nature that sometimes includes processes involved in health and disease," and/or
3. "creative and systematic work undertaken in order to increase the stock of knowledge—including knowledge of humankind, culture and society—and to devise new applications of available knowledge."

Federal funding agencies further indicate that one can consider whether the project includes:

• "a systematic, intensive study directed toward greater knowledge or understanding of the subject being studied, or
• a systematic study directed specifically toward applying new knowledge to meet a recognized need, or
• a systematic application of knowledge to produce useful materials, devices, and systems or methods, or
• development [which] may include designing, developing, and improving prototypes and processes to meet specific requirements."

See:  HHS, NCI, NSF

Overlap between an Outside Interest and a Research Project occurs when there is Relatedness.

“Relatedness” is the condition in which it may reasonably appear that decisions made by the Investigator in the performance of his/her institutional responsibilities could directly and significantly affect the value of his/her Significant Financial Interests or be in conflict with Significant Personal Interests or Foreign Interests.

Relatedness includes situations in which an Investigator’s Outside Interests would reasonably appear to affect, or to be affected by, the individual’s Research or other institutional responsibilities, as well as situations in which the Outside Interest involves an entity whose financial interests would reasonably appear to affect, or be affected by, the Investigator’s Conduct of Research or other institutional responsibilities.

Relatedness is not a judgment on whether the Investigator would deliberately make choices in the Conduct of Research or the performance of his/her Institutional Responsibilities based on considerations related to his/her Significant Financial Interest, Significant Personal Interest or Foreign Interest. Rather, “Relatedness” refers to the condition in which it may reasonably appear that choices made in the Conduct of Research or other performance of the individual’s institutional responsibilities could be directly and significantly influenced by the existence of Outside Interests.

If you are an Investigator, this is a Foreign Interest that must be disclosed for conflict of interest review.  Foreign Interests are:

• Participation in a foreign talent or similar-type program
• All resources and other support, both domestic and foreign, for ongoing research projects, including those conducted at a different institution
• In-kind contributions from domestic and foreign institutions or governments that support your research activities
• Any payment, reimbursement, travel support or other compensation, of any amount, that you personally receive, or will personally receive, from a foreign entity

(If this was a U.S. institution, it would need to be disclosed if you are funded by a PHS agency or the Dept of Energy, even if the value is less than $5,000.)

If your UArizona FTE is 0.50 or greater and this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirementswebpage may be of assistance in making this determination. Individuals can also contact OROI at coi@arizona.edu.

Also, please see: Guidance for Consulting or Employment at Other Postsecondary Institutions.

“It is permissible for members of the faculty on sabbatical leave to supplement their compensation from the university to cover such special expenses resulting from the approved sabbatical leave program, through fellowships, scholarships, employment, or grants-in-aid. Such special expenses referred to might include such items as travel, secretarial assistants, tuition, research, and publication. Additional compensation expected is to be fully explained on the application form and approved before the leave is granted. Should opportunities for supplemental compensation develop after the sabbatical leave has begun or after the application form has been submitted and approved, such opportunities must be cleared with the university at the earliest opportunity.”  See ABOR 6-207(F).

In the past, University Employees were asked to disclose Outside Commitments in the COC database and Outside Interests in the COI database.

The Conflicts of Interest & Commitment Policy incorporated and replaced the following policies:

1.    Conflict of Commitment Policy
2.    Conflict of Interest (UHAP) Policy
3.    Conflict of Interest in Purchasing Policy
4.    Individual Conflict of Interest in Research Policy
5.    Institutional Conflict of Interest Policy

Now, eDisclosure serves as a single platform to meet all policy disclosure requirements.
 

If you are an Investigator and receive a travel reimbursement/sponsorship and/or stipend of any amount from a foreign entity, this must be disclosed as a Foreign Interest for conflict of interest review.

If you are an Investigator and receive a stipend of $5,000 or more, this must be disclosed as a Significant Financial Interest for conflict of interest review.

If you are an Investigator who has funding from a PHS agency or the Department of Energy and receive a travel sponsorship or reimbursement of any amount, this must be disclosed as a Significant Financial Interest for conflict of interest review.

If this activity meets the definition of an Outside Commitment, it should be disclosed for conflict of commitment review.  The Outside Commitment Decision Tree on our Disclosure Requirements webpage may be of assistance in making this determination.

Answer this question ‘Yes’ if this proposal involves companies or non-profits as partners if they are not already listed as a sponsor or prime sponsor. This would be the case for proposals where a company or nonprofit is a subrecipient, consultant, advisor, etc. If the answer is ‘Yes’ then it is required in the UAccess Research (UAR) proposal to list the full name(s) of any company or non-profit organization that will be involved as a partner, separated by commas.

Answer this question ‘No’ if the partner is already captured in the UAR proposal as the sponsor or prime sponsor.

Company and non-profit information helps RII to identify researchers, companies and non-profits interested in partnerships to strengthen responses to future sponsorship opportunities Contact Research Development Services (RDS) at ResDev@email.arizona.edu(link sends e-mail) for additional guidance about this question.

“Research Advancement Grants” describe the internal funding programs administered by RDI. Other departments or colleges on campus may also offer other internal funding programs. Frequently, the RDI Research Advancement Grants are discussed using the colloquial description of “Internal funding.” 

Yes, a few are listed below.

• New Investigator Guide to NIH Funding, by the NIAID
• Early Stage and Early Established Investigator Policies, by the NIH
• Tips for New NIH Grant Applicants, by NIGMS
• Faculty Early Career Development Program (CAREER), by the NSFa
• NASA Science Directorate How-To Guide, by NASA

Answer this question ‘Yes' if the proposal involves handling any human derived products (tissue, saliva, organ, semen, vaginal secretions, feces, urine, blood, cells, etc.), or any other potential infectious materials (PIM) that could carry and transmit bloodborne pathogens. For assistance, contact Research Laboratory & Safety Services at (520) 626-6850 or rlss-bio-support@email.arizona.edu(link sends e-mail) or visit the or visit the Recombinant and Biohazardous Materials web page.

It depends on the country and the item. The U.S. government has export restrictions on certain items. Consult with Export Control to determine if your equipment, materials, data, or software is subject to these restrictions. Export Control will obtain licenses, exceptions or assist with other requirements to facilitate your travels, if required. Traveling with a “clean” laptop is recommended.

Yes. Each opportunity is reviewed independently.

Yes, unfunded research may be subject to export controls, particularly international collaborations.

You will be able to look up Negotations by department in the current version of UAccess Research (v. 5.2.1) until Thursday, January 20th before 5pm. After that, the old system will go dark. During system conversion, all negotiation records will be transferred over to the updated UAccess Research system. You will be able to look up Negotiations by department in the updated version of UAccess Research (Kuali SaaS) after go-live on Tuesday, January 25 after 8am. 

To search for Negotiations by department in the updated version of UAccess Research, click on the Common Tasks button in the left-hand navigation panel. Find the Negotiation card and click Search Negotiation. Enter the Unit Number in the appropriate field and click search. You will only be able to open a Negotiation if you are provisioned to be able to do so for that unit. 

As a National Cancer Institute Designated Comprehensive Cancer Center Facility, any and all use of the facilities of the Cancer Center must be reported to the National Institutes for Health (NIH) on an annual basis. This includes any use of Cancer Center Facilities, including use of the Common Equipment Rooms and/or the Shared Services of the Cancer Center.  use of any lab, office, common equipment or shared services or any part of the Cancer Center Facility requires approval.

Answer this question ‘Yes’ for any proposal that involves research related to cancer.  This information is compiled for the Arizona Cancer Center annual report.

This question was added to the UAccess Research (UAR) proposal in April 2020 to easily track and report on sponsored project proposals and awards related to COVID-19. Is the project scope of work related to COVID-19?

If you have any questions please contact sponsor@arizona.edu(link sends e-mail).

Generally, proposals to external sponsors require institutional review. If in doubt, contact Sponsored Projects and Contracting Services for clarification.

Yes. See the following link for detailed guidance on purchases and shipping. Depending on the item, export control laws and regulations may require security protocols (such as a TCP) to be in place before the item arrives on campus or is released for use. Items intended to be shipped outside the U.S. must be evaluated and coordinated by Export Control. If a license to export the item is required, Export Control will apply for such government authorizations. A customs broker may need to be involved in international shipments and purchases.

No, a chemical spill kit may be shared between an Approval’s laboratories, as long as the laboratories are only separated by a single doorway (i.e. not a hallway). A reference guide for chemical spill kits is available on the RLSS website for more information.

In most cases, no budget is required for the pre-proposal. If a budget is required, a template will be provided as part of the pre-proposal application.

It depends, please visit the Types of Proposals webpage for further assistance.https://research.arizona.edu/research-administration/proposal-preparation/types-of-proposals#PreProposal

Activities that meet the definition of Significant Financial Interest, Significant Personal Interest, Outside Commitment (including Foreign Components), Substantial Interest, Foreign Interest and Institutional Financial Interest need to be disclosed.  Depending on the specific facts, that may include a foreign affiliation or presentation.

Please contact a member of OROI at coi@arizona.edu or 520-624-6406 to assistance.

No, you do not have to disclose your parent’s Outside Interests. 

Federal regulations only require that you disclose you and your Family Member’s Outside Interests.  Family Member means one's spouse, domestic partner and/or dependent child. 

Yes, an IND application is a request to the FDA for authorization to administer an investigational drug (or biologic) to human or a marketed drug in a new indication and/or patient population. However, there are IND Exemptions. Please refer to the section on IND Exemptions for more information.  

Key Persons should always have been added to the proposal and included in routing for review and approval of their role and commitment on the project. Unit Details had to be added manually and were not included or required for Key Persons previously and they were not included in Award Credit and F&A Revenue allocations except in special circumstances.

With this update, the Key Person's HR Home Unit will automatically be pulled in and they default to being included in Credit Allocations. You may simply enter 0% for Award Credit and F&A Revenue allocation for these individuals, or you may uncheck the box "Include in Credit Allocation" to remove them from allocations altogether. 

Yes, all approvals in possession of radioactive material (including in storage and in waste) any time during a calendar month must perform a monthly survey unless the approval has been granted a specific approval condition exempting them from the requirement.

No. As the administrative office that coordinates and manages the review of Limited Submissions, RDS does not assist in proposal preparation for pre-proposals. However, RDS does provide proposal support, when available, for all “tickets” awarded through the Limited Submission process.

Yes. The University of Arizona, as outlined in its Export Control Policy, is committed to complying with U.S. export controls laws and regulations that apply to its activities, including the International Traffic in Arms Regulations (ITAR), the Export Administration Regulations (EAR), and the Office of Foreign Assets Control (OFAC) regulations. All individuals affiliated with the University who work with, or have access to, export-controlled technical data, information, materials, and equipment are required to be familiar with and fulfill the requirements of the U.S. export controls laws and regulations by following applicable University policies and procedures

It depends on the equipment and its classification; contact export control for further review.

Occasionally some funding opportunities will be managed as Institutionally Coordinated Submissions and will appear on the Limited Submission table with that designation. Usually, these opportunities are for large and/or complex funding opportunities that require institutional support, core facilities, or leadership approval. To guarantee the submission of the strongest proposal(s) to the funder, RDS coordinates the institutional UA response.

Enter as many Facilities & Administrative rates as will be applicable to a proposal separated by a forward slash and without the "%" symbol. Example: 53/53.5

If you have any questions please contact sponsor@arizona.edu(link sends e-mail).

Select the appropriate rate category from the drop-down list in the UAccess Research (UAR) proposal. Visit the Facilities & Administrative (F&A) Rates page of the Research Support website and view the F&A rate table for additional guidance.

For further questions, please contact sponsor@arizona.edu(link sends e-mail).

Rate Categories:

• Federal negotiated rate: It is the University of Arizona’s policy to request the appropriate federally negotiated F&A rate for all sponsored activity regardless of funding source, the federally negotiated F&A rate will be the basis for budget purposes on all sponsored activity. When funding flows from a federal prime sponsor to the University of Arizona, through a pass-through entity, as in the case of federal flow-through awards, the University will accept stipulations that meet the requirements of Uniform Guidance 2 CFR 200.414
• Sponsor F&A rate stipulation: If a sponsoring agency limits or forbids the reimbursement of F&A based on federal/state/local law, administrative regulation, or published sponsor policy, exceptions for Federal Flow through or Stipulated F&A Rates apply. Documentation for a stipulated rate must be included with the proposal. To document a stipulated rate, attach a copy of the law, regulation or published policy stating the limitation on F&A reimbursement under the Attachments section of the UAccess Resarch proposal document as attachment type "F&A Stipulation".
• Other standard UA F&A rate: Other standard UA F&A rates are described in the standard F&A rate table on the Facilities & Administrative (F&A) Rates page.
• F&A waiver (rarely approved, attach waiver request template): The decision to grant or deny a waiver request is at the sole discretion of UArizona Research Innovation, & Impact (RII) but is in concurrence with the approval from the representative Department Head, and Dean or Associate Dean for Research. These offices will work with RII to review and obtain the approval in advance of a UAR application or contract. All requests must use the F&A Waiver Request Template with the Department Head and Dean or Associate Dean for Research approval and must be submitted with a UAR proposal no less than five working days in advance of the deadline. Attach the Template in the UAR proposal Attachments section as attachment type "F&A Waiver Request Template."

FDA/EPA Quality Assurance (GLP/cGMP/QA)?

Answer this question ‘Yes’ if the proposal involves any of the terms below or requires adherence to any FDA/EPA quality assurance program. If the project you are proposing involves the manufacture of a medical/therapeutic product, the evaluation of an FDA grant “Test or Control Article”, or collaboration with another researcher/institution upon research requiring FDA/EPA quality assurance program enrollment please contact Research Laboratory & Safety Services at rlss-help@arizona.edu. Visit the Good Laboratory Practices web pages for additional guidance.

At this time, the RLSS maintains a voluntary GLP preparation program (training & inspections), the UArizona has not constituted an institutional Quality Assurance Unit and would need reasonable time to do so to accommodate anyone with an FDA/EPA quality assurance program requirement.

• Good Laboratory Practices
• Good Manufacturing Practices
• Quality Assurance
• 21CFR
• Title 21
• EPA Quality Program
• GLP
• GMP
• cGMP
• Test Article
• Control Article

Enter the account number of a past sponsored project if the current proposal may be funded as a new and separate award but is the next phase or a continuation of the past project.

If you have any questions please contact sponsor@arizona.edu(link sends e-mail).

Answer this question ‘Yes’ if any portion of the project is to be completed with the assistance of collaborators in a foreign nation and use the lookup feature in the UAccess Research (UAR) proposal to select the country of each foreign collaborator.

Answer this question ‘Yes’ if the proposal involves the use and storage (including cleaning and sterilizing of equipment) of any quantity of any solvents, oxidizers, corrosives, compressed gases, cryogenics, heavy metals, dust-generating compounds, ATF regulated materials, DEA Controlled Substances, pesticides, fertilizers, and/or hormones/steroids. Visit the Chemical Safety Program web page for additional guidance or contact Research Laboratory & Safety Services at rlss-help@arizona.edu(link sends e-mail) with questions.

Examples include but are not limited to:

• Ethanol
• Methanol
• Tetrahydrofuran
• Acetone
• Potassium permanganate
• Hydrogen peroxide
• Sodium/Calcium hydroxide
• Sulfuric/Nitric/Acetic acid
• Carbon dioxide
• Argon
• Liquid nitrogen
• Arsenic
• Mercury
• Mine tailings
• Silica powder
• Praxair FE-271 (or other brand additive manufacturing metal powder product)
• Nitrotriazolone (NTO)
• Nitrocellulose
• Ketamine
• Testosterone
• Cannabidiol (CBD)
• Round-Up (or other brand glyphosate product)
• Microthiol (or other brand sulfur fungicide product)
• Pyrethroids
• Novel mode-of-action insecticide
• Urea
• Mono-ammonium phosphate (11-52-0)
• Iron/Zinc/Molybdenum chelates
• Zoetis (or other brand estradiol product)
• Corticosteroids

Conflict of interest (COI) and conflict of commitment (COC) reviews are separate because COI relates to bias in decisions and COC relates to a University employee's time & effort for UArizona, UArizona resources and UArizona Assets.

Sponsors & funders have identified the following concerns: 

1.    conflicts of interest
2.    shadow labs
3.    loss of Intellectual Property
4.    conflicts of commitment, including theft of time, resources and assets
 

There are several portals and databases that can be used to search for potential collaborators. For more information on these as well as collaboration spaces, centers and institutes, core facilities, and other tools and resources, visit the Collaboration section of the Research Gateway.

If you work with an investigator who has a preferred name in addition to their primary legal name, and who may have had proposals, awards, negotiations or subawards under both names, use the vertical line ‘or’ operator, “|”, in lookup screens accessed via Common Tasks in the UAR left hand navigation pane. This will allow a search for all names the person might have used in past records.

In the past, UAR only populated a person’s legal/primary name as it was entered into the UAccess Employee system. As of the January 25, 2022 UAccess Research (UAR) system update, both primary legal name and preferred name are brought into UAR, with the default being preferred name. As a result of added flexibility, people who have a preferred name or who have changed their name over time may have older records under a different name.

Example: john den|ja*den finds John R Den, Johnna Alden, OR Jack Den, Jason Hayden.

Lookup Wildcards

• limiting what you take abroad;
• keeping information in your possession or locked in a secure location;
• using a “clean” laptop – with minimal information;
• using the university VPN if you need to access data;
• encrypting your device; and
• screening collaborators in advance.

Visit the Build a Budget section of the Research Gateway to get started, and contact your departmental/unit business office for assistance.

Click on Common Tasks in the left-hand navigation panel. Find the Proposal Development card and select Create Proposal. 

See the Create and Save a New Proposal video for step-by-step instructions. Be aware that there are additional videos for completing each section of the Proposal Development document and submitting the proposal to routing for review, approval, and submission. 

Stock and equity only need to be disclosed if they are an Investigator's Significant Financial Interest or a University Employees Substantial Interest.

A Significant Financial Interest includes:

• Any equity in a private company, regardless of value

• Equity valued at $5,000 or more in a public company

However, income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by the investment managers within these funds or accounts, do not require disclosure.

A Substantial Interest includes:  The ownership of three percent or more of the shares of a corporation for profit, where the total annual income from dividends, including the value of stock dividends, from the corporation exceeds five percent of the total annual income of the employee.

Completing the Stock in External Entity Page in eDisclosure

On the Stock or Equity page in eDisclosure, there are two options for disclosing stock and equity:

1. "Do you own stock / partnership shares in this organization?" should be used to disclose (1) stocks and shares that you own in a public entity and (2) partnership agreements/shares.
2. "Do you own stock options or any other form of equity in this organization?" should be used to disclose (1) other ownership interests (e.g., equity in a private entity), (2) stock options, including Employee Stock Options ("ESOs"), and stock warrants.

Stock & Equity Definitions

• Equity is any stock or other ownership interest, or an entitlement to obtain any stock or ownership interests (e.g., stock options and warrants). The value of Equity is determined through reference to public prices or other reasonable measures of fair market value (e.g., assets - liabilities = value).
• “Exchange-traded funds (ETFs) are SEC-registered investment companies that offer investors a way to pool their money in a fund that invests in stocks, bonds, or other assets. In return, investors receive an interest in the fund.  Most ETFs are professionally managed by SEC-registered investment advisers.  Some ETFs are passively-managed funds that seek to achieve the same return as a particular market index (often called index funds), while others are actively managed funds that buy or sell investments consistent with a stated investment objective.  ETFs are not mutual funds.” (https://www.investor.gov/introduction-investing/investing-basics/glossary/exchange-traded-fund-etf, last visited Oct. 27, 2022)
• “Options are contracts giving the purchaser the right – but not the obligation -- to buy or sell an underlying asset at a fixed price within a specific period of time. Stock options are traded on a number of exchanges.” (https://www.investor.gov/introduction-investing/investing-basics/glossary/options, last visited Oct. 27, 2022)
• Partnership Shares is a partnership arrangement between two or more people to oversee business operations and share its profits and liabilities. (See generally https://www.irs.gov/businesses/partnerships, last visited Oct. 27, 2022)
• “Stocks are a type of security that gives stockholders a share of ownership in a company. Stocks also are called ‘equities.’”  (https://www.investor.gov/introduction-investing/investing-basics/investment-products/stocks, last visited Oct. 27, 2022)
• A Stock Warrant “is a contract that gives the holder the right to purchase from the issuer a certain number of additional shares of common stock in the future at a certain price, often a premium to the stock price at the time the warrant is issued.” (https://www.finra.org/investors/insights/spac-warrants-5-tips, last visited Oct. 27, 2022)

See Also

• How do I value stock and equity?
• When should I update the value of my stock or equity?

We recommend that you take a proactive role in identifying relevant funding opportunities. To assist you, we have provided helpful resources including a list of hand-curated funding opportunities for Early Investigators, and a compilation of search databases, funding sources, and distribution lists.

The action level for contamination is 50 counts per minute (cpm) above the background count rate.

Prospective Approval Holders register their laboratory or set of laboratories in the Laboratory Chemical Safety Program by completing the New Lab Registration and Assessment.  You will be contacted by the RLSS within 3 business days after registration submission to schedule an initial visit.

Investigators are required to report local problems, concerns, serious risks, and failure to follow the protocol to the IRB for all human subjects research. These reports must be submitted to the IRB within ten (10) business days of discovery. Changes made to eliminate risk to subjects must be reported to the IRB within five (5) business days of discovery. Reportable items must be submitted in eIRB as a Reportable New Information (RNI). If the University of Arizona IRB is the IRB of Record for another site, the site must follow the same requirements. For additional information, please see our guidance on Reporting New Information. 

All Limited Submission opportunities currently in a competition will be listed in Arizona Cultivate. You can log in and apply using your NetID. Most applications require both textbox entry of application information such as a summary, a significance statement, approach, and expected outcomes, as well as uploads in PDF format. RDS recommends logging in to the system to see what is required well in advance of the internal submission deadline.

The value of Equity is determined through reference to public prices or other reasonable measures of fair market value (e.g., assets - liabilities = value).

Stock in a public entity is valued based on Annual Reports and other public valuations.

Valuing stock in a private entity can be done various ways using methods such as valuation ratios, internal rates of return, comparative analysis and discounted cash flow analysis.

See Also

• How do I disclose stock or equity?
• When should I update the value of my stock or equity?

The purpose of the OFAC regulations is to enforce embargoes and economic sanctions. In general, the OFAC regulations prohibit exports to certain sanctioned/embargoed countries such as Iran, Cuba, Sudan, North Korea, and Syria.

OFAC considers providing anything of value or a service to Iran or the government of Iran would require prior government approval. For example, giving a professional presentation, even if it does not contain materials controlled under ITAR or EAR, is deemed under OFAC to be a “service” and “something of value” provided to the recipient audience. 

In addition to the points listed above there are other considerations which vary by country:

• Attending a conference in Iran (OFAC considers this to be an “import”) or speaking at a conference in Iran (providing a service or something of value) requires a license. An OFAC license for Iran generally takes six to nine months (or longer) to process once submitted.
• Participating in certain online courses abroad requires an OFAC license, if the student is ordinarily a resident of sanctioned country (Cuba, Iran, Syria, or the Crimea Region of the Ukraine).
• Any technical discussions, formal or informal, could require a license and would be prohibited prior to the receipt of the necessary license(s).
• Travel to Cuba has special considerations.  For information on Cuba travel, see http://www.treasury.gov/resource-center/sanctions/Programs/Pages/cuba.aspx.

• The University of Arizona will NOT apply for an OFAC License for activities in or with Syria - no University travel to Syria will be approved. Travel to Iran will be approved on a case-by-case basis and only upon receipt of any required OFAC or other government licenses.

If an employee travels to any sanctioned country on their own time, the individual may not take or send anything university-owned such as equipment, software, technology, or data, or represent the university in any capacity.

The University of Arizona’s Export Control team works closely with the Contracting Office to identify contracts with NIST requirements or clauses with publication restrictions (e.g., DFARS 252.204-7012 and 252.204-7000). Export Control is also alerted when there are similar safeguards/restriction clauses in contracts that are not sponsored by Department of Defense (NASA contracts often have similar clauses). 

An export control checklist is used in the evaluation process. The three-part checklist must be completed by the PI, Contracting Office, and Export Control. The checklist highlights DFARs clauses in addition to potential export control red flags. 

UA faculty, staff, and students traveling internationally on behalf of UA for business, research, or other purposes are required to register well in advance of their departure (travel.arizona.edu). In addition to obtaining UA approval, the traveler may require a license, license exception/exemption, or other guidance to hand-carry items abroad, access data, interact with certain persons, speak at a conference, conduct research, provide training or other services, or engage in other UA related activities.

See the Export Control resource on international activities for additional guidance.

Export Control applies for all export control licenses on behalf of the University. NOTE: Obtaining an export license may take several months and there is no guarantee that the U.S. government will approve a license request.

Prior to travel, to avoid collaborating with a prohibited party, foreign parties should be screened using the Restricted Party Screening tool. Export Control or your Department Administrator can assist with conducting screenings. 

What is Arizona’s COI Law?

In addition to federal conflict regulations, the University of Arizona must also comply with Arizona’s conflict of interest (COI) law.

A Substantial Interest is any nonspeculative pecuniary or proprietary interest, either direct or indirect, other than a remote interest. Remote interest is defined in A.R.S. § 38-502(10).

To mitigate the possibility that a personal influence might bear upon a University employee’s decision in his or her capacity as a public employee, a University employee who has, or whose Relative has, a "Substantial Interest" in

1. any contract, sale, purchase, or service by or to the Arizona Board of Regents (“ABOR”) or UArizona, or
2. any decision of ABOR or UArizona,

the University employee shall refrain from voting upon or otherwise participating in any manner as a University employee regarding such contract, sale, purchase, service or decision.

What do I need to do?

University employees must disclose all substantial interest in the official records of ABOR.  UArizona’s Conflicts of Interest & Commitment Policy complies with this law by requiring disclosure in eDisclosure.

What is considered when making Substantial Interest determinations?

1. Will the contract, sale, purchase, service, or decision have an impact, either positive or negative, on an interest of a University employee or their Relative?
2. Is the interest pecuniary (involves money) or proprietary (involves ownership)?
3. Is the interest a remote interest?

How is this state law applicable to Research and Startup Companies?

A University employee who has, or whose Relative has, a Substantial Interest in an entity cannot (1) participate as a University employee in contracting and purchasing decisions related to the entity or (2) subaward research to the entity. This includes the process leading up to the decision (e.g., making recommendations, giving advice, communicating with anyone involved in the purchasing process).

Who is a Relative?

Like we do with federal conflict regulations, the University relies on the state law to define Relative.  Thus, Relative has the meaning set forth in A.R.S. 38-503 (i.e., one's spouse or domestic partner, child grandchild, grandparent, sibling and their spouse or domestic partner, half-sibling and their spouse or domestic partner, and the parent, sibling or child of a spouse or domestic partner).

Even if the University employee does not have a substantial interest in a decision in which they are about to participate, if one of their Relatives has a substantial interest in the decision, they must disclose the interest and refrain from participating in the decision.

Noncompliance with this law cannot be justified by stating you are not unaware of your Relative’s interest. Public officers and employees have an affirmative obligation to become aware of any interests their relatives may have that may create a Substantial Interest.

Who is the Conflict Official for Arizona’s COI law?

While Arizona’s COI law is codified in the Conflicts of Interest & Commitment Policy and Substantial Interest disclosures are made through eDisclosure, Ted Nasser, Chief Procurement Officer, is the Conflict Official for Substantial Interests.

What if I have a question about Substantial Interests?

Please contact the Office for Responsible Outside Interests at coi@arizona.edu for questions related to Substantial Interests.  This law is broadly construed in favor of the public and substantial civil and criminal penalties are provided for failure to comply with the statutory requirements.  It is imperative that your questions are answered.

“Remote interest” means:

1. That of a nonsalaried officer of a nonprofit corporation.
2. That of a landlord or tenant of the contracting party.
3. That of an attorney of a contracting party.
4. That of a member of a nonprofit cooperative marketing association.
5. The ownership of less than three percent of the shares of a corporation for profit, provided the total annual income from dividends, including the value of stock dividends, from the corporation does not exceed five percent of the total annual income of such officer or employee and any other payments made to him by the corporation do not exceed five percent of his total annual income.
6. That of a public officer or employee in being reimbursed for his actual and necessary expenses incurred in the performance of official duty.
7. That of a recipient of public services generally provided by the incorporated city or town, political subdivision or state department, commission, agency, body or board of which he is a public officer or employee, on the same terms and conditions as if he were not an officer or employee.
8. That of a public school board member when the relative involved is not a dependent, as defined in section 43-1001, or a spouse.
9. That of a public officer or employee, or that of a relative of a public officer or employee, unless the contract or decision involved would confer a direct economic benefit or detriment on the officer, the employee or his relative, of any of the following:
   1. Another political subdivision.
   2. A public agency of another political subdivision.
   3. A public agency except if it is the same governmental entity.
10. That of a member of a trade, business, occupation, profession or class of persons consisting of at least ten members which is no greater than the interest of the other members of that trade, business, occupation, profession or class of persons.
11. That of a relative who is an employee of any business entity or governmental entity that employs at least twenty-five employees within this state and who, in the capacity as an employee, does not assert control or decision-making authority over the entity's management or budget decisions.

The ownership of any publicly traded investments that are held in an account or fund, including a mutual fund, that is managed by one or more qualified investment professionals who are not employed or controlled by the officer or employee and that the officer or employee owns shares or interest together with other investors.

Survey records must be maintained for three years after the date of the survey.

There is no set number of areas required to be surveyed, but you must ensure that all radioactive material use areas within the lab are covered.

The information contained in a limited submission pre-proposal and the associated supplemental documents is considered highly confidential and all efforts will be made to ensure the fair, objective, and confidential review of each pre-proposal.  Review panel members are required to sign a conflict of interest statement prior to pre-proposal review and to adhere to strict guidelines to ensure confidentiality of the content of all limited submissions applications.

Answer this Hispanic Serving Institution (HSI) question 'Yes' if the proposal falls into one of the three categories described below.

HSI Grant requests for proposal (RFPs) generally fall into three categories:

HSI Required: These funding opportunities are exclusive to HSIs and require proof that the university is an HSI. A digital copy of proof from the U.S. Department of Education can be provided upon request. Direct inquiries to Riley McIsaac, rmcisaac@arizona.edu.

Minority Serving Institution (MSI) Required: These funding opportunities are not exclusive to HSIs, but instead require that a submitting institution have MSI status (HSIs are included under the umbrella of MSIs). Proof of HSI status may or may not be required. Minority or underrepresented students (e.g., first generation, Pell grant recipient/low income) and/or communities/populations are often expressed as the targeted populations of interest.

Intentionally Involves Minority Students and/or Communities/Populations: These funding opportunities are not exclusive to HSIs or MSIs, but they explicitly call for or encourage the engagement of minority or underrepresented students, and/or communities/populations. Engagement of these students/communities/populations should be coupled with asset-based recruitment strategies, culturally relevant learning experiences, inclusive mentoring practices, and much more.

For questions or to learn more, please contact Riley McIsaac, Associate Director of Grants Development in the Office of Hispanic Serving Institutions (HSI) Initiatives (rmcisaac@arizona.edu).
Visit HSI Initiatives at: https://hsi.arizona.edu/.

The University of Arizona was federally designated as a Hispanic Serving Institution in Spring 2018, having reached the 25% undergraduate Hispanic enrollment requirement. UArizona was the first four-year public university in the state of Arizona to become an HSI and one of 16 R1 HSIs across the nation.

Answer this question ‘Yes’ if human subjects are involved in the proposal. The University is required to safeguard human participants that are involved in research projects. For any project involving the use of human participants, a protocol must be submitted to the University’s Human Subject Protection Program (HSPP) and the Institutional Review Board (IRB) for review and approval. 

The HSPP and IRB ensure that Human Subjects rights and welfare are protected, the risk and potential benefits are weighed accurately, subject selection is fair and that the participants have an informed consent.  Approval is required before any work with Human Subjects is initiated.

Visit the Human Subject Protection Program section of the Research Support website for additional guidance.

Below, please find a list of the potential points of disclosure. 

COC Form – Outside Activity

If your seminars meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.

Below, please find a list of the potential points of disclosure. 

COC Form – Outside Activity

If any of your activities during your travel meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.

Below, please find a list of the potential points of disclosure.

COC Form – Outside Activity

If your visits or seminars to Japanese universities meet the definition of Outside Commitment, you should submit a COC form in eDisclosure to get prior approval to engage in the Outside Activity.

Outside Commitments: (1) are professional and other activities that are related to a University Employee’s professional expertise, outside of their University duties and responsibilities; (2) are for the benefit of an external entity or individual and are not covered by a fully executed written agreement between the University and the external entity; and (3) require a time commitment. Outside Commitments include Outside Employment, independent contracts for consulting services, private consulting groups comprised of University Employees, volunteer/pro bono work, appointments at postsecondary educational institutions, and foreign components, as that term may be updated by the University’s Office for Responsible Outside Interests.

You can also use this decision tree to determine if the activity is an Outside Commitment: Outside Commitment Decision Tree.

COI Disclosure – Foreign Interests

If you do end up receiving a payment of any amount, an in-kind contribution or Other Support, it must be disclosed as a Foreign Interest.

COI Disclosure – Foreign Travel

PHS and Dept of Energy Investigators only: Must disclose any reimbursed or sponsored travel related to your institutional responsibilities, regardless of the amount, unless received from a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

COI Disclosure – Foreign Affiliations

As part of your eDisclosure submissions, you must disclose whether you have a foreign affiliation.

Existing programs or centers with no break in funding (i.e. successful prior renewals or first competitive renewal) will have the opportunity to recompete to the sponsor without internal competition for two submission cycles. If, however, the existing program or center is unsuccessful in obtaining its renewal after two consecutive submissions, an internal limited submission competition will occur. If other pre-proposals are received for the limited submission competition, it is not guaranteed that the PI of the existing programs or centers will be granted the ticket. 

If you are an Investigator, you must disclose, via eDisclosure, affiliations with foreign governments, foreign institutions of higher education, any other foreign entity and foreign nationals when conducting activities such as consulting, laboratories or teaching (whether paid or unpaid, or voluntary). Gifts and/or any travel support of any amount you receive must also be disclosed.

Additionally, all University Employees whose FTE is 0.50 or greater, are required to submit a disclosure of Outside Commitments and/or Outside Employment (COC form) via eDisclosure for any activity that meets the definition of an Outside Commitment or Outside Employment.  The Outside Commitment Decision Tree  may be of assistance to you in making the determination as to whether this activity meets the definition of an Outside Commitment.

See Also

• Who is an Investigator

Contact RDS during normal business hours (M-F, 9a-5p) at 621-8585 or email ResDev@email.arizona.edu for assistance using Arizona Cultivate or for questions regarding any Limited Submission internal competition.

Please visit our Getting Started webpage. 

In some proposals on the Dashboard you will see a small red Compliance pill:  . There is no action required on these proposals. It's simply a visual indicator that the project involves Human Subjects or live Vertebrate Animal Subjects. If you click on the Compliance pill you will see what Type (Animal Subjects or Human Subjects) and Status (Exempt, Not Yet Applied, Pending) were included in the proposal. 

RDS makes every effort to have pre-proposals reviewed in a timely manner, usually within two weeks of the internal deadline. Our goal is to maximize the external proposal preparation time for selected researchers to submit to the sponsor for funding.

University Employees whose FTE is 0.50 or greater, are required to disclose any activity that meets the definition of an Outside Commitment or Outside Employment by submitting a disclosure of Outside Commitment or Employment (COC form) via eDisclosure. University approval is required prior to full-time University Employees (0.50 FTE or greater) entering into an Outside Commitment or Outside Employment (regardless of whether or not compensated for the activity).

• The Outside Commitment Decision Tree on our Disclosure Requirements webpage link may be of assistance to you in determining whether the activity meets the definition of an Outside Commitment. More information on Outside Activity can also be found on our website.

Additionally, as an Investigator, one of the requirements is disclosure of Outside Interests (Significant Financial, Significant Personal and Foreign Interests). You can find an overview of the Disclosure Requirements on our website including Disclosure Table resources which outlines the disclosure guidelines.

Consulting Agreements

Our website has information related to Consulting Agreements including a Consulting Agreement Addendum that the University developed as a resource that University employees can use as an addendum to any agreement that you sign or can be used as guidance on common issues that may arise in a consulting arrangement that may relate to your university employment. 

Preproposals are archived within Arizona Cultivate and are not distributed or made publicly available. 

Once you have received the “ticket” you should work with your department administrator and, if available, the RDS Associate designated to support the proposal development. All limited submissions submitted to an external funding agency or sponsor are handled through Sponsored Projects and Contracting Services.

Prior to IRB submission, all projects that will utilize Banner Health resources (i.e., facilities, patients, employees) must be entered into the University of Arizona Health Sciences (UAHS) Research Administration Portal (RAP). Upon submission to the IRB, please upload RAP approval to eIRB. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.

Yes.

As part of the system conversion, all current access and roles with the exception of Lead-Unit pre-approval will be migrated over to the updated system environment. There is no action required on your part.

The JoinCostShare node will always display in the Current Route Node(s) regardless of whether a budget is included with cost share units as it allows the cost share workflow functionality. 

Yes. As long as an original document was uploaded as an attachment prior to routing, the proposal initiator can replace the attachment with an updated/revised version by navigating to the Attachments section and clicking the Details button on the right side of the page next to the desired attachment. The initiator will then choose the new file to upload and click Save. 

Depending on your destination(s), authorization from the U.S. Treasury’s Office of Foreign Assets Control (OFAC) may be required. Travel to an embargoed/sanctioned country (e.g.,  Cuba, Iran) may require prior authorization in the form of a license. If travel to an embargoed country is for personal reasons, no University equipment may be taken, and no University business should be conducted without prior authorization. Most activities involving Iran (even remotely) will require a license.

Yes. The content included/shown on the Medusa page is the same in the updated UAccess Research System. It just has a different look and feel.

You will still have the options of displaying Proposal > Award where the Proposal is the top item and all awards, negotiations, and subawards associated with the proposal fall under it, or Award > Proposal where the Award is the top and all proposals, negotiations, and subawards associated with the award fall under it. You can expand each item by clicking on it, and have the option to open each item directly from the Medusa page (as long as you are provisioned to view that item). 

RDS publishes the name of the PI selected for each Limited Submission opportunity on the Limited Submission Table on the Research Gateway. RDS seeks to coordinate Limited Submissions for the university to facilitate the best proposal submission from an institutional perspective and encourages communication between all interested applicants to a limited submission opportunity. That said, the choice to collaborate is at the discretion of the PI/Team that receives the ticket to proceed.

No. Deadlines for Limited Submission internal competitions are treated the same as funding deadlines for Federal agency sponsors, Foundations or other external funding sources. These opportunities are advertised widely and well in advance of the application deadlines. To maintain fairness for all, the deadline is firm and consistent for all applicants without exception.

Answer this question ‘Yes’ if live vertebrate animals are involved in the proposal. A protocol must be submitted for approval to the Institutional Animal Care and Use Committee (IACUC) before an award is made, but not at the time of proposal.

IACUC oversees the university’s animal care and use programs. This unit ensures the humane and ethical treatment of the animals used in research, testing and education.  IACUC reviews all requests to use vertebrate animals to ensure compliance with federal regulations. 

Principal Investigators who plan to use animal subjects as a part of their research should contact a member of the IACUC early in the project design stage to determine appropriate species as models for research and appropriate procedures to be used in the course of research (from UHAP). Visit the Institutional Animal Care and Use Committee (IACUC) program pages of the Research Support website for additional guidance.

Enter the primary location where project activity will take place in the format Bldg-Rm-etc. Example: USB-510-A

The on- or off-campus designation of a project is determined by the location of the research and the wages incurred by the project.  Separate On and Off Campus rates will not be used for a single project.  The Off Campus Rate should be used for projects that are not conducted at university owned or leased facilities.  Off Campus projects must include more than 50% of the wages incurred at a non-UArizona owned or leased facility.  If lease costs are charged directly to the project budget, the project will be classified as Off-Campus.

Specific questions may be answered by Sponsored Projects Services (sponsor@arizona.edu(link sends e-mail)) in conjunction with Financial Services Rate Studies (ratestudies@fso.arizona.edu).

Radiation (Radioactive Material, Sealed Source, Radiation Generating Machine)?

Answer this question “Yes” if this proposal involves the use of Radiation.

Your work will need to be approved by the UA Radiation Safety Committee (RSC) before you can start work.  You can access the documents needed to submit to the committee at https://research.arizona.edu/radiation-safety-forms, “Application for (Radioactive Material/Radiation Machine/Sealed Sources) Approval.”

Training is required before any person can handle Radioactive Material, Radioactive Sealed Sources or Radiation Generating Machines.  Radiation Safety Training can be found on https://edgelearning.arizona.edu/. If you have any questions please reach out to rlss-rad-support@email.arizona.edu.

Non-Ionizing Radiation (Laser)?

Also answer this question “Yes” if this proposal involves the use of any laser or laser product.

Your work will need to be reviewed and approved by the UA Laser Safety Officer (LSO) and Laser Safety Committee (LSC).  You can access the documents needed to submit to the committee at https://research.arizona.edu/compliance/RLSS/radiation-safety/laser-safety-program/laser-approval.

Training is required before any person can operate a laser. Laser training (Laser Radiation Protection Course (LRPC)) can be found on https://edgelearning.arizona.edu/. If you have any questions please reach out to rlss-rad-support@email.arizona.edu.

Answer this question ‘Yes’ if the proposal involves any of the terms below or involves any biohazardous and/or recombinant materials. For assistance, contact Research Laboratory & Safety Services at (520) 626-6850 or rlss-bio-support@email.arizona.edu(link sends e-mail) or visit the Recombinant and Biohazardous Materials web page.

If the project you are proposing involves the handling or storage of Risk Group 3 biohazardous and/or recombinant materials that would require the use of a BSL-3 laboratory, please contact Research Laboratory & Safety Services at rlss-help@arizona.edu. BSL-3 work must be approved in advance by the Institutional Biosafety Committee (IBC). You can access the documents needed to submit to the committee at  Institutional Biosafety Committee | UArizona Research, Innovation & Impact. Access and training for the BSL-3 spaces is a lengthy process, so reaching out to RLSS early in the process is optimal.

• Adenovirus
• Adenoassociated Virus
• AAV
• Cloning
• Gene therapy
• Genomic library
• Microarray
• Plasmid
• Probes
• Recombinant
• Retrovirus
• Restriction fragment polymorphism (RFLP)
• Sequencing
• Southern / Northern hybridization
• Transformed cells
• Vector
• Bordetella pertussis
• Campylobacter
• Cell Culture
• Coccidiodes
• Chlamydia
• Clostridium
• Coxiella
• Cryptosporidium
• Cyclospora
• Giardia
• herpes
• HIV
• Influenza
• Monkeypox
• Mycobacterium
• Yesinia pestis (plague)
• Salmonella
• Toxin
• Vaccinia
• SARS-CoV-2
• Risk Group 2
• Risk Group 3
• Virus
• Bacteria
• Fungus
• Parasite
• Rickettsia

This data point will help campus units more accurately calculate proposal success or win rates. Units want to know what percentage of proposals that are reviewed and competitively scored against others for an open funding opportunity are ultimately funded.

Examples:

Answer 'Yes' if the proposed project...

• is an incoming subaward which is part of a proposal submission going in for review with the prime proposal at another institution
• will be reviewed and might or may not be awarded based on merit or a competition

Answer 'No' if the proposed project...

• if UArizona knows in advance that funding will be awarded, a funding decision has already been made and UArizona employs a certain person with unique expertise to accomplish project goals
• is a subaward from another institution that already received a prime award and UArizona is being asked to complete part of the work afterward
• will definitely be funded because UArizona has particular professional expertise
• is an administrative supplement that requires an application but funding is pre-approved

If you have any questions please contact sponsor@arizona.edu(link sends e-mail).

If proposal activity will take place at Banner University Medical Center (BUMC) facilities, answer 'Yes' to the appropriate location. These fields are not required so no response is the same as a 'No' answer.

• Banner - University Medical Center Tucson
• Banner - University Medical Center South
• Banner - University Medical Center Phoenix

 All Investigators on each subaward will be required to complete the training and disclosure requirements. An Investigator means any person who shares the responsibility of Conducting Research. Conducting Research includes the design, development, testing, evaluation, conduct, reporting, review, and oversight of a program of scientific inquiry.  Each Investigator will need to submit an individual disclosure.

In case helpful, below is a brief overview specific to subrecipients but more Information for Non-UA Subcontractors, Consultants, and Collaborators can  be found on our website.

Subrecipients will be presented with two options. They will need to either (1) have an implemented and enforced federally-compliant conflict of interest policy and process and agree to be responsible for compliance under their policy and pursuant to the subcontract or consulting agreement including reporting requirements (our office reviews each subrecipient’s policy to determine it is compliant) or (2) comply with UArizona’s Conflicts of Interest & Commitment Policy (more details on the fees that apply can be accessed from link above).  Our office will be in direct contact with the subrecipients to share a complete overview of all the related requirements. Our office will also provide any assistance and guidance the subrecipient may need.

Export control laws and regulations affect various University activities including, but not limited to conducting research (sponsored and unsponsored), international travel, publishing research, procurement, hiring non-U.S. persons, sponsoring foreign persons (e.g., visiting scholars), collaborations with non-U.S. individuals or entities, international shipments, non-disclosure agreements, and certain services to embargoed or sanctioned countries.

The UA provides both distributed and centralized assistance for proposal administration and development. When planning to develop and submit a proposal, please contact your departmental/unit business office for budget, routing, and submission. To enhance the competitiveness of your proposal, consider contacting RDS. RDS staff provide a range of (free) services from consultation regarding fit with solicitation to proposal management, including document review, technical editing, and more. RDS staff work hand-in-hand with you and your departmental/unit business office to ensure the complete and on-time submission of your proposal.

More information on college and departmental, as well as campus-wide assistance is described in the Institutional Capacity section of the Research Gateway.

Export controls are federal laws that govern the transmission of controlled items and associated technical data to foreign nationals. There are also federal regulations regarding providing services, traveling to, or working with individuals or entities from sanctioned or embargoed countries. These federal regulations not only affect items that are utilized by UA personnel, but can also affect whom the UA engages with on campus as well as around the world.

There are three primary agencies which govern export control laws and regulations: the U.S. Department of State Directorate of Defense Trade Controls; the U.S. Department of Commerce Bureau of Industry and Security; and the U.S. Department of Treasury Office of Foreign Assets Control.

Foreign affiliations are defined as associations/relationships (e.g. conducting activity such as consulting engagements, research collaborations, appointments or titles, or teaching) with foreign institutions of higher education, foreign governments, foreign companies or foreign nationals.

At the time of proposal submission to a federal funding agency, Investigators must have an up-to-date COI certification.  That means each Investigator has:

1.    Submitted either an Annual Disclosure Certification or a Research Certification in the last 364 days, and
2.    Does not have any changes to an existing Outside Interest or new Outside Interest.
 

Investigators must:

1.    Complete the Required COI Disclosure Training after July 1, 2021.
2.    Complete the Required COI Disclosure Training once every 4 years thereafter.
Note:  OROI may direct an Investigator to complete the training more frequently.
3.    Submit an annual certification.  This can be an Annual Disclosure Certification or Research Certification.
4.    Update their certification within 30 days of a change to an existing Outside Interest.
5.    Update their certification within 30 days of acquiring a new Outside Interest.
6.    Submit a Research Certification for all non-sponsored and sponsored Research.
 

Research is not subject to export controls if it qualifies for at least one of three exclusions:

(1) Fundamental research exclusion;

(2) Public domain exclusion; and

(3) Education Information Exclusion.

Penalties for export control violations are substantial, including significant fines, debarment from participation in federal contracting, loss of export privileges, and in some cases imprisonment.

In addition to these severe penalties, the potential reputational damage to an institution from violation of these laws could be difficult to repair, possibly resulting in lost opportunities for attracting world-class researchers and/or decreased access to research funding.

UArizona will receive security updates and new system features for UAR on a continuous basis.  The standard UAR system maintenance windows are:

• Daily from 7:00 PM - 8:00 PM MST
• Sundays from 6:00 AM - 10:00 AM MST

If you choose to work in UAR during the maintenance periods, please save your work often.  While the system updates, you may have an interruption in service and unsaved work will be lost.

All surveys (both monthly and after-use) must include:

• Date survey was performed
• Initials of the surveyor
• A background count or count rate
• Location(s) surveyed
• Results for each location
• Follow-up survey results, if necessary

If the U.S. Government funds research and specific controls are agreed on to protect information resulting from the research, then information resulting from the project will not be considered fundamental research. Such controls are usually contained in contractual clauses. Examples of "specific controls" include requirements for prepublication “approval” by the Government; restrictions on dissemination of information to non-U.S. citizens or other categories of persons; or restrictions on participation of non-U.S. citizens or other categories of persons in the research.

• Perform a survey immediately .
• Inform the Approval Holder or Approval Safety Coordinator that a survey was missed.

A study can be deemed IND Exempt if all of the following criteria are met:

• If the study is not designed to support approval of a new indication or a change in label;
• If the study is not intended to support a significant change in the advertising for the product;
• If the study does not involve a route of administration, dosage level or patient population that significantly increases the risks (or decreases the acceptability of risk) associated with the use of the drug;
• The study is conducted in compliance with the IRB and Informed Consent regulations; and
• The study is conducted in compliance with regulations regarding promotion for investigational drugs.

The area must be immediately decontaminated and a documented follow-up survey must be performed to show  that contamination does not exceed the action level.

Title case is used to provide consistency in the system and in reporting. Please do not use ALL CAPITALS or all lowercase in proposal/project titles. 

In title case, major words are capitalized and most minor words are lowercase. If your title uses alternate capitalization where a letter other than the first letter of a word is used in the acronym and requires special emphasis, please capitalize as you feel is best indicated for your acronym. 

Major words include nouns, verbs, adjectives, adverbs, pronouns, and all words of four letters or more.

Minor words include short (i.e., three letters or fewer) conjunctions, short prepositions, and all articles. 

In title case, capitalize the following words in a title or heading:

• the first word of the title or heading, even if it is a minor word such as “The” or “A”
• the first word of a subtitle
• the first word after a colon, em dash, or end punctuation in a heading
• major words, including the second part of hyphenated major words (e.g., “Self-Report,” not “Self-report”)
• words of four letters or more (e.g., “With,” “Between,” “From”)

Use lowercase for minor words that are three letters or fewer in a title or heading (except the first word in a title or subtitle or the first word after a colon, em dash, or end punctuation in a heading):

• short conjunctions (e.g., “and,” “as,” “but,” “for,” “if,” “nor,” “or,” “so,” “yet”)
• articles (“a,” “an,” “the”)
• short prepositions (e.g., “as,” “at,” “by,” “for,” “in,” “of,” “off,” “on,” “per,” “to,” “up,” “via”)

Once a project is determined to be CUI it is managed under a security plan. The University of Arizona Export Control office worked closely with the IT-CUI team to develop “The Plan,” a joint Technology Control Plan and System Security Plan. This plan outlines the security measures researchers and staff must follow in order to protect the CUI data.

This action is an indication that the direction of the research or some other factor has changed the project in some way to render the export control regulations applicable to this project and that, more than likely, the researcher’s work will now be export controlled.  Contact Export Control before continuing work on the project to re-evaluate for export control protocols.

If both the 7000 and 7012 clauses are in an agreement we can go back to the prime contracting officer and ask if the University of Arizona’s portion on the work is fundamental in nature. If we receive confirmation in writing from the prime contracting officer that the university’s work in fundamental it nullifies the CUI clauses.

The federal government is identifying emerging technologies essential to US national security and placing new or additional export controls on these technologies. Starting in 2019, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published export controls on several emerging technologies. Please review this summary of emerging technologies and let the Export Control team (export@arizona.edu) know if you have any research or projects in these areas so we can work with you to ensure compliance.

A deemed export is the release or transmission in any form of export-controlled technology or software code within the U.S to anyone who is not a U.S. Person.

Restricted Party Screening (RPS) is the process of reviewing foreign and U.S. individuals and entities to prevent illegal transactions with parties on the various federal government lists of restricted individuals, companies, and organizations. or additional information see /compliance/export-control-program/procedures-for-restricted-party-screenings.

Financial Conflict of Interest (FCOI) means an Outside Interest is Related to, or can be perceived to be Related to, an individual’s institutional responsibilities.

FCOI determinations answer the question: Could it reasonably appear to someone outside of UA (e.g., front page of the newspaper) that a decision made in the conduct of research was influenced by your Outside Interest?  That influence could affect the design of the project, a decision to exclude data, a decision to delay publication of research results, a decision to overemphasize or underemphasize research results, etc. for the benefit of your Outside Interest.

Related to is a defined term that refers to the condition in which it may reasonably appear that decisions made by the Investigator in the performance of his/her institutional responsibilities could directly and significantly affect the value of his/her Significant Financial Interests or be in conflict with Significant Personal Interests or Foreign Interests.

Relatedness includes situations in which an Investigator’s Outside Interests would reasonably appear to affect, or to be affected by, the individual’s Research or other institutional responsibilities.

Relatedness is not a judgment on whether an Investigator would deliberately make choices in the Conduct of Research or the performance of their Institutional Responsibilities based on considerations related to their Outside Interest. Rather, “Relatedness” refers to the condition in which it may reasonably appear that choices made in the Conduct of Research or other performance of the individual’s institutional responsibilities could be directly and significantly influenced by the existence of an Outside Interest. 

The FDA defines a medical device as:

• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Non-significant risk (NSR) devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters. An NSR device study requires only IRB approval prior to initiation of a clinical study.

The IRB is tasked with granting NSR determinations, when appropriate.

Sanctioned Countries are designated by the U.S. Government as having limited or comprehensive trade sanctions and embargoes imposed for reasons of anti-terrorism, non-proliferation, narcotics trafficking, or other reasons. Sanctions are prohibitions on transactions (e.g., financial exchanges, providing or receiving services of value) with designated countries, entities, or individuals.

A significant risk (SR) device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.

When a study is investigating a SR device, an IDE from the FDA is required. IRB review will not occur until the study has been granted an IDE from the FDA.

The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.

Limited Submissions are funding opportunities where the funder has limited the number of applications from an organization. Research Development Services (RDS) facilitates Limited Submissions for federal and foundation opportunities for UA and ensures only eligible institutional proposals are submitted to the funder.

A “ticket” is the terminology RDS and Sponsored Projects & Contracting Services use to designate an approved institutional submission for a limited submission opportunity. The “ticket” will be sent to the approved PI/Team via email from Resdev@email.arizona.edu. 

An Approval Holder (AH) is someone who is ultimately responsible for a laboratory or set of laboratories (administratively and operationally) that use or store hazardous chemicals. Usually, the AH is a Principal Investigator. The AH works with their Approval Safety Coordinator (ASC) and the RLSS to maintain compliance with the Laboratory Chemical Safety Program within his/her laboratories.

An ASC is a laboratory worker that is designated by the Approval Holder (AH) to undergo advanced chemical safety training, help with the responsibilities of the AH and to facilitate compliance with the Laboratory Chemical Safety Program. The ASC also has delegated authority from the AH to be a main point of contact for the RLSS.

The Assistance Listing Number (ALN), formerly known as the Catalog of Federal Domestic Assistance (CFDA) Number, is a five-digit number assigned in the award document for all federal assistance award mechanisms, including federal grants and cooperative agreements. It is used for governmental reporting and auditing.

The first two digits of the Assistance Listing Number reflect the federal grantor agency followed by a decimal point. The final three digits following the decimal) indicate the federal program funding the project within the agency. The partial list below represents some common funding agencies for UArizona. Assistance listing format examples: ##.###, 93.866

    10: U.S Department of Agriculture (USDA)
    12: U.S. Department of Defense (DOD)
    15: U.S. Department of the Interior (DOI)
    43: National Aeronautics & Space Administration (NASA)
    45: National Endowment for the Arts & Humanities (NEA, NEH)
    47: National Science Foundation (NSF)
    64: Department of Veterans Affairs (VA)
    81: U.S. Department of Energy (DOE)
    84: U.S. Department of Education
    93: U.S. Department of Health & Human Services (DHHS)

The US Federal Government renamed the "Catalog of Federal Domestic Assistance" (CFDA) to "Assistance Listing Number" (ALN). Agency websites and awards may transition to the new labeling. In June, 2023 this label change appeared in the UAccess Research (UAR) system, most notably in Proposal Development, Institutional Proposal, and Award. UAccess Financials continues to use the "CFDA" label. No matter which label is used, it is the same identifier!

An export is the transfer of export-controlled data, items, equipment, materials, and software or providing a defense service to a non-U.S. Person or entity. An export can occur in a number of ways, such as; a physical shipment, hand-carrying an item out of the U.S., email transmission of data, presentations, discussions, or visually accessing export-controlled data.

An investigational device exemption (IDE) is an approval that allows a medical device to be used in a clinical research study that involves human subjects or human specimens. The term “exemption” as it pertains to IDEs, means that the device is exempt from the laws that prohibit unapproved products to move in interstate commerce.

An approved IDE means that the IRB (and FDA for SR devices) has approved the sponsor’s study application and all regulatory requirements are met.

IDEs cover studies that:

• Support marking applications;
• Collect safety and/or efficacy information about a device;
• Evaluate device modifications;
• Collect device specific data about an unapproved device (even if there is no plan to submit a marketing application); or
• Support a new use of a marketed device.

An investigational drug is defined as:

• An article that is not approved (for marketing) in the US as a drug.
• An approved drug that is not used according to the approved label (or a new combination of approved drugs).

NIH describes Budgetary Overlap as: "Budgetary Overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided by another source."

Executive Order 13556 “Controlled Unclassified Information,” (the Order), issued on November 4, 2010, established the CUI program, which standardizes and simplifies the way the Executive branch handles unclassified information that requires safeguarding or dissemination controls, pursuant to and consistent with applicable law, regulations, and government-wide policies. The National Archives and Records Administration (NARA) serves as the Executive Agent to implement this order and oversee agency actions to ensure compliance.

Drug labeling refers to all the printed material that accompanies a drug, including the label, the wrapping, and the package insert.

Laboratory-Specific Chemical Safety Training is required by the UA Laboratory Chemical Safety Program for all hazardous chemical laboratory workers, in addition to the online General Laboratory Chemical Safety Training. This training must be provided by the Approval Holder or Approval Safety Coordinator of a laboratory to every hazardous chemical worker under their Approval. The laboratory-specific training must cover, at a minimum, the storage and use of hazardous chemicals, required control measures when using hazardous chemicals, the location of safety equipment in the laboratory, and any other laboratory-specific plans, procedures or related hazardous chemical guidelines.

A template for this training can be found on the RLSS website. By affirming to reading and understanding the Laboratory Chemical Hygiene Plan, a laboratory worker also affirms to having been provided adequate Laboratory-Specific Chemical Safety Training. This fulfills the documentation requirements of the OSHA Hazard Communication Standard. The AH/ASC should maintain documentation of the information covered during the Laboratory-Specific Chemical Safety Training.

• Is published or disseminated in the Public Domain
• Arises during, or results from, fundamental research
• Is educational information released by instruction in catalog courses or associated teaching laboratories of academic institutions.

“Off-label use” is any difference in use, including indication, dose, route of administration, patient populations, and drug formulation from what is approved on the FDA label.

“On-label use” means the drug is being used in the same indication, dose, route of administration, patient populations, and drug formulation. There is no deviation from the approved FDA label. Studies involving the on-label use drug do not require an IND, as long as data will not be used in a marketing application.

NIH describes Scientific Overlap as: "Scientific Overlap occurs when substantially similar research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration; or a specific research objective and the experimental design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of funding source."

“Significant Use of University Resources” includes but is not limited to: use of research funding; use of funding allocated for asynchronous or distance learning programs; use of telecommunication and data services beyond ordinary use; use of university computing resources; use of instructional design or media production services; access to and use of research equipment and facilities or production facilities; use of University Assets* such as paid employee time, proprietary information, intellectual property (such as patents, trademarks, and copyrights), logos, land and buildings.

The use of library resources, personal workstations, or personal computers are not typically construed as Significant Use of Board or University Resources.

*University Assets is fully defined in the University's Misuse of Assets Policy.

This clause requires the university to implement security measures as outlined in the NIST 800-171. In the event of a cybersecurity incident, the university’s responsibility under DFARS  252.204-7012 is to report the incident to the DoD within 72 hours. The university should preserve and protect images of all known affected information systems identified in this clause and all relevant monitoring/packet capture data for at least 90 days from the submission of the cyber incident report.

Disclosure of Information restricts the release of information unless the information is already in the public domain, the Prime Contracting Officer has given prior written approval, or the results during the performance of the project involved no covered defense information and has been determined by the Prime Contracting Officer to be fundamental research.

The after-use survey is performed to ensure your radioactive material (RAM) workspace is free of radioactive contamination after each use radioactive material. The monthly survey is performed to ensure all the rooms on your approval are free of radioactive contamination.

Internal funding programs are funded by UA administrations, colleges, or departments while external, sometimes called extramural, funding comes from a federal, state, or local agency, Foundation, or another non-UA source.

An “Upcoming” limited submission is currently accepting pre-proposals through a campus-wide competition with an established internal deadline. An “Open” limited submission means that the internal deadline has passed without any pre-proposals submitted for review: thus, the first expression of interest that RDS receives will be accepted as the institutional submission. A “Completed” limited submission means that the external deadline has passed, and no further proposals are accepted by the funder. “Completed” limited submissions on the Limited Submission Table record the names of the UA institutional selections that received the ticket to submit to the opportunity.

The educational information exclusion covers commonly taught in courses listed in catalogues and associated teaching laboratories of academic institutions in the United States.

Export Control works closely with various Liaisons across campus. Export Control established a liaison toolkit (checklists, forms, and procedures to determine if export control concerns exist). Examples of “red flags” include publication restrictions, foreign person restrictions, and projects related to military and space. Liaisons enable the University to be proactive in identifying/resolving issues. If you are interested in becoming a liaison contact Export Control.

The Fundamental research exclusion is a broad-based general legal exclusion to protect technical information (but not tangible items) involved in research from being controlled by export controls. In other words, research qualifying as “fundamental research” is not subject to export controls.

• The EAR definition of Fundamental Research means research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons.
• The ITAR defines Fundamental Research as basic and applied research in science and engineering conducted at accredited U.S. institutions of higher education where the resulting information is ordinarily published and shared broadly within the scientific community. Such research can be distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary reasons or specific national security reasons.
• University research will not qualify as fundamental research if the university or researcher accepts any restrictions on the publication of the information resulting from the research, other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information provided to the researcher by sponsor or to ensure that publication will not compromise patent rights of the sponsor.

NIST 800-171 Rev. 2:  The National Institute of Standards and Technology Special Publication 800-171 provides agencies with recommended security requirements for protecting the confidentiality of Controlled Unclassified Information (CUI) when resident in Non-Federal Information Systems and Organizations. There are over one hundred security requirements in the NIST; this document is summary in nature and not an exhaustive list. See the NIST for complete details.

Primary Investigators (PIs) are responsible for:

1. Assisting Export Control in the identification of activities that may intersect with export control regulations;
2. Maintaining a current export control training certification;
3. Confirming with Export Control all project personnel have completed training and are cleared to access export-controlled items;
4. Notifying Export Control of potential violations.

Sponsored proposals are submitted for review and approval through the UA’s electronic research administration system, UAccess Research. Work with your departmental/unit business office for routing and submission of the proposal to Sponsored Projects & Contracting Services (SP&CS). SP&CS will submit the proposal on behalf of the institution. For more information visit the Proposal Submission section of the Research Gateway.

The public domain exclusion applies to information that is published and that is generally accessible or available to the public through:

• sales at newsstands and bookstores;
• subscriptions which are available without restriction to any individual who desires to obtain or purchase the published information;
• libraries open to the public or from which the public can obtain documents;
• patents available at any patent office;
• unlimited distribution at a conference, meeting, seminar, trade show or exhibition, generally accessible to the public, in the United States;
• public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant U.S. government department or agency.

Monthly surveys are required to ensure your approved radioactive material use/storage areas are free of radioactive contamination.

Research Development Grants are not designed as part of faculty retention or other reward but rather as a pathway to success for interdisciplinary research to accelerate competitiveness for extramural proposal submissions.

The RLSS User Dashboard is the major communication hub between the laboratory and the RLSS. It maintains pertinent records related to safety and compliance for the Approval Holder’s laboratory. These records include training requirements and completion records, laboratory hazardous chemical inventories, relevant plans (i.e. the University Chemical Hygiene Plan and the Approval Holder’s Laboratory Chemical Hygiene Plan), and worker affirmations to these plans. All laboratory workers under a Hazardous Chemical Approval have access to their training and affirmation records, can read and affirm to updated chemical hygiene plans, and access/edit that Approval’s hazardous chemical inventory and safety data sheet management system.

RDS offers several programs on an annual or biannual basis.

• NSF CAREER Grant Preparation Program
• NIH R Series Grant Preparation Program
• Arts and Humanities Fellowship Preparation Program

Visit the Seminars and Workshops section to learn more about these programs and other training opportunities.

Every room listed on your RAM approval must be surveyed. Monthly surveys may be limited to RAM storage areas during calendar months in which RAM is only in storage and not in use.

• All areas where radioactive material is used or stored
• Commonly touched items, such as light switches, RAM storage area exterior surfaces, telephones, tools, equipment controls, door handles, or computer keyboards/mice
• Commonly travelled floor areas such as entrances or exits and the floor near RAM use areas, waste storage locations and frequently used equipment

The method depends on what radionuclide(s) your approval is approved to possess and use:

• Approvals approved for low energy beta emitters (such as C-14, S-35 and H-3 ) must use a liquid scintillation counter.
• Approvals approved for high energy beta emitters (such as P-32) can use a pancake probe Geiger counter.
• Approvals approved for low energy gammas emitters (such as I-125 or Cr-51) can use a low energy gamma scintillation probe.
• Wipes surveys with a liquid scintillation counter can substitute for portable instrument surveys.

Hazardous chemical workers must complete the online General Laboratory Chemical Safety Training provided through the RLSS online training website and receive laboratory specific training from their Approval Safety Coordinator or their Approval Holder. Additional training may be required, such as respirator or fire extinguisher training. Chemical Safety Training Information.

• Publication, access, and dissemination restrictions in the sponsored research agreement
• Foreign party restrictions stated in the sponsored agreement
• International travel to countries subject to U.S. embargoes and sanctions
• Sponsor is providing export-controlled technology, technical data, or equipment
• Non-U.S. students or visiting scholars participating in a restricted project
• Project is sponsored by the federal government or defense contractor
• Project is military, space-related, or has other implications to national security
• Project will be conducted abroad or with a foreign sponsor or collaborator
• Sponsor /entity/research/collaborator is in Cuba, Iran, North Korea, Sudan, or Syria
• Any shipment of goods, services, information, or technology abroad

If export controls are applicable, the project could require a TCP (Technology Control Plan) and/or an export license prior to commencement of activity. If you need an export control review please contact us. For sponsored projects, please complete the EC checklist.

We are working with Kuali to determine what we can do to improve these notifications to be clearer/more in line with a "Return for Edit". In the meantime, you can create a rule in Microsoft Outlook which marks the message as high importance and flags the message for follow-up that same day. 

1. Create Rule - In Outlook, Rules is in the top toolbar under the Move Section. 

2. Mark initial parameters and then select Advanced Options…

3. Select any additional parameters or refine existing

4. Select actions Mark it as importance and Flag message for follow up at this time. Then if you click on the hyperlinked text follow up at this time you can select Follow up Today and importance you can select high importance.

5. Provide exceptions to refine or ensure you’re not applying the action to replied/forwarded items (when others are asking question) or copied items (where you’re not the main recipient).
   Perhaps “except if the subject contains certain words” and include RE: and FW: as a filter criteria? Would help filter anything that was forwarded to them from others with a question.

6. Name the rule and then check “Run this rule now” to run the actions against anything meeting those criteria currently in their box.

Monthly surveys are not required when there is no radioactive material in your inventory (including in storage and in waste) for the entire calendar month.

Or

The approval has been given a special condition from the Radiation Safety Committee(s).

Both the Proposal number and Document number were available and acceptable under UAR 5.2.1, however the Proposal number was more difficult to locate so the Document number became the preferred way to reference a proposal. In the updated UAR SaaS environment the Proposal number is more prominent and easier to locate, but SPS will still accept both numbers when referencing your proposal. 

Monthly surveys must be performed every calendar month in which radioactive material is possessed.

There are a few potential explanations: 

1. You are searching for items you are not provisioned for. The Search Records feature only displays search results you have access to. You have access to items where you were the document initiator, you were included as personnel on the document, you were provided a specific viewer, editor, or aggregator role on the document, you are provisioned to view or approve documents for any of the included units, or you were added as an Ad Hoc with an Acknowledge, FYI, or Approve action. If you would like to see all search results, you will need to use the specific search functions for Awards, Negotiations, Institutional Proposals, Proposal Development, and Subawards in the Common Tasks section. 
2. Your search parameters are too narrow. You may need to broaden your search terms to capture additional items. The more search terms you combine (Lead Unit, PI, Title, Deadline Date, etc.), the narrower your results will be. By searching for broader categories, you will obtain more results. 
3. You are using an incorrect parameter for a given search term. You may need to look in the All Links section for the specific term to find out what possible parameters are and the specific spelling, spacing, and punctuation. 

An IND is not needed for studies involving marketed drugs such as:

• Some studies using commercially marketed drugs
• Some studies using in vitro diagnostic biological products (e.g., blood grouping serum, reagent red blood cells, anti-human globulin)
• Studies using drugs in vitro or in laboratory research animals

When you enter into any commitment or obligation, even if it is not in writing, to Conduct Research for or on behalf of an individual or entity outside of UArizona (e.g., delivery of research results or data to the outside individual or entity) it constitutes an Outside Commitment and must be declared as such in advance of the activity, unless there is an existing signed agreement or contract between the outside individual or entity and the University of Arizona, on file with either RII Sponsored Project Services, RII Contracting Services or UAHS Research Administration, and which covers this specific commitment or obligation.

Non-sponsored research must be disclosed for conflict of interest review but is not an Outside Commitment that requires conflict of commitment approval unless you are Conducting the Research for or on behalf of an outside individual or entity.
 

Stock and equity valuation should be updated as follows:

Public Entity: Update at least annually, based on Annual Report or other public valuation

Non-Public Entity:

• If original value is $4,999 or less, update within 30 days of value reaching $5,000 or more

• If original value is $5,000 or more, update at least annually

See Also

• How do I disclose stock or equity?
• How do I value stock and equity?

RDS publishes the name of the PI selected for each Limited Submission opportunity on the Limited Submission Table on the Research Gateway.

Visit the Limited Submissions page on the UA Research Gateway to download guidelines and for a complete and searchable table of all upcoming, open, and completed Limited Submissions.

The RDS Limited Submissions Table page on the UA Research Gateway or Arizona Cultivate are regularly updated with all current funding opportunities, deadlines and updates.

There are no specific requirements for where survey records must be maintained.  Survey records must be readily available for inspection by Research Laboratory & Safety Services or outside regulatory agencies.

The applicant must first appoint a proxy from their account. The applicant will need to login to establish the account, and then indicate that a proxy will submit. Visit UA Arizona Cultivate for more details. 

The RLSS is always available for assistance or guidance regarding laboratory chemical use by emailing rlss-chem-support@email.arizona.edu or calling 520-626-6850.

Additionally, other University departments are available for specific questions:

• Facilities Management: for facilities-related issues (e.g. fume hoods, fire extinguishers etc.) call 520-621-3000
• Risk Management Services: for waste disposal, air quality concerns, or respirator fit testing call 520-621-1790

For questions that require immediate attention, please email the general inbox at VPR-IRB@arizona.edu. This inbox is continuously monitored, and your questions will be directed to the appropriate individual. 

Any radiation worker listed on your approval may perform and document a monthly survey.

An Investigator is any person who shares the responsibility of Conducting Research.  

This includes, but is not limited to, the Principal Investigator (PI), Co-PI, Co-Investigator, Project Director (PD), Co-PD, Senior/Key Personnel, and any other person, regardless of title or position, who is responsible for Conducting Research performed by or under the auspices of the University.

This does not, however, include individuals whose performance is purely ancillary.  For example, office staff who provide ancillary support or hospital staff who provide intermittent care and do not make contributions to the research data are not Investigators.

Principal Investigators are responsible for identifying the Investigators who are participating in their research and the Office for Responsible Outside Interests will help Principal Investigators identify such individuals.  Principal Investigators should consider the following:

• The significance of the tasks assigned to the individual with regard to Conducting Research (i.e., making a significant contribution to the research results by participating in the design, development, testing, evaluation, conduct, reporting, review or oversight of the research, or in all of these activities);
• The degree of independence the individual may have in performing their assigned tasks;
• Whether the individual will be directly involved in the research intervention or consenting or evaluation of human research subjects; 
• Will the student/trainee be responsible for Conducting Research without direct oversight from an Investigator; and
• Whether the individual will be a collaborator or given authorship credit on a publication related to the Research or present Research findings at a meeting or conference.

For assistance in making this determination, you can review the following resources: Identifying Investigators & COI Disclosers and Who is an Investigator?, or contact OROI.

Principal Investigator (PI) eligibility is described in the Getting Started section of the Research Gateway.

Many large and/or complex proposals require significant preparation time for development and coordination. To provide the submitting PI or team the maximum amount of time to focus on the external application, internal Limited Submission contests are run well in advance of the external deadline.

While every effort is made to adhere to our preferred Limited Submissions timeline, there are instances when the interval between becoming aware of a limited submission and the sponsor’s deadline makes it impractical to follow our process. In those cases, broad announcements may not be made, expedited reviews with limited or no feedback comments may be performed, and/or submission slots may be awarded on a first-identified basis. Generally, if there are less than six weeks between the identification of the opportunity and the sponsor’s deadline, a competition will not be run, and the competition will be listed as Open or submission permission will be awarded on a first-identified basis.

The pre-proposal requirements are designed to give a sufficient representation of a prospective project or proposal without over-burdening faculty/applicants. Think of the pre-proposal as an “elevator pitch.” 

As a public University and recipient of federal research funding, UArizona is required to comply with federal regulations, state law and ABOR policies.  Additionally, UArizona has a fiduciary responsibility to ensure inappropriate external influences do not affect the performance of one’s primary duties to UArizona.

The information collected in eDisclosure allows UArizona to ensure development and implementation of management strategies in order to facilitate our faculty’s continued cutting-edge research and that all University Employees meet regulatory requirements.

More information on disclosure requirements can be found on our History of Disclosure Requirements webpage.

UArizona’s policy can be found here: Conflicts of Interest & Commitment Policy

To be compliant with OSHA regulations, all laboratory workers under a Hazardous Chemical Approval must read both the University Chemical Hygiene Plan and the Laboratory Chemical Hygiene Plan for that Approval. All laboratory workers must also affirm that they understand the information within these plans, and are aware that they can seek assistance from the RLSS and their Approval Holder if needed. Workers will be reminded by the RLSS User Dashboard to complete this affirmation annually, or upon amendment of the plans.

Using the RLSS User Dashboard, laboratory workers can easily access the University Chemical Hygiene Plan, as well as the Laboratory Chemical Hygiene Plans for any Approvals under which the laboratory worker is registered. Workers can then read and affirm to these documents through their User Dashboard after logging in with their NetID.

The Human Subjects Protection Program requires protocol personnel submit a Research Certification via eDisclosure for each project they are listed on in eIRB.  For sponsored research, the Human Subjects Protection program has mapped IRB protocol roles to the sponsored project personnel categories. This mapping tool can be used to ensure protocol personnel complete Research Certifications: Investigator Mapping.

There is an overnight process that runs behind the scenes in UAccess Research (UAR) to make sure dashboard cards like “Proposals not routing,” “Proposals routing to me” and “Proposal Workload Assignments” are updated with the latest changes. This process usually begins a little after midnight AZ time. Proposals approved after midnight may not be reflected in the UAR dashboard cards that day, they will update with the next overnight update.

If a looming deadline cannot wait for the next overnight update, please email Sponsored Projects Services (SPS) at UARhelp@list.arizona.edu to request assistance. Include the Proposal number or UAR document number in the request.

The Search Records feature will return results excluding disapproved and cancelled documents, while the individual searches in Common Tasks (Awards, Negotiations, Proposals, Subawards) will return all results, including disapproved and cancelled documents. 

Additionally, the Search Records feature is limited by your access/role, whereas the individual searches are not. Search Records will only return results for items you have access to, either because you created the document, you were provided an access role to the document, you are listed as personnel on the document, or you have been provisioned as a unit viewer/approver. You should be able to open any document that appears in your Search Records results. Individual searches in Common Tasks (Awards, Negotiations, Proposals, Subawards) will return all results, regardless of access, however you will only be able to open items for which you have access.  

A recall or return for edit action removes any pending workflow Approval and Ad Hoc FYI/Acknowledge/Approve actions and basically resets routing. 

If you are using an Ad Hoc FYI or Acknowledge to track a proposal in your Action List once it leaves your "Proposals not routing" card, you can take the Ad Hoc action and it will transfer to your Action List Outbox, where it will remain even if the proposal is recalled or returned for edit. 

To turn on our Action List Outbox:

• From your Action List, click the preferences button in the upper right corner.
• Ensure Use Outbox is checked in your Fields Displayed in Action List. 
• Be sure to click the save button at the bottom of the page!

At times your Action List Outbox may get very large and may take more time to load and process pages. You can delete older items if and as desired to pare down your Outbox and make it run more efficiently. 

To delete old items from your Action List Outbox: 

• From your Action List, click Outbox.
• Check each item you wish to delete.
• Click delete selected items.

No. RDS does not publicly identify the members of the internal funding review panels or the specific members assigned to individual proposals or ad hoc reviewers. 

Yes. Review comments are provided to all applicants once the reviews are completed, and the ticket has been awarded.

Yes. Your Automatic Refresh Rate, Action List Page Size, Fields Displayed, Color Coding for Route Status, and Email Notification Preferences will all be migrated over to the updated UAccess Research system.

No. Campus users may only create Proposal Development documents. Only Sponsored Projects, the Office of Research Contracts, and UAHS Contracts will be able to create Institutional Proposals, Negotiations, Awards and Subawards. You will receive an error message if you attempt to create any of these document types and do not have the appropriate provisioning. 

You will have access to items in the 'Proposals not routing' card on the dashboard if you:

• initiated the proposal document
• are included as Personnel on the project (PI, Co-I, Key Person)
• are provided viewer, editor, or aggregator privileges through the Access tab of the proposal
• are provisioned to view or approve proposals for any unit included in the proposal 
• are added as an Ad Hoc with an Acknowledge, FYI, or Approve action

If a project involves work on a U.S. military base abroad, additional international travel insurance requirements may be required. For expert guidance, contact the UA Export Control Program well in advance of travel.

Defense Base Act (DBA) Insurance is a federal requirement for international travel that is associated with the U.S. federal government. There are two primary triggers when DBA must be obtained:

• Travel abroad as part of a public work or service contract with the U.S. federal government where the UA is a contractor or subcontractor
• Travel to conduct work on a U.S. military installation abroad

DBA is generally NOT required for travel under federal research grants, cooperative agreements with federal agencies, or other authorized university travel unless one of the two triggering criteria listed above are applicable. 

To arrange DBA insurance, ask your departmental Business Officer to complete a DBA Insurance Application Form and submit it to Risk Management Services a minimum of 30 days in advance of departure. Email confirmation of DBA coverage will be sent to the traveler and their department. Contact Risk Management Services at (520) 621-1790 or risk@email.arizona.edu for additional forms information.