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The research that occurs at the University of Arizona is innovative and often of high value and needs protecting even if it is not subject to export control restrictions. Take steps to protect your information, access to university systems, and report to your department administration any concerns or peculiarities that emerge. Steps to secure your research include:
  • 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.

Topic:
International Activities
Export Control

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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.

Topic:
International Activities
Export Control

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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.

Topic:
Investigational Device Exemption (IDE) Resources
Human Subjects Protection Program

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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.

Topic:
Investigational Device Exemption (IDE) Resources
Human Subjects Protection Program

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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.

Topic:
Investigational Device Exemption (IDE) Resources
Human Subjects Protection Program

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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."

Topic:
Investigational Device Exemption (IDE) Resources
Human Subjects Protection Program

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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.

Topic:
Identifying CUI
Export Control

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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.

Topic:
Identifying CUI
Export Control

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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. 

Topic:
Identifying CUI
Export Control

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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.

Topic:
CUI Overview
Export Control

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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.

Topic:
CUI Overview
Export Control

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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.

Topic:
CUI Overview
Export Control

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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.

 

 

Topic:
CUI Overview
Export Control

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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.

Topic:
Liaison Program
Export Control

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University of Arizona employees working on an export-controlled project with a Technology Control Plan (TCP) must complete export control training prior to working on a project and/or accessing export-controlled items or data. Agreements will not be processed by Contracting Services until training is confirmed as current and the TCP is in place.

Topic:
Training
Export Control

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Yes! University of Arizona faculty, staff and students can take any of the export control training modules available through the EDGE Learning system or the Collaborative Institutional Training Initiative (CITI) Program. For more information on the modules available contact Export Control or visit our website.

Topic:
Training
Export Control

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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.

Topic:
Penalties
Export Control

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A recent regulatory change was made to DOE Order 142.3A (December 13, 2019). The clause may be in DOE agreements awarded after December 2019 as well older DOE agreements that are being amended by DOE to include this revision. The revised 142.3A requires prior approval of Foreign Nationals working on DOE projects (including U.S. Permanent Residents). Contact Export Control for assistance with navigating this process.

Topic:
Other Considerations
Export Control

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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.

Topic:
Other Considerations
Export Control

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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. 

Topic:
International Activities
Export Control

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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.

Topic:
International Activities
Export Control

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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.

Topic:
International Activities
Export Control

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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.

Topic:
International Activities
Export Control

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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.

Topic:
International Activities
Export Control

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Travel outside the United States can trigger the need for a federally issued license(s), depending on the proposed destination, what you plan on taking with you, the nature of the project associated with the travel, and with whom you work.
 

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.

Topic:
International Activities
Export Control

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Central administrative units, departments, and colleges will coordinate with Export Control on centralized procedures for Restricted Party Screenings and identifying international collaborations, travel, services, and online study abroad requiring OFAC licenses. All individuals affiliated with the University who work with international persons and entities must confirm via Restricted Party Screening and consultation with Export Control that activities are permitted with collaborators.

Topic:
Restricted Parties
Export Control

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The U.S. government maintains lists of individuals or entities with whom the University and its employees may be prohibited by law or require a license to export to or engage in certain transactions.

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.

Topic:
Restricted Parties
Export Control

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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.

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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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

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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“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.

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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“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.

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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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.  

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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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).

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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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.

Topic:
Investigational New Drug (IND) Resources
Human Subjects Protection Program

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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

Topic:
Policy and Guidance
Export Control

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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.

Topic:
Policy and Guidance
Export Control

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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.

 

 

Topic:
Policy and Guidance
Export Control

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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.

Topic:
Export Control Exclusions and Implications
Export Control

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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.

Topic:
Export Control Exclusions and Implications
Export Control

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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.

Topic:
Export Control Exclusions and Implications
Export Control

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

Topic:
Export Control Exclusions and Implications
Export Control

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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.

Topic:
Export Control Exclusions and Implications
Export Control

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No, this kind of review, even when requested, is considered a courtesy rather than a restriction. If the award required "review and approval" it is considered a restriction as this language implies the potential of denying approval to publish or requiring changes to the report, presentation, or article prior to publication. A publication approval requirement would nullify the fundamental research exclusion.

Topic:
Export Control Exclusions and Implications
Export Control

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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.

Topic:
Export Control Exclusions and Implications
Export Control

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Technical data is a term defined in the International Traffic in Arms Regulations (ITAR) as information, which is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of defense articles and software directly related to defense articles.  
 
Technology is defined by the Export Administration Regulations (EAR) as specific information necessary for the “development”, “production”, or “use” of a product.
 
Technical data and technology may take the form of blueprints, drawings, manuals, models, specifications, tables, formulas, plans, instructions, or documentation.

Topic:
Key terms and definitions
Export Control

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Defense articles are all items, data specifically designed, developed, configured, adapted, or modified for a military application.  Defense articles are listed on the U.S. Munitions List (22 CFR Section 121.1).

Topic:
Key terms and definitions
Export Control

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A defense service is furnishing of assistance to foreign persons, whether in the United States or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, processing or use of defense articles; or  the furnishing to foreign persons of any technical data controlled whether in the United States or abroad.

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Key terms and definitions
Export Control

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These are items and associated technologies that are commercially available and also have a military or proliferation applications. Items determined to have a dual capability are enumerated in the Commerce Control List.

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Key terms and definitions
Export Control

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A TCP is a protocol that outlines the procedures to secure certain export-controlled items (technical data, materials, software, or hardware) from unauthorized use, access, and observation by non-U.S. persons. The Export Control staff, with assistance from the Principal Investigator (PI), will develop a TCP that is designed for the specific project. The PI is the ultimate responsible party for adherence to the TCP by project personnel. All project personnel listed on the TCP are required to complete export control training every two years. The TCP remains in effect for as long as UA retains the export- controlled data or item, even if the project is over. Export Control will conduct an annual audit to ensure compliance with the TCP.

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Key terms and definitions
Export Control

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Defense articles are all items, data specifically designed, developed, configured, adapted, or modified for a military application.  Defense articles are listed on the U.S. Munitions List (22 CFR Section 121.1).
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An individual with U.S. citizenship, Permanent resident alien (Green Card holder) or protected individual status such as refugees and asylees. Corporations or organizations incorporated in the United States are
U.S. Persons for purposes of the ITAR and EAR. It is also any business entity incorporated to do business in the United States.

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Key terms and definitions
Export Control

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A foreign entity is any corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States, as well as international organizations, foreign governments and any agency or subdivision of foreign governments. A person (even a U.S. citizen) is considered a foreign person if they work for or represent a foreign entity.

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Key terms and definitions
Export Control

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Export control regulations exempt disclosures of unclassified technical data in the United States by U.S. universities to foreign nationals where:
(1) the foreign national is the University’s bona fide full-time regular employee;
(2) the employee’s permanent abode throughout the period of employment is in the United States;
(3) the employee is not a national of an embargoed country; and
(4) the University informs the employee in writing that information disclosed may not be disclosed to other foreign nationals without governmental approval.

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Key terms and definitions
Export Control

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For University research, there are three ways that technical information may qualify for an exclusion from the deemed export rule. Information is excluded if it:
  • 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.

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Key terms and definitions
Export Control

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

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Key terms and definitions
Export Control

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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.

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Key terms and definitions
Export Control

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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.

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Key terms and definitions
Export Control

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  • 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.

 

 

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Export Control in a University Environment
Export Control

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

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Export Control in a University Environment
Export Control

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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.

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Export Control in a University Environment
Export Control

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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.

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Export Control in a University Environment
Export Control

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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).

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

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Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

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Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

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Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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

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Chemical Safety

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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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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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.

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.

Topic:
Chemical Safety

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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.

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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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.

Topic:
Chemical Safety

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  • 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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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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.

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Chemical Safety

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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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.

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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

Topic:
Radioactive Materials - Monthly Surveys
Research Laboratory & Safety Services (RLSS)

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For a sponsored project, the PI needs to email the COI office and let them know that someone is no longer on the project and we can make sure they do not recieve emails anymore.  For an IRB project, the PI needs to contact the IRB office to update their list of personnel.  They can be contacted at vpr-irb@email.arizona.edu(link sends e-mail).

Topic:
Business Managers
Office for Responsible Outside Interests

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When an sponsored project or an IRB protocol is submitted to the appropriate office, the departments will upload the projects into their system and then those projects will automatically link to all Investigator's Disclosures.  The Investigators will recieve an email telling them that they must certify the project.  In the case of an IRB project, the Investigator must certify within 30 days or the project will be pulled from the IRB system.

Topic:
Business Managers
Office for Responsible Outside Interests

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Conflict of Interest disclosure statuses can be found using the Conflict of Interest by Project dashboard.  You can use this site to review who has completed the conflict of interest training and disclosure requirements and to see if there are outstanding requirements that an individual needs to complete.

What information is available in this dashboard?
The dashboard provides the determination status for COI Project/Protocol Disclosures, as well as the status of an individual’s COI training and annual disclosure certification.  For each project, a determination status will either be: (1) COMPLETE [COI Requirements have been met and project is approved], (2) INCOMPLETE – AWAITING CERTIFICATION [individual must complete their annual COI Disclosure], (3) INCOMPLETE – AWAITING PROJECT CERT [individual must complete their project questionnaire], (4) INCOMPLETE – IN REVIEW [individual has completed disclosure requirements and Office for Responsible Outside Interests is reviewing disclosure], or (5) INCOMPLETE – CONTACT COI.  If an individual does not appear in the dashboard, it is because they have not completed a disclosure or do not have an active project (proposal, award or protocol). The status of manually entered projects is not captured in this dashboard. 

How do I access the dashboard?
You can access the dashboard here.

How do I determine if an Investigator is up-to-date with their COI Disclosures?
To be up-to-date, an Investigator must have submitted a disclosure through the COI Disclosure System after June 1.

Note: Being up-to-date on disclosures is different than the COI process being complete.  Please review the subsequent FAQs to assess if you also need one or more investigators to confirm the completeness of the Office for Responsible Outside Interests' review of a disclosure.

Topic:
Business Managers
Office for Responsible Outside Interests

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The COI Disclosure System imports Institutional Proposals and Awards from the UAccess Research system and protocols that have been submitted to the IRB.  Thus, if your research project is not reflected in UAccess Research as either an Institutional Proposal or an Award, it will not automatically appear in the COI Disclosure System.

For projects that are not automatically imported, investigators will need to manually enter the project into the COI Disclosure System.  To do this, please see STEP 6 on page 5 of these Instructions for using the COI Disclosure System. If the project involves human subjects, please refer to the instructions in the Human Subjects Research tab under Investigators.

Topic:
Business Managers
Office for Responsible Outside Interests

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The investigator will still need to complete the required training and disclosure requirements even if they do not have outside interests that meet the definition of a significant financial interest or a significant personal interest as described above. In this case, they will simply certify that they have no outside interests to report on the form and submit the form.  

Topic:
Business Managers
Office for Responsible Outside Interests

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Anyone who is an “Investigator” on a research project at the University (whether or not externally funded) must submit a disclosure.  “Investigator” is a defined term in the policy, and generally means “any person who is responsible for the design, conduct, or reporting of 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 persons involved in the Conduct of Research, regardless of title or position, who are responsible for the design, conduct, or reporting of Research performed by or under the auspices of the University. This may include students, trainees, collaborators, volunteers, and Consultants if those individuals have some degree of independence in performing some aspect of design, conduct, or reporting of the Research. The term “Investigator” does not include individuals whose performance within the Research is purely ancillary or occurs solely under immediate supervision.”  Note:  This may be a broader universe than the individuals included on the HSPP’s List of Personnel Form.

Topic:
Business Managers
Office for Responsible Outside Interests

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“Relatedness” means that it may reasonably appear that decisions made by the researcher in the performance of their Institutional Responsibilities could directly and significantly affect the value of (or be in conflict with) their outside interest(s). Relatedness includes situations in which a researcher’s outside interest(s) 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 researcher’s Institutional Responsibilities.

Importantly, a finding of a FCOI is not a judgment on whether the researcher would deliberately make choices in the Conduct of Research or the performance of their Institutional Responsibilities based on considerations related to their outside interests. Rather, “Relatedness” refers to the condition in which it may reasonably appear that choices made in the performance of the researcher’s Institutional Responsibilities could be directly and significantly influenced by the existence of outside interests.

Topic:
Business Managers
Office for Responsible Outside Interests

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The HSPP offers a variety of training opportunities including Brown Bag Sessions and Office Hours. For training details, please visit the IRB Training Opportunities webpage. If you are interested in requesting training on a specific topic, or are interested in having an HSPP member present at a class, lab, or faculty meeting, please contact the general inbox at VPR-IRB@email.arizona.edu(link sends e-mail)

Topic:
Getting Started
Human Subjects Protection Program

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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 Intake Application (RIA). Upon submission to the IRB, please upload RIA approval to eIRB. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.

Topic:
Getting Started
Human Subjects Protection Program

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If you are traveling outside of the United States to conduct human subjects research, you will need to register your travel with the UA Travel Registry. The HSPP requires your travel be registered and approved before any research begins. For more information on conducting international research, please visit the Office for Human Research Protections' webpage on International Compilation of Human Research Standards.

Topic:
Getting Started
Human Subjects Protection Program

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The HSPP considers Children, Cognitively Impaired Individuals, Pregnant Women and Neonates, Prisoners, and Native American or International Indigenous Populations to be vulnerable populations that require additional protections and safeguards. When your targeted population includes one or more of these vulnerable populations, the appropriate Appendix for Vulnerable Populations is required with your submission eIRB. Please see our guidance on conducting research in these population:

For specific questions regarding research involving Native American or International Indigenous Populations, please contact Claudia Nelson at cen@arizona.edu(link sends e-mail).

Topic:
Getting Started
Human Subjects Protection Program

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

Topic:
Getting Started
Human Subjects Protection Program

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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

Topic:
Getting Started
Human Subjects Protection Program

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Please visit our Getting Started webpage

Topic:
Getting Started
Human Subjects Protection Program

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Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research (a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. For additional information, please see our guidance on What is Human Research

If you are still unsure whether or not your study is human subjects research, complete and submit the IRB Protocol for Determination of Human Research in eIRB. 

Topic:
Getting Started
Human Subjects Protection Program

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UA must enter into a Data Use Agreement (DUA) whenever it is transmitting or receiving a Limited Data Set, a type of Protected Health Information (PHI), for research, public health activities or health care operations. 

UA Contract Offices and Principal Investigators (PIs)/Business Owners are responsible for:

1. Determining if a Limited Data Set is involved for a specific purpose (research, public health activities, health care operations), and if so;

2. Determining whether:

(a) UA is TRANSMITTING/DISCLOSING a Limited Data Set to a third party (company, sponsor, institution). 

(b) UA is RECEIVING a Limited Data Set from a third party (company, sponsor, instiuttion). 

3. Submitting a request to the Contracting Services email address contracting@email.arizona.edu when a Data Use Agreement is needed.

Topic:
Data Use Agreement
HIPAA Privacy Program

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1.    When UA is disclosing or transmitting a Limited Data Set to another institution, organization or entity, UA requires that a DUA must be signed to ensure that the appropriate provisions are in place to protect the Limited Data Set as required under the HIPAA Privacy Rule.  Contracting Services maintains a template DUA.  When UA is disclosing or transmitting a Limited Data Set, if any material change is made to the UA template form, or if another party’s version of a Data Use Agreement is going to be used, Contracting Services must review and sign-off on the terms of the agreement.  Email contracting@email.arizona.edu to request a DUA.

2.    If a UA researcher is the recipient of a Limited Data Set from a non-UA source, the UA researcher will most likely be asked to sign the other party's DUA.  In such instance, the UA researcher should consult with Contracting Services who will work to determine if it complies in material terms with UA’s DUA template. Email contracting@email.arizona.edu to request a DUA.

Topic:
Data Use Agreement
HIPAA Privacy Program

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No, disclosures of "limited data sets" are not subject to the HIPAA accounting of disclosures requirements.  The Department of Health and Human Services (DHHS) has taken the position that the privacy of individuals with respect to PHI disclosed in a "Limited Data Set" can be adequately protected through a single DUA.

Topic:
Data Use Agreement
HIPAA Privacy Program

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Yes, you will need both a Data Use Agreement (DUA) and Business Associate Agreement (BAA) because the Covered Entity or Hybrid Covered Entity (UA) is providing the recipient with PHI that includes direct identifiers.  For that reason, a BAA would be required to disclose the direct identifiers to the recipient.  Once the Limited Data Set is created under the BAA, all of the PHI, other than the PHI qualifying as the limited data set under the DUA, must be returned to UA.   

Topic:
Data Use Agreement
HIPAA Privacy Program

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A DUA must be entered into before there is any use or disclosure of a Limited Data Set to an outside institution or party. 

Topic:
Data Use Agreement
HIPAA Privacy Program

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A HIPAA Covered Entity, or a Hybrid Covered Entity like UA, may use a member of its own workforce to create the "Limited Data Set."  Alternatively, the recipient may create the "Limited Data Set," so long as the recipient is acting as a Business Associate or Subcontractor (pursuant to a Business Associate Agreement) of the Covered Entity or Hybrid Covered Entity.  

Topic:
Data Use Agreement
HIPAA Privacy Program

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A Limited Data Set is a data set that is stripped of certain direct identifiers specified in the HIPAA Privacy Rule.  A Limited Data Set may be disclosed to an outside party without a patient’s authorization only if the purpose of the disclosure is for research, public health, or health care operations purposes and the person or entity receiving the information signs a data use agreement (DUA) with the covered entity or its business associate.

Limited data sets may include only the following identifiers:

  • Dates, such as admission, discharge, service, and date of birth (DOB)
  • City, state, and zip code (not street address)
  • Age
  • Any other unique code or identifier that is not listed as a direct identifier.

This means that in order for a data set to be a Limited Data Set, all of the following direct identifiers as they relate to the individual or his/her relatives, employers, or household members must be removed:

  • Names
  • Street addresses (other than town, city, state, and zip code)
  • Telephone and fax numbers
  • Email addresses
  • Social security numbers
  • Medical record numbers
  • Health plan beneficiary numbers
  • Account numbers
  • Certificate/driver’s license numbers
  • Vehicle identifiers and serial numbers, including license plate numbers
  • Device identifiers and serial numbers
  • URLs and IP addresses
  • Biometric identifiers
  • Full face photographic images and any comparable images.

NOTE: a Limited Data Set is still Protected Health Information (PHI) under HIPAA.  It is not De-Identified Data, as that term is defined under HIPAA, and thus, must be safeguarded and protected as required under the Privacy Rule.  For more information about the different between Fully Identifiable Data, a Limited Data Set and a De-Identified Data Set, check out the following HIPAA Data Reference Guide.

Topic:
Data Use Agreement
HIPAA Privacy Program

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A Data Use Agreement (DUA) is a specific type of agreement that is required under the HIPAA Privacy Rule and must be entered into before there is any use or disclosure of a Limited Data Set (defined below) from a medical record to an outside institution or party for one of the three purposes: (1) research, (2) public health, or (3) health care operations purposes.  A Limited Data Set is still Protected Health Information (PHI), and for that reason, HIPAA Covered Entities or Hybrid Covered Entities like The University of Arizona (UA) must enter into a DUA with any institution, organization or entity to whom UA discloses or transmits a Limited Data Set. 

At a minimum, any DUA must contain provisions that address the following:

1.    Establish the permitted uses and disclosures of the Limited Data Set--narrowly describes the use/disclosure and outlines parameters of specific purpose (research, public health or health care operations).

2.    Identify who may use or receive the information;

3.    Prohibit the recipient from using or further disclosing the information, except as permitted by the agreement or as otherwise permitted by law;

4.    Require the recipient to use appropriate safeguards to prevent an unauthorized use or disclosure not contemplated by the agreement;

5.    Require the recipient to report to UA any use or disclosure to which it becomes aware;

6.    Require the recipients to ensure that any agents (including any subcontractors) to whom it discloses the information will agree to the same restrictions as provided in the agreement; and

7.    Prohibit the recipient from identifying the information or contacting the individuals.

Additionally, Covered Entities, or Hybrid Covered Entities like UA, must take all reasonable steps to cure a recipient's breach of the DUA.  For example, if UA learns that data it provided to a recipient is being used in a manner not authorized under the DUA, then notify the UA Privacy Officer and UA will work with the recipient to correct this problem.  If these efforts are unsuccessful, UA would be required to cease any further disclosures of PHI to the recipient under the DUA and report the matter to the federal Department of Health and Human Services Office for Civil Rights.

Topic:
Data Use Agreement
HIPAA Privacy Program

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UA’s Contract Offices and Business Owners are responsible for:

  1. Determining if PHI is being shared with another entity, and if so;
  2. Determining whether:
    1. (a) UA is sharing its PHI (or the PHI UA holds on behalf of another Covered Entity in its capacity as a Business Associate) with a third party (company, sponsor, institution) and the third party is the Business Associate.
    2. (b) The third party (company, sponsor, institution) is sharing its PHI and UA is the Business Associate

Submit the Business Associate Intake Form to the UA HIPAA Privacy Office when a Business Associate Agreement is needed.

Topic:
Privacy
HIPAA Privacy Program

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HIPAA requires that a Covered Entity/Hybrid Covered Entity enter into a Business Associate Agreement (BAA) any time it will use a contractor or other non-workforce member to perform "Business Associate" services or activities on behalf of the Covered Entity.  The purpose of the BAA is to protect the data and ensure that any party who performs functions/activities on behalf of the covered entity and will handle PHI in carrying out those duties adhere to certain standards to protect the data.

HIPAA requires that that a BAA must be written and must include several terms and conditions for maintaining compliance with federal privacy regulations, including written assurances that the Business Associate:

  1. Will not use/disclose PHI other than as permitted or required by the agreement or as otherwise required by law;
  2. Will use appropriate safeguards to prevent unauthorized use or disclosure of PHI (other than as provided for by the BAA);
  3. Will report any use or disclosure not provided for in the BAA for which it becomes aware; and
  4. Ensures that any subcontractors that create, receive, maintain or transmit PHI agree to the same restrictions/conditions as the business associate.  

For more information about obtaining a BAA, contact the UA Privacy Office.

Topic:
Privacy
HIPAA Privacy Program

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A Business Associate is a person or entity who, on behalf of a HIPAA Covered Entity, or Hybrid Covered Entity like UA, performs or assists in the performance of a function or activity or provides support services, while not a member of the workforce, to the Covered Entity involving the use or disclosure of individually identifiable health information.  

Some Business Associate functions or activities that may be performed on behalf of a Covered Entity/Hybrid Covered Entity include:

    • data processing
    • data analysis
    • utilization review
    • billing
    • cloud storage vendor services
    • transcription services
    • legal services
    • data aggregation
    • administrative functions
    • financial services
    • management services
    • consulting services
    • accounting services
    • legal services
    • actuarial services
    • accreditation services 

An individual or organization is only considered a Business Associate if they perform a function or service on behalf of the Covered Entity/Hybrid Covered Entity (such as UA) and handle or are expected to Protected Health Information (PHI) as a part of the job function or service they perform/provide on behalf of the Covered Entity/Hybrid Covered Entity.

In some cases, UA may serve as a Business Associate of another Covered Entity if UA is performing services, functions or activities on behalf of the other Covered Entity and handling PHI as part of the services performed.  When UA is acting in its capacity as a Business Associate and will be disclosing any of the Covered Entity’s PHI to a third party, a Subcontractor, to perform any of its services—UA is required to enter into Business Associate Agreement with any downstream Subcontractor that will have access to the Covered Entity’s PHI. 

Topic:
Privacy
HIPAA Privacy Program

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You still need to complete the required training and disclosure requirements even if you have no outside interests that meet the definition of a significant financial interest or a significant personal interest as described above. In this case, you will simply certify that you have no outside interests to report on the form and submit the form.  

Topic:
Office for Responsible Outside Interests

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An investigator is any person who is responsible for the design, conduct, or reporting of research, regardless of his or her title or position at the University.

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 individuals involved in the conduct of research, regardless of title or position, who are responsible for the design, conduct, or reporting of research performed by or under the auspices of the University. This may include students, trainees, collaborators, volunteers, and consultants if those individuals have some degree of independence in performing some aspect of the design, conduct, or reporting of the research.

The term "investigator" does not include individuals whose performance within the research is purely ancillary or occurs solely under immediate supervision.

Topic:
Office for Responsible Outside Interests

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All investigators must complete conflict of interest training as follows:

  1. Prior to participating in research activities at the University;
  2. At least every four years thereafter for the life of the project;
  3. Any time after the University revises the Individual Conflict of Interest in Research Policy or the corresponding procedures in any manner that affects the requirements of the investigators; and
  4. Any time after the University finds that an investigator is not in compliance with the Individual Conflict of Interest in Research Policy or a management plan.

Topic:
Office for Responsible Outside Interests

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  • Within 30 days of Acquiring a New Interest: New significant financial interests and significant personal interests should be disclosed to the Office for Responsible Outside Interests within 30 days of acquiring a new interest by completing a new disclosure form.
  • Annually: Disclosure forms are required to be re-certified annually between June 1st and June 30th of every year even if the investigator has nothing new to report.
  • If you have one or more significant financial interests or significant personal interests, you must update your disclosure when any of the following occur:
    • Your financial interest changes (i.e., the value of your interest increases or decreases, your role in the entity changes, or if you no longer hold an interest in the entity).
    • Each time you have a new proposal or award, a new IRB research project, or non-sponsored research project.

For more information on disclosures, review the Disclosure Instructions page.

Topic:
Office for Responsible Outside Interests

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For University employees or affiliates with system access, log into the Online Disclosure and Training system with your Net ID and password.

For non-University employees, or individuals without system access, a web form is provided for your completion.

Topic:
Office for Responsible Outside Interests

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Investigators must complete:

  • Conflict of Interest Training; and
  • A Conflict of Interest Disclosure Form

Topic:
Office for Responsible Outside Interests

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UAccess Analytics houses the Conflict of Interest Dashboard.  You can use this site to review who has completed the conflict of interest training and disclosure requirements and to see if there are outstanding requirements that an individual needs to complete.

 

Topic:
Office for Responsible Outside Interests

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If an investigator is no longer involved in an IRB protocol then the PI must contact the IRB office to update the list of personnel on the project.  Once the list is updated by the PI, it will take a few days for the names to update in the system so a few more reminder emails may still get sent while the update is happening.

Topic:
Office for Responsible Outside Interests

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Under the University of Arizona’s Institutional Conflict of Interest Policy, sponsorship of an Investigational New Drug (“IND”) or an Investigational Device Exemption ("IDE") application by UA or UA personnel may create an Institutional Conflict of Interest. Accordingly, if you are applying for an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) then you must get approval from the Executive Review Committee.  Please submit an IND/IDE COI Worksheet to the Office for Responsible Outside Interests as far in advance of your anticipated IND/IDE submission date as possible, to minimize the risk of delays while awaiting ERC review.

Topic:
Business Managers
Office for Responsible Outside Interests

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The proposals that are populated in your disclosure are pulled from UAccess Research.  If a proposal was not funded and it is showing up in your disclosure it is most likely because Sponsored Projects was not notified that the proposal was not funded. Please use the “Set as not required” option in your disclosure and select the appropriate reason from the drop down menu.  Also, you or your business office should contact Sponsored Projects & Contracting Services to notify them that the proposal was not funded.  They will set the proposal to the appropriate status.

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For University employees or affiliates with system access, instructions for completing the online disclosure and training form are available on the Disclosure Instructions page. You will find helpful hints, guides and step-by-step instructions.

Topic:
Office for Responsible Outside Interests

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

Topic:
Early Investigators
Research Development

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RDS offers several programs on an annual or biannual basis.

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

Topic:
Early Investigators
Research Development

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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.

Topic:
Early Investigators
Research Development

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

Topic:
Early Investigators
Research Development

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

Topic:
Early Investigators
Research Development

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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.

Topic:
Early Investigators
Research Development

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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.

Topic:
Early Investigators
Research Development

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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.

Topic:
Early Investigators
Research Development

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Yes.

Topic:
Limited Submissions
Research Development

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Preproposals are archived within UA Competition Space and are not distributed or made publicly available. 

Topic:
Limited Submissions
Research Development

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

Topic:
Limited Submissions
Research Development

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

Topic:
Limited Submissions
Research Development

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Contact RDS as soon as possible so other potential applicants can move forward with a submission to the funder. Certain limited submissions are very competitive at UA, e.g. the National Science Foundation (NSF) Major Research Instrumentation (MRI) program. If you receive the ticket to be the institutional submission for a competitive limited submission opportunity (i.e. an opportunity where there was competition for the permission) and you choose not to submit and you do not notify us within four weeks of the sponsor deadline of your decision, you will be ineligible to reapply in the following cycle.

Topic:
Limited Submissions
Research Development

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The Limited Submission opportunity will be listed in the Open category on the Limited Submission Table and the first expression of interest RDS receives will be accepted as the institutional submission. Expressions of interest must be sent to ResDev@email.arizona.edu and the date/time that the email is received will determine the order that expressions of interest are accepted.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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All Limited Submission opportunities currently in a competition will be listed in UA Competition Space. 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.

Topic:
Limited Submissions
Research Development

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

Topic:
Limited Submissions
Research Development

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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. 

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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Subscribe to The Current, the RDS weekly digest of funding opportunities and news which lists upcoming and open funding opportunities. 

Topic:
Limited Submissions
Research Development

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Yes. Each opportunity is reviewed independently.

Topic:
Limited Submissions
Research Development

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It depends. First, check the RDS Limited Submissions Table to see if the funding opportunity is listed and currently accepting internal pre-proposals. If an internal competition is underway, review the pre-proposal requirements and submit your pre-proposal. If the funding opportunity is not listed, email ResDev@email.arizona.edu to express your interest in applying. RDS will establish eligibility to apply based on the Preferred Timeline for Limited Submissions.

Topic:
Limited Submissions
Research Development

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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.” 

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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

Topic:
Limited Submissions
Research Development

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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 Competition Space for more details

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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

Topic:
Limited Submissions
Research Development

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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.

Topic:
Internal (RII) Funding
Research Development

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“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.” 

Topic:
Internal (RII) Funding
Research Development

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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.

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Internal (RII) Funding
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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. 

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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Arizona’s Technology and Research Initiative Fund investment has enabled thousands of scientific discoveries, over 950 patents, 328 new startup companies and hands-on training for approximately 39,000 students across Arizona’s three universities. Publicly supported through voter approval, TRIF is an essential resource for growing Arizona’s economy and providing opportunities for Arizona residents to work, learn and thrive. For the 2021 Arizona Board of Regents TRIF Annual Report visit the ABOR site.

Topic:
Internal (RII) Funding
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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.

Topic:
Limited Submissions
Research Development

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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

Topic:
Limited Submissions
Research Development

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