Resources for Research Participants
The University of Arizona Human Subjects Protection Program (HSPP) office has developed this web page to provide you with information regarding participation in research.
Research involving human participants (often referred to as "subjects") may take place in many locations around the University campus or in locations off campus. Research with human participants is conducted by many colleges and departments including: Departments of Psychology, Sociology, Anthropology, and Colleges of Medicine, Nursing, and Pharmacy. The University of Arizona Institutional Review Board (IRB) is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AAHRPP has published a brochure that explains the AAHRPP accreditation process, as well as some information about being a research participant.
If you are considering participating in a research study, remember that participation is completely voluntary: you can choose not to participate or, if you do decide to participate, you can choose to stop participating at any time. The Participants' Bill of Rights summarizes the rights you have as a research participant.
The National Institutes of Health sponsors a website, called Clinical Trials, that provides information to the public about clinical research studies. There are other sources of information about ongoing research, known as "clinical trials", which can acquaint you with specific topics:
- About Clinical Trials (ACT)
- NIH Clinical Research Trials and You ("Why should I participate in a clinical trial?")
- Learn About Clinical Trials (ClinicalTrials.gov)
- Providing Your Tissue for Research: What You Need to Know
- Searching for Clinical Studies in Cancer Research
The Office for Human Research Protections (OHRP) has a resource page set up for the public to learn more about participating in research and making informed decisions.
General Information about Research
What is Research?
What is a Clinical Trial?
What is a Principal Investigator?
Who oversees research involving humans at the University of Arizona?
Where can I find a Clinical Trial or other research study to participate in?
Can healthy people participate in a Clinical Trial or research study?
What you Should Know Before you Volunteer to Participate in Research
What are research participants asked to do?
What information should I receive from the researcher?
What are the benefits of participating?
What happens if I volunteer to participate?
Will I be paid for participating in a study?
What happens if I want to leave the study before it is complete?
What happens when the study ends?
What are Your Rights as a Research Participant?
What rights do I have as a participant?
How will I be protected?
How do I protect my rights?
Where can I get more information about my rights or if I have a concern?
General Information about Research
What is research?
Research is the systematic investigation into and study of materials and sources to establish facts and reach new conclusions. The University of Arizona conducts research in a variety of areas, including human health and illness and the use of experimental drugs and devices.
What is a clinical trial?
A clinical trial is defined by the US Department of Health and Human Services as "a research study conducted to evaluate a medical procedure or medical product, such as a drug or device."
Not all studies involving humans at the University of Arizona involve drugs or interventions; some studies use surveys or review and evaluate medical records to find new and better ways to help people. Other studies recruit healthy volunteers, or control subjects, to better evaluate and compare their results with those of non-healthy subjects.
What is a Principal Investigator?
A Principal Investigator, or PI, is the person responsible for the conduct of the study and the leader of the team investigating the disease or condition. The PI must be qualified by training and experience to investigate what is being studied. The PI is responsible for ensuring that the study is conducted according to the approved plan and that the necessary rules and regulations are followed.
Who Oversees Research Involving Humans at the University of Arizona?
An Institutional Review Board (IRB) is a group of qualified individuals (physicians, scientists, and non-scientists with a wide range of expertise) that reviews and monitors research involving human participants. IRBs review research protocols and related materials (e.g., informed consent documents). In accordance with federal regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
The purpose of IRB review is to ensure that appropriate steps are taken to ensure that the rights and welfare of humans participating in the research are protected, risks to the participants are minimized and reasonable in relation to anticipated benefits, and the PI is qualified to conduct the study.
Many studies at the University of Arizona are overseen by the University of Arizona IRB, known as the Human Subjects Protection Program, while others are overseen by IRBs at other universities, medical centers, federal departments (such as the Veterans Administration Central IRB), or commercial IRBs. The IRB must also review the research at least once a year to make sure that it is going as planned.
The University of Arizona's Human Subjects Protection Program is the administrative and regulatory support program to the IRBs.
Where can I find a Clinical Trial or other Research Study to Participate In?
There are many sources for information on clinical trials:
- The University of Arizona Health Sciences Center’s Clinical Research Studies site
- The University of Arizona Cancer Center’s “Find a Clinical Trial” site.
- Clinicaltrials.gov, a federal government-run registry that lists many clinical trials conducted in the United States and internationally.
- Searchclinicaltrials.org, a website run by the non-profit organization CISCRP.
- The National Cancer Institute’s clinical trials website.
- Your healthcare provider may be doing research, or they might be able to refer you to a researcher or to other sources of information.
- Advertising for studies on the internet, television, and radio. Advertising also appears in local newspapers and public areas such as clinic waiting rooms.
- Advocacy groups, interest groups, or social organizations often work with researchers who are looking for people with certain characteristics, with a particular disease, or from a specific community or group of people.
- HIVinfo (a government-run website that lists HIV/AIDS research).
Can Healthy People Participate in a Clinical Trial or Research Study?
Healthy individuals can participate in a trial or study. Studies may use healthy volunteers as control subjects to compare them with patients who have the disease or condition under study. Some studies may have additional criteria for healthy volunteers. For example, studies may want volunteers who don't take any medications, or a study may be recruiting participants who do take a specific medication (e.g., birth control) but are otherwise healthy.
What you Should Know before you Volunteer to Participate in Research
What are research participants asked to do?
Participation in a clinical trial can involve surveys, telephone calls, visits with a study doctor or nurse, and/or drugs or other types of treatment. Although many clinical trials involve new drugs, current drugs approved by the FDA may also be tested for new indications. The study may also involve blood draws, electrocardiograms (EKGs), or other clinical procedures. A study doctor or coordinator will explain all of the procedures, risks, benefits, and costs, and you will have the opportunity to ask questions before deciding whether to participate. Study participants can withdraw from a study at any time.
What information should I receive from the researcher?
The researcher will usually give you the following information:
- why the research is being done
- why you are being asked to participate
- how long your participation will last
- what will happen during the research (what you will do, the drugs you will take, etc.)
- any expected risks or discomforts that you might experience
- how information about you will be protected
- any expected benefits
- reasons you might be asked to leave the research
- who can help you with problems or give you more information about the study or your rights
- if you will be provided with the results of the study
In addition, if you are participating in a medical study, you may also receive the following information:
- how the research is different from your usual medical care (research is not the same as treatment)
- any expected costs to you or your insurance provider
- what you can do instead of participating, such as what treatments you can take that might work for you, and how those treatments compare to the research procedures
- what medical treatment you will get in case of problems
- whether data or specimens will be used for future research
- whether data or specimens will be used for commercial profit
- whether clinically relevant results will be shared with you
- whether whole genome sequencing will be performed on your specimens
If you are concerned about any issue or you do not feel like you have enough information, ask the researcher your questions at any time before, during, or after the research.
While you are participating, you also have the right to be given new information that comes up. This information might include changes to what you will be asked to do, new risks, or new treatment options. If you are given new information, you will be asked if you are still willing to participate in the research.
What are the benefits of participating?
Researchers are searching for new information and better answers to societal and/or health-related problems, hoping to design new solutions or programs. Because these solutions take time, most research is not intended to provide you with direct benefits. When you participate in research, you are, however, contributing to scientific progress.
Individuals participate in research studies for a variety of reasons. Healthy volunteers participate to help others and contribute to the acquisition of knowledge. Volunteers with an illness or disease may also participate to help others, but also to obtain access to the newest treatments.
Research is not always the same as treatment. The drugs, devices, and procedures being tested are often experimental and there is no guarantee that a participant’s condition will improve as a result of the study. Some medical research may however result in improved health.
What happens if I volunteer to participate?
- You will be contacted by the research or a study coordinator who will ask you a series of questions. This is usually called a “pre-screening”.
- If, based on your answers, it is determined that you qualify to participate in the study, you will be presented with information about the study. This is called the informed consent process. Members of the study team, including the researchers, will discuss this information with you. They will usually ask questions to make sure that you understand the information.
- Once you understand the information and decide to participate, you will be asked to sign the consent form. You may also be asked to sign other documents, such as a form giving permission to use your medical records.
- After you sign the informed consent, the researchers may need to ask some basic questions or perform procedures to make sure you qualify to participate. If you participate in medical research, this may include a physical examination, blood tests, or other procedures. This part of the research is called "screening".
- Even if you give informed consent, you are not guaranteed a place in the research. In some cases, researchers can accept anyone who volunteers. In other cases, researchers can accept only a certain number of people or only people who fit exactly what they are looking for.
- If you do not qualify, it does not mean something is wrong with you. It just means that the study was not for you. There might be other studies that you qualify for.
- If you qualify for a study, you will go through the exact steps of the approved research plan. What you undergo during the research should be exactly what is described in the consent form.
- What will happen (and for how long) depends on the goals of the research. Sometimes researchers will be able to work around your schedule. In other studies, visits might have to happen at very specific times. All of this should be explained to you during the informed consent process.
Will I be paid for participating in a study?
Participants in studies may or may not be compensated. Contact the Study Coordinator for the specific trial in which you are interested for information about compensation as well as potential costs, risks, and benefits.
Payment will be explained to you during the informed consent process. Some studies do not have the resources to pay you while others might pay you for the time and effort it takes to participate. The money is usually to cover expenses like parking, transportation, meals, etc., and maybe for time spent away from work. The payment should not be enough to convince you to take risks that you normally would not take.
If you leave before the end of the research, you will usually be paid for that portion of the research you completed.
What happens if I want to leave the study before it is complete?
You always have the right to leave the research at any time and for any reason, and you do not have to explain your decision to anyone.
If you leave a medical study, you might be asked to come back once or twice for some extra safety tests to ensure that not having any problems related to the study. You do not have to return, but if asked to do so, it is usually important for your safety.
What happens when the study ends?
When you complete everything required by the study, or you decide to leave the study early, that is usually the end of your participation.
The study team may contact you after the study ends. This will be outlined in the consent form. The Principal Investigator might send you information about the study, including any new information that might affect your health. If you were taking an experimental drug, you may be able to continue taking the drug.
Researchers may or may not be in the position to provide study results at the end of the study. Sometimes it takes many years to achieve study results. You should ask the study investigator about this before you enroll.
When the study is complete, the researchers gather all the information they have collected. They might publish the results in scientific journals, present the results at conferences, and use the results to conduct more research. If a drug company sponsored the research, the company might use the information to support an application for approval for the drug by the U.S. Food and Drug Administration.
What are Your Rights as a Research Participant
What rights do I have as a participant?
It is your decision whether or not you want to participate in a study and you have the right to make this decision without any pressure. You do not have to participate in any research offered by your doctor and there are no consequences for refusing.
To help you make an informed decision, you have the right to receive information about the study. Information will almost always be given to you in writing (written study information is called an "informed consent form" or "research information sheet"). The information must be in a language you understand. If you do not understand something, the study team must explain it to you in a way that you can understand. You have the right to ask questions at any time and to have your questions answered.
If you decide to participate, you will be asked to sign and date the informed consent form. You have the right to receive a copy of the signed and dated written consent form.
You also have the right to change your mind and leave the research at any time. If you leave the research, your decision will not affect your relationship with the University of Arizona, the University of Arizona Health Sciences Center, or any rights or benefits to which you are entitled. You may however be asked to follow certain procedures performed for your safety when you leave a medical study.
The Participants' Bill of Rights summarizes your rights as a participant.
How will I be protected?
Federal regulations, state laws, and University of Arizona policies require that the University protect the rights and welfare of research participants. Everyone at the University of Arizona is responsible for following these requirements and every participant receives the same high level of protection. This is true no matter who pays for the research or where the research takes place.
How do I protect my rights?
The most important thing that you can do is take an active role and communicate with the study team before, during, and after the study. You should always ask questions if anything is unclear, if you are curious about something, or if it appears that the research plan is different from what was explained to you. You have a right to have your questions answered.
Before deciding whether or not to participate, seek the advice of family members, friends, or healthcare professionals. If you feel uncomfortable with what you are doing, or if you think you might be experiencing changes in your health, whether good or bad, inform the study team.
Remember that participation in a research study is voluntary. You can quit the study at any time for any reason, and you do not have to explain your decision. You may, however, be asked to have certain procedures performed for you to safely withdraw from medical studies.
You can contact the University of Arizona Human Subjects Protection Program with questions about your rights, or any problems or complaints about your experience with research at the University.
Where can I get more information about my rights or if I have a concern?
If you are already participating in research, you are encouraged to communicate with your research team first, especially if you are experiencing medical problems.
You can also contact the University of Arizona Office of Human Research Protection Program (see contact information below) for help if:
- you want general information or have general questions about research or your rights
- you wish to discuss problems, suggestions, or concerns
- you do not feel comfortable communicating with the study team
- you want advice about how to communicate with the study team
- you have communicated with the study team, but they have not been able to help you
Every precaution will be taken to maintain your confidentiality. If you report a problem, we might need to reveal your name or other information about you to investigate the problem. A representative from the Human Subjects Protection Program will contact you before revealing information about you.
You may contact the Human Subjects Protection Program by telephone, email, or mail.