Research Participant’s Rights
Anyone who is asked to participate in a research study or who is asked to provide consent to participate on behalf of another has the following rights:
- To be fully informed of the nature and purpose of the research including all procedures to be performed or followed.
- To be treated with respect in every aspect of the research process.
- To have adequate time to consider whether or not to participate in the research.
- To be given a description of any risks, discomforts and/or inconveniences reasonably expected from participation.
- To be given a description of any benefits you may reasonably expect from participation or to be informed of no possible benefit.
- To be provided with an explanation of any alternative procedures that might be available to you, as well as the relative risks and benefits.
- To ask any questions about the research study or any of the other procedures involved.
- To be told how you may be withdrawn and that you may ask to withdraw, at anytime, without affecting your rights to health care or other services.
- To decide to participate in the research study without force, fraud, deceit, duress, coercion, or undue influence.
- To be given a signed and dated copy of the consent form when one is required for the research.
- For Biomedical Research: To be provided with an explanation of any alternative drugs, biologics, or devices that might be available to you, as well as the relative risks and benefits.
- If applicable: To be informed where to get medical treatment if problems from the research study arise.
For information, to voice concerns or report a complaint: [email protected]
Additional Information to help potential and enrolled research participants
Learn about the regulations that protect research volunteers, why we have them, and who enforces them.
1946
The Nuremberg Doctors' Trial, in 1946, was an international military tribunal that tried and convicted Nazi doctors who conducted horrific unethical experiments on concentration camp prisoners during the Holocaust. It resulted in the Nuremberg Code, a set of international ethical guidelines for conducting research with humans.1966
There also were cases of unethical research in the United States. In 1966, Henry Beecher, a medical doctor and researcher, published a widely cited New England Journal of Medicine article (1966; vol. 274, p.1354-1360) detailing numerous examples of unethical experiments involving human subjects that were conducted at various U.S. institutions.1972
In 1972, there was widespread media coverage of the Syphilis Study in Tuskegee, Alabama. Beginning in the 1930s and continuing for decades, U.S. government doctors studied the evolution of untreated syphilis in poor African American men. The doctors did not tell the men they had syphilis, prevented them from learning their diagnosis, and did not offer treatment, even after penicillin became available as a cure for syphilis.1979
As a result of the public outcry from publicized cases of unethical research, Congress passed a law requiring federal rules to protect people who participate in research. The rules rely on ethical principles that were laid out in the Belmont Report, which was written by an advisory committee created by Congress and published in 1979.
The Common Rule
The Federal rules that protect people who participate in research were initially published by the Department of Health and Human Services (HHS).
The first section of the HHS rules (Subpart A) is called the Common Rule because it was simultaneously adopted by 15 Federal departments and agencies in 1991. The Common Rule was revised in 2017 to reflect how research has changed since 1991.
One key protection in the Common Rule is the requirement for appropriate review and approval of research by institutional review boards, or IRBs. IRBs are committees that make sure researchers follow the HHS rules and ethical guidelines as they carry out their studies.
The Common Rule generally requires that researchers get informed consent from those who participate in research. This includes giving them information they would need to make an informed decision about participation in language they would understand.
Additional Protections
In addition to the Common Rule, there are 4 other subparts in the HHS rules. Three of these (Subparts B, C, & D) provide additional protections for certain groups of research participants that could be considered vulnerable.
Office for Human Research Protections (OHRP)
OHRP is part of the U.S. Department of Health and Human Services (HHS). OHRP oversees and enforces the Common Rule and other HHS regulations for protecting participants in research that is funded with HHS money.
HHS agencies include, for example, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Researching involving humans that is funded by these agencies falls under OHRP’s oversight. Research funded by other Federal departments that follow the Common Rule is overseen by the respective departments.
- OHRP works with institutions to ensure compliance with the regulations and responds to complaints about potential violations.
- OHRP provides clarification and guidance about the regulations.
- OHRP educates researchers and institutional staff on ethical expectations for conducting research with humans, Common Rule requirements, and the additional requirements in subparts B, C and D of the HHS regulations.
- OHRP provides the general public information about research participation.
Check out the OHRP website, About Research Participation for more information.
Some Research is Outside of OHRP's Oversight
Even when research is not required to follow the Common Rule, there may be other regulations that provide protections.
For example, pharmaceutical companies that do research on new drugs that they plan to sell in the U.S. must comply with the U.S. Food and Drug Administration (FDA) rules to protect humans in research. The FDA’s rules are very similar to the Common Rule. The FDA protects public health by ensuring the safety and efficacy of drugs, biological products, and medical devices such as artificial heart valves. It is also responsible for advancing public health by helping the public get the accurate, science-based information they need to use medical products to maintain and improve their health.
Many institutions also voluntarily apply the protections laid out in the Common Rule, even if their research does not fall under OHRP oversight.
There are many research activities that do not come under the Common Rule. An example is research funded by private money such as certain research paid for by private companies, charitable foundations, or wealthy individuals that are conducted in private institutions. Some state or even federally funded research may not come under the Common Rule as well.
Protecting research participants is a responsibility shared by different groups, including:
- OHRP
- Responsible for the rules that protect volunteers in HHS funded research
- Funding Organizations
- Ensure that human research is conducted ethically and complies with appropriate rules and standards of protections
- Research Institutions
- Agree to comply with the rules and educate research personnel about appropriate conduct toward research volunteers
- IRBs
- Review and oversee research to ensure that research volunteers are adequately protected according to ethical standards and relevant rules
- Researchers
- Carry out scientifically valid and ethical research. Often this includes providing information to help people make an informed decision about participating
- Individuals
- Learn about the risks and benefits associated with a research study through the informed consent process, and make an informed decision about whether to participate
Talk to the research team for questions about a research study. OHRP has created a list of Questions to Ask [PDF, 2.41 MB] to help participants when meeting with the research team. The institution’s human research protection office and its IRB will address participants’ concerns for the studies it conducts. Find their contact information in the study consent document.
About the Research
- What is the research about and why is it being done?
- What do researchers hope to learn and who might benefit from it?
- Who is funding the study?
- Who has reviewed and approved the study?
- Who is being asked to volunteer to be in the study?
- Why are you, specifically, being asked to participate?
- When is the study expected to be completed?
- How will the findings of the research be shared and would you be informed personally?
- What kind of study is this?
- Is it a clinical trial?
- How many groups (or arms) are there?
- Is assignment to groups randomized, or could you choose?
- Will any of the groups receive a placebo or an inactive treatment?
What Would Happen
- Will any of the groups receive a placebo or an inactive treatment?
- Will you have to go anywhere to participate in the study?
- Will the study involve a novel or untested intervention that is considered experimental?
- Would you be told if you are given the intervention being tested?
- How long would your participation last?
- Would you be given the results of any study tests or procedures that are done?
- If you have a disease or condition that is being studied in the research and you choose not to participate, what treatments or procedures are available to you? Would you still have access to the research intervention outside of the study?
- If you have a disease or condition that is being studied in the research, ask if your doctor is also a researcher on the study. If so, who would watch out for your best interests as a patient?
- How would being in this study affect your daily life?
- How would being in this study affect your current medical care?
Risks Involved
- How much do the researchers know about the risks of the research intervention–especially if the intervention is novel or experimental? Does the intervention have FDA approval or oversight?
- What are the short- or long-term risks, discomforts, or unpleasant side effects? How likely are they to occur, and are any of them severe?
- What are the researchers doing to minimize risks, discomforts, or unpleasant side effects?
- Is there anything you could do to minimize your risks during the study?
Privacy and Confidentiality
- How would your biological materials (such as blood samples), data (such as test results), or other personal information be used or shared?
- How would your privacy and identifiable private information be protected?
- What could happen to you if your identifiable private information were disclosed to others?
Financial Considerations
- Will participating in the study cost you anything? For example, would you have to pay for certain tests or procedures, or the study drug? If so, what is the estimated cost and would it be covered by health insurance?
- If you were harmed while participating in the study, who would pay for the necessary medical care?
- Will there be any travel or other study-associated costs (for example, child care) and will researchers provide any money to cover those costs?
- If the research offers financial compensation, how much is offered and when would you receive it?
Additional Considerations
- Would you, personally, benefit from participating in the research? If so, how?
- How much time will you have to think about your options before making a decision?
- If your doctor is also the researcher on the study and you decide not to participate, would this decision affect your current medical care?
- Who should you contact if you have questions about participating in the research?
- Who should you contact if you have concerns about the research itself?
- What happens if you volunteer to participate now, but decide to quit the study later?
