Rights as a Research Subject (2024)

Research subjects who participate in studies at the UI have rights enshrined in federal laws, state laws, and university policy. Among these rights are:

• The opportunity to voluntarily consent to participate after receiving pertinent information about study purposes and procedures, including potential risks and benefits of participation,
• The ability to end participation at any time,
• Privacy, meaning that subjects are free to not answer questions,
• Confidentiality, meaning that your participation in research will not be disclosed except under conditions explained prior to participation.

Click on the links below to learn more about research subject rights.

• Research Volunteer Brochures, Flyers and Tools- The Office of Human Research Protections offers a variety of materials for people considering enrollment in a research study.
• Veterans' Participation in Research- You may see this brochure at the Veterans Administration Hospital in Iowa City.
• The Bill of Rights for Research Participants- This summarizes the rights you have as a research participant.
• NIH Clinical Research Trials Brochure- This is an extensive list of information about the special kind of research study called a clinical trial.

If you have any questions, concerns or complaints about being a research subject or if you would like to share your experiences of being a research subject, you can call the Human Subjects Office at (319) 335-6564 or send us an e-mail at irb@uiowa.edu.

Children are considered a vulnerable population under federal law, meaning that research with children must receive a thorough review of procedures to ensure that risks have been minimized and benefits maximized. The links below provide useful information on children as participants in human subjects research.

• Children & Clinical Studies (NIH)
• Would Your Child Benefit from a Clinical Trial? (Guide)
• Teaching Children about Animals in Research(Kids4Research.com)
• FDA for Kids

Researchers have a responsibility to minimize the risks of harms to subjects. When unexpected or adverse events occur in the course of a research study, these must be reported to the IRB. The Human Subjects Office and the IRB provide review and monitoring for human subjects research at the UI to ensure that safety protocols are being followed and that research is conducted in line with federal, state, and institutional regulations.

• Report Adverse Events(FDA.gov)
• Easy to Read Health & Safety Info(NIH)
• Agency for Healthcare Research and Quality(HHS)
• News about Clinical Trials(AHRP)
• The Center for Information and Study on Clinical Research Participation (CISCRP)
• Health Information for Seniors (NIH)

Some examples of research that may be restricted or prohibited by UI policy:

• Classified research - This includes activities that contain classification from the federal government and activities that require the use of classified information and materials. Approval from the Vice President for Research is required for use of UI facilities for classified research. Maintaining the confidentiality of proprietary information does not constitute secret research. The UI Operations Manual outlines the conditions under which classified research may be approved. (UI Operations Manual, 27.2b)
• Research subject to export control laws and regulations – This includes laws/regulations that restrict the dissemination of results and access to, and participation in, research activities by foreign nationals. The contract must include acceptable language related to the application of export control requirements (UI Operations Manual, 27.2c)
• Research with detainees (prisoners of war) and testing chemical or biological warfare agents is also restricted. See the UI DoD Guide for details.

The Office of Human Research Protections (OHRP) offers resources for prospective and current subjects in research studies. This office, operating under the Department of Health and Human Services (HHS), focuses on the protection of the rights, welfare, and well-being of human research participants. We encourage you to view the information available at the following OHRP links on the public outreach page:

• Informational Videos about being a participant in a research study
• Protecting Research Volunteers – Regulations that ensure the rights and welfare of subjects
• Questions to Ask – How to ask for information to make an informed decision to participate
• Additional Resources – Glossary of terms, relevant federal resources, and media

OHRP periodically posts new videos or other content on their website. All resources are written in lay terms for the general public. They are all available in English and Spanish.