Research Participant Bill of Rights

  1. To have enough time to decide whether or not to be in the research study, to ask question, and to make that decision without any pressure from the people who are conducting the research.
  2. To refuse to be in the study at all, and to stop participating at any time after you begin the study.
  3. To receive a copy of the consent form
  4. To be told what the study is trying to find out, what will happen to you, and what you will be asked to do if you are in the study.
  5. To be told about the reasonably foreseeable risks of being in the study.
  6. To be told about the possible benefits of being in the study.
  7. To be told whether there are any costs associated with being in the study and whether you will be compensated for participating in the study.
  8. To be told who will have access to information collected about you, and how your confidentiality will be protected.
  9. To be told whom to contact with questions about the research, about research-related injury, and about your rights as a research subject. 
  10. If the study involves treatment or therapy:
  • To be told about the other non-research treatment choices you have.
  • To be told where treatment is available should you have a research-related injury, and who will pay for research-related treatment.

Who Can Research Participants Contact For Help?

If you are already participating in a research study, you are encouraged to communicate with the research team first, especially if you are experiencing medical problems. You should have recieved a copy of a consent form or other document with investigator and emergency contact information.

You may contact the University of Pennsylvania's Institutional Review Board (IRB) for help if:

  • you want general information or have general questions about research or your rights
  • you wish to discuss problems, suggestions, or concerns and you do not feel comfortable talking with the research team
  • you want advice on how to communicate with the research team
  • you have communicated with the research team and they have not been able to help you.
  • You may contact the IRB by mail or by phone. Every precaution will be taken to maintain your confidentiality.

Mailing Address:
University of Pennsylvania
Institutional Review Board
3800 Spruce St. First Floor, Suite 151
Philadelphia, PA 19104
Telephone: (215) 898-2614

Frequently Asked Questions about Participating in Research:

What is research?

  • According to the U.S. Department of Health and Human Services (DHHS) definition §46.102, research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 
  • Clinical trial studies are research studies in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.
  • For more information on clinical trials, you can visit NIH Clinical Center and NIH Clinicaltrials.gov.

Why would I want to participate in research?

People participate in research for a variety of reasons such as helping others or contributing to scientific progress in improving a health or societal condition.

How is research at Penn reviewed and regulated?

  • Before any human research study can start at Penn, its research plan must first be reviewed and approved by a special committee called the Institutional Review Board (IRB). Under FDA regulations, the purpose of the IRB is to ensure that the rights and welfare of people participating in research studies are protected. The Penn IRB is made up of mostly Penn faculty and staff who are either scientists or non-scientists. 
  • Other Penn committees are often requested to provide additional review for specialized scientific issues.
  • Once a research study has obtained approval from the IRB to be conducted at Penn, the Office of Clinical Research and other committees continue to stay involved in watching over the study while it is being conducted.

Where can I find research studies to participate in?

  • Visit Penn's Office of Clinical Research (OCR) for additional information on clinical research at Penn. The OCR works closely with faculty who are conducting clinical research at Penn and can help you identify research participation opportunities. 
  • Research study advertisements can be found in public settings in the form of flyers, television/radio ads, and newspaper ads.
  • Referral from your health care provider 
  • Special interest groups, advocacy groups
  • Clinical trials website

How can I get additional information about my rights as a research participant?

You can contact the Penn IRB for any additional questions related to your rights as a research participant. Contact information is listed at the top of this page.

Who do I contact if I have questions about my privacy during a research study?

Penn Medicine patients who have questions regarding their privacy should contact the Penn Medicine Privacy Office at 215-573-4492 or privacy@uphs.upenn.edu.

Penn Medicine patients who have questions regarding the Research Contact Opt-Out should be directed to the Office of Clinical Research at 1-215-662-4484 or psom-ocr@pobox.upenn.edu.

Educational Resources

If you are interested in learning more about human subjects research or the laws and regulations in place to protect human subjects there is a free online education program available here:

http://cptraining.med.upenn.edu

This training course was created for people in the general community (not scientists and not affiliated with Penn) who might become part of a research team. For example, if a local business owner has been approached by a Penn research team to conduct focus groups or surveys with their employees or customers, the owner would be considered part of the research team. Penn policies require that anyone who is a member of a study team recieve special training related to conducting research. Since a local business owner would not already have research related training as part of their job, and would not have access to Penn researcher training classes, they are asked to complete this online training to ensure they are informed about how research is to be conducted while the experiment is ongoing.

This training program is certainly not required in order to be a reasearch subject however, it is free and available to anyone with an internet connection and a valid email address. The information in these trainings may be helpful for someone who is interested in becoming a research participant, or has already participated in research and wants to know more. You may start and stop the training at your convenience. The website will save your progress and you can log in anytime to review the materials.

the training courses include information about:

  • What is research and how is Human Research different from other types of research?
  • History and background of research involving humans
  • Rules about Human Research conduct
  • Who makes sure researchers follow the rules?
  • Important information about the process of informed consent (making sure participants know what they are signing up for)
  • Rules for protecting participant privacy and confidentiality (being careful with research information)