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 may also contact the University of Pennsylvania's Office of Regulatory Affairs, 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 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.
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. People participate to help others and contribute 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 firstname.lastname@example.org.
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 email@example.com.