Resources > Human Subjects, Bioethics & IRB Resources
Researchers at the Population Studies Center should consult Jan Jaeger, RN, Ph.D., the PSC's IRB Consultant at: jajaeger@ssc.upenn.edu or at 215-573-8104, for information regarding an IRB submission or questions about human subject research.
Introductory Information:
All research proposals that involve human subjects must be submitted to the Office of Regulatory Affairs (ORA) for review by an Institutional Review Board (IRB).
The Office of Regulatory Affairs works with researchers, ethicists, and members of the public to assure that all research conducted under the auspices of the University of Pennsylvania honors Penn's standards for the treatment of people and animals.
The ORA web site contains basic information that faculty and students needs to know about doing research with human beings. Human subject research is a complex endeavor with changing policies, regulatory codes and standards of conduct that must be satisfied before research begins and while research is ongoing. It is the responsibility of all investigators to know what the University of Pennsylvania requires of them. The Office of Regulatory Affairs is the best resource for detailed information with a comprehensive web site and IRB administrators that are present to speak with investigators.
Population Studies Center researchers typically submit proposals for review to the Socio-behavioral Institutional Review Board #8 (IRB #8). IRB #8 is one of eight IRBs at the University of Pennsylvania. Its membership specializes in reviewing social and behavioral research protocols. Almost all of our protocols will be reviewed by this IRB. Social science submissions are reviewed the first Thursday of each month.
The Office of Regulatory Affairs Location and Contact Information:
Office of Regulatory Affairs
University of Pennsylvania
3624 Market Street, Suite 301 S
Philadelphia, PA 19104-6066
Phone: 215-573-1206
(Emergencies: 215-520-1121)
http://www.upenn.edu/regulatoryaffairs/
General Instructions for Submitting Proposals to the IRB
- IRB Homepage
- Adverse Events
- Application Procedures
- Assurances
- IRB Fees
- Forms Page
- Guides
- Meetings
- Training
- Standard Operating Policies
- Links
General Instructions for Research Involving Vulnerable Populations:
The Code of Federal Regulations (CFR) requires that vulnerable populations are afforded an extra level of protection. Instructions for preparing a proposal where vulnerable groups will be enrolled in research are located at the Office for Human Research Protections (OHRP) web site.
General Instructions for Special Issues:
General Instructions for International Research:
Regulations and Policy Guidance:
- Regulations
- Expedited Review Categories
- Guidance By Topic
- Decision Charts
- Belmont Report
- Related Resources
Other Important Links