IRB & Human Subjects
Institutional Review Board Submission Process Guidance:
For assistance in preparing applications for IRB review or for questions about IRB submission contact the Population Studies Center IRB advisor, Jan Jaeger RN, Ph.D. at firstname.lastname@example.org or at 617-496-5593.
Institutional Review Boards (IRBs) are charged with the responsibility of protecting the rights of human research subjects. Faculty and students at the Population Studies Center who are planning to conduct research involving human research subjects must submit to the Office of Regulatory Affairs (ORA) an application for review by an IRB.
The University of Pennsylvania has eight IRBs which meet to review proposals once a month. All IRBs are housed in the ORA and managed by its staff. IRB # 8 is the only IRB dedicated to the review of social and behavioral protocols. Almost all of the Population Studies Center research protocols will be reviewed by this IRB. To see a schedule of IRB meetings refer to the ORA website which provides a meeting calendar.
The ORA web site contains the pertinent information that researchers will need to know to prepare an application for IRB review. The website includes guidance on protocol and informed consent preparation, worksheets for level of IRB review determinations, forms and templates, IRB meeting schedules, staff contact information and is the site for the electronic protocol submission process and tracking. Researchers must access this site to acquire the appropriate documents and templates and to submit an IRB proposal. 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. The ORA provides the most current information regarding policies and procedures and may serve as a valuable resource.
All faculty and students conducting research with human subjects at the University of Pennsylvania must be certified to do so. Proof of certification must accompany IRB applications. Penn requires that researchers take the CITI training and certification exam. To take the CITI training and certification exam log on to PennEra.
Included in the CITI training is information about Health Insurance Portability and Accountability Act (HIPAA) requirements. Proposals must confirm whether HIPAA protected information is part of the research and if so, how it will be protected.
General Instructions for Research Involving Vulnerable Populations:
The CFR requires that vulnerable populations are afforded an extra level of protection. Regulations guiding research with vulnerable populations, such as prisoners and children and research in the developing world are found in the CFR and on the websites of the OHRP and ORA or contact Jan Jaeger, RN, Ph.D. at email@example.com.
Please see the IRB & Human Subjects Frequently Asked Questions page for additional details and see this page of Resources for links to other important information.