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@mail.med.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 (IRB) 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)
Frequently Asked Questions:
Which Institutional Review Board (IRB) will review my study?
The University of Pennsylvania has eight ethics review committees known as IRBs #1- #8, that are charged with promoting the rights and welfare of human research participants. The IRBs are administered by the Office of Regulatory Affairs (ORA) at 3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6006. Seven of the eight IRBs are dedicated to the review of biomedical research. One IRB, which is referred to as IRB #8, is dedicated to the review of social and behavioral science research. When you submit your study for review it should be sent to the above address and to the attention of IRB #8. You can contact the administrative personnel at the ORA by phone at 215-898-2614. The website can be accessed by clicking here: http://www.upenn.edu/regulatoryaffairs//index.php?option=com_content&task=view&id=3&Itemid=8.
When does the Social and Behavioral IRB meet?
Generally, IRB #8 will meet on the third Monday of each month. Your proposal and accompanying information should be submitted approximately three weeks prior to the scheduled meeting date. The submission dates and scheduled meeting dates are subject to change, therefore please see the schedule of dates at: http://www.upenn.edu/regulatoryaffairs//index.php?option=com_content&task=view&id=22&Itemid=8.
You will find the names and telephone numbers of the administrative staff for IRB #8 by clicking here: http://www.upenn.edu/regulatoryaffairs//index.php?option=com_content&task=view&id=8&Itemid=13.
How do I know when my research proposal requires IRB review?IRB review is required when a research activity meets the definition of human subject research as defined by the Department of Health and Human Services, Code of Federal Regulations, otherwise referred to as 45 CFR 46. For information on the Code of Federal Regulations click here: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
If you are not sure whether your research falls within the definition of human subjects’ research or if you need to have the proposal reviewed by an IRB contact Jan Jaeger or see the ORA website and they will assist you in making this determination.What forms do I need to submit to the IRB?
All of the forms you need to submit as part of a proposal for review by IRB #8 are available on the ORA website. In general, you will need a face sheet, a research proposal and a consent document or waiver or alteration of consent. Templates for these documents can be found by clicking here:
http://www.upenn.edu/regulatoryaffairs//index.php?option=com_content&task=view&id=20&Itemid=8How do I know if my research is exempt from IRB review?
The ORA determines if your research is exempt from IRB review. This decision is not to be made by the researcher or student even if you believe that your research is exempt. In order for the ORA to make this determination you will have to complete the IRB application for exemption of research and submit it electronically to the ORA. You will receive notice from the ORA once a determination of exemption has been made. Until you hear from the ORA you are not permitted to conduct research even if you believe that your study satisfies the criteria for exemption from IRB review.
If you are doing research where your only source of data is from a de-identified publically available data set you do not have to submit a proposal for IRB review. However, if you are doing research with a secondary data set that is not publically available and even if you believed it is de-identified data, you will need to submit your study to the IRB where a determination will be made about the level of review.
To determine if your research may be exempt from IRB review click here: http://www.upenn.edu/regulatoryaffairs//Pdf/claimofexemptioninstructions.pdf. If it meets the criteria for exemption, you still need to submit the application for review.
To complete the IRB application for exemption of research go to ORA website, Click on IRB and click on the Forms Page.
How do I know if my study requires an expedited review or a review by the full board?
The federal regulations allow the IRB to review some research using an expedited mechanism. All studies that meet this determination are reviewed at least once a year. An expedited mechanism means the review of research is conducted by the Executive Chair of the IRB or a designee. This reviewer has the authority approve research, but cannot disapprove research. If this reviewer does not provide approval the research will be referred to the full board for review. The ORA will determine if a study meets criteria for an expedited review or a review by the full board. For both reviews, use the forms and templates that are referenced above. For more information about expedited and full board review determinations click here: http://www.hhs.gov/ohrp/policy/.
What is a Continuing IRB Review? What forms do I need to use?
You will be notified by the ORA of the date that your study will expire. Generally, it is one year less one day from the approval date. If your study expires the research will have to stop until you obtain IRB re-approval. It is therefore important to file a Continuing Review (CR) form when it is required by the ORA. To complete the CR form click here:
http://www.upenn.edu/regulatoryaffairs//index.php?option=com_content&task=view&id=20&Itemid=8.What forms do I use to Amend or Modify a study that already has IRB approval?
Once the IRB has approved your study it cannot be changed unless the changes are approved by the IRB. This includes minor or major changes to the protocol and consent documents. To obtain IRB approval for protocol modifications you will need to submit a packet to the IRB explaining the changes you want to make. The forms you will need to complete for a modification or an amendment can by found by clicking here: http://www.upenn.edu/regulatoryaffairs/index.php?option=com_content&task=view&id=20&Itemid=8
What are the certification requirements?
All faculty and students doing research with human subjects at the University of Pennsylvania must be certified to do so. The certification exam and certificate upon completion can be obtained by logging on to PennERA. Also see:
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: