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. Visit the IRB website here.
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.
You will find the names and telephone numbers of the administrative staff for IRB #8 on the Contact page.
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. See the Code of Federal Regulations here.
The Code of Federal Regulations (45 CFR 46) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual; or (2) Identifiable private information.
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 please see this document. You can contact the ORA and they will assist you in making this determination.
To review 45 CFR 46 and learn more about the federal regulations that guide research with human beings please click here.
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.
How 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. 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 click here.
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.
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.
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.
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.