IRB & Human Subjects FAQ's

  • How can I contact the ORA?
    The ORA is located at: 3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6066. 215-573-2614.
  • Who do I contact at IRB?
    IRB Administrator: Kyle Stephens, MA: 215-746-6268, kstep@upenn.edu
  • How do I know if my research proposal requires IRB review? 
    IRB review is required when a research activity meets the definition of human subject research. The definition of human subject research is found in the Code of Federal Regulations (CFR) as defined by the Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP).  If you are not sure if your research falls within the definition of human subjects’ research that requires IRB review, you can refer to the ORA website or contact Jan Jaeger RN, Ph.D. at at jajaeger@mail.med.upenn.edu or at 856-313-8524 for assistance.
  • How do I know if my research is exempt from IRB review?
    The ORA will determine 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 believe it is de-identified data, you will need to submit your study to the IRB for a determination about the level of review.  To complete the IRB application for exemption of research, refer to ORA website, Click on IRB and click on the Forms Page.
  • How do I know if my study qualifies for an expedited review or must be reviewed by the full board?
    The federal regulations allow the IRB to review some research using an expedited mechanism. An expedited mechanism means the review is conducted by the Executive Chair of the IRB or a designee. This reviewer has the authority to approve research, but cannot disapprove research. If this reviewer does not approve the proposal, it will be referred to the full board for review. For both reviews, use the forms and templates provided by the ORA. For more information about expedited and full board review determinations refer to the ORA and OHRP websites.
  • 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. To avoid your study from expiring it is important to submit a timely IRB application for Continuing Review (CR). If your study expires the research will have to stop until you obtain IRB re-approval. Guidance and forms for submission are found on the ORA website.
  • What forms do I use to 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 informed consent documents. To obtain IRB approval for protocol modifications you will need to submit an application to the IRB explaining the changes you want to make. Guidance and forms for submission are found on the ORA website.
  • What do I need to know about the process of voluntary informed consent?
    All researchers must know the requirements for voluntary informed consent. The ORA website provides instruction and templates for written and verbal consent and information pertaining to the circumstances under which a waiver of written consent is permitted. Foreign language templates are available on the website. For more information contact Jan Jaeger, RN, Ph.D. at jajaeger@mail.med.upenn.edu or at 856-313-8524.