Frequently Asked Questions

This page includes general frequently asked questions (FAQs) related to the Institutional Review Board and how it functions. Additional FAQs will be added to this page over time to provide investigators to find answers to commonly asked questions posed to the IRB and the IRB Office.

Where are FAQs related to specific topics located?

In addition to the more general FAQs located in the accordions (the green bars below) on this page, many other FAQs pages can be found located at the bottom of IRB-related webpages. These FAQs address commonly asked questions relevant to information and content discussed on the pages on which they reside.

  1. What is an IRB?

    IRB is an abbreviation for the Institutional Review Board. The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
    The official name of the IRB committees at CHOP is The Committees for the Protection of Human Subjects. For more information about the CHOP IRB, its membership and structure, go to CHOP Institutional Review Board.

  2. How do I contact the IRB?

    For IRB contact information, please go to Contact the IRB.

  3. What is an FWA number and what is CHOP’s FWA number?

    FWA stands for Federal Wide Assurance, which must be submitted to the Office of Human Research Protections (OHRP) in order for an IRB to review research that receives federal funding. An FWA is a document that assures an institution's commitment to comply with the federal research regulations, with national and international ethical principles, and with federal, state and local laws related to the protection of human research subjects. CHOP's FWA number is FWA00000459. For more information about FWAs, go to Federal Wide Assurance (FWA).

  4. What is an Institutional Official and who is that at CHOP?

    The Institutional Official (IO) is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the Federalwide Assurance (FWA). The IO is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. At CHOP, the Institutional Official is Bryan Wolf MD, PhD.

  5. What is the difference between laws, regulations and IRB policies/procedures?

    There are a variety of federal regulations and state laws that apply to human subjects research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking.
    The IRB's Standard Operating Procedures (SOPs) provide the institution's standard approach to the interpretation of the federal regulations, best practice standards and state and local law. The SOPs serve as a reference for the IRB membership, IRB Office staff, and the CHOP community of investigators. Regulations are necessarily grey and their interpretation can evolve over time. The IRB SOPs, therefore reflect our current understanding of the Office of Human Research Protections (OHRP) and the FDA's interpretation of the regulations. In addition, the IRB has identified a number of ways to implement additional flexibility in its SOPs for research that is neither federally funded nor federally regulated. For more information go to Regulations and IRB policies.

  1. Who reviews my study/application?

    When an application is received by the IRB, it is triaged (based on information in the application) to be reviewed either by the convened board or, the IRB chair or a designee of the chair (vice chairs, the IRB director, assistant director or a senior Analyst). Before being forwarded to the reviewer, the application is pre-reviewed by an Analyst to ensure that it is ready to be reviewed (e.g. scientific review has been conducted, the protocol and consent form are attached, as applicable).

  2. I have submitted an application in eIRB. How do I know where it is in the review process?

    The current study state (i.e. where the submission is in the review process) is always indicated in the red bar in the top left hand corner in your eIRB application. Examples of common states your submission may be in are:

    • “In Department/Division Review” (the study awaits review by your Department Chair or Division Chief and has therefore not yet been submitted to the IRB);
    • “In Pre-Review” or “In Review” (it is being reviewed by the IRB);
    • “Changes Requested” (it is with you to respond to stipulations); or
    • “Ancillary Approval Pending” (all IRB issues have been addressed but approval from one or more ancillary committees, such as Conflict of Interest, Technology Transfer etc., may be outstanding).

    If the approval of ancillary committees is pending, you can find which ones are outstanding by going to the “Pre Review Status” tab in your study workspace (it can be found next to your “History”, “IRB Correspondence” and “Documents” tab”).

  3. Who should I contact with questions about the stipulations sent to me?

    The first contact for questions about stipulations sent to you is the Analyst assigned to the study (either by email, phone, office hours or one-on-one meeting as necessary). S/he will then either be able to provide you with the information needed or, if necessary, will contact the reviewer to set up a teleconference or meeting between the PI and the reviewer. In general, questions about the eIRB application and consent form should be directed at the Analyst for the study first. Questions regarding the protocol, reasons for deferral, risk/benefit or waiver determinations should be directed to the reviewer.

  4. Are the same Analyst and reviewer looking at all amendments to my study?

    While it is the IRB’s goal to maintain consistency and keep the same Analyst/reviewer pair on a study throughout its duration, this has to be balanced by the necessity of a timely flow of submissions through the office. Depending on the nature of the amendment (staff change, change to recruitment materials versus substantial changes to the study design) and overall workload (full board meetings, high submission volume, vacation schedules), amendments will also be assigned to Analysts/reviewers who have not reviewed the study before.

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