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IRB & the IRB Review Process
About the IRB
The Children's Hospital of Philadelphia's (CHOP) IRB is organized and operates in compliance with the Department of Health and Human Services regulations, as described in 45 CFR 46, for federally funded research and FDA regulations, as described in 21 CFR Parts 50 and 56, for FDA regulated research. In addition, the IRB operates in compliance with portions of the HIPAA Privacy Rule that apply to research, as described in 45 CFR Parts 160 and 164.
CHOP’s Human Research Protections Program has received full Accreditation from the Association for the Accreditation of Human Research Protections Programs (AAHRPP).
Federalwide Assurance (FWA)
CHOP holds a Federalwide Assurance (FWA00000459). The CHOP IRB complies with the registration requirements for both OHRP and the FDA.
Compliance with Federal Regulatory Requirements and Guidelines
CHOP conducts human subjects research under its Federalwide Assurance (FWA) issued by the Office of Human Research Protections.
What is a Federalwide Assurance?
The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.
FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.
There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.
from OHRP's Assurance Process FAQs
The purpose of the FWA is to ensure that All of the Institution’s human subjects research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. This statement of principles may include (a) an appropriate existing code, declaration (such as the World Medical Association’s Declaration of Helsinki), or statement of ethical principles (such as the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research), or (b) a statement formulated by the institution itself. (from Key Features of an FWA)
A Federalwide Assurance 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 signifies that it is in compliance with all federal requirements for the protection of human subjects for federally funded research and research subject to FDA regulations.
Applying all Federal Regulations to All Research?
IRBs have the option to apply all of the regulations at 45 CFR 46 and all of OHRP's requirements regardless of the funding source for the research. Increasingly institutions are opting not to. The CHOP IRB has decided to not apply all of the federal regulations to non-federally funded, non-federally regulated research. This decision has permitted the IRB to exercise additional flexibility, while still ensuring adequate subject protections. The various IRB SOPs delineate the ways in which the CHOP IRB may deviate from the federal regulations. As an example for how the IRB has increased its flexibility, IRB SOP 401 includes an expanded list of categories of minimal risk research eligible for expedited review.
CHOP's FWA became effective on February 1, 2012 and will expire January 6, 2026. The CHOP IRBs comply with the registration requirements for both OHRP and the FDA. The CHOP FWA (FWA00000459) is on file with the Office of Human Research Protections (OHRP).
For those that are interested or need to view the registration, CHOP's IRB registration number is IORG0000195 and its FWA# is 00000459. Both can be located on OHRP's website.
Other Regulatory, Ethical and Compliance Standards
CHOP participates in clinical research that comes under the jurisdiction of the US Food and Drug Administration (FDA). When conducting this research, CHOP also complies with the regulations found under 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 361, 21 CFR 612, and 21 CFR 812. See IRB SOP 409 for more information regarding investigator-held INDs and IDEs.
Department of Defense
CHOP conducts research funded by the Department of Defense (DoD). The DoD regulations for protection of human research participants are applied when conducting, reviewing, approving, overseeing supporting or managing DoD-supported research with human subjects. See IRB SOP 107 for more information about how CHOP applies the DoD regulations.
CHOP's IRB standard operating procedures follow the ethical principles and guidelines for the protection of human research subjects set forth in the Belmont Report. These principles and guidelines include respect for persons, beneficence, and justice.
OHRP and FDA Guidance Documents
The IRB follows OHRP and FDA Guidance documents as they are applicable to the research being reviewed/conducted.
For clinical trials involving FDA-regulated agents, CHOP recognizes ICH E6: Guideline on Good Clinical Practice as one of the FDA's Guidance Documents; CHOP adheres to E6 where it is consistent with the FDA's regulations for the protection of human research subjects.
Committees for the Protection of Human Subjects (IRBs)
The Committees for the Protection of Human Subjects is the official name of the IRB committees that are appointed by and serve under the auspices of the CHOP Executive Committee of the Medical Staff.
The CHOP IRB reports jointly to the president of the medical staff and to Matthew Hodgson, MA, MS, CHRC, CCRP, who is the institutional official responsible for human research protections. At present, there are two CHOP IRBs. IRB A has 11 members and 11 alternates and meets twice a month; the Executive IRB has 5 members (also members or alternates for IRB A) and meets on an as needed basis. Committee membership is consistent with the requirements of 45 CFR 46.107 and FDA 21 CFR 56.107 and CHOP medical staff bylaws.
The CHOP Research Institute Administrative manual includes Appendix J - Human Subjects Protection Committees - Institutional Review Board Charter, which fully describes the IRBs organization and structure (available only on the CHOP intranet).
Each IRB at CHOP includes voting members, including a chair and vice chairs, in addition to a variable number of alternate members. Members are selected for their willingness to serve, expertise and familiarity with research design and procedures. Members include faculty from a wide variety of clinical disciplines and specialties to ensure adequate expertise. The committees also include legal advisors, nurses, pharmacists and others to provide needed expertise, and community members and non-scientists to represent the viewpoint of the general community and lay audience. Representatives unaffiliated with CHOP also serve on each IRB.
The committee also includes members who can represent the interests of special and vulnerable populations. If necessary, the IRB will seek outside consultation to supplement existing expertise on the committee. By maintaining a diverse membership, CHOP's IRB are able to review the wide variety of research studies conducted at CHOP.
The membership of CHOP's IRBs complies with all federal regulatory requirements. The IRB works closely with related committees, such as Radiation Safety, Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee and the Center for Human Phenomic Science (CHPS), to ensure that the requirements of those groups are addressed before final approval of a project is provided.
Structure of CHOP's IRB Committee
The CHOP IRB is composed of 11 individuals each of whom is paired with an alternate member. (Figure) One member of the pair is expected to attend each meeting, which take place on the first and third Wednesdays of the month.
- The meetings are chaired by either the Chair or a Vice-chair of the Committees for the Protection of Human Subjects;
- Scientific members are represented by the yellow rectangles and include physicians, a nurse and pharmacist;
- Non-affiliated (preferably non-scientific) members are represented by the green rectangles;
- A statistician serves as a alternate and may substitute for any scientific member.
- The Director and the Assistant Director, IRB Analyst IIs, and IRB Analyst IIIs are also alternate members. This enables them to be designated by the chair to review and approve minor changes to research and continuing reviews of minimal risk research.
Working with the IRB: Resources for Investigators
The IRB Office provides administrative and technical support as well as regulatory expertise for the committees and serves as the primary contact for investigators. See Contact Us to get in touch with the IRB Office staff.
Streamlining Ethical Review - This last reference should be of assistance to investigators whose IRBs do not take advantage of the flexibility permitted within the regulations.
IRB Review Process
HIPAA and Research
HIPAA requires that either an IRB or a Privacy Board make determinations about the use of PHI in research. At CHOP, the IRB is responsible for playing this role. The IRB is well suited to review protections for PHI since it already has responsibilities under the Common Rule to protect the privacy of subjects and their confidential information. Consent documents also must provide information describing the how the subject's private information will be protected. Under HIPAA and CHOP Research Institute Policies, the IRB is required carry out the responsibilities outlined in the box on the right.
Frequently Asked Questions
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.
How do I contact the IRB?
For IRB contact information, please contact the IRB.
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).
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 Matthew Hodgson, MA, MS, CHRC, CCRP.
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.
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).
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 workspace. 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 and which approvals have already been received by looking at the information at the top of your study workspace (the section where e.g. the study name, PI, study coordinator, and funder are listed) under "Ancillary Review Status".
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.
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.
My submission is time sensitive. How do I let the IRB know?
If a submission is time sensitive, (e.g. due to a just-in-time grant funding), please indicate this at the time of submission (as a comment in the workspace). Upon receipt of a JIT notice, please promptly contact the IRB. This allows the IRB to triage accordingly. As the IRB will have to prioritizie such submissions over those of other investigators, please attach the correspondence (from e.g. the funding agency) indicating the deadline for approval with the IRB submission.