Compliance with Federal Regulatory Requirements and Guidelines
CHOP conducts human subjects research under its Federalwide Assurance issued by the Office of Human Research Protections.
What is a Federalwide Assurance (FWA)?
The Federalwide Assurance (FWA) 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 Federal Wide Assurance (FWA) 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.
To Check the Box on the FWA or Not?
The FWA application includes 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 to not "check the box." Currently approximately 50% of institutions do not check this box and more are unchecking it every year.
Unchecking the Box
Effective February 1, 2012, the CHOP IRB revised its FWA and no longer checks the box . The decision to not apply all of the federal regulations applies to non-federally funded, non-federally regulated research. This decision has permitted the IRB to exercise additional flexibility. 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 April 21, 2020. 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.