IRB Registration and Federalwide Assurance (FWA) Questions and Answers

Index

How does an organization register an IRB with DHHS?
What is the connection between IRB Registration and Federalwide Assurance (FWA) Filing?
How does an institution file a Federalwide Assurance (FWA) with DHHS?
Under what circumstances can an institution rely on another organization’s IRB?
Under the old system, institutions could file Joint Assurances, Cooperative Amendments, and InterInstitutional Amendments (IIAs) to cover cooperative IRB review arrangements. How are such arrangements handled with FWA’s?
How are "unaffiliated" investigators and physicians in private practice settings covered under the new system?
What education requirements must be completed for Domestic Institutions along with the FWA document?
What education requirements must be completed for International Institutions along with the FWA document?
What constitutes assurance training that's equivalent to the OHRP modules?
Who may serve as the Signatory Official on a FWA?
Who/What is the Human Protections Administrator?
If an institution designates another organization’s IRB(s) in its FWA, what are the institution’s responsibilities for protecting human subjects?
If an institution relies upon the IRB of another organization, how should it answer the questions posed in Item 4 of the FWA?
Will OHRP continue to accept CPAs, and SPAs?
What happens to existing MPAs and CPAs? What about changes to them?
How do I update my IRB membership rosters?
FWA Item (1) asks for IPF and EIN numbers. What are IPF and EIN numbers? Are they required to file an Assurance?

IRB Registration and FWA filing are two seperate but related processes. Any organization may register it's IRB's (FAQ #1 above). However, in order to file a FWA (FAQ #3 below), the FWA institution must designate (in item 5 of the FWA) at least one (or more) registered IRB(s) to serve as the IRB of record for research conducted under the FWA. Item 5 must include the IRB Identifier (begins with IRB), IRB Name, and Name and Title of the IRB Official(Chairperson, IRB Organization Head) and have the signature of the IRB Organization Official. The IRB identifier and Name are assigned upon registration and may be found on the Listings of Registered IRBs/IECs at [http://ohrp.osophs.dhhs.gov/polasur.htm#IRB]. Note, although IRB membership data are not required to register an IRB, they must be provided for designation of an IRB by a FWA, reflected by a date in the MEMBERS column of this WEB listing.

Any institution may file a FWA with DHHS/OHRP. (i) Simply download, complete, and forward to OHRP the 4 to 5 page FWA form at [http://ohrp.osophs.dhhs.gov/humansubjects/assurance/filasuri.htm]; (ii) confirm receipt of the FWA filing at [http://ohrp.osophs.dhhs.gov/humansubjects/assurance/rlog.htm]. OHRP will review FWA filings expediciously and post approvals at it's website. If a FWA is submitted completely free of errors, OHRP will attempt to approve it within 5 to 7 working days and post it on the OHRP website at [http://ohrp.osophs.dhhs.gov/polasur.htm#FWA]. If an e-mail address if provided for the signatory official, they will be e-mailed a notification of approval. OHRP will return a copy of the signed FWA for institutional records. Once approved, human subjects research can begin, subject to funding authority requirements relating to certification of IRB approval.

Institution A can rely on Organization B’s IRB any time Organization B’s registered IRB agrees to the arrangement and satisfies the guidelines for knowledge of the local research context at [http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm]. If such reliance reflects an on-going arrangement, Organization B’s IRB should be designated in Item 5 of Institution A’s FWA (see requirements in FAQ #2 above). If the reliance is an unexpected, one-time arrangement, institutions with FWAs can use the sample "IRB Authorization Agreement for an Individual Protocol" (do not send to OHRP, unless specifically requested) on OHRP’s website at [http://ohrp.osophs.dhhs.gov/humansubjects/assurance/iprotsup.rtf].

Each legally separate entity engaged in human subject research conducted, supported, or otherwise subject to regulations by any Federal Department or Agency [check with legal council] must have its own OHRP approved FWA. Components of a FWA Institution that are not legally separate do not need to submit a separate FWA if (i) the component is listed under item 3 of the FWA and (ii) the signatory official is legally authorized to represent the component. Otherwise, components may not be listed in item 3 of the FWA and will need to file separate FWAs. As explained in FAQ #4 above, an institution may rely on another institution's IRB anytime the two institutions agree to such an arrangement and the IRB satisfies OHRP guidance for taking into account the local research context. Item 5 of the FWA should list all IRBs (see requirements in FAQ #2 above) that the institution may rely upon under any "cooperative" IRB review arrangement. Written policies and procedures should define the human protection responsibilities of all involved parties. These documents should not be submitted to OHRP unless specifically requested.

Investigators who are not acting as employees or agents of an FWA institution when they conduct Federally-supported human subject research are nevertheless subject to all of the usual human protection requirements. Such investigators must enter into an arrangement with an FWA institution under which they agree to be bound by the human protection policies of the institution and its designated IRB(s). The "Unaffiliated Investigator Agreement" on OHRP’s website at [http://ohrp.osophs.dhhs.gov/humansubjects/assurance/unaflsup.rtf] may be used for this purpose. The agreement should not be forwarded to OHRP. Individual physicians operating in private practice settings that are not covered under an Assurance may follow the same procedure. Alternatively, a group of physicians operating within their own private practice may choose to file an FWA in the name of their practice.

The FWA is a voluntary option (at this time) to it's predecessor Assurance mechanisms. The FWA requires that the Signatory Official (see FAQ #10), the Human Protections Administrator (contact person - see FAQ #11), and the IRB Chairperson complete the web-based OHRP modules at [http://137.187.172.201/cbttng_ohrp/default.asp?CBTID=2]. These modules are specifically designed to ensure that these individuals are aware of their responsibilities under the FWA. They replace detailed information included in former Assurance. This process reduces the paperwork and streamlines the new process. OHRP will check to verify that the Signatory Official, Human Protections Administrator, and IRB Chair(s) have completed the appropriate OHRP Assurance training modules before approving the FWA -- unless the institution certifies to OHRP that these individuals have taken equivalent training (see FAQ #9 below).
The OHRP modules are not to be relied upon solely as 'educational' programs. The modules are not interactive nor do they cover the broad knowledge required for the ethical conduct of human subject research and the protection of human subjects in research. OHRP expects institutions to provide a program of education for its IRB Chair and members. Such an expectation derives from the regulatory requirement that an IRB has the expertise to review the research at hand and knowledge of institutional commitments, regulations, applicable Federal and State Laws, and standards of professional practice. Additionally, investigators are expected to understand their role, honor the IRB's oversight, obtain legally effective consent unless appropriately waived by the IRB, and report to the IRB: (i) unanticipated problems involving risks to subjects or others in any human subject research, and (ii) serious or continuing non-compliance.

It is recommended that the OHRP Training Modules for Assurances be completed. However, self-certification of equivalent training will be honored.(see FAQ #8). The Institution's Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), the IRB Chairperson(s), IRB members, IRB staff, and research investigators must receive appropriate training in the protection of human research subjects. Upon request, they need to demonstrate knowledge of the FWA Terms of Assurance for Institutions Outside the United States, and of the Ethical Standards and International Codes referenced in their institution’s FWA.

In order to be equivalent, a program must directly cover all of the information contained in the OHRP Modules. The following topics must be covered: 1) the responsibilities of the institution's signatory official, 2) institutional responsibilities, 3) the responsibilities of the IRB Chair, 4) IRB responsibilities, 5) the administrative responsibilities of a human research protections program, and 6) investigator responsibilities.
OHRP will accept training certified by the institution as equivalent to the OHRP assurance modules. Self-certification would involve the need for an appropriate person from the institution to (1) take both the alternative training and the OHRP modules; (2) compare the two, and if equivalent, (3) identify the alternative and certify to OHRP its equivalency, and (4) attest that the signatory institutional official, IRB Chair, and Human Protections Administrator have completed the alternative training. Certification or training completion should be submitted along with the FWA.

The FWA Signatory must be a high-level, administrative, institutional official who has the legal authority to (i)represent and sign for the institution named in the FWA, including all the institutional components listed in section 3 of the FWA, and (ii) assure compliance to all the terms of the assurance for all components. Entities that the Signatory Official is not legally authorized to represent may not be listed as components and are not covered under the FWA.

The Human Protections Administrator is an employee or agent of the FWA institution who exercises operational responsibility, on a day-to-day basis, for the institution’s program for protecting human research subjects. This individual’s title and position within the institutional structure will vary among institutions. It is important fo this individual to have a comprehensive knowledge of all aspects of the institution’s systemic protections for human subjects. Every domestic FWA institution should have a Human Protections Administrator, even if the institution relies totally on IRBs from other organizations (see below). Generally, this should not be the IRB Chairperson or Signatory Official. However, in some instances, e.g. small businesses, an institutions size may not permit different individuals to serve in this capacity.

When an institution filing the FWA designates another organization's IRB, the FWA institution remains responsible for maintaining an institutional system to protect human research subjects (see item [C] of OHRP guidance at [http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm]. The FWA institution can choose to have some of those responsibilities handled by the IRB organization, but the respective responsibilities of the IRB organization and the FWA institution should be put in writing (this agreement should not be sent to OHRP for approval unless specifically requested by OHRP). The institution providing the FWA retains ultimate responsibility for the protection of human research subjects for all research covered by the FWA, including (i) safeguarding the rights and welfare of human subjects within its local research context; (ii) educating the members of its research community in order to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human subjects; and (iii) implementing, within its local research context, appropriate oversight mechanisms to ensure compliance with the determinations of the reviewing IRB.

These questions refer to the Assuring institution’s overall human research subject protection program, and should be answered from that perspective. As long as there are clear written policies defining areas of responsibility (see above), it does not matter whether the responsibilities in Items 4(a), 4(b), and 4(c) may be implemented by either the Assuring institution or by the IRB organization acting on behalf of the Assuring institution. Item 4(d) refers to the Signatory Official, the Human Protections Administrator, and relevant staff at the institution providing the FWA, as well as to the Chairpersons of all IRBs designated under item 5 of the FWA. Completion of the OHRP training modules at [http://137.187.172.201/cbttng_ohrp/default.asp?CBTID=2] must be accomplished by those designated under intem 4(d) prior to OHRP approval of the FWA. Item 4(e) refers to personnel at the Assuring institution only.

During the initial implementation phase, OHRP will continue to accept CPAs and SPAs. As the implementation proceeds, OHRP will announce a final date after which CPAs and SPAs will no longer be processed.

Existing MPAs and CPAs will remain in effect until their expiration date, or December 31, 2003, whichever comes first. Institutions holding active MPAs and CPAs are strongly encouraged to voluntarily file a FWA at their earliest convenience. OHRP no longer routinely processes MPA or CPA amendments or modifications, and Inter-Institutional Amendments (IIAs). It is recommended that institutions requiring such modifications file a FWA.

All institutions should use the new IRB Registration format to update their IRB membership rosters, regardless of the type of Assurance (FWA, MPA, CPA) they hold. The form should be checked as an 'Update' and include IORG and IRB identifiers obtained from the Web listings at [http://ohrp.osophs.dhhs.gov/polasur.htm#IRB]. Complete all answers to questions that have not previously been submitted to OHRP, or answers that may have changed since the last update.

IPF and EIN numbers are assigned by Agencies other than OHRP. Some funding Agencies use these numbers for tracking purposes. OHRP has requested them simply to assist those Agencies in tracking assurance completion. If your institution has no IPF or EIN number, just leave the item blank. The IPF and EIN are not required for completion of a FWA and will not delay processing of your FWA.

DRAFT

Office for Human Research Protections (OHRP)

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