Federalwide Assurance

(information summarized from OHRP website )

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Introduction

The Office for Human Research Protections (OHRP) in the United States (US) requires that each institution provide written assurance that it will abide by principles and procedures that meet or exceed US standards for research involving human subjects. In addition, each institution must certify to the OHRP that the research has been approved by a Research Ethics Board designated in the assurance. In the past, OHRP accepted assurances included the Federalwide Assurance (FWA), Cooperative Project Assurance (CPA), Single Project Assurance (SPA), or Multiple Project Assurance (MPA). The CPA was the most common type of Assurance held by NCIC CTG centres.

Current Status

Effective February 10, 2005, the FWA will be the only type of assurance application accepted for review and approval by OHRP. Existing CPAs will remain in effect until December 31, 2005. Any institutions currently holding a CPA number must submit and FWA application to OHRP for approval prior to December 31, 2005.

Federalwide Assurance of Protection for Human Subjects (FWA)

This new simplified Assurance covers all of an institution's U.S. federally-supported human subject research. Awardee institutions are automatically considered to be "engaged" in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award. The awardee is also responsible for ensuring that all collaborating institutions engaged in the research hold an approved Assurance prior to their initiation of the research. The FWA will eliminate the need for other types of Assurance documents (e.g. SPA, CPA).

OHRP is responsible for the FWA and Institutional Review Board (IRB) Registration system. Under the new system, each REB is assigned a unique Identification Number (e.g., IRB00000000), each organization operating an IRB/REB is assigned a unique Organization Number (e.g., IORG00000000) and Institutions filing an Assurance will be assigned a unique Assurance Number (e.g., FWA00000000).

Filing an FWA

With the FWA, centres are required to complete the application and forward it directly to OHRP. [Detailed Instructions for completing an FWA, as well as registering an IRB can be found on the OHRP website http://ohrp.cit.nih.gov/efile/Default.aspx.]

Once a centre receives their FWA number, they must notify NCIC CTG. This information will be entered into the database along with the expiration date. A centre cannot be activated on an NCI US affiliated trial unless a current FWA number is on file. The FWA will expire 3 years after the approval date. Any updates to the FWA should be submitted by the centre to OHRP throughout the 3 years whenever there are changes in the information provided on the approved FWA. The Ethics and Regulatory (ER) office will continue to offer reminders to centres when their FWA number is coming due for renewal.

The OHRP lists all REB registration numbers and FWA numbers on their website at: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc. However, it is a centre's responsibility to inform the ER office of this information. ER does not extract this information from the OHRP website for entry into the database without confirmation from the centre. Any institution is eligible to file an FWA with the HHS/OHRP. Detailed instructions for completing an FWA application, as well as, registering an REB can be found on the following OHRP website at http://ohrp.cit.nih.gov/efile/Default.aspx.

The application process can be completed in two ways; paper-based or electronic submission. Steps for completing both the paper-based application and electronic submission can be found on the following OHRP website http://www.hhs.gov/ohrp/assurances/index.html.

Each legally separate entity that engages in U.S. federally-supported human subject research will need its own FWA under the new system. The institutional FWA Signatory must be an individual who has the legal authority to represent the institution named in the FWA, as well as all the institutional components listed in the FWA. Entities that the Signatory Official is not legally authorized to represent may not be covered under the FWA.

Education

The new FWA recommends that the Signatory Official, Human Protections Administrator, and the REB Chairperson complete the web-based OHRP training modules. These modules are specifically intended to ensure that these individuals know their responsibilities under the Assurance as these modules essentially replace the information covered under past paperwork and achieve some of the simplification in the new process.

The OHRP modules are not to be relied upon solely as educational training programs, in part because 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 has expected and continues to expect that institutions provide educational training for its REB Chair and members, as well as its investigators. Such an expectation derives from the regulatory requirement that an REB has the expertise to review the research at hand and knowledge of institutional commitments, regulations, applicable law, and standards of professional practice. The purpose of the modules is to ensure that the three key individuals (The Institutional Signatory Official, the REB Chair, and the Human Protections Administrator) are aware of the responsibilities that must be fulfilled under an FWA. OHRP will acknowledge training certified to OHRP by the institution as equivalent to the OHRP modules. Institutions, however, should note that most general human subject protections training/education programs are not equivalent to the Assurance Training Modules. For example, such general human subject protections training programs such as the online training offered by NIH would not be considered equivalent to the Assurance Training Modules for the purpose of submitting an FWA.

In order to be equivalent, a program must directly cover all of the information covered in the three OHRP Modules.

They are:

1. Federal Regulations & Institutional Responsibilities
2. Investigator Responsibilities & Informed Consent
3. Human Protections Program Administration & REB Responsibilities

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, REB Chair, and Human Protections Administrator have completed the alternative training. An exchange of e-mails between the institution and OHRP would suffice as adequate documentation.

Also OHRP would consider completion of any PRIM&R IRB 101 program on or after March 9, 2001 as an equivalent alternative to completing the OHRP modules.

Other educational materials OHRP/PRIM&R Investigator 101 CD-Rom

The INVESTIGATOR 101 CD-ROM is a new state-of-the-art media that provides education on the responsible conduct of human research and protection of human subjects. This educational tool was developed by the Public Responsibility in Medicine and Research (PRIM&R). It provides a combination of interactive features such as: cross linking, search engines, speakers, slide presentations, transcripts, ethical and research guidelines, and federal regulatory documents. OHRP has announced the availability of this CD-ROM to institutions having an approved Department of Health and Human Services (DHHS) Assurance on file with the OHRP. Those institutions that have a Federalwide Assurance (FWA) will be eligible to receive a copy of the CD-ROM.

Please note that all Federally Assured Institutions who request the Investigator 101 CD-ROM must sign a Recipient License Agreement with the Public Responsibility in Medicine and Research and adhere to the terms and conditions specified in this agreement. Questions regarding this agreement should be directed to Ms. Rebecca Leroux at PRIM&R (rebecca.leroux@PRIM&R.org or 617-423-4112). For instructions on how to order the CD-Rom go to http://ohrp.osophs.dhhs.gov/references/cdrom.pdf.

What are the Education requirements for International Institutions under the FWA? The Institutional Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), the REB Chairperson(s), REB members, REB staff, and research investigators must be appropriately trained in the protection of human subjects. Upon request, they should be able 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.