Supporting Statement for the Federalwide Assurance (FWA)
A. Background
The purpose of the FWA is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are research institutions engaged in HHS-conducted or –supported research involving human subjects.
B. Justification
Need and Legal Basis
Section 491(a) of the PHS Act states that the Secretary shall by regulation require that each entity applying for HHS support to conduct research involving human subjects submit to HHS “assurances” satisfactory to the Secretary that it has established an institutional review board (IRB) to review the research in order to protect the rights and welfare of the human subjects of such research.
Section 491(b) of the Act requires HHS to establish a program (i) for responding promptly and appropriately to requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects; and (ii) for responding promptly and appropriately to information regarding incidences of violations of the rights of subjects of research conducted or supported by HHS.
Pursuant to the requirements of the PHS Act, HHS has promulgated regulations for the protection of human subjects at 45 CFR part 46. These regulations require that each institution engaged in research which is covered by the regulations and which is conducted or supported by HHS provide written assurance satisfactory to the Secretary that it will comply with the requirements set forth in the regulations
[45 CFR 46.103(a)]. In lieu of requiring submission of an assurance, each of the other 15 departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (the Federal Policy) shall accept the existence of a current assurance, appropriate for the research in question, on file with, and approved for Federalwide use by, the Office for Human Research Protections (OHRP)
[45 CFR 46.103(a)].
In accordance with HHS regulations at 45 CFR 46.103(b), assurances applicable to HHS-conducted or supported research shall at a minimum include:
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, regardless of whether the research is subject to Federal regulations [45 CFR 46.103(b)(1)].
Designation of one or more IRBs established in accordance with the requirements of the HHS regulations [45 CFR 46.103(b)(2)].
A list of IRB members identified by name, qualifications, and affiliations
[45 CFR 46.103(b)(3)].
Written procedures which the IRB will follow for conducting its reviews of research [45 CFR 46.103(b)(4)].
Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Secretary of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval
[45 CFR 46.103(b)(5)].
The assurance must be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by the HHS regulations, and must be filed in such form and manner as the Secretary prescribes
[45 CFR 46.103(c)].
OHRP is the HHS component charged with fulfilling the statutory mandates of the PHS Act and enforcing HHS regulations at 45 CFR part 46. The FWA provides a simplified assurance process that replaces the prior assurance mechanisms used by OHRP, all of which were more complicated and burdensome than the FWA. The information collected by OHRP through the FWA is the minimum necessary to satisfy the assurance requirements of the PHS Act and the requirements of HHS regulations at 45 CFR 46.103.
Information Users
The FWA collects the following information for the following purposes:
The legal name, location, HHS Institution Profile File code (if known), Federal Entity Identification number (if known), and the current OHRP-approved assurance number of the institution filing the FWA.
For the FWA for International (Non-U.S.) Institutions, a checkbox is to be completed indicating the procedural standards, that the institution will apply to its U.S. federally supported research, in addition to the Federal Policy for the Protection of Human Subjects. This form has been updated on page 2 to include the current version years for the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects, the Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, and the Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects. The Terms of Assurance for International Institutions have also been updated in the same way.
A list of the IRBs, by name and registration number, that are to be designated under the FWA.
The name, title, address, telephone number, facsimile number, and e-mail address of the signatory official (i.e., the institutional official legally authorized to represent the institution. The institutional official must sign the FWA and assure that human subjects research to which the FWA applies in conducted in accordance with the terms of assurance.
OHRP also provides two supplemental sample forms that may be used by institutions submitting or holding FWAs, but not are not collected routinely by OHRP. The first form is an IRB Authorization Agreement. An institution submitting an FWA that designates the IRB of another institution can use this form. The signatory official of the institution submitting the FWA and the signatory official of the institution with the IRB being designated both sign the form. The form defines in writing the circumstances under which the designated IRB will be used by the institution submitting the FWA. The purpose of this form is to ensure that whenever an institution designates the IRB of another institution, the institution with the IRB being designated is aware of, and approves, such a designation. The form is kept on file by both institutions and is to be made available to OHRP upon request. Institutions are free to modify the form or develop their own form to cover such an arrangement.
The second supplemental form is an Unaffiliated Investigator Agreement. An institution with an approved FWA may use this form to extend the applicability of the FWA to individual investigators not otherwise affiliated with the institution who are collaborating on HHS-supported research being conducted by the institution holding the FWA. The form defines in writing the circumstances under which the unaffiliated investigator is covered by the institution’s FWA. The purpose of the form is to provide a simplified mechanism that allows an institution with an FWA to extend the applicability of its FWA to cover unaffiliated collaborating investigators, in lieu of OHRP requiring that each such individual investigator submit a separate FWA document. The form is kept on file by the FWA institution and is to be made available to OHRP upon request. Institutions are free to modify the form or develop their own form to cover such an arrangement
Improved Information Technology
Institutions submitting a new FWA may submit all information for initial FWAs, or updates and renewals of existing FWAs, except for the signature of the signatory official, via the internet using an interactive page on the OHRP website. The last page of the FWA with the signature of the signatory official still must be submitted on paper via mail or facsimile. As soon as technology permits, OHRP will accept electronic signatures for the FWA, thus eliminating the need for submission of any paperwork, except for institutions that lack internet access. OHRP anticipates that the majority of institutions needing to submit an FWA will do so via the internet. Currently more than 70% of institutions are submitting FWA information via the internet.
Duplication of Similar Information
The FWA does not duplicate any other information collection by OHRP.
Small Businesses
The information collected through the FWA represents the minimum amount of information necessary to satisfy the assurance requirements of the PHS Act and HHS regulations at 45 CFR 46.103. The information collection will not have a significant economic impact on a substantial number of small entities. Furthermore, the simplified assurance procedure provided by the FWA reduces burdens on small entities by (i) eliminating the need for multiple assurance submissions (previously, OHRP in most cases required submission of a separate assurance, called a Single Project Assurance, for each HHS grant, contract, and cooperative agreement supporting human subjects research that was awarded to a small entity); and (ii) making it easier for small entities to identify and rely upon IRBs of other institutions. The FWA also facilitates collaboration between small businesses and large academic institutions.
Less Frequent Collection
Institutions are required to update the FWA whenever there are substantive changes at the institution with respect to key elements of information being collected on the FWA form. Furthermore, institutions are required to submit a complete renewal to the FWA at least every three years. This frequency of collection is required so that OHRP can ensure that the FWA still satisfies the requirements of HHS regulations at 45 CFR 46.103. Based upon OHRP’s experience with prior assurance procedures, less frequent collection would result in FWAs on file with OHRP that contain key information that is outdated and inaccurate.
Special Circumstances
None.
Federal Register Notice/Outside Consultation
Public comments and outside consultation were solicited and addressed prior to obtaining OMB approval for the information collection on the current FWA forms (OMB # 0990-0278). In general, the majority of comments supported the effectiveness and efficiency of the assurance procedures provided by the FWA. On November 14, 2007, vol. 72, No.219; pp. 64081-64082, a notice announcing a 60-day period for public comments on the above cited information collection was published in the Federal Register. No comments were received from the public during that comment period.
Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
Confidentiality
The information collected under the FWA is, and always has been, considered releasable under the Freedom of Information Act (FOIA). The database used to track FWA data, referred to as the Human Assurance Tracking System (HATS), is currently being redesigned to utilize Microsoft SQL Server tables stored on a server maintained by the Center for Information Technology, National Institutes of Health. The redesigned HATS application screens and associated FWA tables/server utilize a username/password and appropriate session variables to access and modify the FWA data. Without the appropriate username/password, unauthorized users will not gain access to the FWA database. FWA database tables will never be provided outside of OHRP. Requests for FWA information under the FOIA are fulfilled via printed reports or disk files containing extracted information. The public can retrieve data from FWA database tables via the internet search screens found on the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp. This link provides read only access to the name, location, and FWA assurance number of institutions holding an OHRP-approved FWA. Information provided to the public via the OHRP website does not include the names and contact information of the FWA signatory official or human protections administrator identified in the FWA form. This information is only accessible to appropriate representatives of the other Federal departments and agencies that have adopted the Federal Policy via a secure internet connection requiring a username and password. Of note, the public and other agencies do not have the ability to modify the FWA database tables.
Sensitive Questions
No sensitive information is being collected by the FWA.
Burden Estimate (Total Hours & Wages)
Burden estimates with respect to the assurance requirements under HHS regulations at 45 CFR 46.103 were accounted for under the Paperwork Reduction Act Submission to OMB that was approved under Control Number 0990-0260. Specific burden estimates for the FWA form only are provided below.
The information being requested in the FWA should be readily available to any institution engaged in human subjects research conducted or supported by HHS as part of its normal operating practices.
Estimated Annualized Burden in Hours Table
Form name |
Number of Respondents |
Number of responses per respondent |
Hours per response |
Response Burden |
Federalwide Assurance (FWA) |
10,000 |
2.0 |
0.75 |
15,000 |
The estimate of the number of respondents is based upon the current number of institutions that have OHRP-approved FWAs (9,395) and projecting that the number may increase to 10,000.
The estimate of the number of responses per respondent is based upon the assumption that an institution will need to submit an initial FWA, or update or renew a previously approved FWA, on average every six months.
The estimate of the hours per response assumes that the majority of respondents will complete the FWA form via internet on an interactive page on the OHRP website. The time estimate includes an estimate of the time needed to (i) read and understand the instructions for completing the FWA; (ii) read and understand the FWA terms of assurance; and (iii) enter the information requested on the FWA form. The estimate assumes that completing a new FWA, or updating or renewing an existing FWA, on average, will be completed in 0.75 hours.
The total annual costs of the FWA are estimated at 15,000 hours X $40/hour = $600,000.
Estimated Annualized Burden in Dollars Table
Form name |
Total Burden Hours |
Hourly Wage Rate |
Total Burden Dollars |
Federalwide Assurance (FWA) |
15,000 |
$40 |
$600,000 |
Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the Terms of Assurance and to complete the FWA form.
Cost to Federal Government
The estimated annual Federal costs for reviewing assurances and certifications of IRB approval required under HHS regulations at 45 CFR 46.103 is $1,992,000.
Program or Burden Changes
The annual burden will decrease from 22,500 hours to 15,000 hours and from $900,000 to $600,000.
Publication and Tabulation Dates
The list of institutions holding an approved FWA will be posted, and updated daily, on the OHRP website.
Expiration Date
OHRP is not seeking approval to not show the expiration date.
Certification Statement
Item (i) of the certification statement on page 2 of OMB 83-I is not applicable and, therefore, is not being certified.
LIST OF ATTACHMENTS
a. Section 491 of the Public Health Service Act
Title 45 Code of Federal Regulations Part 46
Attachment 2 – FWA Terms of Assurance
Current Terms
Proposed Terms
Current Form for Domestic (U.S.) institutions
Current Form for International institutions
Proposed Form for Domestic (U.S.) institutions
Proposed Form for International institutions
Instructions for Domestic (U.S.) institutions
Instructions for International institutions
Attachment 5 – Supplemental sample forms
IRB Authorization Agreement
Individual Investigator Agreement
| File Type | application/msword |
| Author | istithco |
| Last Modified By | DHHS |
| File Modified | 2008-01-25 |
| File Created | 2008-01-25 |