Supporting Statement for the Federalwide Assurance (FWA)
A. Background
The Department of Health and Human Services (HHS) is requesting a revision to the information requirements in OMB No. 0990-0278, Federalwide Assurance for the Protections of Human Subjects for Institutions within the United States and Federalwide Assurance (FWA) for the Protections of Human Subjects for International (Non-U.S.) Institutions, currently approved through May 31, 2011.
The Office for Human Research Protections (OHRP) published a Federal Register notice on September 23, 2010 announcing the availability of, and soliciting public comment within 30 days on, a draft FWA form and Terms of Assurance that reflected several proposed changes, compared to the current FWA form and Terms of Assurance approved by OMB through May 31, 2011, 0990-0279. The key changes proposed in the September 2010 notice in comparison to the current FWA documents were the following:
(i) The current separate FWA forms for U.S. and non-U.S. institutions have been combined into a single form that will still collect the same basic information previously requested in the current separate forms, except as noted in items (iii) and (iv) below;
(ii) The Terms of Assurance document has been shortened and simplified. In the current version, some portions of the text appear twice; those duplications have been eliminated by re-organizing portions of the document. In addition, there are several items covered in the current version that are either not required by the regulations to be part of an assurance, or which are addressed in the FWA form itself. These items have been eliminated from the Terms of Assurance document;
(iii) The revised FWA form would replace the current requirement that all IRBs (both internal and external IRBs) relied upon by the institution be specifically designated with the requirement that only internal IRBs be specifically designated or that, if an institution does not have an internal IRB, only one external IRB be specifically designated);
(iv) The revised FWA form would no longer request submission of the HHS Institution Profile code or the Federal Entity Identification number;
(v) The revised FWA form would allow the FWA to be signed by the institution’s signatory official electronically and eliminate the need for submission of a hard-copy signature page by mail or facsimile. Upon implementation of this change, OHRP intends to require that institutions submit all FWAs (including new submissions, updates, and renewals) using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically. Such electronic submission currently is required for IRB registration. If an institution believed it lacked the ability to submit its FWA electronically, it would be required to contact OHRP by telephone or email and explain why it was unable to submit its FWA electronically;
(vi) The standard period of approval for an FWA would be increased from the current 3-year period to a 5-year period.
Six individuals and two organizations submitted comments on the proposed changes. The majority of the commenters supported the proposed changes.
OHRP is now proposing to adopt changes in the FWA form and terms of assurance largely as described in the September 2010 notice and has revised the FWA form and Terms of Assurance to include those changes. The proposed changes would simplify and shorten the FWA form and Terms of Assurance
A. 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.
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 17 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 these provisions 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 and the current OHRP-approved assurance number (if the institution already has an FWA) of the institution filing the FWA.
For the FWA of 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.
Purpose: OHRP obtains this information in order to be informed of whether an international institution applies another procedural standard to the conduct of U.S. federally supported research, in addition to the Federal Policy for the Protection of Human Subjects.
A list of internal IRBs, by name and registration number, that an institution will rely upon to review the research to which the FWA applies; or, if the institution has no internal IRB the external IRB, by name and registration number that the institution will rely upon, or if only multiple external IRBs are relied upon, the name and registration number of the external IRB that reviews the largest percentage of research to which the FWA applies.
Purpose: This information is collected so that OHRP can confirm that the assurance satisfies the requirements of HHS regulations at
45 CFR 46.103(b)(2).
The name, degree(s) or suffix, institutional title, address, telephone number, facsimile number, and e-mail address of the signatory official (i.e., the official legally authorized to represent the institution). The signatory official must assure that human subjects research to which the FWA applies is conducted in accordance with the terms of assurance and sign and date the FWA. The signatory official must electronically sign the FWA using the electronic submission system available through the OHRP Web site at http://ohrp.cit.nih.gov/efile/, unless the institution lacks the ability to submit its FWA electronically.
OHRP provides two supplemental sample forms that may be used by institutions submitting or holding FWAs, but are not collected routinely by OHRP. The first form is an IRB Authorization Agreement. When an institution holding an OHRP-approved FWA relies upon an IRB operated by another organization or institution to review HHS-conducted research, the institution holding the FWA must execute an IRB Authorization Agreement with the organization operating the IRB. This agreement defines in writing the circumstances under which the IRB will be used by the institution submitting the FWA and both the signatory official of the institution submitting the FWA and the signatory official of the organization operating the IRB must sign the IRB Authorization form. 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 an IRB Authorization arrangement.
The second supplemental form is an Independent Investigator Agreement. An institution with an approved FWA may use this form to extend the applicability of the FWA to individual investigators who are not otherwise employees or agents of an assured institution. The form defines in writing the circumstances under which the collaborating 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 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 a collaborating individual investigator.
Improved Information Technology
Institutions submitting a FWA will electronically submit all information for initial FWAs, or updates and renewals of existing FWAs, including the signature of the signatory official, via the internet using an interactive page on the OHRP website. OHRP recently acquired the technology that permits OHRP to accept electronic signatures of Signatory Officials for the FWA, thus replacing the current requirement that institutions must fax, email, or mail a printed copy of the signatory official page when submitting FWAs. This eliminates the need for submission of any paperwork, except for institutions that lack the ability to submit their FWAs electronically. OHRP anticipates that virtually all institutions will be able to submit 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 will be required to update the FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator or the Signatory Official. Each institution must renew its FWA every 5 years, even if no changes have occurred, in order to maintain an active FWA.
Special Circumstances
None.
Federal Register Notice/Outside Consultation
As mentioned above in the Background section, OHRP published a Federal Register notice on September 23, 2010 announcing the availability of, and soliciting public comment within 30 days on, a draft FWA form and Terms of Assurance that reflected several proposed changes, compared to the current FWA form and Terms of Assurance approved by OMB through May 31, 2011, 0990-0279. The proposed changes would simplify and shorten the FWA form and Terms of Assurance.
OHRP received comments from six individuals and two organizations on the proposed changes. The majority of the commenters supported the proposed changes.
Public comments also were solicited on this information collection request on January 27, 2011. No comments were submitted during the 60-day comment period.
Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
Confidentiality
The information collected under the FWA in the past was considered releasable under the Freedom of Information Act (FOIA). However, currently OHRP no longer requires public requesters to submit a FOIA request in order to obtain non-public FWA information.
The database used to track FWA data, referred to as the Human Assurance Tracking System (HATS), was redesigned in July 2009; it uses Microsoft SQL Server tables stored on a server that are maintained by the Center for Information Technology, National Institutes of Health. The 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 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 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. The public would need to contact OHRP to obtain this information. 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 Hours |
Federalwide Assurance (FWA) |
11,000 |
2 |
30/60 |
11,000 |
The estimate of the number of respondents is based upon the current number of institutions that have OHRP-approved FWAs (10,639) and projecting that the number may increase to 11,000.
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 virtually all respondents will complete the FWA form via the 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 30 minutes.
The total annual costs of the FWA are estimated at 11,000 burden hours X $40/hour = $440,000.
Estimated Annualized Burden in Dollars Table
Form name |
Total Burden Hours |
Hourly Wage Rate |
Total Burden Dollars |
Federalwide Assurance (FWA) |
11,000 |
$40 |
$440,000 |
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.
14.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 $400,000
15.Program or Burden Changes
The annual burden will decrease from 15,000 hours to 11,000 hours a 4,000 burden hour decrease which resulted in a program change due to simplifying the form.
16. Plans for Tabulation and Publication and Project Time Schedule
The list of institutions holding an approved FWA will be posted, and updated daily, on the OHRP website.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
OHRP is not seeking approval to not show the expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
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 [UPDATE THE FOLLOWING INFO]
a. Section 491 of the Public Health Service Act
Title 45 Code of Federal Regulations Part 46
Attachment 2 – FWA Terms of Assurance
Proposed Terms
Proposed Form for Domestic (U.S.) and International institutions
Proposed Instructions for Domestic (U.S.) and International (non-U.S.) institutions
Attachment 5 – Supplemental sample forms
IRB Authorization Agreement
Individual Investigator Agreement
| File Type | application/msword |
| File Title | Statement for the Federalwide Assurance (FWA) |
| Author | istithco |
| Last Modified By | Sherette.FunnColeman |
| File Modified | 2011-05-02 |
| File Created | 2011-05-02 |