Supporting Statement for the Federalwide Assurance (FWA)
A. Background
The Office for Human Research Protections (OHRP) is requesting a three-year extension of the OMB No. 0990-0278, Federalwide Assurance (FWA) for the Protection of Human Subjects Form, currently approved through June 30, 2014 with no changes. 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) (42 U.S.C. 289); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103. The form was modified in June 2011 to combine separate forms for U.S. and non-U.S. institutions into a single form and separate Terms of Assurance into a shortened and simplified terms of assurance document. 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.
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 Individual 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 has the technology that permits OHRP to accept electronic signatures of Signatory Officials for the FWA. This eliminates the need for submission of any paperwork, except for rare institutions that lack the ability to submit their FWAs electronically. Between July 1, 2011 and February 10, 2014, OHRP approved 3,909 FWAs and 3,907 of these FWAs were submitted electronically. OHRP anticipates that virtually all institutions will continue 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 are 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
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 theb current FWA form and Terms of Assurance approved by OMB through May 31, 2011, 0990-0279. The proposed changes included simplifying and shortening the FWA form and Terms of Assurance, changing the then standard period of approval for an FWA from a 3-year period to a 5-year period, and several other changes
Six individuals and two organizations submitted comments on the proposed changes. The majority of the commenters supported the proposed changes. OMB approved the proposed changes in the FWA form and terms of assurance largely as had been described in the September 2010 notice with its approval in June 2011 of the current OMB 0990-0278 form.
More recently public comments were requested during a 60-day period in the Federal Register issue that was published on March 6, 2014 (79 FR, No. 44, p 12693. No public comments were submitted during the comment period that closed on May 5, 2014.
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.
Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
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 form 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) |
11,050 |
2.0 |
0.50 |
11,050 |
The estimate of the number of respondents is based upon the current (as of 2/10/2014) number of OHRP-approved FWAs (10,889) and projecting that the number may increase to 11,050.
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 0.50 hours.
12 b. Annualized Cost Burden Estimate
OHRP staff estimates an average submitter’s hourly wage rate of $40 per hour (for institutional officials, administrators, administrative staff). The total annual costs for reading and understanding instructions and terms of assurance and entering the information via the internet are estimated to be 11,050 burden hours x $40/hour = $442,000.
Estimates of Other Total Annual Costs to Respondents/capital
There are no capital, start-up, operating or maintenance costs associated with this information collection.
14. Annualized Cost to Federal Government
The estimated annualized Federal costs for reviewing assurances required under HHS regulations at 45 CFR 46.103 is $400,000.
15. Program or Burden Changes
The annual burden will increase from 11,000 hours to 11,050 hours and from $440,000 to $442,000.
16. Publication and Tabulation Dates
The list of institutions holding an approved FWA will be posted, and updated daily, on the OHRP website.
17. Expiration Date
OHRP is not seeking approval to not show the expiration date.
18. 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 FWA Form
Proposed FWA Form
Current Instructions for Filing a FWA
Proposed Instructions for Filing a FWA
Attachment 5 – Supplemental sample forms
IRB Authorization Agreement
Individual Investigator Agreement
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Statement for the Federalwide Assurance (FWA) |
| Author | istithco |
| File Modified | 0000-00-00 |
| File Created | 2021-01-27 |