Supporting Statement for the Assurance Identification/IRB Certification/Declarations of Exemption Form
A. Background
The Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form, OMB No. 0990-0263. The purpose of that Form 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 requirements of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule) which is identical to 45 CFR part 46, subpart A.
B. Justification
1. Need and Legal Basis
Section 491(a) of Pub. L. 99-158 states that the Secretary of HHS shall by regulation require that each entity applying for HHS support (e.g., a grant, contract, or cooperative agreement) 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 of the human subjects of such research. IRBs are boards, committees, or groups formally designated by an entity to review, approve, and have continuing oversight of research involving human subjects. The pertinent authorizing legislation is provided in Attachment 1.a., (42 U.S.C. 289).
Pursuant to the requirement of the Public Law, HHS has promulgated regulations under 45 CFR part 46. These regulations require that, before engaging in HHS-conducted or -supported research that is not exempt under 45 CFR 46.101(b), each institution must:
(1) Hold an applicable OHRP-approved written assurance of compliance with the regulations [45 CFR 46.103(a)]; and
(2) Certify to the awarding HHS agency that the application or proposal for research has been reviewed and approved by an IRB designated in the assurance [45 CFR 46.103(b) and (f)].
Since 1991, the Common Rule has implemented a common Federal policy for the protection of human subjects of research conducted, supported or regulated by the following Federal departments and agencies that have adopted the Common Rule:
United States Department of Agriculture (7 CFR Part 1c)
Department of Energy (10 CFR Part 745)
National Aeronautics and Space Administration (14 CFR Part 1230)
Department of Commerce (15 CFR Part 27)
Consumer Product Safety Commission (16 CFR Part 1028)
Agency for International Development (22 CFR Part 225)
Department of Housing and Urban Development (24 CFR Part 60)
Department of Justice (28 CFR Part 46)
Department of Defense (32 CFR Part 219)
Department of Education (34 CFR Part 97)
Department of Veterans Affairs (38 CFR Part 16)
Environmental Protection Agency (40 CFR Part 46)
Department of Health and Human Services (45 CFR Part 46)
National Science Foundation (45 CFR Part 690)
Department of Transportation (49 CFR Part 11).
In addition to departments and agencies which have codified the Common Rule, the Central Intelligence Agency is required by Executive Order 12333 and the Department of Homeland Security is required by statute to follow all subparts of 45 CFR part 46 in their human research programs.
Adoption of the common Federal Policy (56 FR 28003) by these departments and agencies implements a recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research which was established on November 9, 1974, by Pub. L. 95-622. The Common Rule is based on HHS regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The Common Rule and the HHS regulations are included in Attachments 1.b. and 1.c., respectively.
2. Information Users
Information obtained on the authority of Sections 103(b) and 103(f) from the holder of an acceptable assurance is used to ensure (1) that the institution/organization has established adequate administrative policies and procedures for protecting the rights and welfare of human subjects in research and (2) that it accepts this responsibility. Other reporting requirements are to assess whether the institution is following the established procedures; to ensure that no Federal funds are expended for unapproved human subjects research; and to determine if the approved status of an awarded grant should be reviewed, with the ultimate goal of maintaining or increasing human subjects protection.
3. Improved Information Technology
The collection of information is currently conducted largely electronically, but also by exchange of paper documents as part of the contract, grant, or cooperative agreement application process. Institutions submitting such applications can download the form from the OHRP Web site at http://www.hhs.gov/ohrp/assurances/forms/index.html. This document can be filled in, saved, and printed by users for submittal with such applications.
4. Duplication of Similar Information
The Common Rule and agency specific rules establish the only Federal standards for the conduct of federally-conducted or -sponsored research involving human subjects.
5. Small Businesses
Funding of research activities involving human subjects extends to small businesses. The committee that developed the Common Rule considered ways to reduce the burden on small businesses or organizations that receive Federal support and determined that it is not feasible to do so. However, organizations not having on file approved assurances for the proposed research (likely to be small organizations) do not have to certify IRB review until it is requested-generally only when an award is expected to be made.
6. Less Frequent Collection
The reporting of IRB approval is required with the submission of an application or proposal or at such later date as specified by the agency/department sponsoring the research. Institutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the Common Rule department or agency that the application or proposal has been approved by the IRB. This is necessary to ensure that federally-supported research involving human subjects is subjected to the continuing IRB review and approval that is required at least once per year, as the obligation to protect human subjects is an ongoing responsibility and not a one-time effort. Changes in research protocols, new scientific or medical findings or innovations, as well as preliminary results or ongoing research, may change the degree of risks to the subjects; therefore, IRB review is required to be conducted at least annually. Reporting of the date of that review, and approval with the application describing those changes, notifies the funding department/agency of IRB approval of the changed protocol.
7. Special Circumstances
None.
8. Federal Register Notice/Outside Consultation
Public Comments are being solicited for a 60-day period in the Federal Register issue that was posted on November 15 2011. . No public comments were submitted during the comment period, which closed on January 9, 2012.
9. Payment/Gift to Respondents
No payment or gifts are provided to respondents.
10. Confidentiality
The reporting of IRB review is a part of the grant or contract file and is available in many cases under the Freedom of Information Act. The information collected under the Assurance 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 Assurance information.
11. Sensitive Questions
No sensitive information is being collected on the form.
Burden Estimate (Total Hours and Wages)
Institutions seeking support for human subjects research are required by 45 CFR 46.103(f) to certify that the proposed research has been reviewed by an IRB. The estimate of the number of respondents is based upon the current number of institutions that have an OHRP-approved Federalwide Assurances (FWAs), 11,500, and projecting that the number may increase to 12,000. There are an estimated total of 25,000 human research studies supported each year, meaning an average of 2 certifications per institution annually, requiring an estimated one-half hour per certification, accounting for the estimated of 12,000 response burden hours. The previously approved burden was an overestimate.
The total burden dollars are estimated at 12,000 burden hours X $40/hour = $480,000.
The previously approved burden was an overestimate
Estimated Annualized Burden in Hours for IRB Certification Burden
Form name |
Number of Respondents |
Number of Responses per Respondent |
Hours per Response |
Response Burden Hours |
Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption |
12,000 |
2 |
0.5 |
12,000 |
Estimated Annualized Burden in Dollars for IRB Certification Burden
Form name |
Total Burden Hours |
Hourly Wage Rate |
Total burden dollars |
Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption |
12,000 |
$40 |
$480,000 |
13. Capital Costs (Maintenance of Capital Costs
There are no direct capital costs to respondents other than the time to review the instructions and complete the form.
14. Cost to the Federal Government
The estimated annual Federal cost of 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 35,000 hours to 12,000. This decrease is due to adjustment in the number of responses per respondent from 7 to 2.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish or tabulate the information.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
No exception is requested.
C. Justification of Information Employing Statistical Methods
Not applicable.
LIST OF ATTACHMENTS
Attachment 1 - Legal Authorities
a. 42 U.S.C. Section 289
b. 56 F.R. 28003 (Common Rule), in pertinent part
c. 45 CFR Part 46, Subpart A
Attachment 2 – Proposed Form OMB 0990-0263
Attachment 1.a. - Legal Authorities
42 U. S. C. Section 289
TITLE 42 – The Public Health and Welfare
CHAPTER 6A – PUBLIC HEALTH SERVICE
SUBCHAPTER III – NATIONAL RESEARCH INSTITUTES
Part H – General Provisions
INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
Sec. 491. [289](a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this Act for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an >Institutional Review Board=) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.
(b)(1) The Secretary shall establish a program within the
Department of Health and Human Services under which requests for
clarification and guidance with respect to ethical issues raised in
connection with biomedical and behavioral research involving human
subjects are responded to promptly and appropriately.
(2) The Secretary shall establish a process for the prompt
and appropriate response to information provided to the Director of
NIH respecting incidences of violations of the rights of human
subjects of research for which funds have been made available under
this Act. The process shall include procedures for the receiving of
reports of such information from recipients of funds under this Act
and taking appropriate action with respect to such violations.
(July 1, 1944, ch. 373, title IV, Sec. 491, as added Pub.L. 99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 873.)
Attachment 1.b. - Legal Authorities
56 FR 28003
Attachment 1.c. - Legal Authorities
45 CFR 46
Attachment 2
Proposed OMB No. 0990-0263
Protection of Human Subjects: Assurance Identification/Certification/
Declaration of Exemption
| File Type | application/msword |
| File Title | TO: |
| Author | DREWG |
| Last Modified By | ctac |
| File Modified | 2012-03-14 |
| File Created | 2012-03-14 |