Supporting Statement for the Department of Health and Human Services Institutional Review Board (IRB)
Registration Form
Background
The Department of Health and Human Services (HHS) is requesting a revision to the information requirements in OMB No. 0990-0279, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Registration Form, currently approved through March 31, 2011. This form is being modified to be consistent with IRB registration requirements that are included in the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) final rules on IRB registration requirements. As recommended by OMB, the information collection required by OHRP’s and FDA’s rules have been combined in this information collection request because the information will be submitted using the same form. The effective date of both IRB Registration rules is July 14, 2009 and we are requesting that OMB approve the modified form shortly before that effective date,
The purpose of the IRB Registration Form is to provide a simplified procedure for institutions engaged in research conducted or supported by HHS to satisfy the assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act); (2) HHS regulations for the protection of human subjects at 45 CFR 46.103; and FDA regulations for institutional review boards at 21 CFR 56.106. The respondents for this collection are institutions or organizations operating IRBs designated by an institution under an assurance of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a) and that review human subjects research conducted or supported by HHS, or, in the case of FDA’s regulation, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products.
A. Justification
OHRP:
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 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 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 include, among other things:
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)].
HHS regulations at 45 CFR 46.107 impose, among other things, the following requirements on IRBs:
(a) Each IRB shall have at least five members with varying backgrounds [45 CFR 46.107(a)].
(b) The IRB shall be sufficiently qualified through the experience and expertise of its members and the diversity of the members, including consideration of race, gender, and cultural backgrounds [45 CFR 46.107(a)].
OHRP is the HHS component charged with fulfilling the statutory mandates of the PHS Act and enforcing HHS regulations at 45 CFR part 46.
In December 2000, OHRP initiated a process for registering IRBs. The IRB registration system was developed in response to a 1998 HHS Office of Inspector General (OIG) recommendation that all IRBs register with the Federal government on a regular basis as part of an effort to develop a more streamlined, coordinated, and probing means of assessing IRB performance and to enhance the Federal government’s ability to identify and respond to emerging problems. The OHRP IRB
registration system was designed to collect information required under the HHS human subjects protection regulations at 45 CFR 46.103.
Among other things, assurances of compliance must include information on the institution’s designated IRB(s), and a list of IRB members identified by name, earned degrees, representative capacity, experience, and any employment or other relationship with the institution (45 CFR 46.103(b)(2),(3)).
The IRB registration system developed in December 2000 was also designed to collect additional information to be provided voluntarily by institutions or IRBs, regarding the accreditation status of the institution or IRB organization, total numbers of active research protocols reviewed by the IRB (including protocols supported by other Federal departments or agencies) and the nature of those protocols, and IRB staffing.
On July 6, 2004, OHRP published in the Federal Register (69 FR 40584) a Notice of Proposed Rulemaking (NPRM) seeking public comment on changes to the IRB registration system, that would require submission of the information being submitted on a voluntary basis. By requiring IRBs to provide such information, OHRP IRB registration requirements would become substantially consistent with requirements for IRB registration that were simultaneously proposed by FDA in the same issue of the Federal Register (69 FR 40556). OHRP and FDA proposed to use a single registration system, accessible on the OHRP website, in which all IRBs that review research conducted or supported by HHS or clinical investigations regulated by FDA could register.
The final rule requires that the following information must be provided to HHS when registering an IRB: the
name, mailing address, and street address (if different from the mailing address (of the institution or organization operating the IRB(s); and the name, mailing address, phone number, facsimile number and email address of the senior officer or head official who is responsible for overseeing activities performed by the IRB;
name, mailing address, phone and facsimile numbers and electronic email address of: (i) the senior officer or head official who is responsible for overseeing activities performed by that institution’s or organization’s IRB; and (ii) the contact person providing the registration information;
name, if any assigned to the IRB by the institution or organization, and the IRB’s mailing address, street address (if different from the mailing address), phone and facsimile numbers and electronic mail address;
name, phone number and electronic mail address of the IRB chairperson;
approximate number off all active protocols and approximate number of active protocols conducted or supported by HHS; and
approximate number of full-time equivalent positions devoted to the IRB’s administrative activities.
Enhancements to OHRP’s electronic registration system are currently being developed.
The Food and Drug Administration (FDA) is requesting OMB approval for two collections of information associated with IRB registration. The first collection of information would be represented by the form developed jointly by OHRP and by FDA which would be used on the electronic registration website (see Attachment 3). This form is discussed in greater detail below.
Additionally, FDA is proposing to amend its regulations pertaining to IRBs. The final rule (Attachment 1d) would require IRBs to register at a website maintained by the Department of Health and Human Services.
FDA is taking this action pursuant to a recommendation from the Office of the Inspector General, Department of Health and Human Services, to require all IRBs to register with the federal government to develop a more streamlined, coordinated, and probing means of assessing IRB performance and to enhance the government’s ability to identify and respond to emerging problems. Information on registered IRBs will make it easier for FDA to send educational information to IRBs and to identify IRBs for inspection.
Insofar as its final rule is concerned, FDA is requesting approval from OMB of a new collection of information requirement in "Institutional Review Boards; Registration and Use Requirements” codified at 21 CFR 56.106. The new collection of information associated with the rule would be 8,750 hours.
21 CFR 56.106(c) - Reporting
This provision would require an IRB to submit an initial registration to HHS. The initial registration may occur at any time, but each IRB must renew its registration every 3 years. Section 56.106(b) would describe the contents of the registration information, such as:
The name, mailing address, and street address (if different from the mailing address) of the institution operating the IRB and the name, mailing address, phone number, facsimile number, and electronic mail address of the senior officer of that institution who is responsible for overseeing activities performed by the IRB;
The IRB’s name, mailing address, street address (if different from the mailing address), phone number, facsimile number, and electronic mail address; each IRB chairperson’s name, phone number, and electronic mail address; and the name, mailing address, phone number, facsimile number, and electronic mail address of the contact person providing the registration information.
The approximate number of active protocols involving FDA-regulated products reviewed. For purposes of this rule, an “active protocol” is any protocol for which an IRB conducted an initial review or a continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months; and
A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
21 CFR 56.106(e) - Reporting
This provision would require IRBs to revise their registration information:
within 90 days if the IRB’s contact or chairperson information changes;
within 30 days if the IRB decides to disband or discontinue reviewing clinical investigations regulated by FDA; or
for all other information changes, when the IRB renews its registration.
2. Information Users
OHRP:
The IRB Registration Form collects the following information from Institutions or Organizations operating IRBs that are regulated by OHRP, for the following purposes:
The name, location, mailing address, street address (if different from the mailing address, and OHRP-assigned number (called an IORG number)) of each institution or organization that has registered an IRB. The IORG number is a unique number assigned by OHRP to an institution or organization the first time that it registers an IRB. This number is to be provided to OHRP whenever an institution or organization subsequently updates or renews the existing registration of any of its IRBs or registers a new IRB.
(Note: submitting the following information for the institution’s or organization’s senior officer or head officer will be optional: earned degree(s), title or position)
Purpose: This information is collected so that OHRP can contact that person directly if significant issues or problems arise that involve, or could involve, the institution and to forward educational information to that person.
(Note: submitting the following information for the contact person will be optional: earned degree(s), title or position)
Purpose: OHRP uses this information to identify the specific IRBs for which registration information is provided. OHRP will post a list of registered IRBs on its website, including the name and location of each IRB and the name and location of the organization operating the IRB. An institution submitting an assurance will include the IRB registration number for each IRB designated under its assurance, thereby eliminating the need for multiple submissions of the same information to OHRP.
(Note: submitting the following information for the IRB chairperson will be optional: earned degree(s), title or position, mailing address, and facsimile number)
Purpose: This information is collected so that OHRP can confirm that the requirements of 45 CFR 46.103(b)(3) and 46.107(a) are met.
The approximate number of full-time equivalent (FTE) positions devoted to the IRB’s administrative activities.
In brief, the IRB Registration Form pertaining to FDA-regulated IRBs would cover the following information:
The name, mailing address, and street address (if different from the mailing address) of the institution operating the IRB and the name, mailing address, phone number, facsimile number, and electronic mail address of the senior officer of that institution who is responsible for overseeing activities performed by the IRB;
The IRB’s name, mailing address, street address (if different from the mailing address), phone number, facsimile number, and electronic mail address; each IRB chairperson’s name, phone number, and electronic mail address; and the name, mailing address, phone number, facsimile number, and electronic mail address of the contact person providing the registration information.
The approximate number of active protocols involving FDA-regulated products reviewed. For purposes of this rule, an “active protocol” is any protocol for which an IRB conducted an initial review or a continuing review at a convened meeting or under an expedited review procedure during the preceding 12 months; and
A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
FDA will use the registration information to identify IRBs for FDA inspection and to convey information to IRBs.
Improved Information Technology
OHRP:
Each IRB must be registered electronically through http://ohrp.cit.nih.gov/efile unless an institution or organization lacks the ability to register its IRB’s electronically. If an institution or organization lacks the ability to register an IRB electronically, it must send its IRB registration information in writing to OHRP.
FDA:
The collection of information would rely primarily on the use of electronic collection techniques. As stated earlier, OHRP is developing enhancements to its Internet-based registration system, and FDA’s IRB registration information would be part of that
system. FDA’s final rule, however, does allow IRBs to register in writing if they lack the ability to register electronically.
Duplication of Similar Information
The IRB Registration Form does not duplicate any other information collection by OHRP or by FDA. Additionally, FDA has harmonized its registration requirements with OHRP to the maximum extent possible. (OHRP is the principal federal agency responsible for human subject protection issues as they relate to HHS-conducted or supported research involving human subjects. In contrast, FDA’s human subject protection regulations apply to most research involving FDA-regulated products, regardless of federal funding.) If an IRB is subject to regulation by both FDA and OHRP, it would only register once. Therefore, no duplication of data exists.
Small Businesses
OHRP:
The information collection through the IRB Registration Form 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.
FDA:
The final rule does not have a disproportionate impact on small businesses or entities, so no methods were required to minimize any impact. The information sought is simple and straightforward, consisting largely of names and addresses.
Less Frequent Collection
OHRP:
The registration information for an IRB must be updated within 90 days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson. Any renewal or update that is submitted to, and accepted by, OHRP begins a new 3-year effective period.
An institution’s or organization's decision to disband a registered IRB which it is operating also must be reported to OHRP in writing within 30 days after permanent cessation of the IRB’s review of HHS-conducted or -supported research.
Each IRB must renew its registration every 3 years.
This frequency of collection is required so that OHRP can ensure that the HHS IRB registration system is accurate and up-to-date. Based upon OHRP’s experience with prior IRB registration processes, less frequent collection would result in IRB registration information on file with OHRP which contains key information that is outdated and inaccurate. In addition, funding agencies that rely on the HHS IRB registration system will be able to rely on the IRB registration website for a current, accurate list of designated IRBs for an institution.
FDA:
Failure to register would impair FDA’s ability to send information to an IRB and to identify an IRB for inspection. FDA uses inspections to determine an IRB’s compliance with FDA requirements.
Special Circumstances
None.
Federal Register Notice/Outside Consultation
OHRP:
On July 6, 2004, OHRP published in the Federal Register (69 FR 40584) an NPRM seeking public comments to the IRB registration system developed in 2000. OHRP proposed to amend the HHS human subjects protection regulations at 45 CFR part 46 to require any IRB designated under an assurance of compliance approved for federalwide use by OHRP that reviews human subjects research conducted or supported by HHS to submit most of the information listed on the IRB registration form, including the information provided on a voluntary basis. By requiring IRBs to provide such information, OHRP IRB registration requirements would become substantially consistent with requirements for IRB registration that were simultaneously proposed by FDA in the same issue of the Federal Register (69 FR 40556). OHRP and FDA proposed to use a single registration system, accessible on the OHRP website, in which all IRBs that review research conducted or supported by HHS or clinical investigations regulated by FDA could register.
OHRP received 13 comments during the 90-day comment period that ended October 4, 2004. After considering these public comments and consulting with FDA, OHRP adopted the rule largely as it was proposed. However, in response to public comments OHRP deleted from the final rule the proposed requirement regarding
whether the institution or IRB organization registering an IRB was accredited by a human subjects protection program accrediting organization.
FDA:
FDA published its proposed rule in the Federal Register on July 6, 2004 (69 FR 40556). As part of the rulemaking process, FDA invited comment on its estimated information collection burden. We did not receive any comments on those estimates.
FDA’s estimates were developed in cooperation with OHRP. OHRP has experience with registering IRBs.
Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
Confidentiality
The information collected under the IRB Registration Form is, and always has been subject to public disclosure under the Freedom of Information Act (FOIA) and its exemptions to public disclosure. The database used to track IRB registration data, referred to as the Human Assurance Tracking System (HATS), utilizes Microsoft SQL Server tables stored on a server maintained by the Center for Information Technology, National Institutes of Health. The HATS application screens and associated IRB registration tables/server utilize a username/password and appropriate session variables to access and modify the IRB registration data. Without the appropriate username/password, unauthorized users will not gain access to the IRB registration database. Requests for IRB registration information under the FOIA are fulfilled via printed reports or disk files containing extracted information. The public can retrieve limited data from the IRB registration 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, IRB renewal date, date of last IRB membership update, and institutions with OHRP-approved FWA that rely upon IRBs located at other OHRP-approved FWA institutions. Additional IRB registration 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. Of note, the public and other agencies do not have the ability to modify the IRB registration database tables.
Sensitive Questions
No sensitive information is being collected by the IRB registration system.
Burden Estimate (Total Hours & Wages)
OHRP and FDA:
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. Burden estimates for the current IRB Registration Form (OMB 0990-0279) approved through March 31, 2011 are expected to increase by 2,000 burden hours, from 12,000 to 14, 000. This is due to the expectation that up to an additional 1,000 IRBs - largely FDA-regulated - will register in compliance with the new IRB Registration requirements.
Estimated Annualized Burden Table
Form name
|
Number of Respondents |
Number of responses per respondent |
Average burden per response (in hours) |
Total Burden hours |
IRB Registration 0990-0279 |
6,000 |
2 |
1 |
12,000 |
FDA-IRB |
1,000 |
2 |
1 |
2,000 |
Total |
|
|
|
14,000 |
The estimate of the number of respondents is based upon the current number of IRBs registered with OHRP, approximately 6,000 IRBs and that up to an additional 1,000 IRBs are expected to register with HHS with the new IRB Registration requirements. Most of the additional 1,000 IRBs are expected to be FDA-regulated IRBs. This would be a new burden for FDA-regulated IRBs. All 7,000 IRBs will use the same form (0990-0279) to register. The number of respondents for projected FDA-regulated IRBs was reduced from 5,000 to 1,000 in order to avoid double counting IRBs that are already registering under OHRP IRB Registration requirements. Of the 7,000 IRBs, up to 1,000 would submit new registration information and update or renew registration information one time during the year and up to 6,000 would update or renew IRB registration information up to two times each year. If on average 7,000 respondents submit information two times each year and each response takes on average one hour to complete, the total annual burden hours are projected to be 14,000. Total annual burden dollars are projected to be $350,000,
The estimate of the hours per response assumes that the majority of respondents will complete the IRB Registration 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 IRB Registration Form; (ii) collect the information to complete the form; and (iii) enter the information requested on the IRB Registration Form. Based on OHRP’s experience in registering the IRBs currently registered, most of the respondents will be administrative staff persons within organizations and institutions. The hourly wage is estimated to be $25 and the total burden cost is estimated to be $350,000.
Estimated Annualized Burden Table
Form Name
|
Total Burden Hours |
Hourly Wage Rate |
Total Burden Dollars |
IRB Registration 0990-0279 |
12,000 |
$25.00 |
$300,000 |
FDA-IRB |
2,000 |
$25.00 |
$50,000 |
Total |
|
|
$350,000 |
Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the instructions and to complete the IRB Registration 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 is $1,992,000.
For FDA, the annualized cost to FDA is estimated to be $8,216. This figure is based on the following calculations and assumptions: (a) the program will require one day per week for one GS-07 employee, or a total of 416 hours per year (52 weeks/year x 8 hours per day/week = 416 hours/year); (b) the hourly wage for a GS-07 employee in the Washington, DC metropolitan area (effective as of January 2009) is $19.75; so (c) multiplying 416 hours against $19.75 per hour results in an annualized cost to FDA of $8,216.
Program or Burden Changes
OHRP and FDA:
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. Burden estimates for the current IRB Registration Form (OMB 0990-0279) approved through March 31, 2011 are expected to increase by 2,000 burden hours, from 12,000 to
14,000. This is due to the expectation that up to an additional 1,000 IRBs - largely FDA-regulated - will register in compliance with the new IRB Registration requirements.
The annual burden estimate for the current IRB Registration Form (0990-0279) is 12,000 burden hours and is based on the number of IRBs currently registered with OHRP, approximately 6,000. Up to an additional 1,000 FDA-regulated IRBs are expected to register with HHS with the new IRB Registration requirements. It is estimated that the burden estimate will increase to from 12,000 burden hours 14,000 burden hours.
As recommended by OMB, the information collection required by OHRP’s and FDA’s rules have been combined in this information collection request because the information will be submitted using the same form.
Publication and Tabulation Dates
The list of registered IRBs will be posted, and updated daily, on the OHRP website.
Expiration Date
The OMB expiration date will be displayed on all data collection instruments.
18. Certification Statement
There are no exceptions to this certification.
LIST OF ATTACHMENTS
a. Section 491 of the Public Health Service Act
Title 45 Code of Federal Regulations Part 46
OHRP Final Rule
FDA Final Rule
Attachment 2 – Instructions for completing the current IRB/IEC Registration Form
a. Current Instructions
Proposed Instructions
Attachment 3 - IRB/IEC Registration Form
a. Current Form
Proposed Form
| File Type | application/msword |
| File Title | Supporting Statement for the Institutional Review Board (IRB) Registration Form and for Institutional Review Boards: Registratio |
| Author | istithco |
| Last Modified By | DHHS |
| File Modified | 2009-03-13 |
| File Created | 2009-03-13 |