[Federal Register Volume 69, Number 128 (Tuesday, July 6, 2004)]
[Proposed Rules]
[Pages 40584-40590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14679]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 46
RIN 0940-AA06
Institutional Review Boards: Registration Requirements
AGENCY: Office of Public Health and Science, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, Department of Health and Human Services
(HHS), is proposing to require registration of institutional review
boards (IRBs) that review human subjects research conducted or
supported by HHS and that are designated under an assurance of
compliance approved for federalwide use by OHRP. The registration
information would include contact information, approximate numbers of
active protocols involving research conducted or supported by HHS,
accreditation status, IRB membership, and staffing for the IRB. The
proposed registration requirements will make it easier for OHRP to
convey information to IRBs and will support the current IRB
registration system operated by OHRP. Under the current OHRP IRB
registration system, the submission of certain information is required
by the existing HHS human subjects protection regulations, and certain
other information may be submitted voluntarily. A request for the
approval of this collection of information requirement will be
submitted to the Office of Management and Budget (OMB) under the
Paperwork Reduction Act. Under the proposed rule, all registration
information will be required, making the IRB registration system
uniform with the proposed IRB registration requirements of the Food and
Drug Administration (FDA), and creating a single HHS IRB registration
system. FDA simultaneously is publishing a proposed rule regarding FDA
IRB registration requirements.
DATES: You may submit written or electronic comments on this proposed
rule, RIN number 0940-AA06, by October 4, 2004.
ADDRESSES: You may submit comments by any of the following methods:
Federal eRulemaking Portal: http:www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected].
Fax: 301-402-2071.
Mail to: Irene Stith-Coleman, Office for Human Research
Protections, The Tower Building, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852.
Hand Delivery or Courier to: Irene Stith-Coleman, Office
for Human Research Protections, The Tower Building, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852
Comments received within the comment period will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of this notice, at the above
address on Monday through Friday of each week from 8:30 a.m. to 4 p.m.
FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Office for Human
Research Protections, The Tower Building, 1101 Wootton Parkway, Suite
[[Page 40585]]
200, Rockville, MD 20852, 301-402-7005 or by e-mail to:
([email protected]).
SUPPLEMENTARY INFORMATION:
I. Introduction
IRBs are boards, committees, or groups formally designated by an
institution to review, approve, and have continuing oversight of
research involving human subjects. An IRB's primary purpose during such
reviews is to ensure the protection of the rights and welfare of human
research subjects. The HHS regulations regarding the protection of
human research subjects, which address the appropriate role of IRBs in
helping to ensure this protection, are found at 45 CFR part 46.
In 1998, the HHS Office of Inspector General (OIG) issued several
reports on IRBs. The OIG sought to identify the challenges facing IRBs
and to make recommendations on improving Federal oversight of IRBs. One
recommendation was that all IRBs should 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 before they result in ``serious
transgressions.'' (Ref. 1, pp. 20 and 21).
After reviewing OIG's recommendation, OHRP concluded that IRB
registration would serve several important goals. IRB registration
would enable OHRP to: (1) Identify more precisely those IRBs reviewing
research conducted or supported by HHS under an assurance of compliance
approved for federalwide use by OHRP; (2) keep an accurate, up-to-date
list of IRBs; (3) send educational information and other information to
IRBs, increasing the efficiency of OHRP educational and outreach
efforts; and (4) help OHRP identify IRBs that are subject to HHS
regulations for monitoring and oversight purposes.
In December 2000, OHRP initiated a process for registering IRBs.
This IRB registration system was designed to collect information
required under the HHS human subjects protection regulations at 45 CFR
46.103(b)(3). That regulatory provision requires institutions that are
engaged in human subjects research conducted or supported by HHS to
file with OHRP an assurance of compliance with the HHS human subjects
protection regulations. Under 45 CFR 46.103(a), other Federal
Department or Agency heads shall accept an assurance on file with HHS
that is approved for federalwide use by OHRP, and that is appropriate
for the research in question. Among other things, assurances of
compliance must include information on the institution's designated
IRB, 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 also was 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. The
current OHRP IRB registration form can be accessed at: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/regirb.rtf.
OHRP now proposes to require that any IRB designated under an
assurance of compliance approved for federalwide use by OHRP that
reviews human subjects research conducted or supported by HHS submit
most of the information listed on the IRB registration form that is
currently used by OHRP. By requiring IRBs to provide such information,
OHRP IRB registration requirements will become substantially consistent
with requirements for IRB registration that are simultaneously being
proposed by FDA elsewhere in this issue. OHRP and FDA plan to operate a
single registration system for HHS in which all IRBs that review
research conducted or supported by HHS or clinical investigations
regulated by FDA can be registered. The HHS IRB registration system
will be operated at a single Internet site on the OHRP Web site.
OHRP currently posts all registered IRBs on its Web site, including
the name and location of the organization operating the IRB(s), called
the IRB organization, and the name and location of each IRB. Numbers
are assigned to the IRB organization and each IRB is given a unique IRB
registration number. An institution submitting an assurance includes
the IRB registration number for each IRB designated under its
assurance, thereby eliminating the need for multiple submissions of the
same information to OHRP.
The Privacy Act does not apply to the information contained in the
IRB registration database. OHRP will not be retrieving information
about individuals from this Internet site by name or other individual
identifier. Therefore, this Internet site will not be a ``system of
records'' that would be subject to the requirements of the Privacy Act
of 1974.
Upon the effective date of the rule, OHRP will continue to post the
name and location of each registered IRB and its IRB registration
number on the OHRP Web site. All other information collected in the IRB
registration, including names of individual IRB members, would be
subject to the Freedom of Information Act, and therefore, may be
available to the public upon request. Beyond such access to the
information, OHRP will maintain the confidentiality of the information
submitted with the IRB registration to the extent allowed by law.
All of the IRB registration information that is submitted to the
Internet site will be transferred to a separate server which will not
be accessible via the Internet. In this manner, a high level of
security can be maintained for the IRB Registration database.
OHRP will provide browse-only access to the database containing all
information collected in the IRB Registration, via a password protected
mechanism, to all Federal departments and agencies that have adopted
the Federal Policy for the Protection of Human Subjects, known as the
``Common Rule,'' which HHS has codified as 45 CFR part 46, subpart A.
II. Description of the Proposed Rule
The proposed rule would amend the HHS human subjects protection
regulations at 45 CFR part 46 by adding subpart F, entitled
``Registration of Institutional Review Boards.'' The proposed rule
would require IRBs that review human subjects research conducted or
supported by HHS and that are designated under an assurance of
compliance approved for federalwide use by OHRP to register with HHS.
1. Who Must Register? (Proposed Sec. 46.601)
Proposed Sec. 46.601 requires registration of each IRB that is
designated by an institution under an assurance of compliance with HHS
human subjects protection regulations that has been approved for
federalwide use by OHRP, under 45 CFR 46.103(a), and that reviews human
subjects research conducted or supported by HHS.
Proposed Sec. 46.601 also specifies that an individual authorized
to act on behalf of the institution or IRB must submit the registration
information. The individual may be an IRB member or any other person
authorized by the institution, or IRB, to submit the registration
information.
[[Page 40586]]
2. What Information Must an IRB Provide When Registering? (Proposed
Sec. 46.602)
Proposed Sec. 46.602 describes the information to be submitted as
part of the registration process. The proposal requires IRBs to provide
the following information:
The name and mailing address of the institution or
organization operating the IRB; the name, earned degree, title, mailing
address, phone number, fax number, and e-mail address of the senior or
head official of that institution or organization who is responsible
for overseeing the activities performed by the IRB; and the name,
title, telephone number, fax number, and e-mail address of the person
providing the registration information must be provided. The senior or
head official should not be an IRB member or IRB staff. This
information enables OHRP to identify the institution(s) or
organization(s) with which the IRB is affiliated. Information about the
senior or head official of the institution enables OHRP to 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. Information about the contact person enables OHRP to
contact that person directly on routine issues, forward information,
and send electronic mail to the contact person.
The IRB number, registration name and address; the name,
earned degree, title, area of specialty, affiliation, gender,
telephone, fax, e-mail address, and mailing address of the IRB
chairperson; and an IRB roster that includes the names, earned degrees,
gender, area of specialty and affiliation of each voting (including the
IRB chairperson) and alternate IRB members must be provided. Collection
of this information is consistent with the requirements of 45 CFR
46.103(b)(3) and 46.107(a), and helps OHRP to contact the IRB
chairperson quickly, if necessary, on important issues, to send
educational information and electronic mail, and to confirm that IRB
membership meets the minimum regulatory requirements.
The approximate number of active protocols undergoing
initial and continuing review; the approximate number of active
protocols supported by HHS; and the approximate number of full time
positions devoted to the IRB's administrative activities. In this
proposal, ``active protocol'' would mean any protocol or study for
which an IRB conducted an initial review or a continuing review during
the preceding calendar year.
The proposal would not require an institution or IRB organization
to report a specific number of protocols; instead, registration would
indicate the range of the number of protocols reviewed in the preceding
calendar year. The proposal would consider a ``small'' number of
protocols to be 1 to 25 protocols, ``medium'' to be 26 to 499, and
``large'' to be 500 or more protocols. This information will enable
OHRP to determine how active an IRB is and to assign its quality
improvement, educational, and compliance oversight resources based on
an IRB's activity level. For example, scheduling the site of an OHRP
national workshop could involve assessment of the volume of research
conducted by an institution in a potential locale. Furthermore, HHS
regulations for the protection of human subjects at 45 CFR 46.103(b)(2)
require that assurances of compliance applicable to HHS conducted or
supported research include the designation of one or more IRBs for
which, among other things, provisions are made for meeting space and
sufficient staff to support the IRB's review and record keeping duties.
In OHRP's experience, the number of FTEs and the volume of research are
useful parameters for assessing whether an IRB has sufficient staff, as
required by HHS regulations for the protection of human subjects at 45
CFR 46.103(b)(2).
An indication as to whether the assured institution or IRB
organization is currently accredited by a human subjects protection
program accrediting organization, and if so, the date of its last
accreditation and the name of that accrediting organization must be
provided. OHRP recognizes that accreditation is a developing concept,
so information on accreditation will help OHRP to evaluate the extent
and value of IRB accreditation. OHRP specifically solicits public
comment related to the perceived value of collecting information on the
accreditation status of IRBs.
In addition, the IRB registration process includes information
required by FDA under its proposed rule: the number of active protocols
(small, medium, or large) involving FDA-regulated products reviewed
(both initial reviews and continuing reviews); 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
active protocols that the IRB reviews.
Due to statutory and regulatory differences between OHRP and FDA,
the Internet registration site may request more information from IRBs
reviewing research conducted or supported by HHS than those reviewing
clinical investigations regulated by FDA that are not conducted or
supported by HHS. In those instances where the registration site would
seek more information than FDA would require under its proposal, the
internet site would clarify that IRBs regulated solely by FDA are not
required to provide the additional information.
The proposed rule would not require submission of one element of
information that currently is submitted voluntarily. It would not
require IRBs to provide information on the approximate number of
currently active protocols supported by other Federal departments or
agencies. OHRP determined that collection of such information should
not be required because the proposed rule would apply only to IRBs that
are designated under an OHRP-approved assurance of compliance and that
review research conducted or supported by HHS.
3. When Must an IRB Register? (Proposed Sec. 46.603)
Proposed Sec. 46.603 requires IRBs to register when designated
under an assurance approved for federalwide use by OHRP. Specifically,
the proposal would require an IRB to register when any institution
files with OHRP an assurance of compliance with the HHS human subjects
protection regulations under 45 CFR 46.103(a), that is to be approved
for federalwide use by OHRP, and that designates the IRB to review
human subjects research conducted or supported by HHS. IRB registration
will become effective on the date that OHRP lists the IRB registration
on its website.
To show how this would work, assume that an institution is engaged,
for the first time, in human subjects research conducted or supported
by HHS. The institution then would be subject to the HHS human subjects
protection regulations, and would be required to file an assurance of
compliance with those regulations under 45 CFR 46.103(a). Designation
of an IRB is part of that assurance process. If the institution's
assurance is submitted to, and approved for federalwide use by, OHRP,
the IRB(s) designated under the assurance would have to register with
HHS if not previously registered. Further, if the institution
designates an additional IRB under its assurance, the additional IRB
must first register and the assurance must be updated to include the
new IRB. As discussed under item 5 below, OHRP will continue to
recognize IRB registrations that were completed prior to the effective
date of the rule, and will give such IRBs 90 days from the
[[Page 40587]]
effective date of the rule to submit to OHRP revisions to the existing
registration information, if necessary, to meet additional requirements
of the proposed rule.
Proposed Sec. 46.603 also requires IRBs to renew their
registrations every 3 years. Requiring IRBs to renew their
registrations periodically helps to ensure that HHS information remains
current.
4. Where Can an IRB Register? (Proposed Sec. 46.604)
Proposed Sec. 46.604 directs IRBs to register at a specific HHS
Internet site or, if the institution or IRB organization lacks the
ability to register electronically, to send registration information to
OHRP's mailing address. Although Internet registration may be easier
and faster than written registration, OHRP cannot determine how
widespread Internet access is among IRBs. Thus, OHRP also allows for
written registration in addition to Internet registration.
5. How Does an IRB Revise Its Registration Information? (Proposed Sec.
46.605)
Under proposed Sec. 46.605, if contact or IRB membership
registration information changes, the IRB must revise its registration
information within 90 days of the change. All information involving
changes other than changes in an IRB contact, an IRB chairperson or the
IRB roster only need to be updated at the time of the 3 year renewal
pursuant to proposed Sec. 46.603. For example, if an IRB selects a new
chairperson, the IRB, under proposed Sec. 46.605, would revise its
registration information within 90 days after the new chairperson's
selection.
Proposed Sec. 46.605 also considers an assured institution's or
IRB organization's decision, to disband a registered IRB, or to stop
reviewing research conducted or supported by HHS, to be a change that
must be reported to HHS within 30 days. Requiring an IRB to report to
HHS when it has disbanded or discontinued reviewing research conducted
or supported by HHS will enable OHRP to stop sending educational
information to the IRB and ensure that the HHS IRB registration system
is accurate and up to date. More importantly, funding agencies that
rely on the HHS IRB registration system will then be able to rely on
the IRB registration website for a current, accurate list of designated
IRBs for an institution.
OHRP will continue to recognize IRB registrations that were
completed prior to the effective date of the rule, but will give IRBs
that previously did not include complete information 90 days from the
effective date of the rule to provide such information. That is, IRBs
that chose not to provide registration information that previously was
considered voluntary would be expected to complete the registration
form and provide that information within 90 days of enactment of the
rule.
Revised registration information may be submitted electronically to
OHRP or, if an IRB lacks Internet access, in writing, to OHRP's mailing
address.
6. What Happens if an IRB Does Not Register or Fails To Revise its
Registration Information?
An IRB cannot be designated under an assurance of compliance
approved for federalwide use by OHRP if it fails to register. For
example, if an assurance submitted to OHRP for approval lists only one
IRB that reviews research conducted or supported by HHS, and that IRB
fails to register, OHRP would not approve that assurance. If an
assurance approved for federalwide use by OHRP lists two or more IRBs
that will review research conducted or supported by HHS, and one IRB
fails to register, OHRP could issue a restricted approval of the
assurance so that the unregistered IRB may not review HHS-conducted or
supported research.
If an IRB designated under an assurance approved for federalwide
use by OHRP fails to appropriately revise its registration information
in accordance with Sec. 46.605 of the proposed rule, OHRP could
restrict or revoke its approval of the assurance. For example, if an
IRB fails to appropriately revise its registration information in
accordance with Sec. 46.605 of the proposed rule, and the IRB is
reviewing human subjects research conducted or supported by HHS, OHRP
could take appropriate action under the institution's assurance and
OHRP's compliance oversight policies and procedures. OHRP believes that
the proposed registration requirement is both simple and
straightforward, so it does not expect that many institutions or IRB
organizations will refuse or fail to register or revise its
registration information.
III. Implementation
OHRP intends to make any final rule based on this proposal
effective within 60 days after the final rule is published in the
Federal Register. Initial registration with all required information
and required revisions to registration must be submitted within 60 days
of the effective date of the rule. IRBs voluntarily may register before
the required registration deadline.
IV. Legal Authority
Section 491 of the Public Health Service Act authorizes the
Secretary, by regulation, to require each entity which applies for a
grant, contract, or cooperative agreement under the Act for any project
or program which involves the conduct of biomedical or behavioral
research involving human subjects to submit assurances satisfactory to
the Secretary that it has established an IRB to review research
conducted at or supported by the entity in order to protect the rights
of the human subjects (see 42 U.S.C. 289(a)). Section 491 of the Public
Health Service Act also authorizes the Secretary to establish a program
under which requests for clarification and guidance with respect to
ethical issues raised in connection with biomedical or behavioral
research involving human subjects are responded to promptly and
appropriately (see 42 U.S.C. 289(b)). These authorities are delegated
to OHRP (see 67 FR 10216-18, March 6, 2002).
By requiring IRB registration, the proposed rule would, if
finalized, aid in the efficient implementation of the Public Health
Service Act's provisions regarding assurances and providing guidance
and education to IRBs involved in human subjects research conducted or
supported by HHS. Moreover, by requiring IRBs to register, the proposed
rule would enable OHRP to contact IRBs more quickly and efficiently on
various issues, such as new regulatory requirements or policies or
other matters related to the conduct of human subjects research. OHRP
concludes that it has sufficient legal authority to issue the proposed
rule.
V. Economic Impact Analysis
OHRP has examined the impact of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). Under the Regulatory Flexibility Act, if a rule has a
significant impact on a substantial number of small entities, an agency
must analyze regulatory options that
[[Page 40588]]
would minimize any significant impact of the rule on small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement of anticipated costs and
benefits before proposing any rule that may result in an expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million in any one year (adjusted annually for
inflation).
The proposed rule is consistent with the principles set forth in
Executive Order 12866 and these two statutes. As explained below, the
proposed rule is not an economically significant regulatory action as
defined in Executive Order 12866 and does not require a Regulatory
Flexibility Act Analysis. The Unfunded Mandates Reform Act does not
require HHS to prepare a statement of costs and benefits for the
proposed rule because the proposed rule is not expected to result in
any 1-year expenditure that would exceed $100 million adjusted for
inflation. The current inflation-adjusted statutory threshold is
approximately $110 million.
The proposed rule would require IRBs designated under an assurance
of compliance approved for Federalwide use by OHRP to register with
HHS. The information sought through the registration process would be
minimal, consisting largely of names and addresses for a contact
person, the institution operating the IRB (if an institution exists),
the senior or head officer of the institution who is responsible for
overseeing the activities performed by the IRB, the IRB chairperson,
and limited information about the IRB members' gender, earned degree,
scientific or nonscientific specialty, and affiliation. The
registration would also indicate whether the IRB reviews a ``small,''
``medium,'' or ``large'' number of research protocols. IRBs would also
indicate whether they are accredited and, if so, identify the
accrediting body or organization. OHRP estimates that initial IRB
registration may require 1 hour to complete. If the average wage rate
is $40 per hour, this means that each IRB would spend $40 for an
initial registration ($40 per hour x 1 hour per initial registration).
OHRP estimates that renewal of registration would require less
time, especially if the IRB is only verifying existing information. If
renewal registration requires 30 minutes, then the cost of renewal
registration to each IRB would be approximately $20 ($40 per hour x 0.
0.5 hour per renewal registration).
Revising an IRB's registration information would probably involve
costs similar to renewal registration costs. If the revision requires
30 minutes, then the cost of revising an IRB's registration information
would be approximately $20 per IRB.
Additionally, assuming that the maximum number of IRBs that would
be subject to the proposed rule would be 5,000: 2,000 initial
registrations; 1,000 renewals; and 2,000 revisions, the proposed rule,
if finalized, would result in a 1-year expenditure of $140,000 (2,000 x
$40 = $80,000; 1,000 x $20 = $20,000; and 2,000 x $20 = $40,000).
Given the minimal registration information that would be required
and the low costs associated with registration, this proposed rule is
not a significant regulatory action, and OHRP certifies that the
proposed rule would not have a significant economic impact on a
substantial number of small entities. The proposal is not a significant
regulatory action under Executive Order 12866 and does not require a
Regulatory Flexibility Act analysis.
Because the total expenditure under the rule will not result in a
1-year expenditure of $100 million or more, OHRP is not required to
perform a cost-benefit analysis under the Unfunded Mandates Reform Act.
VI. Environmental Impact
OHRP has determined that this action is of a type that does not
individually or cumulatively have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
This proposed rule contains information collection requirements
that are subject to review by OMB under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520). OHRP submitted the IRB Registration form to
OMB for approval pursuant to the Paperwork Reduction Act prior to
issuing this proposed rule.
Title: Institutional Review Boards: Registration Requirements.
Description: The proposed rule would require institutions and IRB
organizations to register their designated IRBs with HHS.
Description of Respondents: Businesses and individuals.
The estimated annual burden associated with the current information
collection is 3,500 hours. The estimated annual burden associated with
the information collection requirements of this proposed rule is 3,500
hours. One element of information currently collected would not be
collected after adoption of the proposed rule (i.e., information on the
approximate number of active protocols supported by other Federal
departments or agencies).
Table 1.--Estimated Annual Reporting Burden (Current)
----------------------------------------------------------------------------------------------------------------
No. of Frequency of Total annual Hours per
45 CFR section respondents responses responses response Total hours
----------------------------------------------------------------------------------------------------------------
Sec. 46.603 (initial 2,000 1 2,000 1 2,000
registration)..................
Sec. 46.603 (re-registration). 0 0 0 0 0
Sec. 46.605 (revisions)....... 2,090 1 2,090 0.5 1045
-----------------
Total....................... .............. .............. .............. .............. 3,045
----------------------------------------------------------------------------------------------------------------
Table 2.--Estimated Annual Reporting Burden (Proposed Rule)
----------------------------------------------------------------------------------------------------------------
No. of Frequency of Total annual Hours per
45 CFR Section respondents responses responses response Total hours
----------------------------------------------------------------------------------------------------------------
Sec. 46.603 (initial 2,000 1 2,000 1 2,000
registration)..................
Sec. 46.603 (re-registration). 1,000 1 1,000 0.5 500
Sec. 46.605 (revisions)....... 2,000 1 2,000 0.5 1,000
-----------------
Total....................... .............. .............. .............. .............. 3,500
----------------------------------------------------------------------------------------------------------------
[[Page 40589]]
There are no capital costs or operating and maintenance costs
associated with this collection of information.
OHRP's estimates are based on the following considerations.
According to a 1998 OIG report, there are 3,000 to 5,000 IRBs in the
United States, and most are associated with hospitals and academic
centers (Ref. 1, p. 3). While not all IRBs review human subjects
research conducted or supported by HHS or otherwise covered under an
assurance approved by OHRP, the agency, for purposes of the Paperwork
Reduction Act, will use 5,000 as the maximum number of IRBs subject to
the proposed rule. Additionally, because the proposed rule would
require basic information about an IRB (such as names and addresses)
and because registration would, in most cases, be done electronically,
OHRP assumes that registration currently takes, and will take (under
the proposed rule), only 1 hour per IRB for new registrations, and one
half hour per IRB for revisions or renewals.
Thus, the total burden hours would be 2,000 for new registrations
per year (2,000 IRBs x 1 hour per IRB).
Renewal registration and revisions to existing registration
information should require less time than initial registration. OHRP
assumes that renewal registration and revisions currently takes, and
will take (under the proposed rule), only 30 minutes per IRB for a
total of 500 burden hours for renewals (1,000 IRBs x 0.5 hour = 500)
and 1,000 for revisions (2,000 IRBs hour x .5 hour) = 1,000 hours.
A notice seeking public comments on the existing IRB registration
requirements was published in the Federal Register on April 19, 2002
(67 FR 19438). OHRP is inviting additional comments on both the current
information collection and the proposed information collection.
Request for Comment: In compliance with the requirements of section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for an agency to
provide opportunity for public comment on current information
collections and also on proposed information collection projects, OHRP
invites comments on: (1) Whether the collection of information is
necessary for the proper performance of OHRP's functions, including
whether the information will have practical utility; (2) the accuracy
of OHRP's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology. In this same issue of the Federal Register,
OHRP also is soliciting public comment on the information collection in
the Federalwide Assurance (FWA).
Interested persons are requested to send comments regarding the
current and proposed information collections by August 5, 2004 to the
following:
Department of Health and Human Services, Naomi Cook, OS/ASBTF/OIRM/
OIRM/OITP, IT Desk Officer/GPEA, 200 Independence Ave., SW.,
Washington, DC 20201
and
Office of Information and Regulatory Affairs, Office of Management and
Budget, fax number (202) 395-6974, Attn: Fumie Yokota.
VIII. Federalism
OHRP has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. OHRP has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.
IX. Request for Comments
Interested persons may submit to OHRP (see ADDRESSES) written or
electronic comments regarding this proposal by October 4, 2004.
X. Reference
The following reference is available from OHRP through the contact
listed above or can be accessed at: http://oig.hhs.gov/oei/ reports/
oei- 01-97-00193.pdf.
1. OIG, HHS, ``Institutional Review Boards: A Time for Reform,'' June
1998.
List of Subjects in 45 CFR Part 46
Health--Clinical research, Medical research, Human research
subjects, Reporting and recordkeeping requirements
Dated: June 2, 2004.
Cristina V. Beato,
Acting Assistant Secretary for Health.
Approved: June 22, 2004.
Tommy G. Thompson,
Secretary of Health and Human Services.
For the reasons set forth in the preamble, it is proposed that 45
CFR part 46 be amended as follows:
PART 46--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for 45 CFR part 46 continues to read as
follows:
Authority: 5 U.S.C. 301; 42 U.S.C.289; 42 U.S.C.300v-1(b).
2. Subpart F is added to part 46 to read as follows:
Subpart F--Registration of Institutional Review Boards
Sec.
46.601 Who must register?
46.602 What information must an IRB provide?
46.603 When must an IRB register?
46.604 Where can an IRB register?
46.605 How does an IRB revise its registration information?
Subpart F--Registration of Institutional Review Boards
Sec. 46.601 Who must register?
Each IRB that is designated by an institution under an assurance of
compliance approved for federalwide use by the Office for Human
Research Protections (OHRP) under Sec. 46.103(a) and that reviews
research involving human subjects conducted or supported by the
Department of Health and Human Services (HHS) must register with HHS.
An individual authorized to act on behalf of the institution or IRB
must submit the registration information.
Sec. 46.602 What information must an IRB provide?
Each IRB must provide the following information to HHS:
(a) The name and mailing address of the institution or organization
operating the IRB; and the name, earned degree, title, mailing address,
telephone number, facsimile number, and electronic mail address of the
senior or head official of that institution or organization who is
responsible for overseeing activities performed by the IRB;
(b) The name, title, telephone number, facsimile number, and
electronic mail address of the contact person providing the
registration information;
(c) The IRB number, registration name (for an initial registration,
OHRP will assign the IRB number and registration name), and address;
[[Page 40590]]
(d) The name, gender, earned degree, title, mailing address,
telephone number, facsimile number and electronic mail address of each
IRB chairperson;
(e) An IRB roster that includes the name, gender, degree,
scientific or nonscientific specialty, and affiliation of each voting
and alternate IRB member, including the chairperson;
(f) Using the measures ``small,'' ``medium,'' and ``large,'' the
approximate number of total active protocols undergoing initial and
continuing review; and active protocols supported by HHS. For purposes
of this subpart, an ``active protocol'' is any protocol or study for
which an IRB conducted an initial review or a continuing review during
the preceding calendar year. A ``small'' number of protocols is 1 to 25
protocols, ``medium'' is 26 to 499 protocols, and ``large'' is 500
protocols or more;
(g) The approximate number of full time positions devoted to the
IRB's administrative activities;
(h) An indication whether the institution or IRB organization is
accredited and, if so, the date of the last accreditation and the name
of the accrediting body or organization.
Sec. 46.603 When must an IRB register?
Each IRB must register when designated under an assurance approved
for federalwide use by OHRP under Sec. 46.103(a). The registration
will be effective for 3 years. Each IRB must renew its registration
every three years. Any complete update or renewal that is submitted to,
and approved by, OHRP, begins a new 3-year effective period. IRB
registration becomes effective when HHS posts that information on its
Web site.
Sec. 46.604 Where can an IRB register?
Each IRB may register electronically through [Web site address to
be added in the final rule]. If an IRB lacks the ability to register
electronically, it must send its registration information, in writing,
to OHRP.
Sec. 46.605 How does an IRB revise its registration information?
If registration information regarding an IRB contact, an IRB
chairperson or IRB roster changes, the IRB must revise that information
within 90 days by submitting any changes in that information. An
assured institution's or IRB organization's decision to disband a
registered IRB or to discontinue reviewing research conducted or
supported by HHS also must be reported within 30 days. All other
information changes may be reported when the IRB renews its
registration. The revised information may be sent to HHS either
electronically or in writing in accordance with Sec. 46.604.
[FR Doc. 04-14679 Filed 7-2-04; 8:45 am]
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