[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Rules and Regulations]
[Page 2399-2405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-23]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 46
RIN 0940-AA06
Office of Public Health and Science; Institutional Review Boards:
Registration Requirements
AGENCY: Office of Public Health and Science, HHS.
ACTION: Final rule.
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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 adding a new subpart E to the HHS protection of human
subjects regulations, which requires institutional review boards (IRB)
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. The registration
information includes contact information, approximate numbers of all
active protocols and active protocols involving research conducted or
supported by HHS, and staffing for the IRB. The 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 this final rule, the IRB registration system is compatible with
the IRB registration requirements of the Food and Drug Administration
(FDA), which are simultaneously published as a final rule in this issue
of the Federal Register, allowing the operation of a single HHS IRB
registration system.
DATES: This rule is effective July 14, 2009. This protracted effective
date is necessary to allow refinement of the electronic registration
system so that it corresponds to this final rule and the FDA's final
rule, and obtain Office of Management and Budget (OMB) review and
approval for the information collection requirements of this rule.
Initial registration with all required information must be
submitted within 60 days of the effective date of the rule, by
September 14, 2009. For any IRB currently registered with OHRP, the
institution or organization operating the IRB must submit all
information required under this rule by the three-year expiration date
previously assigned by OHRP or within 90 days of any changes regarding
the contact person who provided the IRB registration information or the
IRB chairperson.
FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852, telephone (240) 453-6900, e-mail irene.stith-coleman@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
HHS, through OHRP, regulates research involving human subjects
conducted or supported by HHS in regulations codified at 45 CFR part
46. The HHS protection of human subjects regulations address the
appropriate role of IRBs in the human subject research enterprise. IRBs
are boards, committees, or groups formally designated by an institution
to conduct initial and continuing review 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.
OHRP has been operating a system of IRB registration since December
2000, which was initiated 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. 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
(i.e., a Federalwide Assurance [FWA]); (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) identify IRBs that are subject to HHS regulations for
monitoring and oversight purposes.
The OHRP IRB registration system was designed to collect
information required under the HHS human subjects protection
regulations at 45 CFR 46.103. 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. The only type of assurance
currently accepted by OHRP is an FWA. 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 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.
On July 6, 2004, OHRP published in the Federal Register a Notice of
Proposed Rulemaking (NPRM) seeking public comment on changes to the
current IRB registration system administered by OHRP (69 FR 40584).
OHRP proposed to amend the HHS human subjects protection regulations at
45 CFR part 46 by adding subpart F, entitled ``Registration of
Institutional Review Boards.'' In the new subpart F, OHRP proposed 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,
including the information that previously was provided on a voluntary
basis, listed on the IRB registration form that is currently used by
OHRP. 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 (69 FR 40556). OHRP and FDA proposed to use a single registration
system, accessible on the OHRP Web site, in which all IRBs that review
research conducted or supported by HHS or clinical investigations
regulated by FDA can be registered.
The proposed subpart F specifically addressed who must register an
IRB, what information an IRB must provide when registering, when an IRB
must register, where an IRB can register, and how an IRB can revise its
registration information.
In preparing the final rule, HHS has changed the designation of
proposed subpart F to subpart E and changed the numbering of the
provisions from Sec. Sec. 46.601-605 to Sec. Sec. 46.501-505.
[[Page 2400]]
II. Comments
Discussion of Individual Comments
During the public comment period that ended October 4, 2004, the
Department received 13 public comments on the proposed rule from
interested parties. In general, the comments were supportive of IRB
registration, although some commenters disagreed with specific aspects
of the proposed rule. The comments are summarized as follows:
1. What information must an IRB provide when registering? (Proposed
Sec. 46.602)
Proposed Sec. 46.602 described the information to be submitted as
part of the registration process. Specific comments were received on
the following proposed data elements required for registration.
IRB Roster
OHRP proposed to collect an IRB roster that includes the names,
earned degrees, gender, area of specialty and affiliation of each
voting member (including the IRB chairperson) and alternate IRB
members.
One commenter stated that the value or utility of collecting
information about the IRB roster is not clear and that the collection
may be quite burdensome. OHRP notes that the collection of IRB roster
information by HHS for each IRB that is designated on an OHRP-approved
FWA already is required by 45 CFR 46.103(b)(3), and thus has decided to
delete this requirement from the final rule as unnecessarily
duplicative. However, the IRB registration form will continue to
include IRB roster information as part of the IRB registration process
since this information is required by 45 CFR 46.103(b)(3).
Approximate Number of Total Active Protocols
OHRP proposed to require submission of the approximate number of
total active protocols undergoing initial and continuing review and the
approximate number of active protocols supported by HHS. The proposal
would have required identification of the range of the number of
protocols reviewed in the preceding calendar year. A ``small'' number
of protocols would be 1 to 25 protocols, ``medium'' 26 to 499
protocols, and ``large'' 500 or more protocols. OHRP explained that
this information will enable it 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.
One commenter asserted that this collection poses an unnecessary
reporting burden by going beyond the information needed to meet the
registration requirements, and strongly recommended that OHRP limit its
data collection to elements that support regulatory requirements. This
commenter argued that the proposed data collection will not provide
OHRP with information that assists in the constructive assessment of an
institution's IRB activity, and, as a consequence, has limited value.
The commenter noted that, for example, 24 cancer studies will most
likely generate a significantly greater volume of work for an IRB than
500 social or statistical data analyses--many of the latter of which
will be reviewed under expedited review procedures.
Two other commenters expressed concern about this information
collection. One stated that, given the variety of protocols that are
being performed at any large research university and the different
oversight workloads that varying protocols require, such a crude
measure might lead to erroneous interpretation of the registration
data. This commenter asserted that, at a minimum, such data should be
accompanied by a disclaimer to avoid misunderstanding, but that OHRP
may want to reconsider the necessity and validity of such information.
The second commenter said that it is unclear how useful or accurate
such data would be in light of the following factors: The varying
complexity of IRB review and protocol-driven research activity (e.g.,
social and behavioral, biomedical, phase 1, 2, or 3 studies, gene
therapy); the level of IRB review (i.e., review at a convened meeting
or expedited review process) required for different types of research
protocols (e.g., chart reviews, interventions, survey research,
continuation review, etc.); and the frequent and daily changes in the
number of protocols reviewed by an IRB. The commenter recommended that
this information collection be an optional question.
Another commenter questioned whether research volume per se is an
accurate measure of the workload of an IRB. Acknowledging and
appreciating that OHRP did not propose that institutions be required to
supply specific numbers of active protocols undergoing initial and
continuing review each year, this commenter had no objection to the
proposal of numerical ranges that can be selected by registrants to
describe their activity. However, the commenter urged that the
information be interpreted carefully and cautiously in light of the
importance of OHRP's proposed uses of the information collected.
Another commenter supported this information collection but
encouraged OHRP to consider redefining the ranges as small 1-99, medium
100-499, large 500-1,999, and very large 2,000 or more. The commenter
noted that there are a substantial number of organizations that oversee
thousands of protocols and thus operate quite differently from those
that oversee 500 protocols; further, there appears to be a small number
of organizations with fewer than 25 protocols, and organizations with
very few protocols often rely upon an IRB operated by another
organization rather than form their own IRB.
After careful consideration of all comments, OHRP will retain this
information requirement in the final rule for the reasons stated in the
NPRM: This information will provide insight into an IRB's activity
level and allow OHRP to more effectively assign its quality
improvement, educational, and compliance oversight resources. However,
given that the proposed protocol ranges were artificial, we have
revised the rule to eliminate the ``small,'' ``medium'', and ``large''
ranges. Instead, the final rule requires submission of an approximate
number of all active protocols and the approximate number of active
protocols conducted or supported by HHS. For the purpose of the final
rule, an ``active protocol'' is any protocol or study 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
twelve months. OHRP will utilize this data cautiously and does not
intend to use this data to make presumptive or sweeping determinations
regarding an institution's human subject protection program.
Approximate Number of Full-Time Equivalent Positions
OHRP proposed to require submission of the approximate number of
full-time equivalent positions (FTEs) devoted to the IRB's
administrative activities. 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 recordkeeping duties. In OHRP's experience, the
number of FTEs compared to the volume of research is
[[Page 2401]]
one useful parameter 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).
Two commenters objected to this proposed information requirement.
One recommended that these data not be included in the registry,
stating that there is no standard measure for IRB staffing and no
formula for allocation of personnel to administer an IRB; the nature of
the protocols reviewed--biomedical or social and behavioral sciences--
has a direct impact on staffing decisions; and information on the
number of full-time IRB staff positions is of limited value in
assessing the institution's commitment to human subject protection. The
commenter asserted that this collection poses an unnecessary reporting
burden by going beyond the information needed to meet the registration
requirements, and strongly recommended that OHRP limit its data
collection to elements that support regulatory requirements. The
commenter also stated that the request for information about the number
of staff devoted to the IRB does not strengthen the value of the
protocol data; and that as with the approximation of active protocols,
the types of protocols reviewed and managed by the IRB staff--
biomedical or social and behavioral sciences--have a direct effect on
the allocation of resources. The second commenter urged that this
information be interpreted carefully and cautiously in OHRP's
determinations of whether or not an institution has made provisions for
meeting space and sufficient staff to support the IRB's review and
record keeping duties.
OHRP finds that collecting information on the number of FTEs
allocated to IRB administrative activities poses little if any burden
on institutions and would be helpful in OHRP's assessment of whether an
IRB has sufficient staff, and therefore, OHRP has retained this
requirement in the final rule. OHRP will utilize this data cautiously
and intends neither to use this information as the only parameter for
measuring regulatory compliance with 45 CFR 46.103(b)(2), nor to use
this data to make presumptive or sweeping determinations regarding an
institution's human subject protection program. OHRP has no intention
of using this data to develop a formula for assessing the adequacy of
IRB resources.
Accreditation Status
OHRP proposed to require submission of information regarding
whether the institution or organization registering an IRB currently is
accredited by a human subjects protection program accrediting
organization, and if so, the date of its last accreditation and the
name of the accrediting organization. OHRP stated that because
accreditation is a developing concept, information on accreditation
will help OHRP to evaluate the extent and value of IRB accreditation,
and specifically solicited public comment related to the perceived
value of collecting information on the accreditation status of IRBs.
Four commenters endorsed the collection of accreditation status
information. Of these, two urged OHRP to use the accreditation of the
institution, organization, or human research protection program as the
unit of measure rather than IRB accreditation.
Four commenters objected to the proposed collection of
accreditation status information. Two of these commenters indicated
that the accreditation process is relatively new and noted that the
names of accredited institutions and organizations are publicly
accessible at sites that will present more up-to-date information than
would be available in the HHS IRB registration database. One of the
objecting commenters stated that the information may not be accurate,
and another noted that accreditation has shown no proven benefit and no
one set of accreditation standards has been developed or accepted.
In response to these comments, OHRP has decided to eliminate the
requirement for reporting accreditation status from the final rule.
Because similar information is publicly accessible, OHRP has determined
that collection of this information through the IRB registration
process is unnecessary.
Other Data Elements
One commenter noted that the data required for registration fails
to include a parameter that would monitor whether IRB members have
experience that would contribute to an adequate review of research
studies involving children. The commenter requested that proposed Sec.
46.602(e) be modified to require an indication of whether each IRB
member has child health care and research expertise, and that proposed
Sec. 46.602(f) be expanded to include an estimate of the number of
protocols an IRB reviewed that involved children. OHRP finds that the
collection of such information is not necessary to further its goals of
ensuring consistency with the requirements of 45 CFR 46.103(b)(3) that
pertain to IRB composition.
One commenter suggested that the information collected from IRBs
include a sense of the scope of vulnerable populations included in the
research protocols, such as children, pregnant women, the elderly, and
prisoners. OHRP finds that the collection of such information is not
necessary to further the stated goals of the IRB registration system.
2. Where can an IRB register? (Proposed Sec. 46.604)
Proposed Sec. 46.604 directed IRBs to register at an 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.
One commenter expressed pleasure that IRB registration may be
performed online, greatly easing the compliance burden associated with
such a requirement. OHRP agrees that online registration simplifies the
IRB registration process and expects that nearly all institutions or
IRB organizations have the capability to register electronically. The
final rule has been modified to now require that each IRB must be
registered electronically 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.
3. How does an IRB revise its registration information? (Proposed Sec.
46.605)
Proposed Sec. 46.605 required that changes in the IRB contact,
chairperson, or roster information be updated in the registry within 90
days. Whenever the electronic system is used to update or revise such
information, the system instructs that all data on the IRB registration
form be verified.
Proposed Sec. 46.605 also considered 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.
One commenter expressed concern about the requirement for reporting
the closure of an IRB within 30 days, noting that the closure process
may take longer than 30 days and that imposition of this requirement
would put an undue burden on IRBs and the supporting institutions. In
response to this comment, OHRP has added clarifying language to the
final rule (now Sec. 46.505) to indicate that an institution's or
organization's decision to disband a registered IRB designated under an
FWA must be reported to OHRP within
[[Page 2402]]
30 days of permanent cessation of the IRB's review of HHS-conducted or
supported research.
OHRP notes that Sec. 46.505 of the final rule has been modified
from the proposed Sec. 46.605 to delete the requirement that IRB
roster changes must be submitted within 90 days, because 45 CFR
46.103(b)(3) already requires that changes in IRB roster information be
reported to OHRP.
4. General Comments
Nine commenters specifically commented in support of the concept of
IRB registration.
One commenter requested that FDA and OHRP maintain one common
registration site that will automatically include currently registered
IRBs and allow them to retain their currently assigned numbers. OHRP
notes that such a common registration site has been created.
One commenter urged that the information required from registered
IRBs be the same for both FDA and OHRP. OHRP finds that, because of the
differing statutory and regulatory authorities of FDA and OHRP to
collect IRB registration information, the information required from
registered IRBs is not the same for both agencies. However, OHRP notes
that Sec. 46.502 of the final rule has been modified from the proposed
Sec. 46.602 to harmonize further OHRP's final rule with FDA's. These
changes include the following:
Section 46.502(a) (which was Sec. 46.602(a) in the NPRM)
was modified to remove the requirement to submit the earned degree and
the title of the senior or head official of the institution or
organization operating the IRB who is responsible for overseeing the
activities performed by the IRB. This section also was modified to
require submission of the street address (if different from the mailing
address) for the institution or organization operating the IRB.
Section 46.502(b) (which was Sec. 46.602(b) in the NPRM)
was modified to remove the requirement to submit the title of the
contact person providing the registration information. This section
also was modified to require submission of the mailing address of this
contact person.
Section 46.502(c) (which was Sec. 46.602(c) in the NPRM)
was modified to require submission of the IRB's phone number, facsimile
number, mailing address, street address (if different from the mailing
address), and electronic mail address.
Section 46.502(d) (which was Sec. 46.602(d) in the NPRM)
was modified to remove the requirement to submit the gender, earned
degree, title, mailing address, and facsimile number of the IRB
chairperson.
As stated in the preamble to the proposed rule, the Internet
registration site will request more information from IRBs reviewing
research conducted or supported by HHS than from IRBs 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, the Internet site would
clarify that IRBs regulated solely by FDA are not required to provide
the additional information. Likewise, in those instances where the
registration site would seek additional information from IRBs regulated
by FDA but not regulated by HHS, the Internet site would clarify that
IRBs regulated by HHS are not required to provide such information.
One commenter suggested that the rule make clear what of the
information submitted is available through a Freedom of Information Act
(FOIA) request. OHRP notes that although the IRB registration system
information is subject to FOIA, disclosure determinations will be made
in accordance with applicable exemptions.
One commenter questioned whether, if an IRB was originally
registered with the U.S. Department of Education (ED) and reviews both
ED and HHS research projects, the proposed registration update will
meet the ED requirements. ED has informed OHRP that ED will rely upon
the HHS IRB registration system and indicated that ED would ensure that
the IRB will be registered with OHRP.
One commenter asserted that if HHS requires IRBs to register but
does not require industry and investigators to use a registered IRB,
then only the IRBs are at risk of being penalized for a failure to
register. The commenter suggested that HHS should impose a financial
penalty on the investigators and sponsors who do not use a registered
IRB. OHRP declines to impose monetary penalties on investigators and
sponsors who do not use a registered IRB for review of research. OHRP
does not have the legal authority to impose fines for failure to
maintain IRB registration information. Furthermore, OHRP notes that an
IRB cannot be designated under an assurance of compliance approved for
federalwide use by OHRP if it fails to register. OHRP believes that the
registration requirement is both simple and straightforward, so it does
not expect that institutions or organizations operating IRBs designated
under FWAs will refuse or fail to register or revise their registration
information.
One commenter asked whether IRBs will receive confirmation that the
IRB is registered. Confirmation of registration will be provided to the
registering entity under the IRB registration system.
One commenter expressed concern that the proposed rule change will
hinder small- to medium-sized organizations which wish to conduct HHS-
supported research because such smaller organizations may lack
resources to support standing IRBs. OHRP finds that this regulatory
change does not mandate that every research organization that receives
HHS support must have its own IRB. OHRP anticipates that an institution
without an IRB that wishes to conduct HHS-supported human subjects
research may designate under its FWA an independent IRB or another
institution's IRB for review of research, and that this IRB will be
registered in accordance with the regulatory requirements.
Summary of Key Changes in the Final Rule
After considering the comments on the proposed rule, OHRP is
adopting the rule largely as it was proposed. The following key changes
have been made in the final rule:
1. The designation of proposed subpart F has changed to subpart E
and the numbering of the provisions has changed from Sec. Sec. 46.601-
605 to 46.501-505.
2. The proposed requirement to collect 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 (which was Sec. 46.602(e) in the NPRM) has been deleted
from the final rule. However, the IRB registration form will continue
to include IRB roster information as part of the IRB registration
process since this information is required by 45 CFR 46.103(b)(3).
3. Section 46.502(a) of the final rule (which was Sec. 46.602(a)
in the NPRM) was modified to remove the requirement to submit the
earned degree and title of the senior or head official of the
organization or institution operating the IRB who is responsible for
overseeing activities performed by the IRB. This section also was
modified to require submission of the street address (if different from
the mailing address) for the institution or organization operating the
IRB.
4. Section 46.502(b) of the final rule (which was Sec. 46.602(b)
in the NPRM) was modified to remove the requirement to submit the title
of the contact person providing the registration information. This
section also was modified to require submission of the mailing address
of this contact person.
[[Page 2403]]
5. Section 46.502(c) of the final rule (which was Sec. 46.602(c)
in the NPRM) was modified to require submission of the IRB's phone
number, facsimile number, mailing address, street address (if different
from the mailing address), and electronic mail address.
6. Section 46.502(d) of the final rule (which was Sec. 46.602(d)
in the NPRM) was modified to remove the requirement to submit the
gender, earned degree, title, mailing address and facsimile number of
the IRB chairperson.
7. Section 46.502(e) of the final rule (which was Sec. 46.602(f)
in the NPRM) was modified to require submission of the approximate
number of all active protocols and active protocols conducted or
supported by HHS, rather than the number ranges (small, medium, or
large) for total active protocols and active protocols supported by
HHS, as proposed in the NPRM.
8. The proposed requirement to submit information regarding whether
the institution or IRB organization registering an IRB is accredited
(which was in Sec. 46.602(h) of the NPRM) has been deleted from the
final rule.
9. Section 46.503 of the final rule (which was Sec. 46.603 in the
NPRM) was modified to clarify that IRB registration becomes effective
when reviewed and accepted by OHRP, rather than when HHS posts
registration information on its website.
10. Section 46.504 of the final rule (which was Sec. 46.604 in the
NPRM) was modified to require electronic submission of registration
information unless an institution or organization lacks the ability to
do so.
11. Section 46.505 of the final rule (which was Sec. 46.605 in the
NPRM) was modified to remove the requirement that information regarding
IRB roster changes must be submitted within 90 days because 45 CFR
46.103(b)(3) already requires that changes in IRB roster information be
reported to OHRP.
Other minor changes have been made in the final rule for purposes
of clarity and accuracy.
III. What Happens if an IRB Does Not Register or Fails To Update its
Registration Information?
An IRB cannot be designated under an FWA if it fails to register.
If an FWA submitted to OHRP for approval designates an IRB that has not
been registered, OHRP will not approve the FWA with the designation of
that IRB.
If an IRB designated under an FWA fails to appropriately update its
registration information in accordance with Sec. 46.505 of the final
rule, OHRP could restrict or revoke its approval of the FWA. For
example, if an IRB fails to appropriately update its registration
information in accordance with Sec. 46.505 of the final rule, OHRP
could take appropriate action under the institution's FWA and OHRP's
compliance oversight policies and procedures. OHRP believes that the
registration requirement in the final rule is both simple and
straightforward, so it does not expect that institutions or
organizations operating IRBs designated under FWAs will refuse or fail
to register or update their registration information.
IV. Who Has Access to the IRB Registration Information Submitted to
HHS?
OHRP has posted and will continue to post on its Web site the
following information collected under the IRB registration process:
1. The name, location, 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. Provision of the IORG number allows OHRP
to efficiently track and organize all IRB registration information
submitted by the same institution or organization.
2. The name, location, registration expiration date, and OHRP-
assigned registration number of each registered IRB. The first time an
IRB is registered, OHRP assigns it a separate unique IRB registration
number. This number is to be provided to OHRP whenever an institution
or organization subsequently updates or renews an IRB registration.
Provision of the IRB registration number allows OHRP to efficiently
track and organize all IRB registration information submitted by an
institution or organization for the same IRB. Furthermore, an
institution submitting an FWA includes the IRB registration number for
each IRB designated under its FWA, thereby eliminating the need for
multiple submissions of the same registration information to OHRP.
Although all other information collected by the IRB registration is
subject to FOIA, disclosure determinations will be made in accordance
with applicable exemptions.
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 OHRP
will be transferred to a separate server which will not be publicly
accessible. 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 database, 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.
V. Implementation
This rule is effective July 14, 2009. This protracted effective
date is necessary to (a) allow refinement of the electronic
registration system so that it corresponds to this final rule and to
FDA's final rule, and (b) obtain OMB review and approval for the
information collection requirements of this rule.
Initial registration with all required information must be
submitted within 60 days of the effective date of the rule, by
September 14, 2009. For any IRB currently registered with OHRP, the
institution or organization operating the IRB must submit all
information required under this rule by the three-year expiration date
previously assigned by OHRP or within 90 days of any changes regarding
the contact person who provided the IRB registration information or the
IRB chairperson.
VI. 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 (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 (42 U.S.C. 289(b)). These authorities are delegated to
OHRP (67 FR 10216-18, March 6, 2002).
By requiring IRB registration, the rule will aid in the efficient
implementation
[[Page 2404]]
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, collection of the
information required under the rule will 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 this rule.
VII. Economic Impact Analysis
OHRP has examined the impact of the 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). OHRP believes
that this final rule is not a significant regulatory action as defined
by the Executive Order.
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 would minimize any significant impact
of the rule on small entities. Because the required registration
information is minimal and the costs associated with registration is
low, OHRP certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that an agency 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 current threshold after adjustment for inflation is
$127 million, using the most current (2006) Implicit Price Deflator for
the Gross Domestic Product. OHRP does not expect this final rule to
result in any one-year expenditure that would meet or exceed this
amount.
The rule requires IRBs designated under an assurance of compliance
approved for Federalwide use by OHRP to register with HHS. The
information sought through the registration process is minimal,
consisting largely of the following: The name, mailing address, and
street address (if different from the mailing address) for the
institution or organization operating the IRB; the names, addresses,
phone numbers, facsimile numbers, and electronic mail addresses of (i)
the senior officer or head official of the institution or organization
operating the IRB who is responsible for overseeing the activities
performed by the IRB, and (ii) the contact person providing the
registration information; the name, phone number, and electronic mail
address of the IRB chairperson; and, the approximate numbers of all
active research protocols, active protocols conducted or supported by
HHS, and full-time equivalent positions devoted to the IRB's
administrative activities.
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 will spend $40 for an initial registration ($40 per hour x 1
hour per initial registration).
OHRP estimates that the renewal or update of an IRB registration
will require less time, especially if the IRB is only verifying
existing information. If renewing or updating an IRB registration
requires 30 minutes, then the cost of renewing or updating would be
approximately $20 ($40 per hour x 0.5 hour per registration renewal or
update).
Additionally, assuming that the maximum number of IRBs that will be
subject to registration annually would be 6,000, OHRP estimates that
2,000 IRBs will complete one new registration and one update each year
and the other 4,000 IRBs will complete two updates or renewals each
year. The total annual burden costs for 6,000 IRBs are projected to be
$280,000 (2,000 new IRB registrations x 1 hour x $40/hr = $80,000; 1
renewal/update of these 2,000 IRBs x 0.5 hr x $20/0.5 hr = $40,000;
4,000 IRBs will complete 2 updates/renewals each year, 4,000 IRBs x 0.5
hr x $20/0.5 hr x 2 = 160,000).
Given the minimal registration information that would be required
and the low costs associated with registration, this rule is not a
significant regulatory action, and OHRP certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. The rule 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
one-year expenditure of $100 million or more, OHRP is not required to
perform a cost-benefit analysis under the Unfunded Mandates Reform Act.
VIII. 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.
IX. Paperwork Reduction Act
This 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). In compliance with the Paperwork Reduction Act of
1995 (44 U.S.C. 3507(d)), OHRP will obtain OMB review and approval for
the information collection requirements of this rule.
X. Federalism
OHRP has analyzed this 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, we have 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.
List of Subjects in 45 CFR Part 46
Health--Clinical research, Medical research, Human research
subjects, Reporting and recordkeeping requirements.
Dated: December 31, 2008.
Donald Wright,
Principal Deputy Assistant Secretary for Health.
Approved: January 6, 2009.
Michael O. Leavitt,
Secretary of Health and Human Services.
0
Accordingly, 45 CFR part 46 is amended as follows:
PART 46--PROTECTION OF HUMAN SUBJECTS
0
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).
[[Page 2405]]
0
2. Subpart E is added to part 46 to read as follows:
Subpart E--Registration of Institutional Review Boards
Sec.
46.501 What IRBs must be registered?
46.502 What information must be provided when registering an IRB?
46.503 When must an IRB be registered?
46.504 How must an IRB be registered?
46.505 When must IRB registration information be renewed or updated?
Sec. 46.501 What IRBs must be registered?
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 be registered with
HHS. An individual authorized to act on behalf of the institution or
organization operating the IRB must submit the registration
information.
Sec. 46.502 What information must be provided when registering an
IRB?
The following information must be provided to HHS when registering
an IRB:
(a) 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 electronic mail address of the senior officer or head
official of that institution or organization who is responsible for
overseeing activities performed by the IRB.
(b) The name, mailing address, phone number, facsimile number, and
electronic mail address of the contact person providing the
registration information.
(c) The 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 number, facsimile number,
and electronic mail address.
(d) The name, phone number, and electronic mail address of the IRB
chairperson.
(e)(1) The approximate numbers of:
(i) All active protocols; and
(ii) Active protocols conducted or supported by HHS.
(2) For purpose of this regulation, an ``active protocol'' is any
protocol for which the IRB conducted an initial review or a continuing
review at a convened meeting or under an expedited review procedure
during the preceding twelve months.
(f) The approximate number of full-time equivalent positions
devoted to the IRB's administrative activities.
Sec. 46.503 When must an IRB be registered?
An IRB must be registered before it can be designated under an
assurance approved for federalwide use by OHRP under Sec. 46.103(a).
IRB registration becomes effective when reviewed and accepted by OHRP.
The registration will be effective for 3 years.
Sec. 46.504 How must an IRB be registered?
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.
Sec. 46.505 When must IRB registration information be renewed or
updated?
(a) Each IRB must renew its registration every 3 years.
(b) 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. The updated
registration information must be submitted in accordance with Sec.
46.504.
(c) Any renewal or update that is submitted to, and accepted by,
OHRP begins a new 3-year effective period.
(d) 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.
[FR Doc. E9-588 Filed 1-14-09; 8:45 am]
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