[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Rules and Regulations]
[Pages 2399-2405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-588]



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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 [email protected].

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.

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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

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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

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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]
BILLING CODE 4150-36-P