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pdfSupporting Statement
For HHS/OHRP Consultation Process, Institutional Review Board Records
Background
The Office for Human Research Protections is requesting a new approval from the Office of
Management and Budget of an Office for Human Research Protections (OHRP) requirement that
Institutional Review Board records be submitted when an IRB or its institution request an HHS
consultation process, for proposed research involving, respectively: (1) pregnant women, human
fetuses or neonates; (2) prisoners; or, (3) children, as subjects that are not otherwise approvable
by an IRB. This is a new information collection request.
A.
Justification
1.
Need and legal basis
The Department of Health and Human Services (HHS) Protection of Human Subjects
regulations at 45 CFR part 46 include three subparts that have provisions that do not
permit institutional review boards to approve certain categories of research, however do
permit IRBs to refer such proposed research to HHS for approval consideration (referred
to in this supporting statement as “HHS consultation process”). The Secretary of HHS1
may determine that such research can be conducted or supported by HHS, after
consulting with experts and allowing for public review and comment on the proposed
research.
The provisions in the above-referenced subparts are:
(1) 45 CFR part 46, subpart B (Additional Protections for Pregnant Women, Human
Fetuses and Neonates Involved in Research), §46. 207 – Research not otherwise
approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of pregnant women, fetuses, or neonates.2
The Secretary’s authority has been delegated to the Assistant Secretary for Health (ASH), 44 FR 46318 (August 7,
1979); see 67 FR 10216 (March 6, 2002).
2 The Secretary will conduct or support research that the IRB does not believe meets the requirements
of §46.204 or §46.205 only if:
1
1
(2) 45 CFR part 46, subpart C (Additional Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners as Subjects), §46.306 (iii) and (iv) – Permitted
research involving prisoners,
•
•
§46.306 (iii), Research on conditions particularly affecting prisoners as a class (for
example, vaccine trials and other research on hepatitis which is much more prevalent
in prisons than elsewhere; and research on social and psychological problems such as
alcoholism, drug addiction, and sexual assaults) provided that the study may proceed
only after the Secretary has consulted with appropriate experts including experts in
penology, medicine, and ethics, and published notice, in the Federal Register, of his
intent to approve such research;
§46.306 (iv) Research on practices, both innovative and accepted, which have the
intent and reasonable probability of improving the health or well-being of the subject.
In cases in which those studies require the assignment of prisoners in a manner
consistent with protocols approved by the IRB to control groups which may not
benefit from the research, the study may proceed only after the Secretary has
consulted with appropriate experts, including experts in penology, medicine, and
ethics, and published notice, in the Federal Register, of the intent to approve such
research.
(3) 45 CFR part 46, subpart D (Additional Protections for Children Involved as Subjects
in Research), §46.407 – Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious affecting the health or welfare of
(a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses
or neonates; and
(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
medicine, ethics, law) and following opportunity for public review and comment, including a public
meeting announced in the FEDERAL REGISTER, has determined either:
(1) That the research in fact satisfies the conditions of §46.204, as applicable; or
(2) The following:
(042455
) The research presents a reasonable opportunity to further the understanding, prevention,
or alleviation of a serious problem affecting the health or welfare of pregnant women,
fetuses or neonates;
(ii) The research will be conducted in accord with sound ethical principles; and
(iii) Informed consent will be obtained in accord with the informed consent provisions
of subpart A and other applicable subparts of this part.
2
children.3
In order for OHRP, on behalf of the Secretary of HHS, to determine if an expert panel
consultation and public review and comment process should be performed, the referring
institution or IRB must submit information supporting its request.
2.
Purpose and Use of the Information
If an IRB has determined that a research protocol meets the conditions to refer it to
OHRP to be considered under an HHS consultation process, the IRB or its institution
may submit the research protocol and supporting information to OHRP. The information
that must be submitted to OHRP includes the research protocol, informed consent,
parental permission or child assent documentation, and other relevant IRB records (e.g.,
IRB minutes).
OHRP uses this information to determine whether or not an HHS consultation process
should be performed.
3.
Use of Improved Information Technology and Burden Reduction
This information collection imposes no technological or standard format requirements for
respondents. We encourage automated technology if possible.
3
HHS will conduct or support research that the IRB does not believe meets the requirements of §46.404, §46.405,
or §46.406 only if:
(a) the IRB finds that the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of children; and
(b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
medicine, education, ethics, law) and following opportunity for public review and comment, has
determined either:
(1) that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable,
or (2) the following:
(i) the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of children;
(ii) the research will be conducted in accordance with sound ethical principles;
(iii) adequate provisions are made for soliciting the assent of children and the permission
of their parents or guardians, as set forth in §46.408.
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4.
Efforts to Identify Duplication and Use of Similar Information
There is no duplication resulting from these requirements.
5.
Impact on Small Businesses or Other Small Entities
Support of research activities involving human subjects extends to small businesses. The
collection of information requested will not have a significant economic impact on the
small businesses.
6.
Consequences if Information is Collected Less Frequently
Without this information collection, OHRP would not be able to determine whether or
not an HHS consultation process should be performed.
7.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8.
Consultation Outside of Agency
Public Comments were solicited for a 60-day period in the Federal Register published on
July 29, 2021 (86 FR 40860) on this information collection. There was a comment
received. Please see the supplemental document in ROCIS.
9.
Explanation of Any Payment or Gift to Respondents
No payments or gifts will be provided to respondents of this information collection.
10.
Assurance of Confidentiality Provided to Respondents
Collected information will be kept private to the extent required by law.
11.
Justification for Sensitive Questions
No sensitive information is being collected.
12.
Estimates of Annualized Burden Hours and Costs
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12 a.
Annualized Reporting Burden Estimate
As of May 27, 2021, a total of 5,937 active IRBs that indicate they review HHSconducted or supported research are registered with OHRP. The expectation is
that we may receive up to ten referrals a year that involve 1) pregnant women,
human fetuses and neonates; (2) prisoners; or, (3) children, as subjects that are not
otherwise approval by an IRB. We assume that each respondent would need an
hour to submit the required information.
Estimated Annualized Burden Hours
45 CFR part Respondent No. of
No. of
46 - HHS
Type
Respondents Respondents
Consultation
Process
Provision
subpart B,
§46. 207
subpart C,
§46.306 (iii)
and (iv)
subpart D,
§46.407
TOTAL
12b.
IRBs
3
1
Average
Burden
per
Response
(in
hours)
1
Total
Burden
Hours
IRBs
3
1
1
3
IRBs
4
1
1
4
3
10
Annualized Cost Burden Estimate
Estimated Annualized Respondents Costs
45 CFR part
Respondent Total Burden
46 - HHS
Type
Hours
Consultation
Process
Provision
subpart B,
IRBs
3
§46. 207
subpart C,
IRBs
3
§46.306 (iii)
and (iv)
5
Hourly Wage
Rate
Total
Respondent
Costs
$43.00
$129.00
$43.00
$129.00
subpart D,
§46.407
TOTAL
IRBs
4
$43.00
$172.00
$430.00
We estimate an average wage of $43 per hour. When multiplied by the total
number of burden hours (10), we estimate the information collection costs
respondents an average of $430.00 annually.
13.
Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents.
14.
Annualized Cost to the Federal Government
The expectation is that it will take OHRP staff 15 hours to check the collected information
for each set of IRB records that are submitted, at an hourly rate of $66.54. We estimate
the annual cost to the Federal government will be $9,981.00.
15.
Program or Burden Changes
This is a new collection.
16.
Publication and Tabulation Dates
When OHRP determines that an HHS consultation process will be performed, the collected
information (e.g., research protocol and supporting materials) will be posted for public
review and comment. It would be extremely helpful for OMB to approve this information
request as soon as possible.
17.
Reasons Display of OMB Expiration Date is Inappropriate
The program agrees to show the approval date.
18.
Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
ATTACHMENT
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Attachment 1 - Legal Authority
a. 45 CFR part 46
https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46?toc=1
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Attachment 1 - Legal Authority
a. 45 CFR part 46
Access here: https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=201807
19&n=pt45.1.46&r=PART&ty=HTML
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| File Type | application/pdf |
| File Modified | 2021-12-30 |
| File Created | 2021-12-30 |