Supporting Statement _11.02.2022

U. S. Department of Health and Human Services (HHS)
Office for Human Research Protections
Research Complaint Form
Supporting Statement

Background
The Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is requesting a new approval from
the Office of Management and Budget of OHRP’s Research Complaint Form. This form will provide a simplified standardized format
for submitting to OHRP allegations of noncompliance involving human subject research projects conducted or supported by HHS.
The information collected will help OHRP ensure the rights of human subjects involved in such research and that assured institutions
are complying with the HHS Protection of Human Subjects regulations. This is a new information collection request.

A.

Justification
1. Need and Legal Basis
Section 289 of the Public Health Service Act authorizes OHRP, on behalf of HHS, to establish a compliance oversight
process regarding violations of the rights of human subjects of research conducted or supported by HHS. Pursuant to that
authority, OHRP may receive reports of violations and take appropriate action. OHRP also derives compliance authority
from the HHS Protection of Human Subjects regulations at 45 CFR 46 1 (hereafter referred to as “HHS regulations”).
HHS regulations at 45 CFR 46.103(a) require each institution engaged in non-exempt human subjects research conducted
or supported by HHS to provide assurance that it will comply with the requirements of the HHS regulations. The
Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. An OHRP-

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The pre-2018 HHS Protection of Human Subjects Regulations (or pre-2018 Requirements), codified at subpart A, 45 CFR part 46 (as amended), were originally
promulgated in 1991 (56 FR 28012, 28022) and amended on June 23, 2005 (70 FR 36325). The 2018 HHS Protection of Human Subjects Regulations (or 2018
Requirements), codified at subpart A, 45 CFR part 46 (as amended), were originally published on January 19, 2017 (82 FR 7149), and amended on January 22,
2018 (83 FR 2885) and June 19, 2018 (83 FR 28497).
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approved FWA commits an assured institution to full compliance with the HHS regulations whenever the institution is
engaged in HHS-conducted or -supported human subjects research.
Sources of allegations or indications of noncompliance with the HHS regulations, include, but are not limited to, research
subjects and their family members, individuals involved in the conduct of research (e.g., investigators), and institutional
officials.
In carrying out its responsibility for oversight of compliance with the HHS regulations, OHRP reviews allegations of
noncompliance involving human subject research conducted or supported by HHS or that are otherwise subject to th e
regulations, and determines whether to conduct a for-cause compliance evaluation. For details, see OHRP guidance, titled,
“Compliance Oversight Procedures for Evaluating Institutions.”
2. Purpose and Use of Information Collection
Historically OHRP has not standardized the content of the information that is submitted in allegations of noncompliance
with the HHS regulations (hereafter referred to as “complaint(s)”). Currently, such complaints are submitted to OHRP via a
dedicated email address (complaints.ohrp@hhs.gov) and OHRP staff manually enter the complaint information into a
database. This information collection request proposes to standardize both the content of submitted complaint information
and the manner in which the collected information is submitted to OHRP, which should in turn reduce the burden for
complainants. Respondents would complete and submit an electronic version of the proposed research complaint form,
eliminating the need for OHRP staff to manually enter the collected information into a database.
OHRP use the collected information to determine whether it has jurisdiction to evaluate the possible noncompliance, and if
so, whether OHRP will conduct a for-cause evaluation.
3.

Improved Information Technology and Burden Reduction
OHRP will use information technology to allow for electronic completion and su bmission of the collected information that
is automatically transferred to a database. The current need for OHRP to manually enter complaint information into a
database would be eliminated.
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4. Efforts to Identify Duplication and Use of Similar Information
There is no duplication of efforts or use of similar information.
5. Impact on Small Businesses or Other Small Entities
The small businesses that are most likely to be affected are for-profit, independent IRB companies and small companies
that conduct HHS-supported research involving human subjects. The proposed research complaint form minimizes burden
for small businesses by providing a simplified standardized format for reporting complaints. The information collection
will not have a significant impact on small entities.
6. Consequences of Collecting the Information Less Frequently
Not applicable.
7. Special Circumstances Relating to the Guidelines of 5 C.F.R. 1320.5
There are no special circumstances for this information collection.
8. Comments in Response to the Federal Register Notice/Outside Consultation
Comments are being requested from the public for a 60-day period.
9. Explanation of any Payment/Gift to Respondents
No payment or gifts are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The information on the form will not be affirmatively made public due to policy considerations; it will only be made public
to the extent required by the Freedom of Information Act (FOIA) in response to a FOIA request.
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The Research Complaint Form will not collect information that is subject to the Privacy Act; all information collected is
intended to be about organizations or institutions and to be used by OHRP to ensure that those entities address allegations
appropriately.
11. Justification for Sensitive Questions
No sensitive information is being collected.
12. Estimates of Annualized Burden Hours and Costs
There are over 14,000 organizations with active assurances with OHRP. In 2022 OHRP received approximately 1000
complaints related to research conducted in the United States. On average, we estimate that approximately 1000
complaints will be submitted to OHRP annually. Of those 1000 complainants, 500 complainants will submit one report,
400 will submit two reports, and 100 will submit an average of three reports. We estimate the total annualized burden hours
to be 800 hours. We estimate that each respondent will take an average of 30 minutes to complete the form.
12a. Estimated Annualized Burden Hours
Form Name

Number of
Respondents

Number of
Responses per
Respondent

Average Burden
per Response (in
hours)

Total Burden
Hours

Research
Complaint Form

500

1

30/60

250

Research
Complaint Form

400

2

30/60

400

Research
Complaint Form

100

3

30/60

150

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Total

800

We expect that respondents will be research staff persons (to include IRB members, IRB administrators, research
coordinators) within organizations or the general public. We estimate the hourly wage to be an average $41.25 and the total
burden cost is estimated to be $33,000.
12b. Estimated Burden Costs
Form Name

Number of
Respondents

Burden Hours

Hourly Wage

Total Respondent
Costs

Research Complaint
Form

500

250

$41.25

$10,312.50

Research Complaint
Form

400

400

$41.25

$16,500

Research Complaint
Form

100

150

$41.25

$6,187.50

Total

$33,000

13. Estimates of Annualized Cost Burden to Respondents
There are no direct costs to respondents other than their time to complete the form.
14. Estimates of Annualized Cost to the Government
As described in section 12 above, OHRP receives approximately 1,000 complaint emails per year. The average OHRP
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hourly rate of personnel processing complaints is $42.27. Currently, OHRP personnel spend approximately 2 hours per
report to manually input information into federal databases.
o With the use of the proposed form and streamlined submission system, we estimate that OHRP personnel will spend
approximately 30 minutes per report to ensure that information is appropriately entered into federal databases.
o OHRP personnel spend an additional 30 minutes per report to assess the adequacy of the submitted information to
determine if follow-up is needed.
o For approximately 50 complaints per year, OHRP determines that additional investigation is needed. OHRP personnel
spend on average 10 hours conducting additional investigation on each of the complaints.

Description (support
staff)
OHRP input into
database, Conduct
additional investigation

Estimated costs to government
Total Hours
Hourly Cost
2300

42.27

Total cost of processing
complaints/yr
$97,221.00

o 1000 respondents, 2-5 frequency of response, 1664 hours/year. Currently, OHRP has a GS12 equivalent FTE that
spends approximately 80% of their time reviewing and processing complaints about research sent to OHRP annually.
o Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and
using appropriate wage rate categories.
15. Explanation for Program Changes or Adjustments
This is a new collection.
16. Plans for Tabulation and Publication and Project Time Schedule
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Information related to results of the collected information may be published on the OHRP website.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
No certification exception is requested.
List of ATTACHMENTS
Attachment 1 – Legal Authorities
a. 42 U.S.C Section 289
b. 45 CFR 46 (pre-2018 Requirements
c. 45 CFR 56 (2018 Requirements)
Attachment 2 – Research Complaint Form

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