Public Health Service Policies on Research Misconduct (42 CFR Part 93)

Office of Research Integrity
Small Institution Statement
for Handling Allegations of Research Misconduct
Under 42 CFR Part 93
For small institutions (typically 1 to 50 institutional members) applying for or receiving Public
Health Service (PHS) research funds, it may be difficult to conduct an inquiry or investigation
into an allegation of research misconduct as required by the PHS Policies on Research
Misconduct (42 CFR Part 93) without real or perceived conflicts of interest. A small institution is
defined in this regulation as:
§ 93.240 Small institution. Small institution means an institution that may be too small to
conduct an inquiry or investigation into an allegation of research misconduct as required by this
part without actual or apparent conflicts of interest.
Small institutions may file this Small Institution Statement with the Office of Research Integrity
(ORI) in lieu of the written policies and procedures required by 42 CFR §§ 93.300(a), 93.301, and
93.304 when completing the Research Integrity Assurance Establishment form and when filing
the Research Integrity Assurance and Annual Report on Possible Research Misconduct.
Consistent with § 93.303, ORI will notify institutions whether their use of the Small Institution
Statement is approved.
Filing a Small Institution Statement with ORI does not relieve the institution from complying
with any other provisions of 42 CFR Part 93. The regulation states that by submitting a Small
Institution Statement, the institution agrees to report all allegations of research misconduct to
ORI. ORI or another appropriate HHS office will work with the institution to develop and/or
advise on an administrative process for handling allegations of research misconduct consistent
with 42 CFR Part 93. The regulation also states that if a small institution has or believes it has a
conflict of interest during any phase of a research misconduct proceeding, the small institution
may contact ORI for guidance.
All institutions, including small institutions, that apply for or receive PHS support for biomedical
or behavioral research, biomedical or behavioral research training, or activities related to that
research or research training with PHS funding, are required to file the Research Integrity
Assurance and Annual Report on Possible Research Misconduct form with ORI. The annual
report will contain information on the institution’s compliance with 42 CFR Part 93 with respect
to allegations of research misconduct. The Institutional Certifying Official is responsible for
certifying the content of this report and for ensuring the report is submitted as required. Along
with its annual report, an institution must send ORI such other information as ORI may request
on the institution’s research misconduct proceedings covered by Part 93 and the institution’s
compliance with Part 93. ORI has released guidance on small institutions, which can be found
at ori.hhs.gov/guidance-documents.

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Name of Institution:
E-mail Address:
Mailing Address:
Phone:
(Note: Your institution may substitute this information by completing this statement on your
institutional letterhead)
Do you believe your institution qualifies as a small institution, as defined in 42 CFR Part 93? A small
institution is too small to conduct an inquiry or investigation into an allegation of research misconduct
as required by 42 CFR Part 93 without actual or apparent conflicts of interest.
☐ Yes ☐ No
If yes, complete the remainder of this statement.
[Institution Name] has

(number of) institutional members per 42 CFR § 93.219.

[Institution Name] certifies that it will comply with 42 CFR Part 93. Small institutions are exempt from
the requirement to have written policies and procedures per 42 CFR §§ 93.300(a), 93.301, and 93.304
but otherwise must comply with 42 CFR Part 93. [Institution Name] further certifies that:
1. Upon becoming aware of any allegation of research misconduct or other evidence of possible
research misconduct, the designated institutional official of [Institution Name] will immediately contact
ORI at AskORI@hhs.gov or (240) 453-8800.
2. [Institution Name] will work with ORI or other appropriate HHS offices to develop and implement a
process consistent with 42 CFR Part 93 to address allegation(s) of research misconduct.
3. [Institution Name] will cooperate with ORI/HHS during any research misconduct proceeding or
compliance review under 42 CFR Part 93.
4. [Institution Name] will inform its institutional members of their option to report any allegation of
research misconduct or evidence of research misconduct directly to ORI rather than to [institution’s]
designated institutional official.
5. [Institution Name] will submit an annual report (known as the Research Integrity Assurance and
Annual Report on Possible Research Misconduct form) to ORI.

Institutional Certifying Official’s Name:
Institutional Certifying Official’s Title:
Institutional Certifying Official’s Signature:
Date:
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