The Office of Research Integrity (ORI) is seeking a revision of its collection instruments to reflect updates in the Public Health Service Policies on Research Misconduct (42 CFR 93) published on September 17, 2024. The purpose of the Institutional Assurance and Annual Report on Possible Research Misconduct form PHS-6349 is to provide data on the amount of research misconduct activity occurring in institutions conducting PHS-supported research. Research misconduct is defined as receipt of an allegation of research misconduct and/or the conduct of an inquiry and/or investigation into such allegations. These data enable the ORI to monitor institutional compliance with the PHS regulation. Form PHS-6349 has undergone minor revisions, but its function is unchanged. The purpose of the Assurance of Compliance by Sub-Award Recipients form PHS-6315 establishes an assurance of compliance for a sub-awardee institution. Form PHS-6315 is being discontinued because the updated regulation requires all awardees to have an assurance with ORI and does not distinguish sub-awardees. In its place, ORI developed a new form, the Research Integrity Assurance Establishment form PHS-7091. This form allows all institutions conducting PHS-supported research to establish an assurance with ORI. Additionally, ORI developed a second new form, the Institutional Record Transmittal form PHS-7092, which accounts for the varied types of information collection that can occur during the course of institutional research misconduct proceedings.
Although 42 CFR Part 93 revises and clarifies institutional research misconduct proceedings in which ORI has oversight, institutional activities (and associated burden) as they relate to addressing allegations of research misconduct have not fundamentally changed since the original publication of 42 CFR Part 93 in 2005. In the past two decades and moving forward, institutions conducting PHS-supported research may continue to assess research misconduct allegations, conduct inquiries and investigations, sequester and analyze evidence, conduct interviews, convene committees, make determinations, and report to ORI on a case-by-case basis; however, these burden hours were not calculated in ORIâs previous PRA clearance requests.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form PHS-7091 RESEARCH INTEGRITY ASSURANCE ESTABLISHMENT FORM
OMB No_0937-0198_Supporting Statement A.pdf
Public Health Service Policies on Research Misconduct (42 CFR Part 93)