Institutions that receive or apply for research, research-training, or research-related grant or cooperative agreements from the Public Health Services (PHS) must have written policies and procedures for responding to allegations of research misconduct that comply with the PHS regulation (42 CFR Part 93).  As part of its Assurance Program, ORI works with institutions by performing policy reviews and making recommendations to ensure that their policies and procedures are in compliance with the regulation.  To facilitate the policy review process, ORI released a checklist that allows institutions to self-assess their policies.  The checklist is similar to what ORI uses internally for policy reviews.

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Download the Policy Review Checklist (pdf)
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“In more than two decades of conducting policy reviews, we frequently encountered institutional policies that were deficient in one or more areas,” said John Butler, Compliance Officer, who began working at ORI during its inception. “The new checklist is an excellent tool for institutions that are rewriting their policies or just want to make sure they’re in compliance.”

The checklist has two parts.  The first includes the elements that are required to be in the written policies and procedures as stated in 42 CFR Part 93.304. Typically, if ORI finds any of these elements missing from institutional policies, ORI notifies the institutions about the deficiencies and works with them to make their policies compliant with the regulation. The second part of the checklist includes the elements that ORI highly recommends that institutions to include in their policies and procedures.  Although the regulation does not require these elements to be included in the written institutional policy, these elements are important for institutions to properly handle allegations of research misconduct.

“The policies and procedures serve as instructions for institutions to follow when they’re faced with research misconduct allegations,” said Butler.  “Having detailed procedures in place helps  prevent improper actions that may negatively affect an investigation.  The procedures also provide whistleblowers and respondents with the information they need to know about the institutions’ misconduct proceedings."  Butler continued, "In fact, institutions are required by the regulation [§93.308] to provide a copy of the policies and procedures to respondents if an inquiry determines that an investigation is warranted.”

To remain in compliance with regulation, institutions must share their policies and procedures not only with respondents, but also with all institutional members who participate in PHS-funded research, research training, or apply for PHS research support (§93.302).  Informing the entire research staff about how to report research misconduct and how the institution handles allegations is an important part of fostering a culture of research integrity.