42 C.F.R. § 93.310

Current through October 31, 2024
Section 93.310 - [Effective 1/1/2025] Institutional investigation

Institutions conducting research misconduct investigations must:

(a)Time. Begin the investigation within 30 days after deciding an investigation is warranted.
(b)Notice to ORI. Notify ORI of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of §§ 93.307 and § 93.309 .
(c)Notice to the respondent. Notify the respondent in writing of the allegation(s) within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.
(1) The institution must give the respondent written notice of any allegation(s) of research misconduct not addressed during the inquiry or in the initial notice of investigation within a reasonable amount of time of deciding to pursue such allegation(s).
(2) If the institution identifies additional respondents during the investigation, the institution may but is not required to conduct a separate inquiry for each new respondent. If any additional respondent(s) are identified during the investigation, the institution must notify them of the allegation(s) and provide them an opportunity to respond consistent with this subpart.
(3) While an investigation into multiple respondents can convene with the same investigation committee members, separate investigation reports and research misconduct determinations are required for each respondent.
(d)Sequestration of records. Obtain all research records and other evidence needed to conduct the investigation, consistent with § 93.305(a) .
(e)Documentation. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and other evidence relevant to reaching a decision on the merits of the allegation(s).
(f)Ensuring a fair investigation. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest relevant to the investigation. An institution may use the same committee members from the inquiry in their subsequent investigation.
(g)Interviews. During the investigation, an institution must interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent.
(1) Interviews during the investigation must be recorded and transcribed.
(2) Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview.
(3) The transcript of the interview must be made available to the relevant interviewee for correction.
(4) The transcript(s) with any corrections and numbered exhibits must be included in the institutional record of the investigation.
(5) The respondent must not be present during the witnesses' interviews but must be provided a transcript of the interview.
(h)Multiple respondents. Consider, consistent with § 93.305(d) , the prospect of additional researchers being responsible for the alleged research misconduct.
(i)Multiple institutions. A research misconduct proceeding involving multiple institutions must be conducted consistent with § 93.305(e) .
(j)Pursue leads. Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

42 C.F.R. §93.310

89 FR 76295 , 1/1/2025