Conflict of Interest (COI) Screening – Standard Operating Procedures
Estimated Reading Time: 5 MinutesERIK, Office of Research Compliance, Revised 12/07/2020
I. Regulatory and Policy Authority and Requirement
The Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93 (the "PHS Policies"), require institutions to include protections against conflicts of interest on the part of those involved in any stage of a research misconduct proceeding. Specifically, various sections of 42 C.F.R. Part 93 include statements to ensure institutions avoid conflicts of interest, as follows:
§ 93.300 General responsibilities for compliance.
Institutions under this part must—
(b) Respond to each allegation of research misconduct for which the institution is responsible under this part in a thorough, competent, objective and fair manner, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, respondent or witnesses;
§ 93.304 Institutional policies and procedures.
Institutions seeking an approved assurance must have written policies and procedures for addressing research misconduct that include the following—
(b) A thorough, competent, objective, and fair response to allegations of research misconduct consistent with and within the time limits of this part, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the complainant, respondent, or witnesses;
§ 93.310 Institutional investigation.
(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 with those involved with the inquiry or investigation.
The Research Misconduct policy (the "Policy"), Policy Details VII. A, defines conflicts of interest as follows:
- Conflicts of interest in research misconduct proceedings exist when the financial, personal, or professional relationships of an individual involved in the proceedings may affect the proceedings or the resolution of the allegations. Perceived or actual conflicts of interest are treated identically under this policy.
The Policy, Procedures II.D and III.C.5, allow a Respondent to object to the individuals involved in the Inquiry or to the membership of the Investigation Committee (IC) and such objection must be based on the grounds of a lack of the requisite expertise or possible conflicts of interest. At all stages of a research misconduct proceeding, all persons involved shall be vigilant to prevent any real or perceived conflicts of interest, or personal conflicts or relationships between colleagues, from affecting the outcome of the proceedings and resolution of the allegations.
II. Evaluation of Conflicts of Interest
The Research Integrity Officer (RIO) has the responsibility and authority to evaluate all conflicts of interest, including those that may be perceived by a reasonable person to constitute a conflict of interest. The Research Integrity Officer (RIO) will perform an initial screening for any potential conflicts of interest that may exist between the Respondent(s) or Complainant(s) in a Research Misconduct matter and all potential individuals that may participate in an Inquiry or Investigation. The RIO will also screen for potential conflicts of interest between the Respondent(s) or Complainant(s) with institutional officials involved in the proceedings, which may include the RIO, Counsel, Department Chair, College Dean, Senior Vice President for Research (SVPR), and the Provost.
Under the Policy Details VII.A.1 and A.2, possible conflicts of interest may include, but are not limited to, co-authorship of work with the Respondent or Complainant, or professional or personal relationships with the Respondent or Complainant beyond that of mere friends or colleagues (e.g., current or former student or mentor, direct supervisory or subordinate job relationship, or marital/partner relationship). The subordinate relationship of a respondent or complainant to their dean or chair alone does not constitute a perceived or actual conflict of interest under this Policy. The RIO will screen for conflicts of interests as follows:
- Perform an OSU website search of the potential committee member or institutional official, generally reading their departmental pages, bios, etc. for any similarities in research interests, etc. to the Complainant or Respondent.
- Perform an OSU website search combining the names of the potential committee member or institutional official and respondent(s) or complainant(s). Investigate any hits and look for any meaningful collaborations, publications, supervisory or advisory relationships, etc.
- Perform a Google search of the potential committee member or institutional official and respondent(s) or complainant(s). Investigate any hits for meaningful collaborations, publications, prior employment overlaps, supervisory or advisory relationships.
- Perform an OSU PI Portal search. Use the "Set PI" function to look up each potential committee member and institutional official for any sponsored projects in common with the respondent(s) or complainant(s) if applicable. From the main page, look for any co-investigators named on each project. Click on the title of each project, then the "Personnel" tab to check for any naming of or payment to the respondent(s) or complainant(s).
- If a graduate student's thesis is involved, query the OSU Library system for the thesis to identify the dissertation committee members, graduate faculty representative and/or any acknowledgments that might be linked to the potential committee member or institutional official
- The RIO will complete a Conflict of Interest Screening Form to include with the case file.
- When the initial screenings for conflicts of interest are complete, the RIO will question all potential participants in the Inquiry or Investigation about potential conflicts with any involved parties.
- The RIO has the authority to rule on potential conflicts of interest. Conflicts will be resolved as follows:
- The RIO will designate a replacement for a conflict identified with any participant in the Inquiry or Investigation.
- The DO will designate a replacement for a conflict identified with the dean, department chair, or the RIO.
- The president of the university will designate a replacement for a conflict identified with the senior vice president for research or the executive vice president for academic affairs and provost.