NHLBI Guidance on Conflict of Interest (COI) and Confidentiality for Non-Government Board/Committee Members

Conflicts of interest (COI) may arise with members of Data and Safety Monitoring Boards (DSMBs), Observational Study Monitoring Boards (OSMBs), and Protocol Review Committees (PRCs) from employment, financial, personal, professional, or other types of relationships. This includes instances in which a Board/committee member, immediate family member1, or professional associate2 serves as an officer, director, trustee, owner, general partner, collaborator, expert adviser, consultant, employee, or otherwise similarly associated position with the organization regardless of whether the individual is compensated for that position.

It is the responsibility of Board/committee members to:

  • Alert the NHLBI Executive Secretary to any possible, real, or apparent COI situation that may impact their service
  • Disclose and certify on the NHLBI Conflict of Interest and Confidentiality Certification for Non-Government Board/Committee Members form any situation that may be subject to question
  • Recuse themselves from any matter in which there is a real, perceived, or potential COI
  • Maintain the confidentiality of the proceedings and associated materials

The COI and confidentiality disclosures are reviewed annually and in conjunction with each meeting to address any new relationships or changes to relationships, though members should proactively monitor for potential COI throughout the duration of their service. Where permissible, a waiver relating to the COI requirements may be granted.

Examples of Possible COI

The following scenarios are included as examples of possible COI for DSMB/OSMB members. The list is not meant to represent all possible COI situations and is therefore not all-inclusive.

Potential COI may arise if individuals, their close relative(s), and/or employer(s), have a connection with individuals or organizations:

  • Working as an investigator on a similar or closely related study
  • Collaborating currently on research projects with any of the investigators on the study(ies) that the Board will be monitoring
  • Whose products or services will be used or tested in the study under review
  • Whose commercial concerns are likely to be affected by the outcome of the trial or by the procedures or findings in an observational study
  • With certain financial connections, such as:
    • Employment, such as serving as a speaker, consultant, or science advisor
    • Intellectual property rights
    • Negotiating for employment
    • Collaborating on research or other related activities
    • Receiving research support
    • Equity interests (e.g., stock, bonds, stock options) whose current value exceeds $5,000 in companies that were/are involved in designing or conducting the study, funding or sponsoring the study, whose products or services will be used in the study, or whose products, services, or other financial interests would be directly and predictably affected by the conduct or outcome of the study (this includes equity interests held by immediate family members)
    • Litigation cases (e.g., as a plaintiff, defendant, or expert witness) with those who are/were involved in designing or conducting the study, funding or sponsoring the study, or whose products, services, or other financial interests would be directly and predictably affected by the conduct or outcome of the study
  • Affiliation with the same institution as the study investigators (even if they have no involvement with the study); in some scenarios, a mitigation plan may be put in place for a DSMB member to recuse themselves from voting on issues pertaining to a site from their own institution
  • Co-authorship within the past 3 years, with more scrutiny on publications related to studies that are ongoing (not including manuscripts or chapters with large authorship where co-authors did not closely collaborate); ongoing co-authorships must be disclosed and may require recusal
  • Mentorship (either as the mentor or mentee) within the past year, or any mentorship relationship that may give rise to a perceived conflict, regardless of timeframe
  • Membership on another DSMB, OSMB, or PRC with a similar research objective

Because PRC members are serving as peer reviewers, they must adhere to similar standards as COI requirements for peer reviewers.

1Immediate family member refers to a spouse/domestic partner, dependent child or stepchild, or other dependent of the Board/committee member.

2Professional associate refers to a colleague, scientific mentor, student, partner, or business affiliate.