Institutional Responsibilities

Manages Disclosures

INDIVIDUAL DisclosES

WHO? Reviewers

WHO? Administrative Offices

report COnflict

WHO? Adminstrative Offices

Manage conflict

WHO? Committee

Determination of conflict

Disclosure review

Click each hexagon to learn more.

Institutions provide guidance and training to ensure investigators understand disclosure responsibilities.

Work together to design, implement, and maintain an effective COI program.

key players

admins

committees

reviewers

disclosers

Remember, perceived conflict is as risky as an actual conflict of interest. Disclose all possible conflicts. Institutional officials will decide if there's a COI that needs to be managed.

Mitigation strategies implemented according to risk assessment. Consequences for non-compliance and enforcement are pre-determined.

Provide a framework and evaluation processes for review and disclosure with defined roles to assess impact.

Effective conflict management plan uses policies and guidelines to define types of conflicts and how to disclose them.

Oversight by colleague.

Modification of research plan or design.

Severance of relationships.

Recusal or non-involvement from all or part of project.

Peer review, external validation, and open data sharing.

Independent review and monitoring of research

Transparency and disclosure to students, staff, and collaborators.

Public disclosure

Mitigation Strategies

Transparency and disclosure to students, staff, and collaborators.Public disclosure Independent review and monitoring of research Peer review, external validation, and open data sharing. Recusal or non-involvement from all or part of project. Severance of relationships. Modification of research plan or design. Oversight by colleague.

RESTART

Conclusion

At a minimum, disclosure pertains not only to the lead investigator but also to the potential COIs of all key personnel on the project, their spouses, and dependent children. Some institutions expand disclosure requirements to include domestic partners, any member of the household, and, in some instances, close personal friends or other family members. Disclosers must divulge all outside interests either annually or mid-year as a new COI emerges, when funding is awarded for study-specific research, and when human or animal subjects are involved.

Disclosers

An institution’s conflict of interest policies designates one or more persons to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate the conflict of interest.

Reviewers

A committee of faculty, administrators, or others who receive the recommendations and consider a conflict-of-interest management plan.

Committees

The administrative offices create and implement policy and procedures for collecting disclosures, as well as providing training to their research community.

Administrators