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Institutional Responsibilities
Julie Stelter
Created on March 11, 2024
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Transcript
INDIVIDUAL DisclosES
Disclosure review
WHO? Reviewers
Determination of conflict
WHO? Committee
Manage conflict
WHO? Adminstrative Offices
report COnflict
Manages Disclosures
WHO? Administrative Offices
disclosers
Click each hexagon to learn more.
reviewers
Institutions provide guidance and training to ensure investigators understand disclosure responsibilities.
committees
key players
admins
Work together to design, implement, and maintain an effective COI program.
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.
Effective conflict management plan uses policies and guidelines to define types of conflicts and how to disclose them.
Provide a framework and evaluation processes for review and disclosure with defined roles to assess impact.
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.
Public disclosure
Transparency and disclosure to students, staff, and collaborators.
Mitigation Strategies
Recusal or non-involvement from all or part of project.
Oversight by colleague.
Independent review and monitoring of research
Peer review, external validation, and open data sharing.
Modification of research plan or design.
Severance of relationships.
Conclusion
RESTART
Disclosers
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.
Reviewers
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.
Committees
A committee of faculty, administrators, or others who receive the recommendations and consider a conflict-of-interest management plan.
Administrators
The administrative offices create and implement policy and procedures for collecting disclosures, as well as providing training to their research community.