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Chapter VI - Conflict of Interest

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BACKGROUND
Genetic Alliance is committed to basic values of transparency, integrity of scholarship, and independence as it pursues its mission to create, preserve, and disseminate knowledge through research. Accordingly, the Genetic Alliance IRB allows and encourages research personnel to engage in outside activities and relationships that enhance the mission of Genetic Alliance. All research personnel are to act with honesty and integrity when performing their duties, and to abide by the highest standards of research, educational, professional, and fiscal conduct.

Given that Genetic Alliance allows and encourages outside activities and relationships that enhance the research community, potential conflicts of interest and commitment are inevitable. Outside activities should not, however, interfere with an individual’s obligations to the study.

All actual and potential conflicts of interest or commitment must be disclosed to Genetic Alliance IRB; evaluated; and, if found to be significant, eliminated or managed as described in section III. Regulations below.

REGULATIONS
Research personnel’s obligation to implement Genetic Alliance IRB policies and practices related to conflict of interest and conflict of commitment. In meeting this obligation, specific roles and responsibilities described below.

Rights and Responsibilities:

  • Right to Outside Interests: research personnel have the right to acquire and retain outside interests of a professional, personal, or economic nature that do not conflict with the study interests or with the individual’s commitment to the study;
  • Requirement to Disclose: All investigators must disclose all actual or potential conflicts of interest or conflicts of commitment to Genetic Alliance IRB as potential conflicts arise or are identified. An investigator must also provide additional relevant information concerning disclosed or undisclosed matters as may be requested by Genetic Alliance IRB for the purpose of evaluating actual or potential conflicts of commitment or interest. All disclosures must be made promptly;
  • Requirement to Abide by Plans to Resolve Conflicts: When an investigator has disclosed a potential conflict of interest or conflict of commitment, and the Genetic Alliance IRB has determined that a conflict exists, Genetic Alliance IRB will develop a plan in consultation with the investigator, and investigator must abide by the terms of the plan;
  • Prohibition Against Using Position or Influence for Personal Gain or Advancement: It is not acceptable for any investigator to use his or her official position or influence to further his or her personal gain or advancement, or that of family members or personal associates, at the expense of the study.

IRB REVIEW – NEW STUDIES
Investigators submitting new studies for which they or any member of key personnel have been issued a conflict of interest management plan related to the research should ensure that all applicable requirements of the management plan have been reflected in the submission.

For new studies undergoing full board review, the management plan will be made available to the IRB members reviewing the study as a discussion item. All study documents that are affected by the management plan, such as the consent form, must contain any required disclosures at the time of submission to the IRB, and any required restrictions on the conflicted investigator should be reflected in the study submission. Any language that is missing at the time of IRB review will be required by the IRB as a condition of approval.

For the purposes of this policy, “Key Personnel” for a research study are research personnel who are directly involved in conducting the research with human subjects through an interaction or intervention for research purposes, or who are directly involved with recording or processing identifiable private information, including protected health information, related to those subjects for the purpose of conducting the research study.

If any member of key personnel has been issued a management plan, either for a personal conflict of interest or an institutional conflict of interest, the IRB cannot approve or give contingent approval to the research until the IRB has evaluated the financial interest and the management plan. The IRB has the final authority to decide whether the interest and its management allow the research to be approved. The convened IRB will make this determination for studies requiring full board review. This determination may be made by the expedited reviewer for studies that do not otherwise require full board review.

IRB REVIEW – STUDIES ALREADY APPROVED
When conflict of interest is newly identified for approved studies, the investigator must submit an amendment to add disclosure language and any other conditions required by the COI management plan, where applicable. Conflict of interest may be reviewed either by the expedited procedure or referred to full board.

When reviewed by the full board, the COI management plan will be made available to the convened board as a discussion item. The convened IRB will review the financial interest and the management plan in order to decide whether the conflicting interest and its management allow the research to continue to be approved. When reviewed by the expedited procedure, the expedited reviewer will have access to the management plan and will determine whether the conflicting interest and its management allow the research to continue to be approved. At any time, the expedited reviewer may request that the amendment be scheduled for review at a convened IRB meeting.

Investigators with recently issued management plans may be contacted by IRB staff and asked to submit an amendment to update studies requiring COI disclosures. However, it is the responsibility of the PI to ensure conflict of interest requirements are included in applicable protocols, as per recently issued management plans.

IRB MEMBERS
Genetic Alliance IRB Members are responsible for making known any potential or perceived conflicts of interest (COI) concerning protocols reviewed by the IRB. These conflicts could include the IRB member’s role in any of the following categories of activity with respect to the study in question:

  • Acting as Principal Investigator, Co-Principal Investigator or other key personnel;
  • Personally receiving funding orfunded effort from the study, aslisted in the study budget;
  • Acting in a supervisory role over the PI of the study;
  • Being involved in research utilizing a competing technology such that the ability to render an objective assessment could be compromised; OR
  • Being a family member involved in a close personal relationship with a member of the study team (for example, as a spouse or immediate family member).

An IRB member is considered to have a conflicting interest when the member or their immediate family has any of the following:

  • Involvement in the design, conduct, or reporting of the research with the following exception:
    • An IRB member who is listed on an IRB protocol as a member of the study’s Key Personnel but whose study-related activities are limited to (i) the performance of commercial services for the investigator (or performing other genuinely noncollaborative services meriting neither professional recognition nor publication privileges), while (ii) adhering to commonly recognized professional standards for maintaining privacy and confidentiality, is not considered to have a conflicting interest on this basis.
  • Supervisory role over the principal investigator of the research;
  • Stock ownership or stock options, equity, or other financial interest related to the research valued at $5,000 ormore;
  • Personal compensation of $5,000 or more related to theresearch;
  • Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensingagreement;
  • Board or executive relationship related to the research, such as an Advisory Board or Board of Directors, regardless of compensation;
  • Any other reason for which the member or consultant believes that heor she cannot provide an independentreview.

Board members and consultants should make known any conflict of interest prior to the beginning of the Board’s discussion of the protocol under review. They must leave the meeting room prior to the Board’s deliberation and vote.

Additionally, IRB members are responsible for self-identifying any conflicting interests before conducting review using the expedited procedure, so as to remove themselves from involvement in the review of the research.

VIOLATIONS
Failure to comply with the requirements of the Genetic Alliance IRB as expressed in its management plans could result either in termination of the study, or in suspension of some or all study activities.

Violations include but are not limited to situations in which:

  • An investigator knows of a situation that places him or her in a potential or actual conflict of interest or conflict of commitment but fails to disclose it fully, according to the policies; AND
  • An investigator discloses a potential or actual conflict of interest or commitment but fails to abide fully by the required plan for avoiding or managing the conflict.
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