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HD InsightsComprehensive Guidance: Steering Committee

At the Huntington Study Group (HSG), the HSG Chair and Co-chair, in collaboration with the sponsor, appoint a Study Steering Committee (SSC), which is charged with governing the study. This includes reviewing and approving that the overall scientific merit of the program. Even more importantly, it is charged with ensuring safety and well-being of the study participants.

The SSC comprises a Study Principal Investigator (SPI) and sometimes a Co-SPI, as well as one to three investigators and one to three coordinators who are not involved in the evaluation of subjects for that study and not participating as investigators (or any other role that may cause a conflict of interest).

The SSC will also include a Study Statistician for the program, to be appointed by the SSC Chair, in collaboration with the sponsor. The sponsor selects one to two members to the steering committee and may include other sponsor members such as specialized consultants and/or individuals who possess expertise in the area being studied, as relevant for the program. The SSC should also include a community member or layperson advocate involved with Huntington’s disease.

Subject to approval by the HSG chair, the HSG SPI may select the lead Project Manager and the HSG executive director or designee to serve as ex-officio members of the committee.

Duties of Membership

The SSC generally meets quarterly, but may meet more frequently if needed. It is responsible for contributing to the formulation and review of the final study protocol and any subsequent protocol amendments.

The committee selects study sites, site investigators and study coordinators for the program, approves any changes in site personnel, and oversees all aspects of the study, including implementation of the study protocols. The SSC oversees recruitment and enrollment and will assist the SPI and Co-SPI in the analysis and reporting of the study results, preparing and publishing scientific reports.

Keeping Our Commitments

At the Huntington Study Group, the SSC must ensure that study policies governing confidentiality, clinical practice, conflicts of interest, professional conduct, rights of research subjects, disclosure and publication are consistent with the HSG policies and applicable policies of the sponsor.

The same standards of conduct and transparency apply to SSC members as well. On the rare occasion that a member, investigator (administrative or enrolling) or coordinator does not fulfill their obligations to the study or maintain the standards of the HSG with respect to these policies, it is the responsibility of the SSC to evaluate the situation and remove that person from the committee.

Each member must provide a signed and dated statement to certify that there is no real or apparent conflict of interest by the time of the initial steering committee meeting. If at any time during his/her participation on the committee a potential conflict may arise, the member is required to register this interest to the HSG and the sponsor, in writing. Any updates of conflict of interest will be reviewed and documented at the beginning of each subsequent meeting. Serving on a study SSC can be exciting and educational. If you are interested in potentially serving on a study SSC, consider reaching out to the HSG Chair and/or Co-chair to discuss future opportunities.