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Chapter IV - Authority and Jurisdiction of the Genetic Alliance IRB

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AUTHORITIES GRANTED TO THE IRB BY FEDERAL REGULATION
The IRB committees listed on the Genetic Alliance FederalWide Assurance (FWA00017292) are appropriately constituted administrative bodies established to protect the rights and welfare of human participants (including patients) recruited to participate in research activities. In accordance with the Federal Policy regulations (45 CFR 46) of the Department of Health and Human Services (DHHS) and the applicable regulations (21 CFR 50, 56) of the Food and Drug Administration (FDA), the Genetic Alliance IRB has the authority to approve, require modifications to, or disapprove all research activities involving human participants that fall under its authority.

  • Research activities approved by the IRB are subject to further appropriate review and approval or disapproval by the IRB;
  • Unresolved questions or issues between the IRB and investigators will be referred to the Genetic Alliance Institutional Official for additional discussion. Comments and recommendations of the Institutional Official will be considered by the IRB in its subsequent decision to approve or disapprove the proposed research protocol.

The IRB has the authority to determine that a project submitted by an investigator does not meet the regulatory definition of human participant research under 45 CFR 46.102(f) and 21 CFR 56.102(f).

The IRB has the authority to require progress reports from investigators and to conduct continuing reviews of approved human participant research studies at intervals appropriate to the degree of risk, but not less than once per year. Research studies qualifying for “exempt” status in accordance with 45 CFR 46.101(b) will not be subject to continuing review.

The IRB has the authority to approve prospectively all modifications to previously approved research protocols and/or informed consent documents; the only exception being a protocol deviation that may be necessary to eliminate an apparent immediate hazard to a given research participant.

The IRB has the authority to observe or have a third party observe the conduct of approved human participant research studies, including the informed consent process.

The IRB has the authority to suspend or terminate the approval of human participantresearch activities that are not being conducted in accordance with the IRB’s requirements or have been associated with unexpected serious harm to participants.

The IRB has the authority to place restrictions on human participant research activities.

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