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Chapter I - Purpose, Overview, Scope, and Definitions

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Genetic Alliance is strongly committed to ensuring the protection of human research participants. These written policies and procedures establish the operational guidelines for effective functioning of the Genetic Alliance Institutional Review Board (IRB), in full compliance with the federal, and, where appropriate, state and international human protection regulatory requirements.

These policies and procedures describe how the Genetic Alliance IRB operationalizes the federal, state and international regulatory requirements for human participants’ protection. These policies and procedures apply to the Genetic Alliance IRB and all organizations and personnel for whom the Genetic Alliance IRB serves as the IRB of Record.

The primary purposes of the Genetic Alliance IRB are:

  • To protect the safety, rights, and welfare of participants in research that are under the purview of the Genetic Alliance IRB;
  • To serve as a safeguard to prevent the unethical treatment of humans in research that might lead to physical, psychological, social, or other harms; AND
  • To assure that the design and conduct of research involving human participants complies with applicable federal regulatory requirements.

Service as IRB of Record, as part of an effort to improve the efficiency of IRB:

  • To conduct review(s) for collaborative and multi-site research;
  • The Genetic Alliance IRB serves, in some instances, as a central IRB for research conducted at multiple sites or for multiple organizations. For these protocols, the division of responsibilities for human research protections is outlined in either software providing for and finalizing formal ceding agreements for IRB Review between institutions that conduct IRB review and those institutions/sites, who have ceded/deferred to and are relying on the review OR in Memoranda of Agreement or Understanding with the respective institutions.

APPENDIX A. FEDERAL REGULATIONS
APPENDIX B. DEFINITIONS
APPENDIX C. HUMAN PARTICIPANTS RESEARCH TRAINING

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