Statements of Regulatory Compliance
Statements of Regulatory Compliance
The Burrell College of Osteopathic Medicine ensures compliance with state, federal and institutional policies as it relates to all research through the Human Research Protection Program. The purpose of the Burrell College of Osteopathic Medicine Human Subjects Research Protection Program is to protect the rights and welfare of BURRELL researchers and human subjects participating in biomedical and behavioral research.
Components of the Human Research Protection Program include:
- Biological and Recombinant and Synthetic Nucleic Acid Molecules Safety Training and Compliance
- Chemical Safety Training and Compliance
- Human Subjects Research Safety Training and Compliance
- Laboratory Safety Training and Compliance
- Responsible Conduct of Research
The HRPP maintains requisite registrations or assurances and provides administrative office support to oversight committees including the Burrell Institutional Review Board and the Burrell Institutional Biosafety Committee.
HUMAN RESEARCH PROGRAM STATEMENT OF COMPLIANCE
The Burrell College of Osteopathic Medicine (BURRELL) shall ensure the protection of human subjects in research through the College’s Office of Research & Sponsored Programs (ORSP). The ORSP shall provide administrative oversight of all research conducted at BCOM and ensures institutional compliance with appropriate federal, state, and local regulations as well as BCOM policies. ORSP responsibilities include providing guidance, assistance, and training to BCOM researchers and providing administrative support for the BCOM Institutional Review Board.
The BCOM Institutional Review Board (IRB) operates in full compliance with the U.S. Department of Health and Human Services, and U.S. Food and Drug Administration regulations for the protection of human subjects as described in 45 Part 46 as outlined by the BCOM policies for the conduct of human research. The BCOM IRB is registered with the Department of Health and Human Services Office for Human Research Protection as IRB00010422 and has an approved Federalwide Assurance (FWA00024071 ) Membership of the IRB is in compliance with 45 CFR 56.107. It is expected that investigators conducting clinical research adhere to these guidelines. BURRELL IRB Policies provide written procedures for operation, IRB review, initial and continuing review of research proposals, addendum reporting, and adverse event reporting. The IRB assures compliance with 45 CFR 46.107 stipulating that no IRB may have a member participate in the IRB’s initial or continuing review of a research project in which the member has conflicting interest, except to provide information requested by the IRB.
BIOSAFETY STATEMENT OF COMPLIANCE
The Burrell College of Osteopathic Medicine shall follow all current federal, state, local, and institutional regulations/guidelines for the handling and containment of biohazardous material. The College shall establish and maintain an Institutional Biosafety Committee (IBC) responsible for enforcing these regulations. (Burrell B-8520)
HAZARD COMMUNICATION STATEMENT OF COMPLIANCE
BURRELL shall maintain a hazard communication program that complies with 29 CFR 1910, the recommendations of the CDC Biosafety in Microbiological and Biomedical Laboratories, 5th Ed., the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids, and other regulations or guidelines as appropriate. (B-8521)
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