Professionalism, ethical responsibility, and federal regulation all require that an unbiased review by the Scientific review Committee (SRC) and the Institutional Review Board (IRB) precede the implementation of a research program. In compliance with these principles, the duty of the AOMA Research Department is to protect the rights and welfare of human research subjects.
AOMA sets standards for the conduct of research, which mandate well-conceived and well conducted research. The Policy for Institutional Research provides detailed information to support institutional initiatives for guaranteeing compliance with federal regulations governing the conduct of research and the protection of human subjects in research.
Scientific Review Committee
Any research to be conducted whether for pilot study, educational, institutional or formal research purposes, will only be undertaken after such research has been reviewed and approved by the Scientific Review Committee (SRC).
The SRC assists and guides investigators through a review process in advance of, and in support of Institutional Review Board (IRB) application. SRC review is a requirement of the Department of Health and Human Services (DHHS) for all clinical interventional and noninterventional studies. The primary focus of scientific review is on the scientific merit, feasibility, and utilization of AOMA resources.
All investigator-initiated protocols must be submitted to the SRC. Research protocols will be pre-reviewed prior to full scientific review by the SRC; the purpose of the pre-review is to ensure that protocols contain all the required elements and they are organized in a consistent manner in the appropriate format, following the follow the Research Protocol Guidelines.
The purpose of the SRC full review is to provide peer review of research studies and provide researchers an early assessment of their research to identify additional regulatory and institutional requirements and allow researchers to plan for these additional requirements and reduce the delays in initiating such research. The SRC will forward research protocols that involve human subjects or human subject data to the IRB, for IRB review.
Institutional Review Board
Professionalism, ethical responsibility, and federal regulation all require that an unbiased review by an Institutional Review Board (IRB) precede the implementation of a research program. In compliance with these principles, the duty of the AOMA Institutional Review Board is to protect the rights and welfare of human research subjects.
The AOMA IRB provides oversight to all institutional research projects that involve human subjects. In so doing, we, as a research institution:
- Ensure that the risks of scientific advancement shall never outweigh the value of human life.
- Follow our traditions while embracing new technologies and practices.
- Maintain appropriate ethical conduct and regulatory compliance.
- Honor all persons.
- Engage in a continuing quest for excellence.
- Maintain an “open book” policy regarding all studies under consideration.
- Ensure timely disposition of all studies under consideration.
Any research that involves human subjects conducted by AOMA faculty, staff, or students, whether funded or unfunded, is under the jurisdiction of the IRB.
The IRB is responsible for determining and assuring that:
- The welfare and rights of human subjects are adequately protected and that informed consent is given, if necessary.
- Human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research.
- The necessity and importance of the research outweighs the risks to the subjects.
- The researcher(s) is/are qualified to conduct research involving human subjects.