E. NGHS IRB Objectives
The primary objective of this IRB, to the best of its abilities, is to assess projects to determine that it is likely that the rights and the welfare of the human subjects will be protected. In keeping with this objective the NGHS IRB has chosen to not review ‘Phase I’ studies/trials (studies/trial designed to be "initial tests" on humans).
Protection of the investigator and the institution are secondary objectives that are best assured by protection of the subjects. In the event these objectives conflict, the IRB is required to follow its prime directive and should inform the Director of Performance Improvement of the conflict.
Protection of the rights and welfare of human subjects involved in research projects includes but is not limited to:
Restatement of 45 CFR 46.111
- The protection of the rights and welfare of patients and/or volunteers who participate in research and the assurance that patients and/or volunteers are provided with enough information about a study so that they can give effective informed consent prior to their participation.
- A determination that the risks are reasonable in relation to the benefits, if any, to subjects and the importance of the knowledge that may be expected to result.
- Providing a consent document that not only complies with the regulations but also is likely to be understood by the population being sought.
- Providing continuing review at a frequency determined by potential risks, the speed at which the field of study is changing, and events occurring in the conduct of the study, but at a minimum of one review per year.
- To provide objective and timely review services for the investigators.
- To provide educational opportunities related to human research protections for IRB members and staff.