Does my research need IRB approval?
All research involving human subjects that meets the criteria set forth in (45 CFR 46.102 (d) and (f)), irrespective of funding and/or funding source, conducted at HMC must be reviewed by the HMC Institutional Review Board (IRB). No research activities involving human subjects may commence until the IRB has reviewed and approved the protocol and issued a written notice of approval.
Any research that involves human subjects conducted in HMC shall be under the jurisdiction of the IRB. The IRB is responsible for determining and assuring the following:
- The welfare and rights of human subjects are adequately protected and informed consent obtained, 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; and
- the researcher(s) is/are qualified to conduct research involving human subjects.
Not all research submitting to MRC require review from the IRB if it meets the following conditions:
Although some research projects include evaluation, where a project is considered to be solely audit or service/therapy evaluation, it will not be managed as research within the HMC. Such projects do not require ethical review by HMC - IRB Research Ethics Committee or management permission through the MRC office. Under these circumstances, there is no need to submit applications to the MRC or IRB approval.
If the project is audit, service evaluation or public health surveillance, or some other type of non-research activity such as case study, system/equipment testing or satisfaction survey, you should check with the clinical governance office for the site/hospital facility what other review arrangements or sources of advice apply to the project.