It is the purpose of an Institutional Review Board (IRB) to ensure the protection of human subjects who participate in research studies, and to ensure adherence to federal, state, and local regulations. One of the most common questions asked by doctoral students preparing their dissertation is, “What criteria must be met for IRB approval?”
Here are the answers:
- Reduce the risk of subjects’ personal information being exposed. Do not collect subject identifiers unless it is necessary to the integrity of the study. If identifiers are needed, be sure to secure the stored data.
- The benefit of the research must outweigh the risk to subjects. Before approval of the study, the Doctoral Director must ensure that the research contributes valuable knowledge to the field.
- The selection of subjects is equitable. Random selection of subjects ensures fairness. If a specific population is necessary, this needs to be justified.
- Informed consent from the participants shall be sought. Let participants know how the data will be used, and always ask participants’ permission to use information collected.
- Informed consent from the participants needs to be properly documented. Researchers should retain signed copies of participants’ consent, and keep it separate from other data collected from the study.
- Safety of subjects is ensured. This requirement is related to clinical trials. Any substances or procedures used in the research shall pose no threat to or harm the subjects.
- Privacy of subjects will be protected and confidentiality of data maintained. Explain why identifiers are needed, how the information is stored, and how it is protected. In most cases, de-identification of data is recommended
- Safeguard against undue influence or coercion. A superior should not administer surveys to his/her subordinates. Always have a peer of the subjects collect the data.