What are the Reviewers Looking for in My IRB Application?

1. A clear purpose to the study – hypothesis, procedures and how this study would be useful
2. Recruitment is proper
3. Inducement is reasonable
4. The investigators’ experience in this type of research is adequate
5. The subjects are adequately informed
6. The informed consent documents are proper
7. Are there any risks? if so, are they necessary? Did the researcher did everything to minimize the risk?
   1. Risky participants are excused by prescree
   2. The researcher has a proper debriefing process
   3. Appropriate monitoring procedures are in place to assess the safety of the participants
8. There are benefits to the study
9. The investigators make every effort to protect the confidentiality of the participants
10. The researchers explain the data usage properly – data analysis

Whether you make new requests or petition to continue or propose amendments to existing protocols, it is essential the researchers have answers to the above frame work for reviewers’ concerns