What are the Reviewers Looking for in My IRB Application?
- A clear purpose to the study - hypothesis, procedures and how this study would be useful
- Recruitment is proper
- Inducement is reasonable
- The investagors' experience in this type of research is adequate
- The subjects are adequately informed
- The informed consent documents are proper
- Are there any risks? if so, are they necessary? Did the researcher did everything
to minimize the risk?
- Risky participants are exclused by prescree
- The researcher has a proper debriefing process
- Appropriate minotiring procedures are in place to assess the safety of the participants
- There are benefits to the study
- The investigators make every effort to protect the confidentiality of the participants
- The researchers explain the data usage properly - data analysis
Whether you make new requests or petition to continue or propose ammendments to existing protocols, it is essential the researchers have answers to the above frame work for reviewers' concerns