Specific criteria for review of research with human subjects are found in the Federal regulations, Duke policy, and state law.

Review Criteria from the Federal Regulations

1. Risks to subjects are minimized
   
2. Risks to subjects are reasonable in relation to anticipated benefits
   
3. Selection of subjects is equitable
   
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative
   
5. Informed consent will be appropriately documented
   
6. When appropriate, the research plan makes adequate provisions for monitoring data collection to ensure the safety of subjects
   
7. When appropriate there are adequate provisions to protect the privacy of subjects and the confidentiality of data
   
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence such as children or people with mental disabilities, additional safeguards have been included in the study to protect the rights and welfare of these subjects

In addition to criteria relating to the protection of human subjects, the regulations require that the IRB determine that grant applications are consistent with approved protocols.

Additional Duke Criteria

Duke policy identifies students and employees of researchers as vulnerable to coercion or undue influence and describes safeguards.

Duke policy also requires investigators using the Undergraduate Psychology Subject Pool to provide students with a debriefing. The purpose of the debriefing is to make the experience of research participation a learning experience about both the topic under study and research as a method of inquiry. It is strongly recommended that researchers debrief students who are not participating in the Subject Pool, but have been recruited through other means.

North Carolina Law

State law requires researchers to report suspicion of child abuse and neglect. When relevant, this requirement must be addressed in a the protocol and described in the informed consent form.