Reviewer Checklists

Instructions

Engagement Determination

Human Research Determination

Refer to this checklist when completing section I. of the Not Human Subjects Research Determination Request Form.

Exemption Determination

Refer to this checklist when completing section G. of the Exemption Request Form.

Eligibility for Review Using the Expedited Procedure (Initial and Continuing Review)

Refer to this checklist when determining whether a protocol will be eligible for initial or continuing expedited review.

Eligibility for Review Using the Expedited Procedure (Modifications)

Refer to this checklist when determining whether a modification will be eligible for expedited review.

Criteria for Approval and Additional Considerations

Refer to this checklist when completing section B. of the Initial Application for Human Research.

Waiver or Alteration of the Consent Process

For Human Research that does not include plans to obtain consent from participants, withhold information while obtaining consent, and/or involves deception, refer to this checklist when the Research Protocol.

Waiver of Written Documentation of the Consent Process

Short Form of Consent Documentation

Advertisements and Payments

Research Involving Children

For Human Research that involves children, adolescents, minors, or other individuals who have not reached the age of majority (as dictated by local law), refer to this checklist when completing the Research Protocol.

Research Involving Pregnant Women

If the Human Research may involve pregnant women at any time from the period of implantation until delivery, regardless of whether the Human Research is focused on or targets pregnant women, refer to this checklist when completing the Research Protocol.

Research Involving Non-Viable Neonates

If the Human Research may involve non-viable neonates (newborns after delivery that, although living, are not able to survive to the point of independently maintaining heartbeat and respiration, given the benefit of available medical therapy), regardless of whether the Human Research is focused on or targets non-viable neonates, refer to this checklist when completing the Research Protocol.

Research Involving Neonates of Uncertain Viability

If the Human Research may involve neonates of uncertain viability (newborns after delivery that, although living, may not be able to survive to the point of independently maintaining heartbeat and respiration, given the benefit of available medical therapy), regardless of whether the Human Research is focused on or targets neonates of uncertain viability, refer to this checklist when completing the Research Protocol.

Research Involving Prisoners

If the Human Research may involve prisoners (any individual involuntarily confined or detained in a penal institution), regardless of whether the Human Research is focused on or targets prisoners, refer to this checklist when completing the Research Protocol.

Research Involving Adults Unable to Consent

If the Human Research involves adults who may not have the ability, or may have limited ability, to consent to the Human Research procedures, refer to this checklist when completing the Research Protocol.

Drugs and Devices

If the Human Research includes drugs for a use other than the approved medical use or includes the evaluation of the safety or effectiveness of a medical device, refer to this checklist when completing the Research Protocol.

Non-Significant Risk Device

Review of Information Items

Good Clinical Practice

Refer to this checklist for clinical trials, in which the sponsor has required that the investigator comply with the International Council on Harmonization (ICH) – Good Clinical Practice (GCP) Guidelines (E6).