For studies involving vulnerable subjects who are included in 45 CFR 46 Subparts B-D (i.e. pregnant women, human fetuses and neonates, prisoners and children) and/or 21 CFR 50 Subpart D, IRB approval may only be considered if one or more of the following conditions is met:
1) The research does not involve more than minimal risk to the subjects
2) The research is likely to benefit the subjects directly, even if the risks are considered to be more than minimal
3) The research involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalized knowledge about the subject's disorder or condition
If the study is approved by the IRB but it involves subjects considered vulnerable according to federal regulations in Subparts A-D of 45 CFR 46 and/or Subpart D of 21 CFR 50, and if the IRB deems that none of the above conditions is met, the study must also be submitted to the United States Secretary of Health and Human Services for review and approval.
For populations not considered with 45 CFR 46 Subparts B-D and/or 21 CFR 50 Subpart D but who are considered vulnerable by UM ethical standards and the IRB (for example, persons with dementia or other cognitive disorders, students, employees and particularly vulnerable patients), IRB review shall be guided by the principles of the three criteria listed above.