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Common Reviewer Questions & Checklists
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.
| Questions | Regulation(s) | Checklist |
|---|---|---|
| What are my review responsibilities? | 45 CFR 46.111 | Criteria for IRB Approval of Research |
| What should be included in a recruitment document? | Use this checklist to be sure that these elements are included in a recruitment file | Recruitment Worksheet |
| What are the required elements of consent? | 45 CFR 46.116(a) 45 CFR 46.116(b) | Informed Consent Checklist |
| When could documentation of consent be waived? | 45 CFR 46.117(c)(1) 45 CFR 46.117(c)(2) | Waiver of Requirement for Documented Consent |
| When can some elements of informed consent be waived? | 45 CFR 46.116(c) 45 CFR 46.116(d) | Waiver of One or More Elements of Informed Consent |
| When can the requirement to obtain parental permission be waived? | 45 CFR 46.408(c) | Waiver of Parent or Guardian Permission |
| What are special considerations for research with children? | 45 CFR 46, Subpart D | Permissible Research with Children |
| Research Involving Pregnant Women or Fetuses | 45 CFR 46, Subpart B, 46.204 | Permissibile Research with Pregnant Women or Fetuses |
| What are special considerations for research with prisoners? | 45 CFR 46, Subpart C | Personer Research – FAQs |
| Can you clarify the difference between exempt #4, Expedite #5 & not human subjects research (human specimens) | Examples from OHRP to help determine how (and if) research with human specimens must be reviewed by the IRB | Human Subjects Research FAQs |
| What are special considerations when reviewing International Research protocols? | PI & Reviewer checklist and International Research FAQs |