An IRB may waive the requirement for informed consent, or may omit/alter one or more elements of informed consent, if certain regulatory criteria are justified. The waiver or alteration can apply to part or all of a research study with comprehensive IRB approval.
Under the pre-2018 Common Rule, a waiver of consent was required to access records or stored identifiable biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects by interaction or by access to records or stored identifiable biospecimens. Waiver of consent for this purpose is no longer required under 45 CFR 46.116 (g) (Revised).
However, for studies that require a waiver/alteration of consent for ongoing study activity after the Effective Date, 45 CFR 46.116 (f) (3) (iii) (Revised) adds a new criterion that must be justified.
Pre-2018 regulations have 4 criteria; the 2018 rule adds a 5th:
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
At the next Amendment after the Effective Date:
- Screening/recruitment waivers can be retired by updating answers in 10.1 and/or 10.2 in the eResearch application.
- Currently approved studies that still require a partial or full waiver/alteration will add the justification for the 5th criterion in 10-3.2 in the eResearch application.