If a quality improvement project involves non-exempt research with human subjects, do I always need to obtain informed consent from all subjects (patients and/or providers) involved in the research?
No. The HHS regulations protecting human subjects allow an IRB to waive the requirements for obtaining informed consent of the subjects of the research when (a) the risk to the subjects is minimal, (b) subjects’ rights and welfare will not be adversely affected by the waiver, (c) conducting the research without the waiver is not practicable, and (d) if appropriate, subjects are provided with additional pertinent information after their participation (45 CFR 46.116(d)). Other applicable regulations or laws may require the informed consent of individuals in such projects independent of the HHS regulations for the protection of human subjects in research.
Related Questions
- If a quality improvement project involves non-exempt research with human subjects, do I always need to obtain informed consent from all subjects (patients and/or providers) involved in the research?
- If a quality improvement project is human subjects research requiring IRB review, do I need to obtain separate IRB approval from every institution engaged in the project?
- Does IRB review of a quality improvement project that is also non-exempt human subjects research always need to be carried out at a convened IRB meeting?
