Quality Improvement Activities FAQs

How does HHS view quality improvement activities in relation to the regulations for human research subject protections?

Do the HHS regulations for the protection of human subjects in research (45 CFR part 46) apply to quality improvement activities conducted by one or more institutions whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes?

Do quality improvement activities fall under the HHS regulations for the protection of human subjects in research (45 CFR part 46) if their purposes are limited to: (a) delivering healthcare, and (b) measuring and reporting provider performance data for clinical, practical, or administrative uses?

Can I analyze data that are not individually identifiable, such as medication databases stripped of individual patient identifiers, for research purposes without having to apply the HHS protection of human subjects regulations?

Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?

If I plan to carry out a quality improvement project and publish the results, does the intent to publish make my quality improvement project fit the regulatory definition of research?

Does a quality improvement project that involves research need to be reviewed by an IRB?

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?

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?

Human Subject Regulations Decision Charts

Human Subject Regulations Decision Charts

September 24, 2004

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:

• whether an activity is research that must be reviewed by an IRB
• whether the review may be performed by expedited procedures, and
• whether informed consent or its documentation may be waived.

Considerations

The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.

The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

Chart 1: Is an Activity Research Involving Human Subjects?