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Protecting human subjects during research activities is critical and has been at the forefront of HHS activities for decades. In addition, HHS is committed to taking every appropriate opportunity to measure and improve the quality of care for patients. These two important goals typically do not intersect, since most quality improvement efforts are not research subject to the HHS protection of human subjects regulations. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care, and in these cases the regulations for the protection of subjects in research (45 CFR part 46) may apply.
To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order:
For those quality improvement activities that are subject to these regulations, the regulations provide great flexibility in how the regulated community can comply. Other laws or regulations may apply to quality improvement activities independent of whether the HHS regulations for the protection of human subjects in research apply.
No, such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “...a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.
Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes include:
No, such quality improvement activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.
The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates. Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.
Yes, whether or not these activities are research, they do not involve “human subjects.” The regulation defines a “human subject” as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information….Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.” Thus, if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, the analyses do not involve human subjects and do not have to comply with the HHS protection of human subjects regulations.
(See OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, October 2008; available at http://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/cdebiol.pdf.)
Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations.
No, the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. The regulatory definition under 45 CFR 46.102(d) is “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.
Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable FWA.
For more information see exempt categories.
No, if the human subjects research activity involves no more than minimal risk and fits one or more of the categories of research eligible for expedited review, the IRB chair or another member designated by the IRB chair may conduct the review.
The categories of research eligible for expedited review are available at: http://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html.
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
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.
No, not if certain conditions are met. The HHS protection of human subjects regulations allow one IRB to review and approve research that will be conducted at multiple institutions. An institution has the option of relying upon IRB review from another institution by designating that IRB on its FWA and submitting the revised FWA to OHRP, and having an IRB Authorization Agreement with the other institution.
See IRBs and Assurances for information on FWAs and IRB Authorization Agreements.