1 QA, QI and Health Services Activities: Ethical Challenges Christine Grady Department of Bioethics NIH Clinical Center

2 Disclaimer These views are mine and do not represent those of anyone else including the CC Department of Bioethics, National Institutes of Health, Public Health Service, or the Department of Health and Human Services.

3 Ethical challenges In what ways is Quality Improvement (QI) ethically similar to or different from human subjects research (HSR)? Which activities should fall under the federal regulations?

4 How are QI and HSR similar? Both QI and HSR involve systematic investigations that aim to improve care and/or understanding: QI involves systematic investigations of working hypotheses about how a process might be improved (Baily et al. 2006); …small cycles of interventions linked to assessment … goal of improving process, outcome, efficiency of complex systems of health care (Casarett et al 2000) Research means a systematic investigation, including research development, testing, evaluation, designed to develop or contribute to generalizable knowledge 45CFR (d)

5 Similar Many of the methods and measurements are similar Observation and intervention Quantitative and qualitative methods Retrospective, concurrent, and prospective analysis Analytic tools

6 Similar Both sets of activities can pose some risk or burden for the individuals involved There is a wide range of possible risk and burden

7 Similar In both sets of activities, people are a means to a goal that goes beyond the individuals involved. The goal of QI and of research is to learn something from or about individuals that will benefit others like them. Sometimes they will benefit directly, but not necessarily or always.

8 How are QI activities and human subjects research different? Intent/purpose Consonance with interests of patients Generalizability Risk and benefit Bellin and Dubler 2001, Casarett et al. 2000, Nerenz et al. 2003, Lynn et al. 2007, and others

9 Intent/purpose QI- [deliberate, systematic, data guided activities designed] to bring about immediate improvements in health care delivery in particular settings… an intrinsic part of good clinical care [and]… of normal health care operations. (Lynn et al Annals 2007; Baily et al. Hastings 2006, and others)

10 Intent/purpose HSR-the goal and purpose of HSR is to develop socially valuable generalizable knowledge about health, disease, treatment…with the potential to contribute, sooner or later, to improvements in human health. (Natl Commission 1979; Levine 1988, Emanuel et al. 2000; Miller and Joffe 2008, and others)

11 Different- moral imperative? Institutions have a moral obligation to improve quality. QI is a moral imperative for health care institutions But might there also be a moral imperative to improve our understanding of human health and how to prevent, diagnose, treat human illness?

12 … that the general area of activity is commendable does not imply that any given project is acceptable. Quality improvement is the aim of the project, not a guaranteed result. (Perneger T, J Qual in HC 2004)

13 Different- patients interests? The goals of QI- improved care- are more consonant with the interests of patients in receiving quality care The need for oversight in HSR arises from a recognition of the potential for the overall goals of research to be divergent from the interests of the subjects

14 Yet, the interests of patients with X in receiving a safe and effective treatment are not necessarily divergent from the interests of a researcher in finding a safe and effective treatment for X

15 Different-Generalizable/local? Research is designed to produce generalizable knowledge about the intervention, not immediately improved care… QI is an integral part of the ongoing management of the system for delivering care, not an independent knowledge seeking enterprise (Baily et al. Hastings p.S11-12). the results of all QI are generalizable to some extent (Casarett et al JAMA 2000)

16 Generalizability Intent vs. outcome? Apply it to others? Communicate it to others? Internal processes, local improvements

17 Different-Risk? Is the chance or magnitude of risk different? Is the justification of risk or burden different? Are risks compensated for by benefits?

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19 Trying to find a line or clear conceptual divide between QI and Human Subjects Research may not be possible. Some QI is clearly research, Some is clearly different. Much QI is somewhere in the middle

20 QI and Research Both require oversight and attention to protecting the individuals involved Should the standards and form of oversight be the same for both sets of activities? (Bailey et al. Hastings, 2006 p.S13) Should QI activities fall under the current regulatory framework for HSR ?

21 Probably not. Why? The process is burdensome and cumbersome Focus is on compliance and is often stringent, inflexible, and not familiar with QI goals and methods The regulatory system for protecting human subjects in research in the US is increasingly dysfunctional (Levine and Fost, JAMA 2007)

22 Process problems Unjustified variation Cannot accommodate frequent change Over-emphasis on informed consent

23 Quality improvement would be discouraged if thoughtful innovation and measurement cycles required regulatory review or informed consent (Cretin et al. JAMA 2000) While QI movement must … be held accountable, draconian restrictions that could cripple the continued growth and development of QI are unnecessary and unwise (Chernov, A JAMA 2000)

24 This forced marriage between 2 incompatible processes threatens to degrade the effectiveness of either or both of them (Wise, JONA 2007)

25 What is needed? Oversight for both QI and HSR because each asks people to do some things to benefit others, with a possibility of additional risk or burden A constructive oversight system (or systems)–more efficient, less fragmented, less burdensome, designed to help promote important progress (toward improved quality, and useful knowledge) while providing appropriate protections

26 What is needed? Clear organizational authority and criteria for determining what kind of review is needed Review and scrutiny appropriate to risk, uncertainty, deviation from standards Adequate resources devoted to oversight

27 What is needed? Use of expedited review and exemptions Possible expansion of expedited and exempt categories Centralized review for multicenter projects Recognition that informed consent cannot bear all the weight

28 What is needed? Quality Improvement of the process of IRB review and regulatory compliance

29 First, some within the scientific and medical community still fail to fully understand and accept the processes required by law and ethics for review and approval of all research… Second, there is a pressing need for ongoing evaluation, clarification, and appropriate revision of procedural requirements to make them simpler, more consistent, and practicable… Koski, G. Hastings Center Report 2008