QA, QI and Health Services Activities: Ethical Challenges

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QA, QI and Health Services Activities Ethical
Challenges

• Christine Grady
• Department of Bioethics
• NIH Clinical Center

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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.

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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?

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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.46.102(d)

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Similar

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

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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

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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.

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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

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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)

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Intent/purpose

• HSR-the goal and purpose of HSR is to develop
  socially valuable generalizable knowledge about
  health, disease, treatmentwith 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)

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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?

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• 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)

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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

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• 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

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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)

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Generalizability

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

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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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• 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

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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?

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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)

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Process problems

• Unjustified variation
• Cannot accommodate frequent change
• Over-emphasis on informed consent

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• 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)

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

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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

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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

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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

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What is needed?

• Quality Improvement of the process of IRB review
  and regulatory compliance

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• 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