Ethics and Learning Health Care: an overview of the differences between what is considered research and what is considered clinical care, and an introduction to the ethical issues that arise from this boundary being blurred.

1. The Research-Practice Distinction
Paradigm and its Ethical Implications
Ethics and Learning Health Care
Systems

2. How are research and treatment
distinguished conceptually?
Research
• Contains uncertainty
• Participants are exposed to
new approaches
• What is learned can be
“generalized” to other
patients
Practice
• Learned information is
applied to individual
patients
• Guided by what is best for
that patient

3. How are research and treatment
distinguished in regulatory procedure?
Research
• Intent to produce
generalizable knowledge
• Systematic collection of
data
Practice
• No systematic data
collection
• Intent to help patient at
hand

4. How are research and treatment
distinguished in the literature?
Research
• Poses risk; uncertainty
about clinical benefit
• Poses burdens from
activities not necessary for
good care
• Protocols determine the
care patients receive
Practice
• Physician-patient autonomy
to decide
• Treatments given only when
benefits outweigh risks
• All interventions contribute
to good care management

5. What is the moral implication of these
distinctions?
If research is where
patients are exposed to
treatments with
uncertainty (of
safety/efficacy), and
primarily to help other
patients, then it needs
significant oversight and
informed consent.
Clinical practice requires
less oversight and a briefer
discussion of
risks/alternatives because
treatment risks will be
balanced by benefits
patients get from those
same treatments.

6. What is of ethical concern?
That people deserve protection when exposed to more
risks, burdens, or uncertainties is ethically correct;
To assume that all clinical research exposes people to
more risks, burdens, or uncertainties than standard
clinical care is not correct.

7. We are doing more research that
“blurs the boundaries.”
• Prospective Observational research
– Using clinical data that is already being collected for
clinical management purposes- but where researchers
also want to study patients’ experiences over time
• Randomized research with commonly used medicines
– Compare FDA-approved, widely used treatments to see
which one works best (or works best for whom)

8. “Blurring the Boundaries”
• Quality improvement is mandated in hospitals
– QI science demands rigorous methods
– Sometimes different units introduced to different
strategies e.g., to reduce falls or infections
– Or use before/after measures of aggregate data
– Goal is to improve care for those patients but importantly
for future patients
• Doctors can’t simply do/order whatever they want
– Insurance formularies limit which medicines, frequency of
certain tests, etc.

9. Paradoxes of our Current Moral and
Clinical Context
Paradox #1
Health departments, CDC, hospitals routinely
collect data (so useful to patients!!)– permission
not required
– Cancer, obesity, HIV rates in different populations
– Rates of infections, falls, medication errors in hospitals and
impact of related interventions

10. Paradoxes of our Current Moral and
Clinical Context
Paradox #2
Push for doctor-patient “shared decision-
making”
• Health Affairs: “Shared decision making” must rely on
doctors and patients using “best available evidence”
but so little evidence for most clinical decisions
• in part from hurdles of ethics oversight/ privacy
concerns

11. The Goals of an Ethical Framework for
a Learning Health Care System
To increase the likelihood that continuous learning
occurs;
– Learning more (e.g., about what works and what doesn’t
work) is an ethical good
To ensure that this learning proceeds in an ethically
acceptable fashion
– Participants’ rights and interests must be appropriately
protected