The authors, Andy Avins and Harley Goldberg, are both associated with Northern California Kaiser-Permanente. Here's the core of their vision:
Perhaps the most important aspect of change is the need for clinical research to be seen as the enormous social good that it is. By providing the knowledge base that establishes effective prevention and therapy, research participants (often by assuming some amount of risk) provide a gift that transcends the simple scientific aspects of their contributions. Yet, unlike many other members of our society who contribute to the general good, these individuals are rarely recognized for their commitment. Similarly, knowledge of the research process is probably very low among the lay public...Such circumstances contribute strongly to the difficulty in recruiting participants to important research investigations. It is time to take a public-health approach towards confronting these issues directly.
Creating a culture more conducive to clinical research requires actions in several domains:
- As mentioned in the above quotation, the public must see participation in clinical research as a contribution to societal well-being. Charitable gift-giving is strong in the U.S. Participation in clinical research is like making a gift to the heart fund a hospital.
- Clinicians must see supporting clinical research as part of their professional responsibility. We ask clinicians to provide evidence-based care. Without their help evidence won't be created.
- Health plans and large health care organizations benefit from evidence about clinical effectiveness. This creates "a special responsibility to become partners in this process and contribute to this agenda."
- Researchers must make participation in research more feasible for patients and clinicians. And, to an even greater extent than when the article was published two years ago, "research participants are entitled to the expectation that those designing and carrying out research protocols are free from suspicious conflicts of interest."
Preaching about the importance of scientifically and ethically sound clinical research won't enhance the research process - a concerted campaign will be required. Unfortunately, the flood of revelations about suppression of negative results in commercially sponsored research and corruption of medical judgment makes fostering a culture of research much more difficult.
I agree with Avins and Goldberg about the importance of strengthening the clinical research enterprise. And from the perspective of ethics I like the potential impact of their ideas on (a) the doctor-patient relationship and (b) health care organizations.
In my writing, teaching, and in this blog, I've often sounded off about the degree to which we underattend to population interests in our approach to health care ethics. In teaching and in the media we focus on the numerator (the individual) but largely ignore the denominator (the population the individual is part of). This myopic approach to ethics encourages selfishness (as if only the individual matters) and social irresponsibility (as if collateral damage from our overly individual-centered system - like our high uninsurance rate - doesn't matter).
In encouraging clinicians and patients to see themselves as collaborators in supporting the advance of medical knowledge we're encouraging them to add a sense of social responsibility to the guiding ethic of care and to recognize the limits of what we know. These would be salutary changes.
With regard to health plans, hospitals and medical groups, the perspective Avins and Goldberg argue for invites all participants in health care to recognize that we have a shared responsibility to contribute to generating the evidence required for "evidence-based practice." This outlook urges us to make the organizations we are part of true learning communities.
A campaign to create a culture of research as envisioned by Avins and Goldberg would have a constructive effect on the ethics of our health system as well. I'm ready to sign on!