Understanding the research-care demarcation and why it must be revised

Area of Science:

• Bioethics
• Medical Research Ethics
• Clinical Practice

Background:

• The Belmont Report created an artificial separation between research and patient care over 40 years ago.
• This demarcation, initially controversial, was implemented for political reasons.
• Historical research scandals and the theoretical basis of the Belmont demarcation are reviewed.

Purpose of the Study:

• To examine the necessity for revising the research-care demarcation.
• To discuss the consequences of the current demarcation on medical practice.
• To propose an alternative framework for the research-care distinction.

Main Methods:

• Historical review of research scandals.
• Analysis of the theoretical underpinnings of the Belmont Report's research-care demarcation.
• Discussion of the impact on clinical practice and proposal of an alternative.

Main Results:

• The Belmont Report's focus on protecting research subjects inadvertently led to the proliferation of unvalidated interventions in clinical care.
• The distinction between research and care, based on 'generalizable knowledge,' failed to protect patients receiving unvalidated treatments.
• A double-headed problem exists: protecting research subjects and protecting patients from unvalidated care.

Conclusions:

• The research-care demarcation requires revision to incorporate the distinction between validated and unvalidated care.
• Care research is integral to good medical practice and should be facilitated.
• Reintroducing the notion of validated care is essential for ethical medical practice.