Primary Care Research and Protection for Human Subjects

To the Editor: I read with interest the Policy Perspectives article by Dr Moreno et al,¹ but I am concerned that the deliberations on this issue did not address the need to develop rules and procedures that, while protecting subjects, also allow the development of the relatively new field of primary care practice–based research.

Many, although certainly not all, primary care studies conducted in busy community practice settings are minimal risk and involve little or no intervention in patient care. Often they involve the collection of small amounts of data about a specific problem in a few patients in each practice. The practices are diverse and broadly distributed geographically, which is necessary if the research results are to be representative of primary care. Examples of these studies include mental health in children,² chest pain,³ panic disorder,⁴ asthma,⁵ neonatal jaundice,⁶ and a wide variety of other common primary care problems.