Author: Ana Iltis

Description:

A researcher sees patients at two sites: one that caters to predominately inner-city patients, the other a mixture of inner-city patients and patients from the suburbs. Concerns arise about post-trial access and fair subject selection when the researcher becomes interested in recruiting patients from both sites.

Keyword(s): recruitment, fair subject selection, ethnic and racial minorities, resource-poor community, IRB, post-trial access

Case:

Dr. Jacobs is conducting a study of beta-blocking agents. Two days per week, Dr. Jacobs provides care to poor inner-city patients, many of whom are minorities, at a clinic. He also works two days per week at the university medical center office, serving both inner-city patients and patients from the suburbs. The study will compare a new beta-blocker to an existing drug. Dr. Jacobs proposes to recruit study subjects through the city clinic and the university medical center office. The IRB defers his protocol primarily because they are concerned with fairness in subject recruitment. They believe that Dr. Jacobs will be taking advantage of a poor, predominantly minority population, who might not be able to afford beta-blockers outside the study. The IRB expresses concern with access to care for subjects following the 36 week trial.

1. Should the IRB be concerned with fairness in subject selection in this study? Why or why not?
2. What measures, if any, should be taken to ensure post-trial access to care?
3. Are there concerns associated with conducting studies only in better-off patients? What concerns does recruitment from a primarily poor population raise?