The treating physician as active gatekeeper in the recruitment of research subjects.

Abstract

BACKGROUND: Institutional Review Boards vary in regard to the conditions imposed on investigators concerning contacting potential subjects to participate in health-services research studies. OBJECTIVE: The impact of more active involvement of the treating physician was examined in the approval process for recruiting study subjects. DESIGN: In recruiting subjects for a Massachusetts-based, multihospital (n = 17), health-services research study of treatment patterns for early stage breast cancer that required patient interviews, four hospitals stipulated that the treating surgeon provide written permission to the investigators to allow any contact with a potential study subject for the purpose of recruitment (active physician involvement group); the remaining 13 hospitals stipulated that the treating surgeon need only respond to the investigators if contact with a potential subject was forbidden (passive physician involvement group). SUBJECTS: Of the 1401 potential subjects treated for early stage breast cancer, 697 were in the active physician involvement group and 704 were in the passive physician involvement group. MEASURES: The percentages of patients for whom contact was allowed for recruitment purposes and who enrolled in the study were determined for the active physician involvement group and the passive physician involvement group, respectively. Logistic regression models were used to assess the independent effect of physician involvement on study enrollment. RESULTS: Of the 697 patients in the active physician involvement group, contact was approved by the treating surgeon for 72% (n = 505), compared with 91% (n = 638) of the passive physician involvement group (P <0.001). After adjustment for a variety of patient, physician, and hospital-level variables, patients in the passive physician involvement group were found to be significantly more likely to be enrolled in the study (adjusted OR 2.61; 95% CI, 1.53-4.45). However, among those patients approved for investigator contact, there were no significant differences between patients who were enrolled and patients who were not enrolled in the study with regard to physician involvement in the recruitment process (adjusted OR 1.13; 95% CI, 0.70-1.81). CONCLUSION: Our findings demonstrate that more stringent IRB requirements on health services researchers to verify permission from the treating physician to access patients for recruitment purposes adversely impact on the enrollment of patients even in noninterventional research studies. Current procedures for involving the treating physician as a gatekeeper in the recruitment of research subjects may limit access to patient participation in research studies from the perspectives of both researchers and potential subjects.