The treating physician as active gatekeeper in the recruitment of researchsubjects

BACKGROUND. Institutional Review Boards vary in regard to the conditions im posed on investigators concerning contacting potential subjects to particip ate 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 t o allow any contact with a potential study subject for the purpose of recru itment (active physician involvement group); the remaining 13 hospitals sti pulated that the treating surgeon need only respond to the investigators if contact with a potential subject was forbidden (passive physician involvem ent group). SUBJECTS. Of the 1401 potential subjects treated for early stage breast can cer, 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 recr uitment purposes and who enrolled in the study were determined for the acti ve physician involvement group and the passive physician involvement group, respectively. Logistic regression models were used to assess the independe nt effect of physician involvement on study enrollment. RESULTS. Of the 697 patients in the active physician involvement group, con tact 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 variabl es, patients in the passive physician involvement group were found to be si gnificantly 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 con tact, there were no significant differences between patients who were enrol led and patients who were not enrolled in the study with regard to physicia n involvement in the recruitment process (adjusted OR 1.13; 95% CI, 0.70-1. 81). CONCLUSION. Our findings demonstrate that more stringent IRB requirements o n health services researchers to verify permission from the treating physic ian to access patients for recruitment purposes adversely impact on the enr ollment of patients even in noninterventional research studies. Current pro cedures for involving the treating physician as a gatekeeper in the recruit ment of research subjects may limit access to patient participation in rese arch studies from the perspectives of both researchers and potential subjec ts.