Community Partnered Research Ethics Training in Practice: A Collaborative Approach to Certification.

This report describes the development and implementation of a tailored research ethics training for academic investigators and community research partners (CRP). The Community Partnered Research Ethics Training (CPRET) and Certification is a free and publicly available model and resource created by a university and community partnership to ensure that traditional and non-traditional research partners may study, define, and apply principles of human subjects' research. To date, seven academic and 34 CRP teams have used this highly interactive, engaging, educational, and relationship building process to learn human subjects' research and be certified by the University of Pittsburgh Institutional Review Board (IRB). This accessible, flexible, and engaging research ethics training process serves as a vehicle to strengthen community and academic partnerships to conduct ethical and culturally sensitive research.

Success Rates for Notification of Enrollment in Exception From Informed Consent Clinical Trials.

OBJECTIVES: Exception from informed consent (EFIC) for research in emergency settings requires investigators to notify enrolled subjects, family members, or legally authorized representatives about inclusion in the study. We examined the success rate of a notification strategy including mail services for subjects enrolled in EFIC trials. METHODS: We describe notification attempts for subjects in three out-of-hospital cardiac arrest clinical trials in both urban and rural areas around Pittsburgh, Pennsylvania, between the years 2000 and 2014. We examined the time required to notify subjects and the success of contacting subjects or their representatives when notified in person (if alive), by mail (if alive and unable to reach in person), or by mail (if the subject was deceased). We characterized comments received from subjects or their representatives as positive, neutral, or negative. RESULTS: We attempted notification on a total of 1,912 subjects, 1,762 by mail, and 163 in person. Of these, 1,767 (92%) notification forms were successfully delivered, and 431 (24%) were signed and returned. Only 16 subjects or representatives (0.91%) requested to withdraw from the study. In-person notifications were more likely to be signed than mailed notifications (69% vs. 20%; p < 0.001). A total of 3.2% of recipients contacted investigators by phone or letter in response to notifications, but only five recipients expressed negative attitudes toward the trial. Ninety percent of subjects were notified within 35 days of the incident. Time to notification was shorter for in person (median = 5 days, interquartile range [IQR] = 2 to 10 days) than for deceased and mailed (11 days, IQR = 8 to 14 days) or alive and mailed (20 days, IQR = 14 to 29 days). CONCLUSIONS: It is possible to successfully notify recipients of enrollment in a study using EFIC over 90% of the time within 35 days, although only 24% of recipients will sign and return a form. Fewer than 1% of subjects withdraw from the study, and fewer than 5% contact investigators, usually for neutral reasons.