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Article History

Received: 8 August 2017

Accepted: 20 October 2017

First Online: 10 November 2017

Ethics approval and consent to participate

: The Westat IRB reviews all studies involving research on human subjects. Exemption from IRB review was received from the Chair of the Westat Institutional Review Board (IRB) on 23 October 2014 (FWA 00005551). According to [45 CFR 46.101(b5)] and a letter received on 16 October 2014, from Denise Bonds, Medical Officer, NHLBI; this research involves a program evaluation and, therefore, is exempt from IRB review.Westat is conducting an evaluation of the methods and processes that contribute to successful, pragmatic, low-cost clinical trials. The work involves monitoring the design/planning of these trials and, in years 2–5, the implementation of the trials. As members of this cooperative agreement, all investigators consented to participate in these activities and, specifically, provided oral consent prior to the conduct of the interviews as reported in this submission.

: Not applicable.

: The authors declare that they have no competing interests.

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