Funding for this research was provided by:
National Heart, Lung, and Blood Institute (1R01HL125114-01)
Received: 28 September 2018
Accepted: 30 April 2019
First Online: 30 May 2019
Ethics approval and consent to participate
: The Westat Institutional Review Board (IRB) reviews all studies involving research on human subjects. This study is exempt from IRB review as received from the Chair of the Westat IRB on October 23, 2014 (FWA 00005551). Per [45 CFR 46.101(b5)] and a letter received on October 16, 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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