Sakala, Carol
Belanoff, Candice
Declercq, Eugene R.
Funding for this research was provided by:
California Health Care Foundation (19555)
Yellow Chair Foundation (2016-171703)
Article History
Received: 9 March 2019
Accepted: 6 July 2020
First Online: 14 August 2020
Ethics Approval and Consent to Participate
: The Committee for the Protection of Human Subjects of California’s Office of Statewide Health Planning and Development is the study IRB of record, having approved the study protocol and subsequent amendments (16-06-2606). The IRB determined that the study presents low risk to participants. The IRB specified the elements of informed consent required for this study. These elements were included in the cover letter, and the IRB approved the cover letter and other contents of invitational mailings (in English and in Spanish) sent to all sampled women. Further, these elements of informed consent were also included at the beginning of the Qualtrics programming of the survey. The screen would only advance to start questionnaire items after respondents who elected to participate on their own using any device digitally gave written consent to participate. Telephone interviewers read the consent script verbatim and obtained verbal consent to proceed before initiating the questionnaire with respondents who chose to participate with an interviewer. Further, the questionnaire uniformly offered the response choice <i>Prefer not to answer / Prefiero no contester</i> for every question and informed participants they could stop participating at any point. As the study included no participants younger than 18 years, assent or waiver/alteration of assent did not apply. The IRB reviewed and approved these processes and final English and Spanish versions of the study’s programmed questionnaire and interviewer guide, including the telephone script obtaining verbal consent to participate. The University of California, San Francisco IRB, the Human Research Protection Program, also approved the study.
: Not applicable.
: The authors have no competing financial or other interests to declare.