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Article History

Received: 22 December 2017

Accepted: 16 April 2018

First Online: 3 May 2018

Ethics approval and consent to participate

: The study has been approved according to the Declaration of Helsinki and the ethical standards of the ethics committees at VA Boston Healthcare System and the University of Iowa.Following telephone screening, potential participants will meet with the Site’s designated team member for consent and potential enrollment. During this visit, the qualified study staff authorized by the Site Principal Investigator and the potential participant will discuss the contents of the consent form, including but not limited to, the nature of the trial, the purpose of the research, the trial procedures, the possible risks and benefits of participation, randomization, confidentiality and also communicate the voluntary nature of participation in the trial emphasizing the participant’s right to withdraw from the trial at any time. The consenting study team member will inform participants of compensation for their participation in the study.Following this discussion, potential participants will be offered the opportunity to ask any study-related questions and enroll by providing written consent on form approved by the Site’s local IRB. Potential participants may invite a friend or family member to-be-present during the visit, to further discuss their decision to enroll and/or contact (e.g., phone call) a friend or family member that is not physically present for discussion before deciding to enroll. At the potential participant’s request, study staff may be asked to ‘step-out’ of the room to provide privacy for such discussions. In addition, potential participants will be provided the option to defer their decision, bring the consent form and other study information forms home to discuss their decision with friends or family members, and later return to the study site to sign the consent form. No study activities will take place prior to completion of the consenting process.One original, fully-executed copy of the informed consent will be provided directly to the participant, a second will be retained in a secure manner at the research site and be available for inspection at the site upon the request of representatives of the Sponsor, reviewing Institutional Review Board or other relevant regulatory agencies. No study activities will take place prior to completion of the consent process. The copy of the consent forms taken home by the participant will include telephone and email contact information for the Site Study Coordinator and the Site PI. At any point during or after completion of the study, the participant may contact the Site Study Coordinator, Site PI or the reviewing site Institutional Review Board to obtain additional information regarding his/her rights as a participant.To communicate important protocol modifications, site PIs and the overall study PI will have bi-monthly meetings. The study PI will communicate with the overall study IRB, trial registries, and journals whereas the site PIs will communicate with local IRBs and trial participants.

: TV and SD have ownership options in Posit Science Corporation, the study sponsor. Posit Science served as the organizing and data management center. SD as the sponsor coordinator. TV served as the Sponsor PI and involved in study design in collaboration with Site PIs.

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