RT Journal Article SR Electronic T1 Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees JF Journal of Medical Ethics JO J Med Ethics FD BMJ Publishing Group Ltd and Institute of Medical Ethics SP 229 OP 234 DO 10.1136/medethics-2014-102540 VO 42 IS 4 A1 Li, Rebecca H A1 Wacholtz, Mary C A1 Barnes, Mark A1 Boggs, Liam A1 Callery-D'Amico, Susan A1 Davis, Amy A1 Digilova, Alla A1 Forster, David A1 Heffernan, Kate A1 Luthin, Maeve A1 Lynch, Holly Fernandez A1 McNair, Lindsay A1 Miller, Jennifer E A1 Murphy, Jacquelyn A1 Van Campen, Luann A1 Wilenzick, Mark A1 Wolf, Delia A1 Woolston, Cris A1 Aldinger, Carmen A1 Bierer, Barbara E YR 2016 UL http://jme.bmj.com/content/42/4/229.abstract AB A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.