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 Rebecca H Li
A1 Mary C Wacholtz
A1 Mark Barnes
A1 Liam Boggs
A1 Susan Callery-D'Amico
A1 Amy Davis
A1 Alla Digilova
A1 David Forster
A1 Kate Heffernan
A1 Maeve Luthin
A1 Holly Fernandez Lynch
A1 Lindsay McNair
A1 Jennifer E Miller
A1 Jacquelyn Murphy
A1 Luann Van Campen
A1 Mark Wilenzick
A1 Delia Wolf
A1 Cris Woolston
A1 Carmen Aldinger
A1 Barbara E Bierer
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.