title: Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.
abstract: 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.
authors.affiliation: Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA.
authors.forename: Rebecca H
authors.initials: RH
authors.lastname: Li
authors.affiliation: Janssen R&D, Johnson & Johnson, Raritan, New Jersey, USA.
authors.forename: Mary C
authors.initials: MC
authors.lastname: Wacholtz
authors.affiliation: Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA Ropes & Gray LLP, Boston, Massachusetts, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Barnes
authors.affiliation: The Global Health Network/Oxford University, Oxford, UK.
authors.forename: Liam
authors.initials: L
authors.lastname: Boggs
authors.affiliation: Quality Assurance, AbbVie, Chicago, Illinois, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Callery-D'Amico
authors.affiliation: WCG (WIRB- Copernicus Group), Olympia, Washington, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Davis
authors.affiliation: Morgan Lewis, New York, NY, USA.
authors.forename: Alla
authors.initials: A
authors.lastname: Digilova
authors.affiliation: Health Care Group, Verrill Dana LLP, Boston, Massachusetts, USA.
authors.forename: David
authors.initials: D
authors.lastname: Forster
authors.affiliation: Public Responsibility in Medicine and Research, Boston, Massachusetts, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Heffernan
authors.affiliation: Public Responsibility in Medicine and Research, Boston, Massachusetts, USA.
authors.forename: Maeve
authors.initials: M
authors.lastname: Luthin
authors.affiliation: Petrie-Flom Center, Harvard Law School, Cambridge, Massachusetts, USA.
authors.forename: Holly Fernandez
authors.initials: HF
authors.lastname: Lynch
authors.affiliation: WCG (WIRB- Copernicus Group), Olympia, Washington, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: McNair
authors.affiliation: NYU Langone Medical Center, New York, New York, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Miller
authors.affiliation: Colorado School of Public Health Anschutz Medical Campus Aurora, CO.
authors.forename: Jacquelyn
authors.initials: J
authors.lastname: Murphy
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Luann
authors.initials: L
authors.lastname: Van Campen
authors.affiliation: International AIDS Vaccine Initiative, New York, New York, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Wilenzick
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts, USA.
authors.forename: Delia
authors.initials: D
authors.lastname: Wolf
authors.affiliation: Sanofi, New York, New York, USA.
authors.forename: Cris
authors.initials: C
authors.lastname: Woolston
authors.affiliation: Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA.
authors.forename: Carmen
authors.initials: C
authors.lastname: Aldinger
authors.affiliation: Multi-Regional Clinical Trials Center, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Barbara E
authors.initials: BE
authors.lastname: Bierer
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000941:ethics*; D026724:Ethical Review; D028744:Ethics Committees, Research; D032984:Ethics, Research / Q000193:education; D006801:Humans; D028681:Moral Obligations; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000941:ethics
keywords: Clinical Ethics; Clinical trials; Ethics; Ethics Committees/Consultation
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