Office of Clinical Investigation
The Office of Clinical Investigation has been established to oversee the protection of human research subjects at Boston Children's Hospital. Children's is committed to safeguard the rights and welfare of all children, adolescents, adults and family members who volunteer to participate in research. To this end, the Office of Clinical Investigation upholds the principles of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research, as the cornerstone of our mission, organization and daily activities.
Through funding from NIH, Children's has completed a report titled, "The Process of Informed Consent: What's at Stake?" This ethnographic report summarizes observations and provides recommendations for improving the informed consent process for clinical research. It is based on data from interviews with and observations of investigators, subjects, family members, research staff, and the Committee on Clinical Investigation (CCI).
The Office of Clinical Investigation is charged with two functions:
- To provide administrative support for Children's Internal Review Board (IRB), the Committee on Clinical Investigation (CCI), which was established to assure the protection of all human subjects in research projects by reviewing and approving all research that involves human subjects conducted by anyone on the premises of or under the auspices of Children's.
- To provide a mechanism for continual education and improvement for the human research protection program at Children's through the Education and Quality Improvement Program (EQuIP). The goal of EQuIP is to provide education and assist investigators conduct human subjects research according to the highest ethical standards, in compliance with federal, state and institutional regulations, and according to Good Clinical Practice guidelines through randomized or voluntary study reviews, personalized tools and recommendations.
We welcome investigators and research staff to drop in with questions or set up meetings. The Office of Clinical Investigation is located at 2 Avenue Louis Pasteur, Lefavour Hall, 4th Floor. We can be reached by phone at 617-355-7052 or fax at 617-730-0226.