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All clinical trials at Massachusetts General Hospital are conducted according to international scientific and ethical standards to ensure the safety and rights of participants.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
GCP standards for conducting human studies are detailed in the International Conference on Harmonisation (ICH) GCP Guidelines, which incorporate U.S. Department of Health and Human Services (HHS) and United States Food and Drug Administration (FDA) regulations governing human research studies.
The principal investigator (PI) is responsible for the conduct of human subject research in accordance with the investigational plan and all applicable regulations. The PI may delegate duties to co-investigators and other members of the study team, but cannot delegate his or her responsibilities.
FDA regulations apply to all studies involving agents regulated by the FDA. HHS regulations apply to behavioral, observational and social science studies which do not involve FDA-regulated agents.
The Partners Human Research Committee (PHRC), commonly referred to as the Institutional Review Board or IRB, ensures the protection of human subjects in all clinical research projects.
All Partners-affiliated investigators must obtain PHRC approval prior to initiation of a clinical research study.
Investigators conducting studies involving FDA-approved agents being evaluated for unapproved indications, or involving unapproved route of administration, doses, etc. may be required to complete the FDA’s Investigational New Drug (IND) Application or an Investigational Device Exemption (IDE) Application.
The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.
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