Human Subjects Protection Office

Providing Protection, Education and Training for Clinical Trials

The purpose of the Human Subjects Protection Office (HSPO) at Beth Israel Deaconess Medical Center (BIDMC) is threefold:

• To provide comprehensive protection to subjects who volunteer in human subjects research activities at this Institution.
• To provide an educational and training program designed to educate the community, investigators, staff and patients in the safe and ethical conduct of research.
• To assist researchers by monitoring current research activities to ensure the ethical conduct of human subjects research.

Ensure Research is Conducted with Ethical Principles

The HSPO ensures that research activities are conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the Belmont Report, State and Federal regulation and in compliance with internal BIDMC policies by:

• Ensuring that research involving human subjects is reviewed and approved by an Institutional Review Board prior to initiation and that subsequent continuing review and monitoring takes place for approved studies.
• Conducting seminars, online training and compliance activities that is required of researchers and staff.
• Managing and performing a site visit and audit compliance program that applies to all research activity involving human subjects. This program informs the HSPO of the need for additional programs or policy development.
• Achieving and maintaining accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) which signifies that the BIDMC is committed to comprehensive protection for research participants and the highest quality research.

Resources for Participants

The HSPO at BIDMC is available to discuss questions or concerns about your participation in research.

For resources about common procedures or questions related to research, please see the brochures available through the Harvard Catalyst. The following are examples of brochures that are currently available:

• Should I be a Research Subject?
• Research Subject Bill of Rights
• MRI for Research
• CT Scans for Research
• Blood Draw for Research
• Social and Behavioral Research
• Stem Cell Research
• Genetic Research

Please note that these brochures are available in many different languages.