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Human Subjects Research

Human Research Protection Program (HRPP)

Baystate's Human Research Protection Program supports our investigators in conducting compliant and ethically sound research.

Program staff assist investigators with protocol submissions, prospective and retrospective research compliance monitoring visits, and informed consent observation. HRPP also provides education for investigators and study staff on the principles governing the responsible conduct of research.

Our Accredited Program Promotes High Quality Research

Association for the Accreditation of Human Research Protection Programs sealBaystate achieved full accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) in 2010. 

As the "gold seal," AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is commited to scientifically and ethically sound research and continuous improvement.

Federal Regulations and Oversight

Federal oversight is provided by the Office for Human Research Protections (OHRP). OHPR has assigned Baystate Federal Wide Assurance (FWA) number 00004355.

Institutional Review Board (IRB)

No research involving the use of human subjects may be undertaken without first being reviewed and approved by an Institutional Review Board.

An IRB is an independent group of volunteers that includes doctors and other health professionals as well as people from the surrounding community. IRBs approve and monitor research involving people to make sure that the research is ethical, and that research volunteers are safe and their rights are protected. 

Baystate has two IRBs. Meetings are generally held on the second Wednesdays and the fourth Mondays of each month.

IRBNet

Baystate uses IRBNet as its electronic portal for IRB submissions and document maintenance.

Training in Research Ethics

Baystate uses CITI (Collaborative Institutional Training Initiative) for mandatory education in research ethics and the responsible conduct of research. CITI training is required for all investigators and staff involved in the conduct or reporting of research.