Human Research Protection Program (HRPP)
Our fully-accredited HRPP assures research volunteers, researchers and regulators that we are committed to ethically sound research
Supporting Our Investigators In Conducting Compliant and Ethically Sound Research
Baystate Health is committed to fostering the conduct of research in accordance with the highest standards of care and scientific integrity, building and maintaining a culture of compliance with legal and ethical principles, and supporting the education and outreach to both researchers and the community at large.
Federal Regulations and Oversight
Federal oversight is provided by the Office for Human Research Protections (OHRP). OHRP has assigned Baystate Federal Wide Assurance (FWA) number 00004355.
Our Accredited Program Promotes High Quality Research
In 2010, Baystate received full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). The organization maintained this status by earning an additional five-year reaccreditation from AAHRPP in June 2023.
As the "gold seal," AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is committed to scientifically and ethically sound research and continuous improvement.
Institutional Official: Peter Friedmann, MD, MPH
Director of HRPP: Shemetra Owens, CIP, CIM
Education and Quality Assurance Program (EQA)
Education and Quality Assurance Program (EQA) under the Human Research Protection Program (HRPP) oversees human research at Baystate Health. The EQA program is responsible for providing education and support to investigators and study staff conducting clinical research studies at Baystate Health. The EQA is also responsible for performing audits of human subject research studies to ensure compliance with federal, state, and institutional policies.
There are a few ways a study may be chosen for an audit, as part of our ongoing educational audit process these studies are randomly selected, at the request of the study team or at the request of the IRB. The Education and Quality Assurance Program (EQA) is staffed by specialists who develop and implement trainings and educational programs for the research community. This proactive approach is intended to minimize risk to human subject as well as regulatory risk at the investigator and institutional level. Our avenues of outreach include but are not limited to:
- Monthly Clinical Research Community Education Meeting
- Research staff training
- Regulatory Binder trainings
- Clinical Trials Management System (CTMS) OnCore Training
- Consent training
- IRB Member training
Our EQA program is committed to facilitating the proper conduct of research. The research community can request a consultation to ensure studies are in compliance with regulations and professional standards as follows:
- Regulatory Binder Consultation
- Study Start- Up Consultation
- IND/IDE Consultation
- FDA Inspection Preparation Consultation
- General Study Consultation
- Massachusetts Controlled Substance Registration Consultation
- Expanded access/ Compassionate Use Consultation
- eConsent Consultation
Do you have an assistance request? Please submit a request through ServiceNow.
Institutional Review Board (IRB)
Research involving the use of human subjects may only begin when an Institutional Review Board (IRB) has reviewed and approved the research study. Baystate Health has two IRBs that operate as independent groups comprised of volunteers, including physicians, health professionals, and community members. The boards meet on the second Wednesday and fourth Monday of each month to review human subjects research studies and ensure that research is conducted ethically, participants' rights and welfare are protected, and all appropriate regulations are followed.
The Chair for Board 1 is Paul Visintainer, PhD. The Chair for Board 2 is Robert Baevsky, MD.
Interesting in becoming a volunteer member of the Baystate IRB?
Education Requirements and Tools
Forms and Templates
Policies & Procedures
Single IRB
IRBNet
All submissions to the IRB must be submitted using IRBNet.
Contact the HRPP Office at UMass Chan Medical School-Baystate
HumanResearch@baystatehealth.org │ 413-794-4356
759 Chestnut Street, Mailstop 3601 Main Street, Springfield, MA, 01199
Contact the IRB Office at UMass Chan Medical School-Baystate
IRBProtocolSubmissions@baystatehealth.org
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Shemetra Owens, CIP, CIM |
Susan Garrow-Sloan, RN, BSN, CCRP |
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Sola Odesina |
Vanessa Roxo, MPH |
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AnneMarie Mal, MDiv |
Linnea Rademaker, PhD, CIP |
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L. Cliff Rhodes |
Brandon Williams, MS |
|
Matthew Rogers, PhD |
Michael Boland |
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