MaineHealth has established a Human Research Protection Program (HRPP).  The MaineHealth HRPP, in partnership with its research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under MaineHealth’s auspices.

  • Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
  • Provide guidance and support to the research community in the conduct of research with human subjects;
  • Assist the research community in ensuring compliance with relevant regulations;
  • Provide timely and high-quality education, review, and oversight of human research projects; and
  • Facilitate excellence in the conduct of human subjects research.

  • Monitor, evaluate, and continually improve the protection of human research participants
  • Exercise responsible oversight of human subjects research;
  • Educate Institutional Review Board (IRB) members, investigators, and staff about their ethical responsibility to protect research participants
  • When appropriate, intervene in research and respond directly to concerns of research participants.

Federal Governance

MaineHealth maintains a Federal-Wide Assurance through the US Department of Health & Human Services Offices for Human Research Protections.

Status of MaineHealth’s Federal Wide Assurance (FWA) and IRB can be searched by any of the following:

Institution/Organization Name: MaineHealth
FWA Number: 00003993/Expires 03/19/2030
IORG number: 0000154/Expires 03/18/2029
IRB Number: 00000262 Maine Health IRB#1

Certificate of Compliance

These terms apply whenever the Institution becomes engaged in human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

In general, the Institution becomes so engaged whenever:

  • the Institution’s employees or agents intervene or interact with human subjects for purposes of federally-conducted or -supported research;
  • the Institution’s employees or agents obtain individually identifiable private information about human subjects for purposes of federally-conducted or -supported research; or
  • the Institution receives a direct federal award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.

Policies & Procedures

Standard Operating Procedures (SOPs) serve as the governing procedures for all human subjects research at MaineHealth. Researchers, IRB members, and research staff are expected to review and adhere to these procedures. The document is reviewed annually and updated as needed.

Click here to download a copy of MaineHealth’s SOPs

MaineHealth is AAHRPP-accredited. The Association for Accreditation of Human Research Protection Programs, Inc (AAHRPP) accreditation indicates that an organization follows rigorous standards for ethics, quality, and protections for human research. Organizations that earn the AAHRPP seal, earn a place among the world’s most respected, trustworthy research organizations.

IRB

Reliance

Quality Assurance

Education & Training

HRRP Team

Reliance: Emily Berg 

Conflict of Interest: Sarah Boisvert

IRB: Donna Horne, Patrick Sherwood, Nicole Walters

Quality Assurance: Rebecca Lamb

HRPP Operations: Crystal Nayock

Director Research Compliance, Daniela Radu

Feedback Survey

The MaineHealth Human Research Protection Program (HRPP) recognizes that it is a privilege to work with human participants in research and welcomes any information that would support our efforts to assure the continuous quality and compliance of our program.  Submit comments anonymously (your login information will not be collected) by clicking on the button below.

Research Compliance Office

1 Riverfront Plaza
Westbrook, Maine 04092
hrppIRB@mainehealth.org
207.661.4474

Important Links

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