MaineHealth’s Reliance staff help facilitate human research initiatives by providing assistance and support to MaineHealth investigators and their external collaborators.

Submit the study as a New Project in IRBNet. MaineHealth requires study teams to provide the following information as part of the request to use an external IRB:

    • external IRB study approval letter
    • all study documents acknowledged in the approval letter,
    • MH Key Personnel and Site Roster Form
    • MH Registration Wizard

Once administrative review is complete, MaineHealth issues a Cede Letter to document reliance on another IRB.

MaineHealth prefers to use the SMART IRB Reliance Agreement and online to have study teams request reliance arrangements.

Reliance Assistance

The Research Compliance Office hosts virtual office hours on the first Thursday of each month from 12:00 – 2:00 p.m. Register here, and join us on teams!

If you’d like to talk with somebody about reliance outside of office hours, email HRPPreliance@mainehealth.org, and request a meeting so we can assist you.

Authorization Agreement: Also called a Reliance Agreement, is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating institution relying on the ethical review.

Collaborative Study: A study in which two or more institutions coordinate, with each institution completing a portion of the research activities outlined in a specific protocol.

IRB of Record: The IRB that is responsible for the ethical review of human research on behalf of an institution and/or site or individual investigator.

Lead Site: The primary awardee of a federally funded grant who is responsible for identifying the selected sIRB for cooperative research. For non-federally funded research this role is identified as the primary institution and/or site whom develops a research protocol.

Multi-Site Study: Human research involving more than one institution and/or site participating in the same research protocol.

Participating Site (pSite): An institution that participates in a Single IRB (sIRB) Study.

Relying IRB: An IRB that has designated through an agreement to cede review to an external IRB for a particular study.

Single Institutional Review Board (sIRB) Study: A study in which two or more institutions (participating sites, or pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB may or may not be affiliated with any of the pSites.

Research Compliance Office

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

Important Links

Do you have an interest in volunteering for research studies?  Learn More