Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Community-Engaged Research (CEnR)

Overview

Community-engaged research centers around fostering collaborations with and among groups of people affiliated by geographic proximity, special interest, or similar situations with the goal of addressing issues that affect the wellbeing of the people within the group. As stated in the "Principles of Community Engagement" (Second Edition), published by the Centers for Disease Control and Prevention and the Agency for Toxic Substances & Disease Registry (ATSDR), community-engaged research "...is a powerful vehicle for bringing about environmental and behavioral changes that will improve the health of the community and its members. It often involves partnerships and coalitions that help mobilize resources and influence systems, change relationships among partners, and serve as catalysts for changing policies, programs, and practices."

The Regulatory Foundations, Ethics, and Law Program in conjunction with the Population Health Research Program have developed resources to support community-engaged research.

Resources

For Investigators
  • Community-Engaged Research 101 [PDF]
    "Community-Engaged Research (CEnR) and the Institutional Review Board: Principles, Challenges, and Opportunities" provides an overview of community-engaged research, the risks and ethical issues for CEnR, and the IRB operational challenges and solutions related to CEnR.
  • Human Subjects Training for Community Partners - request copy
    This document assists with the required training of community partners and/or lay individuals engaged in the conduct of research. In addition to focusing on ethical conduct related to working with research participants, this training helps educate community partners on their roles and ethical responsibilities during the research project.
  • Ethical Conduct of Research with Human Participants Training for Youth Audiences (available from CES4Health at no charge, registration required) - download product
    This presentation serves as a simple tutorial highlighting the key principles of conducting research in accordance with state and federal regulations that Institutional Review Boards (IRB) apply in their review of research involving human participants. The training includes interactive scenarios to facilitate discussion and is accompanied by a facilitator's guide containing instructions and a brief assessment designed to assess youth understanding of, and comfort with, the training content.
Community Partners
  • Community-Engaged Research 101 [PDF]
    "Community-Engaged Research (CEnR) and the Institutional Review Board: Principles, Challenges, and Opportunities" provides an overview of community-engaged research, the risks and ethical issues for CEnR, and the IRB operational challenges and solutions related to CEnR.
  • Human Subjects Training for Community Partners - request copy
    This document assists with the required training of community partners and/or lay individuals engaged in the conduct of research. In addition to focusing on ethical conduct related to working with research participants, this training helps educate community partners on their roles and ethical responsibilities during the research project.
  • Ethical Conduct of Research with Human Participants Training for Youth Audiences (available from CES4Health at no charge, registration required) - download product
    This presentation serves as a simple tutorial highlighting the key principles of conducting research in accordance with state and federal regulations that Institutional Review Boards (IRB) apply in their review of research involving human participants. The training includes interactive scenarios to facilitate discussion and is accompanied by a facilitator's guide containing instructions and a brief assessment designed to assess youth understanding of, and comfort with, the training content.
  • Short-Form Consent Documents (coming soon)
    Short-form consent translated into Haitian Creole, Portuguese, Russian, Spanish, and traditional Chinese.
  • Reliance (Authorization) Agreement Toolkit for Community Partners (coming soon)
    The Reliance (authorization) Agreement Toolkit will contain general information and customizable tools including sample agreements and policies related to review by institutional review boards (IRBs), both for those institutions providing review for another institution and those delegating review to another institution's IRB or to an independent IRB.
For IRBs
  • Community-Engaged Research 101 [PDF]
    "Community-Engaged Research (CEnR) and the Institutional Review Board: Principles, Challenges, and Opportunities" provides an overview of community-engaged research, the risks and ethical issues for CEnR, and the IRB operational challenges and solutions related to CEnR.
  • Short-Form Consent Documents (coming soon)
    Short-form consent translated into Haitian Creole, Portuguese, Russian, Spanish, and traditional Chinese.
  • Reliance (Authorization) Agreement Toolkit for Community Partners (coming soon)
    The Reliance (authorization) Agreement Toolkit will contain general information and customizable tools including sample agreements and policies related to review by institutional review boards (IRBs), both for those institutions providing review for another institution and those delegating review to another institution's IRB or to an independent IRB.
  • Human Subjects Training for Community Partners - request copy
    This document assists with the required training of community partners and/or lay individuals engaged in the conduct of research. In addition to focusing on ethical conduct related to working with research participants, this training helps educate community partners on their roles and ethical responsibilities during the research project.
  • Ethical Conduct of Research with Human Participants Training for Youth Audiences (available from CES4Health at no charge, registration required) - download product
    This presentation serves as a simple tutorial highlighting the key principles of conducting research in accordance with state and federal regulations that Institutional Review Boards (IRB) apply in their review of research involving human participants. The training includes interactive scenarios to facilitate discussion and is accompanied by a facilitator's guide containing instructions and a brief assessment designed to assess youth understanding of, and comfort with, the training content.
  • Harvard Catalyst Community-Engaged Research Subcommittee (CEnR):
    The CEnR Subcommittee brings together expertise from Harvard Catalyst partnering institutions and community leaders to build research partnerships with community organizations, investigators, and research participants with the goal of educating both researchers and community members, enabling compliance, and collaborating around issues related to regulatory compliance. Learn more on our How We Work page.

Contact

Claude-Alix Jacob, CEnR Co-Chair
Email

Julie Kaberry, CEnR Co-Chair
Email

Sabune Winkler, Director, Regulatory Affairs Operations
Email

Hila Bernstein, Regulatory Affairs Officer
Email