Forms, Templates, and Policies

IRB Application Guidance - these guides help researchers understand human research responsibilities and give insight on the application process:

IRB Policies and Guidance Documents

Section I below lists the most common documents related to new study submissions. If you currently have an active protocol refer to section II. All other forms and templates are in the last section.

I. New Protocol Applications

Forms to be used when preparing a new study for submission to the IRB.


  • IRB Conflict of Interest Form - to be completed by study team members who are not HMS faculty, and are not study team members of a PHS-funded human research study.
  • Department Review Form - required for all new expedited and greater than minimal risk studies
  • Revised Protocol Template for Researchers - a general guide/template to help researchers ensure that the minimum required information is present for IRB review. The document is only a guide; please use in conjunction with the Protocol Development Guidance document above.

II. Previously Approved Applications

Forms to be used to request approval for a change to a previously approved study.

III. Consent and Assent Forms

Other Forms

 

  • Research Participant Brochures (Harvard Catalyst) - a variety of brochures (available in more than 15 languages) that provide useful information to prospective participants on a range of research topics, including:
    • Should I be a research subject?
    • Research Subject Bill of Rights
    • Social and Behavioral Research
    • CT Scans for Research
    • MRI Scans for Research
    • PET Scans for Research
    • Surrogate Decision-Making in Health Research

    Contact Us

  • Ida Rego

    Office Contact P: 617-806-8702 F: 617-806-8710 Email
  • IRB office mailing address

    Cambridge Health Alliance
    Institutional Review Board Office
    1493 Cambridge Street Cambridge, MA 02139
    Email
  • J. Glover Taylor

    Institutional Official
    Chief Compliance Officer
    Email
  • Lior Givon, MD, PhD

    IRB Chair Email
  • Sarah E. Nelson, PhD

    IRB Vice-Chair Email
  • Michelle Ewahi

    Manager, Human Subject Protection and Research Integration Email