Forms & Templates

New protocol submissions to COUHES after January 21, 2019 are subject to the Revised Common Rule, also known as the New Rule, and must fulfill the requirements outlined under the New Rule. This page has been updated to reflect the New Rule effective January 21, 2019.

Investigators with existing protocols approved prior to January 21, 2019 must follow the policy outlined under the Old Rule section unless otherwise directed by COUHES.

Before conducting research involving human subjects, formal approval must be obtained from COUHES. Approval must also be obtained for any changes to a protocol, and all adverse events affecting the subjects of a protocol must be promptly reported to COUHES. Additionally, COUHES conducts on-going review of all approved protocols.

Unless waived by COUHES, all subjects must be given written informed consent to their participation in human subjects research, and give their permission for the disclosure outside MIT of their protected health information.

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Instructions for Using Forms and Templates

  • Download the appropriate form or template from the list below.
  • Save ("Save As") the document with a project-specific name.
  • Complete all portions of the form or template to provide the required information on the proposed study. (Unless otherwise stated on the form or template, no portions may be left blank.)
  • Submit the form to the COUHES office according to the instructions for each form type described below.
  • When preparing for your submission, be sure to view those parts of the section on Guidelines for Selected Procedures and Populations that apply to your study.

 

Please note: Investigators must submit all new initial study applications, amendments, or continuing reviews (renewals) though COUHES Connect. Paper submissions will not be accepted unless previously discussed with COUHES.

 

COVID-19 / Restart Research Forms

Visit the COVID-19 Updates page for more information

Application to Restart Human Subjects Research [DOCX]

  • Based on your responses to the Restart Research Request in COUHES Connect, the system will indicate if this form is required with your submission in COUHES Connect.

 

Please visit the COVID-19 Updates page for consent forms templates and guidance documents.

Supplemental Forms and Reporting Forms

The documents provided below are to be included with submissions through COUHES Connect.

Translation Attestation Form [DOC]

  • Translated forms are required for studies not conducted in English.

Supplement for Disclosure of Financial Interest [DOC]

  • Use this form for disclosure of financial interest for all key personnel who have a financial interest in the research.

Final Report Closure Form [DOCX]

  • Complete the Final Report Closure From if your study is complete or you do not wish to continue your research. Study completion means that all of the following conditions have been satisfied:
    • your study is closed to enrollment;
    • all subjects have completed all study procedures;
    • data collection is completed; AND
    • data analysis is completed.
  • No further research with human subjects can be conducted after the protocol is closed. Closed protocols cannot be re-opened.

Protocol Event Reporting Form [DOC]

  • Complete the Protocol Event Reporting Form to report any of the following to COUHES: Unanticipated Problem, Subject Complaint, Adverse Event, and Protocol Deviation.
  • Serious or unexpected adverse reactions or injuries must be reported to COUHES within 48 hours. Other adverse events should be reported within 10 days.

Review of Scientific and Scholarly Validity [DOCX] (Lincoln Laboratory Only)

Lincoln Laboratory Only

  • Required for Lincoln Laboratory submissions for Comprehensive Review.

Consent and Authorizations Forms

Consent forms are to be included for review with submissions through COUHES Connect.

Investigators must provide a copy of the approved consent form to prospective subjects. Use the form as part of explanations/discussions of study procedures and potential risks. Obtain signatures, confirming willingness to participate and to disclose protected health information. The consent form and the authorization form should be executed at the same time. Keep signed forms in your project files in accordance with COUHES record keeping policies.

Consent to Participate in Biomedical Research [DOCX]

  • Required for all biomedical human subjects research, unless waived by COUHES.

Consent to Participate in Non-biomedical Research [DOC]

  • Required for all non-biomedical human subjects research, unless waived by COUHES.

DoD Sponsored: Consent to Participate in Biomedical Research [DOC]

Department of Defense Funded or Supported Studies Only

  • Required for all biomedical human subjects research, unless waived by COUHES.
  • Includes required statement for Department of Defense research

DoD Sponsored: Consent to Participate in Non-biomedical Research [DOC]

Department of Defense Funded or Supported Studies Only

  • Required for all non-biomedical human subjects research, unless waived by COUHES.
  • Includes required statement for Department of Defense research

Consent to Participate in Interview [DOC]

  • Required for all interviews, unless waived by COUHES.

Mechanical Turk Consent Text (Amazon - Mechanical Turk Guidelines) [DOCX]

  • Required for all Mechanical Turk research, unless waived by COUHES.

Assent to Participate in Research (for minors) [DOC]

  • Required for all human subjects aged 8 to 17, unless waived by COUHES.

Waiver or Alteration of Informed Consent Request [DOCX]

  • Required when waiving or altering any elements of the informed consent.

Authorization for Release of Protected Health Information [DOC]

  • Required whenever protected health information is to be used or disclosed outside of MIT

Reliance Request Forms

See Single IRB Review page for more information.

Reliance Request Form - Relying [DOCX]

  • Complete the Relying form when MIT will rely or cede IRB jurisdiction/review to an outside institution with Federal Wide Assurance Number (FWA).

Reliance Request Form – Reviewing [DOCX]

  • Complete the Reviewing form when MIT will serve as the IRB of record and review on behalf of an outside institution with Federal Wide Assurance Number (FWA).

Exempt Evaluation: Support Documentation

Personnel List for Exempt Research [XLSX]

  • To assist investigators with managing personnel for exempt research and track training, important information about personnel on exempt research.

Application and Reporting Forms

The forms below are no longer required for submissions through COUHES Connect because the information will be collected within COUHES Connect instead of via the forms below. Investigator should not use these forms unless specified by COUHES. All initial study applications, amendments, or continuing reviews (renewals) must be submitted through COUHES Connect.

Application for Approval to Use Humans as Experimental Subjects (Comprehensive Review Form) [DOCX]

  • Required for all studies involving human subjects that do not meet the criteria for exempt status.

Checklist for Comprehensive Form Application [DOCX]

  • This form helps ensure completeness of the Comprehensive Review requirements.

Personnel List [DOC]

  • Required for all new Applications for Comprehensive Review (included with Comprehensive Review Form).

Continuing Review Questionnaire (CRQ) [DOCX]

  • All studies approved by COUHES require continuing review.
  • Approximately 60 days before approval expires, COUHES will send the Principal Investigator a Continuing Review Questionnaire (CRQ) that must be completed and returned to COUHES before the expiration date of the study.

Progress Report Form [DOCX]

  • For studies not requiring annual renewal, investigators must submit a yearly Progress Report.

Application for Changes to an Approved Protocol [DOC]

  • Required for any change to an approved protocol.

See Instructions for filling out Forms and Templates