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.
Instructions for Preparing 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.)
- For applications, attach as applicable, a copy of the consent form and the authorization form where directed, as part of the application.
- In preparing application forms be sure to view those parts of the section on Guidelines for Selected Procedures and Populations that apply to your study.
- Print the completed form.
- Sign the form.
- Make a copy for your records.
- Submit the form to the COUHES office.
- The electronic file should be sent as an attachment to an e-mail:
couhes@mit.edu - Hard copies are no longer required until further notice. (August 2020)
- The electronic file should be sent as an attachment to an e-mail:
After approval for your study has been granted:
- Print out copies of the consent form(s).
- Provide copies 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.
COUHES Forms and Templates
COVID-19 / Restart Research Forms Visit the COVID-19 Updates page for more information | |
Application to Restart Human Subjects Research |
|
Consent Form Addendum for Research During COVID-19 Pandemic |
|
Application and Reporting Forms | |
Application for Approval to Use Humans as Experimental Subjects (Comprehensive Review Form) |
|
Checklist for Comprehensive Form Application |
|
Personnel List |
|
Continuing Review Questionnaire (CRQ) |
|
Progress Report Form |
|
Final Report Closure Form |
|
Application for Changes to an Approved Protocol |
|
Protocol Event Reporting Form |
|
Translation Attestation Form |
|
Supplement for Disclosure of Financial Interest |
|
Review of Scientific and Scholarly Validity (Lincoln Laboratory Only) |
Lincoln Laboratory Only
|
Consent and Authorizations Forms | |
Consent to Participate in Biomedical Research |
|
Consent to Participate in Non-biomedical Research |
|
DoD Sponsored: Consent to Participate in Biomedical Research |
Lincoln Laboratory Only
|
DoD Sponsored: Consent to Participate in Non-biomedical Research |
Lincoln Laboratory Only
|
Consent to Participate in Interview |
|
Mechanical Turk Consent Text (Amazon - Mechanical Turk Guidelines) |
|
Assent to Participate in Research (for minors) |
|
Waiver or Alteration of Informed Consent Request |
|
Authorization for Release of Protected Health Information |
|