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.
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.
- COVID-19 / Restart Research Forms
- Supplemental Forms and Reporting Forms
- Consent and Authorizations Forms
- Reliance Request Forms
- Exempt Evaluation: Support Documentation
- Application and Reporting Forms
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.
Visit the COVID-19 Updates page for more information |
|
|
|
Please visit the COVID-19 Updates page for consent forms templates and guidance documents. |
The documents provided below are to be included with submissions through COUHES Connect. |
|
|
|
|
|
Final Report Closure Form [DOCX] |
|
|
|
Review of Scientific and Scholarly Validity [DOCX] (Lincoln Laboratory Only) |
Lincoln Laboratory Only
|
Complete this form when data from NIH-funded research is being submitted to an NIH Designated Repository. |
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. |
|
|
|
Required for all non-biomedical human subjects research, unless waived by COUHES. |
|
DoD Sponsored: Consent to Participate in Biomedical Research [DOCX] |
Department of Defense Funded or Supported Studies Only
|
DoD Sponsored: Consent to Participate in Non-biomedical Research [DOCX] |
Department of Defense Funded or Supported Studies Only
|
|
|
Mechanical Turk Consent Text (Amazon - Mechanical Turk Guidelines) [DOCX] |
|
|
|
|
|
Authorization for Release of Protected Health Information [DOC] |
|
|
See Single IRB Review page for more information. |
|
|
|
|
Application for Department of Defense Sponsored or Supported Exempt Research [ DOCX] March 2022 |
|
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] |
|
|
|
Personnel List [DOC] |
|
|
|
Progress Report Form [DOCX] |
|
|