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.
Investigators with existing protocols approved prior to the effective date must follow the policy outlined under the Old Rule section unless otherwise directed by COUHES.
Quick Navigation
New Rule: This page has been updated to reflect the New Rule effective January 21, 2019.
Old Rule: For existing protocols approved prior to January 21, 2019, follow the policies outlined on the Old Rule section.
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.
Forms for applying or reporting to COUHES, and instructions for their completion, are available below.
To download an electronic form, select the appropriate item below:
Click on the link below to view instructions on how to complete these forms and templates:
Selecting the Correct Form
| Application for Approval to Use Humans as Experimental Subjects (Comprehensive Review Form) | |
| Download this form | |
|
|
| Continuing Review Questionnaire (CRQ) | |
| Download this form | |
|
|
| Progress Report | |
| Download this form | |
|
|
| Final Report Closure Form | |
| Download this form | |
|
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:
No further research with human subjects can be conducted after the protocol is closed. |
|
| Application for Changes to an Approved Protocol | |
| Download this form | |
|
|
| Adverse Event Reporting Form | |
| Download this form | |
|
|
| Consent to Participate in Biomedical Research | |
| Download this form | |
|
|
| Consent to Participate in Non-biomedical Research | |
| Download this form | |
|
|
| Assent to Participate in Research (for minors) | |
| Download this form | |
|
|
| Authorization for Release of Protected Health Information | |
| Download this form | |
|
|
| Consent to Participate in Interview | |
| Download this form | |
|
|
| Waiver or Alteration of Informed Consent Request | |
| Download this form | |
|
|
| Supplement for Disclosure of Financial Interest | |
| Download this form | |
|
|
Instructions for Forms
- Click on the appropriate download link above to download the selected form.
- Download the form to your computer.
- Give the document a name and save it to your hard drive.
- Type in information as specified in the form template.
- Complete all portions of the form to provide the required information on the proposed study. (No portions of the application may be left blank.)
- 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 out 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 - In addition, two hard copies (one with original signatures) should be sent to the COUHES office:
Building E25-Room 143B
- The electronic file should be sent as an attachment to an e-mail:
Instructions for Templates
On-line templates MUST be used to prepare informed consent and authorization forms.
To access and use a template:
- Click on the appropriate download link above to download the selected template.
- Download the template to your computer.
- Give the document a name, and save it to your hard drive.
- Type in information, as specified in the template.
- Complete all portions of the form to provide required information on the study in all topic areas. (Unless otherwise stated on the template, no portions of this form may be omitted or left blank.)
- Keep standard language, where appropriate.
- In your application to COUHES attach, as applicable, a copy of the consent form and the authorization form where directed, as part of the computer-based and/or paper-based application.
- After approval for your study has been granted:
- Print out copies of the consent form.
- 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.
