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 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 at this site.
Quick Downloads:
To download an electronic form, click on 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 (exempt status form) |
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Download this form |
- May be appropriate for research in a category that is defined in Federal Guidelines as exempt from review, such as research:
- on instructional strategies or techniques
- involving tests, surveys, or observation of public behavior
- involving the collection or study of existing data
- on consumer acceptance of food quality, taste, etc.
- View the definition of exempt status to determine if the proposed research activities qualify for exempt review.
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| Application for Approval to Use Humans as Experimental Subjects (standard form) |
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Download this form |
- Required for all studies involving human subjects that do not qualify for exempt status as explained above.
- Completion of this form also requires completion of the Checklist for Standard Form Application
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| Continuing Review Questionnaire (CRQ) |
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Download this form |
- 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
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| Final Report Closure Form |
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Download this form |
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Use this form if your study is completed or if you do not wish to continue your project. 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.
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| Application for Changes to an Approved Protocol |
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Download this form |
- Required for any change to a protocol that impacts human subjects
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| Adverse Event Reporting Form |
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Download this form |
- Serious or unexpected adverse reactions or injuries must be reported to COUHES within 48 hours. Other adverse events should be reported within 10 days
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| Consent to Participate in Biomedical Research |
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Download this form |
- Required for all biomedical human subjects research, unless waived by COUHES
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| Consent to Participate in Non-biomedical Research |
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Download this form |
- Required for all non-biomedical human subjects research, unless waived by COUHESS
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| Assent to Participate in Research (for minors) |
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Download this form |
- Required for all human subjects aged 8 to 17, unless waived by COUHES
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| Authorization for Release of Protected Health Information |
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Download this form |
- Required whenever protected health information is to be used or disclosed outside of M.I.T.
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| Waiver or Alteration of Informed Consent Request |
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Download this form |
- Required when waiving or altering any elements of the informed consent.
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| Supplement for Disclosure of Financial Interest |
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Download this form |
- Use this form for disclosure of financial interest for all key personnel who have a financial interest in the research.
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Instructions for Forms
- Click on the link above to download the appropriate 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
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 link above to download the appropriate 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.
