Forms & Templates | Welcome to COUHES

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 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)

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	Based on your responses to the Restart Research Request in COUHES Connect, the system will indicate if this form is required with your submission.
Consent Form Addendum for Research During COVID-19 Pandemic	Prior to arrival at the study site, all subjects will complete an approved COVID-19 Consent Form Addendum 24 hours prior to arrival. Consent Form Addendum must be incorporated into existing consent procedures. Amendment is not required. Investigators cannot alter or change the consent form addendum process unless approved by COUHES.
*Application and Reporting Forms*
Application for Approval to Use Humans as Experimental Subjects (Comprehensive Review Form)	Required for all studies involving human subjects that do not meet the criteria for exempt status.
Checklist for Comprehensive Form Application	This form helps ensure completeness of the Comprehensive Review requirements.
Personnel List	Required for all new Applications for Comprehensive Review (included with Comprehensive Review Form).
Continuing Review Questionnaire (CRQ)	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	For studies not requiring annual renewal, investigators must submit a yearly Progress Report.
Final Report Closure 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: 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.
Application for Changes to an Approved Protocol	Required for any change to an approved protocol.
Protocol Event Reporting Form	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.
Translation Attestation Form	Translated forms are required for studies not conducted in English.
Supplement for Disclosure of Financial Interest	Use this form for disclosure of financial interest for all key personnel who have a financial interest in the research.
Review of Scientific and Scholarly Validity (Lincoln Laboratory Only)	Lincoln Laboratory Only Required for Lincoln Laboratory submissions for Comprehensive Review.
*Consent and Authorizations Forms*
Consent to Participate in Biomedical Research	Required for all biomedical human subjects research, unless waived by COUHES.
Consent to Participate in Non-biomedical Research	Required for all non-biomedical human subjects research, unless waived by COUHES.
DoD Sponsored: Consent to Participate in Biomedical Research	Lincoln Laboratory 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	Lincoln Laboratory 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	Required for all interviews, unless waived by COUHES.
Mechanical Turk Consent Text (Amazon - Mechanical Turk Guidelines)	Required for all Mechanical Turk research, unless waived by COUHES.
Assent to Participate in Research (for minors)	Required for all human subjects aged 8 to 17, unless waived by COUHES.
Waiver or Alteration of Informed Consent Request	Required when waiving or altering any elements of the informed consent.
Authorization for Release of Protected Health Information	Required whenever protected health information is to be used or disclosed outside of M.I.T.

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