COVID-19 Updates

Revised: July 30, 2021

Ongoing protocols with approved Restart Requests are NOT required to resubmit if there are no changes to the study location or person-to-person interactions, but all research involving direct person-to-person interactions must comply with the requirements outlined below. This includes using the updated On-Campus Consent Form Addendum for Research During COVID-19 Pandemic.

Restarting Human Subjects Research

For research conducted on-campus

Investigators conducting in-person human subject research on-campus MUST comply with the following:

  1. REVIEW the COVID-19 Updates and Restart Policies.
  2. Submit a Restart Research Request through COUHES Connect if your study is newly approved or if you have not already submitted this request and received approval in the past.  The request can be submitted through the Restart Research Request tab within COUHES Connect following the Restart Research Request - COUHES CONNECT Quickcard Guide provided below. Watch the COUHES Connect Restart Training Video below for more detailed instructions. COUHES Connect will notify you if you are approved or denied.
  3. Require adult participants and their guests complete the On-Campus Consent Form Addendum for Research During COVID-19 Pandemic within 24 hours prior to participation. For minor subjects between 12 and 18 years old, a parent/guardian is required to complete a parental consent addendum for the child and for him/herself within 24 hours prior to arriving at MIT. Consent addendums must be maintained for 3 years upon the completion of the research.
  4. Confirm that no participants 11 and under will participate in on-campus research.
  5. Comply with MIT and DLC specific requirements. This includes but is not limited to MIT Visitor Policy. See MIT Now for more information on the most up to date MIT Policy: https://now.mit.edu/
  6. IF CHANGES ARE REQUIRED to the existing protocol, submit an Application for Changes to an Approved Protocol
  7. Maintain a registry of subjects and their guests for future tracking purposes that records their time and point of entry and exit for contact tracing purposes.

This applies to all human subject research, including exempt research, protocols reviewed by COUHES or research in which MIT relied on an outside IRB for review. Investigators unable to comply with any of the above must submit an Application to Restart Human Subjects Research to COUHES for review. Please submit all restart applications to COUHES@mit.edu.

For research conducted off-campus

Investigators conducting research off-campus, including international locations, MUST submit a Restart Request through COUHES Connect if their protocol involves direct person-to-person research. To restart research, investigators must complete the following:

  1. REVIEW the COVID-19 Updates and Restart Policies.
  2. SUBMIT a request through the Restart Research Request tab within COUHES Connect  following the Restart Research Request - COUHES CONNECT Quickcard Guide provided below. Watch the COUHES Connect Restart Training Video below for more detailed instructions. COUHES Connect will notify you if you are approved or denied.
  3. Require participants complete the Off-Campus Consent Form Addendum for Research During COVID-19 Pandemic within 24 hours prior to participation. Consent addendums must be maintained for 3 years upon the completion of the research.
  4. Confirm that only healthy adults will participate in off-campus research.
  5. Comply with applicable international, national, state and local health authority requirements regarding COVID-19 safety standards.
  6. IF CHANGES ARE REQUIRED, submit an Application for Changes to an Approved Protocol. [link update]

COUHES Connect Guidance

Name Description
Restart Research Request-COUHES CONNECT Quickcard Guide Detailed description of the COUHES Connect submission process, requirements and common troubleshooting.
COUHES Connect Restart Training Video (length: 7:56m) Video demo of the COUHES Connect submission process and a detailed walkthrough of the process.

Forms

Name Description
Application to Restart Human Subjects Research [updated]

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 [DOCX] (On-Campus Only) September 2021

For on-campus only.

Prior to arrival at the study site, all subjects will complete an approved COVID-19 Consent Form Addendum within 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.

Consent Form Addendum for Research During COVID-19 Pandemic [DOCX] (On-Campus - Parental) September 2021 For on-campus only.
Parental Consent Form
Consent Form Addendum for Research During COVID-19 Pandemic [DOCX] (Off-Campus Only) September 2021

For off-campus only.

Prior to arrival at the study site, all subjects will complete an approved COVID-19 Consent Form Addendum within 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.

Additional MIT policies may apply. See the COUHES Additional MIT Policies document.

Memo regarding guidance to restart direct person-to-person human subject research (September 11, 2020)