This webpage provides important information regarding human-subjects research during COVID-19 disruptions. We will continue to update this page as new information becomes available.
Until further communication from MIT, all human-subjects research requiring in-person interactions with subjects should cease unless it is relates to COVID-19 AND special permission is given by the Vice President for Research to conduct the research. However, human-subjects research may continue if it is limited to remote activities, such as online surveys, virtual interviews, and analysis of data already collected.
Q1. Is COUHES operating as usual?
Yes. While the on-campus location is closed, the COUHES office remains fully operational. Staff are working remotely for the foreseeable future. All new submissions should be sent to the COUHES general email: COUHES@mit.edu.
Monthly committee meetings will be held remotely as well.
Q2. How do I contact COUHES for questions about my research?
Email COUHES@mit.edu with questions or concerns. If you wish to discuss by phone, please share your contact information, and a member of the COUHES staff will follow up. You may also leave a voicemail at 617-253-6787.
Q3. Do I still need to submit hard copies?
No. Hard copies for new submissions are not required until further notice. New submissions must be sent to COUHES@mit.edu.
Q4. Can PI or department-head signatures on COUHES applications be obtained electronically?
Q5 Do I need to halt off-campus research and/or international in-person research?
Yes. All in-person research approved by COUHES should cease wherever it is conducted. Research not involving direct contact with subjects, such as online activities, may continue.
Q6. Do I need to halt off-campus, in-person research conducted by a third party on behalf of MIT?
Yes. All MIT-supported research should halt. If possible, change research into an online or virtual format.
Q7. Halting my research might introduce greater harm to subjects currently enrolled in the study. What should I do?
Please consult the principal IRB overseeing the research (this may involve your collaborator’s IRB, and not COUHES). All future enrollment should halt.
Q8. Can I request priority review for new COVID-19 research?
Yes. Make sure to include a comment in your submission explaining that this is an urgent COVID-19 study. If this research involves in-person interactions with human subjects, please explain why and how this research cannot be conducted remotely.
Q9. Do I need COUHES approval if I decide to add/modify my study procedures in order to conduct research remotely?
Yes. If you decide to modify study procedures in order to protect subjects and/or study staff (e.g., to replace in-person visits with remote options for surveys, group discussions, consenting, etc.), please submit a change form to COUHES if your research is not exempt.
If your research is exempt via Exempt Evaluation through COUHES Connect, please double-check your answer choices in your exempt evaluation. No action is needed if your answer choices remain the same. Otherwise submit a new Exempt Evaluation. If your research was exempt prior to Jan. 21, 2019, submit an Exempt Evaluation via COUHES Connect.
Q10. What if I need to modify my research procedures immediately in order to protect subjects and/or researchers?
If it is in the best interest of researchers and subjects to eliminate immediate apparent hazards (e.g., to cancel an enrolled subject’s in-person follow-up visits to campus due to COVID-19 concerns), you may implement changes without prior COUHES approval, but must report such actions by submitting a Protocol Event Reporting Form within 10 days. Please be reminded that serious or unexpected adverse reactions or injuries must be reported to COUHES within 48 hours.
Q11. Does COUHES have any guidance on electronic consent?
Yes. Please see COUHES guidance here: http://couhes.mit.edu/guidelines/electronic-consent. If needed, a waiver or alteration of informed consent request form can be submitted to COUHES.
Q12. Does COUHES have any recommendation on conducting research online?
The following are some options for you to consider:
- Recruiting subjects via phone call, email or Amazon MTurk.
- Internet-based consent or oral consent, depending on the subject population and risk of study.
- Conducting surveys via MIT Qualtrics.
- Conducting interviews via Skype, Zoom, or over the telephone. (If recording, make sure to include this activity in the informed consent.)
Q13. If I need to analyze data on my personal computer from home in order to keep working on my project, how do I address data-security requirements?
If your remote research operation maintains compliance with your approved protocol data security controls (e.g., all electronic data is password-protected and encrypted, all paper data is locked, etc.) and is in compliance with your data-use agreement (if applicable), no further action is required except if you plan to analyze high-risk data on your personal computer.
If feasible, we ask that you only analyze coded or de-identified data without any personal identifiers on your personal computer. Any personally identifiable information, such as the key linking codes to personal identifiers, should be stored on password-protected and encrypted MIT computers, servers, or other secure storage options such as MIT Dropbox.
Data from your home computer should be transferred to secure MIT computers and deleted from your home computer as soon as possible.
High-risk data - If you plan to analyze high-risk data (e.g., national security, illegal activity, identifiable health records, HIPAA data, identifiable genetic data, identifiable student records, identifiable financial records, identifiable employment records, identifiable sexual preference, SSN, etc.) on your personal computer, please submit a change form to COUHES. You are highly encouraged to contact IS&T to ensure your remote operation continues to protect high-risk data. PIs will be required to certify that IS&T’s guideline for Securing High Risk Information will be implemented before analyzing data on personal computers.
Q14. What if I cannot conduct sponsored project(s) remotely?
Check the Research Administration Services information regarding the impact of COVID-19 on sponsored programs: https://ras.mit.edu/about-ras/news/covid-19-information.
For specific questions, please contact the appropriate contract administrator responsible for your department, lab, or center: https://ras.mit.edu/about-ras/staff/by-department.
Q15. What if my research is a class project or thesis with deadlines and I cannot conduct my research remotely?
Please contact your faculty sponsor regarding such concerns.
For more information on MIT’s response, please visit: http://web.mit.edu/covid19/