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questions and answers are available

Will the IRB provide “blanket approvals” for modifications to study procedures to allow for remote/virtual participation?

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No, the IRB cannot provide blanket approvals for modifications to approved protocols, as each study is different and the changes in study procedures must be assessed based on a given study. You are welcome to come up with standard language to use in your modifications if you need to submit changes for multiple studies, but a modification will need to be submitted for each active protocol.

Last update: Wednesday, Aug 19, 2020 - 12:30pm

What should I prepare for in a modification to submit to the IRB if I want to move to remote/virtual participation?

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Suggested modifications to study procedures and documents: 

  • Mail or email study materials; 
  • Transition to online questionnaires & surveys; 
  • Move to Telephone/WebEx/Zoom participation; 
  • Change compensation methods for studies that currently involve face-to-face payment; 
  • Add remote consent procedures, if standard written consent is required
  • Request waivers of documentation of consent (e.g., requests to use verbal consent with documentation in a consent log, or use “click consent” via secure survey) 

The IRB strongly advises researchers to use Tufts Technology Services (TTS) pre-approved resources (e.g., Qualtrics and WebEx/Zoom conferencing) in lieu of other apps or software when requesting changes to allow for remote participation. If requesting to use other online platforms or software, researchers should be prepared for delays in review and approval to allow for a Tufts Information Security assessment.

Last update: Wednesday, Aug 19, 2020 - 2:04pm

Does the suspension of face-to-face human subjects research activities apply to international research and/or research at non-Tufts locations?

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Yes. Face-to-face human subjects research activities performed internationally and/or at non-Tufts locations are suspended. This includes work performed on behalf of Tufts by enumerators or contract organizations. 

Any exception requests must:

  • Receive approval from the PI’s respective school-based research dean and/or academic dean, and/or center director.
  • Receive an evaluation from Tufts Global Operations. Please contact Claudia Jackson or Elisabeth Keegan to submit study details and information about local COVID-19 infection rates, any country-wide or local advisories or orders and other relevant factors for assessment.
  • Receive approval from the Integrative Safety Committee (only after the above approvals are secured). To submit a request to the Integrative Safety Committee, complete the form found here. 

Note, as of August 1, 2020, face-to-face human subjects research where there is a lower risk of COVID-19 exposure resumed as part of Phase 2 of research ramp up upon approval from the investigator's respective Research/School Dean or Designate. Please see the research ramp up website for more information.

Last update: Wednesday, Aug 19, 2020 - 2:03pm

Do I have to suspend human subjects research activities if they are not face-to-face?

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Research activities that do not involve face-to-face interactions with human research subjects and can occur remotely may continue. 
 
For studies that do not currently include remote/virtual participation or that need to expand remote/virtual activities, you may submit modifications to include this flexibility where appropriate. 

Last update: Wednesday, Aug 19, 2020 - 2:02pm

What face-to-face human subjects research activities are suspended?

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In keeping with the need to minimize social contact, almost all human subjects research activities involving face-to-face interactions are suspended until further notice. 

The only exceptions are for clinical and human subjects research studies where:

  • the research holds the potential for direct benefit to the subject (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit; 
  • there is collection of safety data (based on clinical judgment of the importance of the visit to detect potential adverse events); 
  • the PI determines that an in-person visit is vital to the subject’s safety and/or well-being, 
    there is an Emergency Use / Compassionate Use / Humanitarian Use Devices (HUDs) of investigational drugs or devices; 
  • and/or the research has direct relevance to the current COVID-19 pandemic and the research cannot be conducted at another time (must be approved first by your research dean and or dean/center director, the Integrative Safety Committee and the relevant regulatory committees).

Note, as of August 1, 2020, face-to-face human subjects research where there is a lower risk of COVID-19 exposure resumed as part of Phase 2 of research ramp up upon approval from the investigator's respective Research/School Dean or Designate. Please see the research ramp up website for more information.

Last update: Wednesday, Aug 19, 2020 - 2:01pm

What if my lab is running low on face masks for research experiments?

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Face shields may be an adequate substitute for a face mask in certain situations. Both provide protection from droplets, depending on the procedure. Please be sure to assess whether a face shield is adequate for a given procedure. Face shields are available as disposable and re-usable. If possible, secure and assign re-usable face shields for each person in the lab.

Last update: Wednesday, Aug 19, 2020 - 12:41pm

Will the university provide research staff with face masks as PHPE to protect against COVID-19?

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Yes, the university will provide all faculty, staff and students with a disposable face mask for PHPE to protect against COVID-19. The university will also provide cleaning/disinfecting materials. Researchers will continue to be responsible for the PPE needed to meet the regulatory and safety requirements for specific experiments. Please see the University Guidance & Procurement of COVID-19 PPE & Supplies for more information.

Last update: Wednesday, Aug 19, 2020 - 12:37pm

Can I substitute face masks with respirators as PPE for research experiments?

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No, face masks cannot be substituted for respirators and N95 masks as they do not provide the required respiratory protection. As a reminder, respirators and N95 masks should only be used as required by the research experiment or personal health needs; they should not be used as PHPE to protect against COVID-19.

Last update: Wednesday, Aug 19, 2020 - 12:32pm

What type of face mask do I need to wear in the laboratory as PHPE to protect against COVID-19?

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The university-supplied face mask for PHPE to protect against COVID-19 can be worn in the laboratory. Please see the Face Masks & PPE Guidance for Laboratory Personnel for more information.

Last update: Wednesday, Aug 19, 2020 - 10:47am

What is the status of campus research? Will I be able to participate in research activities in the fall?  

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Following state and university guidance, research is going through a phased ramp up. Phase 2 of research ramp up (minimal on-campus research operations) began on June 8. On August 1, Phase 2 of research ramp up was expanded to include face-to-face human subjects research where there is a lower risk of COVID-19 exposure upon approval from the investigator's respective Research/School Dean or Designate. Please click here for more information.

Last update: Tuesday, Aug 18, 2020 - 4:16pm

What on-campus research activities are approved for Phase 2 of research ramp up?

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Phase 2 research ramp up is limited to minimal on-campus operations. Please see the below list of approved activities per type of research.

Basic Research: The focus will be on a gradual increase of on-campus research activities, performing experiments in the labs. This phase will help us to better understand the new workflow in wet labs to ensure the health and safety of faculty and staff, while also allowing us to ramp down on-campus research activities as needed if conditions change. Additional guidance is currently being developed for projects involving human samples/tissues.

Human Subjects Research: The focus will continue to be on preparing to resume face-to-face studies in a safe, effective manner once guidance is received from the Federal government. Continued use of remote work is encouraged where possible. As of August 1, 2020, Phase 2 of research ramp up was expanded to include face-to-face human subjects research where there is a lower risk of COVID-19 exposure upon approval from the investigator's respective Research/School Dean or Designate. Please see the research ramp up website for more information.

Humanities, Social Science, and Policy Research & Scholarship: The focus will continue to be on researchers working with their School and Center leadership to understand who needs to be on-campus and what scheduling might look like. Continued use of remote work is encouraged where possible.

Last update: Tuesday, Aug 18, 2020 - 3:58pm

How can I conserve my lab’s PPE inventory for research experiments?

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While disposable PPE should not be reused, labs should evaluate whether activities can be planned so that the number of entries into a lab is reduced, thereby reducing the amount of disposable PPE that is needed. 
 
Additionally, use reusable respirators. Disposable respirators, such as N95 respirator masks, may be in short supply. Before your supply runs out, consider purchasing PAPRs, which are battery-powered, reusable respirators. 
 
Finally, secure your stocks of PPE. Make sure the PPE is in a locked cabinet or room that is accessible only to personnel who need it.

Last update: Tuesday, Aug 18, 2020 - 3:52pm

These FAQs are subject to change. Please check back here for the latest guidance. If you do not  find the information you are looking for, please send an email to COVID19@tufts.edu.