COVID-19 IRB Resources & References

This page contains the current IRB information for clinical research during the COVID-19 pandemic.

Investigators should review the most current requirements and submit by October 1, 2020, to ensure compliance. The updated requirements are intended to address conducting research during the COVID-19 pandemic.

 

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Do I need an Amendment for COVID-19 Related Changes?
Guidance for New Protocol Submissions and Considerations for Future Amendments
Privacy Notification for Virtual Visits
Many investigators plan to continue to use zoom to conduct research related virtual visits. It is important to advise research subjects about ways to assure their privacy during these virtual visits. The IRB in coordination with General Counsel and the HIPPA Privacy Officer have developed notification language that be used in either of the following situations;
  • The language maybe incorporated in a new or amended informed consent. Note the template language is already included in the Covid-19 Notification Template OR
  • It can be included in a communication when you send a zoom link.
Informed Consent Template Language

The IRB has developed the following template language which can be adapted and included in consent forms for new studies or for approved studies that may require future consent changes. The language is designed to discuss virtual visits/remote visits and changes to study visits, procedures and assessments due to COVID-19.  Please note, other language may be acceptable.  

 

During this study we may need to make changes to study visits and procedures to comply with public health efforts to address COVID- 19 (coronavirus). We may need to adjust the study visit schedule and/or research procedures as a result of study site restrictions on research visits. We may conduct study visits remotely until the restrictions are lifted. Remote visits will be conducted by (insert video conferencing platform or telephone). During these visits, someone from the study staff will contact you (insert video call platform or telephone) and conduct the following types of research activities:

  • List study procedures/assessments/questionnaires which will be administered remotely.

For Drug Studies, address if the drug will be shipped directly to subject and consider including:

 

During this time study drug shipments will be made directly to you. The courier responsible for delivering study drug to you will require your contact information in order to arrange shipments.

Informed Consent Process Questions 
Methods of conducting the consent discussion

In-person: Process which consent discussion is conducted in-person, face-to-face (e.g. clinic visit).

Remote: Process equivalent to obtaining in-person written informed consent, except that the subject/legal guardian is at a different physical location and the consent  discussion is conducted by phone or video-conferencing. This typically includes the following:

  1. Provide subject/legal guardian with a copy of the consent form to review by mail or email
  2. Conduct consent discussion with subject/legal guardian by phone or video-conferencing (e.g. Zoom)
  3. Instruct subject/legal guardian to sign their copy of consent (in handwritten wet signature) and return by mail, scan, email or photo of signed consent.
  4. The investigator then signs the consent form, documents the consent process in a note to file. In all circumstances the study site must obtain the signed consent form from the participant and the signature from the investigator (or whoever obtained consent) before study procedures begin.
  5. A fully executed consent form should be provided to the participant for their records.
  6. All methods to have verbal discussions and return the consent form must be HIPAA compliant. If you have any questions about whether the method you want to use is HIPAA compliant you may contact Research Computing.
  7. These methods may also be utilized for obtaining assent.
  8. Any pages that require signatures or check boxes must be returned by one of the methods above. When you have received the signed pages the investigator or designee needs to sign the form and merge the returned signed pages (and those with check boxes) with the remainder of the consent so there is a record of the entire consent form that was utilized. This then becomes part of the research record.
What is the difference between a wet and electronic digital signature?

Wet signature: Handwritten signature

Digital signature: Process by which a subject provides an electronic signature by using their finger or stylus to actually sign a form on an ipad, computer or phone (e.g. REDCap application developed by BCH IT).


Please remember:

  • Inserting an image of a signature or typing in a name is not considered an electronic signature.
  • All systems used for electronic signatures must be approved by the hospital.
  • Any electronic signature for FDA regulated studies must be obtained on a system that is E11 compliant.
  • Questions may be referred to Research Computing about the availability of electronic signature systems. They are continuing to evaluate options for the research community.
Helpful Links

Boston Children's has developed an electronic consent platform and more information may be found on their website.

In addition, more information about remote consent resources can be found on the Remote Research Resources page.

 

Use of Interpreters for Non-English Speaking Subjects for Remote Consent
Can I use an interpreter and short form for enrolling non-English speaking subjects remotely?

Yes. There are additional considerations since the BCH interpreter (who also serves as the witness) will likely be separate from the subject and investigator: making it difficult to sign the short and long form.

  • Translated long form: if the IRB approved consent form is already translated, an interpreter can join the call or zoom session and participate the same way they would at the bedside or in clinic.
  • Short form: if the protocol is approved to use the short form, the IRB developed a process and checklist that allows the individual who is obtaining consent to ask permission to sign both the long and short forms on behalf of the interpreter/witness. This process was initially developed for contracts with OPI (over the phone interpretation), or iPad based VRI (video remote interpreting) services; however, it has been expanded for when BCH interpreters participate in research consent discussions remotely. This form may be found at Short Form Checklist for Use with Remote Interpreters
Implications for Single IRB Review during COVID-19
Are you a BCH PI that is serving as a Lead PI?

Investigators who serve as the lead PI for protocols that rely on BCH need to consider these requirements in the context of other sites that rely on the BCH IRB.

  • Any modification made to your protocol should be considered and implemented at other sites in coordination with any local COVID-19 guidance and restrictions.
  • Please contact your Co-PI collaborators at other sites to discuss the COVID- related changes and any additional local context notifications that may need to be sent to participants at other sites.
  • PIs may need to notify subjects that changes are being made to accommodate remote or in person visits, it is possible that other sites may not have the same requirements. For example, sites based in communities with high levels of COVID-19 may have more restrictive requirements about research visits. For this reason, it may be necessary to submit different versions of the COVID notification document to accommodate the requirements of the site.
Are you a BCH PI who is relying on an external IRB?

Investigators who rely on the oversight of external IRBs are required to follow the BCH clinical research reopening guidelines and any additional changes or restrictions in the future. This is in addition to any changes requested by the Single IRB.

Still unsure how to proceed with sIRB?

Given the continued and expected regional differences in COVID-19 rates and local institutional clinical research policies, we recognize that the coordination of IRB requirements will continue to be complex when using a single IRB. Please feel free to reach out to Robleinscky Dominquez or Susan Kornetsky with any questions.