IRB Q & A Guidance for COVID-19 Related Issues - April 7, 2020 Update Including Remote Consent, eConsent, and Reliance Issues

Institutional Review

Board (IRB)

April 7, 2020 IRB Special Communication

IRB Q & A Guidance for COVID-19 Related Issues - April 7, 2020 Update Including Remote Consent, e-Consent, and Reliance Issues

Given the quick and evolving COVID-19 issues, the IRB has developed this Q &A document to assist investigators in considering clinical research questions related to the impact of the COVID-19 pandemic. We encourage research investigators to proactively think about their protocols, subject populations, and the potential impact COVID-19 may have on conducting their research protocols. All human subject regulations need to continue to be followed during the COVID-19 outbreak. In addition, all remote visits and tools used to collect data and share or store data must continue to follow the hospital policies for being compliant with HIPPA regulations.

The following question and answer document will continue to be updated as we are presented with new questions and directives from the institution.

Remote and Electronic Consent

1. Are there options to transition to a remote consent process instead of an in-person consent process during the COVID-19 pandemic?

Yes, since many research subjects cannot be recruited or seen in person there are several options that can be utilized to obtain consent/assent. Please remember that at all times you need to follow the hospital guidelines for which clinical research activities can be conducted.

Option 1: Remote Consent

The consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail with scanned attachment. The consent/assent discussion may then be conducted by telephone/zoom/ or other forms of video conferencing. After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and

return the document to the clinical investigator by facsimile or
scan the consent form and return it through a secure e-mail account or
take a picture of the signed consent document and return it through a secure e-mail account.

For all of these remote consent options:

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.
These methods may also be utilized for obtaining assent.
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.
Include in a note to file that the consent form was provided to the participant, consent was obtained, the method used to obtain consent, that the subject signed a separate copy, date/time and the method used to return the consent document.
You may find more information about this process in our IRB Guidelines and Policies web page.

You do not need to submit an amendment to utilize these options as long as the mentioned conditions can be met.

Option 2: Electronic Consent

If the technology is available, electronic methods of transmitting and obtaining a signature on an informed consent/assent form may be utilized. The hospital currently supports the Redcap e-consent application. REDCap is not 21 CFR Part 11 compliant which means it is not acceptable for FDA regulated studies. If other forms of electronic consent become available and supported through the hospital this information will be provided to the research community. In addition, if you have a specific need to utilize an electronic consent method for FDA-regulated research or want to establish a REDCap eConsent application please contact Kris Bolt in Clinical Research IT (CRIT).

You do not need to submit an amendment to transition to REDCap eConsent. If you are proposing any other method or option please contact the IRB Office as it is likely you will need to amend the protocol and we will need to discuss the specifics of the request.

COVID-19 Related Informed Consent Questions

2. When I submit my protocol will the IRB automatically approve a verbal consent process for COVID-19 patients?

In accordance with the existing regulations the IRB may be able to approve a waiver of informed consent or a method other than written (verbal) for many minimal risk protocols (i.e. the collection of small additional amount of blood at a clinical venipuncture). This is the same regulatory process that has always been utilized. The CHeRP forms include questions based on regulatory criteria to justify waivers and methods other than written consent. Please be sure to complete that specific section of the protocol application that may apply to your research. The criteria are limited to minimal risk research and would not pertain to drug or interventional trials.

3. How should I obtain informed consent for a child who is hospitalized with COVID-19 but the parents/guardians are also sick or quarantined at home?

Please consider the methods for remote consent listed above. If the options for sending the consent to the parent and having the form returned by facsimile, email or through a picture are not possible please contact the IRB office for further discussion. We are awaiting further guidance from regulatory agencies and will provide that when available.

4. Is there a method that can be utilized if infection control policies prevent removing a document signed by the patient/guardian from their hospital room?

The FDA recently released guidance that addressed this issue. It includes the following:

If the technology is available, electronic methods of obtaining informed consent (described above in option 2) should be considered. Please note that the use of any electronic device iPad/tablet would need to comply with all infection control guidelines.
When it is not possible to obtain informed consent electronically, the following steps should be followed:

An unsigned consent form is provided to the patient by a health care worker who has entered the room.
If direct communication with the patient in isolation is not feasible or safe, the investigator (or their designee) obtains the patient’s phone number and arranges a three-way call or video conference with the patient, an impartial witness, and if desired and feasible, additional participants requested by the patient, (e.g. next of kin).
When the call/ conference begins:

Identify who is on the call.
Review the informed consent with the patient/guardian and respond to any questions.
The witness is asked to confirm that the patient’s questions have been answered.
Confirm that the patient/ legal guardian is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone.
Verbally confirm by the patient/legal guardian that they would like to participate in the trial and that they have signed and dated the informed consent document that is in their possession.
If the signed informed consent document cannot be collected from the patient’s location the following two options are acceptable to provide documentation that the patient signed the informed consent document:
A photograph of the informed consent document with attestation by the person entering the photograph into the study record that states how that photograph was obtained and that it is a photograph of the informed consent signed by the patient or;
An attestation by the witness who participated in the call and by the investigator that the patient confirmed that they agreed to participate in the study and signed the informed consent.

A copy of an informed consent document signed by the investigator and witness should be placed in the patient’s research record with a notation by the investigator of how the consent was obtained, e.g. telephone. There should also be a note in the record as to how it was confirmed that the patient signed the consent form (i.e., either using attestation by the witness and investigator or the photograph of the signed consent). The note should include a statement of why the informed consent document signed by the patient was not retained, e.g., due to contamination of the document by infectious material.

Note:

Protocols that propose to use this method should specify this consent process in the IRB application.
Implementation of this process will also need to be reviewed and approved by the Research Oversight/Implementation Committee that has been assigned responsibility to work with investigators to determine how the research can be conducted while taking into consideration all infection control practices and minimizing contacts with patients.

Single IRB Questions

5. I am relying on an external IRB. What are my requirements for reporting changes made to comply with the COVID-19 BCH restrictions on clinical research protocols?

Investigators relying on another IRB should contact the lead site investigator to determine if any changes you are making to comply with BCH requirements must be submitted to the Reviewing IRB prior to implementation. While the BCH IRB does not require submission of many COVID related changes (see below) other reviewing IRBs may have not have adopted the same policies and need to be notified.

6. I am the PI of a study for which other IRBs rely on BCH. Are there special issues I need to consider?

Many institutions have COVID-19 restrictions on clinical research activities and we recognize all sites need to be compliant with their own institutional requirements. As the Lead PI you are responsible for communicating contingency plans (if applicable) to all sites. If there are circumstances at individual sites where the contingency plans are significantly different and impact subject safety or data integrity they will need to be reviewed by the BCH. We do not expect that this will happen frequently.

Questions from the March 13, 2020 COVID-19 Q & A

7. What changes do NOT require prior IRB review and approval?

Federal regulations allow any investigator to initiate, without IRB review and approval, changes on approved protocols to eliminate apparent immediate hazards to human subjects. The PI is responsible for assessing that there is a need for immediate action to protect the safety and wellbeing of the participant. If there is a need, the PI may make the change(s) without first obtaining IRB approval. Note this option is only available for changes that would impact participants already enrolled in the study. These changes need to be reported to the IRB within 5 working days as unanticipated events if they are the types of changes that would typically require IRB review and approval. It is not appropriate to make such changes to enroll a new participant (for example exceptions to inclusion/exclusion criteria).

Minor protocol deviations which do not have the potential to negatively impact participant safety or the integrity of study data (ability to draw conclusions from the study data) or affect subjects’ willingness to participate in the study. An example of a minor protocol deviation could include conducting a research visit outside of the window in an approved protocol. This type of minor deviation you would typically include with your continuing review.

8. What changes will require IRB review?

Changes to the protocol and requests for protocol exceptions that may impact participant safety, or the integrity of the study data require IRB review. This may include dispensing study drugs without performing a key safety lab or procedure, changes in doses of drugs, failure to capture endpoint assessment data or changes in study design. These changes need to be submitted as an amendment. Investigators should begin to think ahead about the potential impact of COVID-19 on the ability to safely follow subjects enrolled in research studies and develop contingency plans. These contingency plans should be submitted to the IRB as soon as possible so that they can be reviewed, approved and available for implementation prior to the time that they are needed.

When the amendment involves more substantive changes to the research plan, particularly when safety or data integrity is part of that amendment, the PI needs to consider whether departmental scientific review and/or guidance from any study-related DSM process should be included in the amendment.

9. Do I have to submit an amendment to change an in-person visit to one conducted virtually or by remote means (Conference Call/Video Conference)?

It depends. If the approved procedures to be conducted at that visit can be done remotely without compromising the safety of the research participant or the scientific validity of the study, this would be considered a minor deviation and would not require prior approval by the IRB and no additional consent is required. However, if there are procedures that cannot be conducted because an in-person visit cannot occur AND those procedures could impact the safety of the participant or the scientific validity of the study, this would require an amendment be submitted to IRB for approval as described above.

10. If I need to modify my protocol to eliminate visits, assessments or change drug administration, do I need to submit for IRB approval?

Investigators are required to submit an amendment or an individual exception for all changes that may impact participant safety or the integrity of the study data. Examples may include modifying drug doses, dispensing study drugs without performing a key safety lab or procedure, eliminating visits or failure to capture endpoint assessment data. If there are circumstances when a crucial in-person treatment or safety visit is impossible for a research participant, the study team’s focus should be on ways to mitigate the potential harm to the subject involved. The IRB should then be notified by the study team submitting an Unanticipated Problem Report Event. PIs should consider whether changes in the protocol are required.

11. What if I need to request a change for only one specific research participant? Do I need to submit an amendment?

The IRB has an Exception Request Form in CHeRP. The form can be found under the category of Reportable Events which can be used for an individual patient if there is a time-sensitive modification. It is not intended for multiple patients. Repeated requests for the same modification cannot be granted. If it appears some changes may benefit or used for multiple subjects, please submit an amendment

12. Is the IRB able to quickly review requested exceptions and amendments?

While the IRB meets twice a month, exceptions for an individual patient can be reviewed quickly by an IRB chair. Most amendments can also be administratively approved by an IRB chair. In addition, the IRB has established a Rapid Response IRB which can meet between meetings, when required. We expect that most changes will not require the Rapid Response IRB. Please begin your description of the amendment summary with the “ COVID-19 amendment.” We will try to prioritize these amendments.

13. Is screening of research subjects for exposure to the novel coronavirus subject to IRB approval?

Boston Children’s Hospital has instituted screening for exposure to the COVID-19 or symptoms of illness. This requirement would apply for research participants as well as children coming to BCH for standard care. Therefore, you do not need to obtain approval from the IRB to perform these screenings. Please follow any BCH guidelines pertaining to COVID-19 that are issued.

14. If I want to temporarily halt a NEW study enrollment what do I do?

If an investigator wants to voluntarily halt or delay participant enrollment because of COVID-19 related public health recommendations, facility requirements, study team availability, and/or participants considered to be at high risk for susceptibility to COVID-19, this does not need to be reported to the IRB unless the study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one). Each study team should carefully consider whether they can appropriately conduct screening and recruitment activities, as well as meet protocol requirements for the conduct of the research. Teams should assess whether they will have a sufficient number of trained staff and supplies, support services, and “treatments” (drugs, devices, agents) to continue recruiting subjects without interruption.

15. If I want to temporarily halt research procedures for subjects already consented, contacted or enrolled, what do I do?

If an investigator wants to voluntarily halt ongoing research because of COVID-19 related public health recommendations, facility requirements, study team availability, and/or participant well-being, an amendment needs to be submitted. Plans for transitioning subjects off the protocol or pausing the research need to be described. Any communications that will be sent to research participants should be submitted for IRB review.

16. Can I change blood draws/specimen collections to occur at remote or commercial labs instead of a visit to the hospital?

These types of changes do not need to be submitted for IRB approval if these are the only study changes. Please be sure to consider/plan for costs that could be associated with changing labs to ensure that subjects are not charged.

17. Can I revise my protocol to ship investigational products directly to research participants instead of providing it at a study visit?

The BCH Investigational Drug Service (IDS) pharmacy is unable to provide shipping services. The research team would be responsible for confirming the shipping requirements with the sponsor and for doing the actual shipping after picking up the prescription from the pharmacy. Sponsors may be able to ship directly to the research participants; however, the sponsor and PI will need to figure out how to instruct study subjects on proper usage of the medication(s) since it won’t be labeled by the pharmacy. In addition, BCH cannot receive returned medications that were shipped directly to participants – the sponsor would need to provide return shipping labels and/or boxes to the subjects. Investigators can contact Stephen Chu or Kathleen Gura in the IDS pharmacy for further information. Note: If this is the only change to the protocol and all other procedures are the same, you do not need to submit an amendment to the IRB.

18. Are there any special considerations for home visits?

The IRB is aware that some protocols are currently approved to conduct home visits. The PI must ensure that the activity can continue to be conducted safely within the home and that the study team implements any mandatory screening procedures before the planned study visit. Any additional requests to conduct a study visit or portion of a study visit as a home visit must be submitted to the IRB as an amendment for review and approval.

19. Do I need to report to the IRB if a subject or member of the research team tests positive for COVID-19?

No. The PI and research teams should follow applicable hospital policies for reporting all new COVID-19 infections. The IRB does not require Unanticipated Event reporting for COVID-19 infections.

Contact/Questions

IRB Website

IRB@childrens.harvard.edu

617-355-7052

Office Location:

Landmark Center 7 East

Mailstop: BCH 3164