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
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.