IRB Reminders Regarding Reopening
Clinical Research at Boston Children’s Hospital
Last week a notice was sent to the research community which outlines the different phases for reopening clinical research at BCH. Please note the following reminders:

1. The IRB and EQuIP office staff continues to work remotely and all activities are functioning as normal. Please continue to reach out to your IRB analysts as required for assistance.

2. The IRB will continue to accept and process all submissions, even if they are not related to coronavirus research. Approval by the IRB is not an endorsement that the clinical research activity may begin. All clinical research activities must follow the Hospital’s policies and phases for reopening clinical research.

3. Investigators conducting research under a reliance agreement with an external IRB must still follow the Hospital’s policies for reopening clinical research activities. In addition, investigators need to be certain that reopening of any research is also in accordance with any restrictions of the reviewing IRB. Any questions about ramping up clinical research on protocols under reliance agreements may be directed to Robleinscky Dominguez at 617-355-5935, or by email.

4. The IRB still needs to consider, on an individual protocol basis, if research subjects randomized to placebo controlled studies may visit BCH for research assessments. We recognize placebo controlled research may be classified as therapeutic interventional trials; however in many cases those randomized to placebo are NOT receiving a therapeutic intervention. The risks associated with BCH visits must be considered. Many investigators have already contacted us to discuss these situations and in some cases exceptions have been granted. We expect there will be more situations in the future. An example of an exception might be when a subject requires a final study visit for assessments that cannot be performed at home in order to roll over into an open label trial. Please continue to reach out to your IRB analyst so that these individual situations may be considered.

5. Even with the opening of the hospital for clinical research, remote consent practices should always be used when possible. This practice reduces the amount of time occupying rooms and interpersonal interactions. Reach out to eligible patients to discuss the research before they show up on site.

6. Information about acceptable methods of remote and electronic consent and common questions and answers about COVID-19 associated issues may be found on the IRB COVID Q&A posted on the BCH IRB website.