June 3, 2020 IRB Special Communication: Home Health Care Visits and Reopening of Clinical Research at BCH

Institutional Review

Board (IRB)

June 3, 2020 IRB Special Communication

Home Health Care Visits and

Reopening of Clinical Research at BCH

Home Health Care Visits: Protecting Research Subjects

Over the past months many industry sponsors have arranged for home health care visits for research protocols. We expect that this practice will continue, as many families may not want to visit the hospital. In addition, as clinical operations ramp up, there may be limitations in appointments for labs and the ability to bring patients in for testing and evaluations. There are also very specific institutional phases and criteria for allowing on campus research subject visits. The ability to continue and transition to home visits is welcomed, as long as research subjects are afforded the same COVID-19 precautions that would be taken during a research visit at BCH. In most cases, the industry sponsor is responsible for contracting with the home health care agency. To assure the utmost protection for research subjects, the Clinical Trials Business Office (CTBO) may need to request an amendment to an existing clinical trial agreement that will assure BCH policies with regards to COVID-19 protections are followed during home health visits. This requirement will also be considered for new clinical trial agreements, as necessary. To be sure that all applicable research is covered, we are asking that investigators who have protocols with industry sponsors that include home health visits to send an email to ctbo@childrens.harvard.edu. The CTBO is ready to review the contract and make any adjustments that are necessary.

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.

Availability of Educational COVID-19 Research Flyers

Harvard Catalyst and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard have collaborated and developed a series of flyers that can be included in recruitment and education efforts for COVID-19 research studies. They include pediatric focused flyers. Please feel free to use them if helpful. You do not need separate IRB approval. They contain general information and are not study specific.

They can be downloaded from the MRCT Center website.

As always we welcome all questions and thank you for continued support during this period.

Contact/Questions

IRB Website

IRB@childrens.harvard.edu

617-355-7052

Office Location:

Landmark Center 7 East

Mailstop: BCH 3164