One committee to review it all: A single, multi-disciplinary COVID-19 research committee.

On 1/20/2020 when the first case of a novel coronavirus (COVID-19) was confirmed in Washington state, its major impact was unknown. Memorial Sloan Kettering Cancer Center's (MSK) Hospital Incident Command System (HICS) was activated on 2/5, with our first COVID-19 case identified in early March. By 3/17, our Protocol Activation and Human Research Protection Program was fully remote and on 3/23, MSK leadership requested the creation of the COVID-19 Research Committee. Given the race to identify safe and effective treatments for COVID-19, modifications to workflows and review processes were needed. The goal was to provide quick access to COVID-19 treatments to our patients by creating a COVID-19 Committee as a "one-stop" committee, providing comprehensive review of clinical research related to COVID-19 including scientific review mandated by the Cancer Center Support Grant (CCSG) guidelines, prior to IRB review and protocol activation. Protocols that were reviewed by the COVID-19 Committee opened to accrual in an unprecedented 44 days from submission to the committee to open to accrual. Patients were accrued on most of the therapeutic protocols within 1 day of opening. These statistics have prompted our institution to explore how more protocols can benefit from this "one-stop" committee structure.

Restarting Elective Orthopaedic Surgery During the COVID-19 Pandemic: Lessons Learned.

Introduction  Coronavirus disease 2019 (COVID-19) resulted in postponing non-emergency elective surgeries beginning in April 2020. Our hospital successfully restarted elective orthopaedic surgery during the pandemic to help improve the quality of life of patients with chronic disabilities.  This study describes the development of local protocols and pathways to allow for a safe restart of elective orthopaedic surgery in a COVID-19-free 'green' site. It includes the morbidity and mortality outcomes of those patients who underwent non-emergency orthopaedic operations during this time.  Methods  This is a prospective cohort study over an eight-week period evaluating 104 patients undergoing non-emergency orthopaedic procedures through a COVID-19-free surgical pathway. The primary outcome measure was 14-day postoperative mortality. The main secondary outcome measures were the development of a COVID-19 infection in the hospital and 14 days postoperatively as well as the need for intensive care unit admissions.  Results  No patients developed a COVID-19 infection. There were no intensive care unit admissions or postoperative deaths during our study time frame. There was no statistical difference seen for age (< 70 or > 70), gender, body mass index, or American Society of Anesthesiologists (ASA) grades in the development of postoperative complications.  Conclusions  This study describes a roadmap to setting up a protocolised elective operating service for orthopaedic surgery. It has shown that standardised protocols in a COVID-19-free 'green' site, preoperative COVID-19 testing, and adherence to national guidelines on self-isolation can help prevent developing COVID-19 infection postoperatively and reduce the risk of postoperative mortality.

Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic.

The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.