Managing Human Subjects Research During a Global Pandemic at an Academic Center: Lessons Learned From COVID-19.

By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia's research administration leadership, how the University and its primary teaching hospital ramped down-and later ramped up-human subjects research and reflect on lessons learned. As the pandemic unfolded, only studies offering the prospect of direct benefit to subjects were permitted to continue with in-person contact. New in-person participant enrollment ceased, except for COVID-19 prevention or treatment studies. Centralized, frequently updated communication about policies and procedures was disseminated to the Columbia research community. Procedural efficiencies were rapidly developed and implemented for review and oversight of human subjects research and contractual agreements for clinical trials. More frequent institutional review board meetings and 24-hour support markedly reduced turnaround time for COVID-19 studies, without delaying approvals of non-COVID-19 research. Research administration worked closely with relevant principal federal agencies, whose regulatory flexibility facilitated the efficient implementation of COVID-19-related research. Overall, the ramp-down and ramp-up of the majority of human subjects research, with specified priorities and accelerated processes, worked well. Adjustments were made to handle the increase in administrative tasks, the need to respond rapidly to added oversight responsibilities, and the management of the many new COVID-19-related research protocols. Timely, centralized communication, support for staff needs, prioritization, and collaboration were critical to successful research oversight at a large-scale academic setting in the midst of a pandemic. These perspectives may be useful to academic research centers addressing the current and future pandemics.

Researching the Effectiveness of Tree of Life: an Imbeleko Approach to Counseling Refugee Youth.

With the growing worldwide refugee crisis, there is a need for evidence-based interventions that specifically deal with the consequences of cumulative trauma-exposure in refugee youth. Refugee children have unique service needs and differ from their non-refugee peers in terms of sociocultural trauma, language, culture, and educational barriers. This article explains the complexities associated with understanding refugee youth and presents a proposal for studying the possible benefits of Tree of Life therapy. At the present time, Tree of Life therapy has no evidence-base because the published studies of Tree of Life with refugee and/or immigrant youth have sample sizes of one, six, eight, and twenty-nine. As a culturally-grounded, strength-based group counseling approach, Tree of Life therapy addresses traumatic experiences, recognizes participants' cultural differences, highlights individual skills, and aids in instilling both confidence and hope for the future. Ncazelo Ncube, the co-founder and main developer of Tree of Life, describes this therapy as a collective narrative practice that considers cultural beliefs and values (2006, 2010, 2018, 2019). The proposed research design is to study the effectiveness of the Tree of Life in Canada, the United States, the United Kingdom, and South Africa. The research plan is to use pragmatic, group-randomized controlled trials in the "real world" settings of schools and agencies in each of the four countries. In addition, the article describes the development of the Roots and Wings Questionnaire for Children and Youth, a culturally relevant, child-friendly questionnaire. The Tree of Life is a readily available therapy with great potential for helping traumatized refugee youth as well as other trauma-impacted young people worldwide.

Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.

BACKGROUND: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. MATERIALS AND METHODS: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25-30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service. RESULTS: Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days. CONCLUSION: National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.

When IRBs Say No to Participating in Research about Single IRBs.

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.

Cases in Precision Medicine: Should You Participate in a Study Involving Genomic Sequencing of Your Patients?

Internists and other physicians may be asked to participate in research studies that include genomic screening of their patients. Because genomic studies can identify many variants with potential clinical or personal implications, physicians should carefully consider the effect of participation on their patients, as well as the time and effort needed for the physicians to interpret the results and decide how best to use the information. Among the questions they will need to explore is whether testing will be done in a laboratory that is certified under the Clinical Laboratory Improvement Amendments and authorized to generate results for clinical purposes. Physicians should also determine which results will be returned and how these results are likely to affect their patients. Consent must be obtained from patients for return of results, and physicians may want to use the various informational tools that are available to help their patients through the process of deciding which results to receive. Given the complexity of genomic results, including variable penetrance and possible preventive interventions, the research study should support physicians in understanding the results and their implications for patients. Physicians should be prepared to communicate results in a manner that facilitates patients' understanding of the findings and their implications, using a communication process tailored to the needs of the individual patient. Engaging genetic counselors in helping patients understand the implications of genomic findings can be helpful because of their scientific understanding of genetic disorders, experience in dealing with patients, and training in counseling skills.

Cases in Precision Medicine: Concerns About Privacy and Discrimination After Genomic Sequencing.

Patients and research participants have indicated that privacy of their genetic test results is an important concern, particularly with respect to insurance coverage. Internists and other physicians whose patients ask about legal protections for information generated by genome sequencing for clinical purposes can provide both reassurance and caution. Protections for medical information in general, as well as laws in some states that provide additional safeguards for genetic data, should reassure patients that this information will remain private. Patients themselves will need to weigh the risks versus the benefits of generating genomic data in deciding whether to undergo exome sequencing.

Cases in Precision Medicine: When Patients Present With Direct-to-Consumer Genetic Test Results.

A couple is planning to start a family, and they decide to order a 23andMe test after reading about the company's carrier screening test and the new BRCA1/BRCA2 test. They bring the results to their internist for advice on how to proceed. Given the rise in public interest in human genetics and precision medicine, direct-to-consumer genetic testing is becoming increasingly popular, and clinicians should expect patients to present the results of these tests more frequently. This article uses a case scenario to provide information about what the results of these tests mean, and what they do not mean.

How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study.

PURPOSE: Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs. METHOD: One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review. RESULTS: Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs. CONCLUSIONS: As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.

Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.