Search

Background: Fertility issues have been found to be an important topic for adolescents and young adults (AYAs) with cancer. Medical technology has made fertility preservation (FP) increasingly effective for postpubertal patients whose treatment course may inhibit their future ability to achieve biologic parenthood. Oncology providers' recommendations have been shown to vary, potentially affecting patients' decision-making processes regarding FP. Objectives: This study was designed to assess oncology nurses' recommendations for patients to consider FP options and to explore what patient-related factors may influence discussion of FP with AYAs with cancer. Methods: 116 oncology nurses participated in this study and were randomized to read one of four vignettes about a patient whose proposed treatment course could affect his or her fertility. Participants' recommendations to partake in FP were analyzed to test for differences by patient age and gender. Open-ended responses to questions about their experiences as oncology nurses were analyzed descriptively. Findings: Nurses strongly recommended that all patients explore FP options before the start of treatment. Oncology nurses endorsed stronger opinions that young adult female patients should be given independent decision-making power to delay treatment for FP, compared to male and female adolescent patients and young adult male patients. Participants mentioned barriers to discussions that included concerns about exacerbating negative emotions and the decision-making capacity of young patients. [ABSTRACT FROM AUTHOR]

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.

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., (© 2020 by The Hastings Center. All rights reserved.)

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.

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.