Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)

We present a cross-sectional study of ethical decision-making correlated with spirituality and utilizing moral intensity as a moderator for workers in the Southeastern United States. This study presents spirituality as an individual variable and moral intensity as a situational variable along with ethical decision-making to examine the interaction of these factors in moral dilemmas. Utilizing previously validated instruments for ethical decision-making and individual spirituality, we find that workers with relatively high measured spirituality made less ethical decisions compared to workers with (...) relatively lower measures of spirituality. Further, we find that the introduction of high moral intensity as a situational variable does not moderate the observed correlation between spirituality and ethical decision-making. This research supports the conceptual nature of the Interactionist Theory by presenting in a single study both individual and situational variables in ethical decision-making. (shrink)

Given the primary mandate for institutional review boards (IRBs) to protect potential participants from harm, the egregious history of research abuses, and the fact that there is no mention of incl...

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious (...) wrongdoing by physicians. (shrink)