Walker Morrell, Luke Gelinas, Deborah Zarin, Barbara E Bierer
{"title":"Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study.","authors":"Walker Morrell, Luke Gelinas, Deborah Zarin, Barbara E Bierer","doi":"10.1080/23294515.2022.2160510","DOIUrl":"https://doi.org/10.1080/23294515.2022.2160510","url":null,"abstract":"<p><strong>Background: </strong>Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.</p><p><strong>Methods: </strong>We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and while ongoing. We used a priori and grounded theory to analyze the data and constant comparative method to induce higher order themes.</p><p><strong>Results: </strong>Interviewees perceived determination of scientific value as the responsibility of the investigator and, secondarily, other parties who review or oversee research. Interviewees reported that ongoing trials are rarely reevaluated due to emerging evidence from external sources, evaluation is complex, and there would be value in the development of standards for monitoring and evaluating evidence systematically. Investigators, IRBs, and/or data monitoring committees (DMCs) could undertake these responsibilities. Feasibility assessments are performed but are typically inadequate; potential solutions are unclear.</p><p><strong>Conclusions: </strong>There are three domains where current approaches are suboptimal and in which further guidance is needed. First, <i>who</i> has the responsibility for conducting scientific review, whether it be the investigator, IRB, and/or DMC is often unclear. Second, the standards for scientific review (e.g., appropriate search terms, data sources, and analytic plan) should be defined. Third, guidance is needed on the evaluation of ongoing studies in light of potentially new and evolving evidence, with particular reference to evidence from outside the trial itself.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 2","pages":"99-110"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9553636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"\"They were already inside my head to begin with\": Trust, Translational Misconception, and Intraoperative Brain Research.","authors":"Ally Peabody Smith, Lauren Taiclet, Hamasa Ebadi, Lilyana Levy, Megan Weber, Eugene M Caruso, Nader Pouratian, Ashley Feinsinger","doi":"10.1080/23294515.2022.2123869","DOIUrl":"10.1080/23294515.2022.2123869","url":null,"abstract":"<p><p><b>Background:</b> Patients undergoing invasive neurosurgical procedures offer researchers unique opportunities to study the brain. Deep brain stimulation patients, for example, may participate in research during the surgical implantation of the stimulator device. Although this research raises many ethical concerns, little attention has been paid to basic studies, which offer no therapeutic benefits, and the value of patient-participant perspectives.<b>Methods:</b> Semi-structured interviews were conducted with fourteen individuals across two studies who participated in basic intraoperative research during their deep brain stimulator surgery. Interviews explored interpretations of risks and benefits, enrollment motivations, and experiences of participating in awake brain research. Reflexive thematic analysis was conducted.<b>Results:</b> Seven themes were identified from participant narratives, including robust attitudes of trust, high valuations of basic science research, impacts of the surgical context, and mixed experiences of participation.<b>Conclusion:</b> We argue that these narratives raise the potential for a translational misconception and motivate intraoperative re-consent procedures.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 2","pages":"111-124"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10030379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9501864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Erica K Salter, Jay R Malone, Amanda Berg, Annie B Friedrich, Alexandra Hucker, Hillary King, Armand H Matheny Antommaria
{"title":"Triage Policies at U.S. Hospitals with Pediatric Intensive Care Units.","authors":"Erica K Salter, Jay R Malone, Amanda Berg, Annie B Friedrich, Alexandra Hucker, Hillary King, Armand H Matheny Antommaria","doi":"10.1080/23294515.2022.2160508","DOIUrl":"https://doi.org/10.1080/23294515.2022.2160508","url":null,"abstract":"<p><strong>Objectives: </strong>To characterize the prevalence and content of pediatric triage policies.</p><p><strong>Methods: </strong>We surveyed and solicited policies from U.S. hospitals with pediatric intensive care units. Policies were analyzed using qualitative methods and coded by 2 investigators.</p><p><strong>Results: </strong>Thirty-four of 120 institutions (28%) responded. Twenty-five (74%) were freestanding children's hospitals and 9 (26%) were hospitals within a hospital. Nine (26%) had approved policies, 9 (26%) had draft policies, 5 (14%) were developing policies, and 7 (20%) did not have policies. Nineteen (68%) institutions shared their approved or draft policy. Eight (42%) of those policies included neonates. The polices identified 0 to 5 (median 2) factors to prioritize patients. The most common factors were short- (17, 90%) and long- (14, 74%) term predicted mortality. Pediatric scoring systems included Pediatric Logistic Organ Dysfunction-2 (12, 63%) and Score for Neonatal Acute Physiology and Perinatal Extensions-II (4, 21%). Thirteen (68%) policies described a formal algorithm. The most common tiebreakers were random/lottery (10, 71%) and life cycles (9, 64%). The majority (15, 79%) of policies specified the roles of triage team members and 13 (68%) precluded those participating in patient care from making triage decisions.</p><p><strong>Conclusions: </strong>While many institutions still do not have pediatric triage policies, there appears to be a trend among those with policies to utilize a formal algorithm that focuses on short- and long-term predicted mortality and that incorporates age-appropriate scoring systems. Additional work is needed to expand access to pediatric-specific policies, to validate scoring systems, and to address health disparities.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 2","pages":"84-90"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9553629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2023-02-28DOI: 10.1080/23294515.2023.2180106
Colin Eversmann, Ayush Shah, Christos Lazaridis, Lainie F Ross
{"title":"Coding the Dead: Cardiopulmonary Resuscitation for Organ Preservation.","authors":"Colin Eversmann, Ayush Shah, Christos Lazaridis, Lainie F Ross","doi":"10.1080/23294515.2023.2180106","DOIUrl":"10.1080/23294515.2023.2180106","url":null,"abstract":"<p><strong>Background: </strong>There is lack of consensus in the bioethics literature regarding the use of cardiopulmonary resuscitation (CPR) for organ-preserving purposes. In this study, we assessed the perspectives of clinicians in critical care settings to better inform donor management policy and practice.</p><p><strong>Methods: </strong>An online anonymous survey of members of the Society of Critical Care Medicine that presented various scenarios about CPR for organ preservation.</p><p><strong>Results: </strong>The email was sent to 10,340 members. It was opened by 5,416 (52%) of members and 405 members (4%) completed the survey with few missing data. A majority of respondents (81%) answered that donation status should not influence whether CPR is performed on an imminently dying patient. There was very strong agreement (>85%) that 1) CPR should be performed on a registered donor who experiences a cardiac arrest with an unknown code status before death by neurological criteria (DNC) and 2) CPR should be performed if the patient is not a registered donor and experiences cardiac arrest but the surrogate/power of attorney (POA) has not yet been approached regarding code status and donation. When a registered donor with a DNR order experiences cardiac arrest before DNC, 98% of respondents would not perform CPR. However, <b>after</b> DNC, respondents were evenly divided on whether they would (49%) or would not (51%) perform CPR on a registered donor with an undocumented code status. When asked whether consent should be required for CPR for organ-preserving purposes, 39% answered \"Yes\" when a patient arrests before DNC and 48% answered \"Yes\" when a patient arrests after DNC (P = 0.2).</p><p><strong>Conclusions: </strong>The majority of respondents did not consider donor status relevant to CPR decisions before DNC, and virtually all would respect a DNR order in a registered donor before DNC. Respondents were divided about the need for an affirmative consent for CPR for organ-preserving purposes both before and after DNC.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 3","pages":"167-173"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9900616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2023-06-21DOI: 10.1080/23294515.2023.2224589
Adam J Wesevich, Lauren E Gulbas, Hilary F Ryder
{"title":"Investigating Medical Students' Navigation of Ethical Dilemmas: Understanding the Breakdown and How to Solve It.","authors":"Adam J Wesevich, Lauren E Gulbas, Hilary F Ryder","doi":"10.1080/23294515.2023.2224589","DOIUrl":"10.1080/23294515.2023.2224589","url":null,"abstract":"Abstract Purpose Medical students receive a varying amount of training in medical ethics and are expected to navigate clinical ethical dilemmas innately. There is little literature on attempts to navigate ethical dilemmas experienced during early clinical experiences and whether current curricula prepare students for these dilemmas. This study explores the different ethical dilemmas experienced by medical students on their third-year clerkships and analyzes the factors, sources, and resolutions proposed by them. Methods From 2016 to 2018, third-year medical students completed a written assignment to describe, analyze, and reflect on a clinical situation in which they experienced an ethical dilemma. They identified specific ethical dilemmas present, potential preventative and aftermath solutions, and reflected on their professional development from their experience. The research team utilized applied thematic analysis to identify themes and patterns in the data. A thematic matrix was utilized to examine similarities and differences across medical students. Results Of the 162 reflections, 144 (88.9%) students indicated an ethical dilemma that included issues related to autonomy and beneficence. Of these, 116 (71.6%) students found the two ethical principles in direct conflict. Students identified three common sources of this conflict: lack of communication; unclear understanding of clinical policies regarding family authority and psychiatric capacity; and medical negligence. Lastly, students suggested different solutions for dealing with and preventing this conflict. Conclusion Our findings suggest that an overwhelming number of students face ethical challenges when confronted with medical situations that raise conflicts between autonomy and beneficence. Their recommended solutions reveal an appeal among students to have tools and strategies in place to ease the need to make difficult decisions. Medical students might be better served by learning about the complexities of ethical decision-making and the likelihood of experiencing moral distress when they feel an inability to implement what they envision as the best solution.","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":" ","pages":"227-236"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9672758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2022-12-27DOI: 10.1080/23294515.2022.2160512
Meaghann S Weaver, Christopher Wichman, Shiven Sharma, Jennifer K Walter
{"title":"Demand and Supply: Association between Pediatric Ethics Consultation Volume and Protected Time for Ethics Work.","authors":"Meaghann S Weaver, Christopher Wichman, Shiven Sharma, Jennifer K Walter","doi":"10.1080/23294515.2022.2160512","DOIUrl":"10.1080/23294515.2022.2160512","url":null,"abstract":"<p><strong>Background: </strong>Despite national increase in pediatric ethics consultation volume over the past decade, protected time and resources for healthcare ethics consultancy work has lagged.</p><p><strong>Methods: </strong>Correlation study investigating potential associations between ethics consult volume reported by recent national survey of consultants at children's hospitals and five programmatic domains.</p><p><strong>Results: </strong>104 children's hospitals in 45 states plus Washington DC were included. There was not a statistically significant association between pediatric ethics consult volume and hospital size, rurality of patient population, or number of consultants. Academically-affiliated children's hospitals had fewer ethics consults compared to nonacademically affiliated. Association was found between full-time equivalent (FTE) hours and number of ethics consults (p < 0.0001). Spearman rank correlation between ethics consult volume and FTE was 0.5.</p><p><strong>Conclusions: </strong>While the results of this study should be interpreted with caution, investment in protected time for ethics consultancy work may translate into increased volume of pediatric ethics consults.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 3","pages":"135-142"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9899915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2023-02-22DOI: 10.1080/23294515.2023.2180105
Minna Song, Camille T Kramer, Carolyn B Sufrin, Gabriel B Eber, Leonard S Rubenstein, Chris Beyrer, Brendan Saloner
{"title":"\"It was like you were being literally punished for getting sick\": formerly incarcerated people's perspectives on liberty restrictions during COVID-19.","authors":"Minna Song, Camille T Kramer, Carolyn B Sufrin, Gabriel B Eber, Leonard S Rubenstein, Chris Beyrer, Brendan Saloner","doi":"10.1080/23294515.2023.2180105","DOIUrl":"10.1080/23294515.2023.2180105","url":null,"abstract":"<p><strong>Background: </strong>COVID-19 has greatly impacted the health of incarcerated individuals in the US. The goal of this study was to examine perspectives of recently incarcerated individuals on greater restrictions on liberty to mitigate COVID-19 transmission.</p><p><strong>Methods: </strong>We conducted semi-structured phone interviews from August through October 2021 with 21 people who had been incarcerated in Bureau of Prisons (BOP) facilities during the pandemic. Transcripts were coded and analyzed, using a thematic analysis approach.</p><p><strong>Results: </strong>Many facilities implemented universal \"lockdowns,\" with time out of the cell often limited to one hour per day, with participants reporting not being able to meet all essential needs such as showers and calling loved ones. Several study participants reported that repurposed spaces and tents created for quarantine and isolation provided \"unlivable conditions.\" Participants reported receiving no medical attention while in isolation, and staff using spaces designated for disciplinary purposes (e.g., solitary housing units) for public health isolation purposes. This resulted in the conflation of isolation and discipline, which discouraged symptom reporting. Some participants felt guilty over potentially causing another lockdown by not reporting their symptoms. Programming was frequently stopped or curtailed and communication with the outside was limited. Some participants relayed that staff threatened to punish noncompliance with masking and testing. Liberty restrictions were purportedly rationalized by staff with the idea that incarcerated people should not expect freedoms, while those incarcerated blamed staff for bringing COVID-19 into the facility.</p><p><strong>Conclusions: </strong>Our results highlighted how actions by staff and administrators decreased the legitimacy of the facilities' COVID-19 response and were sometimes counterproductive. Legitimacy is key in building trust and obtaining cooperation with otherwise unpleasant but necessary restrictive measures. To prepare for future outbreaks facilities must consider the impact of liberty-restricting decisions on residents and build legitimacy for these decisions by communicating justifications to the extent possible.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 3","pages":"155-166"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9915970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2022-12-27DOI: 10.1080/23294515.2022.2160513
Jordan Joseph Wadden, Jordan Hermiston, Tom D Blydt-Hansen, Ranjeet Dhaliwal, Shelby Gielen, Alice Virani
{"title":"Exploring the Ethical Considerations of Direct Contact in Pediatric Organ Transplantation: A Qualitative Study.","authors":"Jordan Joseph Wadden, Jordan Hermiston, Tom D Blydt-Hansen, Ranjeet Dhaliwal, Shelby Gielen, Alice Virani","doi":"10.1080/23294515.2022.2160513","DOIUrl":"10.1080/23294515.2022.2160513","url":null,"abstract":"<p><strong>Background: </strong>Nonanonymized direct contact between organ recipients and donor families is a topic of international interest in the adult context. However, there is limited discussion about whether direct contact should be extended to pediatric settings due to clinician and researcher concerns of the potential harms to pediatric patients.</p><p><strong>Methods: </strong>We interviewed pediatric organ recipients, their families, and donorfamilies in British Columbia, Canada, to determine their views on direct contact. Interviews were conducted in two stages, with those who were further removed from the transplant process informing the approach to interviews with those who more recently went throughthe transplant process.</p><p><strong>Results: </strong>Twenty-nine individuals participated in twenty in-depth interviews. The study included participants from three major organ systems: kidney, heart, and liver. Only five participants expressed that direct contact might cause harm or discomfort, while twenty-three indicated they saw significant potential for benefits. Nearly half focused on the harms to others rather than themselves, and nearly two-thirds focused on the benefits for others rather than themselves.</p><p><strong>Conclusion: </strong>There appears to be a community desire for direct contact in pediatric organ transplant programs among those living in British Columbia, Canada. These results suggest a need to revisit the medical community's assumptions around protection and paternalism in our practice as clinicians and researchers.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 3","pages":"143-154"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9899917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2023-07-07DOI: 10.1080/23294515.2023.2224588
Marion Danis, Christine Grady, Mariam Noorulhuda, Ben Krohmal, Henry Silverman, Lee Schwab, Hae Lin Cho, Melissa Goldstein, Paul Wakim
{"title":"Ethical Concerns of Patients and Family Members Arising During Illness or Medical Care.","authors":"Marion Danis, Christine Grady, Mariam Noorulhuda, Ben Krohmal, Henry Silverman, Lee Schwab, Hae Lin Cho, Melissa Goldstein, Paul Wakim","doi":"10.1080/23294515.2023.2224588","DOIUrl":"10.1080/23294515.2023.2224588","url":null,"abstract":"<p><p>Patients and family members (<i>N</i> = 671) were surveyed in five Mid-Atlantic U.S. hospitals to ascertain the number and kinds of ethical concerns they are presently experiencing or have previously experienced while being sick or receiving medical care. Seventy percent of participants had at least one (range 0-14) type of ethical concern or question. The most commonly experienced concerns pertained to being unsure how to plan ahead or complete an advance directive (29.4%), being unsure whether someone in the family was able to make their own decisions (29.2%), deciding about limiting life-sustaining treatments (28.6%), wondering about disclosing personal medical information to others in the family (26.4%) and not being sure whether to undergo treatment because of cost (26.2%). Most were interested to some degree in getting help from ethics consultants in the future (76.6%). Given this prevalence, common concerns might usefully be addressed systematically, rather than exclusively on a case-by-case basis.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":" ","pages":"218-226"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10615705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9758739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AJOB Empirical BioethicsPub Date : 2023-01-01Epub Date: 2023-02-23DOI: 10.1080/23294515.2023.2180107
Stuart G Nicholls, Holly A Taylor, Richard James, Emily E Anderson, Phoebe Friesen, Toby Schonfeld, Elyse I Summers
{"title":"A Cross Sectional Survey of Recruitment Practices, Supports, and Perceived Roles for Unaffiliated and Non-scientist Members of IRBs.","authors":"Stuart G Nicholls, Holly A Taylor, Richard James, Emily E Anderson, Phoebe Friesen, Toby Schonfeld, Elyse I Summers","doi":"10.1080/23294515.2023.2180107","DOIUrl":"10.1080/23294515.2023.2180107","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":38118,"journal":{"name":"AJOB Empirical Bioethics","volume":"14 3","pages":"174-184"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10444906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10429627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}