Office For Human Research Protections Research Articles

Participation With Compensation: Ethical Considerations for Research Payment Practices With People Who Are Incarcerated.

The participation of incarcerated individuals in research is necessary to appropriately address the health disparities that affect them and to adapt and implement health services for the carceral setting. Incarceration significantly impacts health, leading to negative outcomes including accelerated aging and increased mortality, with these effects disproportionately impacting communities of color. The U.S. Department of Health and Human Services' Office for Human Research Protections outlines ethical approaches to compensating individuals who participate in research activities, yet lacks specific guidance for payment within carceral settings. Historical abuses in carceral research underscore the persistent need for robust protections for incarcerated research participants. Existing regulations offer some protection but inadequately address ethical payment practices. Substantial variability in payment policies across carceral systems and vague national guidelines pose ethical challenges in ensuring equitable treatment for incarcerated research participants. We outline the ethical concerns related to compensating incarcerated individuals for participating in research and present a framework of approaches to payment. We argue for payment parity between incarcerated and community research participants. More community-engaged research is needed to understand the perspectives of incarcerated individuals on ethical payment.

Unlocking What Makes Military Behavioral Health Interventions Work, Stumble, or Fade Away.

The Office of the Secretary of Defense and each of the services have made an unprecedented commitment to the prevention of sexual assault and related behavioral health phenomena. Indeed, the Department of Air Force has selected, in some cases tailored, and disseminated a wide array of evidence-based preventative programs, policies, and practices (EBPs) over the last few decades. However, many of these efforts seem to follow a predictable life course. EBPs are initially implemented with great enthusiasm, supported for a few years, then fall out of favor, and are replaced by a different effort. This research effort aims to build on the existing civilian implementation science research to (1) offer a military-specific model of sustained, high-quality implementation and (2) test this model in a series of interconnected studies. New York University's Institutional Review Board approved the study protocols, and the Army's Human Research Protection Office provided permission to collect data. We conducted interviews first with prevention leaders in the services and at the Office of the Secretary of Defense level regarding factors that they thought helped or hurt the sustainment of EBPs. We used these interviews to identify EBPs currently implemented in Department of Air Force and selected four EBPs out of the 25 identified for intensive study. We then interviewed implementers of those four EBPs regarding what they thought helped or hurt the sustainment of that EBP. We also gathered information about the 25 currently implemented EBPs themselves and gathered policy and guidance, as well as leadership communication about those EBPs and the target problems they focus on. We coded this information to allow us to test EBP parameters and policy and leader communication that predict sustained high-quality implementation. We conducted over 100 observations of the 4 EBPs we are studying intensively and have collected quantitative data from implementers and participants to help us test factors related to sustained high-quality implementation within each of those 4 EBPs and across the EBPs. Several military-specific factors were nominated for inclusion in the military-specific model of implementation sustainment. The implementation of even highly standardized EBPs varies greatly. Implementers and participants are generally highly engaged, but implementers vary in the extent to which they understand the mechanisms of action for the EBP they are implementing. We recommend training implementers in the mechanisms of action in the EBPs they are expected to implement and including quality assurance as a component of prevention efforts in a manner more similar to how the military addresses aspects of the operational mission. By moving beyond counting classes and attendance, and specifying how to engage participants in the EBPs in the manner that produces the key outcomes, it is likely that EBPs will have more robust implementations that can be better sustained over time.

Propofol enhancement of slow wave sleep to target the nexus of geriatric depression and cognitive dysfunction: protocol for a phase I open label trial

IntroductionLate-life treatment-resistant depression (LL-TRD) is common and increases risk for accelerated ageing and cognitive decline. Impaired sleep is common in LL-TRD and is a risk factor for cognitive decline. Slow...

Protecting Confidentiality in the Digital Ecosystem of Humanitarian Aid

Protecting Confidentiality in the Digital Ecosystem of Humanitarian Aid

Engaging African American Faith Leaders as Partners in Ethical Research

This paper outlines an initiative to adapt the Community Partnered Research Ethics Training (CPRET) for the cultural context of the CHURCH (Congregation as Healers Uniting to Restore Community Health) project. The CHURCH project is a community-partnered participatory research project that seeks to promote the mental well-being of African American populations by developing, implementing, and evaluating a mental health training curriculum for faith leaders in Black churches. Participatory research, in which community stakeholders collaborate with researchers as equal partners to address problems impacting marginalized communities, has recently become more popular in academia. Training is necessary to equip community partners with the skills and knowledge required for full research participation. Community partners frequently encounter ethical issues in participatory research, but limited training resources are available to proactively prevent and address such issues. The CPRET was developed through a collaboration between the Clinical and Translational Science Institute and the Human Research Protection Office and Community Research Advisory Board at the University of Pittsburgh. It surveys research processes and core research ethics principles, and it stimulates discussion regarding best practices by engaging participants in scenario-based exercises in which they identify ethical and unethical research. By describing how we utilized the CPRET in the CHURCH project and presenting a summary of participant feedback, we aim to build resources for community-engaged scholars seeking to engage community members in ethical research.

Prejudice in US Academia drives unethical behaviour with global consequences

In 2015, a 2012 paper concerning human research conducted in China in 2008 was retracted1 . This article briefly recounts events over a four-year period and challenges the justification for retraction based on the Commitee on Publication Ethics principles. Retraction represents the most severe criticism of a scientific article. This research focuses on analysing contemporary (2012–2015) documentary evidence, organised by key narrative participants: Greenpeace, the Chinese Government, Tutis University, the American Society for Nutrition, the US National Institutes of Health2 and the US Office for Human Research Protections. The analysis indicates that technological bias within a university and a learned society, which is also a publisher, led to unethical behaviour and the subsequent retraction. In the USA, oversight of an Institutional Review Board falls under the Office for Human Research Protections. Despite being the principal funder, the NIH's reliance on this office for the retracted paper's research to be publicly available, suggests ineffective oversight. The retracted paper detailed a crucial nutritional study relevant to combating vitamin A deficiency, a significant cause of child mortality and blindness in Low- and Middle-Income countries. The retraction likely heightened suspicion around this vital public health intervention.

A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study.

Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive biorepositories are typically required. We propose that remnant biospecimens are an alternative for mechanistic sepsis research, although the viability and scientific value of such remnants are unknown. The Remnant Biospecimen Investigation in Sepsis study is a prospective cohort study of 225 adults (age ≥ 18 yr) presenting to the emergency department with community sepsis, defined as sepsis-3 criteria within 6 hours of arrival. The primary objective was to determine the scientific value of a remnant biospecimen repository in sepsis linked to clinical phenotyping in the electronic health record. We will study candidate multiomic readouts of sepsis biology, governed by a conceptual model, and determine the precision, accuracy, integrity, and comparability of proteins, small molecules, lipids, and pathogen sequencing in remnant biospecimens compared with paired biospecimens obtained according to research protocols. Paired biospecimens will include plasma from sodium-heparin, EDTA, sodium fluoride, and citrate tubes. The study has received approval from the University of Pittsburgh Human Research Protection Office (Study 21120013). Recruitment began on October 25, 2022, with planned release of primary results anticipated in 2024. Results will be made available to the public, the funders, critical care societies, laboratory medicine scientists, and other researchers.

Normative Values forPupillary Light Reflex Metrics Among Healthy Service Academy Cadets.

Assessments of the pupil's response to light have long been an integral part of neurologic examinations. More recently, the pupillary light reflex (PLR) has shown promise as a potential biomarker for the diagnosis of mild traumatic brain injury. However, to date, few large-scale normative data are available for comparison and reference, particularly, in military service members. The purpose of this study was to report normative values for eight PLR measurements among healthy service academy cadets based on sex, age, sleep, race, ethnicity, anisocoria, and concussion history. Freshmen entering a U.S. Service Academy completed a quantitative pupillometric assessment in conjunction with baseline concussion testing. PLR measurements were conducted using a Neuroptics PLR-3000 with a 121µW light stimulus. The device measured maximum and minimum pupil diameter (mm), latency (time to maximum pupil constriction post-light stimulus [s]), peak and average constriction velocity (mm/s), average dilation velocity (mm/s), percentage pupil constriction, and T75 (time for pupil re-dilation from minimum pupil diameter to 75% maximum diameter [s]). During baseline testing, cadets also reported concussion history (yes and no) and hours slept the night before (<5.5 and ≥5.5). Normative values for each PLR measurement were calculated as mean ± SD, percentiles, and interquartile range. Mann-Whitney U tests were used to assess differences based on sex, concussion history, ethnicity, and hours slept for each PLR measurement. Kruskall-Wallis testing was used to assess differences based on age, race, and anisocoria. Alpha was set at .05 and nonparametric effect sizes (r) were calculated for statistically significant results. Effect sizes were interpreted as no effect (r < .1), small (r ≥.1-<.3), medium (r ≥.3-<.5), or large (r ≥ .5). All procedures were reviewed and approved by the local institutional review board and the U.S. Army Human Research Protection Office before the study was conducted. Each subject provided informed consent to participate in the study before data collection. Of the 1,197 participants baselined, 514 cadets (131 female; 18.91 ± 0.96years) consented and completed a valid baseline pupillometric assessment. Eighty participants reported at least one previous concussion and participants reported an average of 5.88 ± 1.63 h slept the previous night. Mann-Whitney U results suggest females had larger initial (z = -3.240; P = .001; r = .10) and end pupil diameter (z = -3.080; P = .002; r = .10), slower average dilation velocity (z = 3.254; P = .001; r = .11) and faster T75 values (z = -3.342; P = .001; r = .11). Age, sleep, and race stratified by sex, also displayed a significant impact on specific PLR metrics with effect sizes ranging from small to medium, while ethnicity, anisocoria, and concussion history did not display an impact on PLR metrics. This study provides the largest population-specific normative values for eight PLR measurements. Initial and end pupil diameter, dilation velocity, and the T75 metrics differed by sex; however, these differences may not be clinically significant as small effect size was detected for all metrics. Sex, age, sleep, and race may impact specific PLR metrics and are worth consideration when performing PLR assessments for mild traumatic brain injury management.

Assessing Common Content and Responsiveness of the QoR-15 and the SF-8 in the Context of Recovery from Regional Anesthesia for Joint Replacement.

There is no consensus regarding how best to measure postoperative quality of recovery after anesthesia/surgery (e.g., using 24-hour survey instruments) in veterans or active military. Our goals were to (1) describe health-related quality-of-life (HRQoL) and recovery across time in veterans, (2) examine the commonality between the quality of recovery (QoR-15) and short-form (SF) surveys (including the SF-8, 24-hour version), and (3) examine the responsiveness of these surveys. This study was approved by the Institutional Review Boards from the University of Pittsburgh, the VA Pittsburgh, and the Human Research Protection Office of the Department of Defense. Secondary analyses of data were executed based on a randomized trial dataset of knee/hip arthroplasty patients, the study having recruited 135 total veterans. QoR-15 and HRQoL SF surveys were completed and self-reported before surgery (pre-op), on postoperative day 2 (PO-D2), and 6 weeks postoperatively. Descriptive statistics were used to examine scores across time. Common content was examined using Pearson's r. Responsiveness was examined using distribution-based methods. Average veteran age was 67 year, 89% were male, 88% white, and average body mass index was 33 kg∙m-2. QoR-15 scores declined from pre-op to PO-D2 but were higher than pre-op at 6 weeks. SF physical component summary (PCS) scores were low both pre-op and PO-D2, but were elevated over baseline at 6 weeks. SF mental component summary (MCS) scores declined from baseline to PO-D2 but were higher than pre-op at 6 weeks. Associations of the QoR-15 total score and PCS/MCS were medium/large and statistically significant at P ≤ .01. Both instruments were responsive to changes. QoR-15 and SF-8 have high content commonality and performed similarly in veterans across time. SF-8 has added benefits of (1) brevity, (2) assessment of physical and mental health components, and (3) being normed to the general population. The SF-8, if used without the QoR-15 in tandem in future study of anesthesia-related outcomes, would need to be supplemented by separate questions addressing postoperative nausea/vomiting (a frequent outcome after anesthesia that is relevant to same-day and next-day mobilization after elective joint replacement surgery).

117 The Research Coordinator Support Services (RCSS) and Coordinator Apprentice Program (CAP) at Johns Hopkins University (JHU)

OBJECTIVES/GOALS: METHODS/STUDY POPULATION: The duration of the apprenticeship program is 2 years, with promotability to: -Research Program Coordinators -Senior Coordinators. CRCs learn essential clinical research foundations through courses and instructor led training, mentoring, and shadowing of other CRCs, such as: -Good Clinical Practices (GCP) -International Committee on Harmonization guidelines (ICH) -Institutional Review Board (IRB) -Office for Human Research Protections (OHRP) -Shipping Dangerous Goods (DOT/IATA) -REDCap data entry -Clinical Research Management System (CRMS) -Clinical Skills (i.e., vital signs, ECG, and phlebotomy) -CPR (etc.) -EPIC training RESULTS/ANTICIPATED RESULTS: -Over 100 CRCs have been trained since 2012 -Currently more than 40 active studies assigned between 16 CRCs -Over 10,000 hours of clinical trial activity in the past 15 months -The program is moving towards cost neutrality CRCs have gained access to begin DISCUSSION/SIGNIFICANCE:

Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research.

Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research. Conducted at a single institution, this was a prospective cross-sectional study that evaluated blood draws from 122 patients. The median daily remnant blood volume was 11.6 (interquartile range [IQR]: 12.3, 15.2) ml for all patients and 12.9 (IQR: 13.1, 16.9) ml for patients admitted to the intensive care unit. Our findings regarding daily remnant blood volume suggest that the currently allowable blood-volume limits to qualify for expedited review or to qualify as not more than minimal risk research involving blood draws from nonhealthy adults are less than what patients experience in routine medical testing. These findings support permitting an increase in the allowable blood-volume limits to meet the regulatory definition of minimal risk research for obtaining expedited IRB review of studies in which blood samples will be collected.

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

Objective To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. Method This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. Results Some US academic health “centers” IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects’ research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection’s (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. Conclusions REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation

IntroductionAmong critically ill patients undergoing orotracheal intubation in the emergency department (ED) or intensive care unit (ICU), failure to visualise the vocal cords and intubate the trachea on the first...

INSTITUTIONAL RESEARCH REVIEW &amp; ETHICS BOARD APPROVAL: A NECESSITY FOR PUBLICATION AND INSTITUTIONAL PERCEPTION

Institutional Review Boards (IRBs) or research ethics board of an institute is meant to provide safety and protection to all the concerns being raised in human and animal research.1 These boards are meant to cover wide range of ethical concerns which includes respect­ing autonomy, consent, confidentiality, beneficence, non-maleficence, justice and other such concepts ini­tially raised in the verdict of Nuremberg (United States) and then covered in declaration of Helsinki and Coun­cil of International Organizations of Medical Scientists (CIOMS).2-5 Since then, such research committees are continuously being evolved from national to institution­al levels with certain Terms of References (ToRs) to reg­ulate the ethical aspects in research conduction. One must understand here, the responsibility of the institutions, colleges, and universities to curb the men­ace of unethical research and promote research integ­rity. It is the institutions which provide clean chit to the authors/investigators for conducting ethical research, while its practise during the research and maintaining integrity is something that remains unaddressed. Im­portantly, concerns about knowledge regarding ethics in research among the members of such boards, the number of functional ethics/review boards in an insti­tute, and number of meetings conducted &amp; recorded by the board annually is something which always raises doubts. It is presumed that a common practise is be­ing adopted by many boards, wherein the Chairperson or Secretary of such board issues approvals without scheduling any meeting or analysing the proposals. Approval of such unethical research might have le­thal outcomes for the research participants as has happened in the past, wherein conduction of studies without following ethical concerns had fatal outcomes.3 Accountability, and regularisation of ethical boards is a dire need in order to uplift research from an ethi­cal perspective. In the United States of America, Office for Human Research Protections (OHRP) is one such department to overview the ethical conduction of re­search for a better outcome.6 In a study conducted on 313 protocols submitted to OHRP, only 47.1% of proto­cols were reviewed by full boards.6 In Pakistan, National Bioethics Committee (NBC) is the designated authority to look after ethical research, but institutions must also prioritise their role towards ethical research and ensuring research integrity. Proper training of members by different recognised certificate courses can be one solution. Courses like Certificate of Medical Editing or Journalism or biomedical ethics can play a pivotal role in teaching basic concepts of ethical research. In addition, proper ToRs, scheduling of meetings, records of approvals along with follow up monitoring and a functional regulating body are some other things which would help and promote ethics in research. The role of investigators, writers, and authors is another important pillar in the whole process of main­taining the ethics for research in humans. Mostly, the investigators are unaware of the Ethics/Review Board approval part of the study.7,8 Here, the knowledge of ethics among investigators is yet to be assessed, as it is believed that many are not fully aware of issues re­lated to research integrity in this region.8 The investiga­tors’ only concern is getting an ethical board approval for publication, which is a step made mandatory by the journals. The board on the other hand, merely check the words “ethical considerations will be met” written in the methodology and grants the approval. This situation obviously calls for remedial steps, wherein it is the re­sponsibility of Medical Colleges, Institutions, &amp; Univer­sities to incorporate these basic principles of research ethics in the curriculum of the undergraduate and post­graduates. Regular workshops, Continuing Medical Ed­ucation (CME), and refresher courses addressing these concerns are the need of the day for the investigators. This is one means through which investigators can be guided and equipped with important principles of ethi­cal research and research integrity. Lastly, on part of journals, majority of whom, just ask for the Ethics/Review Board approval certificate as a pre-requisite.7 The concerns regarding the knowledge of ethical research among editors and its representa­tion on the website of many journals is yet to be explored properly. It is pertinent to add and appreciate that in the past, it was due to persistent pressure by different journals and the input by Pakistan Association of Medical Editors, in this context that made institutions formulate Ethical/Review Boards.9 Policies published by Higher Education Commission (HEC) are also a source of guidance towards better research outcomes.10 Moreover, con­tinuous training and refresher courses for the editorial board can also be a means to spread knowledge regarding ethical re­search and uplift research integrity. Nonetheless, research without ethics is not only meaningless but also more impor­tantly, an unprincipled thing to attempt. The role of institutional bodies, investigators and journals along with their editorial board is irrefutable in promoting ethics in research, and should be appreciated at all levels.

Q-TWiST in Venetoclax-Based Regimens in Elderly Patients with AML: A Quality-Adjusted Analysis

Introduction: Non-intensive venetoclax-based regimens are the current standard of treatment for acute myeloid leukemia (AML) in the elderly. Phase 3 VIALE-C (LDAC vs. LDAC+Ven) and VIALE-A (Aza vs. Aza+Ven) trials showed improved median overall survival (OS) from 4.1 to 7.2 months (VIALE-C) and from 9.6 to 14.7 months (VIALE-A), with serious adverse events (SAEs) in 73% low-dose AraC (LDAC), 83% (Aza + Ven), 66% (LDAC + Ven). Quality of the time gained with these regimens is particularly important in this population. Q-TWiST is a useful tool to adjust the OS to quality time without symptoms or toxicity. This kind of analysis has been previously published in newly diagnosed AML in glasdegib + LDAC vs LDAC trials (Solem CT, 2020), and in the CPX-352 vs 7+3 (Cortes JE, 2021) trial. However, venetoclax-based non-intensive regimens have not been analyzed with this method. Methods: We performed a retrospective, longitudinal analysis of data gathered from a single-center cohort. All newly diagnosed, >60 years old patients with upfront management with venetoclax-based non-intensive chemotherapy combined with LDAC or hypomethylating agents (HMA) at our institution were included. TOX time was defined as the period of time before remission and/or time with serious adverse events (SAE) as defined by Office for Human Research Protections (OHRP) guidance (2007). REL time was defined as time from relapse until death, last follow-up or the start of a second line treatment, TWiST was defined as the time in remission and without SAEs. Q-TWiST analysis was performed as previously described (Solem CT, 2020). Results: We included 17 patients, 58.8% were male, mean age was 74 (70-78) years. The diagnosis was de novo AML in 52.9%, and secondary AML in 46.9%. European LeukemiaNet (ELN) risk was favorable in 5.8%, intermediate in 11.7% and adverse in 41.1%, 35.2% was unknown, FLT3-ITD mutations were present in 23.5%. 25% of the population had basal ECOG performance status ≥3, HCT-CI score was ≥3 in 47%. Considering the patients with baseline geriatric assessment: 14.2% were frail, 42.8% pre-frail and 42.8% robust. Venetoclax was combined with azacitidine in 35.2% and LDAC in 64.7%, 11.7% received additional midostaurin. Venetoclax dose was 100 mg/day in combination with strong CYP3A4 inhibitors (mainly itraconazole) in all patients. By last cycle, venetoclax was adjusted to <28 days in 76.6% of patients. Azacitidine dose was adjusted in 60% of patients, and LDAC in 9%. 76% of patients achieved complete remission (CR) or complete remission with incomplete hematological recovery (CRi) with the treatment, 23.5% had no response and 28% relapsed. With a mean follow up of 42.4 (25.7-59.1), mean OS was 43.1 (95% IC 26.6-59.6), progression free survival (PFS) 37 (95% IC 19.1-54.8), Q-TWiST 36.3 (95% IC 19.7-53), and TWiST 30.3 (95% IC 13.5-47.1) weeks. Other variables related to toxicity are shown in table 1. Comparison with previously reported Q-TWiST with LDAC and 7+3 as frontline therapy in the elderly is described in Figure 1. Conclusions: the Q-TWiST in our unselected population was better than the Q-TWiST described for LDAC arm in the glasdegib trial, this is striking considering the comparison between real world data in a low-income setting with clinical trial population. This suggests that venetoclax-based non intensive chemotherapy not only offers longer OS but also longer quality-adjusted time compared to previous standard to this vulnerable population. When compared to 7+3 regimens the Q-TWiST was slightly shorter in our cohort,probably associated with the inclusion criteria of the trial, including ability to tolerate 7+3 regimen and an age limit of 75 years, which different from our population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Diversity in IRB Membership: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership. Methods We surveyed IRB chairpersons leading U.S. boards registered with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs). Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts. Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets.

Should the Food and Drug Administration Limit Placebo-Controlled Trials?

Should the Food and Drug Administration Limit Placebo-Controlled Trials?

Underutilization of guideline-concordant smoking cessation treatments in surgical patients: Lessons from a learning health system.

While smoking is a well-established risk factor for surgical complications, it is unclear how frequently guideline-concordant tobacco treatments are prescribed to surgical patients. In this cross-sectional study including 164673 unique patients evaluated in outpatient surgery clinics at a single institution in 2020, despite a relatively high smoking prevalence (14.7%), guideline-concordant treatment rates were very low, with only 12.7% of patients receiving pharmacotherapy and 31.7% receiving any treatment. Addressing disparities in smoking cessation treatments are critical given the disproportionate impact of smoking on surgical outcomes.

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Military Injuries-Understanding Posttraumatic Epilepsy, Health, and Quality-of-Life Effects of Caregiving: Protocol for a Longitudinal Mixed Methods Observational Study.

BackgroundVeterans with posttraumatic epilepsy (PTE), particularly those with comorbidities associated with epilepsy or traumatic brain injury (TBI), have poorer health status and higher symptom burden than their peers without PTE. One area that has been particularly poorly studied is that of the role of caregivers in the health of veterans with PTE and the impact caring for someone with PTE has on the caregivers themselves.ObjectiveIn this study, we aim to address the following: describe and compare the health and quality of life of veterans and caregivers of veterans with and without PTE; evaluate the change in available supports and unmet needs for services among caregivers of post-9/11 veterans with PTE over a 2-year period and to compare support and unmet needs with those without PTE; and identify veteran and caregiver characteristics associated with the 2-year health trajectories of caregivers and veterans with PTE compared with veterans without PTE.MethodsWe conducted a prospective cohort study of the health and quality of life among 4 groups of veterans and their caregivers: veterans with PTE, nontraumatic epilepsy, TBI only, and neither epilepsy nor TBI. We will recruit participants from previous related studies and collect information about both the veterans and their primary informal caregivers on health, quality of life, unmet needs for care, PTE and TBI symptoms and treatment, relationship, and caregiver experience. Data sources will include existing data supplemented with primary data, such as survey data collected at baseline, intermittent brief reporting using ecological momentary assessment, and qualitative interviews. We will make both cross-sectional and longitudinal comparisons, using veteran-caregiver dyads, along with qualitative findings to better understand risk and promotive factors for quality of life and health among veterans and caregivers, as well as the bidirectional impact of caregivers and care recipients on one another.ResultsThis study was approved by the institutional review boards of the University of Utah and Salt Lake City Veterans Affairs and is under review by the Human Research Protection Office of the United States Army Medical Research and Development Command. The Service Member, Veteran, and Caregiver Community Stakeholders Group has been formed and the study questionnaire will be finalized once the panel reviews it. We anticipate the start of recruitment and primary data collection by January 2022.ConclusionsNew national initiatives aim to incorporate the caregiver into the veteran’s treatment plan; however, we know little about the impact of caregiving—both positive and negative—on the caregivers themselves and on the veterans for whom they provide care. We will identify specific needs in this understudied population, which will inform clinicians, patients, families, and policy makers about the specific impact and needs to equip caregivers in caring for veterans at home.International Registered Report Identifier (IRRID)PRR1-10.2196/30975