Human Research Protection Program Research Articles

Returning Clinically Relevant Research Results to Participants: Guidelines for Investigators and the IRB.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB.

Risk Evaluation in Occupational Safety and Health Research: Results from a Benchmarking Exercise of Federal and Academic IRBs.

Research involving working populations can pose unique ethical and risk evaluation challenges. The purpose of this benchmarking project was to assess how federal agencies and academic institutions approach the interpretation and application of key risk evaluation concepts in research involving workers in their places of employment. Key informant interviews were conducted to ascertain current practices related to assessing soundness of research design, determining risk reasonableness and research-relatedness of risks, and evaluating the risk of non-invasive clinical tests in occupational settings. There were noteworthy commonalities among the approaches described to review and address critical aspects of risk evaluation for OSH research involving human participants. The insights gleaned may help guide Institutional Review Boards and Human Research Protection Programs as they consider the ethical issues of human subjects research in occupational settings.

Does anesthesia duration or number of cases per patient predict safety events?

The need for dental rehabilitation under general anesthesia is increasing, with varying needs between patients. Mortality has been found to be a rare event in these patients; however other perioperative events can and do occur. Previous studies have established increased incidence of perioperative events with younger, sicker children, and longer anesthetics, however, no studies to date have evaluated if the incidence of perioperative events is more closely associated with one long anesthetic or multiple anesthetics per patient. To evaluate the association of perioperative events related to single anesthetic duration or number of anesthetics per patient for dental rehabilitation. After Children's Wisconsin Human Research Protection Program determined this quality activity did not meet the definition of human subjects research, we performed an epidemiologic observational evaluation by extracting all dental related cases (dental alone or with oral surgeon vs. dental with other specialties) with an associated general anesthesia encounter from Children's Wisconsin electronic data warehouse from June 1, 2015 to December 31, 2021. These cases occurred at a free-standing children's hospital or associated pediatric-only ambulatory surgery center. The risk of perioperative safety events was analyzed for previously identified risk groups such as American Society of Anesthesiologists Physical Status (ASA-PS), patient age, anesthesia case time with the addition of number of dental cases per patient. In this study, 8468 procedures were performed on 8082 patients. Of this cohort, 7765 patients underwent one procedure for dental care while 317 patients underwent a total of 703 dental-related procedures, ranging from two to five procedures per patient. Multivariable logistic regression identified increased risk of perioperative events in patients with ASA-PS 3 (n = 1459, rate 1.78%, p value .001, OR 5.7, CI 2.1-15.5) and ASA-PS 4 (n = 86, rate 5.8%, p < .001, OR 17.2, CI 4.4-67.3), anesthesia duration (p < .001, OR 1.46, CI 1.21-1.76), but no increased risk with number of anesthetics per patient (p value .54, OR 0.81, CI 0.4-1.61). Limiting dental care under general anesthesia to multiple short cases may decrease the risk of perioperative events when compared to completing all treatment in one long operative session.

Socio-Demographic and Behavioral Predictors of Admission for Kidney Disease in an Urban Hospital in Northwest Indiana

Background: The CDC estimates more than 1 in 7 American adults have Chronic Kidney Disease (CKD) and nearly 800,000 live with End-Stage Renal Disease (ESRD); the majority of whom require dialysis. Current literature demands further exploration on how social determinants of health (SDOH) influence inpatient and emergency services utilization for CKD/ESRD-related exacerbations. This study examined socio-demographic and behavioral factors associated with hospital admission for CKD/ESRD. It is part of a three-phased Community-Based Participatory Research (CBPR) partnership between IUSM-NW and St. Mary Medical Center (SMMC) to examine and address relationships between SDOH, patient demographics, health behaviors, and health outcomes from January 2022-January 2025.&#x0D; Methods: This retrospective study analyzed a limited dataset generated by SMMC from EPIC™ with SDOH, demographic, health behavior, and health outcomes data obtained from adult inpatients between January 2021 and March 2023. CKD/ESRD was determined by admission diagnosis ICD-10 Code N18. Data analysis utilized SPSS 29.0 to produce frequencies, Chi-Square tests (p&lt;0.05), and a binary logistic regression (p&lt;0.05). This study was exempted by Indiana University Human Research Protection Program (IRB # 14040).&#x0D; Results: This study included 10,953 inpatient admissions involving predominantly white (78.4%) and older adult (68 ± 21) patients. CKD/ESRD represented 96 admissions. The bivariate analysis found a significant association between CKD/ESRD admissions and age (p&lt;0.001), race (p&lt;0.001), sex (p=0.008), insurance type (p=0.030), and smoking tobacco use (p=0.004). After adjusting for all factors, being Asian (OR=12.172, p&lt;0.001), Black (OR=3.702; p&lt;0.001), female (OR=0.518; p=0.003), publicly insured (OR=2.76; p=0.014), and former smoking (OR=1.606; p=0.045) were significantly associated with CKD/ESRD admission.&#x0D; Conclusions: This study revealed several demographics, SDOH, and health behaviors associated with CKD/ESRD admission in an urban hospital. Uncovering predictors of CKD/ESRD admission enables focused interventions to decrease admissions. The next CBPR phases will apply advanced statistical analyses to further explore these relationships and codevelop interventions.

Association of Socio-Demographic Factors, Social Determinants of Health, and Weekly Physical Activity in an Urban Hospital in Northwest Indiana

Background: Engaging in regular physical activity has been proven to have beneficial health effects such as preventing chronic diseases and improving mental health. Recent studies have demonstrated correlations between socio-demographic factors and physical activity levels. This study determined the associations between socio-demographic factors, social determinants of health and the amount of weekly physical activity in patients occupying an urban underserved area.&#x0D; Methods: This study retrospectively analyzed a dataset generated by St. Mary Medical Center from EPIC™ with demographic characteristics and physical activity levels partitioned by time per week for adult inpatient visits from January 2021 to March 2023. Patients were stratified into physical activity levels based upon published guidelines: inactive (no physical activity), insufficiently active (&lt;150 minutes per week) or sufficiently active (≥150 minutes per week). Data analysis was conducted in SPSS 28.0 using tests of association including Kruskal Wallis H and multivariate ordinal regression model. This study was exempted by Indiana University Human Research Protection Program (IRB # 14040).&#x0D; Results: The sample of individuals from the dataset who answered physical activity questions was comprised of 1498 patients. There was a statistically significant difference in physical activity level by age group (p&lt;0.001), sex (p&lt;0.05), insurance category (p&lt;0.001), and social connections risk score (p&lt;0.001); with race (p=0.057) and language (p=0.054) approaching significance. Multivariate analysis showed that age was the only significant factor when accounting for all variables, with higher age groups reporting lower proportions of physically active individuals.&#x0D; Conclusion: Determining how socio-demographic factors influence physical activity levels will direct efforts to form and implement new interventions in the Northwest Indiana urban area and support community health initiatives. This data makes it possible to inform practitioners of the demographics that are at risk of being insufficiently active and having them direct those patients to programs in place to help bridge the lapse.

Neurovascular Conditions and Associated Socio-Demographic and Behavioral Factors in an Urban Hospital in Northwest Indiana

Background: Brain health equity remains an underexplored research area despite high prevalence of neurovascular conditions and related health impacts. This study examined the associations between socio-demographic, behavioral factors, and hospital admissions for neurovascular-related morbidity in an urban underserved community. It is part of a multi-phased Community-Based Participatory Research (CBPR) partnership between Indiana University School of Medicine-Northwest and St. Mary Medical Center (SMMC) to examine the prevalence, distribution, and relationships between social determinants of health (SDOH), demographics, health behaviors, and health outcomes in Northwest Indiana.&#x0D; Methods: This retrospective study analyzed a limited dataset generated by SMMC from EPIC™ with SDOH, demographic, behavioral and health outcomes data for adult inpatient visits from January 2021 to March 2023. Neurovascular admission was determined by ICD-10 Codes I67-69. Data analysis was conducted in SPSS 29.0 using descriptive statistics (i.e., frequencies and central tendency), bivariate analysis (Chi-square; p&lt;0.05), and multivariate analysis (binary logistic regression; p&lt;0.05). This study received exemption from Indiana University Human Research Protection Program (IRB #14040).&#x0D; Results: There were 1,489 participants included in this study. The majority were white (77.7%), older adults (67 ± 21.5) and publicly insured (77.8%). The bivariate analysis demonstrated significant relationships between admission for neurovascular conditions and age group (p&lt;0.001), veteran status (p&lt;0.001), insurance type (p&lt;0.037), and physical activity (p&lt;0.001). After adjusting for these factors in multivariate analysis, age group (p&lt; 0.003) and physical inactivity (p&lt;0.008) were significantly associated with admission for neurovascular conditions.&#x0D; Conclusion: Understanding how SDOH and behavioral factors influence neurovascular admissions and inequities in urban settings will enhance collaborative efforts to develop, implement, and evaluate evidence-based interventions. The subsequent CBPR phases will utilize these findings to explore how socioeconomic status affects these patients’ ability to seek emergent and/or surgical care. This will enable implementation of strategies that better account for SDOH in patient care.

Identifying Socio-Demographic and Behavioral Predictors of Prolonged Hospital Stay in an Urban Hospital in Northwest Indiana

Background: Hospital length of stay (LOS) is a crucial metric that impacts patient outcomes, healthcare resource utilization, and financial burden. In 2019 the CDC reported the average LOS in community hospitals was 5.4 days. Prolonged LOS is associated with an increased risk of hospital-acquired infections, decreased hospital bed availability limiting patient access to care, and cognitive impairment, particularly among the elderly. This indicates the importance of addressing LOS as a healthcare priority. This study examined the relationship between LOS and social determinants of health (SDOH), patient demographics, health behaviors, and health outcomes as part of a long-term Community Based Participatory Research partnership between IUSM-NW and St. Mary Medical Center (SMMC).&#x0D; Methods: This retrospective study analyzed EPIC™-generated data for adult inpatient visits at an urban hospital in Northwest Indiana from January 2021 to March 2023. Data analysis was performed using SPSS 28.0, consisting of descriptive statistics, bivariate analysis (One-way ANOVA, Independent T-tests, Kruskal Wallis H; p&lt;0.05), and Simple Linear Regression. This study was granted an exemption by the Indiana University Human Research Protection Program (IRB #14040).&#x0D; Results: The sample comprised of 10,916 predominantly white (77.7%) patients with a median age of 65 (IQR=22) and a median LOS of 4 days (IQR= 5). Bivariate analysis revealed LOS was significantly associated with age (p&lt;0.001), race (p&lt;0.033), sex (p&lt;0.012), insurance type (p&lt;0.001), physical inactivity (p&lt;0.001), and smoking tobacco (p&lt;0.001). After controlling for all factors in the multivariate analysis, age (p&lt;0.020), physical inactivity (p&lt;0.013), and insurance type (p&lt;0.013) retained their significance.&#x0D; Conclusions: These findings highlight the significance of demographic, behavioral, and social factors in relation to hospital LOS. Understanding these factors holds immense potential to guide the development of targeted interventions and healthcare strategies to optimize patient care and reduce LOS.

Social Determinants of Health and 30-Day Readmissions in an Urban Community Hospital in Northwest Indiana

Background: Hospital readmission within 30 days of discharge is a quality of care indicator with implications for healthcare systems, payers, and patients. The Hospital Readmission Reduction Program enacted in 2012 aimed to reduce preventable readmissions. Yet in 2018, there were 3.8 million adult 30-day readmissions with an average rate of 14% and estimated cost of $15,200 per readmission. This study examined the influence of social determinants of health (SDOH), demographics, and health behaviors on 30-day readmissions at an urban hospital in Northwest Indiana. This is part of a Community-Based Participatory Research (CBPR) partnership between Indiana University School of Medicine-Northwest and St. Mary Medical Center (SMMC) to address SDOH.&#x0D; Methods: This retrospective study analyzed a limited dataset generated by SMMC in EPIC™ with SDOH, demographics, health behaviors, and health outcomes measures from inpatient admissions between January 2021 to March 2023. Data analysis consisted of descriptive, bivariate (Chi-Square; p&lt;0.05), and multivariate (binary logistic regression; p&lt;0.05) analyses in SPSS 29.0. This study was exempted by the Indiana University Human Research Protection Program (IRB #14040).&#x0D; Results: The sample consisted of 7445 patients, majority 65 years and above (56.5%), white (77.47%), and publicly insured (76.83%). 30-day readmissions represented 10.5% of admissions. The bivariate analysis revealed statistically significant associations between 30-dayreadmissions and age (p&lt;0.001), language (p=0.008), insurance type (p&lt;0.001), veteran status (p=0.017), and smoking (p&lt;0.001). The multivariate analysis found that age (OR=1.008; p=0.004), being a non-English speaker (OR=1.866; p=0.009), public insurance (OR=2.096; p&lt;0.001), and former smoking (OR=1.243; p=0.011) remained significantly associated with 30-day readmission.&#x0D; Conclusions: Social and behavioral factors were associated with 30-day readmissions in an urban community hospital. Incorporating SDOH and behavioral interventions into hospital readmission reduction programs may reinforce these programs. The upcoming CBPR phase will conduct advanced analysis on these findings to uncover new relationships relevant to SMMC’s objectives.

The Association for the Accreditation of Human Research Protection Programs: 15 years of emphasizing research safety, ethics, and quality

This year marks the 15th anniversary of the founding of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization that has been instrumental in strengthening protections for research participants. AAHRPP was established by seven Founding Members in response to a series of high-profile incidents that shook the foundation of the U.S. research enterprise. The Founding Members viewed voluntary accreditation as one way to strengthen research protections and restore and preserve public trust. Today, AAHRPP accreditation is widely regarded as the gold standard for research protections. To attain accreditation, organizations must demonstrate that they adhere to rigorous standards covering three domains: The Organization, The Institutional Review Board or Ethics Committee, and Researcher and Research Staff. The emphasis is on system-wide policies and procedures that strengthen an organization’s commitment to participants and help ensure a more consistent, more effective approach to protecting them. Because AARHPP accreditation is considered an objective indicator of quality, the benefits to accredited organizations can be considerable. Their accreditation status sends a signal — to potential research partners, to sponsors and other funders, and to research participants — that the organization has the systems in place to conduct research in a scientifically and ethically sound manner.

“Vets Restoring Vets”

Introduction&#x0D; Military Veterans disproportionately experience mental health issues due to unique service-related experiences. Peer and social support interventions have shown promise in improving Veterans’ mental health alongside clinical mental health interventions yet there are limited studies on Veteran-designed and Veteran–led peer or social support interventions. This study explored the perceptions and experiences of Veterans participating in an innovative Veteran-designed and Veteran-led peer and social support program. It was a preliminary study in a long-term Community Based Participatory Research partnership between Indiana University School of Medicine-Northwest regional campus and Operation Combat Bikesaver (OCB).&#x0D; Methods  &#x0D; This mixed methods study utilized a limited dataset from pre-and-post-session surveys collected by OCB between September 2019 and August 2021. We examined pre-post differences in participants’ self-rated “feelings” (i.e., emotional state) with the following independent variables through Linear Mixed Models in SPSS: OCB location, OCB event attended, day of the week, time of day, duration of attendance, frequency of attendance, and social assistance. We analyzed participants’ qualitative OCB experiences using inductive thematic analysis in Dedoose.  This study was reviewed and exempted by The Indiana University Human Research Protection Program (Protocol # 12499) on August 16, 2021.&#x0D; Results  &#x0D; A total of 128 participants completed pre-post surveys for 746 OCB sessions. There was a statistically significant pre-post session increase in participants’ feelings (mean=34.6; SD=21.7; p&lt;0.001), with increasing effects by duration (p=0.002) in an OCB session. There was no linear trend in individual pre-and-post session changes in feelings over time. The following themes describe participants’ OCB experiences: sense of purpose and meaning, regaining comradery and brotherhood, “Vets restoring Vets,” satisfaction with OCB structure and processes, and experiencing OCB impacts. &#x0D; Conclusions  &#x0D; Convening Veterans with shared experiences around innovative and supportive social activities may develop their perceived sense of purpose, belonging, and mutual support and produce improvements in perceived mental health. Future research within this community-regional medical campus research partnership will explore jointly determined research questions to follow-up on the main findings and limitations of the current study.

Evaluation of evolving sepsis screening criteria in discriminating suspected sepsis and mortality among adult patients admitted to the intensive care unit

BackgroundInstitutions struggle with successful use of sepsis alerts within electronic health records. ObjectiveTest the association of sepsis screening measurement criteria in discrimination of mortality and detection of sepsis in a large dataset. DesignRetrospective, cohort study using a large United States (U.S.) intensive care database. The Institutional Review Board exempt status was obtained from Kansas University Medical Center Human Research Protection Program (10-1-2015). Setting334 U.S. hospitals participating in the eICU Research Institute. ParticipantsNine hundred twelve thousand five hundred and nine adult intensive care admissions from 183 hospitals. MethodsExposures included: systemic inflammatory response syndrome criteria ≥ 2 (Sepsis-1); systemic inflammatory response syndrome criteria with organ failure criteria ≥ 3.5 points (Sepsis-2); and sepsis-related organ failure assessment score ≥ 2 and quick score ≥ 2 (Sepsis-3). Discrimination of outcomes was determined with/without (adjusted/unadjusted) baseline risk exposure to a model. The receiver operating characteristic curve (AUROC) and odds ratios (ORs) for each decile of baseline risk of sepsis or death were assessed. ResultsWithin the eligible cohort of 912,509, a total of 86,219 (9.4 %) patients did not survive their hospital stay and 186,870 (20.5 %) met the definition of suspected sepsis. For suspected sepsis discrimination, Sepsis-2 (unadjusted AUROC 0.67, 99 % CI: 0.66–0.67 and adjusted AUROC 0.77, 99 % CI: 0.77–0.77) outperformed Sepsis-3 (SOFA unadjusted AUROC 0.61, 99 % CI: 0.61–0.61 and adjusted AUROC 0.74, 99 % CI: 0.74–0.74) (qSOFA unadjusted AUROC 0.59, 99 % CI: 0.59–0.60 and adjusted AUROC 0.73, 99 % CI: 0.73–0.73). Sepsis-2 also outperformed Sepsis-1 (unadjusted AUROC 0.58, 99 % CI: 0.58–0.58 and adjusted AUROC 0.73, 99 % CI: 0.73–0.73). In between differences of AUROCs were statistically significantly different. Sepsis-2 ORs were higher for the outcome of suspected sepsis when considering deciles of risk than the other measurement systems. Conclusions and relevanceSepsis-2 outperformed other systems in suspected sepsis detection and was comparable to SOFA in prognostic accuracy of mortality in adult intensive care patients.

Moral distress in long-term care questionnaire modification and psychometric evaluation.

Licensed nurses working in long-term care facilities experience ethical challenges if not resolved can lead to moral distress. There is a lack of an English-language validated tool to adequately measure moral distress in the long-term care setting. To describe the modification and psychometric evaluation of the Moral Distress Questionnaire. Instrument development and psychometric evaluation. Internal consistency using Cronbach's α to establish reliability was conducted using SPSS version 27.0 while SPSS Amos version 27.0 was used to perform a confirmatory factor analysis of the Moral Distress Questionnaire. A national sample of US-licensed nurses who provided direct resident care in long-term care settings were recruited via a targeted sampling method using Facebook from 7 December 2020 to 7 March 2021. The study was approved by the university's human research protection program. Informed consent was provided to all participants. A total of 215 participants completed the surveys. Confirmatory analysis indicated that the 21-item scale with a 4-factor structure for the Moral Distress Questionnaire model met the established criteria and demonstrates an acceptable model fit (CMIN/DF = 2.0, CFI = 0.82, TLI = 0.77, RMSEA = 0.07). Factor loadings for each item depict a moderate to a strong relationship (range 0.36-0.70) with the given underlying construct. Cronbach's α coefficient was 0.87 for the overall scale and 0.60-0.74 for its subscales which demonstrate good reliabilities. This is the first English-language validated tool to adequately measure moral distress in the long-term care setting experienced by US long-term care nurses. This reliable and well-validated tool will help identify moral distress situations experienced by US long-term care nurses. The modified 21-item English version of the Moral Distress Questionnaire is reliable tool that demonstrates good psychometric properties to validly measure sources of moral distress among direct resident care nurses.

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study

IntroductionThe effect of testosterone (T) therapy on the vaginal microbiota of transgender men (TGM) is not well characterised, although one cross-sectional study comparing the vaginal microbiota of cisgender women to...

Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial

IntroductionThere are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access...

A Cross Sectional Survey of Recruitment Practices, Supports, and Perceived Roles for Unaffiliated and Non-scientist Members of IRBs

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.

329 - Human research protection program contact attempt policies and diversity, equity, and inclusion in clinical research

329 - Human research protection program contact attempt policies and diversity, equity, and inclusion in clinical research

Relationships Between Health Behaviors, Social Determinants of Health, and Patient Demographics in an Urban Northwest Indiana Hospital

Background: Social determinants of health (SDOH) contribute to over 50% of health outcomes and inequities. Healthcare institutions are increasingly implementing SDOH screenings and referrals. St. Mary Medical Center (SMMC) in Northwest Indiana was the first acute care hospital to implement a comprehensive SDOH pilot screening and referral program in Indiana using the validated Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE). This study is part of a three-phased Community-Based Participatory Research (CBPR) partnership between IUSM-NW and SMMC to examine and address SDOH within SMMC’s service area from January 2022-January 2025. This study’s research question is: What are the relationships between SDOH, behavioral, and demographic factors in SMMC’s inpatients?Methods: This descriptive study analyzed a limited dataset generated by SMMC from EPIC™ with SDOH, demographic, behavioral (tobacco use, alcohol use, physical activity), and health outcomes data for adult inpatient visits from January 2021 to June 2022. Data analysis was conducted in SPSS 28.0 using descriptive statistics (i.e., frequencies and central tendency) and tests of association including Chi-square, Fisher’s Exact, Wilcoxon-Mann Whitney, and Kruskal Wallis H (p&lt;0.05). This study was exempted by Indiana University Human Research Protection Program (IRB # 14040).Results: This study included 4370 inpatients, who were predominantly White (75.7%), older adults (65 ± 24), and publicly insured (76.3%). There were significant relationships between SDOH and tobacco use, alcohol use, and physical activity. Tobacco use was significantly associated with the majority of SDOH including insurance type (p&lt;.001), housing risk (p&lt;.001), financial resource risk (p&lt;.001), unmet transportation needs (p&lt;.001), and overall social risk (p=.012).Conclusions: Understanding how SDOH influence health behaviors will inform efforts to develop, implement, and evaluate multi-level interventions. The next phases of this CBPR will use advanced statistical techniques to further explore these relationships, evaluate SMMC’s pilot program, and co-develop SDOH interventions.

Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators.

Using single IRB consultations to meet the educational needs of investigative teams

Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.

How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs?

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement. Methods We conducted 3 small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard. Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical. Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review.