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Constanze Stolz-Klingenberg,1 Claudia Bünzen,1 Marie Coors,2 Charlotte Flüh,3 Klarissa Hanja Stürner,4 Kai Wehkamp,5,6 Marla L Clayman,7,8 Fueloep Scheibler,1,9 Jens Ulrich Rüffer,9,10 Wiebke Schüttig,2 Leonie Sundmacher,2 Daniela Berg,4 Friedemann Geiger1,9,11 1National Competency Center for Shared Decision Making, University Hospital Schleswig-Holstein, Kiel, Germany; 2Chair of Health Economics, Technical University of Munich, Munich, Germany; 3Department of Neurosurgery, University Hospital Schleswig-Holstein, Kiel, Germany; 4Department of Neurology, University Hospital Schleswig-Holstein, Kiel, Germany; 5Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany; 6Department of Medical Management, MSH Medical School Hamburg, Hamburg, Germany; 7Center for Healthcare Organization and Implementation Research (CHOIR), Veterans Administration, Bedford, MA, USA; 8Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA; 9SHARE TO CARE Patientenzentrierte Versorgung GmbH, Cologne, Germany; 10TakePart Media+Science GmbH, Cologne, Germany; 11Department of Psychology, MSH Medical School Hamburg, Hamburg, GermanyCorrespondence: Constanze Stolz-Klingenberg, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, Haus 9, Kiel, 24105, Germany, Tel +49 431 500 20208 ; +49 151 17271928, Email Constanze.Stolz-Klingenberg@uksh.dePurpose: SHARE TO CARE (S2C) is a comprehensive, multi-module implementation program for shared decision making (SDM). It is currently applied at the University Hospital Schleswig-Holstein in Kiel, Germany, and among general practitioners at the Federal State of Bremen. This study examines the results of the full implementation of S2C in terms of effectiveness within the Kiel Neuromedical Center comprising the departments of neurology and neurosurgery.Method and Design: The S2C program consists of four combined intervention modules: 1) multimodal training of physicians; 2) a patient activation campaign including the ASK-3 method; 3) digital evidence-based patient decision aids; and 4) SDM support by nurses, e.g., as decision coaches. The SDM level before and immediately after implementation was retrospectively assessed in consecutively selected patients on the subscale “Patient Decision Making” of the Perceived Involvement in Care Scale (PICSPDM). Mean scores were compared with t-tests.Results: Eighty-nine percent of all physicians (N = 56) completed the SDM training. We developed a total of 12 evidence-based digital decision aids in the center, educated two decision coaches to support patients’ decision processes by using decision aids. Physicians adjusted patients’ pathways to incorporate the use of decision aids. Patients (n = 261) reported a significant increase in participation (p< 0.001; Hedges’ g = 0.49) in medical decision making.Conclusion: The S2C program has been successfully implemented within the entire Neuromedical Center. Patients reported a medium to small increase of perceived involvement in decision making demonstrating the effectiveness of the implementation. For future research, it might be interesting to investigate the sustainability of the effects of S2C. In addition, it seems useful to complement the patient-based evaluation with observer-based data.Keywords: shared decision making intervention, decision aids, physician training, patient activation, neurology, neurosurgery, SDM

Der Aufsatz geht der These nach, dass der Lauf der Zeit des menschlichen Lebens in Erzählungen zur Sprache gebracht wird. Ausgehend von Paul Ricoeurs „Zeit und Erzählung“ wird dargestellt, wie durch Erzählungen die subjektive Zeiterfahrung neugestaltet (refiguriert) wird und wie Erzählungen über das eigene Leben (in Analogie zu historischen Erzählungen) das subjektive Zeiterleben in den Horizont objektiver universaler Zeit eintragen. Die „Denkinstrumente“, anhand derer diese Verschränkung von subjektiver und objektiver Zeit – die nicht aufeinander zurückführbar sind –geschieht, sind Kalender, Generationenfolge und Spur. Vor dem Hintergrund dieser Zeittheorie kann das Altern des Menschen als Form des Lebens in der Zeit interpretiert werden und kommt als kalendarisches Altern, als soziales Altern und als ständige Krisis der personalen Identität in den Blick.

Objective: To assess the 12-month cost-effectiveness of the nurse-led transitional care program "Cardiolotse" (CL) for patients with cardiovascular diseases compared to usual care (UC)., Methods: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) were conducted from the perspective of statutory health insurance (SHI), covering a time horizon of 12 months. Analyzed outcomes included the number of rehospitalizations and health-related quality of life (HRQoL). Total costs comprised program costs and the utilization of healthcare resources. Point estimates are presented as incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs). Sensitivity and subgroup analyses were conducted to illustrate uncertainty and provide insights into the impact mechanisms of the CL program., Results: The study population consisted of 2550 patients, with 1256 allocated to the intervention group and 1294 to the control group. Patients who received support from CLs experienced fewer rehospitalizations and lower inpatient costs from an SHI perspective, compared to the UC group. HRQoL assessments indicated higher utility values for CL patients at the 12-month follow-up. Total program costs amounted to €1454.65 per patient. The CEA and CUA demonstrate that the CL program is dominant compared to UC from the SHI perspective., Conclusion: Our study shows that the CL program not only reduces the number of rehospitalizations and costs but increases HRQoL, resulting in a dominant ICER and ICUR. Further research is necessary to evaluate longer periods of time, different levels of care intensity, and perspectives of different healthcare stakeholders., Trial Registration: German Clinical Trial Register DRKS00020424, 2020-06-18, retrospectively registered., (© 2024. The Author(s).)

Background: We conducted a prospective, randomized, controlled, two-group parallel trial investigating the effectiveness of a care management program employing cardiac care navigators providing post-discharge support to patients compared to standard care., Methods: The intervention commenced in 2019/2020 for 2862 patients hospitalized with heart failure, coronary heart disease, or cardiac arrhythmias in departments of cardiology across eight participating sites of a hospital group in Berlin, Germany. We analyzed the results using an intention-to-treat approach. The primary outcome was the all-cause rehospitalization rate after 12 months. Secondary outcomes included rehospitalizations due to one of the qualifying cardiac diagnoses, duration of rehospitalization, mortality, health-related quality of life, and several process indicators. Trial data were collected from a combination of face-to-face and phone interviews conducted by hospital staff throughout the 12-month follow-up period using standardized questionnaires. Administrative claims data were provided by a large statutory health insurer. Outcomes for the intervention and control groups were compared using logistic regression, generalized linear models (GLMs) with a negative binomial distribution, ordinary least squares, and Cox proportional hazards regression., Results: Compared to the control group (N = 1294), the intervention group (N = 1256) had a lower rate of all-cause rehospitalizations (62.6% vs. 66.4%, p = 0.05) and shorter lengths of stay (14.49 vs. 16.89 days, p = 0.02) during the 12-month follow-up period. These differences were also present for rehospitalizations due to the cardiac diseases qualifying for study recruitment, with rehospitalization rates for the intervention and control groups being 58.0% vs. 61.4% (p = 0.08) and particularly pronounced for lengths of rehospitalization stay of 12.97 vs. 15.40 days (p = 0.01), respectively. Subgroup analyses indicated positive effects of the intervention for patients 70 years and older (p = 0.05), females (p = 0.06), and those with little or no German language proficiency (p = 0.03). Furthermore, we found positive effects on patients' adherence to health-related behavioral recommendations (81.91% vs. 73.95%, p = 0.000)., Conclusions: This study adds to the body of evidence indicating that care management interventions supporting patients as they transition from the inpatient to the outpatient sector can lower rehospitalizations, decrease length of rehospitalization stays, and improve adherence to post-discharge recommendations., Trial Registration: German Clinical Trial Register, DRKS00020424 . Registered 2020-06-18. (retrospectively registered)., (© 2024. The Author(s).)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: Recent analyses have shown that in health services research in Germany, healthcare organisations are often considered primarily as a study setting, without fully taking their complex organisational nature into account, neither theoretically nor methodologically. Therefore, an initiative was launched to analyse the state of Organisational Health Services Research (OHSR) in Germany and to develop a strategic framework and road map to guide future efforts in the field. This paper summarizes positions that have been jointly developed by consulting experts from the interdisciplinary and international scientific community., Methods: In July 2023, a scoping workshop over the course of three days was held with 32 (inter)national experts from different research fields centred around OHSR topics using interactive workshop methods. Participants discussed their perspectives on OHSR, analysed current challenges in OHSR in Germany and developed key positions for the field's development., Results: The seven agreed-upon key positions addressed conceptual and strategic aspects. There was consensus that the field required the development of a research agenda that can guide future efforts. On a conceptual level, the need to address challenges in terms of interdisciplinarity, terminology, organisation(s) as research subjects, international comparative research and utilisation of organisational theory was recognized. On a strategic level, requirements with regard to teaching, promotion of interdisciplinary and international collaboration, suitable funding opportunities and participatory research were identified., Conclusions: This position paper seeks to serve as a framework to support further development of OHSR in Germany and as a guide for researchers and funding organisations on how to move OHSR forward. Some of the challenges discussed for German OHSR are equally present in other countries. Thus, this position paper can be used to initiate fruitful discussions in other countries., Competing Interests: LA ist Vorstandsmitglied der DGMS und des DNVF. Sie ist Mitglied des Editorial Boards des Journal of Health Care Services and Implementation. JB erhält Fördermittel für mehrere OVF-Projekte in Australien und Europa. ME ist Vorsitzender der Society for Studies in Organizing Healthcare (SHOC). Die Arbeit des Instituts für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung, Universitätsklinikum Tübingen, wird durch einen zweckungebundenen Zuschuss des Arbeitgeberverbands der Metall- und Elektroindustrie Baden-Württemberg (Südwestmetall) unterstützt. Die übrigen Autor*innen erklären, dass keine Interessenkonflikte bestehen., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Objectives: To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM)., Design: Pre-post study., Setting: University Hospital Schleswig-Holstein (UKSH), Kiel Campus., Participants: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH., Interventions: The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate., Main Outcome Measures: In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICS PDM ). Pre-post comparisons were done using t-tests., Results: The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICS PDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects., Conclusions: The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care., Competing Interests: Competing interests: All authors received funding from the German Innovations Fund; FS, FG and JUR are co-founders of the SHARE TO CARE Patientenzentrierte Versorgung; KW received honoraria for being member of an advisory board for BMS on SDM; MC received consultancy fees from University Hospital Schleswig-Holstein LS is consultant for the Federal Ministry of Health (Germany), Federal Insurance Office and 4 statutory health insurance companies., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Precision medicine initiatives across the globe have led to a revolution of repositories linking large-scale genomic data with electronic health records, enabling genomic analyses across the entire phenome. Many of these initiatives focus solely on research insights, leading to limited direct benefit to patients. We describe the biobank at the Colorado Center for Personalized Medicine (CCPM Biobank) that was jointly developed by the University of Colorado Anschutz Medical Campus and UCHealth to serve as a unique, dual-purpose research and clinical resource accelerating personalized medicine. This living resource currently has more than 200,000 participants with ongoing recruitment. We highlight the clinical, laboratory, regulatory, and HIPAA-compliant informatics infrastructure along with our stakeholder engagement, consent, recontact, and participant engagement strategies. We characterize aspects of genetic and geographic diversity unique to the Rocky Mountain region, the primary catchment area for CCPM Biobank participants. We leverage linked health and demographic information of the CCPM Biobank participant population to demonstrate the utility of the CCPM Biobank to replicate complex trait associations in the first 33,674 genotyped individuals across multiple disease domains. Finally, we describe our current efforts toward return of clinical genetic test results, including high-impact pathogenic variants and pharmacogenetic information, and our broader goals as the CCPM Biobank continues to grow. Bringing clinical and research interests together fosters unique clinical and translational questions that can be addressed from the large EHR-linked CCPM Biobank resource within a HIPAA- and CLIA-certified environment., Competing Interests: Declaration of interests K.C.B. owns stock in Tempus and Galatea Bio and is an employee of Oxford Nanopore Technologies. C.R.G. owns stock in 23andMe, Inc., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Privacy protection is a core principle of genomic but not proteomic research. We identified independent single nucleotide polymorphism (SNP) quantitative trait loci (pQTL) from COPDGene and Jackson Heart Study (JHS), calculated continuous protein level genotype probabilities, and then applied a naïve Bayesian approach to link SomaScan 1.3K proteomes to genomes for 2812 independent subjects from COPDGene, JHS, SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) and Multi-Ethnic Study of Atherosclerosis (MESA). We correctly linked 90-95% of proteomes to their correct genome and for 95-99% we identify the 1% most likely links. The linking accuracy in subjects with African ancestry was lower (~ 60%) unless training included diverse subjects. With larger profiling (SomaScan 5K) in the Atherosclerosis Risk Communities (ARIC) correct identification was > 99% even in mixed ancestry populations. We also linked proteomes-to-proteomes and used the proteome only to determine features such as sex, ancestry, and first-degree relatives. When serial proteomes are available, the linking algorithm can be used to identify and correct mislabeled samples. This work also demonstrates the importance of including diverse populations in omics research and that large proteomic datasets (> 1000 proteins) can be accurately linked to a specific genome through pQTL knowledge and should not be considered unidentifiable., (© 2023. The Author(s).)

The paper reports the results of an exploratory online survey among German, Austrian, and Swiss hospital chaplains (n = 158, response rate 17%) to identify the ethical conflicts they encounter in their work. Respondents indicated that questions surrounding end-of-life care are predominant among the conflicts faced. Chaplains get involved with these conflicts most often through the patients themselves or through nursing staff. Most encounters occur during pastoral care visits rather than in structured forms of ethics consultation such as clinical ethics committees. The results add to the ongoing discussion of chaplains as agents in ethics consultation within healthcare systems as well as their specific role and contribution., (© 2022. The Author(s).)

Introduction: SHARE TO CARE (S2C) is a comprehensive implementation program for shared decision making (SDM). It is run at the University Hospital Schleswig-Holstein (UKSH) in Kiel, Germany, and consists of four combined intervention modules addressing healthcare professionals and patients: (1) multimodal training of physicians (2) patient activation campaign including the ASK3 method, (3) online evidence-based patient decision aids (4) SDM support by nurses. This study examines the sustainability of the hospital wide SDM implementation by means of the Neuromedical Center comprising the Departments of Neurology and Neurosurgery., Methods: Between 2018 and 2020, the S2C program was applied initially within the Neuromedical Center: We implemented the patient activation campaign, trained 89% of physicians ( N = 56), developed 12 patient decision aids and educated two decision coaches. Physicians adjusted the patients' pathways to facilitate the use of decision aids. To maintain the initial implementation, the departments took care that new staff members received training and decision aids were updated. The patient activation campaign was continued. To determine the sustainability of the initial intervention, the SDM level after a maintenance phase of 6-18 months was compared to the baseline level before implementation. Therefore, in- and outpatients received a questionnaire via mail after discharge. The primary endpoint was the "Patient Decision Making" subscale of the Perceived Involvement in Care Scale (PICS PDM ). Secondary endpoints were an additional scale measuring SDM (CollaboRATE), and the PrepDM scale, which determines patients' perceived health literacy while preparing for decision making. Mean scale scores were compared using t -tests., Results: Patients reported a significantly increased SDM level (PICS PDM p = 0.02; Hedges' g = 0.33; CollaboRATE p = 0.05; Hedges' g = 0.26) and improved preparation for decision making (PrepDM p = 0.001; Hedges' g = 0.34) 6-18 months after initial implementation of S2C., Discussion: The S2C program demonstrated its sustainability within the Neuromedical Center at UKSH Kiel in terms of increased SDM and health literacy. Maintaining the SDM implementation required a fraction of the initial intensity. The departments took on the responsibility for maintenance. Meanwhile, an additional health insurance-based reimbursement for S2C secures the continued application of the program., Conclusion: SHARE TO CARE promises to be suitable for long-lasting implementation of SDM in hospitals., Competing Interests: FG and FS are co-founders, JR is CEO and co-funder of SHARE TO CARE Patientenzentrierte Versorgung GmbH (Cologne/Germany). JR is CEO of TakePart Media + Science GmbH, Cologne, Germany. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Stolz-Klingenberg, Bünzen, Coors, Flüh, Margraf, Wehkamp, Clayman, Scheibler, Wehking, Rüffer, Schüttig, Sundmacher, Synowitz, Berg and Geiger.)

Introduction: Providing comprehensive stroke care poses major organisational and financial challenges to the German healthcare system. The quasi-randomised TEMPiS-Flying Intervention Team (TEMPiS-FIT) study aims to close the gap in the treatment of patients who had ischaemic stroke in rural areas of Southeast Bavaria by flying a team of interventionalists via helicopter directly to patients in the regional TEMPiS hospitals instead of transporting the patients to the next comprehensive stroke centre. The objective of the present paper is to describe the methods for the economic evaluation (TEMPiS-Gesundheitsökonomische Analyse (TEMPiS-GÖA)) alongside the TEMPiS-FIT study to determine whether the new form of care is cost-effective compared with standard care., Methods and Analysis: The within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will be performed from a statutory health insurance perspective as well as from a societal perspective over the time horizon of 12 months after the patients' hospital discharge. Direct costs from outpatient and inpatient care are collected from routine data of the participating health insurance funds, while medical and non-medical costs from a patient's perspective are retrieved from primary data collected during the TEMPiS-FIT study and follow-up questionnaires. Results will be presented as incremental cost-effectiveness ratio and incremental cost-utility ratio quantifying the incremental costs and health benefits compared with standard care practice. The outcome of the CEA will be measured in costs per minute reduction in mean process time to thrombectomy. The outcome of the CUA will be presented as costs per quality-adjusted life year gained., Ethics and Dissemination: Ethical approval for the TEMPiS-FIT study was granted by the Bavarian State Medical Association Ethics Committee (# 17056). Results will be disseminated via reports, presentations of the results in publications and at conferences and on the TEMPiS website., Trial Registration Number: German Clinical Trials Register DRKS00023885. Registered on 2 July 2021 - retrospectively registered., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2021.)

The number of institutional and governmental biobanks and the target enrollment sizes of modern biobanks are increasing, affording more opportunities for the public to participate in biobanking efforts. In parallel with these expansions are pressures to increase the efficiency of obtaining informed consent using shorter consent forms that cover a broader scope of research and increasingly include provisions for return of research or clinical genetic test results to participants. Given these changes, how well these participants understand genetics, their level of understanding of what they are consenting to, and their wishes to engage longitudinally and receive biobank results are not well understood. We surveyed participants in a large, medical system-based biobank who had enrolled through a two-page, self-consent process about their baseline knowledge of genetics, understanding and recall of the consent process, wishes for future contact and engagement, and level of interest in receiving clinical genetic testing results. A total of 856 consented persons participated in the survey (67% women; 67% white). Participants' general reported genetics knowledge was relatively high (mean 11.60 of 15 questions answered correctly) as was recall of key elements from the two-page consent form. Overall participant enthusiasm for future contact by the biobank and for receiving clinical genetic testing results was high. The use of a two-page, self-consent process in a large, institutional biobank resulted in high levels of consent recall and enthusiasm for future ongoing engagement and receipt of genetic testing results by participants., (© 2020 National Society of Genetic Counselors.)

Background/aims: Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities., Methods: Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed. Description of the trial design and barriers to facility and patient recruitment along with regulatory issues are presented., Results: The recruitment of Denver-metro skilled nursing facilities was facilitated by key stakeholders of the skilled nursing facilities community. However, there were still a number of barriers to facility recruitment including leadership turnover, varying policies regarding research, fear of litigation and of an increased workload. Engagement of facilities was facilitated by their strong interest in reducing hospital readmissions, marketing potential to hospitals, and heart failure management education for their staff. Recruitment of patients proved difficult and there were few facilitators. Identified patient recruitment challenges included patients being unaware of their heart failure diagnosis, patients overwhelmed with their illness and care, and frequently there was no available proxy for cognitively impaired patients. Flexibility in changing the recruitment approach and targeting skilled nursing facilities with higher rates of admissions helped to overcome some barriers., Conclusion: Recruitment of skilled nursing facilities and patients in skilled nursing facilities for clinical trials is challenging. Strategies to attract both facilities and patients are warranted. These include aligning study goals with facility incentives and flexible recruitment protocols to work with patients in "transition crisis."

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.