Emily E. Anderson

Research Ethics Education for Community-Engaged Research: A Review and Research Agenda

Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.

Identifying potential kidney donors using social networking web sites.

Social networking sites like Facebook may be a powerful tool for increasing rates of live kidney donation. They allow for wide dissemination of information and discussion and could lessen anxiety associated with a face‐to‐face request for donation. However, sparse data exist on the use of social media for this purpose. We searched Facebook, the most popular social networking site, for publicly available English‐language pages seeking kidney donors for a specific individual, abstracting information on the potential recipient, characteristics of the page itself, and whether potential donors were tested. In the 91 pages meeting inclusion criteria, the mean age of potential recipients was 37 (range: 2–69); 88% were US residents. Other posted information included the individuals photograph (76%), blood type (64%), cause of kidney disease (43%), and location (71%). Thirty‐two percent of pages reported having potential donors tested, and 10% reported receiving a live‐donor kidney transplant. Those reporting donor testing shared more potential recipient characteristics, provided more information about transplantation, and had higher page traffic. Facebook is already being used to identify potential kidney donors. Future studies should focus on how to safely, ethically, and effectively use social networking sites to inform potential donors and potentially expand live kidney donation.

The development and assessment of an NIH-funded research ethics training program.

In an effort to increase the number of researchers with skills “in identifying and addressing the ethical, legal, and social implications of their research,” the National Institutes of Health (NIH) solicited training grant proposals from 1999 to 2004 and subsequently funded approved programs. The authors describe the content, format, and outcomes of one such training program that ran from 2002 to 2006 and share key lessons learned about program formats and assessment methods. Jointly developed by the Saint Louis University Center for Health Care Ethics and the Missouri Institute of Mental Health Continuing Education department, the training program focused on mental health research and adopted a train-the-trainer model. It was offered in on-site and distance-learning formats. Key outcomes of the program included educational products (such as 70 case studies posted on the course Web site, a textbook, and an instructional DVD) and program completion by 40 trainees. Assessment involved pre- and posttesting focused on knowledge of research ethics, ethical problem-solving skills, and levels of confidence in addressing ethical issues in mental health research. The program succeeded in increasing participants’ knowledge of ethical issues and their beliefs that they could identify issues, identify problem-solving resources, and solve ethical problems. However, scores on the case-based problem-solving assessment dropped in posttesting, apparently because of diminished confidence about the right course of action in the specific dilemma presented; the implications of this finding for ethics assessment are discussed. Overall satisfaction was high, and dropout rates were low but three times higher for distance-learners than for on-site participants.

Environmental Factors Contributing to Wrongdoing in Medicine: A Criterion-Based Review of Studies and Cases

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research.

Understanding Research Misconduct: A Comparative Analysis of 120 Cases of Professional Wrongdoing

We analyzed 40 cases of falsification, fabrication, or plagiarism (FFP), comparing them to other types of wrongdoing in research (n = 40) and medicine (n = 40). Fifty-one variables were coded from an average of 29 news or investigative reports per case. Financial incentives, oversight failures, and seniority correlate significantly with more serious instances of FFP. However, most environmental variables were nearly absent from cases of FFP and none were more strongly present in cases of FFP than in other types of wrongdoing. Qualitative data suggest FFP involves thinking errors, poor coping with research pressures, and inadequate oversight. We offer recommendations for education, institutional investigations, policy, and further research.

Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention

AbstractIntroduction Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians, and researchers to evaluate a survivor–caregiver QOL intervention.MethodsA CBO in the mid-Atlantic region, Nueva Vida, developed a patient–caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and three CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient–caregiver program to usual care.ResultsIncorporating team feedback and programmatic considerations, we adapted the prior patient–caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the patient-reported outcomes measurement information system, dyadic communication between the survivor and caregiver, and survivors’ adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery.ConclusionThe development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors, and caregivers.

IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review

Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.

I Will Never Let That Be OK Again: Student Reflections on Competent Spiritual Care for Dying Patients

Purpose To examine medical students’ reflections on the spiritual care of a patient who has died so as to understand how students experienced this significant event and how they or their teams addressed patients’ spiritual needs. Method In 2010–2011, the authors gave third-year students at Loyola University Chicago Stritch School of Medicine an essay assignment, prompting them to reflect on the experience of the death of one of their patients. The authors analyzed the content of the essays using an iterative, multistep process. Three authors independently coded the essays for themes based on the competencies (developed by Puchalski and colleagues and reflected in the essay prompt) of communication, compassionate presence, patient care, and personal and professional development. The authors reached consensus through discussion. Results A salient theme in the students’ writings was awareness of their personal and professional development. Students reported being aware that they were becoming desensitized to the human dimension of care, and particularly to dying patients and their families. Students wished to learn to contain their emotions to better serve their patients, and they articulated a commitment to addressing patient and family needs. Students identified systemic fragmentation of patient care as a barrier to meeting patient needs and as a facilitator of provider desensitization. Conclusions Written student reflections are a rich source of data regarding the spiritual care of dying patients and their families. They provide insight into the personal and professional development of medical students and suggest that medical schools should support students’ formation.

Assessing the Need for a Research Ethics Remediation Program

With supplement funding to the Washington University CTSA, the Restoring Professionalism and Integrity in Research (RePAIR) program was developed at Saint Louis University to meet the remediation needs of institutions nationwide regarding investigators who violate research regulations. With the aim of determining the frequency and kinds of wrongdoing at leading research institutions in the United States, as well as institutional responses and levels of interest in a formal remediation program, an online questionnaire was distributed by email to a research integrity officer (RIO) and institutional review board (IRB) chair at all medical schools and comprehensive doctoral institutions in the United States (N = 194). One hundred sixty‐one individuals responded (44%) representing 66% of institutions. For those institutions that had both RIOs and IRB chairs responding, 96% had investigated at least one case over the past 2 years; the modal individual response was 3–5 cases, with a range from 0 to more than 16 cases. The most common forms of wrongdoing were violations of procedure, informed consent, research integrity (fabrication, falsification, plagiarism), privacy, and conflict of interest policies. Most RIOs and IRB chairs expressed interest in the RePAIR program, despite concerns about costs and faculty resistance.

Views of Academic and Community Partners Regarding Participant Protections and Research Integrity: A Pilot Focus Group Study

When community partners have direct interaction with human research participants, it is important to consider potential threats to participant protections and research integrity. Few studies have directly compared the views of academic and community partners. This pilot focus group study explores the views of academic partners (APs) and community partners (CPs) regarding challenges to the protection of research participants and research integrity in community-engaged research (CEnR). Data are analyzed to understand how APs and CPs define and think about ethical problems and how meaning and analysis may differ between the two groups. Findings have implications for the development of research ethics training materials for academic-community research partnerships and IRBs; Revised best practices for CEnR; Revised and future research on ethical issues in CEnR.