Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review.

Research engaging children and adolescents living with HIV (CALWH) is critical for youth-friendly services and HIV care, and researchers need to ensure that such engagement is ethical. We conducted a systematic review to identify key ethical considerations for the engagement of CALWH in research. The review focused on primary research articles conducted in African countries that examined ethical issues in CALWH engaged in research. Ten studies met the inclusion criteria; the following seven key domains were extracted: 1) justifications for engaging CALWH in research; 2) community involvement; 3) informed consent/assent; 4) caregiver involvement; 5) perceptions of benefits; 6) perception of the risks of involvement; and 7) confidentiality. These domains can inform the ethical engagement of CALWH in research.

Research Ethics during Pandemics: How IRBs Can Prepare.

The Covid-19 pandemic has raised a range of complex challenges for the research community in the United States. This essay uses Covid-19 as a model pandemic illness to consider two such issues that have yet to be fully explored in the ethics literature: first, whether the informed consent process should include a discussion of pandemic risks and, if so, how precisely these risks should be conveyed to potential research participants and, second, whether and under what circumstances vaccination status should be taken into consideration when enrolling subjects in non-pandemic-related studies during a pandemic.

Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members' attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES's domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful. IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.

A Qualitative Study of Factors Affecting Morale in Psychiatry Residency Training.

OBJECTIVE: Resident morale is an important yet poorly understood aspect of the residency training experience. Despite implications for program quality, resident satisfaction, patient care, and recruitment, little is known about the variables influencing this complex phenomenon. This study sought to identify important factors affecting morale in psychiatry residency training. METHODS: The authors conducted four semi-structured focus groups at a moderately sized, urban, psychiatry residency program during the 2013-2014 academic year. They used qualitative data analysis techniques, including grounded theory and content analysis, to identify key themes affecting resident morale across training levels. RESULTS: Twenty-seven residents participated in the focus groups with equal distribution across post-graduate years (PGY) 1-4. Five major conceptual categories affecting resident morale emerged: Sense of Community, Individual Motivators, Clinical Work, Feeling Cared For, and Trust in the Administration. CONCLUSIONS: Morale is an important topic in residency education. The qualitative results suggest that factors related to a Sense of Community and Individual Motivators generally enhanced resident morale whereas factors related to a lack of Feeling Cared For and Trust in the Administration tended to contribute to lower morale. The authors describe the possible interventions to promote stronger program morale suggested by these findings.

Assessing endoscopic colorectal screening adherence in an emergency department population.

OBJECTIVES: Colorectal cancer (CRC) has the second highest cancer-related mortality rate in the United States. However, CRC screening rates, particularly by endoscopy, are dismally low. The purpose of this study is to determine the factors associated with adherence to endoscopic screening using the emergency department (ED) population. METHODS: Structured interviews in English or Spanish were administered to 122 patients, aged > or =50 in the ED of an urban academic medical center. Questions focused on sociodemographic and medical factors, knowledge deficits and attitudes towards screening as well as psychosocial factors that may be associated with screening adherence. Compliance with current screening guidelines was measured by self-report. RESULTS: The population was sociodemographically diverse. There were significant differences across ethnic groups with regards to awareness and attitudes toward screening as well participation in screening. Age >65, Spanish language during the interview, white ethnicity and having a primary care physician were significant correlates of adherence to screening colonoscopy. Once decisional balance (conspros) was entered into the model, the other factors were no longer significant. Furthermore, physician referral was the strongest correlate of adherence to endoscopic screening. CONCLUSIONS: There are significant sociodemographic, medical and psychosocial barriers preventing CRC screening adherence in ED patients, yet the strongest correlate is physician referral. The ED encounter may serve as an opportunity to provide information and referral for CRC screening.

Alcohol-related problems: emergency physicians' current practice and attitudes.

To determine whether emergency physicians' (EPs) attitudes affect their support and practice of brief intervention in the Emergency Department (ED), EPs completed an anonymous survey. EPs were asked about their attitudes toward patients with alcohol problems, current ED screening, use of brief intervention, and barriers to use of brief intervention. Chi-square analysis was used and a step-wise regression model was constructed. Respondents reported a high prevalence of patients with alcohol-related problems: 18% in a typical shift. Eighty-one percent said it is important to advise patients to change behavior; half said using a brief intervention is important. Attending physicians had significantly less alcohol education than residents, but were significantly more likely to support the use of brief intervention. Support was not associated with gender, race, census, hours of education, or personal experience. EPs who felt that brief intervention was an integral part of their job were more likely to use it in their daily practice.

Communicating with subjects: special challenges for resuscitation research.

In May 2005, Academic Emergency Medicine sponsored a one-day consensus conference held in association with the 2005 Society for Academic Emergency Medicine meeting in New York City. The conference, entitled "Ethical Conduct of Resuscitation Research," addressed a variety of issues regarding the successful conduct of research in acute care settings. A number of important breakout sessions were convened based on challenges specific to resuscitation research. "Communicating with Subjects" was one such session, dedicated toward perfecting the conduct of informed consent for research. The breakout session was attended by 15 insightful emergency medicine investigators, administrators, and ethicists. Issues of research information disclosure, subject comprehension, and the voluntariness of research participation were addressed. Consensus statements were developed and are discussed within this report.

Research without consent: community perspectives from the Community VOICES Study.

OBJECTIVE: To explore community attitudes toward the federal regulations that allow investigators to conduct emergency research without obtaining informed consent from participants. METHODS: Focus-group participants were recruited from residential sites in New York City that were enrolled in the Public Access Defibrillation (PAD) Trial. The PAD Trial, a National Institutes of Health-funded, randomized trial in which laypersons were trained to treat cardiac arrest, was granted an exception from informed consent under these rules. Community residents and those who had been trained as lay responders in the PAD Trial were asked about the ethical issues raised by the conduct of research without consent (RWC), their definition of community, and appropriate methods of community consultation regarding RWC studies. Grounded theory content analyses were conducted on focus-group data. RESULTS: Seventeen (40%) men and 25 (60%) women from 15 buildings participated in six focus groups: four in English; two in Spanish. Definitions of "community" varied widely among and across groups; no strategy for community consultation was consistently endorsed by the participants. There were significant support and occasional adamant opposition to conducting RWC; participants often recounted specific personal experiences as the basis for both positive and negative opinions. Individuals with negative attitudes toward RWC often voiced strong support for specific RWC scenarios. CONCLUSIONS: There is no consensus regarding the definition of "community" or appropriate methods of consultation. Community members' attitudes toward RWC are often shaped by their personal experiences, and their general attitudes often differ from their reactions to specific RWC protocols.

Implementation of community-based public access defibrillation in the PAD trial.

BACKGROUND: The Public Access Defibrillation (PAD) Trial was a randomized, controlled trial designed to measure survival to hospital discharge following out-of-hospital cardiac arrest (OOH-CA) in community facilities trained and equipped to provide PAD, compared with community facilities trained to provide cardiopulmonary resuscitation (CPR) without any capacity for defibrillation. OBJECTIVES: To report the implementation of community-based lay responder emergency response programs in 1,260 participating facilities recruited for the PAD Trial in the United States and Canada. METHODS: This was a descriptive study of the characteristics of participating facilities, volunteers, and automated external defibrillator (AED) placements compiled by the PAD Trial, and a qualitative study of factors that facilitated or impeded implementation of emergency lay responder programs using focus groups of PAD Trial site coordinators. RESULTS: The PAD Trial enrolled 1,260 community facilities (14.8% residential), with 20,400 lay volunteers (mean +/- standard deviation = 13.4 +/- 10.7 per facility) trained to respond to OOH-CA. The 598 locations randomized to receive AEDs required 2.7 +/- 1.8 AEDs per facility. Volunteer attrition was high, 36% after two years. Barriers to recruitment and implementation included identification of appropriate "at-risk" facilities, lack of interest or fear of litigation by a facility key decision maker, lack of motivated potential volunteer responders, training and retraining resource requirements, and lack of an existing communication/response infrastructure. CONCLUSIONS: These data indicate that implementation of community-based lay responder programs is feasible in many types of facilities, although these programs require substantial resources and commitment, and many barriers to implementation of effective PAD programs exist.

How patients and visitors to an urban emergency department view clinical research.

OBJECTIVES: To assess views about clinical research, drawing current opinion from an urban, largely minority population within the authors' emergency department (ED). METHODS: Two focus groups of ED patients and visitors were conducted. These data informed the development of a 27-item interview examining views about clinical research and knowledge of human subjects protections. RESULTS: The authors interviewed a total of 172 patients and visitors within an adult ED. Study participants reflected the diverse patient population: 38% were African American, 32% Hispanic, 25% white, and 6% other. When asked why one might choose to participate in medical research, 46% said to benefit mankind, 26% said to improve one's own health, 18% cited access to medical care, 17% said financial incentive, and 11% said curiosity. When asked why one might decline research participation, 38% cited fear, 24% cited lack of interest in research, 10% cited medical mistrust, 9% indicated not wanting to feel like a "guinea pig," 6% indicated lack of time, and 5% suggested privacy concerns. When asked about the meaning of informed consent, 32% did not know. Many respondents (26%) were unaware that they could withdraw from a study. Although the majority (96%) endorsed a statement about the potential benefit of research for themselves or their loved ones, a sizable proportion of respondents (49%) equated research subjects to "human guinea pigs." CONCLUSIONS: Although many individuals tend to view clinical research favorably, a level of medical mistrust exists. The concerns about human experimentation and the limited understanding of human subject protections underscore the need to improve informed consent.