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.

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.

A paradigm for understanding trust and mistrust in medical research: The Community VOICES study.

Background: To promote justice in research practice and rectify health disparities, greater diversity in research participation is needed. Lack of trust in medical research is one of the most significant obstacles to research participation. Multiple variables have been identified as factors associated with research participant trust/mistrust.

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.

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.

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.

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.

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.

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.

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.

The effects of pyruvate supplementation on body composition in overweight individuals.

A 6-wk, double-blinded, placebo-controlled study was done to ascertain the effects of pyruvate supplementation (6 g/d) on body weight, body composition, and vigor and fatigue levels in healthy overweight Caucasian men and women. Twenty-six individuals were randomly assigned to a placebo group (seven men, seven women) and a pyruvate-supplemented group (three men, nine women). In addition, all subjects participated in a 3 d/wk exercise program, which consisted of a 45-60 min aerobic/anaerobic routine.

Abnormalities of serum amylase and lipase in HIV-positive patients.

Objective: We sought to study asymptomatic pancreatic enzyme abnormalities in patients with human immunodeficiency virus (HIV) infection.

Methods: Serial serum amylase and lipase determinations were performed in ambulatory HIV-seropositive patients in whom pancreatitis was not suspected.

Results: Eighty-six patients were enrolled in the study.

Linking women in jail to community services: factors associated with rearrest and retention of drug-using women following release from jail.

Women in jail experience high rates of many health and social problems. This study examined the effects of preexisting social and health characteristics and the type of services received on retention in community aftercare for 193 drug-using women released from the New York City jail to two low-income communities. Rearrest rates for program participants were compared to a group of women not eligible for services because of their residence outside the target communities.

Recovery time and safe discharge of endoscopy patients after conscious sedation.

The aim of this study was to identify the best method for determining when to safely discharge the endoscopy patient; specifically, it was designed to determine whether the patient's risk factors, intraoperative occurrences, and/or medications used during endoscopy should be used to determine the minimum length of stay postconscious sedation or whether a general policy can be used, as is currently practiced at many institutions. Preoperative, intraoperative, and postoperative data were collected on a convenience sample of 405 adult ambulatory outpatients undergoing upper endoscopy and/or colonoscopy. Subjects were also interviewed by phone within 48 hours of discharge to assess postdischarge complications and their duration.

Psychiatric comorbidity among hospitalized AIDS patients vs. non-AIDS patients referred for psychiatric consultation.

Data were collected on 3,420 psychiatric consultations from July 1, 1989, to January 1, 1994, of which 675 were for patients identified as infected with the human immunodeficiency virus (HIV). Comparisons of psychiatric comorbidity among persons with AIDS (PWAs), HIV+ asymptomatic patients, and non-HIV patients were made. Dementia was a significantly frequent comorbid diagnosis among the referred PWAs compared with the general consultation population and was related to older age.

Tolerance of initial diphtheria-tetanus-pertussis immunization in preterm infants.

With the use of neurologic examinations, cranial sonograms, electroencephalograms, an cry analyses, we assessed neurologic function before and after an initial diphtheria-tetanus-pertussis immunization in 22 very low birth weight infants. Mean birth weight was 1036 +/- 137 gm; mean gestational age was 28.0 +/- 1.

Impact of endocrine and diabetes team consultation on hospital length of stay for patients with diabetes.

Purpose: To determine whether consultation by an individual endocrinologist or by a multidisciplinary diabetes team (endocrinologist, diabetes nurse educator, and registered dietitian) can impact length of hospital stay of patients with diabetes.

Patients And Methods: Hospital stays of consecutive patients with a principal diagnosis of diabetes were compared. Forty-three patients were seen by an individual endocrine consultant and 27 were managed by the internist alone.

Patient knowledge about electroconvulsive therapy: effect of an informational video.

We wished to ascertain whether the addition of an informational video to the informed consent procedure for electroconvulsive therapy (ECT) results in improved patient knowledge about ECT. Eighteen ECT patients were randomized to consent using the usual written document or using the written document and an informational video. The two groups were similar when compared on demographic variables and scores on the Brief Psychiatric Rating Scale (BPRS) and Mini-Mental State Examination (MMSE).