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At least 19 recordsLinked to original sources
PubMed2006

Ethical process in human research published in thoracic surgery journals.

BACKGROUND: Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002. METHODS: We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852). RESULTS: Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%). CONCLUSIONS: There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

Bibliometrics↗
PubMed2001

The Aberdeen Indian Health Service infant mortality study: design, methodology, and implementation.

Of all Indian Health Service areas, the Aberdeen Area has consistently had the highest infant mortality rate. Among some tribes in this area the rate has exceeded 30/ 1000 live birth and half the infant deaths have been attributed to Sudden Infant Death Syndrome,a rate four to five times higher than the national average. The Indian Health Service, Centers for Disease Control and Prevention, National Institute of Child Health and Human Development, and the Aberdeen Area Tribal Chairmen's Health Board collaborated to investigate these high rates with the goals of refining the ascertainment of the causes of death, improving cause-specific infant mortality rates and identifying factors contributing to the high rates. Ten of the 19 tribes or tribal communities, representing 66%of the area population, participated in a 4-year prospective case-control study of infants who died after discharge from the hospital. Infant care practices and socio-demographic, economic, medical, health care, and environmental factors were examined. The study included parental interviews, death scene investigations, autopsies, neuropathology studies, medical chart abstractions, blood cotinine assays, and a surveillance system for infant deaths. Controls were the previous and subsequent infants born on the case mother's reservation. From December 1,1992 until November 30,1996,72 infant deaths were investigated. This report describes the study methods and the model employed for involving the community and multiple agencies to study the problem of infant mortality among Northern Plains Indians. Data gathered during the investigations are being analyzed and will be published at a later date.

Case-Control Studies↗
PubMed2002

Human factors in aviation crashes involving older pilots.

BACKGROUND: Pilot errors are recognized as a contributing factor in as many as 80% of aviation crashes. Experimental studies using flight simulators indicate that due to decreased working memory capacity, older pilots are outperformed by their younger counterparts in communication tasks and flight summary scores. OBJECTIVE: This study examines age-related differences in crash circumstances and pilot errors in a sample of pilots who flew commuter aircraft or air taxis and who were involved in airplane or helicopter crashes. METHODS: A historical cohort of 3306 pilots who in 1987 flew commuter aircraft or air taxis and were 45-54 yr of age was constructed using the Federal Aviation Administration's airmen information system. Crash records of the study subjects for the years 1983-1997 were obtained from the National Transportation Safety Board (NTSB) by matching name and date of birth. NTSB's investigation reports were reviewed to identify pilot errors and other contributing factors. Comparisons of crash circumstances and human factors were made between pilots aged 40-49 yr and pilots aged 50-63 yr. RESULTS: A total of 165 crash records were studied, with 52% of these crashes involving pilots aged 50-63 yr. Crash circumstances, such as time and location of crash, type and phase of flight, and weather conditions, were similar between the two age groups. Pilot error was a contributing factor in 73% of the crashes involving younger pilots and in 69% of the crashes involving older pilots (p = 0.50). Age-related differences in the pattern of pilot errors were statistically insignificant. Overall, 23% of pilot errors were attributable to inattentiveness, 20% to flawed decisions, 18% to mishandled aircraft kinetics, and 18% to mishandled wind/runway conditions. CONCLUSIONS: Neither crash circumstances nor the prevalence and patterns of pilot errors appear to change significantly as age increases from the 40s to the 50s and early 60s.

Accidents, Aviation↗
PubMed2003

Research ethics and consent in the intensive care unit.

PURPOSE OF REVIEW: The subject of research ethics and informed consent in the ICU has recently received unprecedented attention during the past year, the reasons for which are reviewed herein. RECENT FINDINGS: The controversy over research design and informed consent issues in studies conducted by the Acute Respiratory Distress Syndrome Network in the United States have been responsible for much of the attention on research ethics. So has the draft directive to create a harmonization of the provisions governing clinical trials within the European Union. These and other factors have prompted renewed interest in the proper design of clinical trials, the difficulty of obtaining informed consent for research from critically ill patients and their surrogates, conflicts of interest on the part of investigators and their institutions, the need for improving institutional protections for human subjects, and the desirability of clarifying the investigator-subject relationship. SUMMARY: Clinical trials should compare new therapies with "standard" ones if a standard of care exists. Surrogate consent is required for research involving most critically ill subjects, and state laws in the United States and national statutes in Europe should reflect this requirement. Conflicts of interest should be identified at both the individual and the institutional levels. Institutional review boards should focus on ethical issues after conflicts of interest are evaluated. Making the investigator-subject relationship transparent should help protect subjects.

Conflict of Interest↗
PubMed1984

Predictors of performance on National Board Examinations Part II.

An effort was made to determine successful predictors of performance on National Board Examinations Part II. Preliminary results, using stepwise regression analysis, identified two predictor variables accounting for 65 percent of the variance in the criterion variable. Cross-validation regression analysis again identified the same two predictor variables accounting for 69 percent of the variance in the criterion variable. In both investigations, the correlation coefficients for the predicted National Board averages and the actual National Board averages are statistically significant. Implications of the studies are discussed.

Certification↗
PubMed2006

Children as research subjects: moral disputes, regulatory guidance, and recent court decisions.

The millennium has ushered in a new era of oversight for pediatric research, with renewed moral and legal attention to the upper thresholds of potential harms to which children may be exposed in studies. Watershed events discussed include: First, the deaths of two research subjects, allegedly due to insufficient oversight by the investigators and their institutional review boards. Second, the courts expressed concerns about research policies for incompetent persons or children in two cases, T.D. v. N.Y. and Grimes v. Kennedy Krieger Institute, and reinforcement of the principle that the best interest standard must be used for incompetent persons even in research. Third, the Best Pharmaceutical for Children Act and the Pediatric Rule created incentives as well as uncertainty among Institutional Review Boards and researchers about conducting pediatric studies. Fourth, the Office of Human Research Protection signaled the start of more rigorous oversight with its public rebuke and suspension of a National Institute of Child Health and Human Development pediatric obesity study. Failure to clarify the meaning of the pediatric regulations has sometimes misled generally risk-averse institutions and dedicated investigators about what is permissible.

Biomedical Research↗
PubMed2002

Community involvement in the ethical review of genetic research: lessons from American Indian and Alaska Native populations.

The National Bioethics Advisory Commission has proposed that regulatory oversight for research with human subjects be extended beyond the protection of individual research participants to include the protection of social groups. To accomplish this, the commission recommends that investigators and ethics review boards a) work directly with community representatives to develop study methods that minimize potential group harms, b) discuss group implications as part of the informed consent process, and c) consider group harms in reporting research results. We examine the utility of these recommendations in the context of research with American Indian and Alaska Native communities. Because much attention has been given to the question of how best to consult with members of these communities in the design and conduct of research, we believe it behooves investigators to consider the lessons to be learned from research involving American Indians and Alaska Natives. After describing several difficulties surrounding the application of the commission's approach to these research contexts, we propose a research agenda to develop best practices for working with local communities in the ethical assessment of epidemiologic and environmental health research.

Alaska↗
PubMed1995

Cloning without prior approval: a response to recent disclosures of noncompliance.

In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994. In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.

Clone Cells↗
PubMedDate not supplied

New challenges for Life Sciences flight project management.

Scientists have conducted studies involving human spaceflight crews for over three decades. These studies have progressed from simple observations before and after each flight to sophisticated experiments during flights of several weeks up to several months. The findings from these experiments are available in the scientific literature. Management of these flight experiments has grown into a system fashioned from the Apollo Program style, focusing on budgeting, scheduling and allocation of human and material resources. While these areas remain important to the future, the International Space Station (ISS) requires that the Life Sciences spaceflight experiments expand the existing project management methodology. The use of telescience with state-the-art information technology and the multi-national crews and investigators challenges the former management processes. Actually conducting experiments on board the ISS will be an enormous undertaking and International Agreements and Working Groups will be essential in giving guidance to the flight project management Teams forged in this matrix environment must be competent to make decisions and qualified to work with the array of engineers, scientists, and the spaceflight crews. In order to undertake this complex task, data systems not previously used for these purposes must be adapted so that the investigators and the project management personnel can all share in important information as soon as it is available. The utilization of telescience and distributed experiment operations will allow the investigator to remain involved in their experiment as well as to understand the numerous issues faced by other elements of the program The complexity in formation and management of project teams will be a new kind of challenge for international science programs. Meeting that challenge is essential to assure success of the International Space Station as a laboratory in space.

Aerospace Medicine↗
PubMed2005

Characteristics of alcohol-related fatal general aviation crashes.

BACKGROUND: The effects of alcohol on piloting performance have been studied extensively. Information describing alcohol-related aviation crashes, however, is scant. METHODS: We developed a data system for fatally injured pilots in Maryland, New Mexico, and North Carolina by linking autopsy data from the state medical examiner offices and crash investigation reports from the National Transportation Safety Board. Alcohol-related crashes are defined as those in which the pilot had a blood alcohol concentration of 20 mg/dL or greater. Differences between alcohol- and non-alcohol-related crashes were assessed with regard to pilot characteristics, crash circumstances, and human factors. RESULTS: The National Transportation Safety Board recorded 313 general aviation crashes fatal to the pilot in the three states between 1985 and 2000. Of these crashes, 255 (81%) were matched successfully with medical examiner records. Alcohol testing results were available for 233 of the fatally injured pilots. Of those tested for alcohol, 25 (11%) had blood alcohol concentrations > or =20 mg/dL (mean=75 +/- 64 mg/dL). The majority of alcohol-related crashes (52%) occurred at night (7p.m. to 6a.m.), compared with 28% of other crashes (P < 0.01). Alcohol-related crashes were significantly more likely than other crashes to have involved continued flight under visual flight rules (VFR) into instrument meteorological conditions (IMC) (32% versus 12%, P < 0.01), and flawed decisions (64% versus 41%, P = 0.03). CONCLUSIONS: Distinctive epidemiological patterns are exhibited in alcohol-related fatal general aviation crashes. Alcohol appears to play a particularly important role in crashes involving flight under VFR into IMC.

Accidents, Aviation↗
PubMed1993

Nurses on hospital IRBs: a critical voice in protecting human subjects.

The nature and extent of nurses' participation on hospital institutional review boards (IRBs) has not previously been investigated. This descriptive study provides some insights into the characteristics of nurses serving on IRBs and describes the IRBs on which they serve. The nurses are typically master's-prepared nurse managers who have served as volunteer or appointed members of the IRB for an average of 2.67 years. The IRBs have an interdisciplinary membership, and differ widely in structure and procedure, but generally, they conform to the requirements specified in the National Research Act for IRBs. The findings of this study have implications for nursing administration, practice, research, and education.

Adult↗