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A gene locus for progressive familial heart block type II (PFHBII) maps to chromosome 1q32.2-q32.3.

Cardiac conduction defects that are associated with dilated cardiomyopathy (DCM) are generally considered to be sporadic clinical entities, although familial forms of disorders with these clinical features have been identified in a number of families in different countries. An autosomal dominant cardiac disorder characterised by conduction abnormalities and DCM, termed progressive familial heart block type II (PFHBII) (OMIM 140400), has been described in a South African Caucasian family of Northern European descent. Known candidate loci for isolated conduction disorders, isolated DCM and conduction disorders complicated by DCM were excluded from disease causation in this family by linkage analysis, with the exception of the DCM-associated (CMD1D) locus on chromosome 1q32, where a maximum multipoint lod score of 3.7 in the interval between D1S3753 and D1S414, was generated. This region encompassed the troponin T gene (TNNT2), however, genetic fine mapping and haplotype analysis excluded TNNT2 as cause of PFHBII and placed the disease-causative gene within a 3.9 cM (2.85 Mb) interval, flanked by D1S70 and D1S505. Analysis of KCNH1, KIAA0205, LAMB3 and PPP2R5A, which map within the critical interval, indicated that the PFHBII-causative mutation does not lie within the coding regions or splice junctions of these plausible candidate genes. The data indicate the existence of a novel locus involved in the pathogenesis of cardiac conduction abnormalities and DCM.

Chromosome Mapping↗

Principles of good clinical practice (GCP) in clinical research.

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

Clinical Trials as Topic↗

Evaluation of the bacteriological quality of seafood.

Bacteria largely determine the quality of fresh and lightly preserved fish products. This paper surveys traditional and rapid methods for estimation of bacterial levels in seafood. The use of traditional agar techniques is discussed with reference to development of substrates and procedures suited for fish and fish products. This includes estimation of the bacteria specifically involved in the spoilage process. During the last decade, several microbiological rapid methods or principles (DEFT, microcolonies, Limulus lysate, ATP, conductance, microcalorimetry, reduction of trimethylamine oxide (TMAO)) have been suggested for estimating the bacteriological quality of seafoods. A brief survey of these methods and the results obtained is given. Preliminary results on development of poly- and monoclonal antibodies against Shewanella putrefaciens are mentioned. Future research may involve the development of DNA-probes against genes coding for specific spoilage reactions.

Agar↗

The ethical use of placebo controls in clinical research: the Declaration of Helsinki.

Medical ethicists have questioned the use of no-treatment (placebo and sham procedure) controlled studies of new therapies when safe and effective standard therapies are available for use as an active or "equivalence" control. Current ethical principles of conduct for biomedical research specifically prohibit designs that withhold or deny "the best proven diagnostic and therapeutic" treatment to any participant in a clinical study, including those individuals who consent to randomization into a control group. Studies of psychophysiological therapies are often criticized on the grounds they lack a placebo or sham treatment control group. This paper briefly reviews the history of the problem and discusses the ethical standards that govern human research as derived from the Nuremberg Code and the Declaration of Helsinki. An examination of the problem with regard to research involving EEG biofeedback therapy for Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, and depression serves to highlight the issues. It is concluded that the active treatment control (treatment equivalence) design is most appropriate for those clinical studies examining disorders for which there is a known, effective treatment. Sham- or placebo-controlled studies are ethically acceptable for those disorders for which no effective treatment is available.

Biofeedback, Psychology↗

Workplace-violence investigations by the California Division of Occupational Safety and Health, 1993-1996.

In response to the growing recognition of violence in the workplace, government agencies who oversee workplace safety are beginning to incorporate security issues into comprehensive safety plans. The California Division of Occupational Safety and Health began conducting inspections for violent events in 1993, and information from these security inspections was collected from January 1993 through January 1997. The inspections were examined by initiating source, industry, type of event, and citations issued and compared with distributions of known victimizations. The factors predicting whether a citation was issued were determined through logistic models. Over 200 inspections were conducted in 11 industries, with retail and health care establishments inspected most frequently. Employee complaints initiated 50.6% of events and accident reports initiated 40.1%. One third of inspections were initiated because of a fatal event, and 27.4% were initiated in response to a physical assault. Citations for security hazards were issued to 23.6% of businesses. Inspections initiated by employee complaints, in response to customer-related security issues, and involving non-fatal assaults were the most frequently cited reasons for inspection. The California Division of Occupational Safety and Health conducted security inspections in a large range of industries and for diverse issues, even though no specific security codes exist.

Accidents, Occupational↗

Why do the elderly seek or avoid care? A qualitative analysis.

BACKGROUND AND OBJECTIVES: This study attempts to understand why the elderly seek or choose not to seek health care. Most studies on barriers to health care have measured obstacles defined by the researchers. We attempt to define variables that are relevant to the elderly but have not yet been articulated. METHODS: Using grounded theory, open-ended interviews of 15 non-housebound elderly were conducted and coded. The data obtained were analyzed to discover and characterize the subjects' perceptions of barriers. RESULTS AND CONCLUSIONS: The major theme that emerged involved the interactions among autonomy, self-esteem, and the degree of illness or health. The study generated two hypotheses: 1) Self-esteem is directly correlated with the willingness of the elderly to seek care, especially as illness increases and autonomy decreases. 2) The individual's perception of health status, the perceived roles of the physician and the patient, the physician-patient relationship, and systems issues contribute to the dynamic paradigm that positions the elderly patient to seek or avoid seeking health care.

Aged↗

Deception research involving children: ethical practices and paradoxes.

This commentary draws on the thoughtful contemplation and innovative procedures described in the special section articles as well as current professional codes and federal regulations to highlight ethical practices and paradoxes of deception research involving children. The discussion is organized around 4 key decision points for the conduct of responsible deception research involving children: (a) evaluating the scientific validity and social value of deception research within the context of alternative methodologies, (b) avoiding and minimizing experimental risk, (c) the use of child assent procedures as questionable ethical safeguards, and (d) debriefing as both remedy and risk.

Behavioral Research↗

A study of nurses' knowledge of the UKCC code of conduct.

This study investigated nurses' and midwives' knowledge of the Code of Professional Conduct (UKCC 1992). Knowledge was assumed to be dependent on practitioners' abilities to identify correctly authentic statements and to discriminate against statements which were constructed as distracters. Generally, there was a relatively high mean of correct identification. Certain spheres of responsibility were more likely to be identified than others. These areas involved statements that were practitioner-centred and occurred early in the code. The authors recommend further research into nurses' understanding of the code.

Community Health Nursing↗

Medical internet ethics: a field in evolution.

As in any new field, the merger of medicine, e-commerce and the Internet raises many questions pertaining to ethical conduct. Key issues include defining the essence of the patient-provider relationship, establishing guidelines and training for practicing online medicine and therapy, setting standards for ethical online research, determining guidelines for providing quality healthcare information and requiring ethical conduct for medical and health websites. Physicians who follow their professional code of ethics are obligated not to exploit the relationship they have with patients, nor allow anyone else working with them to do so. Physicians and therapists are obligated to serve those who place trust in them for treatment, whether in face-to-face or online Internet encounters with patients or clients. This ethical responsibility to patients and clients is often in direct conflict with the business model of generating profits. Healthcare professionals involved in Medical Internet Ethics need to define the scope of competent medical and healthcare on the Internet. The emerging ethical issues facing medicine on the Internet, the current state of medical ethics on the Internet and questions for future directions of study in this evolving field are reviewed in this paper.

Confidentiality↗

Ethical conduct recommendations for quality improvement projects.

The distinction between QI, research, and clinical care projects has never been clear. However, QI projects may raise ethical concerns, and organizations need to ensure that patients involved in QI projects are adequately protected. The recommendations within the VHA report are intended as a starting point for dialogue to provide guidance for the responsible ethical conduct of QI projects. Discussion and oversight will need to occur at several levels within organizations to ensure ethical care is being provided.

Codes of Ethics↗

The attending round observation system.

Two separate reliability studies were conducted on an observational instrument derived from previous qualitative research and designed for collecting data on teaching behaviors demonstrated by attending physicians during attending rounds. The first study involved five observers coding 17 20-minute, videotaped segments of attending rounds. The second study involved two observers coding 27 two-hour attending round sessions as they occurred live on hospital wards. The reliability estimates from both studies were quite high, indicating that the instrument shows promise for use in both research and evaluation studies.

Evaluation Studies as Topic↗

The Nuremberg Code and the Nuremberg Trial. A reappraisal.

The Nuremberg Code includes 10 principles to guide physician-investigators in experiments involving human subjects. These principles, particularly the first principle on "voluntary consent," primarily were based on legal concepts because medical codes of ethics existent at the time of the Nazi atrocities did not address consent and other safeguards for human subjects. The US judges who presided over the proceedings did not intend the Code to apply only to the case before them, to be a response to the atrocities committed by the Nazi physicians, or to be inapplicable to research as it is customarily carried on in medical institutions. Instead, a careful reading of the judgment suggests that they wrote the Code for the practice of human experimentation whenever it is being conducted.

Codes of Ethics↗

[Development of bioethics. Analysis of practices in 20 hospital departments].

OBJECTIVE: In order to analyze the constitution and management of DNA banks and the limitations on procedures currently used in France, we conducted a study in a sample of French hospital units. A DNA bank was defined as any facility where individual samples of DNA, irrespective of the form, are stored for ongoing or future gene studies. The aim of this work was to focus attention on the need for in-depth thought on the ethical issues involved in storing and using DNA as part of everyday clinical practice and research and to provide elements for a debate on the interest and limitations of the French bioethics laws whose revision is currently being considered. METHODS: A questionnaire was sent to the heads of departments in two university hospitals. Five areas were retained for evaluation: the nature and degree of DNA storage activities, procedures followed for reporting the DNA bank, procedures used to protect confidentiality, information given to patients and procedures used for informed consent, and finally, internal rules governing the bank's operation. The answers to the questionnaires were analyzed anonymously. RESULTS: Among 20 hospital units collecting DNA samples, 70% also stored other samples (DNA, blood, tissue, cell lines) including a large proportion of tissue samples. These samples were collected for purposes of fundamental research and clinical practice. The number of samples stored was quite variable, ranging from a few dozen samples to more than 40,000. Only 55% of the units had reported the facility to a control body, in compliance with current law. Seventy percent maintained computerized data bases but only 50% used an anonymous code. Seventy-five percent obtained written consent but patients were not always informed of the site of the storage or the transfer of their DNA. In addition, the validity of the consent over time, the duration of storage and the types of studies that could be conducted on the DNA were poorly detailed. Internal rules governing the bank's activities were not implemented by most of the units (65%). CONCLUSION: The responses to our questionnaire survey show that there is currently a gap between everyday practice and regulatory procedures concerning DNA banks in France. Further analysis of current practices would appear to be necessary so professionals could become more aware of the human and social issues involved with the use of DNA banks. These data on everyday practices should be made available to health care workers, public officials and law makers in order to promote ethical practices that, as has been observed, are not dictated solely by legislation which often lags behind everyday activities. All those involved in the management of DNA banks must be aware of their responsibilities in protecting patients' rights within the framework of a system based on information, consent, and over-the-board trustworthiness regularly submitted to short and long term assessments. A correct response to ethical issues is the only means of developing a real process of social interaction which cannot be achieved by revision of the bioethics laws alone.

Confidentiality↗

Use of the veterans history project to assess World War II veterans' perceptions of military experiences and health.

OBJECTIVE: This qualitative research study evaluated the attitudes, perceptions, and opinions of World War II veterans regarding the health impact of their military service. METHODS: The study design involved adding relevant health questions to the interview format developed by the ongoing Veterans History Project, a military oral history depository directed and maintained by the U.S. Library of Congress. Audiotaped interviews conducted with individuals and a focus group were coded and evaluated. Key informants provided background information. RESULTS: Findings included a general consensus among participants that military service during World War II was beneficial to their health. Preventive health practices were instilled as lifelong habits, as were feelings of self-confidence and independence. The Veterans Administration was viewed positively by respondents but was not used to any great extent. CONCLUSIONS: Current good health and feelings of patriotism, duty, and selflessness may underlie expressed positive attitudes about the health impact of service during World War II.

Aged↗

Human subjects--are they protected?

From the time of Hippocrates, physicians have sworn to "abstain from all intentional wrongdoing and harm," (Lifton, 1986). They are guided by ethical principles and theories that are intended to help them in their practice of medicine and scientific research. The purpose of this paper was to define research and human subjects, to review cases of abuse, address benefits and risks of human experimentation, discuss regulations governing experiments on humans, and address ethical principles and theories regarding this type of research. Human experimentation is an important activity of great societal benefit that must be conducted in a manner consistent with basic societal beliefs and values about the rights and worth of an individual (Gray, 1975). Ethical issues in human experimentation defy definite solutions, and the problems involved in human experimentation will almost certainly continue to receive active attention in future years.

Bioethical Issues↗

'How can they tell?' A qualitative study of the views of younger people about their dementia and dementia care services.

There is growing interest in eliciting the views of younger people with dementia (i.e. those under 65 years of age) within health and social care research. The often erroneous view that these individuals are not capable of expressing their views and experiences has now been seriously challenged. The present paper draws on the findings from 14 qualitative in-depth interviews with younger people with dementia conducted in the South-west of England, and considers some of the issues involved in interviewing people with dementia. Purposive and snowballing techniques were used to recruit participants. Data were transcribed and subjected to comparative textual analysis to index, code and analyse the data for emergent themes. Four major themes emerged: (1) the general experience of having dementia; (2) dementia diagnosis; (3) the importance of age; and (4) risk and danger issues. The results indicate that the majority of participants were articulate and insightful about their experiences and needs. The present paper concludes by arguing that the challenge for health and social care professionals is to engage with and consult such individuals about their experiences and what they want from dementia care services, and the authors consider some of the issues involved in interviewing people with dementia.

Adult↗

Bone morphogenetic protein 15 (BMP15) alleles predict over-response to recombinant follicle stimulation hormone and iatrogenic ovarian hyperstimulation syndrome (OHSS).

OBJECTIVE: Controlled ovarian stimulation (COS) using recombinant follicle-stimulating hormone (rFSH) is the main treatment in assisted reproduction. We performed a pharmacogenetic analysis of bone morphogenetic protein 15 (BMP15) gene using single nucleotide polymorphisms (SNPs) in COS. We also investigated the role of the BMP15 gene in ovarian hyperstimulation syndrome (OHSS). METHODS: We analysed different intragenic SNPs located within the BMP15 gene in 307 women treated with rFSH, evaluating its involvement in COS outcome. RESULTS: First, we analysed two polymorphisms, by applying different tests for genetic association, and we found a minimum P-value in patients producing > or =12 follicles in COS (high responders) in both polymorphisms of the BMP15 gene. Using bi-directional DNA sequencing, we identified two additional single nucleotide DNA variants. Second, we conducted association studies with all polymorphisms together, and noticed that none of them seemed to fully explain the association of the BMP15 gene with over-response to rFSH. However, N103S missense mutation is predicted to disrupt the secondary structure of human BMP15 protein and is weakly associated with OHSS. This coding mutation of the BMP15 gene may partially explain the results obtained during our research. Using Thesias software, we reconstructed haplotypes with the four intragenic variants and calculated their frequencies in normal and over-responders to rFSH. The haplotype TGGA was over-represented in high responders when compared with the rest of patients. Moreover, this association was higher in patients with OHSS, with a significant global haplotypic effect of the BMP15 gene. CONCLUSION: Our results suggest a direct relationship between increased follicle production during COS and BMP15 alleles in response to rFSH in humans. The use of BMP15 markers to prevent OHSS is also a possibility that requires thorough evaluation.

Adult↗

Divorce transition differences of midlife women.

Divorce transition experienced by and its influence upon midlife women's health is not fully understood. Interviews were conducted with 24 divorced women who self-classified into decider status groups: initiator (who first decided to end marriage), non-initiator (recipient of end of marriage decision), and mutual decider (shared decision to end marriage). Interpretive content analysis involving pattern coding was conducted. The divorce transition by initiators (n=8) included self-focused growth, optimism, and social support losses and opportunities, while the divorce transition by non-initiators (n=8) included being left, ruminating, vulnerability, and spiritual comfort. No profile emerged for the mutual-decider group (n=8). This study supports that differences in divorce transition exist for initiators and non-initiators.

Adaptation, Psychological↗