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Results for “Code of Conduct for Research involving Humans”

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PubMed1998

Practical knowledge in expert coaches: on-site study of coaching in sailing.

The purpose of this study was to analyze the practical knowledge of expert sailing coaches of the French team preparing for the 1996 Olympic Games in Atlanta. Coaching knowledge was studied from a cognitive ergonomics perspective based on the task activity model. According to this model, a task is a set of constraints facing individuals. To meet the demands imposed by these constraints, an individual engages in an adaptative activity which can be studied from the point of view of his or her knowledge and cognitive operating modes. In-depth interviews were conducted after observation of five training sessions, and the verbal protocols obtained were coded inductively. The results showed that coaching tasks were considered by coaches as a set of interacting constraints which generate complex, contradictory, and ill defined problems. Coaches' operating modes appeared to be based on organization routines, cognitive anticipation on flexible plans, flexible on-site adaptation, joint control of training with athletes, and involvement in the training situation based on past experiences.

Adaptation, Physiological↗

PubMed2004

Implementing the British Columbia Nutrition Survey: perspectives of interviewers and facilitators.

The British Columbia Nutrition Survey was the last of ten provincial nutrition surveys completed between 1988 and 1999. A qualitative process evaluation was conducted to identify strengths and weaknesses of British Columbia Nutrition Survey procedures, as perceived by 27 public health nurses and dietitians directly involved in data collection. Data for the process evaluation were collected through in-depth telephone interviews, during which interviewers and facilitators described their experiences working for the survey. Qualitative analysis of interview transcripts identified codes that were then organized into eight categories, including issues arising from interviewer and facilitator training, challenges in recruiting survey participants, reflections on safety for survey personnel and participants, facilitators' key role, the flexibility required to implement the protocol, and communication within the survey research team. Two final categories related to rewarding aspects of the job: insights affecting professional practice, and meeting survey participants and personnel. Evaluation findings show the importance of establishing open communication between research planners and those conducting surveys. This communication is needed to ensure that workers' needs are met, the quality of the study is maximized, and evaluations of study protocols include the perspectives of those directly involved in data collection.

British Columbia↗

PubMed2006

Nurses and the sterilization experiments of Auschwitz: a postmodernist perspective.

The medical experiments conducted on non-consenting prisoners of Nazi concentration camps during World War II necessitated the codification of principles to protect human subjects of research. Auschwitz was the largest and one of the most infamous of the camps and the site of numerous 'medical' experiments. This historical study uses primary source documents obtained from archives in England and Germany to describe one type of experiment carried out at Auschwitz - the sterilization experiments. The purpose of these experiments was to perfect a technique in which non-Aryans could be prevented from reproducing while still being able to work as slave laborers. These narratives regarding the sterilization experiments at Auschwitz are remarkable in that they contain previously undocumented information regarding the voluntary and involuntary involvement of nurses. Following these narratives, a discussion of ethics in relation to the Holocaust is presented with a specific focus on the work of Agamben. Implications of the Auschwitz narratives for the application of codes of ethical principles and contemporary nursing are discussed from a postmodernist perspective.

Codes of Ethics↗

PubMed2006

Albumin locust valley: a new case of analbuminemia.

OBJECTIVE: To discover and document cases of the rare disease analbuminemia. DESIGN AND METHODS: Blood specimens of a subject were analyzed by routine clinical laboratory procedures, by immunochemical tests for albumin, and by electrophoresis with immunofixation using anti-human serum albumin (HSA). Single-strand conformational polymorphism (SSCP), heteroduplex analysis (HA), and DNA sequencing of the 14 exons of the HSA gene were conducted on DNA from leukocytes. RESULTS: Albumin concentration was 0.003 g/L; serum globulins and cholesterol were elevated. Immunoelectrophoresis showed no trace of albumin in any of the serum components. The coding region plus all mRNA splice sites were normal and mutation-free, and SSCP and HA showed no abnormalities. CONCLUSIONS: Data define a bona fide case of analbuminemia. We suggest that the mutation causing the analbuminemic trait in this subject might involve a remote regulatory element.

Adult↗

PubMed1993

Development and testing of the autobiographical memory coding tool.

Development and testing of the autobiographical memory coding tool (AMCT) is detailed. The tool uses quantitative content analysis procedures to code interpretations of autobiographical memories as validating or lamenting. Development of a system of measuring autobiographical memories from transcribed reminiscence interviews involved defining the units of analysis, defining the categories and themes, constructing a codebook, assessing content validity, assessing reliability and making revisions. Thirty-nine transcripts of reminiscence interviews were used for tool development and testing. The AMCT contains a series of step-by-step guidelines for conducting the analysis and includes an autobiographical memory thematic dictionary and descriptions of range and variations in each theme to assist with coding data. Intercoder reliability estimates were 0.93, 0.93 and 0.95. Test-retest reliability was 1.00.

Abstracting and Indexing↗

PubMed1999

Families: accounts of the causal processes in food choice.

Much of the previous research into the processes involved in food choice has made use of methodologies that neglect the social and familial context in which such decisions are made. The study reported here used a different approach to gather qualitative data from family members regarding their decision processes in the form of naturally expressed social explanations or attributions. Interviews were conducted with 149 family members from a total of 83 British families from four locations. The participants were encouraged to discuss their own personal experience of food choice, including their dietary decisions and behaviours and the factors involved in the process, using systemic interviewing techniques. The 52 h of interview material obtained were subjected to attributional analysis using the Leeds Attributional Coding System (LACS), a qualitative research tool designed for work with families. The data, in the form of 7062 fully coded belief statements or attributions, provided some preliminary observations of the way that families understand and socially explain their food-based decisions. The approach offers a different perspective on family food choice to those provided through more traditional experimental research and surveys.

Adult↗

PubMed2004

Conducting research: practical steps.

Developing a research protocol and obtaining funding for carrying out the research are only the first steps in doing research. Understanding the means to conduct the research is equally important. As research is a joint effort of a team, a mechanism of collaboration must be developed to engage all those with an interest in the research. This includes the community in which the research is to be undertaken, representatives of those who will participate in the research, the academic community who will be involved in the research, and those who will sponsor the research. These individuals can be formed into a 'steering committee' to guide the development, conduct, analysis and communication of the research. Careful consideration must be given to the benefits and risks of the research. These must be precisely spelled out in the research protocol, and all aspects of the research must be independently evaluated for technical competence, accuracy, communication and liability for injury by an ethics review committee. The research must follow precisely the protocol developed. Administrative procedures, including recruitment and management of staff, outlining standard procedures and quality assurance procedures must be clearly outlined and followed. Carefully handling the information collected in a research project is vital to ensuring the quality and validity of the research.

Biomedical Research↗

PubMed1989

Theoretical analysis of the cognitive processing of lexical and pictorial stimuli: reading, naming, and visual and conceptual comparisons.

This article reviews the research literature on the differences between word reading and picture naming. A theory for the visual and cognitive processing of pictures and words is then introduced. The theory accounts for slower naming of pictures than reading of words. Reading aloud involves a fast, grapheme-to-phoneme transformation process, whereas picture naming involves two additional processes: (a) determining the meaning of the pictorial stimulus and (b) finding a name for the pictorial stimulus. We conducted a reading-naming experiment, and the time to achieve (a) and (b) was determined to be approximately 160 ms. On the basis of data from a second experiment, we demonstrated that there is no significant difference in time to visually compare two pictures or two words when size of the stimuli is equated. There is no difference in time to make the two types of cross-modality conceptual comparisons (picture first, then word, or word first, then picture). The symmetry of the visual and conceptual comparison results supports the hypothesis that the coding of the mind is neither intrinsically linguistic nor imagistic, but rather it is abstract. There is a potent stimulus size effect, equal for both pictorial and lexical stimuli. Small stimuli take longer to be visually processed than do larger stimuli. For optimal processing, stimuli should not only be equated for size, but should subtend a visual angle of at least 3 degrees. The article ends with the presentation of a mathematical theory that jointly accounts for the data from word-reading, picture-naming visual comparison, and conceptual-comparison experiments.

Adult↗

PubMed2004

Generalized Electronic Interviewing System (GEIS): a program and scripting method for conducting interviews in multiple modes.

A program called the Generalized Electronic Interviewing System (GEIS) was developed for conducting interviews, using computer-assisted telephone interview (CATI) and interactive voice response (IVR) modes without the need for a programmed interface. GEIS questionnaires were prepared using a common script syntax in all supported modes. Scripted development allowed for rapid interview development without the need for programming. A GEIS script specified the following: question texts, including variable texts; answer option texts; numeric codes for answers; range check information; logical question-branching information; interview status information; do-loop information; and IVR information, such as key codes and voice messages. GEIS thoroughly checked scripts for logical or syntactical errors. GEIS required SAS Version 8.0, and survey data were accumulated within SAS data sets. An application of GEIS to conduct a survey involving CATI, IVR, and a combined hybrid method is described. The CATI results deviated in the direction expected for sensitive questions, whereas IVR obtained a small sample size, rendering the results unreliable. However, the hybrid method was found to provide more accurate telephone survey data on alcohol consumption than did CATI alone. The program may be downloaded from the Psychonomic Society Web archive at www.psychonomic.org/archive/.

Electronics↗

PubMed2001

Safer sex decision-making among men with haemophilia and HIV and their female partners.

An exploratory qualitative study of adult heterosexual men with haemophilia and HIV and women who were their sexual partners was conducted as formative research to better understand cognitive factors involved in behavioural intentions and practices which comprise HIV risk-reduction for sexual transmission. The study sought to generate hypotheses, uncover themes, and develop a broad perspective on possible determinants of behaviours related to HIV transmission risk reduction. Qualitative analysis of these data served as a basis for developing a subsequent quantitative, hypothesis-testing survey and an intervention. Face-to-face interviews were conducted with 23 single men and 28 married men with haemophilia and HIV infection, and 28 married women partners selected through stratified, purposeful sampling. The interviews identified beliefs, attitudes, and values underlying decisions regarding target behaviours related to preventing sexual transmission of HIV, including (1) using condoms consistently during vaginal intercourse and (2) talking to partners about risk reduction. The interviews elicited information about perceived advantages and disadvantages of performing each of the targeted behaviours, and factors that facilitate or prevent performing them. Qualitative analysis of coded responses yielded important themes regarding how choices are made about sexual activity and safer sex. Most notably, communication between partners (1) plays a direct, key role in facilitating condom use and (2) forms the basis for maintaining emotional intimacy in these relationships. The link between condom use and communicating about safer sex was viewed as pivotal in achieving HIV prevention for individuals in serodiscordant couples. Recommendations for risk reduction intervention development are discussed.

Adult↗

PubMed1997

High heterogeneity for cystic fibrosis in Spanish families: 75 mutations account for 90% of chromosomes.

We have analyzed 640 Spanish cystic fibrosis (CF) families for mutations in the CFTR gene by direct mutation analysis, microsatellite haplotypes, denaturing gradient gel electrophoresis, single-strand conformation analysis and direct sequencing. Seventy-five mutations account for 90.2% of CF chromosomes. Among these we have detected seven novel CFTR mutations, including four missense (G85V, T582R, R851L and F1074L), two nonsense (E692X and Q1281X) and one splice site mutation (711+3A-->T). Three variants, two in intronic regions (406-112A/T and 3850-129T/C) and one in the coding region (741C/T) were also identified. Mutations G85V, T582R, R851L, E692X and Q1281X are severe, with lung and pancreatic involvement; 711+3A-->T could be responsible for a pancreatic sufficiency/insufficiency variable phenotype; and F1074L was associated with a mild phenotype. These data demonstrate the highest molecular heterogeneity reported so far in CF, indicating that a wide mutation screening is necessary to characterize 90% of the Spanish CF alleles.

Cystic Fibrosis↗

PubMed2006

Informed consent: an international researchers' perspective.

We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

Africa↗

PubMedDate not supplied

[Mesenchymal stem cells. A review.].

The bone marrow contains various types of stem cells. Among them are hematopoietic stem cells, which are the precursors of all blood cells, and mesenchymal stem cells. Mesenchymal stem cells have recently received a lot of attention in biological research because of their capability to self renewal, to expand and transdifferentiate into many different cell types; bone cells, adipocytes, chondrocytes, tendocytes, neural cells and stromal cells of the bone marrow. Mesenchymal stem cells can be cultured in vitro although their differentiation potential is not yet fully understood. Several experiments have been conducted in animal models where mesenchymal stem cells have been transplanted in order to enhance hematopoiesis or to facilitate the repair of mesenchymal tissue. Similar experiments are being conducted in humans. Mesenchymal stem cells are believed to be able to enhance hematopoietic stem cells transplantation by rebuilding the bone marrow microenvironment which is damaged after radiation- and/or chemotherapy. Mesenchymal stem cells are promising as vehicles for gene transfer and therapy. It may prove possible to tranduce them with a gene coding for a defective protein i.e. collagen I in osteogenesis imperfecta. The cells could then be expanded ex vivo and transplanted to the patients where they home to the bone marrow, differentiate and produce the intact protein. Future medicine will probably involve mesenchymal stem cells in various treatment settings.

English Abstract↗

PubMed2003

Do doctors rely on pharmaceutical industry funding to attend conferences and do they perceive that this creates a bias in their drug selection? Results from a questionnaire survey.

PURPOSE: To determine the sources of funding for doctors attending conferences and meetings and the doctors' perception on whether their involvement with the pharmaceutical industry created a conflict of interest or bias in their drug selection. METHOD: A postal questionnaire was distributed to 622 hospital doctors and 515 general practitioners (GPs) working in the Edinburgh area in Scotland, UK. RESULTS: The pharmaceutical industry funded approximately half of the meetings and conferences attended by doctors. Less than 20% of the doctors funded themselves. One-third of the meetings would not have been attended if funding from the industry had not been available. Hospital doctors and GPs had similar views on conflict of interest and bias. A minority of doctors (40%) thought that industry involvement created a conflict of interest but the majority of doctors (86%) thought that it did not create a bias in their own drug selection. CONCLUSIONS: If continuing medical education (CME) for doctors is going to rely on pharmaceutical industry funding in the future, then we need more explicit codes of conduct. It is of concern that while many doctors recognise the potential for the industry to influence their prescribing habits, few recognise that they themselves are susceptible.

Attitude of Health Personnel↗

PubMed1993

Understanding autobiographical memories: a study of the reminiscences of elderly men.

This study examined the stability of autobiographical memory constructs and provided data about male styles of reminiscing that are useful for expanding the generalizability of the Autobiographical Memory Coding Tool. Six males ranging in age from 76 to 84 who lived in the community served as subjects. Subjects participated in two one-to-one reminiscence interviews that were conducted 8 weeks apart. Interpretations formulated by this sample of elderly men were both validating and lamenting. Dominant themes in the transcripts were joys, social connections, difficulties, and choices. The frequency with which memories involving choice and lack of choice were verbalized suggest that control may be an important issue for this sample. The interpretations were quite stable with 91% agreement between Time 1 and Time 2 transcripts.

Abstracting and Indexing↗

PubMed2001

Trial duration and follow-up.

The chronic nature of most seizure disorders requires that antiepileptic drugs (AEDs) be administered for many years. Therefore, new drugs should be evaluated over a period sufficient to assess potential development of tolerance as well as long-term safety. While patients and prescribers desire extensive long-term data prior to registration, too stringent requirements would discourage industry's investment into new treatments, and a compromise between these stakes should be sought. In add-on studies, it is recommended that patients completing double-blind assessment be offered indefinite open-label treatment, and that safety data be collected prospectively. Monotherapy trials in refractory patients include presurgical and conversion to monotherapy studies. Duration of assessment in these studies rarely exceeds few weeks, and endpoints relate to seizure deterioration rather than improvement; this surrogate measure of efficacy is not necessarily predictive of clinical usefulness and, in view of ethical concerns, the rationale for these studies should be questioned. There may be scope, however, for alternative study designs whereby refractory patients are converted to monotherapy and followed up for several months. Active-control long-term monotherapy trials in newly diagnosed patients represent the mainstay for evaluating efficacy and safety. In patients with partial or generalized tonic-clonic seizures, most trials conducted to date had a duration of 6-12 months, but this period may be insufficient to assess seizure freedom rates at optimized dosages, and at least one 2-year trial would be desirable. With respect to open-label follow-up, many protocols require that the randomization code not be broken until the database has been sealed. Patients completing blind assessment are often forced through unblinding procedures which involve tapering of trial medication and institution of an open-label therapy which may differ, in dosage or type of medication, from that taken previously. In view of ethical concerns, the rationale for this practice should also be questioned.

Anticonvulsants↗

PubMed2002

Improved preventive care in family practices with outreach facilitation: understanding success and failure.

OBJECTIVES: To understand why some family practices with a facilitator improved preventive performance more than others. Sustainability of practice improvements one year after the intervention was also explored. METHODS: Interviews with physicians and nurses from seven practices and data gathered during the intervention were used to form case studies of three high performing and four low performing family practices. Case studies were developed using cross-case analysis with a combination of the constant-comparative method and memoing-diagramming. Two researchers independently conducted in-depth coding of transcripts and documents, individual case construction for each study site, and then cross-case analysis of the identified themes between study sites. RESULTS: Staff involvement and a positive attitude toward implementation of changes were central to high improvement in performance. A lack of computers, low staff involvement or high staff turnover were associated with low improvement in performance. Personal characteristics of the facilitator are important. Six of the seven practices still had the prevention tools in place one year after the intervention and all noted that participation had improved their understanding of preventive medicine. CONCLUSIONS: When using facilitators, one should avoid practices in turmoil, strive for continuity over time, and recognise the importance of the relationship between the facilitator and the practice.

Attitude of Health Personnel↗

PubMed1983

The neural signal for skin indentation depth. I. Changing indentations.

Psychophysical tests on human subjects showed that judgments of skin indentation depth made when the fingertip was indented at rates from 0.2 to 16 mm/sec were quite insensitive to changes in indentation velocity. Similar results were obtained on the forearm at indentation velocities of 0.4 to 16 mm/sec. Recordings were made from mechanoreceptors in the monkey's hand that were able to respond over the same range of velocities and at comparable depths to determine how skin indentation depth might be signaled (coded) at the receptor level and to examine the rate sensitivity of the possible depth codes. It was found that most of the receptors with foci under the stimulator were recruited relatively early during an indentation, especially at velocities of 1.6 mm/sec and higher, making it improbable that the full range of indentation depths is signaled by the "subsurface" recruitment of different receptors at different indentation depths. A subsurface recruitment code involving subcutaneous receptors is not likely since subjects could feel virtually none of the stimuli after skin anesthesia. Progressive recruitment with depth of receptors whose foci lie further and further away from the stimulator ("lateral" recruitment) was considered an unlikely depth code because changing the area of the stimulator had little effect on its perceived depth. Also, it was shown that subjects could sense the curvature of the indentation (the profile of the depth at right angles to the skin surface), which requires information about the depth of individual patches of skin beneath the stimulator. There is no obvious way that a lateral recruitment code can provide this information. Thus it is probable that the discharge rate of some or all of the receptors excited by the indentation is involved in indicating its depth. Both impulse frequency and receptor recruitment at any given depth increased as the velocity of the indentation increased. The demonstrated reliability of information about skin indentation depth in humans indicates that the central neural circuitry responsible for judgments of skin indentation depth is able to compensate for the rate-sensitive receptor signals.

Adult↗