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Results for “Code of Conduct for Research involving Humans”

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PubMed2005

Positive youth development linked with prevention in a Vietnamese American community: successes, challenges, and lessons learned.

PURPOSE: To describe a positive youth development program that was successfully designed and implemented in partnership with a Vietnamese American community and to provide insight into the types of outcomes that can result from such programs in similar communities. METHODS: In-depth interviews were conducted with Vietnamese community leaders (n = 8) and youth (n = 10) who were involved in a positive youth development program in Oklahoma City. Interviews were tape recorded, transcribed verbatim, and coded by two independent analysts. Data matrices were used to help identify major themes. RESULTS: Participants felt they had strengthened numerous assets as a result of involvement in the youth development program, including communication with parents or another adult, leadership skills, constructive use of free time, and positive peer influences. Some of the participants also reported establishment of a relationship with a nonparent adult, inclusion of community service in their aspirations for the future, and avoidance of high-risk behaviors owing to their involvement in the program. Both adults and youth felt that the Vietnamese community had changed its perception of youth as a result of increased involvement of young people in community service and cultural activities. CONCLUSION: Positive youth development is a promising prevention strategy that can be adapted to Vietnamese communities in the United States.

Adolescent↗

PubMed2000

Probable involvement of a germ-line mutation of an unknown mismatch repair gene in a Japanese Muir-Torre syndrome phenotype.

A combination of haplotype analysis and direct sequencing were conducted on Japanese Muir-Torre syndrome kindred. In the kindred, two females revealed a hereditary non-polyposis colon cancer (HNPCC) phenotype and one male had a sebaceous tumor in addition to a HNPCC phenotype. Haplotype analysis and direct sequencing failed to show involvement of the known mismatch repair genes, with the exception of MSH5, in this kindred. Analysis of large fragments (from 3.9 to 6. 2 kb) covering the entire 25 kb MSH5 gene in the proband revealed the absence of gross changes in the promoter region and exons. The direct sequencing of the promoter region and all 25 exons failed to demonstrate any mutations in the coding regions except for a CA repeat polymorphism in intron 3 and a C/A polymorphism in intron 15. Taken together present results indicate that a novel and yet unknown mismatch repair gene is likely involved in the HNPCC in this kindred.

Adult↗

PubMed1993

Research samples from families with genetic diseases: a proposed code of conduct.

Research on samples from families with genetic disease underlies many of the major advances that are occurring in medical genetics. But ethical and practical problems may arise when samples from relatives who are healthy but at risk are included in such studies. In particular, new molecular tests for specific gene mutations may result in the detection of a genetic defect in relatives who had neither expected this possibility nor given specific consent to such testing. Family members at risk should not be included in such studies unless strictly necessary, and in such cases specific consent should be obtained and information should be given about the implications of an abnormal result of a test. This is particularly important when stored samples from previous studies without such implications are being reused and is also relevant to the genetic testing of samples taken primarily for epidemiological studies of disorders when only a small proportion of cases is thought to be genetic in origin. There is a need for guidelines to protect both subjects and investigators in a field which is spreading rapidly and involving many clinical and laboratory research workers previously unfamiliar with genetic testing.

Anonymous Testing↗

PubMed2003

Community action against asthma: examining the partnership process of a community-based participatory research project.

BACKGROUND: Community Action Against Asthma (CAAA) is a community-based participatory research (CBPR) project that assesses the effects of outdoor and indoor air quality on exacerbation of asthma in children, and tests household- and neighborhood-level interventions to reduce exposure to environmental asthma triggers. Representatives of community-based organizations, academia, an integrated health system, and the local health department work in partnership on CAAA's Steering Committee (SC) to design and implement the project. OBJECTIVE: To conduct a process evaluation of the CAAA community-academic partnership. DESIGN: In-depth interviews containing open-ended questions were conducted with SC members. Analysis included established methods for qualitative data, including focused coding and constant comparison methods. SETTING: Community setting in Detroit, Michigan. PARTICIPANTS: Twenty-three members of the CAAA SC. MEASUREMENTS: Common themes identified by SC members relating to the partnership's ability to achieve project goals and the successes and challenges facing the partnership itself. MAIN RESULTS: Identified partnership accomplishments included: successful implementation of a complex project, identification of children with previously undiagnosed asthma, and diverse participation and community influence in SC decisions. Challenges included ensuring all partners' influence in decision-making, the need to adjust to "a different way of doing things" in CBPR, constraints and costs of doing CBPR felt by all partners, ongoing need for communication and maintaining trust, and balancing the needs of science and the community through intervention. CONCLUSIONS: CBPR can enhance and facilitate basic research, but care must be given to trust issues, governance issues, organizational culture, and costs of participation for all organizations involved.

Asthma↗

PubMed2006

Ophthalmologic findings in Cornelia de Lange syndrome: a genotype-phenotype correlation study.

OBJECTIVE: To evaluate individuals with Cornelia de Lange syndrome previously screened for mutations in the NIPBL gene for genotype-phenotype correlations with regard to severity of ophthalmologic findings. METHODS: Fifty-four patients with Cornelia de Lange syndrome (26 mutation positive and 28 mutation negative) with varying extent and severity of ophthalmologic findings participated in the study. We conducted a retrospective analysis of ophthalmologic data obtained through survey responses and medical records. The severity of nasolacrimal duct obstruction, myopia, ptosis, and strabismus was classified. The severity of eye findings was compared relative to the presence vs the absence of mutations in the coding region of NIPBL and relative to mutations predicted to result in a truncated protein (nonsense and frameshift mutations) vs missense mutations. Fisher exact test was used to determine the significance of these correlations. RESULTS: A trend toward increased ptosis severity was found among individuals with truncating (nonsense and frameshift) mutations compared with individuals with missense mutations (P = .07). CONCLUSION: NIPBL may be directly involved in ptosis pathogenesis. CLINICAL RELEVANCE: Elucidating the pathogenetic mechanisms of ophthalmologic morbidities in patients with de Lange syndrome may lead to more effective treatment.

Adolescent↗

PubMed2004

Paraoxonase 1 and atherosclerosis: is the gene or the protein more important?

The oxidation of low-density lipoprotein (LDL) is centrally involved in the initiation and progression of atherosclerosis. High-density lipoprotein (HDL) paraoxonase 1 (PON1) retards the oxidation of LDL and is a major antiatherosclerotic component of HDL. The PON1 gene contains a number of functional polymorphisms in both the coding and the promoter regions, which affect either the level or the substrate specificity of PON1. Genetic case-control and prospective studies conducted to date have produced confusing results. Meta-analysis of these studies indicates no simple relationship between the PON1 polymorphisms and the presence of coronary heart disease (CHD). However, at the present moment in time, it seems that PON1 status, i.e., activity and/or concentration, is more closely related to CHD, and indeed, PON1 has shown to be an independent risk factor for CHD in a prospective study, compared to the genetic polymorphisms. PON1 levels can also be modulated by environmental\lifestyle and possibly pharmaceutical factors. Larger, better designed, preferably prospective studies are needed to determine further the association of PON1 genetic polymorphisms and status with CHD.

Arteriosclerosis↗

PubMed2004

SARS and hospital priority setting: a qualitative case study and evaluation.

BACKGROUND: Priority setting is one of the most difficult issues facing hospitals because of funding restrictions and changing patient need. A deadly communicable disease outbreak, such as the Severe Acute Respiratory Syndrome (SARS) in Toronto in 2003, amplifies the difficulties of hospital priority setting. The purpose of this study is to describe and evaluate priority setting in a hospital in response to SARS using the ethical framework 'accountability for reasonableness'. METHODS: This study was conducted at a large tertiary hospital in Toronto, Canada. There were two data sources: 1) over 200 key documents (e.g. emails, bulletins), and 2) 35 interviews with key informants. Analysis used a modified thematic technique in three phases: open coding, axial coding, and evaluation. RESULTS: Participants described the types of priority setting decisions, the decision making process and the reasoning used. Although the hospital leadership made an effort to meet the conditions of 'accountability for reasonableness', they acknowledged that the decision making was not ideal. We described good practices and opportunities for improvement. CONCLUSIONS: 'Accountability for reasonableness' is a framework that can be used to guide fair priority setting in health care organizations, such as hospitals. In the midst of a crisis such as SARS where guidance is incomplete, consequences uncertain, and information constantly changing, where hour-by-hour decisions involve life and death, fairness is more important rather than less.

Attitude of Health Personnel↗

PubMed1992

Occluded-ear simulator with variable acoustic properties.

Ear simulators were designed to replicate acoustical characteristics of the average adult ear. Due to variability of ear-canal geometry and eardrum impedance among individuals, the possibility of any one person exhibiting such "average" characteristics--especially if that person is a child and/or has a conductive pathology--is remote. Thus, ear simulators have been of only peripheral value when prescribing a hearing aid (a high output impedance device) to fit the acoustical requirements of a particular patient. Reported herein is development of a programmable artificial ear (PAE) that can account for individual differences in ear-canal geometry and eardrum impedance. It consists of a 2.0-cc coupler, microphone, amplifier, computer, PAE code, and a computer card and/or software for digitization and Fourier transformation. Required input data includes ear-canal dimensions, eardrum impedance, and output impedance of the hearing aid being tested. Sound-pressure recordings produced in the 2.0-cc coupler by the hearing aid are adjusted by the computer to what they would have been had the recordings been made at the eardrum of a particular patient wearing the same hearing aid. Good agreement was observed between experiment and theory for one test case involving a totally occluding miniature earphone.

Acoustic Impedance Tests↗

PubMed2003

Functional consequences of an LMNA mutation associated with a new cardiac and non-cardiac phenotype.

Heritable dilated cardiomyopathy is a genetically highly heterogeneous disease. To date 17 different chromosomal loci have been described for autosomal dominant forms of dilated cardiomyopathy with or without additional clinical manifestations. Among the 10 mutated genes associated with dilated cardiomyopathy, the lamin A/C (LMNA) gene has been reported in forms associated with conduction-system disease with or without skeletal muscle myopathy. For the first time, we report here a French family affected with a new phenotype composed of an autosomal dominant severe dilated cardiomyopathy with conduction defects or atrial/ventricular arrhythmias, and a specific quadriceps muscle myopathy. In all previously reported cases with both cardiac and neuromuscular involvement, neuromuscular disorders preceded cardiac abnormalities. The screening of the coding sequence of the LMNA gene on all family members was performed and we identified a missense mutation (R377H) in the lamin A/C gene that cosegregated with the disease in the family. Cell transfection experiments showed that the R377H mutation leads to mislocalization of both lamin and emerin. These results were obtained in both muscular (C2C12) and non-muscular cells (COS-7). This new phenotype points out the wide spectrum of neuromuscular and cardiac manifestations associated with lamin A/C mutations, with the functional consequence of this mutation seemingly associated with a disorganization of the lamina.

Adult↗

PubMed1992

Exposure to styrene and health complaints in the Dutch glass-reinforced plastics industry.

A study of the health hazards for workers exposed to styrene in the Dutch glass-reinforced plastics industry was undertaken. The open mould techniques of filament winding, spraying and hand laminating were chosen for study because exposure of workers using them was expected to be high. Occupational hygiene surveys were conducted in four plants. In addition to measurements of exposure, data on health complaints were collected. In 12 smaller plants exposure was estimated in walk-through surveys. The results show that although most of the plants had implemented control measures such as ventilation and extraction, the levels of exposure constituted a health risk. Time-weighted average concentrations for workers involved in filament winding ranged from 134 to 716 mg m-3, for those who were spraying from 48 to 602 mg m-3 and for those laminating manually from 18 to 538 mg m-3. The 'no-adverse-effect level' based on effects observed in man is considered to be 105 mg m-3, and the acute subjective health effects experienced by the population studied supported this value. To reduce exposure to below 105 mg m-3, control measures should combine engineering with codes of practice adapted to the particular process or processes employed.

Environmental Monitoring↗

PubMed1985

Urticaria in a family practice.

A review of the charts of 79 patients with urticaria was conducted in a residency-based family practice center. All patients seen with urticaria in 7 years who were identified by the practice-data retrieval system were included in the review. The annual incidence of urticaria was 0.27 percent. Female patients predominated (76 percent), and 70 percent of the cases lasted less than 6 weeks. A personal history of atopy was more common in acute urticaria than in urticaria lasting longer than 6 weeks (P less than .05). No causes were identified in 54 percent of the cases. Association with zomepirac and symptomatic dermographism were each noted in three cases. Diagnostic tests were performed in 17 percent of cases, and consultation or referral occurred in 15 percent. Treatment usually included antihistamines (89 percent). The coded diagnosis was judged by the chart reviewers to be incorrect or inadequately supported in 28 of the 108 charts (26 percent) coded urticaria. In 25 charts coded for other skin disorders, three cases (12 percent) of urticaria were noted by the chart reviewers. Coding errors involving digit transposition were noted in three of 1,044 cases. Diagnostic error, incorrect coding by nonphysicians or by physicians not familiar with the coding system, or even clerical error may be a significant problem in this type of study.

Adolescent↗

PubMedDate not supplied

Developing a church-based diabetes prevention program with African Americans: focus group findings.

PURPOSE: The purpose of this study was to use a community-based participatory research (CBPR) approach to identify resources and barriers to implementing a church-based diabetes prevention program (DPP) in a rural African American church community in Georgia. METHODS: In collaboration with community leaders, researchers conducted 4 focus groups with 22 key informants to discuss their understanding of diabetes and identify key resources and barriers to implementing a DPP in the church. Three researchers analyzed and coded transcripts following a content-driven immersion-crystallization approach. RESULTS: The participants' comments on diabetes and prevention covered 5 research domains: illness perceptions, illness concerns, illness prevention, religion and coping, and program recommendations. Program success was deemed contingent on cultural sensitivities, a focus on high-risk persons, use of church resources, and addressing barriers. Barriers identified included individuals' lack of knowledge of risk and prevention programs, lack of interest, and attendance concerns. Solutions and resources for overcoming barriers were testimonials from persons with illness, using local media to advertise the program, involving the food committee of the church, ministering to the healthy and at risk, and acquiring a support buddy. CONCLUSIONS: A CBPR approach engaged church members as partners in developing a church-based DPP. Focus groups generated enthusiasm among church members and provided valuable insights regarding barriers and resources for program implementation. This methodology may prove useful in other church-based chronic disease prevention efforts with at-risk populations.

Adaptation, Psychological↗

PubMed1984

Labor time code for assembling and microwave heating menu items in a hospital galley.

Labor times for microwave-heating activities were developed by using Master Standard Data (MSD). Step 1 involved defining the layout of the actual hospital galley , dividing into small motions the labor activities involved in assembling menu items that would be microwave heated, and identifying basic elements for each motion. Step 2 was the development of seven macro elements under simulated conditions in the laboratory. In step 3, a stopwatch time study in the laboratory was used to verify MSD-predicted times for the seven macro elements. For the final step, a stopwatch time study was conducted under actual operating conditions in a hospital galley . Predicted time derived from laboratory simulation of microwave-heating activities indicated that it should take a foodservice employee 1.71 minutes to assemble menu items from two trays and heat the items by using two microwave ovens . Total labor time for assembling and microwave heating menu items under actual conditions in the hospital galley was similar to MSD-predicted times. Although labor times reported are specific for the cook/chill foodservice system used in this study, the methods and the code may be applied in other hospital foodservices to develop specific labor times for those facilities.

Food Handling↗

PubMed1988

Newer developments in the identification of beta-thalassemia.

One of the easiest and most sensitive methods of detecting mutations in the beta-globin gene leading to beta-thalassemia is by the use of oligonucleotide probes. The current method involves digestion of 5-10 micrograms of genomic DNA followed by gel electrophoresis, and blotting onto nitrocellulose. The membrane is then hybridized with a 32P-radiolabeled oligonucleotide probe containing the specific point mutation of interest. Finally, the membrane is subjected to X-ray film for 3-10 days. We wish to report a method for detecting these mutations which involves 1 microgram of genome DNA or less. The method involves the use of a gene amplification technique. A series of primers are synthesized which span the beta-globin gene. In each primer set, one primer is complementary to the beta-gene and the other primer is complementary to the non-coding strand. The suspected mutation point is located between these two primers. With the use of this primer set, the beta-globin gene region is amplified by denaturing, annealing, and DNA synthesis. The amplification cycle is repeated 25 to 30 times. The amplification is conducted using the Klenow fragment of DNA polymerase I or Taq polymerase in the presence of all four deoxynucleotide triphosphates. The resulting amplified DNA is applied to a nylon membrane with the aid of a dot-blot apparatus and directly hybridized with normal and mutant deoxynucleotide probes. The entire process requires one to two days. More than 300 beta-thalassemia homozygotes have been identified in our laboratories; over 20 different mutations have been observed.

Base Sequence↗

PubMed2003

Classification of working processes to facilitate occupational hazard coding on industrial trawlers.

BACKGROUND: Commercial fishing is an extremely dangerous economic activity. In order to more accurately describe the risks involved, a specific injury coding based on the working process was developed. METHOD: Observation on six different types of vessels was conducted and allowed a description and a classification of the principal working processes on all kinds of vessels and a detailed classification for industrial trawlers. In industrial trawling, fish are landed for processing purposes, for example, for the production of fish oil and fish meal. The classification was subsequently used to code the injuries reported to the Danish Maritime Authority over a 5-year period. RESULTS: On industrial trawlers, 374 of 394 (95%) injuries were captured by the classification. Setting out and hauling in the gear and nets were the processes with the most injuries and accounted for 58.9% of all injuries. A relatively large number of injuries occurred when embarking and disembarking. Specific risks were identified in a number of other working processes. CONCLUSION: Specific areas for risk prevention in fishery may be identified by using a detailed classification system that takes both the specific method of fishing and the working processes into consideration.

Denmark↗

PubMed1978

Correlation of electrocardiographic and pathologic findings in healed myocardial infarction.

A correlative study in 50 cases of healed myocardial infarction compared the 12 lead electrocardiogram with pathologic observations. The electrocardiogram was interpreted according to established Minnesota codes with some modifications. The following conclusions were reached: (1) The electrocardiogram underestimates the extent of myocardial infarction. (2) When a healed myocardial infarct at a specific location is recognized with electrocardiographic criteria, it is likely that there are unrecognized infarcts involving other areas of the left ventricle. (3) Infarctions involving the lateral and inferobasal areas are frequently unrecognized. (4) The electrocardiogram is more likely to miss myocardial infarcts in patients with multiple, than in those with single, electrocardiographically diagnosed infarcts. (5) Apical myocardial infarction does not appear to have specific electrocardiographic findings, other than those related to general infarct localization by electrocardiogram, particularly in patients with anteroseptal or anterolateral infarction. (6) Abnormal Q waves, generally thought to indicate transmural myocardial infarction, are frequently found in subendocardial infarction. (7) The simplified electrocardiographic classification of myocardial infarct site (anteroseptal, inferior, anterolateral) used in this study is preferable to more detailed classifications previously suggested by others.

Adult↗

PubMed2000

Association between bipolar disorder and monoamine oxidase A gene polymorphisms: results of a multicenter study.

OBJECTIVE: Although genetic factors have been implicated in the etiology of bipolar disorder, no specific gene has been conclusively identified. Given the link between abnormalities in serotonergic neurotransmission and bipolar disorder, a candidate gene association approach was applied to study the involvement of the monoamine oxidase A (MAOA) gene, which codes for a catabolic enzyme of serotonin, in the susceptibility to bipolar disorder. METHOD: In France and Switzerland, 272 patients with bipolar disorder and 122 healthy subjects were typed for three polymorphic markers of the MAOA gene: the MAOA-CA repeat, the MAOA restriction fragment length polymorphism (RFLP), and a repeat directly adjacent to the variable number of tandem repeats (VNTR) locus. RESULTS: A significant difference in the distribution of the alleles for the MAOA-CA repeat was observed between the female bipolar patients and comparison group. CONCLUSIONS: The results obtained in the French and Swiss population confirm findings from two studies conducted in the United Kingdom.

Adult↗

PubMed1992

Molecular characterization of cystic fibrosis: 16 novel mutations identified by analysis of the whole cystic fibrosis conductance transmembrane regulator (CFTR) coding regions and splice site junctions.

The spectrum of cystic fibrosis (CF) mutations was determined in 105 patients by using denaturing gradient gel electrophoresis to screen the entire coding regions and adjacent cystic fibrosis transmembrane conductance regulator (CFTR) gene sequences. The nucleotide substitutions detected included 16 novel mutations, 11 previously described defects, and 11 nucleotide sequence polymorphisms. Among the novel mutations, 6 were of the missense type, 4 were nonsense mutations, 4 were frameshift defects, and 2 affected mRNA splicing. The mutations involved all the CFTR domains, including the R domain. Of the 61 non-delta F508 CF chromosomes studied, mutations were found on 36 (59%), raising the proportion of CF alleles characterized in our patient cohort to 88%. Given the efficacy of the screening method used, the remaining uncharacterized mutations probably lie in DNA sequences outside the regions studied, e.g., upstream-promoter sequences, the large introns, or putative regulatory regions. Our results further document the highly heterogeneous nature of CF mutations and provide the information required for DNA-based genetic testing.

Base Sequence↗