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PubMed1979

Written informed consent in patients with breast cancer.

One hundred breast cancer patients, 35 adjuvant and 65 advanced, were interviewed 0-24 months after the start of chemotherapy to assess their knowledge and perceptions of the purposes, risks and benefits of treatment. Prior to therapy, all had been given verbal explanations and had signed informed consent forms explicitly detailing drugs, objectives and possible adverse effects of therapy. Seventeen percent of adjuvant and 29% of advanced patients were unable to name any of their drugs. While most patients recognized distressing side effects such as nausea and hair loss, less than 50% were aware of the potentially lethal complications of infection and bleeding. While the purpose of adjuvant therapy was cure, only 29% of the adjuvant patients were aware of this. In contrast, 35% of the advanced patients incorrectly stated that they were told their therapy was potentially curative. Explanations given by a nurse in addition to a physician were better understood than those given by a physician alone. We conclude that, in spite of intensive efforts at improving informed consent procedures, current results are unsatisfactory.

Adult↗
PubMed2002

Ethical reflections on pharmacogenetics and DNA banking in a cohort of HIV-infected patients.

The aim of this study was to analyse ethical issues concerning the storage of human biological samples to be used in genetic analyses and pharmacogenetic research based on a French experience of DNA banking in a cohort of human immunodeficiency virus (HIV)-infected patients started on a protease inhibitor-containing treatment. We describe the ethical issues raised during the establishment of a DNA bank, including questions dealing with autonomy, benefit to the patient, information sharing and confidentiality as well as guarantees concerning the storage and use of DNA. The practical applications of themes illustrated theoretically in the literature are discussed. Most of the points raised are not specific to HIV, but some of them may be more accurate due to the characteristics of the HIV population, which is more involved in the social debate through the community life and the increased risk of stigmatization. Our results are summarized in the memorandum and consent form presented in the Appendices. One issue still open to discussion is the way the results of genetic data will be given to the patients. This work should allow other researchers and members of evaluation committees to enrich their considerations and should stimulate discussion on this topic.

Biological Specimen Banks↗
PubMed2001

"Bones of Contention". The donation of temporal bones for dissection after the organ-retention scandals.

It is essential for the Otologist in training to become familiar with the anatomy of the temporal bone. Generations of trainees have acquired this knowledge, together with basic surgical skills and techniques by dissection of cadaver temporal bones. In recent years, however, the supply of temporal bones for dissection has become a contentious issue in many British hospitals. Media and public attention has recently focused on issues surrounding the retention of human tissues following post-mortem examinations. In response, the Chief Medical Officer, the Royal College of Pathologists in the UK, the Faculty of Pathology of the Royal College of Physicians in Ireland, the British Medical Association, and other bodies have issued new guidelines that are of relevance to the Otolaryngologist. This paper gives details of some of the UK guidelines and where they can be accessed. A copy of the Royal College of Pathologists preferred post-mortem consent form is presented. The authors' experience in Manchester is discussed and details of an information leaflet on the subject of temporal bone donation are given. It is concluded that, with knowledge of the existing guidelines and good communication with other hospital colleagues, as well as families of the deceased, it is still possible legally to obtain temporal bones for dissection.

Education, Medical, Graduate↗
PubMed2003

Identifying ambulatory cancer patients at risk of impaired capacity to consent to research.

Ethicists and others have expressed concerns that some patients with cancer might lack adequate decision-making capacity to give consent for research. Although this concern is plausible, it is not known what patient characteristics might be used to identify those patients who are at risk and who therefore should undergo a formal assessment of decision-making capacity. Forty-five patients with cancer were presented with a description of a randomized controlled trial, accompanied by an Institutional Review Board-approved consent form. Two raters who were blind to all patient characteristics assessed decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research. These scores were summarized in overall capacity judgments using criteria established by a panel of experts. Subjects also completed a symptom rating scale and a battery of neuropsychiatric tests. No relationship was observed between symptom severity and any domain of decision-making capacity (understanding, appreciation, reasoning, ability to express a choice) or summary judgments. However, several other patient characteristics, including age, education, and selected neuropsychiatric test results, were found to be strongly associated with capacity scores. These data suggest that several patient characteristics, such as age, education, and tests of cognitive functions, may help investigators to identify patients with impaired capacity to give consent for research.

Aged↗
PubMed2006

How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital.

BACKGROUND/AIMS: Informed consent for outpatient gastroscopy should involve many elements and many patients may not have spoken to an endoscopist beforehand. The aim was to audit the completeness of the consent process in patients undergoing outpatient gastroscopy. METHODS: This is a retrospective study in which a 37-point questionnaire was sent to 200 patients who had undergone outpatient gastroscopy. Questions covered information given before and on the day of the procedure. RESULTS: The response rate was 71.5% (143/200) and 141 questionnaires were analysed. Before the day of the procedure: 92.2% understood why they were having a gastroscopy, 90.8% had the procedure explained to them and of these 96.1% understood the explanation. 48.9% were told the risks of the procedure, 51.8% were given the opportunity to decline, but only 11.3% were told of an alternative to the procedure and 24.1% of possible consequences of not having the test. On arrival at the endoscopy unit: 92.2% of respondents had the procedure explained to them but only 55.4% received an explanation from the endoscopist. 45.4% were told the risks of the procedure, 48.2% were given the opportunity to decline. 39.0% did not read the consent form before signing and, of those that did, 98.7% understood it. CONCLUSION: Nearly all the patients understood the nature of gastroscopy and the reasons for the test before attending; however, there was poor explanation of the risks of gastroscopy and of its alternatives. Approximately half the patients were not given the opportunity to decline gastroscopy either before or on the day of the procedure.

Adult↗
PubMed2001

A randomized trial of a problem-based learning approach for teaching epidemiology.

PURPOSE: To conduct a controlled trial of traditional and problem-based learning (PBL) methods of teaching epidemiology. METHOD: All second-year medical students (n = 136) at The University of Western Australia Medical School were offered the chance to participate in a randomized controlled trial of teaching methods for an epidemiology course. Students who consented to participate (n = 80) were randomly assigned to either a PBL or a traditional course. Students who did not consent or did not return the consent form (n = 56) were assigned to the traditional course. Students in both streams took identical quizzes and exams. These scores, a collection of semi-quantitative feedback from all students, and a qualitative analysis of interviews with a convenience sample of six students from each stream were compared. RESULTS: There was no significant difference in performances on quizzes or exams between PBL and traditional students. Students using PBL reported a stronger grasp of epidemiologic principles, enjoyed working with a group, and, at the end of the course, were more enthusiastic about epidemiology and its professional relevance to them than were students in the traditional course. PBL students worked more steadily during the semester but spent only marginally more time on the epidemiology course overall. Interviews corroborated these findings. Non-consenting students were older (p < 0.02) and more likely to come from non-English-speaking backgrounds (p < 0.005). CONCLUSIONS: PBL provides an academically equivalent but personally far richer learning experience. The adoption of PBL approaches to medical education makes it important to study whether PBL presents particular challenges for students whose first language is not the language of instruction.

Adult↗
PubMed2002

Ethical regulations for innovative surgery: the last frontier?

BACKGROUND: There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research. STUDY DESIGN: In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire. RESULTS: The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate. CONCLUSIONS: The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.

Ethical Review↗
PubMed2003

[Bioethics in studies on genetic polymorphisms].

In studies on human genetic polymorphisms, such as single nucleotide polymorphisms (SNPs), little immediate benefit is expected for the individuals contributing the test samples. Such lack of immediate benefits should be noted in the informed consent form obtained prior to sample collection. Ethical considerations are indispensable in obtaining human samples for any type of human gene analysis, and researchers should respect the human rights of the contributors of the samples. Considerable differences in the guidelines for human gene analysis are seen between internationally distributed guidelines and the guidelines of the Japanese government. Lack of education in human genetics in medical schools in Japan could be a reason underlining this difference, and improvement of such situation is needed.

Bioethics↗
PubMed2004

Reporting of ethical standards: differences between complementary and orthodox medicine journals?

OBJECTIVES: This study aimed at assessing whether there are differences in the reporting of ethical aspects of complementary and alternative medicine (CAM) and mainstream medical research. DESIGN: Review of published literature. SETTING: Research department of medical school. MAIN OUTCOME MEASURES: Reports of ethical aspects including adherence to clinical guidelines, ethical approval from ethics committees, consent of the patient, declaration of conflict of interest, and declaration of funding for a study. RESULTS: We included 21 articles from CAM journals, as well as 16 from equal impact factor mainstream (EIF) journals and 27 from high impact factor (HIF) journals. A statistically significant difference was found in the reporting of ethical approval: 62% of all CAM articles, 75% of the EIF and 93% of the HIF journal articles reported approval from ethics committees [chi2 = (2, n = 64) 6.631, p<0.05]. Regarding the reporting of obtaining patients' consent there were no statistically significant differences: 48% of all CAM articles, 38% of the EIF mainstream and 67% of the HIF mainstream journal articles explicitly stated that patients signed a consent form [chi2 = (2, n = 64) 3.813, p>.05]. High impact factor journals were more likely to report on ethical standards than other journals on conflicts of interests and sponsorship. However, they were less likely to report a reference to ethical guidelines. Articles from CAM journals had more strict reporting requirements than mainstream medicine journals with comparable impact factors. CONCLUSIONS: Differences exist between complementary and orthodox medical journals in the reporting of ethical aspects of trial design.

Codes of Ethics↗
PubMed2005

Why do women consent to surgery, even when they do not want to? An interactionist and Bourdieusian analysis.

The 'informed consent' process has been placed at the centre of bioethical and policy discourses about how the autonomy and rights of patients can best be protected. Although there has been critical analysis of how the process functions in relation to participation in research and particular ethical 'dilemmas', there has been little examination of the routine business of consenting to medical procedures. Evidence is now beginning to emerge that people may consent to surgery even when reluctant to do so. In this paper, we develop an analysis informed by Bourdieusian and interactionist social theory of the accounts of 25 British women who consented to surgery in obstetrics and gynaecology. Of these, nine were ambivalent or opposed to having an operation. When faced with a consent form, women's accounts suggest that they rarely do anything other than obey professionals' requests for a signature. Women's capacity to act is reduced as they become enmeshed in the hospital structure of tacit, socially imposed rules of conduct. However, the interactionist account of power operating through the social rules of particular situated encounters, and the sanctions associated with rule-breaking, may not provide a sufficiently powerful explanation for why women submit to surgery they are opposed or ambivalent towards. Bourdieu's concepts of habitus, capital and symbolic power/violence offer a potentially more elaborated account, by showing how the practical logic that women apply in the field of surgery confers a 'sense of place' relative to professionals. Women experience deficits in capital, intensified by their physical vulnerability in critical situations, that severely constrain their ability to exercise choice. This work demonstrates the weakness of the consent process as a safeguard of autonomy. Far from reinforcing autonomy, the process may reinforce rather than disrupt passivity, but more generally our findings raise the question of the extent to which autonomy is an illusory goal.

Adult↗
PubMed2000

NHLBI family blood pressure program: methodology and recruitment in the HyperGEN network. Hypertension genetic epidemiology network.

PURPOSE: Hypertension is a common precursor of serious disorders including stroke, myocardial infarction, congestive heart failure, and renal failure in whites and to a greater extent in African Americans. Large genetic-epidemiological studies of hypertension are needed to gain information that will improve future methods for diagnosis, treatment, and prevention of hypertension, a major contributor to cardiovascular morbidity and mortality. METHODS: We report successful implementation of a new structure of research collaboration involving four NHLBI "Networks," coordinated under the Family Blood Pressure Program. The Hypertension Genetic Epidemiology Network (HyperGEN) involves scientists from six universities and the NHLBI who seek to identify and characterize genes promoting hypertension. Blood samples and clinical data were projected to be collected from a sample of 2244 hypertensive siblings diagnosed before age 60 from 960 sibships (half African-American) with two or more affected persons. Nonparametric sibship linkage analysis of over one million genotype determinations (20 candidate loci and 387 anonymous marker loci) was projected to have sufficient power for detecting genetic loci promoting hypertension. For loci showing evidence for linkage in this study and for loci reported linked or associated with hypertension by other groups, genotypes are compared in hypertensive cases versus population-based controls to identify or confirm genetic variants associated with hypertension. For some of these genetic variants associated with hypertension, detailed physiological and biochemical characterization of untreated adult offspring carriers versus non-carriers may help elucidate the pathophysiological mechanisms that promote hypertension. RESULTS: The projected sample size of 2244 hypertensive participants was surpassed, as 2407 hypertensive individuals (1262 African-Americans and 1145 whites) from 917 sibships were examined. Detailed consent forms were designed to offer participants several options for DNA testing; 94% of participants gave permission for DNA testing now or in the future for any confidential medical research, with only 6% requesting restrictions for tests performed on their DNA. Since this is a family study, participants also are asked to list all first degree relatives (along with names, addresses, and phone numbers) and to indicate for each relative whether they were willing to allow study staff to make a contact. Seventy percent gave permission to contact some relatives; about 30% gave permission to contact all first degree relatives; and less than 1% asked that no relatives be contacted. Successes after the first four years of this study include: 1) productive collaboration of eight centers from six different locations; 2) early achievement of recruitment goals for study participants including African-Americans; 3) an encouraging rate of consent for DNA testing (including future testing) and relative contacting; 4) completed analyses of genetic linkage and association for several candidate gene markers and polymorphisms; 5) completed genotyping of random markers for over half of the full sample; and 6) early sharing of results among the four Family Blood Pressure Program networks for candidate and genome search analyses. CONCLUSIONS: Experience after four years of this five-year program (1995-2000) suggests that the newly initiated NHLBI Network Program mechanism is fulfilling many of the expectations for which it was designed. It may serve as a paradigm for future genetic research that can benefit from large sample sizes, frequent sharing of ideas among laboratories, and prompt independent confirmation of early findings, which are required in the search for common genes with relatively small effects such as those that predispose to human hypertension.

Adult↗
PubMed2004

Improving risk disclosure during the consent process.

OBJECTIVES: To provide guidance about the risks which should be disclosed to patients and documented during the consent process. METHODS: The Delphi Consensus Technique was used to decide what constitutes mandatory risk disclosure for three index procedures. Documentation of risk on consent forms was audited and compared to these locally agreed standards. A four stage strategy for change was undertaken following which practice was reviewed. RESULTS: Mean mandatory risk documentation rose from 61.2% (95% CI: 58.1-64.4) pre-intervention, to 78.1% (95% CI: 72.6-83.6) post-intervention (ccc2; P < 0.001). CONCLUSIONS: Although we demonstrated some benefit from this simple approach, the need for pragmatic means of achieving and sustaining complete discussion and documentation of risks across all surgical interventions based on universally accepted standards remains.

Humans↗
PubMed2005

Informed consent in schizophrenia: the use of cues in the assessment of understanding.

The purpose of this study was to determine if providing cues could facilitate participant understanding for consent form information. Understanding scores were measured in a group of participants diagnosed with schizophrenia and a control group using cued recognition and uncued recall methods. When understanding was measured with uncued methods, persons with schizophrenia showed lower scores compared to the control group. However, when cues were provided, there was no difference between the two groups on understanding scores, and persons with schizophrenia showed normal levels of understanding. The results suggest that cued methods may be a better alternative to measure participant understanding.

Adolescent↗
PubMed1997

Ethical issues of genetic testing and their implications in epidemiologic studies.

PURPOSE: To discuss and summarize the ethical controversies related to genetic testing and screening, and their effects on the research and other professional activities of epidemiologists. METHODS: We reviewed the literature and proposed legislation to discuss the controversies related to the ethical issues of genetic testing in epidemiologic research. RESULTS: From a review of the literature and proposed legislation, we found these controversies may continue for some time and will probably add to the duties and difficulties of epidemiologists. It is important for the profession to respond to developments such as the proposed federal Genetic Confidentiality and Nondiscrimination Act of 1996 (Senate Bill 1898), which is summarized here; changes in research protocols and informed-consent forms as well as inclusion of other professionals from many disciplines will be necessary. In addition to revising training, and expanding their ethical code, epidemiologists should respond to public concerns about genetic information by disseminating knowledge about freedom to conduct clinical research, protection of the individual, and the limits of genetic information. CONCLUSIONS: The possibility of genetic discrimination may complicate epidemiological research unless the public, employers, insurers, physicians, and researchers reach a consensus on the meaning of, and need for, genetic information. Although ethical concerns are appropriate, they will make accrual of study subjects and tissue samples more difficult.

Epidemiology↗
PubMed2003

A phase 1 trial of riluzole in spinal muscular atrophy.

BACKGROUND: Severe spinal muscular atrophy (SMA) (Werdnig-Hoffmann disease, acute SMA, and SMA I) is a disease of the motor neuron characterized by onset before 6 months of age, failure ever to achieve sitting without support, and a life expectancy of 2 years or less. There is no known treatment for SMA, and, until recently, no therapeutic trials have been attempted. There is reason to believe that glutamate, an excitatory neurotransmitter, enhances programmed cell death of anterior horn cells. Riluzole, a glutamate inhibitor, has been shown to slow the rate of decline in patients with amyotrophic lateral sclerosis, another form of motor neuron disease. OBJECTIVES: To determine whether a glutamate inhibitor might be tolerated by infants with SMA and, furthermore, whether this medication could have a positive effect on life expectancy. DESIGN: Subjects with homozygous deletions of the survival motor neuron gene were recruited from pediatric neuromuscular clinics and randomized in a 2:1 ratio, 2 riluzole to 1 placebo. Neurologic examination was performed at the first visit by one of the investigators. Complete blood count, hepatic and renal screens, and urinalysis were performed at baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 9 months after drug or placebo was started. An electrocardiogram was done at baseline, 3 months, 6 months, and 12 months. Treatment was stopped after 9 months, and blood work was repeated at 12 months. Treatment was reinstituted at 1 year if requested by the parents. The enrollment goal was 30 patients; however, support from the pharmaceutical company was withdrawn when Rhone-Poulenc Rorer was taken over by Aventis. The investigational review boards of the participating centers approved the protocol and consent forms. RESULTS: Seven patients received riluzole and 3 received placebo medication. All 3 patients in the placebo group died (mean age, 9 months). Three of 7 who received active drug are still living at ages 513 years, 4 years, and 30 months. None of the 10 subjects experienced adverse effects or changes in laboratory test results. None showed any change in motor abilities. CONCLUSIONS: Riluzole appears to be safe in young children. This was a limited study with insufficient power to show a difference between the 2 groups. Because there is a suggestion of possible benefit in treated subjects, we recommend further study of riluzole in pediatric patients with SMA.

Age of Onset↗
PubMed1996

Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project.

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.

Aged↗
PubMed1994

Informed consent: what do patients want to know?

Informed consent is an important aspect of surgery, yet there has been little inquiry as to what patients want to know before their operation. This study has questioned 50 patients within 3 months of an ENT (ear, nose and throat) operation. We found that most were happy to allow doctors to determine their treatment but they wanted to know about their condition, the treatment, and the important side effects. Fifty per cent of patients admitted worrying about some aspect of their recent surgery. More than two-thirds thought signing a consent form primarily signified agreement to undergo treatment and that it was a legal document; 54% thought there was an important medico-legal aspect. Over half thought information sheets would be reassuring, one-third thought they would provoke anxiety and 8% thought they would frighten them from having surgery. Closer examination of the answers to our questions showed that those who were most worried about aspects of their surgery had a higher mean anxiety score, as did those who thought an information sheet would be either frightening or anxiety provoking. However, a higher anxiety score was not associated with a desire to know less about the proposed treatment.

Adolescent↗
PubMed1985

Informed consent--mandating the consultation.

This article illustrates how a mandatory consult procedure identified treatable psychiatric problems. Using a computerized data-based format, 372 (37.4%) patients (the "judgment" group) of 996 psychiatric consultations were identified as referred to assess the patient's capacity to execute a consent form for a medical or surgical procedure. One hundred twenty-nine (35%) of the 372 patients thus referred by hospital mandate were given psychiatric diagnoses (DSM-II) by the consultant and received recommendations for primary psychiatric treatment. The "judgment" group had significantly more organic brain syndrome and psychoses associated with CNS conditions (p less than 0.001), whereas the "nonjudgment" group was diagnosed as exhibiting significantly more neurosis, alcoholism, psychophysiologic disorders, transient situational reactions, and personality disorders (p less than 0.001). Without a required psychiatric consultation sanctioned by administrative hospital mandate, the majority of the "judgment" cases with major psychopathology would not have been identified. The use of the mandated psychiatric consultation in the general hospital is discussed.

Aged↗