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PubMed1991

Effects of researcher follow-up of distressed subjects: tradeoff between validity and ethical responsibility.

Researchers studying depression often encounter research participants in serious preexisting distress. Examining investigators' ethical responsibilities to these subjects, Stanton and New (1988) found that depression researchers reported actions that ranged from doing nothing to contacting both the distressed subject and a significant other. By experimentally manipulating consent form information regarding potential treatment referral, we examined whether subjects (n=357) adjusted their responses on depression measures as a function of the level of follow-up they expected to receive. Results reveal that subjects who potentially could receive the most intrusive intervention (i.e., experimenter contact with the subject and a significant other) were less likely to report depressive symptoms than were subjects who anticipated less intrusive follow-up. Willingness to report depressive symptoms in particular conditions varied in part as a function of subject sex. Thus, ethical safeguards used in studies with subjects in preexisting distress may have consequences for the validity of self-report depression measures.

Behavioral Research↗
PubMed2005

Informed consent: it's not just signing a form.

Informed consent plays a major role in forming a therapeutic alliance with the patient. The informed consent process has evolved from simple consent, in which the surgeon needed only to obtain the patient's permission for a procedure, into informed consent, in which the surgeon provides the patient with information about clinically salient features of a procedure, the patient understands this information adequately, and the patient voluntarily authorizes the surgeon to perform the procedure. Special circumstances of informed consent include conflicting professional opinions, consent with multiple physicians, patients who are undecided or refuse surgery, patients with diminished decision-making capacity, surrogate decision making, pediatric assent, and consent for the involvement of trainees.

Communication↗
PubMed2005

Therapeutic misconception in early phase gene transfer trials.

Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy'. We use three variables to construct a composite measure of therapeutic misconception TM, tapping misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM.

Adult↗
PubMed1992

Refusal of implantable cardioverter defibrillator generator replacement: the nurse's role.

An adult patient who is conscious and mentally competent has the right to refuse any medical or surgical procedure even when the best medical opinion deems it necessary for life. The doctrine of informed consent is grounded on the premise that a physician's judgment is subservient to the patient's right to self-determination. Some suggestions for the future are offered. It may be beneficial to have a formal doctrine of informed refusal incorporated into the existing system of informed consent thus having patients sign a refusal of treatment form just as they sign a form consenting to treatment. Even if the physician and patient share an ideal relationship that includes mutual respect and participation in decision making, the consent to treatment or refusal of treatment should be documented both on a form and in the physician's own words in the patient record to avoid any discrepancies that may arise later. Items that may eventually be added to the list of requirements for informed consent or refusal include the impact of the treatment or procedure on the patient's job or family situation, impact on quality of life, and the potential long-term cost to the patient or to public or private health care payers.

Aged↗
PubMed2006

Use of a modified informed consent process among vulnerable patients: a descriptive study.

BACKGROUND: Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. OBJECTIVE: To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. DESIGN: Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal). PARTICIPANTS: Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives. MEASUREMENTS: Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). RESULTS: Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. CONCLUSIONS: Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Aged↗
PubMedDate not supplied

Consent to treatment: myths and realities.

In the last 10 years, court rulings have questioned the validity of current practices of obtaining consent to treatment. Consent is sought to protect health institutions and staff from litigation. This is no guarantee of protection, however, if the consent process has consisted merely of obtaining the patient's signature on a consent form without full disclosure. This article looks at the inconsistency of current consent practices and outlines ways to improve the legal standard for obtaining consent to treatment.

Canada↗
PubMed2005

Ethical and legal aspects of applied genomic technologies: practical solutions.

Many ethical and legal issues surround genomic technologies, some of which are present for other kinds of medical data, but some of which are specific to genomic data. Specifically the global nature of genomic data and the life-long implications of genetic defects on the health of the individual subject produce challenges in the ethical and legal handling of this data. In general, data derived from transcriptome analysis, which studies gene expression, as well as proteomics and metabolomics, carry less ethically-charged information than measures of the germ line genome. However, theoretical issues that have been raised related to withholding therapy based on a specific genotype which could also apply to a specific expression profile. Potential solutions for these challenges are discussed, such as maintaining a connection with research participants through a trusted third party, using electronic means to manage that contact and reconsent subjects. A flexible, secure information technology infrastructure is proposed to manage and search consent forms, provide the ability to collect additional data and consent while maintaining participant confidentiality.

Access to Information↗
PubMedDate not supplied

Consent to surgery: the role of the nurse.

In the first of two articles relating to consent issues, the author examines the role of the nurse in helping patients to have a more equal relationship with doctors when they sign a consent form. It is based on sociological research studies of consent to surgery (1-3). Next week, the author will look at issues relating to consent to research.

Adolescent↗
PubMed2005

Eligibility of cryopreserved human embryos for stem cell research in Canada.

OBJECTIVE: To determine whether cryopreserved embryos in Canadian in vitro fertilization (IVF) clinics available (in theory) for research use are actually eligible (in practice) for stem cell research in accordance with the Assisted Human Reproduction Act, the Canadian Institutes of Health Research's Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. METHODS: Copies of current and past patient information sheets and consent forms for embryo cryopreservation, the future disposition of cryopreserved embryos, and the donation of cryopreserved embryos for research were requested from Canadian IVF clinics. Fourteen of 24 clinics (response rate 58%) provided one or more of the requested documents. RESULTS: A review of the documents currently in use showed that, as of May 2005, all 14 responding clinics require an advance directive for the eventual disposition of cryopreserved embryos. Ten of these 14 clinics allow the donation of cryopreserved embryos for research. Only three of these 10 clinics, however, satisfy in writing the disclosure requirements for embryo research at the time of initial consent for the cryopreservation and future disposition of embryos. Only one clinic specifically identifies the option of embryonic stem cell research. CONCLUSION: Only three of the responding Canadian IVF clinics provide written details about future donation of cryopreserved embryos for research use and about the need for re-contact in accordance with relevant legislation and guidelines. Two of these three clinics, however, include disposition options that may not be legally available. In the event of death or loss of contact, it will not be possible to get project-specific research consent from the legitimate embryo providers as required by law. These same two clinics also fail to mention embryonic stem cell research as one of the research categories. It follows that we have identified only one Canadian IVF clinic with cryopreserved embryos unequivocally eligible for stem cell research, provided the forms we reviewed were used to obtain consent for the cryopreservation of those embryos.

Canada↗
PubMedDate not supplied

Brain donation for research: consent and re-consent post Alder Hey.

BACKGROUND: Recent scandals relating to the unconsented retention and use of human organs in the UK have led to widespread changes to governance and ethical frameworks for research throughout England and Wales. Ethics committees now ask for proof of specific consent where general medical research consent was once sufficient. In order to meet these new requirements ongoing medical research studies have had to replace existing consent forms with more detailed ones that must be signed anew by prospective donors. In this paper we discuss how one such study has tackled this process of re-consent. METHOD: The MRC Cognitive Function and Ageing Study has recently been asked to consider renewal of consent on all individuals with existing signed intentions to donate brain tissue. We approached 218 of our respondents successfully for more detailed consent. RESULTS: All agreed to genetic research and only a very small proportion did not want samples used by commercial companies or collaborators abroad. Our interviewers reported that respondents were perplexed by the need to give consent again with more detailed forms, as they considered they had already received sufficient information and had given implicit consent for all the detailed uses of their tissues and their original signing of a broad consent. CONCLUSION: Such re-consenting has considerable implications for study infrastructure and costs of research. It did not alter the outcome and it seems unlikely that the public, or our respondents, would see regular updating of consent to constitute an efficient use of public research funds.

Brain↗
PubMed2003

The requirement for prior consent to participate on survey response rates: a population-based survey in Grampian.

BACKGROUND: A survey was carried out in the Grampian region of Scotland with a random sample of 10,000 adults registered with a General Practitioner in Grampian. The study complied with new legislation requiring a two-stage approach to identify and recruit participants, and examined the implications of this for response rates, non-response bias and speed of response. METHODS: A two-stage survey was carried out consistent with new confidentiality guidelines. Individuals were contacted by post and asked by the Director of Public Health to consent to receive a postal or electronic questionnaire about communicating their views to the NHS. Those who consented were then sent questionnaires. Response rates at both stages were measured. RESULTS: 25% of people returned signed consent forms and were invited to complete questionnaires. Respondents at the consent stage were more likely to be female (odds ratio (OR) response rate of women compared to men = 1.5, 95% CI 1.4, 1.7), less likely to live in deprived postal areas (OR = 0.59, 95% CI 0.45, 0.78) and more likely to be older (OR for people born in 1930-39 compared to people born in 1970-79 = 2.82, 95% CI 2.36, 3.37). 80% of people who were invited to complete questionnaires returned them. Response rates were higher among older age groups. The overall response rate to the survey was 20%, relative to the original number approached for consent (1951/10000). CONCLUSION: The requirement of a separate, prior consent stage may significantly reduce overall survey response rates and necessitate the use of substantially larger initial samples for population surveys. It may also exacerbate non-response bias with respect to demographic variables.

Adolescent↗
PubMed1999

Informed consent for antipsychotic medication.

OBJECTIVE: To determine family physicians' attitudes and practices regarding documentation of informed consent for antipsychotic medication. DESIGN: Pilot cross-sectional study. SETTING: Teaching and non-teaching hospitals in Toronto, Ont. PARTICIPANTS: Thirty family physicians were selected in equal numbers from teaching and non-teaching hospitals with no more than five physicians from a given hospital. Participants were treating at least 10 patients with antipsychotic medication. Participants' mean age was 44.3 years; 83% were men. MAIN OUTCOME MEASURES: Documentation of consent and of disclosure of consent for antipsychotic medication in patients' charts. RESULTS: Documentation was found in only 13% of charts. Whether it was there or not did not correlate with information disclosed, score on an attitude scale, or demographics. Physicians who found documentation time-consuming were less likely to document. Most physicians disclosed reasons for antipsychotic medication, but less than half described tardive dyskinesia, a potentially irreversible movement disorder that affects about 25% of patients on long-term treatment. CONCLUSIONS: The low rate of documentation observed in this sample was consistent with reports of similar samples and might indicate that family physicians are unaware of recommendations for documentation or simply do not have time to keep abreast of current recommendations. Many physicians thought signed consent forms unnecessary for psychotic patients, and even more believed seeking consent for antipsychotic medications would increase patient anxiety.

Adult↗
PubMedDate not supplied

Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders.

Individuals with schizophrenia may show impaired capacity to make decisions about participating in research, yet these patients also show considerable heterogeneity in decisional abilities. Problems with procedures contribute to patients' difficulties in understanding consent forms. Few studies have focused on improving comprehension of research consent in older patients with psychotic disorders. In this study, 80 middle-aged and elderly outpatients with schizophrenia or related psychotic disorders and 19 normal comparison subjects were randomized to receive a routine consent (RC) or enhanced consent (EC) procedure. The EC procedure consisted of a computerized slide show incorporating more structure and review of important information. A comprehension test was administered after the consent procedure; subjects were given up to three trials of the post-test to answer all of the questions correctly. Overall, the normal comparison subjects obtained a higher score on the post-consent comprehension test than the patients. Within each of these two groups, those who received EC had better comprehension than those who received RC. Interestingly, EC patients did not differ significantly from RC normal comparison subjects in their post-test scores. Among the patients, comprehension test scores correlated with level of education and cognitive performance.

Adult↗
PubMed2004

Hepatitis C seroprevalence in accepted versus deferred blood-donor candidates evaluated by medical history and self-exclusion form.

BACKGROUND: Hepatitis C virus (HCV) represents a viral pandemic that is five times as widespread as human immunodeficiency virus. Blood transfusion posed a major risk of HCV infection in developed countries before 1990, but the introduction of improved blood-screening measures has decreased the risk of transfusion-associated HCV infection, which may now be even lower since the introduction of screening of pooled samples by nucleic acid testing (NAT). Unfortunately, NAT is not affordable in most developing countries. The goal of this work is to assess the usefulness of both screening measures, the medical history, and the self-exclusion form to distinguish between high-risk and low-risk populations of HCV-carrier blood-donor candidates in Mexico. STUDY DESIGN AND METHODS: From February 2002 to April 2003, 4174 consecutive candidates were enrolled in a prospective, nonrandomized and comparative study. In total, 4158 candidates were included in the analysis and divided in two groups: Group A consisted of 3101 accepted donors and Group B consisted of 1057 deferred donors according to a complete medical history and self-exclusion form. The only exclusion criteria was the lack of a signed consent form to enter the study. All candidates from both groups underwent anti-HCV detection by third-generation enzyme immunoassay (EIA). Those who had either a positive or gray-zone signal-to-cutoff ratio underwent polymerase chain reaction and a second EIA test. If the second EIA test resulted in either a positive or gray-zone signal-to-cutoff ratio, a recombinant immunoblot assay test was performed. The chi-square test was used for statistical analysis, and a p value less than 0.05 was considered significant. RESULTS: Anti-HCV prevalence by the EIA method was as follows: 0.61 percent for Group A and 1.32 percent for Group B (p = 0.0243); whereas with recombinant immunoblot assay the prevalence was 0.19 percent for Group A and 0.47 percent for Group B (p = 0.1265). When we analyzed the polymerase chain reaction test results, the prevalence in Group A was 0.10 percent (95% confidence interval, 0.089-0.110) and in Group B was 0.47 percent (95% confidence interval, 0.439-0.500) (p = 0.0159). CONCLUSIONS: The medical history of blood donors in conjunction with serologic screening tests helps to improve blood transfusion safety. This measure is recommended in blood banks of those countries where NAT is still unaffordable.

Adult↗
PubMed2005

Bias from requiring explicit consent from all participants in observational research: prospective, population based study.

OBJECTIVE: To evaluate the differences between adults who consent to participate in observational research, and those who do not. DESIGN: Prospective, population based cohort study. SETTING: Primary and secondary care throughout Scotland. PARTICIPANTS: 187 adults (aged > or = 16 years) resident in Scotland at the time of their first diagnosis of a brain arteriovenous malformation in 1999-2002. INTERVENTION: Postal consent form sent via participants' general practitioner. MAIN OUTCOME MEASURES: Differences between consenters and non-consenters in demographic and clinical features at first presentation, and outcome during follow-up. RESULTS: 111 adults (59%) consented to participate in the study. These consenters were not significantly different from non-consenters in age, sex, or socioeconomic status at first presentation. However, consenters were significantly more likely than non-consenters to present alive and independent, and with a seizure. During follow-up, consenters were significantly more likely to receive interventional treatment. Although consenters' survival was significantly better, they were more likely to have a seizure during follow-up. Presentation with intracranial haemorrhage conferred a higher risk of subsequent haemorrhage when the whole cohort was analysed, but not when it was restricted to consenters. CONCLUSIONS: We have found differences between adults who consent to participate in observational records-based research and those who do not, or cannot, consent. Blanket requirements for explicit consent for the use of individuals' identifiable data can bias disease registers, epidemiological studies, and health services research.

Adolescent↗
PubMed2001

Ethical issues in a Brazilian hospital.

PURPOSE: The objective of this paper is to discuss ethical issues such as data protection, confidentiality, and patient freedom taking two ongoing studies as examples. METHODS: The two studies are being carried out at a public hospital in southern Brazil. Study 1 evaluates inadequate use of drugs (mainly vancomycin) and aims at reviewing criteria for drug use control. It includes records of 100 patients whose prescriptions are dispensed at the hospital's pharmacy. A major ethical concern in this study was to ensure data confidentiality. Study 2 evaluates treatment adherence by hypertension patients with a focus on hydrochlorothiazide. Here, in addition to data protection, a major ethical concern was the ability of patients to understand the informed consent form and therefore freely enter or refuse to enter the study. Both projects were approved by the Institutional Review Board at Hospital de Clínicas de Porto Alegre. RESULTS: In both studies, data confidentiality is ensured by the removal of all personal information from the forms used for data analysis. In Study 2, readability of the informed consent was considered adequate by the IRB for the population served by the clinic, and one-third of the patients who were contacted agreed to participate in the study. CONCLUSIONS: To obtain reliable results, basic ethical principles must be observed throughout the planning and execution of research projects, whether data are obtained from medical records or from actual interaction with patients. Thus, monitoring by an Institutional Review Board or equivalent is of paramount importance.

Bioethics↗
PubMed2004

[Informed consent in research: a new approach].

INTRODUCTION: The Informed Consent allows the person invited to participate of a research project to understand the procedures, risks, discomforts, benefits and rights involved; determining an autonomic decision. We want to verify in the informed consent process the adequacy of given information to research subjects in a collective way. METHODS: A research project was chosen from the gynecologic area. The collective obtainment consisted of an oral presentation. After that, The Consent form was shown. Forty-five patients were interviewed, immediately after the consent obtainment. RESULTS: Remembrance capacity of information about procedures, risks and benefits explained were verified. All participants (100%) remembered the procedures, 54% of them remembered the risks and 96% the probable benefits. Comparing these data with others from a similar study using conventional informed consent process (individual information transmission) the subjects remember more information in the present study. CONCLUSION: These results evidence the possibility to inform collectively the research subjects when getting the Informed Consent in those projects where this choice is available.

Biomedical Research↗
PubMed1994

Managing oncology research protocols.

Oncology research protocol management is important for the effective execution of clinical trials with oncology patients. Clinical trials explore investigational drug safety, efficacy, and effectiveness. Investigational drugs have not received approval for widespread use and marketing by the Food and Drug Administration (FDA). The National Cancer Institute (NCI) has several branches concerned with investigational drug procurement, distribution, and recordkeeping of investigational cancer chemotherapy agents. Before an investigational drug is approved by the FDA for marketing in the United States, it must undergo several phases of pre-clinical and clinical trials. The Institutional Review Board (IRB) must review and approve clinical trials to ensure that studies meet legal, ethical, and scientific standards. The principal investigator (PI) takes responsibility for the clinical trial. Informed consent must be obtained from subjects before they may participate in clinical trials. The informed consent form is reviewed by the IRB. The investigational drug storage, accountability, ordering, distribution, and drug information dissemination process is improved with a pharmacy-coordinated investigational drug service.

Clinical Trials as Topic↗