SEARCH · Search PubMed
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Case scenario: staff nurse Fawn was asked to take on the role of getting the patients to sign the consent forms before surgery was carried out. She was concerned at the legality of her being asked to undertake this since she would not be carrying out the operations. What is the law?
OBJECTIVE: To understand the psychosocial outcomes related to decision-making processes of individuals eligible for participation in clinical trials. METHODS: Individuals eligible to participate in selected clinical trials were contacted to complete two surveys; one shortly after participants were identified, and the second 6 weeks after the first survey was completed (N=50). Measures included subjective informed consent; satisfaction with decision-making; decisional regret; and timing of consent (early versus late signers). ANOVA and correlation coefficients were used to test the relationships between variables. RESULTS: Early signers reported themselves to be less informed about the details of their particular clinical trials than later signers (M=81.9 versus 91.2; F=5.5; p=.02). There was a non-significant trend for early signers to be less satisfied with their decisions than late signers. Satisfaction with decision-making and subjective informed consent were both strongly associated with later decisional regret (r=-.32 and -.30, respectively). However, there was no relationship between timing of consent and decisional regret. CONCLUSION: Participants who enroll in clinical trials quickly may not believe they fully understand the implications of trial participation. In general, participants who do not believe they fully understand the implications of trial participation, or who are less satisfied with their decision to enroll in the trial may ultimately feel regret about their decision to participate. PRACTICE IMPLICATIONS: More effort is needed to ensure that clinical trial participants fully understand the risks and benefits of participation and are satisfied with their decision to enroll in a trial prior to signing consent forms.
CONTEXT: Informed consent entails more than signing a document. Ideally, it should involve a process in which individuals are given sufficient information to make a voluntary decision. Little is known about the process of informed consent for cadaver donation. OBJECTIVE: To assess existing consent procedures for cadaver donation in a sample of US medical schools. DESIGN: Cross-sectional survey and content analysis of informational brochures and consent forms given to potential cadaver donors. SETTING AND PARTICIPANTS: The 22 largest medical schools in the United States, as ranked by the number of medical students in the Association of American Medical Colleges Institutional Profile System Annual Report 1995-1996. MAIN OUTCOME MEASURES: Description of dissection procedure, information provided about dissection, and the process for obtaining consent. RESULTS: Of the 22 schools studied, 18 schools (82%) mentioned the altruistic nature of cadaver donation. Twenty-one schools (96%) specified that bodies would be used to teach students, and 16 schools (73%) specified that bodies would be used for research. One school (4%) noted that organs could be permanently preserved for teaching purposes. Only 2 schools (9%) provided any description of the dissection procedures to be performed on the cadavers. Seven schools (32%) used the term dissect at least once. None of the schools offered to provide a complete account of the dissection procedure. CONCLUSIONS: The existing consent procedures for cadaver donations at US medical schools do not provide sufficient information to potential donors to constitute a fully informed consent.
Standard consent forms for blood and tissue sampling are inadequate for DNA sampling. However, creating new and separate forms for each type of activity associated with DNA analysis (banking, linkage analysis and genetic diagnosis) tends to dissociate the participant from what is essentially a medical continuum. Furthermore, DNA sampling involves the sharing of samples and data among centres. To ensure patient control throughout this multifaceted process, we have developed an integrated approach to obtaining consent for DNA sampling at each level of participation. Movement from one level to another is reflected in the choices offered to participants. This inclusive approach is based on the underlying principle of informed consent, namely the respect for individuality, confidentiality and freedom of choice. This approach should help practitioners of medical genetics recognize the medical context of DNA sampling.
In the last half century, informed consent has become a central tenet of all research involving human subjects. However, even after the worldwide adoption of regulations aimed at ensuring the protection of subjects, some abuses continue. The installation of oversight bodies, such as institutional review boards, has prevented the bulk of deliberate mistreatment; however, unintentional coercion is still a problem. Informed consent is not limited to obtaining a signature on a consent form, but a process of decision making designed to protect the rights of patients and subjects. It is a constant, ongoing exchange of information between researcher and subject. Although research is invaluable to the advancement of medicine and transplantation, researchers have the responsibility to protect their subjects' rights and autonomy. This paper provides an overview of informed consent, principles behind the process, and implications of current regulations to assist readers in their endeavor for sound and ethical research.
The improvement in life expectancy, following better cancer therapy combined with new options in treating male infertility have increased the use of sperm freezing. We describe a rare case of twin pregnancy of a childless widow, using donated oocytes after ICSI with her deceased husband's banked frozen spermatozoa. Sperm was frozen before chemotherapy treatment and a written consent for future thawing and injection to donor oocytes was given. Use of thawed spermatozoa after death was not mentioned in the consent form. During the husband's illness years, ICSI of donated oocytes fertilized with thawed spermatozoa yielded three embryos, but no pregnancy was achieved after ET. While waiting for a subsequent oocyte donation, the male partner died of his malignancy. The woman expressed her wish to be treated with the frozen spermatozoa of her deceased husband. Since the original informed consent did not cover postmortem use of the husband's sperm, a special application for its use was made and subsequently approved by the Israeli Ministry of Health legal advisor. Another six donated oocytes were fertilized with the deceased's thawed spermatozoa, and the transfer of four embryos to the uterine cavity resulted in a twin pregnancy and later delivery of two healthy babies. This case emphasizes the importance of written informed consent signed by patients with a life-threatening disease at the time of banking spermatozoa, and discussing the possibility of its posthumous use. Several legal and ethical concerns are discussed.
Obtaining informed consent for clinical investigations represents a major legal, ethical, and moral consideration in human experimentation. Mechanisms for informing the patient vary widely, and usually no system exists to confirm the degree of information retained by the patient. A Veterans Administration Cooperative Study, begun in 1975, has used a videotape information package in addition to a standard written consent form to ensure uniformity. Each presentation was followed by a questionnaire to assess the amount of material learned before attempting randomization. Repeated showings were occasionally necessary and did not affect the rate of randomization. A videotape presentation, especially in cooperative studies, ensures uniformity, makes allowance for varying educational levels of patients, and provides documentation of the degree of informed consent.
In non-industrialized countries, populations with the lowest literacy rates have the poorest health status. In the United States, however, there is no published research on whether illiteracy, independently of other sociodemographic factors, is related to health status. There are numerous plausible mechanisms by which such a relationship could occur. For example, published reports indicate that most information handouts, consent forms, and other materials for patients are written at reading levels too difficult for most American adults. These and other findings may have important implications in the health care of underserved populations. Research is needed to determine the health effects of impaired literacy skills among Americans, and to develop non-literacy-dependent methods for providing patient education, obtaining informed consent, and administering diagnostic tests.
Establishing the value of a new medicine by applying the tools and methods of pharmacoeconomics has become an important third objective in many clinical trials. The pharmacoeconomic investigator conducting research in clinical trials must understand and conform to the rules and procedures governing the clinical trial process. This article addresses some of the vital yet often overlooked details associated with conducting pharmacoeconomic research in clinical trials. The protocol, the informed consent form, the data collection instruments, the study initiation, and the final study report are all discussed. Additionally, limitations of the study results are reviewed.
AIM: In French legal terminology, the definition of autopsy is "organs'withholding". This phrase is ambiguous, meaning both removing the organs for their macroscopic exam and their retention for subsequent histology. The autopsy of a child requires an informed consent from both parents. The issue is that the pathologist who performs the autopsy is not the one who delivers the information and gets the parents' consent: therefore, he does not know what they were told and what they actually agreed upon. MATERIALS AND METHODS: A questionnaire was sent to 3 groups of paediatricians (N=891) to approach their knowledge regarding autopsy. RESULTS: Among 362 paediatricians who answered the questionnaire, 57.2% never attended an autopsy and procedures were badly known. They did not know whether or not organs, were systematically sampled especially brain. Regarding the possibility of conservation of organs, a majority thought that one should not solely answer to parents'queries (63.8%) but rather that one should point out every possibility, without giving the ins and outs (60.8%). The majority favoured organs retention and use for research. CONCLUSION: We make 3 suggestions: to register autopsy in the Natioanal Securite Sociale nomenclature, to establish information and consent forms for organs'removal, retention and disposal, and to offer parents the possibility of an interview with the pathologist before and/or after the autopsy, in association with the paediatrician.
Patient education materials and hospital forms are given to patients with little regard for their ability to read them. Nationwide sampling and data from the 1980 census suggest that a high proportion of patients cared for in public hospitals are functionally illiterate. In this study, 151 adult primary care patients in five different ambulatory care settings were tested for reading comprehension. Patient education materials and forms from each clinic were analyzed for readability using a standard computer program. A large discrepancy was found between the average patient reading comprehension and the ability levels needed to read patient education materials. The average reading comprehension of public clinic patients was 6th grade 5th month. Most tested patient education materials required a reading level of 11th to 14th grade, and standard institutional consent forms required a college-level reading comprehension. In the public clinics there was a gap of more than 5 years between patient reading levels and the comprehension levels required by written patient materials.
Most practicing oncologists are committed to the concept of prospective clinical trials but, because of multiple logistic and perceptual deterrents, actually enter only a small portion of their patients into such studies. Physician concerns include discomfort with placebo or "no treatment" randomizations, the burden of cumbersome monitoring of protocol patients, and fear of displeasing referring physicians. Patients have difficulty accepting the uncertainty of randomized trials, particularly those with a placebo arm. They resent the inconvenience and expense of extra visits and studies associated with protocol participation. Informed consent documents are often complex and their intent misconstrued by patients. Rigorous eligibility requirements, although necessary for accurate analysis, reduce accrual. Multiplicity of protocols, with the resulting necessity to prioritize, rapid closure of Phase II studies for common tumors, and negative public attitudes reinforced by the media are significant deterrents to clinical trial participation. Increasing accrual is a daunting challenge to the physician. Simplification of burdensome data collection, consent forms, and institutional review board procedures will reduce reluctance to participate. Most important, physicians must be educators, emphasizing the advantages of clinical trials to their patients and their families, their colleagues, and the public.
Alcohol and drug abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested.
OBJECTIVE: The authors assessed a statewide school-based Hepatitis B (HepB) vaccination program for preadolescents in Hawaii over three consecutive school years. Factors assessed included number of schools and students participating and number of students receiving three doses of hepatitis B vaccine. METHODS: Records of the program, which targeted 4th and/or 5th graders in public and private schools, were reviewed for the period from 1996 to 1999. RESULTS: The proportion of participating schools increased from 76% of all schools in the state in School Year 1 to 94% in School Year 3. The proportion of children with completed consent forms who received three doses of HepB vaccine at school exceeded 80% throughout the project. In School Year 1, 10,003 (70%) of 14,333 children enrolled at participating schools received three vaccine doses in school; however, this proportion declined over subsequent school years to 51% (7,722/15,013) in School Year 2 and 24% (7,344/30,429) in School Year 3. A survey of 477 parents not consenting to school vaccination indicated that 84% of their children completed the vaccine series at a private provider office. CONCLUSION: Statewide school-based HepB vaccination campaigns for at-risk populations can result in a majority of children in targeted age groups receiving three doses of hepatitis B vaccine, though declining participation may be observed as uptake in the private sector increases.
The desirability of obtaining written informed consent for low-risk radiologic procedures has been the subject of controversy. A group of 80 patients was studied to evaluate the effect of informed consent for excretory urograms on: (1) incidence of contrast reactions; (2) discomfort during the procedure; (3) level of patients' anxiety before and after the procedure; (4) patients' perception of the procedure; and (5) desirability of informed consent from the patients' viewpoint. Results revealed no statistically significant difference between the 2 groups in the incidence of reactions, discomfort, perception of the examination, or anxiety level prior to the procedure. The informed consent group had a statistically greater factual knowledge of the procedure evaluated objectively (P less than 0.01). Of the patients who received the written consent form, 83% regarded it as helpful and none viewed it as harmful or refused the examination. In the control group, 32% desired more information.
Current professional guidelines concerning information and consent for anaesthesia are a fair representation of English law. However, they reject the need for specific, written consent for anaesthesia, a position which is in accordance with other Western jurisdictions. This is understandable, as there would be a number of problems inherent in such an approach: the consent process would be unnecessarily labour and time intensive, the generic nature of the information to be disclosed would not allow for operator-dependent variables, and many of the disclosable risks continue to be of uncertain incidence. Moreover, written consent is not needed in order to defend cases of assault by anaesthetists. However, for the very reason that there are a large number of risks associated with anaesthesia (risks that are unknown to the majority of surgeons), together with the possibility of the courts moving towards a reasonable patient standard of information disclosure (as a result of the introduction of human rights legislation into English law), it is our view that the Association of Anaesthetists of Great Britain and Ireland should change their guidelines and advise anaesthetists to obtain separate, written affirmation from patients that certain risks and consequences of anaesthesia have been explained to them. In addition, a standardised consent form for anaesthesia may prove invaluable in retrospectively defending a claim of negligence founded around information disclosure, by recording exactly the risks and consequences of interventions discussed by the anaesthetist and the patient.
The purpose of this survey in 50 healthy volunteers from a single-centre study was to assess from a questionnaire filled in by the participants, their comprehension and evaluation of the written and oral information and the legal framework, as well as their uncertainty regarding participation, in terms of age, gender and profession. Overall satisfaction with regard to comprehension and oral information was recorded, but 42% of volunteers considered the informed consent form too long and one-quarter of them did not read it completely. Knowledge of the legal framework (20%) did not influence either their understanding or hesitation to participate. The hesitant individuals (26%) more often judged this framework to be reassuring than the non-hesitant individuals (77% versus 38%; p = 0.015). These findings concerned females, medics or paramedics and younger individuals (< or =35 years). In individuals who do not give their consent, it would be interesting to study the reasons for refusal to participate and the influence of the ethical and legal framework in clinical trials in enhancing the patients' partnership in a context of evidence-based medicine.
In this article, the author describes the responsibility of the admitting nurse to inform the patient about the procedure before the consent form is signed. The importance of an informed patient in relation to the legal implications and also the increased comfort level that the patient will experience are described. Results of a research program on pre-procedure patient education will be referenced.