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PubMed2006

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk.

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.

Comprehension↗
PubMed2004

Impracticability of informed consent in the Registry of the Canadian Stroke Network.

BACKGROUND: Government legislators and research ethics boards in some jurisdictions require all patients to give written informed consent before enrollment in clinical registries. However, the effect of such a requirement on the use of clinical registries and the extent to which registry data can be generalized remain uncertain. METHODS: We examined the effectiveness of a comprehensive attempt to obtain informed consent between June 2001 and December 2002 on the overall participation rate and the characteristics of participating patients in the Registry of the Canadian Stroke Network, a prospective registry based at 20 major stroke centers across Canada. RESULTS: The overall participation rate (i.e., the consent rate among all potential participants) was 39.3 percent of 4285 eligible patients during phase 1 of the project (June 2001 through February 2002) and 50.6 percent of 2823 eligible patients during phase 2 (June 2002 through December 2002), despite the presence of neurologic research nurse coordinators at each site. Many patients died or left the hospital before they could be approached for consent. Major selection biases were found; the in-hospital mortality rate was much lower among patients who were enrolled (6.9 percent) than among those who were not enrolled (21.7 percent) (relative risk of in-hospital death, 3.13; 95 percent confidence interval, 2.65 to 3.70; P<0.001). We estimate that approximately 500,000 dollars (Canadian dollars) was spent on consent-related issues during the first two years of the registry. CONCLUSIONS: Obtaining written informed consent for participation in a stroke registry led to important selection biases, such that registry patients were not representative of the typical patient with stroke at each center. These findings highlight the need for legislation on privacy and policies permitting waivers of informed consent for minimal-risk observational research.

Canada↗
PubMed1994

A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain.

To determine whether informed consent in a therapeutic trial modifies the analgesic effect of naproxen and placebo, we conducted a prospective, randomised, single dose, placebo-controlled trial. Patients were randomly selected to receive or not information concerning the study. All patients included were then given a single dose of naproxen and placebo according to a crossover, double-blind design. Forty-nine patients with mild or moderate cancer pain which did not need narcotic analgesics entered the study. Twenty-five received both treatments without any information and constituted the uninformed group. Twenty-four had a complete information about the trial; six refused to participate. The 18 others constituted the informed-consent group. Visual analogue scales of pain before and 30, 60, 120 and 180 min after the intake of naproxen and placebo were recorded. As an analgesic, naproxen was more effective than placebo in both groups of patients (p = 0.001). For naproxen as well as for placebo, the analgesic effect was better in the informed-consent group compared to the uninformed group (p = 0.012). The difference in therapeutic activity between naproxen and placebo was moderately higher in the uninformed patients (p = 0.08). We concluded that, in contrast with parallel studies, giving information in a crossover, placebo-controlled trial may increase the apparent efficacy of both the tested agent and the placebo, and decrease the perceived difference the two.

Adult↗
PubMedDate not supplied

Anonymity and informed consent in artificial procreation: a report from Denmark.

The practice of informed consent in biomedicine is so widely spread that it must be considered the most important principle within bioethics, and the most universally appealed to within recent legislation. There seems to be a consensus as to its value in research on autonomous persons, but also a problem concerning its application when dealing with people having a serious mental, social or even physical disability. Within the field of artificial procreation there are even more problems. Informed written consent is often demanded from anonymous donors of gametes in order to ensure their consent to the legal and moral consequences of their anonymity. The child resulting from the artificial procreation, on the contrary, cannot consent to, nor be informed before being conceived, of the secrecy laid on the identity of its genetic parents. Some countries resolve this problem by allowing the children, when they reach their majority, to obtain some information pertaining to the health or the identity of their genetic parents. This presents ethical problems. It can be argued that the anonymity of the parents chiefly affects the children, so that an agreement on this point among parents, doctors and others must be regarded as invalid. The paper will argue that a law ensuring the complete anonymity of the parents is disregarding the informed consent and the interests of the children resulting from artificial procreation, and is thus doing more damage to society than good.

Child↗
PubMed2004

Confronting the ethical challenges to informed consent in emergency medicine research.

The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.

Emergency Medicine↗
PubMed1994

[The medicolegal aspects of informed consent in the dental treatment of the handicapped patient].

The authors reiterate the necessity of informed consent in medical and surgical care. The importance of patient's consent is represented by significance that law grants to the psychic and physical health of the citizen and to his right to be protected. This paper considers the problem of informed consent relatively to the dental therapy of handicapped patient, that can't always undergo an operation in ambulatory and that often needs to be cured with general anaesthesia. The patients causing more difficulties to the doctors, with regard to the acquisition of informed consent, certainly are persons of unsound mind and subjects with sensorial alterations. In fact, for the others, is admitted a volitive and cognitive capacity resembling to their age. Certainly, it's possible to obtain a sufficient management of this patient's category. Finally, the authors underline the importance of prevention to improve dental status of the handicapped, and to avoid increase of patients that come to medical observation when their pathology needs of treatment with general anaesthesia.

Dental Care for Persons with Disabilities↗
PubMed1987

Informed consent: the physicians' perspective.

Using the current controversy in breast cancer treatment as a model, this paper reports on physicians' attitudes and behavior in the use of informed consent. Findings are based on a survey of 170 oncologists from eight countries and representing three medical specialties. Physician responses indicate that they regarded informed consent as an intrusion into the doctor-patient relationship. Problems identified by the physicians included: decreasingly effective doctor-patient communication; less personalized relationships with patients and curtailed freedom with regard to disclosure procedures. They also viewed the informed consent regulation as having a negative impact on their patient care. The constraints of obtaining informed consent reduced physicians' willingness to participate in scientific experiments. The consent form was seen to highlight their dual role as care-giver and scientific investigator, making them uncomfortable in dealing with patients. These findings demonstrate the ways in which legal restrictions associated with the introduction of new technologies critically affect the practice of medicine.

Breast Neoplasms↗
PubMed2000

Informed consent.

Patients have a right to informed consent and a right to forego treatments, procedures, or surgery if they feel uninformed or have changed their minds.

Communication Barriers↗
PubMed1995

Obtaining informed consent in Alzheimer's research.

While current drug studies focus on treating cognitive symptoms and pose little risk to dementia subjects who participate, future drug studies may very well impose greater risks. Investigators are challenged in both present and future AD research to respect and safeguard the rights and welfare of a vulnerable population while promoting the highest quality research to investigate the causes, treatment, and prevention of Alzheimer's disease. In procuring informed consent for research, researchers should exercise caution in concluding that an AD subject is not competent to consent to participate in research protocols based solely on the presence of dementia. Informed consent should be sought from a competent AD subject, and if indeed the participant is not fully competent, the investigator should obtain full informed consent from a proxy while obtaining assent from the subject. Finally, while the augmentation of advance consent directives with informal family consent or durable power of attorney may make for a qualitatively better informed consent for dementia research, it should not be legally required before research takes place. Advance consent directives should be seen as an adjunct to the current proxy consent/subject assent and not a substitution.

Advance Directives↗
PubMed2003

Evaluating medical students' skills in obtaining informed consent for HIV testing.

OBJECTIVE: To evaluate fourth-year medical students' abilities to obtain informed consent or refusal for HIV testing through a performance-based evaluation method. DESIGN: Student competence was assessed in a standardized patient interaction in which the student obtained informed consent or refusal for HIV testing. A previously validated 16-item checklist was completed by the standardized patient. A subset was independently reviewed and scored by a faculty member to calculate interrater reliability for this report. Student feedback on the assessment was elicited. SETTING: School of Medicine at the University of New Mexico. PATIENTS/PARTICIPANTS: All senior medical students in the class of 2000 were included. INTERVENTIONS: A 10-minute standardized patient interaction was administered within the context of a formal comprehensive performance assessment. MEASUREMENTS AND MAIN RESULTS: Seventy-nine students participated, and most (96%) demonstrated competence on the station. For the 15 specific items, the mean score was 25.5 out of 30 possible points (range, 13 to 30; SD, 3.5) on the checklist. A strong positive correlation (rs =.79) was found between the total score on the 15 Likert-scaled items and the score in response to the global item, "I would return to this clinician" (mean, 3.5; SD, 1.0). Scores given by the standardized patients and the faculty rater were well correlated. The station was generally well received by students, many of whom were stimulated to pursue further learning. CONCLUSIONS: This method of assessing medical students' abilities to obtain informed consent or refusal for HIV testing can be translated to a variety of clinical settings. Such efforts may help in demonstrating competence in performing key ethics skills and may help ensure ethically sound clinical care for people at risk for HIV infection.

Clinical Competence↗
PubMed1991

Informed consent, competency, and the illusion of rationality.

Since the advent of informed consent, patients have become more involved in treatment decisions than ever before. To give an informed consent or refusal a patient must be competent to understand the information being presented. Although most authors agree on the need for a structured format for assessing competency, in practice this step is often omitted if the patient's decision "makes sense." In this paper we present two cases in which acutely ill patients gave apparently rational refusals of potentially life-prolonging treatment. Following their recovery, both viewed their earlier decisions as irrational. These cases demonstrate some of the difficulties in assessing competency and rationality in gravely ill patients, and the need for careful evaluation regardless of the apparent rationality of expressed desires.

Activities of Daily Living↗
PubMed2002

Dutch dental patients on informed consent: knowledge, attitudes, self-efficacy and behaviour.

In The Netherlands, the legal doctrine of informed consent is established in the 'Medical Treatment Contract Act', which was introduced in 1995. This study assessed dental patients' knowledge, attitudes and self-efficacy, as well as their self-reported behaviour concerning informed consent. One hundred and twenty-eight patients (response rate: 91.4%) filled out a questionnaire on these topics, right after their treatment or consultation. Results show that only a minority of the patients is acquainted with the 'Medical Treatment Contract Act'. However, their specific rights concerning informed consent are better known. On the other hand, patients' attitudes and self-efficacy were less positive. Dental patients' self-reported behaviour, did not reflect their attitudes and self-efficacy though. Contrary to social-psychological theory, almost no significant relations were found between the four measured variables, and self-reported behaviour could hardly be predicted by patients' knowledge, attitudes and self-efficacy. In light of these findings, it is concluded that other factors, which take into account more of a consumerist perspective on the dentist-patient relationship, probably play a more important role in predicting to what extent patients assert their rights in dental practice.

Dental Care↗
PubMed2003

[Medical intervention and assault: On the legal foundations of informed consent in German surgery, 1892-1940].

The recent historiography of informed consent in German medicine has chiefly focused on the issue of consent to human experimentation. This paper widens the historical perspective by demonstrating that the foundations of the concept of informed consent to surgery were laid in German law around 1900. From the 1890s onwards a debate about the legal basis of surgical operations developed in response to cases of medical intervention without full consent. While surgeons were unwilling to accept a legal interpretation of non-consensual treatment as assault, jurists were divided over the issue. Whereas Carl Stooss (1849-1934) and Joseph Heimberger (1865-1927) and Ludwig von Bar (1836-1913), endorsed the view that consent was a crucial requirement for the legality of surgical operations. Moreover, the German Supreme Court (Reichsgericht) in Leipzig consistently emphasized in its decisions the necessity of patients' consent. From 1912 it dealt also with the question of adequate pre-operative information of patients. Despite pressures during the Third Reich to reduce patients' "rule" over their own body in favour of notions of the health of the Volk, the Supreme Court upheld the requirement of individual patient consent in two further decisions, in 1936 and 1940.

General Surgery↗
PubMedDate not supplied

Informed consent and investigational new drug abuses in the U.S. military.

OBJECTIVE: The focal point of this investigation was to research the ethical issues surrounding the military's requests for informed consent waivers when using investigational drugs, and the recent debate surrounding the anthrax vaccine as an investigational new drug (IND). DESIGN: The military's management of the informed consent process was examined using documents obtained through the Freedom of Information Act, Institutional Review Board (IRB) minutes, legal pleadings, and protocols for specific investigational drugs. RESULTS: In December 1990, prior to Operation Desert Storm, the Federal Drug Administration (FDA) granted the Department of Defense (DoD) an unprecedented waiver to the federally mandated informed-consent requirement for the use of investigational drugs. However, the waiver approval was conditional, and the FDA insisted on several safeguards. Partially in response to the subsequent Gulf War Syndrome debate, the FDA recently evaluated the military's use of investigational drugs during the Gulf War. The FDA cited the military for significant deviations from the originally approved protocols. Most notably, the military was found to be abusing the IRB process by convening a second IRB when the first IRB concluded that waiving informed consent was unethical. In addition, there was a gross lack of documentation and no monitoring of adverse reactions. The DoD's plan to use the current anthrax vaccine on all 2.4 million troops against inhalation anthrax has kindled an additional investigational drug controversy. The safety and efficacy of the use of the anthrax vaccine as a prophylactic against inhalation anthrax have been questioned by both military and medical organizations. There have never been any published studies of human efficacy or long-term effects for the anthrax vaccine. In addition, the military is not using the vaccine for its intended purpose, and it is also not adhering to prescribed dosing schedules. There is clear evidence to support the claim that, in fact, the military's use of the anthrax vaccine should be considered unethical. CONCLUSIONS: I argue that in medical situations, the military is obligated to treat its troops as autonomous persons entitled to basic rights and protections. The DoD is currently using an approved drug, the anthrax vaccine, for an unapproved purpose and in an unapproved manner. In doing so, the DoD is not only violating the FDA's regulations against such practices, it is also violating an executive order which only allows the president to authorize the use of INDs on service members without their consent.

Anthrax↗
PubMed1994

[Willingness to give informed consent in elderly demented and confused (delirious) patients].

In the treatment of elderly patients the question often arises whether they are able to give an informed consent to medical operations. According to German jurisdiction the patient must be able to comprehend the kind, the aim and the consequences of the projected surgical operation as well as to declare his will. If this is not the case, he cannot give an informed consent, being "under disability" and in Germany a guardian has to be installed by the court. E.g., moderately demented or delirious patients are unable to give an informed consent to medical operations. A discussion on this topic is under way, as to whether a patient has the right to give an informed consent in advance in case of becoming unable to declare his will (in dementia etc.).

Aged↗
PubMed1993

Testing for HIV antibodies. Guide for obtaining informed consent.

Testing for HIV and such issues as test accuracy, informed consent, reporting requirements, and confidentiality related to testing are reviewed. Pre-test and posttest counseling is discussed, and a sample form to guide family physicians in obtaining informed consent is provided.

AIDS Serodiagnosis↗
PubMedDate not supplied

Autonomy, privacy and informed consent 2: postnatal perspective.

The nursing and healthcare ethics literature over the past 10 years has focused on issues of patient autonomy and patient rights. Despite the growing volume of literature exploring such topics, there is little empirical work investigating what is actually happening in clinical nursing or midwifery practice in relation to patient autonomy, privacy or informed consent, from the perspective of either patients or staff. This four-part series reports the results of a Scottish study that formed part of a multisite comparative research project funded by the European Commission, investigating issues of patient autonomy, privacy and informed consent. This article, the second of four, explores the issues of autonomy, privacy and informed consent in maternity care. The research questions asked were: (1) What is the perception of mothers' autonomy, privacy and informed consent in Scottish NHS hospitals, from the point of view of both mothers and midwives? (2) Are there differences in the perceptions of mothers and midwives on these issues? Data were collected by a self-completion questionnaire for mothers (n = 243) and staff (n = 170) on postnatal units in both district general and university teaching hospital. Results indicated that there are differences between the perceptions of mothers and midwives in relation to mothers' autonomy, privacy and informed consent. Most differences were found in the information-giving and decision-making elements of autonomy.

Decision Making↗
PubMed2004

Communication and miscommunication in informed consent to research.

Biomedical ethics require that research subjects be aware that the drugs they take or procedures they undergo are designed to fulfill the conditions of the experiment and not to benefit a subject's health. This apparently straightforward distinction between research and treatment is a source of much controversy and misunderstanding. Ethicists have labeled this problem the "therapeutic misconception." This misconception and, more broadly, informed consent have been studied extensively. Nonetheless, the therapeutic misconception persists among research subjects. This paper argues that one factor overlooked in the persistence of the therapeutic misconception is the effect of the theoretical paradigm that guides the practice and analysis of informed consent. The paradigm poses an idealized model of communication that ignores social context. This paper examines informed consent practices associated with a cancer research trial to demonstrate an alternative approach to studying informed consent to research. Through analysis of informed consent session transcripts, it demonstrates the importance of taking account of not only what is said, but how and by whom it is said.

Clinical Trials, Phase I as Topic↗