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Results for “informed consent”

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PubMed2004

Informed consent skills in internal medicine residency: how are residents taught, and what do they learn?

PURPOSE: Obtaining informed consent is an essential skill in internal medicine (IM). The authors' informal observations and formal testing revealed deficiencies in residents' informed consent skills. This study evaluated how residents acquire informed consent skills and how informed consent skills are addressed in Canadian IM residency programs. METHOD: A questionnaire was delivered to all 16 IM program directors in Canada, asking how informed consent is taught and assessed. At the University of Saskatchewan IM residency program, residents were assessed through an objective structured clinical examination station, written examination, and a self-assessment questionnaire. RESULTS: No consistent approach to teaching or evaluating informed consent skills exists within Canadian IM programs. Program directors and residents identified informal mentoring by residents as an important learning modality. Although residents performed well in discussing procedural indications and techniques, discussing risks was inadequate. Residents focused on general and minor risks but avoided discussing serious risks and had difficulty discussing the frequency of complications. Residents lacked a structured approach to assessing capacity and often assessed only comprehension. Residents were unfamiliar with concepts such as material risk, implied consent, and therapeutic privilege. CONCLUSION: Explicit training in informed consent skills is urgently needed. Informal mentoring must be recognized as an important training method for informed consent and supported by appropriate teaching and evaluation strategies to ensure that resident-instructors do so effectively.

Canada↗
PubMed2003

Incapacity to give informed consent owing to mental disorder.

What renders some mentally disordered patients incapable of informed consent to medical interventions? It is argued that a patient is incapable of giving informed consent owing to mental disorder, if a mental disorder prevents a patient from understanding what s/he consents to; if a mental disorder prevents a patient from choosing decisively; if a mental disorder prevents a patient from communicating his/her consent; or if a mental disorder prevents a patient from accepting the need for a medical intervention. This paper holds that a patient's capacity to give informed consent should be assessed clinically by using these conditions necessary for informed consent, and should be assessed specifically for each intervention and specifically at the time when the consent has to be given. The paper considers patients' incapacity to give informed consent to treatment, to give informed consent to be examined clinically, and to give informed consent to participate in research.

Choice Behavior↗
PubMed2000

Informed consent for labour epidurals: what labouring women want to know.

PURPOSE: To determine A) what a labouring woman expects to hear about epidural analgesia before consenting, B) if she feels able to understand the risks and thereby assess if we are obtaining informed consent. METHODS: Sixty actively labouring women were surveyed immediately after requesting an epidural. Demographic, labour, epidural and consent information were included in the questionnaire. Answers were categorical (yes/no, multiple choice) or scored on a scale from 0 to 10 (visual analogue scale). RESULTS: The majority of parturients wanted all potential epidural complications but not their incidences disclosed in the consent process. However, a discussion of risks would not dissuade women from consenting to an epidural in the majority of cases. Labouring women have a moderate understanding of epidural risks. The ability to understand risks was not affected by labour pain, anxiety, opioid premedication, duration of labour pain, desire for an epidural, previous epidural experience, level of education or age. CONCLUSION: This prospective survey characterizes what 60 reasonable labouring women wanted to know about labour epidural analgesia. Parturients wanted all risks of epidural analgesia disclosed in the informed consent process. The majority of women did not want the incidences quoted. This study suggests that labouring patients are as able to give informed consent as are other members of our patient population.

Adult↗
PubMedDate not supplied

Informed consent for maternal serum alpha-fetoprotein screening in an inner city population: how informed is it?

OBJECTIVE: To determine if women who received information from a provider and viewed a videotape about maternal serum alpha-fetoprotein (MSAFP) screening understood enough to sign informed consent. DESIGN: A prospective qualitative design using tape recorded interviews of women who were provided information regarding MSAFP testing from a provider and from viewing a videotape. PARTICIPANTS: Fifty-three inner city pregnant women (58% Hispanic, 39% African-American, 3% white). RESULTS: Two women answered all questions correctly; no one answered all questions incorrectly. Sixty-two percent correctly answered "What is MSAFP?" Sixteen percent thought "something has to be taken from my belly" for the test. Fifty-nine percent understood that children with spina bifida could have difficulty walking or urinary problems. Seventy-two percent thought their infant would be healthy in all respects if the test was negative. Only 45% could describe the follow-up to a positive test. Eighty percent planned to have the test. Many misconceptions were apparent, and for some knowledge items, as many as 80% of the women answered incorrectly. CONCLUSIONS: Obtaining truly informed consent for a complex test is not a simple process. Participants met a few, but not all, of the criteria for informed consent. Women understood that the test was voluntary, but their comprehension of the meaning and implication of a positive test results was deficient. Despite this, they signed the informed consent document. The larger question of just how much comprehension is required to consider a woman "informed" has not been answered.

Comprehension↗
PubMed1996

Logic, hermeneutics, and informed consent.

A belief in the validity of informed consent is one of the most important consequences of the doctrine of autonomy in medical ethics. Truly informed consent requires full disclosure of all relevant information by the doctor, competence of the patient to appreciate what the information signifies, understanding of the facts and issues by the patient, a voluntary choice by the patient and an autonomous authorisation for treatment or entry into a trial. Each of these conditions is hard to fulfil. In particular, full autonomy cannot exist in illness, and this is acknowledged by the act of consultation. The issue is further complicated by the stochastic nature of biological systems and the responses to illness and treatment. Disclosure of likely outcomes is, of necessity, unsatisfactory when a patient seeks surety when entering the clinical process with a serious and life threatening disease. Neither strict logic nor the law provide answers to this problem. The legal and moral issues have become confused. This is unfortunate, because the legal concern often centres on avoidance of actions in law rather than on the more fundamental issue of benefit to the patient. There is a need to teach doctors that discussion is a necessary part of the doctor-patient relationship, that fully informed consent is seldom-if ever-possible, and that skill in understanding what the patient is seeking is more important than the development of rigid and legally "complete" consent forms.

Communication↗
PubMed2001

Informed consent in genetic research.

History demonstrates that, without adequate informed consent, research participants rights may be violated and their confidence in research as an enterprise undermined. If participants lose confidence in research, they may hesitate to participate in future research protocols. Without human participants to donate biological samples and participate in protocols, research will be difficult, if not impossible to conduct. Thus, appropriate informed consent protects both research participants and the enterprise of research itself. Informed consent principles in genetics not only help ensure the appropriateness of specific research protocols, but they also help support the continuation of all types of research on human participants. Most research involving human participants raises some issues fundamental to the informed consent process, such as whether potential participants truly understand the consequences of their participation in a study, and in which circumstances a person is competent to give consent. Advances in genetics are raising a new set of informed consent issues. The risks that may be involved in genetic research extend far beyond the standard considerations of immediate potential harm to study participants. Genetic information carries with it the possibility of uncovering a future propensity for a given illness. The disclosure of genetic information may lead to problems in obtaining health insurance, employment and/or housing discrimination, and to social and personal problems not only for participants, but also for their family members.

Cross-Cultural Comparison↗
PubMed2003

Clinical trials in pediatric cancer: parental perspectives on informed consent.

To better understand parental perceptions of the informed consent process in pediatric oncology clinical trials, 20 parents of newly diagnosed children at two pediatric cancer centers described their perceptions in a semi-structured interview. They recalled well the diagnosis, the general treatment plan, and the statistics of survival and/or cure, but the research nature of the clinical trials, particularly randomization, was not well understood. However, despite the need to assimilate a great deal of information, time pressure to make decisions, and reportedly high levels of distress during the discussions, parents expressed general satisfaction with the informed consent discussions with their pediatric oncology providers. However, half to two thirds of parents felt there had been inadequate discussion of alternatives to the proposed treatment and of the research nature of the protocol. While further study of the informed consent process should be conducted in larger, representative samples, the findings from this pilot study suggest that a goal of future informed consent interventions should be to improve parents' understanding of the research aspects of treatment. It is critical to parents' ability to provide informed consent that they feel satisfied that they know alternatives to proposed treatment and that they understand the randomization of treatments, which is the gold standard of clinical trials in pediatric oncology.

Adolescent↗
PubMed1989

Enforcing patient preferences. Linking payment for medical care to informed consent.

The legal and ethical doctrine of informed consent is well accepted in modern medicine. Nonetheless, medical interventions sometimes take place in the absence of informed consent, particularly in the case of life-sustaining medical procedures. These procedures ordinarily are reimbursed by third-party payers. This article proposes as a strategy to ensure greater attention to patient preferences in medical decision making that financial reimbursement for each medical service be linked to a requirement of valid patient (or surrogate) consent to the service involved. Utilization review bodies could monitor informed consent in the same way that other aspects of necessity, appropriateness, and quality are now monitored.

Consent Forms↗
PubMed2006

A new look at informed consent.

Problems with traditional informed consent processes could be fixed through an automated approach that: Allows providers to better inform and educate their patients. Gives hospitals the ability to better compile, record, and manage patient information. Provides access to patient information in real time. Simplifies documentation. Reduces risks of litigation. Enhances compliance with standards. Improves reimbursement.

Automation↗
PubMedDate not supplied

Failure mode and effects analysis as an informed consent tool for investigational cardiothoracic devices.

The informed consent process is one of the most critical segments of any device clinical trial. Informed consent requires that patients be provided with ample and accurate information about the risks and benefits of trial participation in a manner that respects their learning ability. Knowing this, the dilemma for clinical investigators lies in identifying the risks without having had clinical experience with the device in question. It is offered that the device manufacturer's FMEA (failure mode and effects analysis) document can be a valuable aid in determining the potential clinical risks of investigational devices, and thus should be available to clinical investigators for their preparation of informed consent documentation.

Clinical Trials as Topic↗
PubMed1976

Avoiding malpractice suits through the use of informed consent.

The doctrine of informed consent is based on a long tradition of promoting self-autonomy and rational decision-making. The amount of information required to be disclosed by the doctor to the patient is that which permits the patient to decide for himself whether or not to undergo the recommended treatment. It includes information about risks of death or serious bodily harm, probability of success, problems of recuperation, and alternative modes of treatment. Disclosing such information contributes to the doctor-patient relationship and therefore makes recourse to malpractice litigation in the face of an unsatisfactory or untoward result less likely. Attempts to abolish the doctrine are potentially counterproductive and could lead to widespread mistrust of the medical profession on the part of a society that increasingly demands more information in all areas. Physicians will best serve both themselves and their patients by fully disclosing all relevant information before asking patients to consent to specific therapies.

Adult↗
PubMed1987

An overview of informed consent for radiologists.

Because of the procedure-oriented nature of their specialty, radiologists obtain informed consent from patients daily. This paper attempts to help the radiologist obtain informed consent without incurring malpractice liability by discussing the important legal concept of simple consent as distinguished from informed consent, the elements a patient must prove to succeed in court with an allegation of lack of informed consent, the varying state requirements about the amount of information the patient must be given, the persons who must obtain consent from the patient, and the persons who can give consent for the patient. Consent for IV injections of contrast medium and consent forms are discussed because of the current controversy on these subjects. Courts and state legislatures have usually addressed only specific aspects of informed consent. However, except for the amount of information that must be given the patient, the courts have been relatively uniform in their requirements. Therefore, it is likely that a state court faced with issues of informed consent about which no law exists in their own state will use the existing law in other states as a precedent and adopt similar rules. However, each radiologist must be familiar with the specific rules for informed consent that have been developed by the courts and legislatures in the state in which he or she practices.

Contrast Media↗
PubMedDate not supplied

Ethical issues surrounding informed consent: Part III. The crucial role of nursing in insuring valid consent.

Three ethical principles upon which informed consent is founded are respect for persons, promotion of the best consequences, and rights. A valid informed consent--that is, one given by a person who has been informed, is competent, and has not been coerced--is one way of respecting persons, of enabling their rights. Consent given in the absence of information and competence, or in the presence of coercion, does not achieve these ends. Hence, it is not valid. The nurse is in a unique position to ensure the validity of consent. Nurses do this both by enhancing patients' opportunities for becoming informed and by observing for signs of incompetence and coercion. When the ability of a patient to execute a valid consent is compromised, the nurse needs to act to restore the patient's decision making capacities to the greatest level possible. Nursing's efforts in promoting morally valid consents are one way the profession recognizes the importance of each individual. This importance has been formally acknowledged by the American Nurses Association Code of Ethics (6). It is informally acknowledged when individual nurses act to maximize their patients' understanding and participation in the decisions surrounding health care. In helping patients to participate to the fullest possible extent, nurses show respect for the very unique human nature we all share. It is for this reason that insuring informed consent is worth whatever time and effort it takes.

Ethics, Nursing↗
PubMedDate not supplied

The origin and nature of informed consent: experiences among vulnerable groups.

The concept of informed consent has evolved over the past century. Today it is a mainstay of clinical practice and human subjects research. This article traces informed consent from its origins in law and bioethical thought to the creation of codes and a system of regulations. In this discussion, informed consent as a point of law and as an ethical construct is viewed from historical and contemporary perspectives in conjunction with the experiences of vulnerable population groups. This consideration does not extend to the use of specific research methodologies. The need to recognize the influence and importance of the sociocultural context in the implementation of informed consent is strongly supported. A correlation is drawn between aspects of consent and the ethical principles of beneficence, nonmaleficence, and autonomy. Four major guidelines for nurse researchers and clinicians are presented.

Child↗
PubMed2003

Ethical aspects of informed consent in obstetric anesthesia--new challenges and solutions.

Informed consent is a cornerstone and routine component of the ethical practice of modern medicine. Its full theoretical application to specific clinical situations, however, presents a number of ethical dilemmas for health care providers. Obstetric anesthesia, in particular, presents many unique challenges to the process of informed consent. In this review, the ethical background to the doctrine of informed consent within the context of "principlism" is explored and critiqued. The application of principlism to actual clinical situations, the limitations of principlism in the peculiarities of the patient-physician encounter, as well as possible alternative models of ethical discourse is discussed. The process of informed consent can be broken down into seven elements: Threshold elements or preconditions, which include 1) decision-making capacity or competency of the patient, 2) freedom or voluntariness in decision-making, including absence of over-riding legal or state interests; informational elements, including 3) adequate disclosure of material information, 4) recommendation, and 5) an understanding of the above; consent elements, which include 6) decision by the patient in favor of a plan and 7) authorization of that plan. Each of these elements is discussed in turn, and their implications, especially for the anesthesiologist and the obstetric patient, are addressed.

Adult↗
PubMed2001

Quality of informed consent: a new measure of understanding among research subjects.

BACKGROUND: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. METHODS AND RESULTS: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials. The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents. We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials. Two hundred seven subjects (72%) completed the QuIC. To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective understanding and.77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete. CONCLUSIONS: The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.

Adult↗
PubMed1998

Informed consent: assessment of comprehension.

OBJECTIVE: The authors designed and evaluated a structured and rigorous informed consent procedure involving subjects with schizophrenia. METHOD: Informed consent forms were read and explained to 49 schizophrenic patients participating in ongoing clinical treatment research trials. The subjects answered a questionnaire relating to each research protocol. Protocol procedures were reiterated until the patients answered 100% of the questions correctly. Subjects were asked the same questions 7 days later to ascertain how much of the information they had retained. RESULTS: The patients' median score on the first trial of the informed consent questionnaire was 80% correct. To achieve 100% correct responses, 53% of the patients required a second trial of the questionnaire, and 37% of them required three or more trials. Scores improved between the first trial and the trial on day 7. Ninety-six percent of the subjects felt adequately informed, 66% reported participating in the research protocol for personal reasons, and 34% reported participating at the suggestion of others. CONCLUSIONS: These findings demonstrate that when adequate informed consent procedures are established, schizophrenic research subjects are able to understand and retain critical components of informed consent information.

Adult↗
PubMedDate not supplied

Informed consent: legal, behavioral, and educational issues.

The doctrine of informed consent is examined from legal, behavioral, and educational perspectives. A brief legal history of the doctrine is presented along with a discussion of contemporary standards of disclosure and the emerging right of the patient to understand informed consent disclosures. Behavioral and educational issues include the relationship between disclosure and patient anxiety, patient recall of disclosures, readability of consent forms, and alternatives to the traditional doctor-patient disclosure model. A role for the patient-health educator in strategies to improve both the consenting and informing processes of the informed consent requirement is suggested.

Cognition↗