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PubMedDate not supplied

Informed consent in dentistry: the impact of "Who pays the bills?".

This paper analyzes the concept of informed consent in dentistry from a bioethical and philosophical perspective. It is my contention that informed consent, as presently utilized in daily dental practice, might be illusory at best. After analysis of the concept in general to derive a philosophical underpinning, this basis is applied to alternate delivery systems including Medicaid, Capitation Programs, and the "overbilling" scenario. Then an approach that is respectful of the patient's autonomy and that can achieve a truly meaningful informed consent is suggested.

Beneficence↗

PubMed2006

Long term clinical trials: how much information do participants retain from the informed consent process?

Previous studies report mixed results about how much information study participants actually can read, understand and retain after completing the informed consent process; fewer studies have examined disparities in the retention and recall of information by patient factors, such as age, education, and race. Not retaining or being able to recall information from the informed consent process has potentially important ethical and legal implications and consequences for research quality and integrity, especially when found in populations that commonly are underserved or underrepresented in clinical trials. To determine how much basic knowledge participants finishing a five-year, multi-center, double-blinded randomized, placebo-controlled clinical trial had about the study, participants (n=1,789) were asked at their final follow-up visit three multiple-choice questions: (1) the study's purpose; (2) the name of the medication under investigation; (3) the main side effect of the medication. The associations between knowledge of these fundamental details and participant social and demographic factors were investigated. A majority of participants correctly recalled the study's purpose (64.7%) and medication (79.6%), but few correctly reported the main side effect (31.1%). In spite of relatively high recall for study purpose and medication, disparities by age, education and race exist. Increasing age was significantly associated with higher odds of incorrectly recalling both the study purpose and the name of the study medication. Likewise those with less than a high school education were more likely to incorrectly identify the study's purpose and the name of the study medication. Black and other non-white race or ethnic groups were more than two and a half times as likely to incorrectly identify the study's purpose. These findings suggest that even the most basic information may not be understood or retained by important subgroups of patients enrolled in clinical trials. Implementing effective strategies, such as additional time and effort for consent or repetition of study information, may be necessary in order to assure ethical and valid consent.

Age Factors↗

PubMed2006

Psychiatrists' documentation of informed consent: a representative survey.

OBJECTIVE: To review psychiatrists' documentation of informed consent and present data on Canadian psychiatrists' attitudes and practices regarding documentation of the informed consent process. METHOD: We surveyed a stratified random sample of psychiatrists practising in Ontario, using a mailed self-report questionnaire. RESULTS: The response rate was 72%. Among respondents, 63% routinely documented the consent process, with younger respondents reporting more documentation than older ones. Although most respondents (77%) favoured recording the consent process, only 11% felt signed consent forms were necessary. CONCLUSION: There are differences in the self-reported documentation behaviour of younger and older psychiatrists. Psychiatrists should document the consent process in the clinical record.

Adult↗

PubMed2002

Informed consent for gastrointestinal endoscopy: a 2002 ESGE survey.

BACKGROUND/AIM: Gastroenterologists are required to obtain informed consent before undertaking any endoscopic examination. Published data indicate that in practice there are many deficiencies in this process. The aim of this survey was to determine the quality of information given to patients before the endoscopic procedures in countries that are members of the European Society of Gastrointestinal Endoscopy (ESGE). METHODS: A structured questionnaire was sent to representatives of endoscopic societies that are members of ESGE regarding the quality of informed consent. RESULTS: The response rate was 59% (26/44). The endoscopist is responsible for giving the required information prior to written consent in only 23.1% (6/26) of the countries. Although information about the procedure is given to the patients in 96% of the responding countries, in only 77% is there sufficient time for the patients to ask questions about the nature of the procedure. In 15% (4/26) of the countries neither the diagnostic or therapeutic alternatives to endoscopy are discussed nor the potential complication rates. Finally, the procedure-related mortality is provided in only 23% (6/26) of countries. CONCLUSION: The procedure of obtaining informed consent for endoscopy varies considerably and may need reevaluation.

Endoscopy, Gastrointestinal↗

PubMed2005

Informed consent: ethical and legal aspects.

The legal doctrine of informed consent looms large over the medical profession with many interest groups trying to expand and narrow the doctrine, including patient rights advocates, managed care organizations, government agencies, and accreditation organizations. The legal profession itself has taken no small part in defining the doctrine. No physician today is practicing without the daily influence of law on his or her practice of medicine. The doctrine of informed consent, with all of its ambiguities and difficulties, has established a medical duty on the physician to make a reasonable attempt to unite the goals of the patient and the physician. Ultimately, physicians gain from the knowledge that their wisdom and skill has fostered a decision that is amenable to the patient. The patient gains from a facilitated decision that truly reflects that individual's self-determined will. As a result, both parties enjoy a newly formed partnership and the return of something that has long been taken for granted--trust in the physician-patient relationship.

Humans↗

PubMed1994

Framing treatment options: a method to enhance informed consent.

Advanced practice nurses are challenged with counseling and providing information to clients about treatment options during the informed consent process. In the clinical area of oncology, clients are faced with choosing treatment options that are undesirable or affect quality and quantity of life directly. Framing as a nursing intervention to assist advanced practice nurses during the informed consent process is explored in this article. Framing provides a method to present information from different vantage points and perspectives with a focus on the client's values and perceptions of quality of life. Parse's man-living-health theory is used to guide nursing practice. Quality of life is addressed with an assessment tool by Ferrans. The use of framing to present treatment options from the client's perspective of health and quality of life, as well as from the biomedical and nursing perspectives, can result in a consent that is truly informed.

Disclosure↗

PubMed1991

Informed consent for extended-wear patients.

Because of the risk of complication posed by extended-wear lenses, contact lens practitioners must comply with the requirements of informed consent, which obligate the optometrist to communicate these risks to patients. Documentation of informed consent can be obtained by using printed agreements that describe the risks of wear, instructions for lens care, wearing schedules, and required follow-up evaluations. In determining wearing schedules for patients, optometrists should not recommend more than 7 days (ie, 6 nights) of continuous wear without demonstrable benefit to the patient, and informed consent requirements should be complied with and adequate documentation retained whenever extended periods of wear are contemplated. For wearers of disposable lenses, informed consent is necessary because practitioners are not able to inspect lenses prior to wear. Patients must be advised to remove lenses if pain, redness, reduced acuity, discharge, or photophobia result and to return for examination when these symptoms occur. Documentation of this warning and of other aspects of disposable lens wear may be provided by a printed agreement.

Consumer Product Safety↗

PubMed1994

Medical experimentation, informed consent and using people.

In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials may be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means.

Coercion↗

PubMed1983

Informed consent: ambiguity in theory and practice.

The law of informed consent expresses in legal form the ethical principle of autonomy and respect for autonomy. It is intended to enhance self-determination and rational decision-making in medicine. Three tests might be made of whether a law is a good law: (1) Is it clear and unambiguous enough to admit of fair, equal, and consistent enforcement? (2) Does it gain compliance, and widespread ideological agreement? (3) Does it enjoy a measure of success in achieving its intended goals? The law of informed consent does not impressively pass any one of these tests. It is deeply ambiguous, both in its formal structure and its pragmatic implementation. It has not won ideological agreement, doctors having been openly hostile to it, and legislatures having written statutes limiting it. There is little evidence that it has succeeded in its goals. Paradoxically, its pragmatic value might be rooted in its ostensible weakness, its ambiguity, in that this very quality keeps the discussion going. Perhaps the essential problem lies in the fact that the philosophical notion of autonomy is not a phenomenologically accurate description of the condition of the person who seeks medical help--the map is not the territory.

Attitude of Health Personnel↗

PubMed1998

Informed consent for BRCA1 and BRCA2 testing.

While the cloning of BRCA1 and BRCA2 in 1994 and 1995 engendered great enthusiasm from cancer patients, their families and physicians, concerns about potential problems faced by those undergoing genetic testing were also evident. Although much can be learned from previous research on informed consent for testing and research for predictive genetic testing in diseases other than cancer, there are some specific issues related to cancer that make the questions more pressing, more difficult, and of larger social concern. Organizations such as the National Advisory Council for Human Genome Research, the American Society for Human Genetics, the American Society of Clinical Oncology and the Task Force for Genetic Testing have presented recommendations about informed consent for cancer susceptibility testing. However, many unanswered questions remain concerning the informed consent process. This review provides background on informed consent, summarizes studies that have been conducted in the area of genetic testing, with a focus on testing for BRCA1 and BRCA2, and details recommendations for achieving informed consent for genetic testing for cancer susceptibility and research on cancer genetics.

Breast Neoplasms↗

PubMedDate not supplied

Informed consent in Malaysia: an overview.

The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

Comprehension↗

PubMed2006

[Informed consent in aesthetic plastic surgery].

The informed consent plays a very decisive part in aesthetic plastic surgery. As there is often no medical indication in plastic surgery, the patient has to be informed about all the facts of an operation, especially about the possible risks. The legal requests for therapeutic and economic clarification gain in importance. The jurisdiction in Germany demands a merciless clarification for the patient. The patient needs to be clarified about all facts early enough so that he has a sufficient amount of time to weigh-up the pros und cons of the operation and if necessary to take advice from someone else. The sufficient documentation is very important at the sight of the extensive burden of proof at the expense of the physician.

Germany↗

PubMed1999

Barriers to informed consent in clinical trials.

Clinical trials are a type of scientific study conducted in human beings. They are designed to evaluate the safety and effectiveness of new drugs, procedures, or other means of treating, diagnosing, or preventing diseases. The ethical issues involved in clinical trials are nothing new, but because of the increased access to studies, they are steadily affecting more people. The sheer volume of clinical trials, as well as the number of patients and professionals involved in them, has increased in the past decade. Informed consent is a key element of clinical research. Meaningful informed consent requires that subjects weight the associated risks and benefits of an experimental intervention and then voluntarily give consent. One concern regarding informed consent in research is the confusion between therapeutic intervention and experimental treatment. This confusion could lead to barriers in informed consent. This column addresses this concern and includes a case study to illustrate the misunderstandings that might arise from the patient who is compelled to consent to clinical trials because of his sense of hopelessness from a chronic health condition and the traditional medical intervention he is receiving.

Adult↗

PubMed2003

Goodness-of-fit ethic for informed consent to research involving adults with mental retardation and developmental disabilities.

This article reviews current theory and research on informed consent policies for adults with mental retardation within a relational ethics framework that re-conceptualizes consent vulnerability in terms of the goodness-of-fit between participant decisional capacities and the specific consent context. Conceptualizing informed consent competence as a product of the relationship between person and consent context shifts assessment of decisional capacity away from an exclusive focus on a research participant's cognitive deficiencies to (a) an examination of those aspects of the consent setting that are creating or exacerbating consent vulnerability and (b) consideration of how the setting can be modified to produce a consent process that best reflects and protects the hopes, values, concerns, and welfare of adults with developmental disabilities.

Adult↗

PubMed2004

Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimens.

Increasingly, genetic and biomedical researchers are developing protocols to reexamine human tissue specimens that were obtained and stored during clinical care or previous research studies. Although some communities and associations are developing guidelines for human-tissue research, guideline development rarely considers consumer preferences for informed consent and disclosure of results. This study, examining Native Hawaiian preferences for informed consent and disclosure of results (n = 429, 83.2% Native Hawaiian), was modeled after a national study of consumer preferences, allowing comparison between the national sample and the Hawai'i-based sample. The interview schedule included two scenarios on research requiring the re-use of clinically derived and research-derived biological specimens. For each, participants were asked if informed consent should be required: a) in general; b) if the specimen was personally identified; and c) if the specimen was de-identified, or anonymized. Participants were also asked if they would want to know the results of the research and if they would want their doctor to be told. Regardless of how specimens were obtained, 78% of Native Hawaiians would want to be asked for their consent for the re-use of identified specimens and about 35% would want to be consented for the re-use of anonymized specimens. In both cases, Native Hawaiians in the Hawai'i sample were more likely than Whites in the national sample to want an informed consent process. Similar proportions in both samples would want findings from research on stored specimens reported to them (about 90%) and to their physicians (about 80%). These findings call into question the "Common Rule" and the guidelines of the American Society of Human Genetics, which do not require researchers to obtain informed consent for research use of anonymized specimens.

Adolescent↗

PubMed1984

Factors influencing comprehension of information for informed consent: ethical implications for nursing research.

Empirical studies on comprehension of information for informed consent show that research subjects often do not understand major portions of that to which they have consented. This raises the ethical question of whether or not the consent process has accomplished its purpose--the protection of the individual's right to self-determination. This article focuses on the following factors derived from the research literature that influence comprehension of information for informed consent: the nature of information, method of presentation of information, demographic factors, and personal factors. From these factors and methodological considerations, ethical implications for nursing research are addressed.

Comprehension↗

PubMedDate not supplied

[Informed consent forms in medical practice: the results of a knowledge survey].

"Federico II" University of Naples Hospital Management's Staff considered 47 informed consent forms in order to evaluate quality and quantity of the information transmitted to patients. Every form, distinguished by procedure (surgical, pharmacological, anesthesiologic or related to blood transfusions) was evaluated for the accuracy and validity of information related to: diagnosis, prognosis, diagnostic and therapeutic opportunities, expected benefits, adverse-side effects, iatrogenic risks, privacy policy on personal data. The forms were judged by information completeness criteria "conformed" or "not conformed" with standards. Our analysis demonstrate that physicians often are unaware of legal and ethical topics related to constructing informed consent forms. They usually omit crucial information or would use strict technical language. So far, we conclude Hospital Management's Staff definitively has a role in improving informed consent forms by establishing guidelines and promoting ethical issues. Final result could be to deserve stronger patient confidence in medical institutions.

Adult↗

PubMed1999

The ethical foundation of informed consent in clinical research.

OBJECTIVES: To provide a foundation for understanding the ethical concept of informed consent with particular emphasis on the characteristics and principles that make it a moral imperative. DATA SOURCES: Government reports, published articles, and book chapters from the ethics literature. CONCLUSIONS: Informed consent is central to the conduct of cancer clinical trials and good patient care. It is a thoughtful, collaborative process whereby an individual gives autonomous authorization and the decision of the individual is respected by the health professionals. IMPLICATIONS FOR NURSING PRACTICE: Understanding the theory and practice of informed consent is an essential aspect of the nurses role. There are many challenges to this process in the oncology setting because of the severity of the diseases and the complexity of the research, and nurses must be prepared to assure that informed decision-making takes place.

Clinical Trials as Topic↗