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PubMed1999

Assessing medical students' competence in obtaining informed consent.

BACKGROUND: Medical schools increasingly place emphasis on preparing students to perform routine, ethically important clinical activities with sensitivity and acumen. A method for evaluating students' skills in obtaining informed consent that was created at our institution is described. METHODS: Formal assessment of medical students' professional attitudes, values, and ethics skills occurs in the context of three required and developmentally attuned comprehensive examinations. A videotaped station tested senior medical students' ability to obtain informed consent from a standardized patient who expresses concern about undergoing cardiac catheterization. Two checklists were completed by the patient. Videotapes were reviewed by a faculty member, and students' reactions to the assessment experience were documented. RESULTS: Seventy-one senior students participated, and all performed well. Mean scores of 6.3 out of 7 (range 5 to 7, SD = 0.5) on the informed consent checklist and 8.7 out of 9 (range 6 to 9, SD = 0.5) on the communication skills checklist were obtained. Students endorsed the importance of the skills tested. CONCLUSIONS: This method of examining medical students' abilities to obtain informed consent has several positive features and holds promise as an ethics competence assessment tool.

Adult↗

PubMed1996

Informed consent: the nurse's dilemma.

The author builds upon the concept of informed consent whereby the patient agrees to undergo experimental medical procedures. Ideally, the doctor will inform the patient fully on the proposed treatment so as to assure the patient's right to participate intelligently and freely in the decisions regarding his treatment. The nurse is drawn into the doctor-patient relationship in cases where the patient seeks her counsel because he feels insufficiently informed by the doctor, or because the nurse becomes aware of inadequacies in the information-giving process. She is then faced by the nurse's dilemma: a conflict between the loyalties she owes to her patient and to her physician team mate. A work sheet is presented which can help the nurse decide upon the proper course of action in solving this dilemma, guided by her personal and professional beliefs and by specific ethical concepts in the Code for Nurses. Solution of the dilemma and attainment of informed consent requires willing cooperation between doctor and nurse. Both can develop the skills for imparting information to the patient under difficult conditions and for verifying its comprehension by the patient. Both must learn to respect the patient's decision and to temper their professional skills with sensitivity, a strong moral sense and a deep respect for their fellow human beings.

Decision Making↗

PubMed1992

Avoiding malpractice claims for lack of informed consent.

While malpractice claims alleging lack of informed consent are proliferating, the courts are requiring more detailed information regarding the risks of proposed treatment. Increased use of consent forms and brochures designed to provide comprehensive, objective information for specific procedures could help physicians avoid most of these types of claims.

Acquired Immunodeficiency Syndrome↗

PubMed2005

A case for informed consent? Indoor UV tanning facility operator's provision of health risks information (United States).

OBJECTIVE: Indoor UV tanning is associated with skin cancer. This study describes consumer health risks information provided by indoor UV tanning facility operators in four states (Colorado, Illinois, Texas, and Wisconsin) with varying operator training, regulations, enforcement and penalties. METHODS: Using a cross-sectional survey study design, 100 randomly selected licensed indoor UV tanning facilities from each state were surveyed anonymously by telephone. Facility operators were questioned regarding the provision of information on potential adverse effects of indoor UV exposure. RESULTS: Of 628 licensed indoor UV tanning facilities contacted, 400 facilities were surveyed. Most (87%) advised patrons of the potential risk of sunburn from indoor tanning. Less than half of facility operators in Colorado, Texas and Wisconsin informed patrons about the risk of skin cancer (42, 43 and 48%, respectively) compared with 81% of Illinois operators. Likewise, more operators in Illinois reported the risk of premature aging (79%) compared with other states (41% Colorado, 43% Texas and 51% Wisconsin). CONCLUSIONS: Tanning facility operators frequently misinformed patrons of indoor UV exposure risks. The provision of informed consent by indoor tanning facility operators needs improved adaptation by the tanning industry as a standard for customer service.

Aging, Premature↗

PubMed2001

Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan.

Protecting the rights of research participants when conducting studies within an international context presents many challenges. The purpose of this article was to compare and contrast the process of obtaining informed consent in two very different countries - Swaziland and Pakistan. Major aspects of the informed-consent process presented included identification of gatekeepers, seeking permission from officials, negotiating with these officials and Institutional Review Board (IRB) committees in regard to the type of data to be collected, and explaining informed consent to participants in the field. Data for this article is based upon qualitative research of collaboration between nurses and healers in Swaziland and from a variety of studies completed in Pakistan. These studies demonstrate the inadequacy and complexity of applying western-based concepts of informed consent to developing countries.

Cross-Cultural Comparison↗

PubMedDate not supplied

[Guidelines for preparing informative material for obtaining informed consent from individuals undergoing diagnostic and therapeutic procedures].

The authors describe the ethical principles and legal basis of obtaining informed consent for diagnostic and therapeutic procedures. They also quote a text of proposed guidelines directed at rationalizing activities, behaviours and modalities of obtaining informed consent in a hospital setting. In line with the general objectives of guidelines, such as improvement of results through behaviour changes, including reduction of the variability of behaviour, a standard form is proposed for obtaining a valid informed consent.

Consent Forms↗

PubMed1989

The myth of informed consent: in daily practice and in clinical trials.

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests.

Beneficence↗

PubMed2002

Reporting of informed consent and ethics committee approval in clinical trials.

CONTEXT: To determine whether journals have improved their disclosure of ethical protections in clinical trials. METHODS: Comparison of clinical trials published before and after 1997 (July 1995 to December 1996 and January 1998 to June 1999) in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and The New England Journal of Medicine. Sixty articles per journal per period were randomly selected and assessed for rate of reporting on informed consent and on ethics committee approval. RESULTS: Informed consent was not described in 79 articles (26%) published before 1997 vs 53 (18%) published after 1997 (P =.01), and ethics committee approval was not mentioned in 93 (31%) before 1997 vs 54 (18%) after 1997 (P<.001). Neither protection was described in 48 articles (16%) published before 1997 vs 28 (9%) after 1997 (P =.01). In subgroup analyses, those journals with the worst initial rates generally improved the most. BMJ did not describe informed consent in 25 articles (42%) before 1997 vs 15 (25%) after 1997 (P =.05), and JAMA did not describe ethics committee approval in 25 (42%) before 1997 vs 13 (22%) after 1997 (P =.02). BMJ, JAMA, and Annals had the lowest initial rates of reporting on both protections in the same article, with 25 (42%), 32 (53%), and 34 (57%), respectively, but improved markedly to 38 (63%), 43 (72%), and 45 (75%) (P =.02,.04, and.03, respectively). CONCLUSIONS: Major medical journals have improved their reporting on informed consent and ethics committee approval; however, 9% of studies still report neither.

Clinical Trials as Topic↗

PubMed1998

What should men know about prostate-specific antigen screening before giving informed consent?

PURPOSE: Since prostate-specific antigen (PSA) screening is controversial, some authorities recommend that patients give informed consent before testing. We identified and compared what facts experts and patients thought men should know. SUBJECTS AND METHODS: We recruited a Delphi panel of national experts (6 urologists and 6 non-urologists) and conducted 6 focus groups of couples (48 subjects) with 24 screened and unscreened men from a university hospital. We ranked key facts that experts and couples thought men ought to know before consenting to PSA screening and conducted a multidisciplinary focus group to help interpret the findings. RESULTS: All participants would disclose that false positive and false negative results can occur and that it is not known whether PSA screening reduces prostate cancer mortality. The 12 experts would disclose the uncertain benefits of treating early, localized prostate cancer. All 24 couples would disclose that the PSA test is a blood test and that patients may worry about results. The 6 urologists would disclose that prostate cancer is often incurable when symptoms appear; the 6 non-urologists, that it can be asymptomatic. The 12 couples with screened men would disclose that the PSA test can detect cancer sooner than the digital rectal examination; the 12 couples with unscreened men, that PSA testing is controversial. CONCLUSIONS: Physicians and patients agree upon some facts that men should know about PSA screening before giving informed consent. However, physicians fail to emphasize other facts that patients find important. Physicians may differ by expertise; patients, by experience. Our findings provide content for informed consent for PSA screening, and our method may be useful for other controversial tests.

Delphi Technique↗

PubMed1999

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment.

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.

Drugs, Investigational↗

PubMed1990

Informed consent and the elderly. An ethical challenge for critical care nursing.

Nursing ethics was long reticent about ethical challenges that elderly patients pose for critical care nursing. One of these, the legal doctrine of informed consent, has important implications for critical care nursing ethics. Deriving from the principle of respect for persons and intended to preserve their autonomy, informed consent represents both a duty and an ideal for care givers to implement in the process of ethical decision making. All too often the ideal is lost, however, and the doctrine reduced to a sterile and bureaucratic procedure. When elderly patients are unable to give an adequately informed consent, advance directives can enable them to express their wishes by prior choosing. If they become cognitively impaired, however, it is much more difficult to determine what, if any, preferences such a patient might express if able to do so. Medical empowerment of the elderly, a laudable social goal, can be as contradictory as informed consent itself and many elderly patients may opt out of their own decision making. The resultant moral distress of such a complex process is still another ethical challenge that faces the critical care nurse. Because nursing holds a position of moral centrality among the health care professions, critical care nurses cannot avoid the prospect that issues like those identified in this article will continue to challenge and confront them in the coming decade. By turning to colleagues in nursing as well as other professions, nurses can best strengthen and consolidate their vital role as mediators of meaning and morality in life-and-death situations.

Aged↗

PubMed1994

Informed consent as an ethical issue in modern optometry.

BACKGROUND: Modern optometric practice contains many more mildly invasive procedures than it has traditionally. Concurrently, patients expect a more active role in decisions concerning their own health care, as, increasingly, these decisions may have harmful, as well as, salubrious, consequences. METHODS: Literature from the philosophy of ethics as it pertains to the issue of informed consent was examined and applied to optometric procedures and practices. RESULTS: A strong analogy exists between particular aspects of optometric practice and corresponding elements of medical practice with respect to well established ethical principles of informed consent. The legal doctrine of informed consent is not the only view applicable to optometry. CONCLUSION: Modern optometric practice may easily and advantageously be adapted to incorporate ethical principles of informed consent. These principles, which should be distinguished from legal principles which bear upon the same issues, may enhance the quality of health-care decisions by optometrists without creating serious obstacles to the individual optometrist's practice mode.

Ethics, Medical↗

PubMed2002

Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study.

In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.

Focus Groups↗

PubMedDate not supplied

[Consent: between legality and legitimacy or between "formal" and "informed" consent].

As shown by a recent decree of the supreme court, the legal aspect of information given before consent is more and more important. At beginning, the written consent was reserved to particular cases, as biomedical research for example. It concerns now all the fields of care, since it is considered as a proof of the existence of a prior information. The informed consent changes in a formal consent: the consequence is a modification of the relation between the physician and the patient. We may imagine that this evolution paradoxically results in a worse integration of subjectivity. Then, it seems necessary to stress the clinical aspect so as to give to the consent concept its legitimity back: it consists in an ethical and humanistic acknowledgement of alterity.

Ethics, Medical↗

PubMed1990

Understanding informed consent and its relationship to the incidence of adverse treatment events in conventional endodontic therapy.

Forty-three endodontic specialists recorded the occurrence of all adverse treatment events in 3308 consecutive conventional endodontic cases. Statistical analysis confirmed that retreatment cases and mid-treatment referral cases have a greater incidence of adverse treatment events. Since the doctrine of informed consent requires that the doctor inform the patient of reasonably foreseeable consequences of treatment, it is therefore important that the endodontist be cognizant of such events and decide what information is appropriate for disclosure. Since jurisdictional differences exist in the interpretation of what constitutes sufficient informed consent, it is important that local groups investigate the statutes in their state and construct reasonable informed consent documents.

Humans↗

PubMed1997

[Informed consent in psychiatry--European standards and differences, problems and recommendations].

Development and state of regulations and ethical debates of "informed consent" in 9 European countries are exposed. Commonalities and differences in significance, evaluation, and use of information, capacity to consent, and voluntariness as prerequisites of a valid consent are discussed with regard to care/dure and research. Consequently recommendations for regulations, research, teaching, and practice of "informed consent" and for research with incapacitated patients are given. The legal doctrine of "informed consent" tries to realize or even to operationalize the ethical demand for respect towards dignity and autonomy of the patient. This is particularly relevant in psychiatry because many states of mental disorders may impair the capacity to consent and the internal as well as external freedom of the patient. Validity, reliability, practicability, and acceptance of criteria and procedures of assessment of capacity to consent and of voluntariness of the patient, substitutes in the case of loss of these prerequisites of "informed consent", and its limitations, e.g. by the other ethical principle of the "best interest" of the patient or by his sociocultural context, are in need to be evaluated empirically in practice.

Cross-Cultural Comparison↗

PubMed1991

Informed consent for treatment of childhood cancer: factors affecting parents' decision making.

Both the treatment for childhood cancer and the legal requirements for gaining parents' consent to treatment have become increasingly complex. The purpose of the exploratory investigation reported here was to identify influential circumstances surrounding the consent process in the pediatric setting, to describe the relationship of parental anxiety to these factors, and to delineate related practice and research implications. Twenty-eight parents of children entered on one of four protocols for the treatment of newly diagnosed acute lymphoblastic leukemia at the Childrens Hospital Los Angeles and the University of California San Francisco were asked to complete two questionnaires within 48 hours after consenting to treatment: the State-Trait Anxiety Index and the Parent Informed Consent Questionnaire. Results of the study confirmed clinical experience that parents are given complex information and asked to make decisions about their child's life in a highly anxious state. Although participants were generally satisfied with the informed consent process 48 hours after signing a consent form, further research is needed to document how well parents understand and remember key information, as well as the influence of time, experience, and changes in state anxiety on their perceptions of the adequacy of the consent process. In current clinical practice, simple strategies can be applied to improve the informed consent process for families of children with cancer.

Adult↗

PubMed2003

Informed consent for interventional radiology procedures: a survey detailing current European practice.

PURPOSE: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. METHODS: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms and written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention, the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. RESULTS: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%), non-academic (40.5%) or private (2.8%). Depending on the procedure, in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patient's chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. CONCLUSIONS: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.

Attitude of Health Personnel↗