Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “informed consent”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 325 records · Page 18Linked to original sources
PubMed2004

[Informed consent: a pragmatic view].

The author highlights some pragmatic aspects of informed consent that could help to bridge the gap between the currently valid legal requirements and the practical realities of providing medical information in Hungarian health-care settings. One of the crucial point of informed consent is whether the patient properly understood the provided medical information. Consequently, effective communication becomes an inevitable condition of providing informed consent. The results and insights coming from psychological research--concerning lay understanding of medical information, of the readability of consent forms, and especially of the lay understanding of statistical information, and risk communication--could help to create a better practice of medical communication that could satisfy both ethical and legal requirements. The author argues as well for creating more concrete and practically oriented guidelines concerning informed consent that would also help to increase the quality of medical information giving. These might help us approach the medical ideal that was conceptualised in the doctrine of informed consent.

Communication↗
PubMed1984

Informed consent: a crucial step in cancer patient education.

Informed consent is an issue of major importance for cancer patients and for the practitioners who treat them. Recently, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the educational goals of the consent process. Nevertheless, past research confirms that these goals are difficult to attain. In this paper, we present an overview of informed consent and describe a study of informed consent to cancer treatment conducted at the Fox Chase Cancer Center in which the consultation between the patient and physician (and/or other health professional) was observed and patients were interviewed. On the average, patients recalled less than 40% of what they were told. Patients who were told more items recalled more; however, they recalled a smaller proportion of what they were told. Several implications for health education are drawn from the study results.

Cognition↗
PubMed1986

Response of patients to informed consent for excretory urography.

The desirability of obtaining written informed consent for low-risk radiologic procedures has been the subject of controversy. A group of 80 patients was studied to evaluate the effect of informed consent for excretory urograms on: (1) incidence of contrast reactions; (2) discomfort during the procedure; (3) level of patients' anxiety before and after the procedure; (4) patients' perception of the procedure; and (5) desirability of informed consent from the patients' viewpoint. Results revealed no statistically significant difference between the 2 groups in the incidence of reactions, discomfort, perception of the examination, or anxiety level prior to the procedure. The informed consent group had a statistically greater factual knowledge of the procedure evaluated objectively (P less than 0.01). Of the patients who received the written consent form, 83% regarded it as helpful and none viewed it as harmful or refused the examination. In the control group, 32% desired more information.

Adult↗
PubMed2001

Informed consent in psychotherapy.

OBJECTIVE: The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. METHOD: The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. RESULTS: The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. CONCLUSIONS: Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

Forensic Psychiatry↗
PubMed2005

Video informed consent improves knee arthroscopy patient comprehension.

PURPOSE: The purpose of this study was to test the hypothesis that video informed consent improves knee arthroscopy patient comprehension and satisfaction compared with traditional verbal informed consent. TYPE OF STUDY: Prospective, randomized controlled trial. METHODS: Consecutive patients having informed consent in preparation for knee arthroscopy by a single surgeon were stratified by educational level < or =12th grade or greater than 12th grade, then randomized to video or traditional verbal informed consent groups. Immediately after the informed consent process, patients completed an outcome questionnaire evaluating comprehension and satisfaction. RESULTS: Patients in the video group showed significantly higher comprehension (78.5%) than patients in the verbal group (65.4%) (P = .00001). In the subgroup with < or = 12th grade education level, the video patients scored 73.1% comprehension and the verbal patients only 54.2% (P = .0011). In the subgroup with greater than 12th grade education level, the video patients scored 82.3% and the verbal patients scored 72.2% (P = .0002). There was no significant difference in subjective self-assessment of satisfaction between groups. CONCLUSIONS: Video informed consent improves knee arthroscopy patient comprehension compared with traditional verbal informed consent. LEVEL OF EVIDENCE: Level I.

Adolescent↗
PubMed1999

Implementing the Food and Drug Administration's final rule for waiver of informed consent in certain emergency research circumstances.

In 1996, the Food and Drug Administration released its Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances (the Final Rule). The Department of Health and Human Services (DHHS) also released an update of its regulations related to waiver of informed consent in emergency research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. Waiving informed consent for research participation has profound ethical and scientific implications. However, in unpredictable life-threatening clinical situations for which current therapy is unproven or unsatisfactory, patients usually are unable to consent on their own behalf to participate in clinical trials of potentially beneficial but experimental interventions. Because of the time-dependent nature of most resuscitation interventions, it is usually not feasible to identify and contact the legally authorized representative who can speak on behalf of the patient within the presumed therapeutic window of the intervention under investigation. For such clinical trials to proceed, a waiver of informed consent is usually necessary. Patients who are critically ill or injured and unable to provide meaningful prospective informed consent because of their current life-threatening condition are vulnerable and require additional protections beyond those for research subjects who can speak on their own behalf. The Final Rule and the DHHS-updated regulations incorporate a number of additional patient safeguards that must occur if a clinical trial is to proceed with waiver of informed consent. Specific means of adequately meeting these requirements are not described in the regulations. Although this was intentional on the part of the federal regulators so that individual protocols and research environments would direct the development of these patient safeguards, the lack of specific guidance has led to confusion on the appropriate implementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of implementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.

Clinical Protocols↗
PubMed2006

Native Hawaiian preferences for informed consent and disclosure of results from genetic research.

BACKGROUND: Informed consent is generally waived when using anonymous stored specimens in research because individual harm is minimal; however, group harm may arise if specimens contain ethnic identifiers. METHODS: We assessed preferences for informed consent and disclosure of results from genetic research through a survey (N = 429, 83.2% Native Hawaiian). RESULTS: Native Hawaiians were more likely than non-Hawaiians to require informed consent for genetic research using personally identified (81% vs 77.8%), anonymous (40.9% vs 34.7%), and ethnically identified specimens (51.3% vs 33.3%). Most respondents wanted results reported to them (87.6%) and to their physicians (79.0%). CONCLUSIONS: Recognizing community preferences for informed consent and disclosure of research results may alleviate concerns about group harms inherent in genetic research.

Adolescent↗
PubMedDate not supplied

Risk, autonomy, and responsibility: informed consent for prenatal testing.

Why is informed consent required for prenatal testing? Consent is routinely sought, but examination of the theory behind and the implementation of informed consent for prenatal testing suggests that we need to reconceptualize both the risks and the responsibilities involved in offering and accepting such prenatal tests.

Abortion, Eugenic↗
PubMedDate not supplied

Exploring the nature of informed consent in coronary care practice.

The nature of informed consent is bound within legal and moral duties. An analysis of informed consent includes the elements of understanding, disclosure, competence, voluntariness and authorisation, all of which can be affected by a variety of factors. Nurses can make a unique contribution to informed consent situations either as advocates, interpreters, coordinators, witnesses or culture brokers. In order to fulfill their obligations to the patient and manage potential conflicts, nurses need to have a substantial awareness to the diversity of issues and pitfalls. Communication skills and building a therapeutic alliance with the patient are at the heart of nursing care. Nurses are taking on duties previously associated with medical practice-it is unclear how this affects their roles as information givers.

Communication↗
PubMedDate not supplied

The contours of informed consent.

The doctrine and content of informed consent are discussed. General guidelines, which apply in most cases, are summarized. Requirements for providing informed consent vary when the patient's age or mental status do not allow complete understanding, or when an emergency situation precludes following the usual procedure.

Eye Diseases↗
PubMed2002

Informed consent: a necessity for human research.

As flaws in the informed consent process have come to light, rising research costs and heightened competition have exposed informed consent to increasing scrutiny as a possible source for industry savings. However, we believe that the informed consent process needs to be refined and strengthened, not weakened or abandoned. This article describes why protecting human research participants through informed consent is necessary for institutions that conduct human research.

Academies and Institutes↗
PubMed2004

[Informed consent--a simulation workshop for surgeons and gynaecologists].

BACKGROUND: Informed consent as part of the Israeli Patient's Rights Act (1996) is poorly known and only partly followed among physicians in Israel. PURPOSE: A one-day workshop on informed consent was designed with a dual purpose: a) to instruct on the legal requirements for obtaining consent to surgery for physicians in the surgical disciplines, and b) to practice effective and humane physician-patient relationships. METHODS: Sixty-one residents and senior staff took part in 6 sessions of a one-day workshop. Participants watched twice and performed twice videotaped simulated consent conversations with standardized patients. Six professional actors personified patients with common surgical problems and different characters and behaviours. Each participant was challenged with medical problems in her/his discipline. Following the first simulation, the participants attended a group discussion concerning legal requirements for informed consent, and expectations of patients and physicians in terms of communication skills and patient-physician relationships. Three types of feed-back were employed: a) non-professional personal feedback from the actors; b) personal feedback from a communication specialist using one of the videotaped encounters; and c) group discussions of each of the 6 types of simulations with examples from the encounters. RESULTS: Feedback from the participants was positive and showed interest and need of knowledge of the law as well as of communicative skills. CONCLUSIONS: There is a place, among residents and senior physicians, for experiential learning of how to effectively and humanely obtain informed consent.

Education, Medical, Continuing↗
PubMed2003

Informed consent without bureaucracy.

A comparison is drawn between informed consent in medicine and consenting practices in other areas of human activity, and an underlying conceptual unity is detected in all of these consenting practices. We insist on obtaining consent, in medicine and elsewhere, because of the value we place on personal autonomy. The conceptual unity of informed consent and consenting practices outside of medicine is defended against a series of objections. On the basis of the comparison with consenting practices in other areas of human activity, it is argued that bureaucratic informed consent processes in medicine are both unnecessary and unwarranted.

Disclosure↗
PubMed2005

The spectrum of informed consent in emergency psychiatric research.

STUDY OBJECTIVE: I evaluate the variation in requirements for informed consent in studies evaluating chemical tranquilization of agitated patients. METHODS: A computer-assisted literature search of the National Library of Medicine was performed. Additional use of the references listed in the articles identified with the search yielded 144 citations. Studies performed outside the United States were excluded, as were studies performed before the current US Food and Drug Administration regulations came into effect. Research not yet published but presented at national meetings was included, as was one study currently under way but otherwise meeting the inclusion criteria. Authors were contacted for further clarification in cases in which information was ambiguous or unavailable in print. RESULTS: Twelve studies were identified, and the approach to informed consent varied widely. The primary method of enrollment was informed consent in 7 studies. Three studies used a waiver of informed consent, but in these cases the federal regulations underlying these waivers varied. One study implied that neither consent nor a waiver of consent was needed. In one case, the primary method for consent was not specified. CONCLUSION: There is poor agreement about the application of current regulations about informed consent in emergency psychiatric research. Regulations are understood in such a variety of ways that they are effectively irrelevant. There needs to be much greater clarity about the use of waivers of informed consent in emergency research in general and emergency psychiatry in particular.

Drug Evaluation↗
PubMed1999

Ethical issues in informed consent with substance abusers.

Alcohol and drug abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested.

Coercion↗
PubMed1993

Long-term psychotherapy and informed consent.

Many long-term psychotherapies begin without sufficient attention to an informed-consent process. Failure to obtain informed consent may leave patients ill prepared to question the recommendation for long-term psychotherapy or to make alternate treatment choices. The author presents a model for informed consent to stimulate debate on ethical approaches to this type of treatment. The approach covers six areas therapists should discuss with candidates for long-term psychotherapy: the diagnostic model used and the recommendation for treatment, potential risks and benefits of treatment, availability of less expensive short-term interventions, clarification of the necessity for psychotherapy, limits of insurance coverage, and plans for measuring the patient's response to treatment. The decision to recommend long-term psychotherapy should be made through careful analysis of indications and contraindications for such treatment and in the context of informed consent.

Disclosure↗
PubMed2004

Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest.

OBJECTIVES: When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only after a community consultation and public disclosure process and the granting of exception from informed consent from the federal government. The applicability of exception from informed consent to pediatric resuscitation research has not been described. The objectives of this study were 1) to perform a community consultation and public disclosure process specific to a trial of induced hypothermia immediately after pediatric cardiac arrest and 2) to determine the applicability of exception from informed consent to randomized, controlled trials of emergency interventions after resuscitation from inpatient pediatric cardiac arrest. METHODS: Focus groups, information sheets with options for written responses, posted notices, e-mails, and telephone conversations with parents of critically ill children and hospital staff were conducted at a tertiary care children's hospital. Data were stored, organized, and retrieved using NVivo qualitative analysis software (QSR International). RESULTS: In focus groups (n = 8), parents (n = 23) and hospital staff (n = 33) concluded that prospective informed consent is not feasible for a trial of induced hypothermia after inpatient pediatric cardiac arrest. Focus group participants endorsed exception from informed consent for a trial of induced hypothermia but only if study information is easily available prospectively and if all parents have an explicit opportunity to decline participation in a verbal conversation before study enrollment. Separate from and without knowledge of the focus group results, 7 (100%) of 7 parents of past or current patients and 21 (50%) of 42 hospital staff who provided written opinions endorsed exception from informed consent for this study. Five (12%) of 42 hospital staff opposed, and 16 (38%) of 42 were neutral. In telephone conversations, 14 (70%) of 20 parents of children who were previously resuscitated from cardiac arrest endorsed exception from informed consent for this study, 3 (15%) of 20 opposed, and 3 (15%) of 20 were unsure. CONCLUSIONS: Community consultation for inpatient resuscitation research can be conducted in a children's hospital, with hospital staff and parents of patients as the relevant community. Exception from informed consent is necessary and appropriate for a randomized trial of induced hypothermia begun within 30 minutes after pediatric cardiac arrest. A process in which families are informed prospectively and have a pre-enrollment option to decline participation will likely be acceptable to families, health care providers, and the institution.

Attitude of Health Personnel↗
PubMed1996

Ethical principles and informed consent: an NIMH perspective.

In conclusion, several points are worth emphasizing at this juncture: 1. Clinical researchers must attend to a set of ongoing concerns in new ways and reconsider how best to explain research protocols to potential subjects. Consent procedures and documents 5 or 10 years old may not be considered adequate by current standards. It is clearly important to ensure that consent documents, and the process by which informed consent is obtained and maintained, are state-of-the-art. 2. Many valuable sources of information are available to help researchers, family members, and potential participants learn about proper informed consent. NIMH is taking steps to improve this educational process. Members of IRBs are educated through conferences, newsletters, case books, etc. OPRR (May 1994) has also provided considerable information relevant to informed consent in clinical research. OPRR and NIMH staff may be useful sources of information concerning informed consent. 3. Research on competency and the consent process itself is needed so we can compare what was explained with what was understood and learn what research subjects want to know, what they believe has occurred, and why. 4. Progress in discovering the underlying causes of schizophrenia and other severe mental disorders, and improving their treatment, will require scientifically rigorous studies involving people affected by these disorders. Attempts to prohibit competent people with mental disorders from making decisions about participating in research protocols seem misguided, paternalistic, and stigmatizing. If we are to improve the treatment of severe mental disorders, clinical research is essential, including research that is not likely to directly benefit each individual participating. 5. This is a time of great opportunity for clinical research. New medications being tested have the potential to revolutionize the treatment of severe mental disorders. During recent years, a number of large scale projects have been focusing on underlying genetic vulnerability factors that may shed light on the etiology of these disorders, with profound implications for diagnosis, treatment, and eventually even prevention. Unfortunately, clinical research is also under attack on several fronts, including concerns about consent and the protection of human subjects with mental disorders. If we do not take steps now to ensure that the process by which we protect and inform research participants is state-of-the-art, the very progress we seek will be at risk.

Animals↗