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.

SourceResearch connectionFrom yearThrough year

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

At least 541 records · Page 30Linked to original sources

PubMed1991

[Informed consent and the physician-patient relations in thoracic oncology].

Medical ethics have always required patient consent as a prerequisit to therapy. The law concerning the "protection of persons accepting to be subjects in biomedical research" requires specific oral and written information to be given to all patients entering a clinic research project. New effects of the principal of "informed consent", on the physician-patient relationship, are analysed. Fifty patients with bronchial cancer were included in controlled studies from June 1989 to June 1990. These patients were asked to give their informed consent involving 5 different studies (2 Phase II studies investigating tolerance to a new treatment and 3 Phase III studies comparing a new treatment with a reference treatment). The patients were informed beforehand of the possibility of a research treatment and the legal requirement for their signature as well as to the possibilities of replacement solutions in case they refused. Detailed and adapted information concerning the different therapeutic solutions and their predictable side effects were presented before reading the informed consent statement. Of the 50 informed consent statements proposed, 49 were accepted. The principal of informed consent was favourably apprehended by the patients (active participation, notion of protection, information source, possibility of dialogue) and induced conditions of better acceptation by the patient. Nevertheless, it was more difficult to obtain statements of consent for studies comparing a new treatment with a reference treatment than for studies simply proposing a new treatment alone.

Adult↗

PubMed2004

Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice.

BACKGROUND AND PURPOSE: Little is known about informed consent for tissue plasminogen activator (tPA). Our objectives were to determine how frequently informed consent is obtained when tPA is given to stroke patients in clinical practice and whether the person providing consent (patient or surrogate) was the appropriate decision-maker. METHODS: This retrospective cohort included acute stroke patients given tPA in 10 Connecticut hospitals (1996-1998). Consent was defined as any documentation of discussion about risks and benefits of tPA. Patients had adequate decision-making capacity if they were alert, oriented, and without aphasia or neglect (patient was appropriate decision-maker). Patients with any of these deficits were considered to have diminished capacity (surrogate was appropriate decision-maker). RESULTS: Among 63 patients who received tPA, 53 (84%) had informed consent documented; 16/53 (30%) gave their own consent. Among patients with adequate decision-making capacity, 5/8 (63%) had consent by surrogate. Among patients with diminished capacity, 7/38 (18%) provided their own consent. CONCLUSIONS: A substantial percentage of patients who received tPA for stroke had no consent documented. Surrogates often provided consent when the patients had capacity; conversely, patients with diminished capacity sometimes provided their own consent. Given the urgency and weight of the decision regarding tPA, more explicit informed consent and capacity assessment should be considered for treatment protocols.

Acute Disease↗

PubMed1999

Genetic testing and informed consent.

OBJECTIVES: To discuss unique issues related to cancer predisposition genetic testing and informed consent. DATA SOURCES: Published professional articles, review articles, research articles, clinical practice, position statements, websites, and textbooks. CONCLUSIONS: The discovery of germline mutations that confer a predisposition for the development of cancer will continue. The provision of adequate information is central to the process of genetic counseling and testing so that individuals may give informed consent and make choices appropriate to their own specific circumstances. IMPLICATIONS FOR NURSING PRACTICE: The use of genetic information for the management of cancer will impact the practice of all oncology nurses in the coming years. Knowledge of genes that predispose for cancer and standards that delineate essential components of quality care during the informed consent process is vital.

Confidentiality↗

PubMed2004

Informed consent: ethical implications in clinical practice.

PURPOSE OF REVIEW: The concept of involving pediatric patients in medical decision-making, in both clinical and research anesthesia and surgical care, has support from specialists involved in pediatric care. Production pressure in the workplace creates conflict between ethical anesthesia practice - such as obtaining informed consent - and time efficiency. Specialized documentation of anesthesia consent may increase efficiency but could weaken the consent process. Concerns with cost containment have led to interventional quality improvement activities that may constitute research and therein require informed consent. This review discusses these three consent issues as they relate to anesthesia care. RECENT FINDINGS: Children are more capable of participating in medical decision-making than previously thought. Despite the call for physicians to involve children in decision-making regarding their medical care, few physicians or parents do so. Quality improvement research potentially harmful to patients, achieved without patient knowledge or consent, may violate the Nuremberg Code. Opinions differ about the potential advantages and pitfalls of specific and separate anesthesia consent forms. SUMMARY: Anesthesiologists have ethical obligations to involve children in the medical decision-making process as much as the child's capacity allows, and to place patient advocacy in the informed consent process above production pressures. While a specific and separate anesthesia informed consent form may be useful, it should not undermine the process of informed consent or relegate the consent process to non-physician personnel. The informed consent process for anesthesia care remains the province and responsibility of the individual anesthesiologist.

Journal Article↗

PubMed2006

[Has the informed consent for people with schizophrenia prevailed among Japanese psychiatrists by changing the name? The outcome of 3-year study].

UNLABELLED: "Togo-shiccho-sho"--the integration ataxic disorder--which has been recommended as the alternative Japanese translation of schizophrenia rather than "Seishin-bunretsu-byo", had the approval of the Japanese Society of Psychiatry and Neurology (JSPN) at the 98h annual meeting in August, 2002. OBJECTIVE: This study aims to know the prevalence of the informed consent for people with schizophrenia and to find out the factors related to the informed consent among the Japanese psychiatrists. METHODS: Subjects of this study were all psychiatric members of JSPN. They received the self-report questionnaire entitled "The Actual State of Informed Consent" by the return cards and sent it back by the return at around mid November every year between 2002 (right after the change) and 2004 (after 2 years). Author took 3 months for recovery. RESULTS: Rates of the psychiatrists who informed the patient himself have been relatively increasing for 3 years (37%, 2002; 65%, 2003; 70%, 2004), while the rates of the one who didn't have been decreasing (44%, 2002; 21%, 2003; 15%, 2004). The users of Togo-shiccho-sho for the informed consent have been increasing (68%, 2002; 86%, 2003; 90%, 2004), while the non-users have been decreasing (19%, 2002; 9%, 2004). The non-users of Seishin-bunretsu-byo increased from 63% in 2003 to 71% in 2004 and the other-name-users also increased from 18% in 2003 to 42% in 2004. DISCUSSION: The prevalence of togo-shiccho-sho became about 90% among the Japanese psychiatrists and they seem to use it not accompanied with Seishin-bunretsu-byo or any other names. Moreover, 70% of psychiatrists informed their patients himself of their diagnosis, especially eagerly among younger generation. As well as the disease condition of patients and doctor-patient relationship, whether patient and his/her family could understand or not affected to the decision of informed consent. There were also differences among districts on informed consent, especially negative at Kinki district.

Humans↗

PubMed1985

Informed consent as a form of volunteer bias.

Two nontreatment studies of tardive dyskinesia were examined to see if giving or refusing informed consent might bias results. Three prominent psychiatric journals were also reviewed to determine whether the outcome of informed consent procedures was sufficiently well described to permit evaluation of potential bias. The nontreatment studies suggested that the bias created by requiring informed consent may cause both false-positive and false-negative findings. The literature review showed that treatment studies have generally ignored the potential impact of these biases on results. Accurate interpretation of research reports, particularly clinical trials, demands that more attention be given to the process of obtaining and reporting informed consent.

Adolescent↗

PubMed2006

Informed consent for therapy and research in continuous renal replacement therapy: an international survey.

OBJECTIVE: To study the approach of health care workers (HCW) to informed consent for therapy and research in the field of continuous renal replacement therapy (CRRT). DESIGN: Administration of questionnaire. SETTING: Two International Courses on Critical Care Nephrology (CCN) held in Vicenza and Melbourne. PARTICIPANTS: Eight hundred and twenty one course participants. RESULTS: We obtained 349 analysable questionnaires (42.5% of participants). Only 22.5% of responders always obtain informed consent for CRRT; 70.3% just inform patients/relatives without seeking consent, 7.1% never obtain informed consent. In ICU patients, informed consent is considered 'good, correct and feasible' for therapy and for research by only 13% and 27% of responders, respectively. Consent for clinical research obtained from the next of kin or legal guardian is considered good, correct and feasible' by 56.3% of respondents, while 39.1% believe that next of kin or legal guardians can not really make informed decisions. Finally, nearly half of responders think that present rules hamper research in ICU. For many questions, significant variability of responses was found according to profession, specialty and origin of responders. CONCLUSIONS: In the field of CRRT, stated practice, beliefs and currently accepted ethical standards vary greatly according to profession, specialty and origin. A significant disagreement between what is widely promoted to be the 'correct' approach and what is currently done is evident.

Attitude of Health Personnel↗

PubMed2002

Cervical manipulation--how might informed consent be obtained before treatment?

This article discusses methods and mediums of obtaining informed consent in physiotherapy clinical practice, specifically in relation to cervical manipulation. Whilst cervical manipulation is a useful method of treatment for spinal joint pain and dysfunction, it has also been shown to be ineffective or even positively harmful. Legal precedents have set boundaries for informing patients of such adverse consequences. However, a degree of uncertainty exists in the physiotherapy profession, as in other health care professions, as to how to obtain informed consent in a busy clinical setting in order to discharge the legal duties owed. Obtaining meaningful informed consent in clinical practice raises issues of patient comprehension, memory and decision-making capacity. A large quantity of research directed at enhancing patient understanding has been undertaken in recent years. The important findings are that a variety of communication methods and mediums need to be employed in both providing information and assessing patient understanding. A combination of verbal, written and audiovisual information provides patients with maximum opportunity to be involved in treatment decisions.

Audiovisual Aids↗

PubMed2005

Lack of standards in informed consent in complementary and alternative medicine.

OBJECTIVES: To examine whether U.S.-based professional complementary and alternative medicine (CAM) organizations have explicit informed consent policies. DESIGN AND SETTING: Phone survey conducted in July-August 2003. RESULTS: Data were obtained from 37 out of a total of 39 eligible and accessible organizations representing 19 commonly used provider-administered CAM techniques (95% response rate.) Only 21 organizations (57%) had any informed consent policy and standards, whilst only six (16%) mandate their clinician members to routinely obtain an informed consent. CONCLUSIONS: We found no consistent standards with respect to the practice of informed consent across a broad range of CAM practices. CAM information that is not communicated appropriately or is otherwise unavailable to patients during the decision-making process may increase the potential for healthcare oversights and adversity.

Complementary Therapies↗

PubMed1990

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Antipsychotic Agents↗

PubMed1997

The ethics of informed consent: a critical variable in the self-determination of health and mental health clients.

Informed consent is a critical variable in the self-determination of consumers receiving health and mental health services. Consent has become a more stringent requirement in recent years. However, providers emphasize legal requirements rather than the true participation of consumers--the "spirit" of informed consent. This article discusses the elements of informed consent, the issues that reflect the "spirit" of consent, and recommendations for actions that foster self-determination in practice.

Ethics, Medical↗

PubMed2005

Informed consent and participant perceptions of influenza vaccine trials in South Africa.

BACKGROUND AND OBJECTIVES: There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa. METHOD: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration. RESULTS: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication. CONCLUSION: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.

Administration, Intranasal↗

PubMed1999

Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research.

This article summarizes the current requirements for a waiver of informed consent for emergency research and analyzes ethical issues that are involved. Researchers who intend to apply for a waiver of informed consent for emergency research must understand that they are asking for the major protector of human subjects, the informed consent process, to be removed. In its absence, other protections are required. These include communication with the community, family members, and others close to the patient. It is unlikely that even these additional protections can equal that afforded by an adequate consent process. With this understanding, investigators' actions must be in accordance with the highest ethical standards. It is therefore necessary for investigators to know the ethical implications of conducting controlled research without the subjects' consent.

Community-Institutional Relations↗

PubMed2005

Ethical issues of informed consent in acute stroke. Analysis of the modalities of consent in 56 patients enrolled in urgent therapeutic trials.

BACKGROUND: Many patients may be mentally incompetent or physically unable to give informed consent at the acute stage of stroke. Accordingly, we aimed to investigate the modalities of informed consent in urgent therapeutic stroke trials, the awareness of patients and relatives regarding stroke clinical trials and the impact of decision making on patients and relatives. METHODS: We present a study of 56 acute ischemic stroke patients who were randomized in 4 trials (2 trials testing neuroprotective agents, 1 testing thrombolysis and 1 testing antithrombotic agents). A standardized questionnaire was used to assess the modalities of informed consent in this setting. RESULTS: The mean age was 67.1 (SD 12.6) years. The mean baseline Scandinavian Stroke Scale (SSS) score was 23.8 (SD 10.5). Only 13 patients (23% of cases) gave consent while relatives gave consent for 43 patients (77%). The main reason for not getting consent from the patient was aphasia in 29 patients (67.4%). Multiple logistic regression analysis showed that the two independent factors influencing the ability to give consent are age and baseline neurological deficit as assessed by the SSS score. Concerning the psychological impact of consent, none of the 10 patients who answered our questionnaire declared feeling uncomfortable when giving consent, while 7 out of the 13 relatives who could be reached declared they felt uncomfortable, mainly because of the psychological stress induced by urgent decision making. CONCLUSIONS: Our study emphasizes the specific ethical difficulties of informed consent in the setting of acute stroke research. Only a minority of patients are able to give consent at the acute stage. Increasing age and neurological deficit are independent predictors of inability to give consent. Thus, the responsibility for consent usually relies on relatives with potential inaccuracy of decision concerning the patient's wish or even conflict of interest. Further evaluation of the psychological impact of decision on relatives is needed in this setting of acute stroke.

Adult↗

PubMedDate not supplied

Anxiety, depression and informed consent in patients referred to a radiotherapy department.

AIMS AND BACKGROUND: Informing cancer patients is an ethical, legal and deontological aspect of patient management. Patients need clear instructions in order to be able to accept or refuse medical procedures. Many reports in the literature have shown differences among physicians in informing cancer patients. The aim of this study was to assess patients' understanding of diagnosis, planned radiotherapy and risk of early and late effects, their satisfaction with the discussion with the doctor and correlation with anxiety and depression after the disclosure of a cancer diagnosis. METHODS: From April to July 2000 a physician with psychiatric training conducted interviews with patients after their consultation with the radiotherapist and asked them to fill in a questionnaire. Anxiety and depression were measured by means of a scoring system [HAD(A) and HAD(D)] such as the patient's satisfaction and the physician's belief in it. Eighty-two outpatients referred to our radiotherapy department were studied. RESULTS: We did not find any correlation between HAD(A) and HAD(D) scores and comprehension scores of disease, treatment schedule, side effects and patient satisfaction, or between any scores and presumed predictive variables such as diagnosis, gender, age, treatment aims, time from diagnosis, education, marital status, profession, life habits, and the role of the doctor obtaining the informed consent. CONCLUSIONS: We may conclude that informed consent does not seem to increase reactive anxiety or depression. Its quality is high in our department but must be improved.

Adult↗

PubMed2006

A brief measure of perceived understanding of informed consent in a clinical trial was validated.

BACKGROUND AND OBJECTIVE: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial. METHODS: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). RESULTS: The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). CONCLUSIONS: The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent.

Adult↗

PubMed1993

[Informed consent: a prerequisite for psychotherapy?].

Is it desirable to extend the practice of explicit informed consent to psychotherapy? Is it possible? How? This article offers preliminary answers to these questions following a literature review and reflection on the theory of informed consent and psychotherapy. It explores the advantages and the possibility of using explicit informed consent in place of the implicit consent obtained currently. Explicit consent for psychotherapy would be interactive, iterative, repeated and revokable. It would take into account specific characteristics of psychotherapy, such as the fact that it is a process rather than a procedure, its relative unpredictability, the active part the patient plays in treatment, and the importance of the unconscious, transference and counter-transference. It would have the advantages of respecting the patients' autonomy without sacrificing their well-being, of having meaning not only for medico-legal protocols but for the patient, and would improve satisfaction with and the efficacy of psychotherapy as a treatment modality. The proposed model provides direction for future research, both empirical and theoretical.

Countertransference↗

PubMed1995

Informed consent: a survey of physician outcomes and practices.

We mailed a survey to the domestic membership of the American Society of Gastrointestinal Endoscopy in an attempt to investigate how endoscopists obtained informed consent and the effect of these practices on medical malpractice claims. One thousand two hundred thirty-two (23.8%) surveys were returned. We determined that although informed consent is obtained in 98.5% of endoscopic cases, 30% of physicians leave the task of obtaining such consent to hospital or office personnel. Although endoscopists tend to be complete in terms of describing the risks of procedures to patients, all risks are not revealed equally; some complications, for example, the risk for requiring a colostomy, are disclosed by relatively few physicians, perhaps revealing a higher comfort level with a particular procedure, such as colonoscopy. Likewise, endoscopists generally explain the benefits of and alternatives to procedures, but they do not explain the more hazardous alternatives. Documentation of the informed consent process is an area in which physicians could be more thorough. Twenty-one percent of respondents had been sued, and in 42% of these instances, the informed consent process was an issue. Lawsuits in general (38%) changed the way respondents obtained consent, especially (64%) when this process had been an issue in the suit. No correlation was found between either the thoroughness of the informed consent process or the status of the person who obtained consent and the likelihood of being sued.

Communication↗