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PubMed1980

Legal and ethical issues in clinical pharmacy research--informed consent, Part I.

The continued growth of hospital and clinical pharmacy should be paralleled by the development of sound research methods justifying innovative practices. Such research will, on occasion, require experimentation involving human subjects. The principal means of assuring that the welfare of research participants is not compromised is through the procurement of effective informed consent. Pharmacists, like many other health professionals, have had relatively little exposure to methodology involved in the writing of an informed consent instrument. A comprehensive document must not only conform to the requirements of federal regulatory agencies, but must also satisfy various institutional guidelines. Past instances of unethical human experimentation are discussed, and a format for preparation of an informed consent instrument is examined. Circumstances requiring informed consent and identification of the basic elements of consent are also explained.

Clinical Trials as Topic↗
PubMed2002

Informed consent and the capacity for voluntarism.

OBJECTIVE: Informed consent is built upon the elements of information, decisional capacity, and volunteerism. Of these elements, voluntarism in clinical and research consent is the least well understood. This has interfered with the ability to resolve key ethical problems faced by the field of psychiatry. METHOD: The author suggests that voluntarism encompasses an individual's ability to act in accordance with one's authentic sense of what is good, right, and best in light of one's situation, values, and prior history. Voluntarism further entails the capacity to make this choice freely and in the absence of coercion. Deliberateness, purposefulness of intent, clarity, genuineness, and coherence with prior life decisions are implicitly emphasized in this construction. RESULTS: The author offers and illustrates a framework for voluntarism in clinical and research consent decisions, focusing on four domains of potential influence: 1) developmental factors, 2) illness-related considerations, 3) psychological issues and cultural and religious values, and 4) external features and pressures. CONCLUSIONS: It is hoped that improved understanding of voluntarism will help in our efforts to fulfill the principle of respect for persons in clinical care and research.

Attitude to Health↗
PubMed1993

[Informed consent in orthopedic surgery].

Twenty-eight patients who had total joint replacement (TJR) and twenty-eight patients who sustained open reduction for fracture within or close to the joint were studied to determine their recall of the informed consent procedure. The questionnaire covered a postoperative time range of more than 5 months and less than 6 years (average: 2 years and 4 months). The patient's recall and the doctor's document of informed consent were scored 4 points for diagnosis and treatment, 1 point for prognosis, 3 points for benefits, 4 points for complications and 1 point for alternatives with a total of 13 points. In TJR, the average recall and document score were 8.6 points and 6.5 points respectively; and in fracture, 6.6 points and 4.9 points. Fifty-seven per cent of the patients with TJR recalled the risk of infection; and 54 per cent recalled the problem of loosening. Twenty-nine per cent of the patients with fracture recalled the risk of infection, and 29 per cent the risk of nonunion. In TJR, the recall score was related to the patient's age and the document score. There was significant difference in document scores among doctors. As a result of this study, standard documents for informed consent in each operation have been compiled with the aid of a word-processor to improve the quality of informed consent.

Female↗
PubMed1999

Informed consent: British otolaryngologists surveyed.

A repeat postal questionnaire of British otolaryngologists has been carried out to assess changes in their practice of obtaining informed consent. The previously reported high level of good practice is maintained. Currently informed consent is more often obtained in outpatients or the preadmission clinic than it was in 1991. Consultants and specialist registrars are more involved in this process. Although there is little evidence given to support a persistent increase in a defensive approach towards gaining informed consent, there is some change in the reporting of surgical complications that may reflect an increased awareness of the concept of 'material risk'.

Ethics, Medical↗
PubMedDate not supplied

Informed consent--wishful thinking?

This article is concerned with the concept of "informed consent" as applied both in biomedical research involving human subjects and in clinical medicine in general. The current crisis over the elaboration and interpretation of the concept will be examined, along with the broader question of whether "informed consent" is any longer meaningful or viable as a criterion for complex bioethical policy-making. Finally, I will attempt to sketch a prognosis for the concept in doctor-patient relations, even if it is only wishful thinking.

Communication↗
PubMed2004

Seeking informed consent to cancer clinical trials: describing current practice.

Clinical trials have come to be regarded as the gold standard for treatment evaluation. However, many doctors and their patients experience difficulties when discussing trials, leading to poor accrual to trials and questionable quality of informed consent. We have previously developed a typology for ethical communication about Phase II and III clinical trials within four domains: (a) shared decision making, (b) sequencing information, (c) type and clarity of information, and (d) disclosure/coercion. The aim of this study was to compare current clinical practice when seeking informed consent with this typology. Fifty-nine consultations in which 10 participating oncologists sought informed consent were audiotaped. Verbatim transcripts were analysed using a coding system to (a) identify the presence or absence of aspects of the four domains and (b) rate the quality of aspects of two domains: (i) shared decision-making and (ii) type and clarity of information. Oncologists rarely addressed aspects of shared decision-making, other than offering to delay a treatment decision (78%). Moreover, many of these discussions scored poorly with respect to ideal content. The oncologists were rarely consistent with the sequence of information provision. A general rationale for randomising was only described in 46% of consultations. In almost one third of the consultations (28.8%) doctors made implicit statements favouring one option over another, either standard or clinical trial treatment. Doctors complied with some but not other aspects of a standard procedure for discussing clinical trials. This reflects the difficulty inherent in seeking ethical informed consent and the need for communication skills training for oncologists.

Adult↗
PubMed1988

Informed consent issues in the cardiac transplantation evaluation.

As consultation-liaison psychiatrists to a cardiac transplantation team, we have observed various informed consent issues that are particularly associated with evaluation for cardiac transplantation. We discuss complicating factors that relate to each component of informed consent and present the defense mechanism of denial as a barrier to making the decision to accept or refuse transplantation. Changes in the evaluation protocol could preclude existing impediments to provision of information and patient autonomy; however, certain intrapsychic issues must be recognized as ongoing clinical realities to be addressed as the doctrine of informed consent continues to evolve.

Adult↗
PubMed2004

Involvement and (potential) influence of care providers in the enlistment phase of the informed consent process: the case of AIDS clinical trials.

This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, physician assistants) during the enlistment, or recruitment, phase of the informed consent process. It shows that sometimes care providers are involved in the receipt, evaluation and distribution of information on clinical trials through their interactions with research professionals and patients. It suggests that the involvement of care providers has the potential to influence the informed consent process. Some of the ethical and practice considerations of this are discussed.

Acquired Immunodeficiency Syndrome↗
PubMed1999

An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa.

It has recently been debated whether it is possible or desirable to have one internationally recognised standard of "informed consent" or whether research ethics should be adapted to the culture and educational level of the study population. This study examined the attitudes of the Gambian people to consent to medical research, and evaluated the informed consent process used in a major efficacy trial of a Haemophilus influenzae vaccine. Consent was requested after parents had received a verbal explanation and an information sheet which described the vaccine trial in a local language. A semi-structured interview was conducted with 137 acceptors and 52 refusers. Certain points of knowledge were recalled well by the acceptors; 90% knew the purpose of the vaccine was to prevent disease, but the placebo control design was understood by only 10%. The prime motive for consenting was to receive the HIB vaccine (93%) and that for refusing was that the vaccine was experimental (35%) and might have unknown side effects (29%). Although parents took advice from researchers (50%), health workers (24%), friends (16%) and family (12%), in all cases the decision was made by one of the child's parents. Only 1% of parents sought the opinion of traditional or religious leaders. The principles of informed consent, that it should be free, autonomous and informed were affirmed by this community. Therefore, in The Gambia, the international code of informed consent is appropriate.

Adult↗
PubMed1989

Combat casualty care research and informed consent.

Combat casualty care research on far-forward resuscitation is necessary for optimizing the future care of the wounded soldier. Present legal directives pertaining to the use of humans as subjects in Department of Defense (DOD)-funded research require that prior informed consent from the subjects or their legal representatives be obtained. Application of these legal directives to present and future combat casualty care research will ultimately obstruct significant progress toward optimizing the care of the injured soldier. This article reviews the medical considerations surrounding resuscitation research that make obtaining traditional informed consent impossible, the present legal directives pertaining to DOD-funded research and informed consent, and the ethical issues that influence the conduct of human research. The necessary changes required to continue resuscitation research without informed consent, while still safeguarding the welfare of the patient, are suggested.

Ethics Committees, Clinical↗
PubMedDate not supplied

[Multicenter prospective study of informed consent in general surgery].

To understand the level of acceptance, awareness and usefulness of informed consent, a group of 119 patients (59 men and 60 women) from different types of hospitals were given a questionnaire which required only 'YES or NO' answers, both before and after surgery. The questionnaire concerned the patient's knowledge about pathology, operative risks, approval, anxiety caused, understanding of information received and consent given, and also if he would inform a relative in the same condition. From the analysis of the results it was established that: the more information a patient has about his illness and operation risks, the more he will want to have; the less he knows the less he will want to know, and he will also have more faith in the doctors. Some patients would not inform a relative with a similar pathology. To conclude, informed consent, instead of being a right of the patient is progressively becoming more a right of the doctor. It does not have any real effect on the patient's choice but is useful, as it represents a moment of personalised attention from medical personnel, though the patient may not completely understand the information received. There are few advantages in strictly medical terms but informed consent has increased malpractice litigation.

Female↗
PubMed1983

Obtaining informed consent in the teaching nursing home.

The authors observed attempts to obtain informed consent for clinical research at the Jewish Institute for Geriatric Care. One study entailed the use of venipuncture, urine collections, urethral catheterizations, and antibiotic therapy. The other required that venipunctures and lumbar punctures be performed on dementia patients. Patients and families were observed to be unwilling to consent to any procedure more invasive than venipuncture. Poor recall and other physical and psychologic factors impaired comprehension of the protocols, and some patients requested second opinions from trusted "others." Written consent could be refused despite verbal consent. Furthermore, incompetent patients could refuse to participate in protocols for which family members had given consent. The implications of these observations are discussed. Despite concerns, which are enumerated, it is concluded that informed consent can be obtained in the teaching nursing home.

Bacteriuria↗
PubMed2001

Obtaining informed consent from continuing care residents: issues and recommendations.

As the number of older adults residing in continuing care facilities increases, mental health professionals will provide more services and conduct more research in this setting. Mental health professionals working with continuing care residents will find themselves regularly challenged by ethical issues, particularly obtaining informed consent. Characteristics of the continuing care setting and residents make obtaining informed consent especially challenging. Mental health professionals must overcome these challenges in order to fulfill the following three requirements of informed consent: (1) the client is competent, (2) the client is provided with sufficient information, and (3) the client has not been coerced and/or the consent is voluntary. This article will examine the issues surrounding the fulfillment of these requirements in a continuing care facility, and will provide suggestions and guidelines that mental health professionals can utilize during the informed consent process.

Aged↗
PubMed1992

Teaching the process of obtaining informed consent to medical students.

This paper describes a unit on the informed consent process taught to 119 first-year students at the Michigan State University College of Osteopathic Medicine in 1988-89. The unit consisted of a pretest and a posttest, a lecture, readings, small-group discussions, a model videotaped interview, and the students' videotaped interviews with one of two simulated patients. In the interviews, the students were most successful in establishing rapport and engaging the patients in discussions of treatment alternatives, and were less successful in perceiving the patients as unique individuals and in dealing with situations that involved conflict or confrontation. The authors suggest that curricula can be enhanced by focusing on the importance of patients' participation in the informed consent process.

Curriculum↗
PubMed2000

[Informed consent, QOL and cost benefit in the treatment of lung cancer].

Ethical issues, including informed consent, quality of life and cost/benefit, are discussed. Informed consent is not only ethical discipline but also legal concept. It is important to know how and when to disclose the truth. Training and experience are critically important to acquire clinical-behavioral skill. Physicians also should know some pitfalls, including patient's right to decline information especially in terminal situation. Quality of life(QOL) is an important concept for medical practice in the treatment of lung cancer. Although several instruments have been developed for QOL measurement, poor compliance and feedback to patient care, and meaningless domains are criticized. Disease related symptom(DRS) and cost analysis should be used in future clinical trials of lung cancer.

Cost-Benefit Analysis↗
PubMed2004

Informed consent for genetic research.

BACKGROUND: Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. OBJECTIVE: To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. DESIGN: Survey conducted between February 1, 2002, and March 31, 2003. SETTING: Academic, tertiary free-standing children's hospital. PARTICIPANTS: A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. MAIN OUTCOME MEASURES: Reasons for refusal. RESULTS: Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. CONCLUSIONS: The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

Employment↗
PubMed2001

Participation in research: informed consent, motivation and influence.

OBJECTIVE: To investigate the process and quality of informed consent, motivation and influence in parents who were invited to enroll their baby in a research project. METHODOLOGY: A mixed quantitative/qualitative questionnaire was sent to a cohort invited to participate in a physiological research project on sudden infant death syndrome (SIDS) at the Dunedin Public Hospital, Dunedin, New Zealand. Separate questionnaires were used for parents who participated (94) and those who declined to participate (103). Response rates were 69% and 47%, respectively. RESULTS: All consenting parents felt they understood the purpose and procedure of the study. The majority (90%) thought the information about the study was very good; 6.5% felt more detail was required. Eighty-five per cent found the verbal explanation the most useful source of information. All participated for altruistic reasons such as to aid SIDS research. Although 27% had concerns about safety of the tests, after the tests all responders felt happy with the safety of the tests. Inconvenience was the main reason (53%) for declining to participate. Twenty-eight per cent of declining parents were concerned about the safety of the tests. CONCLUSION: Of those who responded to the questionnaire, the process for obtaining informed consent in the SIDS studies was satisfactory. Parents' motives for participating were mostly altruistic. The role of recall bias and selection bias may make the implications of this study unclear.

Adult↗
PubMed1998

[Informed consent--on the right of self-determination].

The idea of informed consent asks for the right of self-determination which is very difficult to achieve. Human life does not depend on one's will, and neither does suffering. That is human being does not control one's own life, even though one must be responsible for it. The right of self-determination has long and struggling history. As a result we have acquired the concept of informed consent. And then the physician-patient relationship is no longer considered to be based on paternalism and now the new model is seeked for. All human beings are mortal and cannot inevitably escape suffering. Therefore we must consider the physician-patient relationship as the one based on equality. The problem of self-determination should arise from this understanding.

Freedom↗