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PubMed2004

[Informed consent in research: a new approach].

INTRODUCTION: The Informed Consent allows the person invited to participate of a research project to understand the procedures, risks, discomforts, benefits and rights involved; determining an autonomic decision. We want to verify in the informed consent process the adequacy of given information to research subjects in a collective way. METHODS: A research project was chosen from the gynecologic area. The collective obtainment consisted of an oral presentation. After that, The Consent form was shown. Forty-five patients were interviewed, immediately after the consent obtainment. RESULTS: Remembrance capacity of information about procedures, risks and benefits explained were verified. All participants (100%) remembered the procedures, 54% of them remembered the risks and 96% the probable benefits. Comparing these data with others from a similar study using conventional informed consent process (individual information transmission) the subjects remember more information in the present study. CONCLUSION: These results evidence the possibility to inform collectively the research subjects when getting the Informed Consent in those projects where this choice is available.

Biomedical Research↗
PubMed2005

CKD patients and erythropoietin: do we need evidence-based informed consent?

BACKGROUND: Consent to therapy is increasingly requested in the form of ''informed consent''. OBJECTIVE: To validate an evidence-based informed consent form for erythropoietin (EPO) therapy and to evaluate patient opinions about the informed consent approach. METHODS: An evidence-based informed consent form was developed as part of the Evidence-Based-Medicine course at the Medical School of Turin, Italy. It was validated by anonymous questionnaires (0-10 analogical scales and open answers) administered to patients at different stages of CKD (19 pre-ESRD, 26 hemodialysis, 12 transplant patients) attending an outpatient unit of the University of Turin, to 8 nurses, and to 26 medical students. RESULTS: All individuals filled in the questionnaire. Interest in a detailed explanation of the therapy was high (median 9), as was comprehension (median 9), with no differences between patients with regard to disease stage (pre-ESRD vs. RRT) or educational level. Prior knowledge of the therapy was affected by the educational level (p=0.013 for the advantages and p=0.004 for the side effects) and the professional role (patients vs caregivers: p=0.009 for the advantages and p<0.001 for side affects); patient knowledge of the advantages (median 6) tended to increase as the disease progressed (p=0.015). The most common response by patients was that informed consent was necessary for all drugs (35.1%); 73.1% of the caregivers considered it necessary only for severe side effects. The preferred modality of consent was discussion with the caregiver during the clinical controls (42% of all cases). CONCLUSIONS: Patient interest in and comprehension of an informed consent form with a detailed explanation of the therapy was high; the caregiver's opinion was still the most valued teaching tool.

Adult↗
PubMed2005

Informed consent in oral health care.

BACKGROUND: Informed consent and autonomy are the major ethical principles that define the relationship between health workers and the patient. A patient should be given adequate information on the risks and benefits of treatment to be undertaken and also alternative treatment options. OBJECTIVES: To investigate what and how much information dental patients perceived to had been given by oral health workers about treatment, benefits, risks and management alternatives in order to take decisions and give informed consent about their treatment. DESIGN: Cross sectional descriptive survey. SETTING: The study was conducted at Ann Latsky Nursing College, Johannesburg. SUBJECTS: The sample size consisted of 173 student nurses in their first, second and third years of training. Only students who had treatment in the previous three years were included in the study. RESULTS: The majority of the students were treated in the private sector (85.0%) by male oral health workers (61.6%) and dentists (89.5%) as opposed to dental therapists or oral hygienists. The study indicated that the majority of the respondents (75.6%) were given information about the treatment to be undertaken. The information appeared to have pertained to costs, pain, chances of success and duration of treatment. One hundred (74.07%) gave verbal consent and (16.30%) gave both verbal and written consent. Only 37.79% of the respondents were told of alternative options available, 47.17% of the benefits, and 38.6% of the risks of treatment. CONCLUSION: These findings have ethical implications for oral health workers. There is an urgent need to sensitise oral health workers on the specifics of informed consent.

Adolescent↗
PubMed2004

Informed consent for research participation in frail older persons.

Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must be protected, protection should not prevent research on this important population. Similarly, because informed consent documents are often written to prevent legal jeopardy, these technical documents, expressed in language sometimes difficult to understand, can prevent comprehension of basic issues, defeating the ethical purpose of human protection.

Aged↗
PubMed2004

Beyond informed consent.

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.

Codes of Ethics↗
PubMed2005

'At the point at which you can do something about it, then it becomes more relevant': informed consent in the pharmacogenetic clinic.

Sociological investigation of informed consent has generated rich and complex descriptions of the clinical encounter, often challenging the straightforward picture painted by medical ethicists. This paper builds on this work, drawing on ideas from the Sociology of Science and Technology, to explore informed consent issues surrounding the use of the drug Herceptin, widely cited as an example of a novel approach to drug development called pharmacogenetics. Drawing on qualitative semi-structured interviews with 25 UK-based breast cancer specialists, this paper explores Herceptin's disputed epistemological status, as an example of pharmacogenetics or as something out of the ordinary in terms of clinical practice. It considers how, in turn, this impacts on the way in which informed consent is sought and influenced by clinicians' desire to protect patients from possibly distressing test results. It highlights the flexible, contingent and context dependent nature of informed consent in the clinical setting.

Antibodies, Monoclonal↗
PubMed1998

A guide to understanding informed consent.

Anesthesia providers are expected to provide information to the patient during the preanesthesia interview that enables the patient to make informed choices. Adequate disclosure during the informed consent process ensures the equalization of the practitioner/patient relationship and the decision-making rights of the patient. Both certified registered nurse anesthetists (CRNAs) and anesthesiologists are not only legally required to provide information that will allow a patient to make an informed judgment about how to proceed with various anesthetic modalities but are also obligated by their standards of practice. This article informs the CRNA about the principles of informed consent so that they can better understand their role in the informed consent process.

Algorithms↗
PubMed2003

Informed consent in dermatologic surgery.

BACKGROUND: The issue of informed consent retention has not been previously addressed in dermatology literature. Several studies in other fields of medicine have shown that retention rates are below 50%. OBJECTIVE: To determine the percentage of complications recalled at 20 minutes and at 1 week after the informed consent process. METHODS: Eighty-five consecutive patients undergoing Mohs micrographic surgery were given verbal and written instructions, including 10 potential complications. Patients were asked to recall these complications at 20 minutes and at 1 week after the informed consent process. RESULTS: Overall group retention rate at 20 minutes and at 1 week were 26.5% and 24.4%, respectively. CONCLUSION: Patients undergoing elective Mohs micrographic surgery have an overall retention rate of 26.5% just 20 minutes after being informed of 10 possible complications. It is obvious that the informed consent protocol needs additional modalities in order to improve overall retention rates.

Aged↗
PubMed2005

Informed consent in the intensive care unit: ensuring understanding in a complex environment.

PURPOSE OF REVIEW: Informed consent in the intensive care unit continues to receive marked attention. As greater numbers of patients enter into the intensive care unit with devastating illness, patients and families are faced with more complex medical problems and decisions regarding therapy. Furthermore, research investigations of critical illness add a level of complexity to informed consent and decision making that mandates a careful approach. RECENT FINDINGS: Publications in the past year evidence the potential obstacles for appropriate informed consent. Physicians demonstrate variability in interpretation for the need for informed consent and frequently lack formal training in communicating informed consent. Critical care researchers must communicate the goals and benefits of trial participation carefully, avoiding the demonstrably common pitfall of therapeutic misconception. Excellent consensus statements now exist to guide the researcher in pursuing critical care research, creating informed consent documentation, and recognizing the appropriate setting for waiver of consent. As expected, extended discussion is the most effective tool for improving the quality of informed consent. SUMMARY: Quality of informed consent for the critically ill improves as attention is paid to standardizing indications and formalizing training for physicians. In research, conflicts of interest should be recognized and used to guide the investigator's dialogue on research benefits and risks. Patient safety must be maintained as the primary priority; however, waiver of consent may be considered in situations in which the benefit to medical knowledge far exceeds patient risk.

Clinical Trials as Topic↗
PubMedDate not supplied

On failing to understand informed consent.

Many doctors view informed consent as merely a medicolegal concept. This article points out that other discourses are possible and that patients would benefit if doctors were to take a wider view.

Decision Making↗
PubMed1996

Clinicians' judgement of capacity of nursing home patients to give informed consent.

OBJECTIVE: The study determined the rate of incapacity to give informed consent for medical treatment among patients admitted to a nursing home and assessed whether clinical staff members recognized this incapacity and whether they used alternative means to provide surrogate decision making for their patients' treatment. METHODS: After 44 patients admitted to a nursing home affiliated with a major teaching hospital gave oral consent, two standardized tests, the Hopkins Competency Assessment Test (HCAT) and the Mini Mental State Examination (MMSE) were administered to them. Later a researcher blind to the test results reviewed subjects' clinical records to determine whether staff recognized any incapacity in giving informed consent for medical treatment. RESULTS: Twenty of 44 subjects were identified by the HCAT as incompetent to give informed consent for medical treatment. Clinical staff had identified 13 of those subjects as clinically incompetent. None of the subjects whom clinical staff identified as clinically incompetent was provided with surrogate decision makers in accordance with procedures outlined in state law. CONCLUSIONS: The prevalence of incapacity to give informed consent in the nursing home population was high. Clinical screening by staff did not identify all clinically incompetent patients, and staff had unresolved conflicting opinions about individual patients' capacity to give informed consent. Even when staff recognized a patient's incapacity to give informed consent, proper legal procedures for appointing surrogate decision makers were not followed.

Adult↗
PubMed1996

Legal issues in blood banking. Elements of informed consent.

In the past, informed consent in pathology was confined chiefly to autopsies. Changes in both consent law and pathology practice led to consent being important in a broader sense in the laboratory. Areas discussed in this article include blood transfusion, tissue specimens, fine needle aspiration, and phlebotomy.

Autopsy↗
PubMed1994

A retrospective analysis of institutional review board and informed consent practices in EMS research.

STUDY OBJECTIVE: To assess the frequency of institutional review board (IRB) review and informed consent in emergency medical services (EMS) research. DESIGN: Two-year, retrospective review of published EMS research. MEASUREMENTS AND MAIN RESULTS: One hundred two studies were analyzed. Seventy-one (70%) were exempt from IRB review; 31 (30%) were not exempt. Seventeen nonexempt studies (55%) did not obtain IRB review. Eight of these did not specify a consent method; one used implied consent and eight used volunteers. Volunteers gave informed consent in one study. Of the 14 nonexempt studies with IRB approval, seven did not specify a consent method. Two used informed consent, one received an informed consent waiver, one used verbal consent, and three involved volunteers. Written parent permission was used once when volunteers were minors. CONCLUSION: IRB review is often omitted by EMS investigators. This raises ethical concerns about EMS research. Investigators should document their consent method or approval to use an informed consent waiver in their manuscripts. A consent method should be specified for volunteers.

Emergency Medicine↗
PubMed1983

Barriers to informed consent.

The law of informed consent seeks to actively involve patients in decision making. Most authorities agree that this involvement has not occurred but disagree about why. Some suggest that patients are incapable of understanding medical issues and others that physicians have not explained issues clearly or extensively enough. We observed decision making in several hospital settings and found other significant barriers to patient participation. These barriers include the fact that treatment decisions take place over a long period; there are often many decisions to be made; although patients want information about treatment, they typically believe that decision making is the physician's task; physicians do not understand the rationale for the patient's role in decisions; and the medical decision-making process often involves so many people that the patient does not know who is responsible.

Aged↗
PubMed1995

Informed consent for percutaneous lung biopsy: comparison of two consent protocols based on patient recall after the procedure.

OBJECTIVE: Informed consent is now required for the majority of radiologic procedures, but few studies have evaluated the efficacy of informed consent protocols. We compared our standard consent protocol of obtaining consent prior to percutaneous lung biopsy with a modified protocol by using patients' recall of procedure risks after the biopsy as an indicator of patients' comprehension. SUBJECTS AND METHODS: The study sample consisted of 50 patients who underwent percutaneous lung biopsy between December 1992 and June 1994. Twenty-seven patients received our standard informed consent procedure in which four important procedure risks were described briefly using our standard method. Twenty-three patients underwent a consent procedure that had the following modification. After the four procedure risks were described, the patient was tested verbally until all risks could be recited to the physician. This change required 5 additional min at most. In both protocols, efficacy of the procedure was evaluated by testing patient recall 4 hr after consent was obtained. We also assessed any effect that might have been introduced by differences between the groups, age, sex, time between consent and recall, and complications during the procedure. RESULTS: Patients' recall was significantly better in the modified consent group than in the standard group (p = .005). This result could not be attributed to differences in age, sex, or time between consent and recall. There was a trend for improved recall in patients with complications. This trend did not appear to influence our principal finding. CONCLUSION: The standard consent procedure for lung biopsy appears inadequate when patients' recall of procedure risks later is used as a measure of the patients' comprehension. Based on this study, the informed consent process may be improved substantially by teaching patients to recite the procedure risks to the physician as part of the informed consent protocol.

Adult↗
PubMed1985

Radiologists and informed-consent lawsuits.

A national survey on informed-consent lawsuits that resulted from studies using contrast material revealed that 123 (8%) of 1,513 radiologists surveyed or others in their groups had been involved in informed-consent lawsuits. In response to a detailed follow-up questionnaire, 67 radiologists anonymously provided additional information regarding their lawsuits, which most often involved excretory urography (37%) or angiography (38%), with death or neurologic impairment the most common patient injuries. As a result of these lawsuits, many radiologists provide more detailed information to patients. In the United States, the total number of informed-consent lawsuits, however, was small in relation to the total number of studies done using contrast material.

Angiography↗
PubMed2005

Impact of French 'Comités de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information.

Information is the keystone to the participation of subjects in biomedical research. Clear comprehension of the informed consent documents (ICDs) is primordial and a necessary requirement is that they are readable. While submission of a protocol to a French 'Comités de Protection des Personnes' (CPP) is a mandatory step with regard to the French legislation on biomedical research, no published data are available concerning its influence on ICDs readability. The aim of our study was to determine the impact of French CPP on the readability of ICDs, using lexico-syntactic readability indexes and ICDs from four clinical research centres and one clinical research unit. Twenty-five ICDs were analysed. The Flesch score was not modified after CPP review, while the Cordial score was significantly lower [from 4 (1-14) to 1 (1-13), P = 0.014]. The information was longer and more complex following CPP review. No protocol characteristics had any impact on the variation before and after review for either the Flesch or the Cordial indexes, nor on the number of syllables per word. Changes in the total number of words before and after review varied considerably between study centre, supporting heterogeneity of CPP review. Since August 2004, French CPP have to study the intelligibility of ICDs in addition to the scientific and ethic aspects of a research. We show that their current reviews do not increase the readability, while increasing the length of ICDs.

France↗