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PubMed2006

Informed consent for research obtained during the intensive care unit stay.

INTRODUCTION: Patients in the intensive care unit (ICU) may be in an inadequate condition to give their informed consent for research. The aim of this study was to analyse the ability to recall participation in a clinical trial for which ICU patients had given their consent. METHODS: The data presented are a two-step observational study: first, a protocolled informed consent procedure was conducted then the informed consent was given by the patient, and second, a patient interview was held 10 +/- 2 days later by the same investigator. The primary endpoints were the ability to recall their participation in the clinical trial, as well as its purpose and related risks. As secondary endpoints, we investigated whether asking questions about the clinical trial or reading the informative leaflet was related to the recall. To be included in the study, the patient had to have a Glasgow Coma Scale score of 15, be fully oriented and free of mechanical ventilation, and be judged competent by both the investigator and the attending physician. Patients admitted to the ICU after major surgery or trauma were eligible. However, patients who refused to participate, or those whose next-of-kin gave consent, were excluded. RESULTS: Of the 44 patients, 35 (80%) recognized, 10 to 12 days after informed consent had been obtained, that they had participated in the clinical trial, but only 14 out of 44 (32%) could recall the clinical trial purpose and its related risks. More patients with complete recall had read the informative leaflet or asked at least one question before signing the informed consent. Asking at least one question was associated with complete recall. CONCLUSION: Our results confirm that obtaining informed consent for research during an ICU stay is associated with poor patient recall of participation in a clinical trial and its components (purpose and risk). Whether encouraging reading the informative leaflet and asking questions about the clinical trial improves the informed consent procedure remains to be fully investigated.

Adult↗
PubMed2003

Recall of the risks of forefoot surgery after informed consent.

PURPOSE: To determine the number of risks a patient can recall from the informed consent process prior to surgery and if recall can be improved with a visual aid and to assess patient satisfaction with the informed consent process utilized. METHODS: Randomly selected patients, from all patients requiring forefoot surgery, were randomly assigned into two groups from August 2001 through October 2001. All patients were asked to recall the risks of surgery and to rate their satisfaction with the informed consent process at their final routine postoperative visit. RESULTS: There were 19 patients in each group. All patients uniformly expressed their satisfaction with the preoperative informed consent discussion at their final visit. The mean number of the 11 risks recalled per patient was 1.0 for group A (range, 0-3) and 0.94 for group B (range, 0-4). CONCLUSION: At the final routine postoperative visit, patients in both groups had poor or no recall of the risks of surgery. The visual aid had no effect on improving recall.

Audiovisual Aids↗
PubMed2004

A typology of shared decision making, informed consent, and simple consent.

Enhancing patient choice is a central theme of medical ethics and law. Informed consent is the legal process used to promote patient autonomy; shared decision making is a widely promoted ethical approach. These processes may most usefully be seen as distinct in clinically and ethically important respects. The approach outlined in this article uses a model that arrays all medical decisions along 2 axes: risk and certainty. At the extremes of these continua, 4 decision types are produced, each of which constrains the principal actors in predictable ways. Shared decision making is most appropriate in situations of uncertainty, in which 2 or more clinically reasonable alternatives exist. When there is only 1 realistic choice, patient and physician may gather and exchange information; however, the patient cannot be empowered to make choices that do not exist. In contrast, informed consent does not require the presence of clinical choice; it is appropriate for all decisions of significant risk, even if there is only one option. When a clinical decision contains both risk and uncertainty, shared decision making and informed consent are both appropriate. For decisions of lower risk, consent should still be present, but it can be simple rather than informed. Clinicians may use this analysis as a guide to their own interactions with patients. In the continuing effort to provide patients with appropriate decisional authority over their own medical choices, shared decision making, informed consent, and simple consent each has a distinct role to play.

Decision Making↗
PubMed1994

Informed consent: clinical and legal issues in family practice.

While patient informed consent is an important clinical and legal dimension of specialty medical care, many important issues arise in primary care. Family physicians are in a unique position to implement informed consent discussions in the ethical spirit in which the doctrine was intended. Because of their long-term relationships with patients and sensitivity to psychosocial issues, family physicians can engage patients in collaborative health care decision making. Primary care physicians are optimally suited to assess patients' understanding of medical information and their competence. Instead of viewing the informed consent process simply as a necessary legal requirement, it should be a method for educating patients and allowing them to participate in their health care decision making.

Comprehension↗
PubMed2006

Enhancing the informed consent process: a conceptual overview.

Concern about limitations in the ability to give valid informed consent among certain groups of individuals has led to increased interest in defining, measuring, and enhancing consent-related decision-making. In this overview, we summarize issues related to the definition of decision-making capacity, discuss methods that have been used to assess decision-making abilities and other aspects of informed consent, and briefly describe studies that aim to understand variation in different elements of informed consent. We then review strategies that have been used with the intent of improving aspects of the informed consent process. Finally, we provide an outline of areas that are in need of future studies in order to reach the ultimate goal of preserving as much autonomy as possible in at-risk populations, while still achieving valuable research and treatment goals.

Bioethics↗
PubMed1997

The role of decision analysis in informed consent: choosing between intuition and systematicity.

An important goal of informed consent is to present information to patients so that they can decide which medical option is best for them, according to their values. Research in cognitive psychology has shown that people are rapidly overwhelmed by having to consider more than a few options in making choices. Decision analysis provides a quantifiable way to assess patients' values, and it eliminates the burden of integrating these values with probabilistic information. In this paper we evaluate the relative importance of intuition and systematicity in informed consent. We point out that there is no gold standard for optimal decision making in decisions that hinge on patient values. We also point out that in some such situations it is too early to assume that the benefits of systematicity outweigh the benefits of intuition. Research is needed to address the question of which situations favor the use of intuitive approaches of decision making and which call for a more systematic approach.

Choice Behavior↗
PubMed1984

Informed consent: a haunting presence.

As informed consent case law evolves, physicians and hospitals are increasingly becoming responsible for what patients are not told as well as for what they are.

Humans↗
PubMed2003

Improving the process of informed consent in the critically ill.

CONTEXT: Invasive procedures are often performed emergently in the intensive care unit (ICU), and patients or their proxies may not be available to provide informed consent. Little is known about the effectiveness of intensivists in obtaining informed consent. OBJECTIVES: To describe the nature of informed consent in the ICU and to determine if simple interventions could enhance the process. DESIGN, SETTING, AND PATIENTS: Prospective study of 2 cohorts of consecutively admitted patients (N = 270) in a 16-bed ICU at a university hospital. All patients admitted to the ICU during the baseline period from November 1, 2001, to December 31, 2001, and during the intervention period from March 1, 2002, to April 30, 2002, were included. INTERVENTION: A hospital-approved universal consent form for 8 commonly performed procedures (arterial catheter, central venous catheter, pulmonary artery catheter, or peripherally inserted central catheter placement; lumbar puncture; thoracentesis; paracentesis; and intubation/mechanical ventilation) was administered to patients or proxies. Handouts describing each procedure were available in the ICU waiting area. Physicians and nurses were introduced to the universal consent form during orientation to the ICU. MAIN OUTCOME MEASURES: Incidence of informed consent for invasive procedures at baseline and after intervention; whether the patient or proxy provided informed consent; and understanding by the consenter of the procedure as determined by the responses on a questionnaire. RESULTS: Fifty-three percent of procedures (155/292) were performed after consent had been obtained during the baseline period compared with 90% (308/340) during the intervention period (absolute difference, 37.4%; P<.001). During baseline, the majority (71.6%; 111/155) of consents were provided by proxies. This was also the case during the intervention period in which 65.6% (202/308) of consents were provided by proxies (absolute difference, 6.0%; P =.23). Comprehension by consenters of indications for and risks of the procedures was high and not different between the 2 periods (P =.75). CONCLUSIONS: Invasive procedures are frequent in the ICU and consent for them is often obtained by proxy. Providing a universal consent form to patients, proxies, and health care clinicians significantly increased the frequency with which consent was obtained without compromising comprehension of the process by the consenter.

Adult↗
PubMed2004

Informed consent in Texas: theory and practice.

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as "qualified relatives" who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families.

Decision Making↗
PubMed2006

Improving the informed consent process for surgery.

OBJECTIVE: Obtaining and documenting informed consent is of vital importance to physicians. We developed a procedure-based consent form that facilitates patient discussion and validated this process by surveying the patient regarding elements of the consent process, using an independent evaluator. METHODS: One hundred and twenty consecutive outpatients were evaluated before different neurosurgery procedures. The consent form listed specific diagnoses, procedures, alternatives (eight listed), and risks (22 listed), and each point discussed was checked off by the surgeon. Between 10 and 20 minutes later, each element was questioned by one lay-member of the office staff. A group of patients not at risk for cognitive decline were resurveyed months later. RESULTS: One hundred and twenty (100%) of 120 of patients answered correctly regarding their diagnosis and the planned procedure. Four hundred and twenty-eight alternative treatments were discussed, and 420 (98.1%) of the 428 were recalled correctly. Of 1207 risks that were discussed, 1176 (97.4%) were recalled correctly. When a subset of the patients were reevaluated at a mean of 4.5 months later, all 20 patients correctly recalled their procedure and diagnosis. Of 79 alternatives discussed with patients before surgery, 73 (92.4%) were subsequently recalled. Of 217 risks discussed before surgery, 199 (91.7%) were recalled. Although the immediate or delayed recall rates were high (> 90%), there was a reduction in the recall rate over time (alternatives, P = .007; risks, P < 0.0001). CONCLUSION: A consent process designed for an individual surgeon's practice was validated and showed high rates of patient recall in the postprocedural period. We think that this method to obtain and document informed consent should be considered for use by physicians.

Consent Forms↗
PubMed2003

Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials.

Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials. A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), a prospective cohort study of HIV seroincidence in eight U.S. metropolitan areas. Twenty percent of VPS participants were selected at random to undergo the prototype informed consent process at VPS month 3. Participants' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months. Knowledge of HIV vaccine trial concepts was low at baseline. Participation in the prototype process was associated with substantial and sustained increases in knowledge (relative risks for the 10 items, 1.04-2.26), which were of similar magnitude across HIV risk groups, race/ethnicity, and educational levels. It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas.

AIDS Vaccines↗
PubMed2004

Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial.

OBJECTIVE: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. DESIGN: A questionnaire based follow up survey including patients who gave informed consent as well as patients who did not consent to the trial. PATIENTS: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI-2). RESULTS: 76% of the trial participants and 63% of the non-participants agreed or mostly agreed that they felt able to make a decision about whether or not to participate in the trial; 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non-participants read the information sheet before they made the decision. CONCLUSIONS: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the patients. Patients' self assessed ability to make a decision should be explicitly addressed during the informed consent process and patients should not be pressurised into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.

Acute Disease↗
PubMed1996

Protection of human subjects; informed consent--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.

Clinical Trials as Topic↗
PubMed1994

Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine.

To determine subjects' perception of the purpose of informed consent, 113 subjects were recruited from a dose-controlled clinical trial of didanosine (ddI). Subjects were surveyed regarding how they made decisions regarding their medical care in general, about how they obtained information about this trial in particular, and several aspects of the informed consent procedure. Subjects were then randomly allocated to receive information about the trial by either a written only format or a written and verbal format 1 week before commencement of the trial. An eight-item instrument assessed knowledge of ddI prior to and subsequent to receiving information. Most subjects obtained information about HIV-related issues from their specialist (70%) or general (51%) medical practitioner. A large proportion of subjects (88%) reported that they believed their specialist medical practitioner always acted in their best interest. The majority of subjects (79%) believed that subjects should be allowed the choice between participating in the clinical trial and receiving the drug outside the trial mechanism. Of the subjects, 96% believed that informed consent was necessary in clinical trials; however, their opinions of the purpose of informed consent varied widely. Although they signed the informed consent, 44% of the subjects stated that they did not understand 'all' of the information that was provided. We found that the provision of information by written mode alone, or written and verbal modes were both associated with significant increases in knowledge levels and that there was a significant interaction in the degree of change between the two methods, with the written plus verbal method showing the most improvement over time. There was an interaction between degree of improvement in knowledge of didanosine in subjects who received written information versus those who received written and verbal knowledge and time (pre- versus post-consent) and a significant main effect for time. All subjects were relatively well-informed about the drug and stated that specialist and general medical practitioners were their major source of knowledge for all aspects of their HIV health care.

Adult↗
PubMed2004

Orthognathic surgery: an informed consent model.

In this study, the authors propose an informed consent form for orthognathic surgery. A careful review of the international literature and clinical practice suggested the feasibility of dividing the informed consent form into two parts. In first part, the diagnostic procedures and the therapeutic and surgical times are described. The patient must sign it as soon he or she accepts the orthodontic/surgical therapy proposed. The second part describes the possible problems and difficulties of the procedure, and it must be read by the patient before starting the therapy. In the opinion of the authors, this informed consent form allows the patient to know the risks related to the orthodontic/surgical therapy, thus preserving the surgeons from the civil risk and penalties of omission.

Consent Forms↗
PubMed2005

A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials.

OBJECTIVE: To pilot informed consent materials developed for Aboriginal parents in a vaccine trial, and evaluate their design and the informed consent process. METHODS: Cross sectional quantitative and qualitative survey of 20 Aboriginal and 20 non-Aboriginal women in Alice Springs. Information about the proposed research was presented to Aboriginal participants by an Aboriginal researcher, using purpose designed verbal, visual, and written materials. Non-Aboriginal participants received standard materials developed by the sponsor. Questionnaires were used to evaluate recall and understanding immediately and five days later. Qualitative analysis of Aboriginal participants' interviews was performed. RESULTS: There were no differences between the groups in understanding of diseases prevented by the vaccine, the potential risks of participating, or the voluntary nature of participation. Most Aboriginal participants had difficulty with the concept of a "licensed" versus "unlicensed" vaccine. The non-Aboriginal group had a good understanding of this. Aboriginal participants identified the use of the flipchart, along with a presentation by a doctor and Aboriginal health worker, as preferred delivery modes. Group presentations were preferred rather than one-on-one discussions. The use of the questionnaire posed considerable methodological difficulties. CONCLUSIONS: A one-off oral presentation to Aboriginal participants is unlikely to produce "informed consent". Key but unfamiliar concepts require identification and particularly considered presentation.

Clinical Trials as Topic↗
PubMed1987

Informed consent in contact lens practice.

The legal doctrine of informed consent mandates that the doctor provide sufficient information so a patient can refuse or consent to an optometric procedure in a knowledgeable, intelligent manner. Informed consent is especially important in contact lens practice. The informed consent procedures presented here are simple and straightforward. They should be a natural part of optometric practice, and will better educate patients who will less likely be displeased with the course of treatment because of unrealistic expectations.

Contact Lenses↗
PubMed1999

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.

Clinical Trials as Topic↗