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PubMed1996

Shared understandings for informed consent: the relevance of psychological research on the provision of information.

The achievement of informed consent from patients and potential research participants is considered a basic requirement in clinical care and clinical research, but ethicists have paid little attention to the psychological processes and social factors involved in sharing information between individuals. Although many studies on consent have provided useful results, they are rarely informed by basic research in the social sciences. As a result, there are a large number of methodological and conceptual issues which have not been adequately addressed. The purpose of this paper is to illustrate how the work of cognitive and social psychologists can provide insights that are both relevant and valuable to the process of attaining consent. Research in these areas within psychology has indicated that there are important individual differences in how much information people require and that patients' current state of mind can affect estimates of probability, thus making analogue studies misleading. Collaboration between psychologists and ethicists would be of great value in identifying likely areas of mutual interest, particularly the choice of language in consent forms and information sheets, the design of consent forms, the amount of information provided, and the specification of risks and benefits.

Data Display↗
PubMed1977

Disclosure and informed-consent: does it matter how we tell it?

Traditionally, informed consent has been handled by the physician in a one-to-one interchange with the patient. As standards for adequate disclosure become more rigid and demands on physician time increase, however, the physician-patient model may cease to be practical. This study evaluated four alterative disclosure models: a formal discussion, a videotape, a pamphlet, and an informal discussion, each designed and executed by a team of health educators. Study results suggest that the informed consent process is little affected by disclosure medium and that it may be possible to strive for cost-efficiency in disclosure without compromising the quality of the consent obtained. Based on these results, a two-part disclosure process is proposed which allocates certain aspects of the disclosure to the treating physician, others to health education.

Adult↗
PubMed1998

Use of video in the informed consent process.

We created a video-tape about the concept of telemedicine for informational and educational purposes. Two video-tapes, one with and one without the informed consent segment, were distributed to each of the Kentucky TeleCare sites. On the day of their teleconsultation, patients were asked to watch the video-tape (with the version containing the informed consent segment) before signing the informed consent to participate. Site coordinators then asked patients whether they had any specific questions about telemedicine. To date, patients have reported high levels of satisfaction with this method of consultation, using telecommunications technology to deliver health care.

Humans↗
PubMed2000

Limitations of informed consent for in utero gene transfer research: implications for investigators and institutional review boards.

Only 10 years after the first human gene transfer protocols were approved for adults and children, researchers have begun to consider gene transfer on the fetus. While preliminary animal research is ongoing, the enthusiasm and pace of research in this area suggest that human protocols for in utero gene transfer research may be seriously considered in the foreseeable future. Federal guidelines for fetal research rely on minimizing risk and informed consent to protect the "rights and welfare" of both the fetus and pregnant woman. However, in utero gene transfer research poses special challenges to informed consent. This research represents an innovative approach for very ill subjects and takes place in the prenatal setting. These features may converge to undermine the expectant parents' comprehension of, and voluntariness for participation in, research. In this case, informed consent may not be able to bear the weight of adequately protecting the fetus from undue research risks. To compensate for this limitation, and using the regulations for pediatric research as a guide, a greater emphasis should be placed on the benefit/harm assessment rather than informed consent. Selecting diseases/patients where good alternative treatments exist may maximize informed consent, yet this may be a trade-off that exposes the fetus to greater relative risks. On the other hand, selecting diseases/patients without good alternative treatments to prolong life may convey an overestimation of the potential benefits of these interventions, and although care should be taken to strive to improve understanding of these limitations, misunderstanding may persist. However, selecting diseases/patients with no good alternatives might make serious risks more tolerable, and this should take precedence over informed consent. The limitations of informed consent brought into focus by the special features of in utero gene transfer research may be relevant to a broader range of innovative investigations.

Clinical Protocols↗
PubMed1997

Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies.

The process of informed consent has been suspected to raise patient anxiety, but this supposition has not been well studied or validated. The aim of this study was to evaluate the effect of a detailed informed consent protocol on patient anxiety. Fifty patients (36 men, 14 women, mean age 55 +/- 18 years) undergoing diagnostic cardiac electrophysiologic studies were enrolled. Patients were randomly assigned to receive either a consent that did not detail specific risks regarding the procedure (consent A) or one that detailed the risks (consent B). The Spielberger State-Trait Anxiety Inventory was administered before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the electrophysiologic testing procedure, when the results of the test were known to the patient (state 3). Midazolam was administered during the procedure by staff who were blinded to the state/trait anxiety scores and the type of consent the patient had received. Patients receiving consent A had a significant decrease in state 2 anxiety compared with those who received consent B (adjusted mean difference 3.3; 95% confidence intervals 0.2 to 6.4). In the consent A group, 74% of patients received midazolam as opposed to 96% in the consent B group (p <0.02). Patients without inducible ventricular arrhythmias had a significant decrease in state 3 anxiety compared with those with inducible ventricular arrhythmias (adjusted mean difference 8.9; 95% confidence intervals 2.3 to 15.5). Thus detailed informed consent is associated with increased anxiety relative to a consent that does not detail specific risks. However, the difference in anxiety is mild and its clinical impact requires further exploration.

Anti-Anxiety Agents↗
PubMed2002

Ethical issues of informed consent: mothers' experiences enrolling their children in bone marrow transplantation research.

Twelve mothers whose children had undergone bone marrow transplantation were interviewed about their experiences giving informed consent. They were asked to describe how they were introduced to bone marrow transplantation as a course of action to treat their gravely ill children, what their understanding of the protocol was, and the process by which they gave their consent. Their stories reveal complex ethical issues that may surface in the course of informed consent for research involving children. Findings suggest that mothers perceive life-and-death circumstances when a child is offered bone marrow transplantation, altering the voluntary nature of the research enterprise. The emotional trauma of the diagnosis decreases a mother's ability to absorb and understand vital information, and the emergent nature of the children's condition and the urgency to begin treatment further compromise informed consent by constricting the time and resources mothers may need to make a decision. Once a protocol is underway, mothers often experience regrets and self-recriminations about their decision to consent. Recommendations are offered that expand upon the current cognitive/rational approach to informed consent and take into account emotional experiences and the importance of building relationships to ensure informed consent over the life of a clinical trial.

Adolescent↗
PubMedDate not supplied

[Informed consent and the approval of evaluation committees in Mexican medical research].

OBJECTIVE: To establish the frequency of informed consent and review by institutional review boards in Mexican medical journals. DESIGN: Retrospective review of prospective medical research published in seven Mexican medical journals between 1990-1993. MEASUREMENTS AND MAIN RESULTS: 391 prospective studies were analyzed: 259 (66%) were cross-sectional and 132 (34%) longitudinal; 197 (51%) descriptive and 194 (49%) comparative; 277 (71%) observational and 114 (29%) experimental. In general, the informed consent was reported in 123 studies (31%), and its institutional review board approval in 41 (10%). In the 114 experimental articles the informed consent was reported in 53 (46%) and the review board approval in 28 (25%). CONCLUSIONS: Most Mexican researchers do not report or do not obtain informed consent nor review board approval in the articles we reviewed. This suggests the presence of legal and ethical flaws which should be overcome.

Bibliometrics↗
PubMed2004

Correlates of parental participation during informed consent for randomized clinical trials in the treatment of childhood leukemia.

This study described parent participation in the informed consent conference for randomized clinical trials (RCTs) in childhood leukemia and documented the relationship of physician communication to parent participation. Parents of 140 children with newly diagnosed leukemia who were eligible for RCTs were studied at six sites using comprehensive methods involving direct observation and transcripts of parent-physician communication based on audiotapes. Parent participation during the informed consent conference reflected a wide range of content categories. Consistent with hypotheses, Physician Rapport and Partnership Building related to parent participation in the informed consent conference but Information Giving did not. Higher parent socioeconomic status also was related to greater parent participation for two of the three measures of parent participation. Findings suggest that physician behaviors that provide support and facilitate communication may enhance parental participation in the informed consent conference for RCTs in childhood leukemia.

Child↗
PubMed2000

Informed consent in palliative radiotherapy: participation of patients and proxies in treatment decisions.

Informed consent is regularly discussed, but little attention has been paid to the daily practice of the patient participation in treatment decisions regarding palliative care. Therefore, an exploratory study was conducted into shared decision making between radiation oncologists and patients and proxies in interviews where decisions regarding palliative radiotherapy have to be made. Interviews of 6 radiation oncologists with 26 outpatients were recorded on audiotape. Each verbal utterance was coded with the aid of the Roter Interaction Analysis System (RIAS). Results indicated that in over 75% of the interviews, patients and proxies were not asked for their opinion regarding treatment decisions. Other treatment options or the option of abstaining from treatment were discussed in 46% of the interviews. In conclusion, in this sample informed consent was not a natural part of the daily practice of palliative radiotherapy. The question remains to what extent informed consent in palliative radiotherapy is realistic.

Aged↗
PubMed1994

Informed consent and anonymous tissue samples: the case of HIV seroprevalence studies.

Human Immunodeficiency Virus (HIV) seroprevalence studies use anonymous tissue samples obtained in hospitals and clinics without donor consent. This can be justified as a response to a public health emergency, but should not be seen as setting a precedent for waiving consent whenever samples are anonymous. The following recommendations grow out of this discussion: (1) Studies using anonymous tissue samples should not be automatically exempt from consent requirements, and consent should not be waived simply to avoid anticipated refusals, low participation rates or self selection bias. (2) The consensus on informed consent favors fulfilling as many of the elements of informed consent as reasonably possible, so studies should be assessed individually to determine if any or all elements of informed consent should be modified or omitted. (3) There is a need for greater regulation of the research use of tissue samples. (4) Investigators seeking approval to waive consent or modify elements of informed consent should document the sort of new findings that they believe would effect their calculations about the benefits and burdens to subjects who are enrolled in the study, and institutional review boards should indicate whether they agree with the investigators' analysis.

Anonymous Testing↗
PubMed2003

Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.

Adolescent↗
PubMed2004

Staged informed consent for a randomized clinical trial in childhood leukemia: impact on the consent process.

BACKGROUND: Children Cancer Group (CCG) 1991 is the first childhood acute lymphoblastic leukemia trial within CCG that allowed the utilization of a staged approach to the consent process. METHODS: One hundred and forty subjects participated in the Project on Informed Consent which compared the primary outcome measures in the consent process of patients enrolled in CCG-1991 with those enrolled in other CCG leukemia studies. RESULTS: The parents' trust scores were higher for the CCG-1991 compared with other protocols. Eighty percent of parents enrolled in CCG-1991 understood the distinction between the randomized clinical trial and the standard treatment arm, compared with 62.5% in the other studies, P = 0.05. Multiple other outcome measures suggested a positive impact from staged informed consent. CONCLUSIONS: Our results suggest that a consent process with a staged approach can help investigators obtain a more truly informed consent. Future research is needed to confirm the benefits of the staged approach to the informed consent process.

Child↗
PubMed2004

Informed consent: not just for procedures anymore.

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Communication↗
PubMed2004

Optimizing the HIV/AIDS informed consent process in India.

BACKGROUND: While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low. METHODS: In this study, we examined pregnant women's understanding of group education and counseling (GEC) about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues. RESULTS: We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%. CONCLUSIONS: This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.

AIDS Serodiagnosis↗
PubMed1989

How to lose informed consent.

It is possible to begin a medical procedure with informed consent and to complete the procedure without the patient's consent. The question is, how do you lose informed consent between the beginning and the end of a procedure?

Hospital Departments↗
PubMed1983

Informed consent to treatment in clinical trials.

Special characteristics of clinical trials place unique demands on the concept and practice of informed consent to treatment. We focus on the practical problem that consent to treatment forms are not typically able to be understood by patients in clinical trials research. Informed consent forms are significantly less comprehensible than popular press written material and may be as difficult to read as medical journals. Several guidelines for improving informed consent to treatment documents such as the use of non-professionals and patients to critique drafts of consent to treatment forms are proposed and discussed. The use of these guidelines can insure that patients have the opportunity to understand more clearly what their treatment will involve within a clinical trial before they give an informed consent.

Clinical Trials as Topic↗
PubMed1979

Informed consent for neuroleptic therapy.

The author suggests that the frequency and severity of tardive dyskinesia in patients treated with neuroleptic drugs requires that informed consent be obtained from all patients receiving such treatment. The three basic conditions for obtaining informed consent are reviewed with discussion of some of the ethical problems encountered in the informed consent procedure. Most of these problems will be resolved if specific, written, informed consent is obtained from the patient, or his representative, within six weeks of initiating therapy, although in some cases questions may be raised about the very possibility of obtaining consent.

Antipsychotic Agents↗