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PubMed1998

Informed consent. Evaluation of the information provided to patients before anaesthesia and surgery.

The procedure for obtaining informed consent is often poorly appreciated by patients. The aim of this paper is to evaluate the verbal information given as part of the informed consent process before anaesthesia and surgery. A total of 300 randomly chosen patients (141 male and 159 female) were asked their opinion between 1993 and 1995 at the University of Murcia Hospital (Murcia, Spain). One hundred and fifty of these patients received scheduled surgery and the other 150 received emergency surgery. In general, the patients were not happy with the information they had received concerning their pathology and treatment. Although they had signed the consent documents, the patients did not feel they had really understood the risks involved in the surgery they had undergone.

Adolescent↗
PubMed1975

A surrogate system for informed consent.

Since "informed consent" is frequently obtained in a clinical setting where the patient is anxious and overwhelmed with feelings, toward the physician, of awe, trust, and dependency, it is often of dubious value in protecting human subjects. We devised, as a possible alternative mechanism for uncovering patient views toward a specific research protocol, a surrogate system of consent. The surrogates' responses seemed more candid and diverse than the responses one usually hears in the "real" clinical setting. Potential applications of such a system lie in further study of the consent process, and as a means for individual investigators to better gauge consumer attitudes toward specific projects.

Attitude of Health Personnel↗
PubMed1998

Process consent: a model for enhancing informed consent in mental health nursing.

Informed consent, essentially a legal doctrine, is designed to protect the rights of patients. However, in an area of practice such as psychiatry, informed consent imposes many problems if one considers it to be a static process. In this paper we propose that process consent, the type of consent considered essential in qualitative research projects, is not only appropriate but necessary for mental health nursing practice. This type of consent is an ongoing consensual process that involves the nurse and patient in mutual decision making and ensures that the patient is kept informed at all stages of the treatment process. We have used neuroleptic medications as an example throughout the paper and have suggested that seeking informed consent should be added to the role of the nurse in the mental health setting.

Disclosure↗
PubMed2006

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

BACKGROUND: A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. METHODS: To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. RESULTS: Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. CONCLUSION: The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.

Attitude↗
PubMed1974

Infants, children, and informed consent.

Obtaining informed consent for non-therapeutic experimentation on infants and children has ethical and legal implications that cause great controversy. There is some danger that worthy research will be inhibited if current ethical codes are interpreted too strictly, yet infants, children, and other vulnerable groups clearly must be protected from exploitation as research subjects. It is suggested that permission from parents coupled with integrity of the investigator will remain the child's best protection, but several additional protective mechanisms are available and should be used. Some guidelines for non-therapeutic research are suggested which should not only provide adequate protection for infants and young children involved in research projects, but allow investigators reasonable freedom to prosecute worthy research vital to continued improvements in child care.

Child↗
PubMed2002

Audiovisual documentation of oral consent: a new method of informed consent for illiterate populations.

Informed consent is a legal and ethical requirement of most research in human beings, but obtaining proof of consent in illiterate populations can prove problematic. We used audiovisual documentation of oral consent (video and audiotape recording and photography), a new method of informed consent designed for illiterate populations, in the Guarani Indians Project, a genetic study in the Paraguayan Guarani Indians. We obtained consent from 42 of about 100 potential participants. We believe that our procedure allowed more than half the potential participants to exercise their freedom of refusal. We propose to include this new method as a standard procedure for clinical research in illiterate populations as an alternative to written and signed consent.

Educational Status↗
PubMed2002

An approach that integrates patient education and informed consent in breast augmentation.

Informed consent requires surgeons to provide information about all available alternatives and their associated risks and tradeoffs to every prospective breast augmentation patient. The informed patient and surgeon then make decisions based on the information the patient has received, clinical parameters that may affect those decisions, and the patient's willingness to accept specific risks and tradeoffs. During the authors' 22 years of clinical practice, substantial changes have occurred in the requirements for adequate informed consent and the methods of ensuring that patients receive it. The numbers of alternatives for augmentation and the relative benefits and risks of each method have changed substantially over the past two decades. Four specific areas of postoperative issues stimulated major changes in the authors' approach to patient education and informed consent: 1) questions or dissatisfaction with implant size postoperatively, 2) questions about financial responsibility for costs associated with untoward events requiring reoperation postoperatively including capsular contracture or other problems, 3) spouses or other concerned parties rendering opinions postoperatively when they had not been involved in the informed consent process, and 4) criteria for whether reoperations were indicated, how many were indicated, and when implant removal without replacement might be most logical. This paper describes an approach that integrates patient education and informed consent in stages by 1) providing detailed, highly specific written and verbal information, 2) utilizing a staged approach to education and informed consent that provides information and requires simultaneous, informed consent in stages, 3) repeating each critical topic at least two or three times during the process, requiring repetitive written documentation by the patient on at least three different occasions, 4) emphasizing patient accountability for choices selected, and 5) organizing the education and informed consent process so that it is clinically practical and also increases thoroughness and documentation while conserving surgeon time. This staged, integrated system of patient education and informed consent uses a comprehensive set of informed consent documents that are available for downloading from the Plastic and Reconstructive Surgery Web site (www.plasreconsurg.org). Before incorporating any of the informed consent documents or statements reported in this paper, each surgeon should seek review by the surgeon's malpractice insurance carrier and by appropriate legal counsel to ensure compliance with state and federal laws applicable to the surgeon's practice. These documents have evolved to prospectively address patient management issues that have occurred over the authors' 22-year experience in augmentation. The documents are not endorsed by ASPS and do not necessarily represent the views of ASPS.

Breast Implantation↗
PubMed2005

Step into my zapatos, doc: understanding and reducing communication disparities in the multicultural informed consent setting.

Current informed consent standards are aimed at promoting an equitable and ethical environment for conducting research across diverse patient populations. This paper explores the possible effects of ethnicity and culture on the consent process for pediatric cancer clinical trials. Informed consent discussions were observed, recorded, transcribed, and coded. Question asking by parents and clinician/parent word ratios were used to create an interactivity measure, or "I-score." Visual analog scales were used to rate the clarity of specific explanations. Cases were sorted into two groups on the basis of parents' self-reported ethnicity: Caucasian (n=79, 56%) and minority (predominantly Latino) parents (n=61, 44%). Chi-square and t-tests were used to compare the groups. A series of logistic regression analyses (controlling for ethnicity and SES) were run for variables that showed statistically significant differences (p < 0.05). Our findings suggest that the content and quality of the informed consent process is linked to parental ethnicity, or clinician attitudes toward parental ethnicity. These findings are discussed in terms of current perspectives on culture and "cultural competence" in health care. Further research is needed to understand how cultural factors affect outcomes such as parental understanding, decision making, mutual trust, and satisfaction within the informed consent process.

Adolescent↗
PubMed1989

Informed consent: an overview.

Informed consent is a process, not an isolated incident. It therefore requires that health care professionals approach the process with expert knowledge, open communication, and a willingness to participate in shared decision-making. Table 2 identifies the major ethical and legal issues of informed consent. Legal precedents and professional collaboration will be necessary to further define and refine informed consent. The complexity of treatment regimens, potential system toxicities, and the chronicity of the disease process have fostered the development of a multidisciplinary team approach to the care of oncology patients. Therefore, collaboration is essential to meet the demands of the informed consent process and provide an optimal environment for the oncology nurse to intervene actively as a patient advocate.

Ethics, Nursing↗