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PubMed2004

The student and the ovum: the lack of autonomy and informed consent in trading genes for tuition.

Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure) as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction), of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established.

Disclosure↗
PubMed2003

Readability standards for informed-consent forms as compared with actual readability.

BACKGROUND: Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight. METHODS: To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch-Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites. RESULTS: The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch-Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch-Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P<0.001). Readability was not associated with either the level of research funding (P=0.89) or local rates of literacy (P=0.92). However, the 52 schools that had been made subject to oversight by the Office for Human Research Protections (46 percent) had lower Flesch-Kincaid scores than the other schools (10.2 vs. 10.9, P=0.005). CONCLUSIONS: IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability.

Comprehension↗
PubMed2004

Patient advocacy: witnessing informed consent for research in acute care.

Two views exist about witnessing informed consent for research in acute care settings: nurses witness a signature, and nurses witness the informed consent itself. Nurses are obligated to fulfill legal responsibilities and ethical expectations because of their role in the clinical arena, and to serve as advocates for patients to be informed, willing research participants. This role promotes change in institutional policies to keep up with the changing face of research.

Consent Forms↗
PubMed2003

Are subjects satisfied with the informed consent process? A survey of research participants.

OBJECTIVE: Letters of information (LOI) for clinical trials are becoming longer and more complicated. We investigated patients' perspectives of their ability to understand the information presented during a clinical trial. Satisfaction with and motivation for participation in clinical trials were also ascertained. Perceptions from various treatment disciplines were compared. METHODS: Participants were chosen from 14 clinical trials (departments of rheumatology, ophthalmology, and cardiology) conducted at the same university. Subjects were asked to complete a written questionnaire that assessed demographic information, recall and understanding of information, subjects' decisions to participate, and perceptions/opinions of the study. The response rate was 75% (rheumatology, n = 74; ophthalmology, n = 32; cardiology, n = 84). RESULTS: The majority of respondents (98%) indicated that they were satisfied with the informed consent process and with their involvement in a trial (97%). Subjects who reported having understood the LOI had better recall of placebo/active drug comparator (p < 0.03), and better understanding of why placebo was used (p < 0.04). No differences were found between those who reported understanding and those who did not on understanding the concept of concealed allocation (blinding). Subjects who felt they had received "the right amount of information" were more likely not to understand concealed allocation. The most frequent reason for trial participation was to help medical science (80%). Subjects with higher education were more likely to understand the reason for placebo use (p < 0.0003), but were not more likely to understand concealed allocation (p < 0.08). CONCLUSION: Subjects reported that they were satisfied with the informed consent process and their experience in a clinical trial, and that they understood trial concepts. Subjects may be able to self-assess their own level of understanding for trial concepts that intrinsically make sense within the context of their beliefs about medical care, but other trial concepts may be misunderstood/misinterpreted regardless of self-assessment of understanding or education level (i.e., concealed allocation). Subjects may prefer to believe that investigators know which treatment they are receiving, and have made a good treatment decision specific to their case, despite having being told about concealed allocation and placebo use.

Adult↗
PubMed2002

Informed consent in physical medicine and rehabilitation. The physician/patient relationship--the doctor as a fiduciary.

This article reviews the principle of informed consent and the ethical and legal bases upon which it rests. The process of obtaining an appropriate informed consent is explored, and the elements that make a consent valid are delineated. The principles of substitute decision-making and the special rules applied to circumstances such as emergency, therapeutic privilege, refusal of consent, and medical necessity are discussed. The concept of the relationship between physician and patient as a fiduciary relationship is explored as the fundamental basis for the modern doctrine of informed consent.

Ethics, Professional↗
PubMed1997

The cautious acceptance of informed consent in Japan.

The Japanese medical profession has come under increasingly intense scrutiny from the media and the public. Calls for recasting the traditional paternalistic doctor-patient relationship have become sufficiently pervasive that the medical profession itself has accepted the need to incorporate "infomudo konsento" (the English term is commonly used, for lack of a satisfactory phrase in Japanese) into medical practice. The medical establishment is attempting to accomplish this endeavor in a tamed and "Japanized" form which preserves professional autonomy. This paper attempts to illuminate the distinctive tenacity of Japanese medical paternalism. First, the paper presents a descriptive model of cultural paternalism characteristic of traditional Japanese medicine, taking as examples four specific practices: concealing from patients the diagnosis of cancer; withholding from patients information about drugs; requiring patients to sign waivers of rights; and refusing patients access to their own medical records. Second, the paper describes how the economic structure of Japanese health care reinforces these cultural proclivities toward paternalism. Third, the paper explores the paradox of the legal system's treatment of informed consent issues. The paper then addresses the sources of a gradual transformation in attitudes concerning informed consent. Emphasis is given to transformative forces peculiar to Japan: the controversy over brain death and organ transplantation, in which the rhetoric of informed consent has come to be used by all parties as a weapon of convenience and the enforcement (amidst publicity surrounding deaths from experimental drugs and international pressures for drug exports to meet accepted standards of biomedical ethics) of rules requiring informed consent in clinical trials of investigational drugs. The paper finally assesses the impact of the 1995 report of the prestigious Study Commission on Informed Consent.

Cross-Cultural Comparison↗
PubMed1987

Physician response to informed consent regulations for randomized clinical trials.

To improve our understanding of physician reluctance to participate in randomized clinical trials, we examined physician responses to the regulation of obtaining written informed consent. Between June 1984 and February 1985 a purposive sample of 170 breast cancer specialists from eight countries completed a self-administered questionnaire and follow-up interview. The sample included 90 medical oncologists, 65 surgeons, and 29 radiotherapists. Responses to individual questions are presented in three global categories: (1) physician role--physicians believed that their view of their professional "self" was not compatible with informed consent regulations; (2) physician autonomy--physicians perceived a loss of individual decision-making power and an increase in professional accountability; and (3) physician-patient relationship--physicians stated that informed consent regulations influenced what they told trial patients and affected the ensuing doctor-patient relationship. Respondents developed complex methods to accommodate the incongruities they perceived between their view of their professional self and the need to obtain informed consent.

Clinical Trials as Topic↗
PubMed2004

Turkish and German patients' recall of diagnosis and therapy before and following informed consent.

OBJECTIVE: Adequate patient knowledge is essential for good compliance, effective doctor-patient communications and is the basis for informed consent. The purpose of the study was to examine differences in recall of informed consent procedures between patients with different ethnicity and to identify potential explanatory factors. DESIGN: We analyzed 579 patients, attending and released from a gynecology department in Berlin, Germany, between March 1997 and October 1998. To assess actual understanding of disclosure information, Turkish and German patients' perceptions were compared with documented data of their diagnoses and therapy. RESULTS: Overall, patients correctly identified 69% of their diagnosis and 76% of their therapy. On discharge overall patients' recall decreased significantly. Whereas German patients' knowledge increased, Turkish patients showed significant decreases in diagnosis and therapy recall. CONCLUSION: The results reflect socio-demographic differences between ethnic groups and indicate deficiency of the informed consent process for patients belonging to an ethnic minority.

Adult↗
PubMed2005

Clinical implications of the ethics of informed consent for first-trimester risk assessment for trisomy 21.

OBJECTIVE: We identify the clinical implications of the ethics of informed consent for risk assessment for trisomy 21. FINDING: Based on the ethics of informed consent, we find that routinely offering first-trimester risk assessment in centers qualified to provide it is ethically obligatory, and routinely withholding the results of first-trimester risk assessment is ethically unjustified. CONCLUSION: The ethics of informed consent is an essential dimension of first-trimester risk assessment for trisomy 21.

Down Syndrome↗
PubMed1999

The future of informed consent in British common law.

Within the common law world, the use of the term informed consent implies the American doctrine. Informed consent as a doctrine is not part of the law in the United Kingdom. However, it is possible to predict a way forward in disclosure cases yet to be heard in the courts of the United Kingdom. These predictions are based on current developments in the common law in the United Kingdom as well as those in Canada and Australia, on the European Convention on Human Rights and Biomedicine and on trends within the medical profession itself in the light of the Bolam test.

Australia↗
PubMed2001

A consumer perspective on informed consent and third-party issues.

Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely.

Child↗
PubMed2004

From informed consent to shared consent: a developing process in paediatric oncology.

Little research has been done on consent in clinical management of cancer in children. Many parents think that the informed-consent process is helpful but often confusing; discussions regularly prove more helpful. It can be difficult for parents to understand the notion of randomisation, not to mention the request for consent to this procedure. In this essay, we discuss the clinical problems that arise in the informed-consent process for treatment and research in paediatric oncology and that need an understanding of bioethical issues and psychological principles. We suggest that the process of informed consent is managed as a negotiated shared-consent process, using the problem-based learning method as a guide. Our model provides appropriate and honest information to children and adolescents through easy-to-understand dialogues with the doctor and we propose that medical students and doctors receive specific skills instruction in communications, relational behaviour, and ethics.

Adaptation, Psychological↗
PubMed1990

Informed consent for bone marrow transplantation: identification of relevant information by referring physicians.

Two hundred Michigan hematologists-oncologists were sent a 34-item questionnaire designed to assess what patients should know at the time of giving consent to bone marrow transplant (BMT). Sixty-three (32%) responded to a single mailing and rated items on a 8-point scale, varying from 0 = no need to know to 7 = appreciation of consequences essential. The mean rating across items was 5.2, indicating that all items were important. Statistically, the items separated into three groups: (1) above average importance - 13 items; (2) average importance - 9 items; (3) below average importance - 12 items. Items of above average importance included the rationale for BMT and the collective risks and benefits of the process, including the patient's well-being post-transplant. Informed consent documents did not include 5/13 items of above average importance, yet 12/21 items of average and below average importance were included. Fourteen demographic variables were correlated with each item and none were significant, indicating that the ratings represent a broad consensus in the referring physician community as to what a patient should understand before consenting to BMT. The vast majority of referring physicians agreed that patients usually have an adequate understanding of BMT at the time of giving informed consent and that a fully informed patient is more likely to adhere to the treatment regimen.

Adult↗
PubMed1999

Improving informed consent in clinical trials: a duty to experiment.

Practitioners of clinical trials have a responsibility to ensure that patients' participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. We should test innovations in informed consent in realistic contexts (i.e., in clinical trials) and with randomization, when it is appropriate, at the first opportunity. In this study, we develop a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. We discuss the conceptual, ethical, organizational, and technical bases for such an effort.

Choice Behavior↗
PubMedDate not supplied

Context and process of informed consent for pharmacologic strategies in labor pain care.

The care of women experiencing labor pain often challenges midwives to provide ethical informed consent for the pharmacologic strategies common in most of America's childbearing environments. A systematic approach to this clinical dilemma begins with a conceptual understanding of the origins of labor pain stimuli, factors affecting their central nervous system processing, and the differentiation of the concepts of pain, suffering, and comfort. These concepts can be integrated into a labor pain care, rather than pain management, model for clinical practice. Because most midwives provide care for laboring women in acute care hospitals, the midwife must also understand how the standards of the Joint Commission on Accreditation of Healthcare Organizations influence the behavior of other professionals in the health care environment for laboring women and the process of informed consent. A systematic approach to informed consent for pharmacologic strategies for labor pain care strategies should begin during pregnancy and includes full, unbiased disclosure of the nature, benefits, risks, side effects, and efficacy of all methods that are available in the chosen birth setting.

Analgesia, Obstetrical↗
PubMed1997

The World War II plutonium experiments: contested stories and their lessons for medical research and informed consent.

During the Second World War medical researchers around the USA injected 18 hospital patients with radioactive plutonium in order to learn its effects on the body. Two documents, a newspaper account and a university committee report, tell divergent stories of the scientists and patients involved in that experiment. This article uses those documents-plutonium narratives-as a catalyst for exploring the problematic representation of past human experimentation, assumptions of moral progress in medical research, and the nature of informed consent today. Informed consent is shown to be an evolving process and discursive practice that cannot be understood apart from its historical and cultural embeddedness.

Bone Neoplasms↗
PubMed1998

Working through the public disclosure process mandated by use of 21 CFR 50.24 (exception to informed consent): guidelines for success.

New Food and Drug Administration guidelines allow research to be done under an "exception to informed consent." These guidelines mandate advance public disclosure (PD) but provide no specifics for how to accomplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administration regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study using a blood substitute. This descriptive report can serve as a guideline for subsequent emergency care investigators in the development of a strategic plan for PD.

Algorithms↗
PubMed1984

Informed consent for intravenous contrast-enhanced radiography: a national survey of practice and opinion.

A detailed questionnaire regarding the obtaining of patient consent for the administration of intravenous contrast agents was sent to 3845 radiologists in those hospitals across the United States having more than 100 beds. The results represent the current community practice and opinion of the 1547 radiologists (40%) who answered. They showed that 66% of respondents obtained no type of informed consent before injecting intravenous contrast agents. Half of those who did obtain consent did not inform their patients of possible specific major adverse reactions. Half of those who did not obtain consent believed the risk of adverse reaction was remote. Another 40% believed the consent procedure might heighten anxiety and, therefore, increase the risk of reaction. Obtaining informed consent, however, was not significantly associated with an increased incidence of major reactions. Since 8% of the respondents indicated some involvement in malpractice lawsuits regarding the question of informed consent for various procedures, the obtaining of informed consent might lessen the risk of exposure to malpractice litigation. Additional results showed that written consent did not appear to lessen the number of studies performed and that it offered more specific information to the patient regarding complications. Finally, most radiologists (80%) requested a specific policy regarding informed consent from at least one of the following organizations: the American College of Radiology (ACR) (96%), the Radiological Society of North America (RSNA) (26%), state chapters of the ACR (15%).

Attitude of Health Personnel↗