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PubMed2002

Genetics decision-making: a template for problems with informed consent.

Developments in information technology and advances in genetics present challenges to physicians in terms of providing adequate informed consent. Genetic mechanisms and related therapies are very complex and involve a number of uncertainties. Yet, physicians have very little training in genetics or in dealing with uncertainty. Further, genetic decisions impact others, yet physicians are trained to see the patient as an individual, independent decision-maker. Cultural, ethnic, gender, religious and other differences influence patients in their genetic decision-making, but physicians have little training in understanding these kinds of influences. Genetic information also gives knowledge about disease and dysfunction where no therapeutic intervention is available. Physicians are trained to heal in crisis situations, to engage in therapeutic intervention and not always to deal with chronic or unresolved illness. They may find this situation difficult to handle in an informed consent context. All ofthese difficulties pose the possibility that physicians will not be "informed" enough to facilitate good informed consent in genetic decision-making. Given all of this we need to address fundamental changes in medical education.

Decision Making↗
PubMedDate not supplied

Current trends in behavior management techniques as they relate to new standards concerning informed consent.

Standards governing informed consent are changing across the United States, and these changes have potential impact on the techniques of behavior management used by pediatric dentists. The purpose of this study was to determine pediatric dentists' awareness of standards of informed consent in the state in which they practice, as well as the impact of the professional community standard versus the reasonable patient standard on their use of certain behavior management techniques. A stratified random sample of 502 practitioners was selected from the total membership of the American Academy of Pediatric Dentistry; 292 returned surveys provided data related to behavior management techniques, consent standards, and demographic variables. These were analyzed by Chi-square (P less than 0.05). Results revealed that 73% of the respondents do not know which consent standard is in effect in the state in which they practice; 50% do not get verbal consent; and 80% do not get written consent to use the specific management techniques. There is a lack of knowledge on the part of some pediatric dentists concerning the changing laws governing informed consent and a reluctance to acknowledge the implications that these changes would have on behavior management techniques.

Behavior Therapy↗
PubMed1999

A proposed consent process in studies that use an exception to informed consent.

Federal regulations allow an exception to informed consent when it is not feasible to obtain informed consent in certain emergency research circumstances. A multicenter, randomized, single-blinded, normal saline procedure-controlled efficacy trial of diaspirin cross-linked hemoglobin (DCLHb) in acute traumatic hemorrhagic shock was conducted. The study intended to include 850 of the most severely injured trauma patients with hemorrhage and persistent hypoperfusion as demonstrated by vital signs suggestive of vascular collapse or a base deficit that signified prolonged hypoperfusion. It was anticipated that some patients would be unable to provide informed consent, and that identification and availability of some patients' legally authorized representatives (LARs) would be unlikely within the therapeutic window of the intervention. Each participating institution therefore developed a process to implement exception to informed consent. Each hospital's proposed process was reviewed by the institutional review board, the sponsor, the FDA, and the study's data monitoring committee chair. The goal was the development of local implementation processes by which the best interests of patients and their families could be fulfilled using prospective informed consent, the exception to informed consent, and consent to continue in emergency research, as appropriate for each individual patient. This paper describes the proposed implementation method developed for Cook County Hospital. It includes several important features, 1) prospective informed consent by the patient, when feasible; 2) the ability of the patient to decline participation, even when deemed incompetent to provide prospective informed consent; 3) prospective consent by the family/LAR, when feasible; 4) the use of a scripted abbreviated consent by the patient family/ LAR in life-threatening situations when it is possible only to briefly discuss the research being conducted; 5) independent approval for the use of the consent exception by a second physician immediately prior to patient enrollment; 6) the repeated use of consent to continue (both for the family/LAR and by the patient) when an exception to consent has been utilized; and 7) ongoing review of the informed consent process on a case-by-case basis by the institution's scientific review committee. The authors believe this proposed informed consent process maximizes the communication between investigators, patients and their proxies, and the institution's scientific review committee. Multiple mechanisms exist that allow for consent to be provided or declined, both prior to and after enrollment in the research protocol. The ongoing immediate review of the process allows for process enhancements to be made as needed.

Aspirin↗
PubMed2005

[The origin of informed consent].

The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised, in the Hippocratic physician, that cared about the patient's suffering, but never neglected looking after his own outcome, endeavouring to avoid becoming involved in lack of success and death of a patient. The concept of consensus is inexistent, albeit, there is an awareness of the presence of precautious and preventive information. In the behaviour of doctors, in ancient times, it is not difficult to recognize the true motives and the real reasons that, already in those days, give rise to the necessary "defensive medicine" particularly as far as concerns the social status of the patient. Already from the early origins, continuing the Hippocratic tradition, the relationship between doctor and patient was consolidated, based upon two very definite criteria, represented, on the one hand, by the professional duty of the physician to do what is bestfor the patient and, on the other, the duty of the patient to completely accept the physician's decisions and intervention. The Hippocratic physician respected a principle of professional responsibility which was more religious and of a moral type, but, from a legal point of view, very weak inasmuch as it depended upon regulations elaborated by human beings. The conviction and certainty that the physician acted, in the interest of his patient's well-being, has been passed down over the centuries endowing the physician with moral authority and a kind of legal impunity, conditions which corresponded, in an almost reflection-likefashion, with the duty of obedience and subjection, on the part of the patient. Christianity was grafted into this consolidated vision of the sacral character of medicine and medical practice, which did not substantially change the Hippocratic type of ethical behaviour. Non only the population but also the Christian physician was aware of the religious importance of his intense activity as a mission and compared to a special kind of priesthood in safe-guarding health, considered as a gift of God. Therefore, invested with this authority which derived from his professional role and from his very work, he felt it his duty to guide the patient, deciding and for him. The patient is an ignorant person who does not have the knowledge, the intellectual capacity or moral authority to oppose or disagree with the wishes and decisions of the physician who, instead, on account of his doctrine, knows exactly what is goodfor him. In this regard, if we were to speak of consensus concerning the physician's intervention, he would be considered useless in as much as obvious and understood when seeking help. The attitude of the patient towards the physician has always tended to one of strong faith and characterized by psychological subjection borne out by traditions thousands of years old. A patient who was sick, again, as an attitude of respect and gratitude, followed the treatment but never asked for any explanations regarding the therapeutic effects and the physician refrained from taking any initiative to inform the patient or his/her family. Each phenomenon, therefore, has a precise origin, a well-defined history and when its importance tends to significantly condition the activities concerning Man, a desire emerges to learn the origin and the history. As is well known, a trial commenced in Nuremberg, on December 19, 1946, of Nazi doctors and a code was defined in which the judges, all Americans, clearly emphasized a view of medical research and technology: science should never transform or consider human beings as an instrument to be employed for scientific purposes. In actual fact, documents exist providing evidence that a few decades before the drawing up of the Nuremberg Code, the need had been expressed, in Germany itself to somehow make medical interventions and actions legal by means of the use and practice of consensus. The moral and ethical principles in those documents, even if not available as bibliographic references in the English literature, certainly merit, from a historical viewpoint to be considered as conceptual elements and doctrinal and socio-cultural products, even if at that time, of little practical importance, which belong to the European culture and, in particular, and almost paradoxically, in the light of what happened, to the German culture. The United States of America is held to be the country of origin of informed consent, the initial aim of which was make sure that the correct dignity of the patient's independence be reserved at the time of decision making and choice of medical options. Reports on this topic, in fact, first appeared in the USA, at the beginning of the 18th Century, with problems focusing on and limited to only the simple rights of the patient in giving his/her approval of the health intervention later to be conceptually developed, along the lines of an itinerary with, at intervals, famous legal actions, until in the 20th Century, informed consent was reached, a criterion that, as is well known, foresees and includes not only the important and fundamental autonomy of the patient to decide, which stems ones personal rights, but also the essential objective element, which is, information. The expression informed consent has simply been transposed in Italian and roughly translated in an ambiguous fashion into "consenso informato" when, on the contrary, it should be referred to as "informazione per il consenso" "information for consensus" not only to respect the concept but, surely, for a more correct deciphering and a more precise interpretation related to the numerous concepts it presupposes and implies. Information and consent may be compared to the two sides of the same coin. These are the two important pillars that coincide and are joined giving weight to the medical responsibility, as far as concerns consent to the health intervention: on the one hand, having obtained consent,following correct and sincere information interpreted and deciphered as an important phase and an essential indicator of correct, scrupulous medico-professional procedure and, on the other, the consensus itself conceived as a duty aiming at the maximum respect of the rights to autodetermination, independence and autonomy of the patient, as a person. At the beginning of the Nineties, as we have seen, we were made aware of a series of legal actions regarding medical responsibility which was greatly conditioned by the Anglosaxon influence which initially induced many Italian magistrates and forensic physicians to adopt an extremely rigid attitude with no attempt to comply, in any way, with the culture and traditions of our country and our tradition which has always been inspired by good common sense, both medical and human. The American experience has been very rapidly adopted, by some, without a profound, complete and necessary historical and evolutional analysis aimed at those intertwined principles that have been motifs that have gradually led to the legal references in those emblematic cases referred to, the conclusions of which continue to attract a great deal of attention. In Italy, the legal and doctrinal evolution of informed consent, even if following a little more rapidly the traces, steps, problems and interpretations of the various aspects drawn up, characterized and applied in the United States, has not only occurred at a later time, but, despite reaching the same meaningful objectives, the same considerations, the same importance, and, unfortunately, the same inconveniences, has had quite different aims, approaches and articulations. In this respect, it is enough to focus attention on the different cultural traditions and religious routes, on the different doctrinal background, the particular historical origins and the individual legal aspects, all extremely different one from the other. (ABSTRACT TRUNCATED)

Christianity↗
PubMed2004

Informed consent in China: quality of information provided to participants in a research project.

AIMS: A study was carried out of informed consent strategies in an epidemiological project approved by the regional research ethics committees in Sweden and China and conducted in three areas south-west of Shanghai. METHODS: All participants in the epidemiological project (EP) were included in the research ethical study (RES), which was conducted as a questionnaire-based interview survey in the three areas. Answers were collected by five field interviewers. RESULTS: All participants included answered the questionnaire. Almost all perceived the information provided as rather good or quite good. However, a majority (on average 76%) had the impression that the EP was part of routine healthcare measures, and not a research project. Almost all participants felt free to abstain from participation although 38% in area II stated that they had not been informed about freedom to abstain from participation. A large proportion of participants did not fully understand the nature of the EP. However, almost all participants stated that they would agree to participate in a similar study in the future. CONCLUSION: Although informed consent procedures are supposed to be internationally applicable our study illustrates that it is not always easy to convey information and obtain consent in the present study setting.

Adult↗
PubMed1997

Myth and reality of informed consent in clinical trials.

Informed consent is a prerequisite for any medical intervention or for participation in scientific research. Legal requirements in health care towards informed consent provide qualifications of information disclosure and focus on procedures to obtain a valid consent. The premise of informed consent as a rational decision making process implies an informed consideration, assessment and patient choice and may be perceived as an ideal in the nature of a myth. These principles and assumptions will be discussed to obtain more insight into informed consent in clinical trials. A cogent model of informed consent is presented, which could be useful in clinical trials. We suggest a gradual distinction between informed consent in regular treatment vs. clinical trials, based on concepts like achievable benefits and risk disclosure. Suggestions are made for further empirical research, to obtain more insight into the myth and reality of informed consent in clinical trials.

Clinical Trials as Topic↗
PubMed1994

[Informed consent in anesthesia].

Informed consent is required for not only operative procedures but also anesthesia. One hundred and sixty-two patients, including those in a control group, were interviewed between the 3rd and 10th days after operations. An information sheet describes the anesthetic management and complications (possibilities of teeth damage, hoarseness and sore throat) in a simple style. This survey showed that those who had received the information sheet before operation showed significantly deeper understanding of anesthesia (56.2%) compared with those who had not received the information sheet (40.3%) (P < 0.05). The information sheet did not cause or increase anxiety about anesthesia. Those who had anxiety about anesthesia before the operation needed detailed printed information (63.8%) compared with those without anxiety (36.6%) (P < 0.01). An information sheet describing the anesthetic management and complications is useful for obtaining informed consent.

Aged↗
PubMed2006

The therapeutic misconception and our models of competency and informed consent.

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests.

Bioethics↗
PubMed2005

Views of US researchers about informed consent in international collaborative research.

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.

Adult↗
PubMed1993

Informed consent and medical ethics.

Informed consent is based on a shared decision between physician and patient, with the physician understanding the relevant values of the patient and the patient understanding the nature of the disease and intervention, including risks and benefits. Informed consent has developed rapidly since it was introduced in the 1950s, reflecting recent changes in the practice of medicine that respect the increase of patient autonomy. The purpose of the written consent form is to document that a process of informed consent has taken place. It is generally agreed that all surgical as well as research procedures require written consent. For certain nonsurgical procedures, the decision regarding obtaining written consent will consider both the risk involved for the patient and the general community standard. Informed consent serves as an important symbol of a physician-patient relationship that adheres to the valued principles of medical ethics.

Consent Forms↗
PubMed2000

Informed consent.

The origins of informed consent come from philosophy, medical experimentation, the law, and contemporary trends in doctor and patient relationships. Every surgical patient signs an informed consent form but the literature would suggest that many times there is incomplete information conveyed by the physicians or understood by the patient. Informed consent should be considered as an expression of respect for patient autonomy and the patient education necessary for a truly informed consent should be considered a surgical virtue.

History, 19th Century↗
PubMed1994

The effect of an introduction of a new consent form on settlement of the doctrine "informed consent".

Paternalism has been criticized lately in the japanese medical world, but it remained rather unfamiliar for a majority of the medical doctors to exercise the informed consent in the daily practice. It seemed that a consent form was one of the ways by which the medical and co-medical staffs became aware of importance of the informed consent. As it has been believed in Japan to be too formal to obtain a signature from the patient only for the evidence of the consent, it was worth while directing attentions of both the attending staffs and their patients to a renewed form, making them know that the doctrine of the informed consent had been introduced in the daily practice. Although it was an effective way, it turned out to be rather time-consuming process for a practical understanding of the informed consent.

Forms and Records Control↗
PubMed2000

The history and current status of competence and informed consent in psychiatric research.

Informed consent to research has recently become a focus of public attention as questions have been raised about the adequacy of information disclosed to potential research subjects and about the competence of psychiatric research subjects to provide valid informed consent to participate in potentially high risk studies. Around the world, policies and position statements have been written to address these concerns and to offer suggestions to protect potentially vulnerable research subjects, such as persons with neuropsychiatric disorders. Relevant literature has demonstrated that a subset of persons with such disorders have significant competence-related deficits, and thus may require specific means of protection with regard to informed consent to research. Recent guidelines offered to improve the informed consent process include review of potential studies for scientific merit and potential risk, assessment of subject competence to consent to research, and the use of proxy decision-makers when subjects are deemed incompetent.

Forecasting↗
PubMed1995

Ethics, informed consent, and assisted reproduction.

Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

Bioethics↗