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PubMed2004

Dutch dentists' views of informed consent: a replication study.

The aim of this study was to replicate a previous study on informed consent in dental practice, because of the low response-rate of that study. The present study assessed Dutch dentists' knowledge, their attitudes and self-efficacy towards the principle of informed consent, by means of a strongly shortened version of the questionnaire used in the original study. This questionnaire was sent to 384 Dutch dental practitioners; 60.2% of them responded. The results obtained in this study are highly comparable with the results of the original study, thereby increasing the confidence in the outcomes. Results of both studies indicate that dentists still have problems with some aspects of informed consent. Specifically, dentists' fear for legal procedures and the difficulty they have with informing immigrant patients warrants further attention.

Adult↗
PubMed1995

Informed consent for genetic research on stored tissue samples.

OBJECTIVE: To develop recommendations for obtaining adequate informed consent in the future when gathering tissue samples that may be used for genetic studies and defining the circumstances under which it is necessary to obtain further consent if tissue samples already in hand are to be used for such research. PARTICIPANTS: Scientists, ethicists, lawyers, and consumers selected by the National Center for Human Genome Research and the Centers for Disease Control and Prevention to represent a wide array of opinions. EVIDENCE: Statutes, regulations, and cases and articles on law and ethics. CONSENSUS PROCESS: Initial workshop, followed by circulation of several drafts of this document with opportunities for comment by workshop participants and others as well as smaller meetings involving participants with widely differing views. CONCLUSION: Genetic research using stored tissue samples poses an array of benefits and risks to individuals, researchers, and society. As a result, the workshop participants conclude that (1) informed consent is required for all genetic research using linkable samples unless conditions for limitation or waiver are met; (2) informed consent is not required for genetic research using anonymous samples but may be considered if identifiers are to be removed from currently linkable samples; (3) institutional review boards could usefully review all protocols that propose to use samples for genetic research; and (4) further work regarding these issues is warranted.

Anonymous Testing↗
PubMed1995

Do not resuscitate: informed consent in the operating room and postanesthesia care unit.

The perioperative nursing team needs clear direction regarding the surgical patient's do-not-resuscitate (DNR) status. It is unreasonable to expect health care givers to make ethical decisions at a time of crisis such as cardiopulmonary arrest in the OR or PACU. Patients maintain their right to make health care decisions even on entry into the surgical suite. Therefore, the decision to maintain or rescind a patient's DNR status must be made in conjunction with the operative consent if that consent is to be an informed consent.

Humans↗
PubMed1983

Informed consent: what does it mean?

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered.

Australia↗
PubMed1989

Informed consent for intravascular administration of contrast material: how much is enough?

To determine the usefulness of informed consent prior to the intravascular administration of contrast material, the authors evaluated four equal groups of patients with different degrees of counseling concerning risks and risk factors. Group 1 was given no information. Group 2 was informed of the common risks in a written statement. Group 3 was informed of all known risks in a written statement. Group 4 was informed of all known risks by means of physician counseling. The average times it took for the technologist (groups 1-3) or the physician (group 4) to counsel the patient and obtain informed consent were 1.7, 6.2, 13.6, and 11.4 minutes, respectively. Counseling by physicians would require approximately 7% of their professional time in a busy radiology department. On a postprocedure test, the patients in groups 1-4 scored on average 38.4%, 68.2%, 63.2%, and 69.8%, respectively. There was no statistical difference in the performance of groups 2-4 on the postprocedure test. If informed consent is to be obtained prior to intravascular administration of contrast material, use of a straightforward written consent form detailing the common risks and risk factors appears to be the best method.

Comprehension↗
PubMed2005

Informed consent in endoscopic sinus surgery: the patient perspective.

OBJECTIVES: To understand patient expectations during the informed consent process for functional endoscopic sinus surgery (FESS). STUDY DESIGN: Multi-institutional, cross-sectional survey design. METHODS: Anonymous surveys were administered to patients in two tertiary academic centers with a chief complaint relating to "allergy and sinus" problems. Patients completed an eight-item questionnaire that assessed both the nature and the level of risks that they wished to be informed of prior to FESS. RESULTS: Three hundred eighty-nine surveys were returned. Sixty-nine percent of patients wished to be informed of complications that occur as infrequently as 1 in 100 cases, regardless of severity. Ninety percent of patients wanted to know of a risk that occurred as frequently as 1 in 10 cases. Patients also reported whether or not they wished to be told in detail about specific complications during the informed consent process, regardless of their infrequency. Affirmative responses were as follows: 83% for cerebrospinal fluid leak and orbital injury, 81% for infection, 76% for revision surgery, 74% for impairment of smell, 73% for bleeding and myocardial infarction, 72% for cerebrovascular accident, and 58% for scarring. CONCLUSIONS: Patients wanted to be informed about severe FESS complications at a higher rate than physicians previously surveyed, even if the incidence is low. This study, combined with our previous examination of the physicians' perspective, highlights that there may be a discrepancy between what the physician and the patient believe are priority topics during the informed consent process.

Attitude to Health↗
PubMed1993

Preliminary report on informed consent for mental capacity assessments.

The goal of the study was to investigate the issue of informed consent for mental capacity. Seventeen clients referred to the Competency Clinic at the Baycrest Centre for Geriatric Care were interviewed after the assessment had been completed. Their responses to questions regarding the reasons for and possible consequences of the assessment indicated a range of understanding and of capacity to give informed consent. The results are discussed in terms of the appropriateness of having a fairly low threshold for informed consent in situations where other capacities are already in question.

Aged↗
PubMed2001

Informed consent and randomised controlled trials.

Truly informed consent is a difficult thing to achieve! Patients are not healthy volunteers and their vulnerability challenges their ability to assess the risk/benefit of health choices. In this paper we consider some or the issues surrounding this important aspect of modern practice, and offer some suggestions on how to improve the process, with the goal of increasing participation in clinical research, and enhancing patients' confidence in their medical advisors.

Ethics, Medical↗
PubMed2005

Informed consent in pediatric clinical trials.

PURPOSE OF REVIEW: Clinical research in children is increasing. Concerns have been raised about both the inclusion and the exclusion of children in such research. Corresponding to these concerns, issues in informed consent for pediatric trials have become more pressing. This review discusses informed consent in pediatric trials and characterizes the latest literature. RECENT FINDINGS: Research into the consent process has shown that central concepts in pediatric research such as randomization and the distinctions between phases of clinical trials are not uniformly understood by parents or older pediatric patients. Newer approaches that are being developed to help remedy these deficits include the use of staged informed consent, the incorporation of interactive computer technologies to convey complex ideas, and variations in approaches to assent of the child based on multifactorial assessments of competence. Other variables in the consent process that are being studied for their impact on the process include individual life experiences and cultural background. Gaps in federal regulation and oversight of "informed consent" are emerging as new cases test established assumptions. SUMMARY: Lessons learned from recent studies regarding oversight of the consent process in pediatric clinical trials, the complex nature of assent, the impact of cultural variables, and more effective means of communicating what is involved in a clinical trial will shape future studies in consent and help to improve the process.

Adolescent↗
PubMed1996

Informed consent: research and the psychotic patient.

During the past few decades, western societies seem to have placed a particularly high premium on the individual's personal integrity and right to self-determination. Presently, obtaining a patient's consent is accepted as a prerequisite for the performance of any form of medical treatment, whether diagnostic or therapeutic in nature. A study was undertaken in various centres involved with clinical trials to compare the procedures used for obtaining informed consent from a psychotic patient. Although the study did not investigate the legal aspects related to consent and informed consent, it is necessary that one must be aware of these aspects when doing clinical trials.

Clinical Trials as Topic↗
PubMed2001

[Prerequisites and limits of informed consent].

The process of getting an "informed consent" is based on judicial necessity as well as on the relationship between the patient and his doctor, which has been changing remarkably over the last years. In this alliance the idea of autonomy increases, while the paternal treatment is loosing its influence continuously. Although patients have the right to decide, they also need competence in order to make a decision. Many circumstances may be responsible for a corruption of this competence. A communication based on appreciation, empathy and authenticity is able to discover such circumstances and fight against them. This kind of communication is able to prevent communication gaps, even when severe or dangerous realities have to be verbally expressed. Despite the judicial necessity the healing power of communication should get a more central place in therapy.

Austria↗
PubMed1975

Informed consent and its implications in family practice.

The doctrine of informed consent has had its practical introduction to medical malpractice litigation in the past five years. Its definition has not changed since the days when its definitive application was only a fond dream of the malpractice plaintiffs attorneys. However, with neh new methods of presenting this theory to the courts, and with the newly emerging practice fo having rulings on matters of law substituted by judges for prevailing standards of medical practice, the implications for family physicians have become tremendous. Hopefullum by understanding the principles involved in its application in the pertinent landmark cases, family physicians will be better able to abid the pitfalls engendered by the doctrine of informed consent.

Adolescent↗
PubMed2004

Informed consent: a process to facilitate older adults' participation in research.

Trust is the foundation of the informed consent process. According to Kass et al., Yet only through vigilance and humility will we, as investigators, be able to live up to the trust that is placed in us; and only if that trust is deserved can the research enterprise survive (1996, p. 28). Therefore, further research should examine the effect of the informed consent process in limiting older adults' participation. Only by re-evaluating the first point of contact, implementing creative strategies to overcome barriers to the informed consent process, and validating these strategies through research will nurses facilitate the inclusion of older adults in research.

Aged↗
PubMed2004

Awareness of the process of informed consent among family practice patients in Karachi.

OBJECTIVE: To study the awareness of 'Informed Consent', among patients presenting to Family Physicians. METHOD: A cross-sectional study was carried out at the Community Health Centre, Aga Khan University Hospital, Karachi in July 2002. Written Consent was taken and confidentially was assured RESULTS: Out of the 100 patients interviewed, 80 agreed to participate in the study, forty-four men and thirty-six women. Approximately half the participants (45%) were graduates and 40% had less than five years of school education. The awareness of the process of 'informed consent' was observed in only 20% of the respondents, all in the educational category of graduates. CONCLUSION: A lack of awareness of informed consent was observed in patients attending the Community Health Centre, Aga Khan University, despite stringent institutional policies, which are adequately followed. To improve awareness, 'Health Education Programs' for the population are required with media support. Readability of written consent forms should be of class V level or less to give advantage to the less educated classes in the society. Local languages should be utilized for written and verbal consent. Public health programs should also be aimed at educating physicians, nurses and paramedics. Provisions should be made to legalise the process of taking consent.

Awareness↗
PubMed1988

A national survey concerning the ethical aspects of informed consent and role of medical students.

The authors surveyed a national random sample of medical students (10 percent of the graduating class of 1985) to identify the ways in which the students obtained informed consent from their patients and to learn the students' views of certain issues concerning informed consent. The results showed that the students introduced themselves to patients using methods that the authors grouped by levels of forthrightness. Those students who introduced themselves as medical students differed in their views on selected informed consent issues from students who introduced themselves as physicians. In general, all the students were less forthright about their status when given the opportunity to perform invasive procedures. Student gender, type of patient, and type of hospital were statistically associated with the students' behavior, according to bivariate analysis. After multivariate regression analysis, however, only the actions of the students' role models (residents and attending physicians) remained significantly associated with the students' behavior. The authors conclude that because some aspects of student behavior are at odds with the requirements of informed consent, medical educators must scrutinize the ethical dimensions of the policies they establish.

Attitude of Health Personnel↗
PubMed1992

Altruistic surrogacy and informed consent.

A crucial premise in many recent arguments against the moral permissibility of surrogate motherhood arrangements is the claim that a woman cannot autonomously consent to gestating and relinquishing a child to another couple, because she cannot be fully informed about what her future emotional responses will be to the foetus developing within her, and to the giving up of the newborn infant to its social parents. When conjoined with some moral principle about the justifiable limits on the ways others can be expected to exercise their autonomy on our behalf, this claim is often taken to establish that various forms of surrogate motherhood arrangements are morally wrong. In this paper I want to show that there is a serious non sequitur in this kind of argument. That is, I want to show that even if women cannot in fact have this kind of information about what their future emotional responses to pregnancy and relinquishment will be, nothing follows about the wrongness or otherwise of surrogacy. For, when we consider what counts as informed consent in the context of other important ventures with uncertain consequences, it becomes clear that informed consent does not require having this kind of information about one's future emotional states. In putting these arguments, I also hope to clarify some of the connections which might be thought to hold between informed consent and autonomous decision-making generally.

Altruism↗
PubMed2005

Are US informed consent requirements driving resuscitation research overseas?

Following a 2-year federally imposed moratorium on acute resuscitation research due to concern regarding the inability of patients in cardiac arrest to provide prospective, informed consent to participate in such research, the United States federal government in 1996 released regulations with provisions for exemption of prospective informed consent in certain types of emergency research. While very few acute resuscitation research studies have been attempted in the United States since that time, such research has continued overseas. We discuss one large multi-center, out-of-hospital trial of a device intended to improve the hemodynamics of cardiopulmonary resuscitation. After pilot implementation overseas, this trial could not be conducted in the United States, largely due to the difficulties and costs involved in implementing the requirements of the 1996 regulations. A recent European Union directive on the conduct of clinical trials may halt European research on patients who are unable to provide prospective, informed consent. The directive contains no provisions for exceptions or waiver of informed consent, and may hinder acute resuscitation research in Europe to an even greater degree than the 1996 regulations have in the United States.

Cardiopulmonary Resuscitation↗
PubMed2006

Impact of written information consent on the number of intravenous contrast--enhanced CT and MR studies.

RATIONALE AND OBJECTIVES: The purpose of this study was to evaluate the impact of written informed consent on the number of intravenous contrast-enhanced CT and MR imaging studies. MATERIALS AND METHODS: On December 2002, the Conference of Physicians and Medical Directors in our institution decided that all referring physicians must obtain written informed consent in each case before intravenous injection of contrast material for CT and MR imaging studies. The numbers and proportions of contrast-enhanced CT and MR imaging studies before introduction of the written informed consent requirement (January 2002-December 2002) were compared with those after (January 2003-December 2003). RESULTS: The number of contrast-enhanced CT studies decreased from 5930 (50.6% of all CT studies) to 5539 (49.0% of all CT studies) (odd ratio [OR]: 0.94, 95% confidence interval [CI]: 0.89-0.99). The number of contrast-enhanced MR studies also decreased from 1895 (46.5% of all MR studies) to 1712 (43.4% of all MR studies) (OR: 0.88, 95% CI: 0.81-0.96). CONCLUSION: Findings suggest that the written informed consent requirement reduces the number of intravenous contrast-enhanced CT and MR imaging studies.

Contrast Media↗