Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “informed consent”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 343 records · Page 19Linked to original sources
PubMed2001

Informed consent in two Swedish prisons: a study of quality of information and reasons for participating in a clinical trial.

OBJECTIVES: To study the quality of informed consent in two samples of prisoners participating in a therapeutic trial. RESULTS: All participants (n=43) were aware of the fact that they had participated in a research project, that they were free to abstain from participation, and that they were free to withdraw from participation at any time. All but six were aware of the objective of the clinical trial and all but three understood the implications of participating. Twenty individuals did not consider the pros and cons. When making their respective decisions, no one felt that they had been subjected to undue persuasion or force. Concerning the reasons for participating, a majority (n=35) supposed that participation would benefit themselves' as the primary reason. Some (n=11) considered the benefits for future patients and science. No differences concerning gender or age were discerned. CONCLUSIONS: The results do not indicate that the informed consent procedure in general was inadequately performed. Rather, the answers provided and the subjects who withdrew indicate that participation was perceived as fully voluntary.

Acupuncture Therapy↗
PubMed2002

Informed consent: issues for providers.

Although obtaining informed consent is an important part of the hematologist/oncologist's practice, understanding the legal consequences can assist the practitioner to understand why it is necessary to disclose as much information as he or she does. By following the standard of care used in the state of practice, the physician can decrease the risk of being sued by patients for lack of informed consent, thus fulfilling his or her legal and ethical duties by providing the patient with all the information necessary to make an informed decision.

Health Personnel↗
PubMed2001

Obtaining informed consent for clinical pain research: patients' concerns and information needs.

Investigators who conduct clinical pain research are required to obtain voluntary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such studies. It is important that investigators understand these information needs so they can effectively and clearly describe the research risks and potential benefits that matter to potential subjects. By understanding these needs for information, investigators may also be better able to anticipate patients' concerns and to recruit subjects more efficiently. This study was designed to define information needs that patients have when they decide whether to participate in clinical pain research. This paper describes these information needs, and identifies clinical and demographic variables associated with specific needs.

Adult↗
PubMed2005

[Informed consent in the surgical patient. Reflections on the basic law of patient autonomy].

Informed consent is the final step in informing the surgical patient. The basic law of patient autonomy specifies the conditions in which patient authorization should be given with the aim of guaranteeing that a free decision is made. However, surgeons are sometimes faced with clinical situations in which it is difficult to obtain informed consent, whether because the patient is unable to provide consent or because of the need to intervene in a life-threatening situation, or because the informed consent document must specify the risks and consequences of the intervention. The present article aims to analyze what happens when the patient is unable to provide consent ("consent by representation") and the characteristics of the informed consent document according to the stipulations of the basic law of patient autonomy.

Humans↗
PubMed1990

Informed consent in head and neck surgery.

Informed consent is the fastest growing problem in the medical negligence debate. It was highlighted recently in the United Kingdom in the Sidaway case. Informed consent comprises the advice you would give the patient, the consequences of not taking your advice, the specific risks of the surgery or treatment you have in mind, and the risks of surgery in general. In an attempt to identify what the present practice in otolaryngology was, a postal survey was carried out of the members of the Scottish and North of England Otolaryngological Societies.

Attitude of Health Personnel↗
PubMed2003

Is the concept of informed consent applicable to clinical research involving critically ill patients?

Informed consent is a process through which patients or their surrogates authorize medical interventions or involvement in research. The concept of informed consent is supported by ethical principles and legal tradition in the United States. It grew in importance during the 20th century because of documented abuse of research subjects, which led to its codification in federal consent requirements for clinical research. For the most part, the concept and the codification are based on a model of competent patients who are capable of informed decision-making and can communicate their wishes. However, most critically ill patients are incompetent and cannot communicate easily. As a result, family members usually must give consent for them. Yet family members frequently are unavailable, and when they are available, they may not know the patient's wishes. Furthermore, family members may not be legally authorized to give consent for research involvement under state law. For these and other reasons, it has been argued that the concept of informed consent is not applicable to clinical research involving the critically ill and that such consent is not necessary in certain circumstances. Yet, for all its inadequacies, the concept of informed consent and the federal consent requirements should be retained because they promote respect for patients and their right of self-determination and because investigator discretion is not adequate. Stronger research oversight may be as important as informed consent in protecting patient welfare.

Clinical Trials as Topic↗
PubMed2006

Organ procurement organizations Internet enrollment for organ donation: abandoning informed consent.

BACKGROUND: Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. METHODS: An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. RESULTS: There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20-47), 79% (57-86), and 75% (50-100), respectively. The informed consent score was 0% (0-33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. CONCLUSION: The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

Brain Death↗
PubMedDate not supplied

A risk-specific anesthesia consent form may hinder the informed consent process.

STUDY OBJECTIVE: To evaluate the effect of a preprinted, risk-specific consent form on the amount of anesthetic risk information patients retain from the preoperative interview. DESIGN: Postoperative survey of consecutive inpatients to determine risk information retained before and after implementation of a preprinted anesthesia consent form, using standard preoperative risk discussions. SETTING: Inpatient units of a university medical center. PATIENTS: Two groups of patients, both of whom received a standard oral discussion of anesthetic risk information, were compared. Patients in the control group (125 consecutive inpatients) received this information only orally and were interviewed two weeks prior to implementation of a preprinted anesthesia consent form. Patients in the study group (92 consecutive inpatients) received this information orally and via a preprinted consent form and were interviewed between the fourth and sixth weeks after implementation of a preprinted anesthesia consent form. INTERVENTIONS: Anesthesia residents discussed five standard anesthetic risks with elective, adult inpatients (n = 233) during a two-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. These patients were interviewed postoperatively by one of the authors to determine the amount of anesthesia risk information they retained. MEASUREMENTS AND MAIN RESULTS: Results of the postoperative survey showed that patients in the control group retained more information concerning anesthetic risks than did those in the study group (33% vs 19%, p less than 0.01). CONCLUSIONS: To improve the informed consent process, either a better method of presenting the preprinted, risk-specific consent form or another method of simultaneously conveying and documenting risk information is needed.

Anesthesiology↗
PubMed1999

Informed consent in the emergency department.

This article reviews the doctrine of informed consent to treatment, with particular attention to its role in the emergency department. The article begins with a brief look at the moral and legal foundations of informed consent. The article then examines the three essential features of informed consent, patient capacity, disclosure of information, and voluntariness. After a review of five exceptions to the duty to obtain informed consent, the article concludes with a brief summary of issues of special significance for emergency physicians.

Adult↗
PubMed1999

[Information provided in writing for "informed consent" in clinical trials].

The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration. 61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated. The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment. Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

Clinical Trials as Topic↗
PubMed1997

Informed consent: protection or obstacle? Some emerging issues.

There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a "proxy" consent (Biros M.H. et al. JAMA 1995; 273:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals.

Emergency Treatment↗
PubMed2000

['Informed consent' and prerandomization].

The usual procedure in randomised controlled trials is to obtain informed consent first, after which participants can be randomised. The reversal of the order, first randomisation and then informed consent, is called pre-randomisation (Zelen design). In the Netherlands, there is discussion as to whether pre-randomisation should be allowed in medical research. Full informed consent regarding the design of the investigation may lead to unwanted loss of distinction between the experimental and control groups, thus reducing the internal validity of the investigation. A possible solution could be to include, in the informed consent procedure, the statement that certain information has been withheld because revealing it now would make the investigation useless, but that it will be revealed to all participants afterwards and that the study design was approved by the medical ethics committee. In this way, the advantage of the enhanced internal validity of the pre-randomisation design is retained while simultaneously keeping intact the sequence of first informed consent and then randomisation.

Humans↗
PubMed2001

The process of informed consent for urgent abdominal surgery.

OBJECTIVES: To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery. DESIGN: A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared to the information perceived to have been provided by the consent obtainers. SETTING: Gastrointestinal surgical service of a university teaching hospital. PATIENTS: Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. MAIN MEASUREMENTS: Principal outcome measures were patients perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. RESULTS: Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. CONCLUSION: The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes.

Abdomen, Acute↗
PubMed1998

Informed consent, parental awareness, and reasons for participating in a randomised controlled study.

BACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures. RESULTS: 181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%). CONCLUSIONS: Parents' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.

Adult↗
PubMedDate not supplied

[Informed consent in clinical practice and medical research].

The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats). However, it is important to recognize the limitations of these formats when used outside the context of a continuous communication process with the patient. For this reason, ultimate instrumentation is through continuous dialogue between patient and physician. Finally, Informed Consent might help improve the patient-physician relationship which, in the end, might be the best way to counteract the influence of the establishment of health management services.

Biomedical Research↗
PubMed2000

Malpractice risk assessment among different approaches for informed consent.

INTRODUCTION: The standards for obtaining informed consent, set forth by the Hawaii Revised Statutes, establish that it is the physician's duty to disclose what a reasonable person objectively needs to hear in order to make an informed decision. It is the purpose of this study to report the opinions of medical malpractice attorneys to survey their opinion whether full or limited disclosure of alternative treatments in informed consent is viewed as having a lower malpractice risk. METHODS: Hawaii medical malpractice attorneys viewed a compilation of arguments for and against both full and limited disclosure, and completed an opinion survey after reading samples of disclosure statements in two different case scenarios: 1) a pediatric emergency department case involving a febrile child at risk for occult bacteremia, and 2) an obstetrics case involving a woman with a postdate pregnancy. RESULTS: A vast majority of respondents believe that, in general and in the obstetrics case, full disclosure results in less liability. In the pediatrics ED case, 46% chose full disclosure as having less liability, 38% believe that the same liability exists with both full and limited disclosure, and 15% believe that limited disclosure is associated with less liability in this case. CONCLUSIONS: Hawaii attorneys with medical malpractice experience overwhelmingly agree that, in general, full disclosure is associated will less medical legal liability. Full disclosure was also the option selected as associated with less liability by a majority of attorneys in a sample obstetrical case. Opinions were more diverse in the pediatrics ED case. Many attorneys stressed that judging the risk of liability in general is difficult, and should be done on a case by case basis.

Adult↗
PubMed1996

Informed consent in emergency medicine: ethics under fire.

Many ethical issues in emergency medicine involve the question of informed consent. In this article, the ethical basis for informed consent, the essential elements of a morally valid informed consent, and the inadequacy of the law as a moral guide for informed consent are discussed. The ways in which the nature of emergency medicine affects the application of moral principles are examined, and specific guidelines for assessing a patient's decision-making capacity regarding informed consent are provided.

Decision Making↗
PubMed2002

Improving informed consent: insights from behavioral decision research.

BACKGROUND: With publication of The Belmont Report concerning ethical principles, informed consent gained explicit guidelines for the protection of human subjects of research. However, there is still little evidence about how well informed consent works to assist patients to reach informed decisions about research participation. OBJECTIVE: To review behavioral decision theory and research to identify implications for informed consent. RESEARCH DESIGN: Traditional literature review and hand search of literature were used. RESULTS: Psychological research on biases and heuristics identifies cognitive biases in information processing (selection and interpretation of risks and benefits) that have implications for improving the informing process. A growing literature on patient decision aids provides evidence for the feasibility of more fully informing patients, and includes examples of "debiasing" procedures (to improve information comprehension and consent). CONCLUSIONS: Informing and consenting involve conceptually different challenges concerning effectiveness versus values. Debiasing techniques need to be developed and empirically tested to determine their effectiveness in informing patients. Consenting involves both social and individual values. Appealing to altruism when summarizing the goals of research may increase research participation and does not necessarily violate voluntariness of informed consent. Additional research is needed to determine when information-processing biases occur problematically in health-related informed consent, and whether appealing to altruism increases research participation.

Behavior↗