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PubMed2005

How informed is online informed consent?

We examined participants' reading and recall of informed consent documents presented via paper or computer. Within each presentation medium, we presented the document as a continuous or paginated document to simulate common computer and paper presentation formats. Participants took slightly longer to read paginated and computer informed consent documents and recalled slightly more information from the paginated documents. We concluded that obtaining informed consent online is not substantially different than obtaining it via paper presentation. We also provide suggestions for improving informed consent--in both face-to-face and online experiments.

Analysis of Variance↗
PubMedDate not supplied

Informed consent revisited: Japan and the U.S.

Informed consent, decision-making styles and the role of patient-physician relationships are imperative aspects of clinical medicine worldwide. We present the case of a 74-year-old woman afflicted with advanced liver cancer whose attending physician, per request of the family, did not inform her of her true diagnosis. In our analysis, we explore the differences in informed-consent styles between patients who hold an "independent" and "interdependent" construal of the self and then highlight the possible implications maintained by this position in the context of international clinical ethics. Finally, we discuss the need to reassess informed-consent styles suitable to the needs of each patient regardless of whether he or she resides in the United States or in Japan.

Aged↗
PubMed1997

[Informed consent: what is the question? Correlation between practice and theory].

Informed consent in medical or human experimentation is a concept generally accepted by most doctors. The foundation of informed consent is self-determination and, in the legal setting of France, contractual agreement. The practical application of informed consent in medical specialities such as psychiatrics or intensive care raises difficult problems subject to much debate. Contemporary history would suggest that the strength of informed consent may be highly insufficient to avoid the risk of dictated power dominating-patients. In order to find a solution to these problems, the field of action of informed consent must be widened. We propose here to define informed consent as one of many means to defend patient dignity and human rights.

Emergency Medicine↗
PubMed1998

Informed consent in the Childrens Cancer Group: results of preliminary research.

BACKGROUND: Informed consent is critical to the ethical conduct of pediatric cancer clinical research. Research regarding such consent has been limited. METHODS: After conducting a background survey of institutional practice from principal investigators (PIs) at 113 Childrens Cancer Group (CCG) centers, the authors obtained more detailed data regarding informed consent from 23 parents of children recently enrolled in CCG research trials and from 23 clinician-investigators at 5 CCG institutions. RESULTS: Approximately 73% of PIs responded to the background survey, providing context in which to interpret the more detailed information. Parents reported that they found the informed consent process helpful, although somewhat confusing. Satisfaction with informed consent was not related to ethnicity or education level. Parents found discussion with staff more helpful than the consent document, and the majority reported that the amount of information conveyed was appropriate. Although only 3 parents (13%) reported that too much information was given, nearly 50% of the investigators believed too much information usually is provided. All investigators believed that patients benefit from participation in CCG studies; the majority recommend that the child be enrolled on study, and the majority believe the major obstacle to good informed consent is parents' "state of shock." CONCLUSIONS: Parents expressed general satisfaction with the consent process. By contrast, clinician responses indicate dissatisfaction with the informed consent process. Future research must include more centers and larger numbers of parents of children who we enrolled as well as those who declined to participate in CCG studies, examine consent in minority subgroups, and further investigate the role of clinician-investigators and their interaction with parents and children during the informed consent process.

Adult↗
PubMed1995

[Decision making and informed consent in clinical medicine].

Information used in clinical medicine is always uncertain and every choice has risk of unfavorable outcome. The concept of informed consent includes full access and understanding of all relevant information by the patient with autonomic participation to the decision process. In this paper, possible cause of the lack of communication between physicians and patients is discussed along with the usefulness of decision science technology in clinical medicine.

Clinical Medicine↗
PubMed1990

Informed consent for presbyopic contact lens patients.

The doctrine of informed consent requires that health care practitioners provide each patient with sufficient information about a proposed treatment so that the patient can make a knowing, willing and intelligent decision about the recommended treatment. The need for a thorough, well documented informed consent is especially important when prescribing monovision or bifocal contact lenses for presbyopic patients because of the relatively low success rate and possible associated vision compromise. Patients should be advised of the alternatives available and provided with a supplemental or alternative correction which will optimize the patient's vision for driving and other potentially hazardous activities. An example of an informed consent document that could be used to record the warnings and advice given to presbyopic contact lens patients is included. Failure to obtain the patient's informed consent and properly document it can be a major source of liability in contact lens practice. Use of informed consent documents such as the one described in this paper can minimize this possibility.

Contact Lenses↗
PubMed1989

Informed consent for clinical research in the emergency department.

Informed consent serves as the basis for a partnership between patients and physicians as they attempt to find better methods of diagnosis and treatment. Despite the importance of informed consent, this is an area of research that is frequently overlooked. In fact, an improperly designed consent form is the most common reason research protocols are rejected or approval is delayed. The essential elements of informed consent and problems obtaining informed consent from patients is an emergency department are reviewed.

Consent Forms↗
PubMed2001

The role of community advisory boards: involving communities in the informed consent process.

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.

Advisory Committees↗
PubMed1990

Informed consent, risk, and blood transfusion.

Informed consent for blood transfusion has become a necessity in light of the known risks associated with this service. All transfusion services should institute written informed consent that clearly defines the patient's options, including the use of homologous blood, autologous blood, and directed donations. The risk of transfusion with an infectious blood product is dependent on the number of donors per recipient and the prevalence of undetected, contaminated blood in the tested blood supply. The chance that an adverse transfusion will occur can be calculated by use of these variables. Comparative risks can be explained to patients, thereby providing an understanding of the transfusion risk of human immunodeficiency virus, the human T-cell leukemia virus, and the agent of non-A, non-B hepatitis (hepatitis C).

Humans↗
PubMed2005

Informed consent: it's not just signing a form.

Informed consent plays a major role in forming a therapeutic alliance with the patient. The informed consent process has evolved from simple consent, in which the surgeon needed only to obtain the patient's permission for a procedure, into informed consent, in which the surgeon provides the patient with information about clinically salient features of a procedure, the patient understands this information adequately, and the patient voluntarily authorizes the surgeon to perform the procedure. Special circumstances of informed consent include conflicting professional opinions, consent with multiple physicians, patients who are undecided or refuse surgery, patients with diminished decision-making capacity, surrogate decision making, pediatric assent, and consent for the involvement of trainees.

Communication↗
PubMed1989

Informed consent for federal clinicians.

The principle of informed consent to medical care is by now well recognized but incompletely understood and implemented. This article discusses the ethical and legal foundations of the informed consent doctrine, the relevance of informed consent for health care providers employed by the federal government, the elements of valid consent, the concept of state substantive law as governing, different information disclosure standards, disclosure elements, exceptions to the consent requirement, and the proper documentation of consent.

Consent Forms↗
PubMed1993

Informed consent.

The origin of the doctrine of informed consent is traced. If a patient is not competent to give valid consent, it should be sought from an informed close family member, guardian, proxy or surrogate. Where a doctor alleges incompetency of the patient as the reason for withholding adequate information, the 'Grannum test' should be applied. Doctors should not make disclosures to competent patients in a frightening manner, which may cause mental anguish. Some guidelines for tactful disclosure which avoids excessive discomfort are given. While the doctrine of informed consent reaffirms the right of every person to decide what will be done with his or her body, the living will only confers these rights, instead of recognizing them, thus leaving those who do not carry such a document in a state of limbo. The living will may produce counter-effective results. Some recent court rulings concerning informed consent are discussed.

Adult↗
PubMed1981

Informed consent and the family physician.

Informed consent, regardless of patient recall, is required in increasing detail. The family physician must obtain consent from every patient for every procedure except for a few clearly defined areas: "Emergency," "Waiver," "Therapeutic Privilege," "Immaterial Risks," and "Generally Known Risks." Because courts have adopted the "reasonable patient" standard of disclosure, suits can be won without expert testimony. The elements of informed consent require explaining the nature of the procedure, the consequences that will probably occur, the material risks that may occur, alternatives available, and problems in recuperation. Consent, like any contract, is a meeting of the minds and the physician has an obligation to himself to document that agreement.

Disclosure↗
PubMed2002

Informed consent: patients listen and read, but what information do they retain?

AIM: To determine the percentage of knowledge retained immediately following an outpatient consultation for total hip and knee joint arthroplasty, and whether any improvement in that knowledge occurred after reading an information leaflet about the operation. METHODS: Patients on the waiting list for joint replacement surgery were given verbal information during the consultation about basic operative details, post-operative programme, and potential complications. A questionnaire was completed asking them to recall these details. They were then given information leaflets to read. Six weeks later, they were contacted again and asked the same questions. RESULTS: Immediately following a consultation, patients recall only a small percentage of information. In particular, retention of post-operative recovery time frames, and possible operative complications is poor. Despite an information booklet, patients' level of knowledge deteriorates from the initial consultation. CONCLUSIONS: Verbal and written information supplied to a patient may be understood, but it is easily and quickly forgotten. In an increasingly medicolegal environment, it is essential to gain informed consent from a patient when performing interventions. The provision of an information booklet may provide nothing more than proof for the surgeon of information provision to the patient.

Aged↗
PubMed1998

Informed consent in refractive surgery.

The informed consent process represents a key component in providing the highest quality of care for our patients and minimizing liability risk. Patients undergoing refractive surgery have high expectations for an excellent outcome and may become easily dissatisfied and upset if this is not achieved. Careful attention by the surgeon and supporting staff to educate the patient in a thorough and supportive fashion is paramount to this process. Breakdown in communication between physicians and patients combined with a poor outcome and feelings of mistrust often leads patients to consider malpractice litigation. The importance of understanding the key components and principles of the informed consent process cannot be over-emphasized and are presented in detail in this review.

Humans↗
PubMed1987

Informed consent and the psychiatric patient.

Informed consent is reviewed as it applies to psychiatric patients. Although new legislation, such as the Mental Health Act 1983, provides a useful safeguard for the protection of the civil rights of patients, it could actually reduce their humane care unless applied with sensitivity for the nature of their unique difficulties. In order to guard against this possibility, we suggest that legal requirements should be considered in light of the ethical principles which underlie them. Three principles are considered: those of autonomy (freedom); beneficence (paternalism); and the fiduciary principle (partnership). Psychotherapy is offered as a model for informed consent, which might be generalised to other clinical situations.

Beneficence↗
PubMed1999

Improving understanding of the informed consent process and document.

OBJECTIVES: To review theoretical perspectives relating to the communication of informed consent and to describe research efforts and strategies to enhance the informed consent process and document. DATA SOURCES: Research studies review articles, education and communication models, and NCI National Working Group on Informed Consent Recommendations. CONCLUSIONS: Information communicated during the informed consent process is difficult to understand, raising ethical concerns about whether informed decision-making has taken place. Empirical research focuses on the nature of patient-provider interactions and the effectiveness of various delivery systems, a need exists to overcome conceptual and methodologic limitations. IMPLICATIONS FOR NURSING PRACTICE: Nurses must ensure that patients understand informed consent information. Several communication strategies are posited.

Clinical Trials as Topic↗
PubMed1998

Informed consent meets managed care.

The doctrine of informed consent requires that health care providers disclose to patients the nature of procedures to be performed and the attendant risks, benefits, and alternatives. Equipped with an understanding of their options, patients then have the right to consent to treatment or to refuse it. Obtaining informed consent can be an intricate process, in part because of variations in patients' capacity for understanding and the complexities of health conditions. Managed care further complicates the procedure because structural and economic factors may influence providers' options and patients' choices. This article reviews the features of informed consent as they apply under managed care and addresses ways to ensure that consent is appropriately delivered under managed care systems.

Female↗