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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.

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PubMed2007

Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure.

Conducting emergency research in the out-of-hospital and emergency department setting is a challenge because of the inability of patients to provide informed consent in many situations. Federal guidelines allowing research under an exception from informed consent for emergency research have been established (21 CRF 50.24). Community consultation and public disclosure, 2 required components of obtaining this exception, are seen by many as a barrier to resuscitation research. This article will provide a brief overview of the history of the exception from informed consent for emergency research and summarize our methods recently used to successfully complete community consultation and public disclosure for a trial evaluating 2 devices used during cardiopulmonary resuscitation in a large metropolitan area.

Attitude to Health↗

PubMed1994

Futility, autonomy, and informed consent.

If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

Disclosure↗

PubMed1997

Communal discourse as a supplement to informed consent for genetic research.

Genetic technologies present unique problems for the practice of informed consent. They provide information that may affect a study participant's family or kindred, which may be identifiable as an ethnic or locally isolated population. That information may be used to construct adverse perceptions of such identifiable populations, including non-participants who may not have been informed of or consented to the analyses. To address collective implications of genetic research, we describe a process that can supplement individual consent. Our approach engages pre-existing social units in discourses about proposed research. Communal discourses can influence individuals' decisions to participate in research studies.

Attitude↗

PubMed1993

Screening for prostate cancer. How can patients give informed consent?

Many urologists in North America are increasingly enthusiastic about prostatic cancer screening. Annual digital rectal examination is almost universally endorsed, and prostate-specific antigen testing is favored by most. But doctors really should not screen by either method without patients' informed consent. However, the information required for informed consent is complex and contradictory, difficult for physicians to give and for patients to absorb.

Communication Barriers↗

PubMed1985

The rationale behind the informed consent doctrine.

Court cases and state statutes set forth a physician's responsibilities for providing patients with information about the nature of their illnesses and the risks and alternatives of proposed diagnostic or treatment procedures. Exceptions are made when a particular patient is not competent to participate in the informed consent interchange, when a medical emergency exists, when informing the patient would be harmful, or when the patient expresses a desire not to be informed. Informed consent not only protects an individual's freedom to make health care decisions but, according to empirical studies, the provision of information can provide a physical and psychological benefit to the patient.

Humans↗

PubMed2002

Informed consent and research involving the newly dead.

This paper examines informed consent in relation to research involving the newly dead. Reasons are presented for facilitating advance decision making in relation to postmortem research, and it is argued that the informed consent of family members should be sought when the deceased have not made a premortem decision. Regardless of whether the dead can be harmed, there are two important respects in which family consent can serve to protect the dead: (1) protecting the deceased's body from being used for research that is incompatible with the person's postmortem preferences and values and (2) protecting the deceased's body's from being subject to disrespectful treatment. These claims are explained and justified, and several objections are critically examined. Additional reasons for securing family consent are presented including to protect them from additional emotional distress, to respect their wishes about wanting to have a say, and to maintain public trust in the medical profession and medical research. The paper also examines the scope of disclosure in relation to postmortem research.

Advance Directives↗

PubMed2005

Communication and informed consent.

PURPOSE OF REVIEW: To examine recent cancer research literature on the extent to which effective communication with adult and pediatric patients and their surrogates occurs during the informed consent process. RECENT FINDINGS: The limited recent empirical evidence found reveals several gaps in knowledge about the quality and process of communication and informed consent. Although commentary and recommendations about the process are available, little is known regarding the actual ways in which treatment and clinical trial information is explained by oncologists (and/or other healthcare providers) to patients and/or their authorized representatives. The few studies reported show wide differences in the ways the process is conducted in differing oncology settings (i.e., academic compared with community clinics), with different types of patients (i.e., adults and children), and in different cultural contexts. SUMMARY: Despite the identified shortcomings in the ways the communication process is transacted and the relative paucity of empirical studies, nearly all investigators and authors agree that personal interaction between healthcare providers and patients (or surrogates) is critical to maintaining the integrity and ethical standards necessary to achieve informed consent.

Clinical Trials as Topic↗

PubMedDate not supplied

Physicians, battery, and the duty to give informed consent.

This essay discusses the issue of informed consent as it relates not only to physician duty but also to patient duty. The author is particularly concerned with the possibility of battery charges against the physician unless a clear patient duty is articulated. In summary, the author concludes that we can prevent doctors from being forced to commit battery in a way which allows them to make reasonable choices for their patients without being open to the charge of having committed battery. At the same time, we would not allow doctors to abuse this privelege.

Disclosure↗

PubMed1997

Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?

Due to possible methodological and practical problems, many researchers refrain from using a randomized controlled trial design to evaluate procedures already embedded in routine health care. We performed a randomized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians. The trial started after 4 years of feedback and lasted for 2.5 years. With some adaptations a randomized trial proved to be possible. In evaluating health-care procedures that cannot be blinded in a traditional way, asking full and study-specific informed consent may conflict with the validity of the design. In such studies, an alternative procedure is to be considered. Our trial, with doctors as study subjects, was held on an already accepted routine procedure (feedback). This made it possible to refrain from obtaining study-specific informed consent. Consequently, a Hawthorne effect and contamination of the trial arms through information leakage could be avoided. Justification and general criteria for not obtaining full and study-specific informed consent are worked out. In health-care research on the performance of doctors or on interventions into the quality of care, obtaining a general informed consent in advance is an acceptable alternative approach.

Diagnostic Tests, Routine↗

PubMed2005

The ethics of research using biobanks: reason to question the importance attributed to informed consent.

BACKGROUND: During the past decade, the use of stored tissue has become an object of increased ethical query. A Swedish biobank and a biotech company have been praised for solving the ethical problems with explicit informed consent procedures, and we decided to investigate donors' perceptions of the system. METHODS: A questionnaire was sent to a randomized sample of 1200 donors who had donated blood and signed informed consent forms. RESULTS: The response rate was 80.9%. Of the respondents, 64.5% were aware that they had consented to donate a blood sample, 55.4% thought that they had consented to donate phenotypic information, and 31.6% believed that they could withdraw their consent. Among respondents, 3.9% considered informing donors about the research objective as the most important ethical issue in relation to biobanks, and 5.6% were unsatisfied with the information they had been given. There was 85.9% acceptance of surrogate decision making by regional research ethics committees. CONCLUSIONS: Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research.

Biotechnology↗

PubMed1994

Informed consent in Missouri: where has it taken us?

Between 1987 and 1990 there has been an increase in the number of medical malpractice claims in which lack of informed consent was the sole allegation. This should alert physicians to the need for a better awareness of recent changes in the doctrine of informed consent. Some states have liberalized the scope of the disclosure made to the patient, but Missouri has resisted any further doctrinal expansion in this area. In contrast, changes in the law relating to the doctor/patient relationship are more universally applied and permanent. It is clear that any actual treatment or nontreatment decision remains solely a right of the patient (parent or surrogate). Easily applied guidelines for obtaining informed consent that incorporate these changes are suggested.

Communication↗

PubMed1995

[Informed consent in the framework of biomedical research: a survey].

Inquiry on the quality and steps taken to obtain informed consents for biomedical research projects, based on the cases of 39 patients coming from 15 different projects with immediate therapeutic goals and 16 healthy subjects coming from 4 different projects without immediate therapeutic goals. Comparison between observed reality and the more or less demanding norms that were recommended. We noted a much bigger gap (therefore a consent actually informed in a lesser way) in the group of patients than in the group of healthy subjects. Explanatory hypotheses: the healthy subjects' higher social and cultural level, but also the investigators' difficulty and comprehensible discomfort to integrate, with respect to the patient, the essentially different and possibly contradictory points of view of scientific research and medical care; the "double market" notion.

Adult↗

PubMed2005

Module two: informed consent.

The objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.

Community-Institutional Relations↗

PubMed1990

On informed consent.

The question of whether patients should influence medical decisions, and if so how much, is not simple. Among other things, it is necessary to decide whether the patient's well-being should take precedence over respect for the patient's autonomy, or vice versa; whether or not the patient has the capacity to exercise true autonomy; what information should be furnished in order to provide the patient with the basis for making a decision about treatment; and how such information should be provided. This article examines these matters, reviews the pros and cons of various methods for obtaining patients' informed consent, presents some broad guidelines for dealing with informed consent issues in a therapeutic setting, and discusses ethical principles that should be applied in obtaining patients' informed consent to participate in clinical research.

Clinical Trials as Topic↗

PubMedDate not supplied

Physical restraint, informed consent and the child patient.

Parent's expressed, informed consent should be obtained before physical restraining devices are used on the child patient, in the course of dental treatment. Implied consent does not apply to any procedure not normally expected by an average, reasonable person; these procedures include the use of premedicating agents, the use of nitrous oxide sedation, or the use of physical restraint. It is a good, preventive idea to use a well-written general consent form. A specific consent form, clearly labelled, provides a strong defense in court for the dentist.

Child↗

PubMed2003

Reporting of ethical approval and informed consent in clinical research published in leading anesthesia journals.

BACKGROUND: Ethical conduct in human research in anesthesia includes approval by an institutional review board (IRB) or ethics committee and informed consent. Evidence of these is sometimes lacking in journal publications. METHODS: The authors reviewed all publications involving human subjects in six leading anesthesia journals for the year 2001 (n = 1189). Rates of IRB approval and informed consent were examined and compared with potential predictors that included journal, type of publication, and patient demographics (age, sex, elective or emergency status). Rates were compared by use of chi-square and logistic regression. RESULTS: The authors found that IRB approval was documented in 71% of publications and consent was obtained in 66% of publications. Significant variation in IRB approval and consent was found among journals (P < 0.0005) and according to type of publication (P < 0.0005). Because publication type affected rates of IRB approval and consent (trials > mechanistic studies > observational studies > case reports), an analysis restricted to prospective studies also found a significant difference in IRB approval and consent among journals (P < 0.0005). CONCLUSIONS: This study suggests that rates of IRB approval and informed consent vary among publications in anesthesia journals. Clearer guidelines (and author adherence) for all types of publication are needed, both as a protection for research subjects and to maintain public trust in the process.

Anesthesiology↗

PubMed2003

[Genetic research on blood samples stored for years in biobanks. Most people are willing to provide informed consent].

Genetic research involving biobanks has been the subject of numerous declarations, recommendations and guidelines produced by professionals, administrators, legislators and other decision-makers. Yet, there is little published empirical information on people's willingness to participate in genetic studies on blood samples that they donated many years ago, at a time when the informed consent did not include the possibility of genetic research. We here report on our experiences of obtaining informed consent for academic and as well as commercial genetic research on blood samples collected more than a decade ago. Participants in a population-based risk factor survey who had donated blood to a biobank in 1990 were contacted eleven years later (in 2001) and asked for informed consent for genetic studies. A total of 1,311 out of 1,409 participants (93%) gave their consent to use blood samples for academic genetic research, provided that an Ethics Committee had approved the research. Thirty-one participants (2.2%) did not give their consent for academic genetic research. Another 35 subjects (2.5%) did not consent to industrial genetic research even if their blood samples were anonymized. Sixty-four individuals did not reply or provided incomplete answers (together 4.8%). Of the 1,311 individuals that agreed to participate, 292 (22.3%) wanted to be informed and give their concent to every new specific project. All the others gave a general concent provided that an Ethics Committee had approved the research.

Adult↗

PubMed1998

Critical care research and pre-emptive informed consent: a practical approach used in Chris Hani Baragwanath ICU.

OBJECTIVES: 1) To establish a protocol within international and local ethical guidelines to obtain informed consent for critical care research, overcoming constraints previously described and 2) To evaluate eventual recruitment using this protocol. DESIGN: Prospective descriptive study. SETTING: Multidisciplinary ICU in a community-based university teaching hospital. PATIENTS AND PARTICIPANTS: Following approval by the University Ethics Committee and Hospital Review Board, patients admitted between January and May 1996 were assessed on weekdays for potential enrollment into existing clinical trials. Discussion with potential candidates and/or next-of-kin occurred at the earliest opportunity and informed consent was obtained preemptively. Next-of-kin was notified if enrollment subsequently occurred. We evaluated the number of patients screened, the number of potential study candidates, the number for whom consent was obtained or refused and the number subsequently enrolled. INTERVENTIONS: None RESULTS: Of 249 patients screened, 149 (60%) did not meet the inclusion criteria. Of 100 potential study candidates (40% of all patients screened), we failed to make contact with the next-of-kin in 29 cases (12% of all patients screened). Thus 71 patients or next-of-kin were counselled (28% of all patients screened). In all, 30 patients (12% of all patients screened) were subsequently enrolled into a study. CONCLUSIONS: A policy of pre-emptive informed consent enabled us to overcome some of the problems previously experienced in our unit with regards to patient enrollment in critical care research. Although overall recruitment remained low, predictions for future enrollment can be made from this study.

Algorithms↗