Characteristics associated with informed consent for genetic studies in the ACCORD trial

BackgroundPrior studies found that some groups have lower genetic consent rates than others. Participant consent for genetic studies enables randomized trials to examine effects of interventions compared to control in participants with different genotypes.MethodsUnadjusted and multivariate associations between genetic consent rates and participant, study, and consent characteristics in 9573 participants approached for genetics consent in the multicenter Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which used a layered genetics consent.ResultsEighty-nine percent of eligible participants consented to genetic studies (“Any Consent”) and 64.7% consented to studies of any genes by any investigator (“Full Consent”), with similar rates in randomized groups. Controlling for multiple characteristics, African-Americans had lower consent rates than others (Any Consent Odds Ratio, OR = 0.62, p = 0.0004; Full Consent OR = 0.67, p < 0.0001). Those with high school or higher education level had higher rates than less than high school graduates (Full Consent ORs 1.41–1.69, p-values < 0.0001). Consent rates were lower when genetics consent was separate from the main trial consent on the same day (Any Consent OR 0.30; Full Consent OR 0.52, p values < 0.0001) or on a subsequent day (Any Consent OR 0.70, p = 0.0022; Full Consent OR 0.76, p = 0.0002).ConclusionHigh rates of consent for genetic studies can be obtained in complex randomized trials, with lower consent rates in African-Americans, in participants with less than high-school education, and for sharing samples with other investigators. A genetics consent separated from the main trial consent was associated with lower consent rates.     

Consent and assessment of capacity to decide or refuse treatment

Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.     

Informed consent for clinical photography

The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage. The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent, and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.     

Obtaining consent: the use of a consent form

A consent form provides clear, unambiguous proof that a patient consented to treatment. Consent forms do not reveal the content of discussions with a patient. Staff awareness needs to be raised of the importance of providing information, obtaining consent and demonstrating that this has occurred.     

Best interests at end of life: an updated review of decisions made by the Consent and Capacity Board of Ontario

Purpose

To increase our understanding of the notion of “best interests” in end of life disagreements through an updated review of decisions made by the Consent and Capacity Board of Ontario. There was a significant increase (235%) in decisions from this tribunal between 2009 and 2011. “Best interests” test is used when no prior expressed wishes are known to the surrogate decision-makers.

Methods

Purposively sampled written decisions of the Consent and Capacity Board of Ontario between 2003 and 2011 that focused on the “best interests” of patients at the end of life. Interpretive content analysis was performed independently by 3 reviewers, and themes were identified by consensus.

Results

We found substitute decision makers (SDMs) rely on an appeal to their own values or religion in their interpretation of best interests; physicians rely on clinical conditions; board emphasizes alignment with Health Care Consent Act. In the more recent cases, we found that SDMs report that patients value suffering; that SDMs have unrealistic hope for recovery and can communicate and get direction from the incapable patient; that SDMs need education on their role and responsibility as SDM; and that SDMs need time to provide consent, and that most proposed treatment plans that were sources of conflict included “palliative care.”

Interpretation

Several lessons are drawn for the benefit of health care teams engaged in disagreements at end of life with SDMs over the best interests of patients.     

Ethics and consent to treat issues in acute stroke therapy

Consent to treat with thrombolytic therapy for acute ischemic stroke presents an ethical dilemma for hospitals, physicians, patients, and their families. This article presents four aspects of this controversial topic and provides recommendations for conditions that allow for ethical consent to treat.     

Understanding informed consent

The failure of a physician to disclose all of the risks associated with an operative procedure is considered a breach of professional duty and, therefore, a negligent act. Consent for a procedure does not necessarily have to be written; however, signed forms provide written evidence of the patient's agreement. Documentation is essential, especially in cases where the consent form is incomplete or incorrectly filled out. Any concerns about a patient's consent or lack of consent should be discussed with the surgeon.     

浅析药物临床试验中对受试者的权益保障

药物上市前须经过人体试验,参与药物临床试验的受试者将承担不同程度的风险,我国GCP明确规定要充分保障受试者的权益,伦理委员会和知情同意书是保障受试者权益的主要措施,但在实际中仍存在不少问题。为此,如何切实保障受试者的权益,是临床试验所要解决的一个重要问题。     

Philosophical, ethical, and legal aspects of resuscitation medicine. I. Deferred consent and justification of resuscitation research

Informed prospective consent for clinical resuscitation research may not be possible. Deferred consent is an untenable notion. Consent to continue in research cannot be used to support a claim that there was, or would have been, consent to the initiation of research. The conditions for the justifiability of resuscitation research without informed consent are: a) patient is comatose; b) lifesaving treatment must be given immediately; c) given all available evidence, there is reason to believe that the probability of death or severe deficit with experimental or control therapy is not greater than the probability of death or severe deficit on usual therapy; d) given all available evidence, there is reason to believe that the probability of normal or near-normal outcome is greater on experimental or control therapy than on usual therapy; and e) the study can provide evidence on whether there is a significant difference between experimental and control therapies in the incidence of normal or near-normal survival.     

Informed Consent with Children and Adolescents

Nurses are becoming increasingly responsible for obtaining consent from children and adolescents for psychiatric treatment. The current practice of obtaining consent for participation in research is discussed. Consent from minors has implications for clinical treatment. This article examines power and powerlessness, and restrictiveness of the treatment setting in relation to nurses obtaining consent from children and adolescents.     

A concept analysis of consent

This paper considers the meaning of consent for nursing. Consent had traditionally been looked at in relation to the medical profession. The paper argues for patient advocacy and discusses issues of competency and advocacy and implications for practice. The paper then goes on to critique the process of concept analysis and suggests ways of proceeding with this vital development for nursing.     

Factors affecting consent in pediatric critical care research

Purpose  

Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors.     

Informed consent to healthcare interventions in people with learning disabilities – an integrative review

Title. Informed consent to healthcare interventions in people with learning disabilities – an integrative review. Aim. This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Background. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions – or be assessed as incompetent to give consent. Data sources. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. Review methods. An integrative review was conducted and the data analysed thematically. Results. Twenty‐two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. Conclusion. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.     

Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study

Purpose  

Consent for research participation in the intensive care unit (ICU) is often obtained from a substitute decision maker (SDM). In this study we explored SDMs’ reasons for declining or providing consent for research studies for critically ill adult family members.     

Best interests at end of life: A review of decisions made by the Consent and Capacity Board of Ontario

Purpose

When patients are unable to communicate their own wishes, surrogates are commonly used to aid in decision making. Although each jurisdiction has its own rules or legislation governing how surrogates are to make health care decisions, many rely on the notion of “best interests” when no prior expressed wishes are known.

Methods

We purposively sampled written decisions of the Ontario Consent and Capacity Board that focused on the best interests of patients at the end of life. Interpretive content analysis was performed independently by 2 reviewers, and themes that were identified by consensus as describing best interests were construed, as well as the characteristics of an end-of-life dispute that may be most appropriately handled by an application to the Consent and Capacity Board.

Results

We found that many substitute decision makers rely on an appeal to religion or God in their interpretation of best interests, whereas physicians focused narrowly on the clinical condition of the patient in their interpretations.

Conclusions

Several lessons are drawn for the benefit of health care teams engaged in end-of-life conflicts with substitute decision makers over the best interests of patients.     

Assessing the readability statistics of national consent forms in the UK

Introduction: When obtaining consent for an invasive procedure, the patient needs to understand what is happening to them in broad terms. Best medical practice advocates that written consent is given to acknowledge patient agreement. Across the UK, the Department of Health has provided standard consent forms for obtaining consent in all situations. Potentially these written sources of information may not be comprehended by patients and thus invalidate consent. Method: Consent forms were assessed by the Flesch readability and Flesch‐Kincaid grade formulae and compared with the national reading age, the recommended level for patient medical information, three newspaper articles and a journal article. Results: The consent forms have acceptable statistics [average Flesch readability 61.1 (range 57.2–66.1) and Flesch‐Kincaid grade 7 (range 6.3–8)]. This grade, however, is above the recommended level of patient health information (Flesch‐Kincaid grade 6). When the patient statements are isolated the reading statistics worsen [average Flesch readability 52.6 (range 41–62.6) and Flesch‐Kincaid grade 9.6 (range 7.9–11.1)]. Conclusion: Consent forms should be used as adjuncts to detailed conversations, describing what a procedure involves to ensure that a patient understands, in broad terms, what is happening to them. The patient’s statement section of the form may be being written at a level above patient comprehension currently and thus could invalidate any consent given. We would advocate a documented conversation with patients to ensure they have a broad understanding of the procedure and using the consent form as an adjunct to this discussion. The patient’s statement section should be re‐written to avoid invalidating consent.     

The Standard of Care and conflicts at the End of Life in critical care: Lessons from medical-legal crossroads and the role of a quasi-judicial tribunal in decision-making

Purpose

The goals of this qualitative study were to review the last 7 years of end of life legal decisions within the critical care field to explore how medical benefit is defined and by whom and the role of the standard of care (SoC) in conflict resolution.

Methods

A public online, non-profit database of the Federation of Law Societies of Canada was searched for relevant Consent and Capacity Board decisions from 2003 to 2012. In total, 1486 cases were collected, and purposive sampling identified a total of 29 decisions regarding use of life-sustaining treatments at end of life. Using modified grounded theory, decisions were read and analyzed from a central SoC concept to understand definitions of benefit, rationales for case adjudication, and repercussions of legal recourse in conflict resolution.

Results

Medical benefit was clearly defined, and its role in determining SoC, transparent. Perceptions of variability in SoC were enhanced by physicians in intractable conflicts seeking legal validation by framing SoC issues as “best interest” determinations. The results reveal some key problems in recourse to the Consent and Capacity Board for clinicians, patients and substitute decision makers in such conflict situations.

Conclusions

This study can help improve decision-making by debunking myth of variability in determinations of medical benefit and the standards of care at end of life and reveal the pitfalls of legal recourse in resolving intractable conflicts.     

Abnormal findings in "normal" research volunteers

We report three cases in which medical students who participated in clinical studies as normal volunteers were discovered, during the course of the research, to have potentially serious abnormalities. Their previously unsuspected conditions included chronic persistent hepatitis, a lesion in the cerebral cortex, and seropositivity for hepatitis B and HIV antibodies. These findings were surprising and distressing to both subject and investigator, and raised questions of the need for institutional guidelines, and the potential legal liability of the investigator. We discuss how improvements in Informed Consent Forms might aid in reducing these problems, by alerting the researcher and the subject to the possibility that unsuspected disease might be discovered during the course of a clinical research study.     

Issues of patient consent: a study of paediatric high-dependency care

This article reports on the issues relating to obtaining informed, signed consent for a study of paediatric high-dependency care and provides practical guidance on confidentiality for health service researchers. Consent and confidentiality are not new concepts but recent changes to the legislation and guidance offered from nursing and medical regulatory bodies have caused concerns and confusion for researchers with respect to both issues. Balancing health service research and the development of services against the requirements of patients for confidentiality is essential yet challenging. This was a time consuming, costly exercise. Resource implications may ultimately mean that studies which are of benefit to patients in relation to the delivery of their care may not be undertaken. Health professionals need to be continually updated and made aware of the legislation and confidentiality requirements for health service research involving the collection of patient-identifiable details.     

Children in the hospital: issues of power and vulnerability

Findings from a phenomenological study into the experience of pediatric nurses highlight the unequal power relationships between children and adults, including parents and health care providers. Based on the principle of 'in the child's best interest' this thinking has the potential to deny children an age appropriate right to be involved in health care decisions and may conflict with the tenets of the United Nations Convention on the Rights of the Child. Adults are presumed competent to make health care decisions, children are presumed incompetent without any validation as to whether the child has the knowledge and ability to make the decision. Consent does not only apply to major procedures, but to all patient care activities. The right of access to children's bodies is always in the hands of others and some everyday practices may conflict with protective behavior education.