Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.     

Solicitation for patient's consent creates duty to inform fully

A U.S. district judge in Philadelphia rejected part of a defense motion to dismiss an informed consent complaint. A heart surgery patient, Morris Kotofsky, gave informed consent to have a blood transfusion in January 1992. His physician neglected to tell him about the risk of HIV transmission from a transfusion, and did not mention a directed donor option where the patient receives a transfusion from a family member or friend. The judge said that when a provider seeks consent voluntarily, the provider assumes a duty to use reasonable care in performing the task. The hospital prevailed in another aspect of the suit. The judge said the hospital cannot be held liable for allegations of negligence in failing to establish adequate policies governing informed consent.     

The patient's right to information in Japan--legal rules and doctor's opinions

A questionnaire survey concerning informed consent was administered among Japanese physicians in Yamaguchi prefecture. The survey results showed that even though these Japanese physicians are willing to give their patients sufficient information to obtain informed consent, the discretion of the physician to provide information is still prevalent. The survey also revealed that Japanese physicians believe that information regarding the treatment to be administrated should be fully disclosed both in case when the treatment is still experimental and when it is established among specialists. Finally, the survey showed that despite the liberal attitude of the Japanese physicians toward informed consent, they are reluctant to make medical records accessible to the patients. It was found that when Japanese physicians were faced with special cases such as prior to administering high-risk diagnostic procedures, prior to disclosing the presence of cancer in their patients, or when faced with patients unwilling to receive treatment, the involvement of the patient's family members in the decision-making process was preferred so as not to aggravate the patient's emotional anxiety. With respect to cancer patients, the survey suggested that many Japanese physicians believe that cancer operations performed without informed consent from the patient should be legal. Finally, the survey concluded that, although the concept of individualized informed consent has been generally accepted among physicians, the involvement of family members in the decision-making process and a conservative attitude toward disclosure of information are still prevalent in Japan.     

提高医疗安全意识注重老年患者围手术期质量管理

目的提高医疗安全意识,保障老年患者围手术期医疗质量。方法复习2008年度住院的老年手术患者病历1430份,从年龄、住院科室分布、基础疾病、术前检查、知情告知等方面进行分析。结果老年手术患者占全部手术病例的32．77％,60～75岁的老年患者占全部病例的70％,以入住普外科、泌尿外科、骨外科为主。患有基础疾病的老年患者占90．84％。手术、麻醉、特殊治疗同意书签署率达到100％,特殊检查同意书签署率却只有88．04％,而谈话记录仅占全部病例的39．72％。结论重建术前准备流程,加强对老年手术患者的围手术期管理,进一步提高医疗质量,保证医疗安全。     

Ethical and legal problems of informed consent

INTRODUCTION: The previously accepted paternalistic relationship between patients and doctors has changed in last century. The expectation for patients to be involved in medical decisions is growing, but this involvement cannot be imagined without informed consent, hence it became one of the most important elements of a physician's responsibilities. Although informed consent is broadly regulated legally in Hungary, experiences show that practical realization is insufficient. This is also represented in the large number of lawsuits in connection with the inadequate or wrong use of informed consent. The aim of this study was to survey for the first time in Hungary the state of informed consent by the analysis of written consents to anaesthesia. METHODS: The authors collected and studied written consents to anesthesia from 36 hospitals and clinics in Budapest. They studied among others the presence of the following formal elements: individual consent forms for anesthesia, signatures on forms etc. They also examined whether the consents contained all of the conventional elements of informed consent. RESULTS: 61% of hospitals had individual forms for consent to anesthesia. Every consent form required a signature by the patient and almost every form (except two) by the doctor as well. 39% of forms describe the medical treatment in detail and only 25% mention its advantages and disadvantages. 28% of them specify definite risks, but only 19% mention their probability. 67% of the documents refer to the possible need to extend intervention. Patients have to declare whether they permit urgent blood transfusion in 25 institutions (69%). In only two hospitals are patients informed of their rights to revoke consent or to resign from being informed of medical treatment. CONCLUSION: Although all institutions have written consent forms that adhere to legal regulations, in terms of their format and matter they leave much to be desired. It is especially conspicuous that possible risks are named in less than a fourth of all forms, thus they have to be mentioned verbally and this obviously is a source of later arguments. The authors believe that all invasive medical procedures require templates for consent forms put together by professional panels. These forms could then be adapted to all specific medical procedures of the hospital in question.     

The art of consent: visual materials help adult patients make informed choices about surgical care

Abstract

Supporting patients in making informed healthcare decisions is a cornerstone of ethical medical practice. Surgeons frequently draw for and show images to patients when consenting them for operations but the value of this practice in informed decision-making is unclear. An audit was conducted in a General Surgery Department. 244 patients completed questionnaires on the value of visual materials when giving consent for surgery. The complexity of the operations was classified into “simple”, “moderate” or “complex”. 100% of patients felt they had given informed consent to surgery. 62% of patients received at least one form of visual material during the consenting process. All patients who received a drawing, and 99% of those provided with other images, valued these resources. Visual materials were considered more useful to patients when giving consent for moderate or complex operations than simple ones. Approximately one third of patients who did not receive visual materials would have appreciated these when making an informed decision. This research highlights the value of surgeons drawing for, and providing other visual resources to, their patients as part of the consent process. There is a role for further research and training materials in drawing skills for surgeons.     

Rapid response systems in The Netherlands

Sixty-three (approximately 80%) of the 81 hospitals that responded to a survey sent to all hospitals in The Netherlands with nonpediatric intensive care units had a rapid response system (RRS) in place or were in the final process of starting one. Among many other findings regarding RRS infrastructure and implementation, only 38% of the hospitals allowed nurses to activate the rapid response team without physician consent.     

The rights of psychiatric patients in China: a survey of medical staff and consumers' attitudes toward patient participation in clinical trials

To explore and compare attitudes of consumers (patients and their family members) and medical staff toward clinical trials related to mental health in China, we developed two questionnaires for medical staff and patients and their family members. Approximately 66.2% of medical staff who had no research experience believed that patients could be persuaded to participate in clinical trials, but the percentage of consumers who believed so was just 12.5%. Both groups agreed that written informed consent was required; however, more medical staff than patients agreed that such consent could be provided by patients or their guardian (88.4% vs. 71.4%). Only 9.5% of medical staff thought that patient treatment would be compromised by refusal to participate; the proportion of consumers who thought the same was 29.4%. Great differences exist between medical staff and consumers' attitudes and beliefs regarding clinical trials. Medical staff were more likely to have a favorable attitude toward their patients participating in clinical trials and considered that informed consent could be provided by guardians rather than the patient.     

1080份知情同意书填写缺陷分析

目的探讨病案中知情同意书填写存在的问题,并采取有效的改进措施,提高病案质量。方法分析我院2011年1～11月出院病案,对1 080份知情同意书填写情况进行统计分析。结果 1 080份知情同意书中,缺陷最多的是一般项目填写不全350例,占32.4%;其次是多次操作或治疗只签一次知情同意书150例,占13.9%。结论正确填写好每份知情同意书,提高医务人员对知情同意书的重要认识,是减少医疗纠纷的重要途径。     

Infection control programs in Italian hospitals.

OBJECTIVE: To quantify the frequency and features of infection control programs implemented in Italian public hospitals. METHODS: In 2000, a questionnaire was mailed targeting all teaching and research hospitals and those with more than 300 beds, and a random sample of 50% of the district hospitals with fewer than 300 beds. RESULTS: The overall response rate was 80%. Fifty percent of the 428 respondent hospitals claimed to have an infection control committee, 43% an infection control physician (average, 1 infection control physician per 2,963 beds), and 33% an infection control nurse (average, 1 infection control nurse per 572 beds). Having an infection control committee, nurse, and physician occurred significantly more frequently in Northern and Central Italy, where the Regional Authority had implemented a regional infection control policy, and in larger hospitals. Thirty-nine percent of the hospitals claimed to have ongoing surveillance in place, mostly based on laboratory results. Eighty percent of the hospitals had defined at least one written protocol related to infection control policies, mostly for housekeeping, cleaning, disinfecting and sterilizing patient equipment, or standard precautions; on the contrary, policies aimed at preventing specific infections were less frequent. CONCLUSION: This national representative survey showed that the infrastructure for infection control is suboptimal when compared with the guidelines and surveys published in other countries.     

住院病历书写质量的分析

目的：了解病历书写缺陷,以便采取有效措施提高病历书写质量。方法：回顾性调查3256份住院病历首页、入院记录、病程记录、出院记录、辅助检查、知情同意书、医嘱及基本要求。结果：在所查3256份病历中,首页、出院记录、辅助检查、知情同意书、医嘱的缺陷率非手术科室在22．9％-37．7％,手术科室在27．5％-49．6％;入院记录、病程记录的缺陷率非手术科室82．2％-84．1％,手术科室86．9％～93．9％。结论：病历书写缺陷与临床医师素质密切相关,提高病历书写质量的关键在于强化病历书写意识,加强临床医师素质培养,严格执行病历书写规范。     

Inquiry into the potential value of an information pamphlet on consent to surgery to improve surgeon-patient communication.

OBJECTIVES: To find out how patients recently undergoing surgery experienced the consenting process and the response of these patients to a pamphlet on consent to surgery. To test the reaction of health professionals to the pamphlet. DESIGN: A pilot pamphlet was produced and a questionnaire was sent to patients inquiring about their consenting experience, and how the pamphlet might have helped them through the consent procedure. A pamphlet and a questionnaire were also sent to a random sample of the health professionals serving these patients. SUBJECTS: Patients and health professionals. RESULTS: 61% of patients returned the questionnaire. Knowledge about the consent procedure was shown to be limited. 49% were unaware that they had the right to insist that the surgeon could only perform the specified operation and nothing more. 83% were unaware that they could add something in writing to the consent form before signing. 28% of health professionals returned their questionnaire, most of whom thought that the pamphlet provided a useful contribution to surgeon-patient communication. CONCLUSION: Evidence shows that patients are not well informed about consenting to surgery and further information would provide much needed guidance on understanding their role in the consent procedure. The low response from the health professional study is perhaps an indication that at present this is an issue which is not seen as a priority.     

An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa

It has recently been debated whether it is possible or desirable to have one internationally recognised standard of "informed consent" or whether research ethics should be adapted to the culture and educational level of the study population. This study examined the attitudes of the Gambian people to consent to medical research, and evaluated the informed consent process used in a major efficacy trial of a Haemophilus influenzae vaccine. Consent was requested after parents had received a verbal explanation and an information sheet which described the vaccine trial in a local language. A semi-structured interview was conducted with 137 acceptors and 52 refusers. Certain points of knowledge were recalled well by the acceptors; 90% knew the purpose of the vaccine was to prevent disease, but the placebo control design was understood by only 10%. The prime motive for consenting was to receive the HIB vaccine (93%) and that for refusing was that the vaccine was experimental (35%) and might have unknown side effects (29%). Although parents took advice from researchers (50%), health workers (24%), friends (16%) and family (12%), in all cases the decision was made by one of the child's parents. Only 1% of parents sought the opinion of traditional or religious leaders. The principles of informed consent, that it should be free, autonomous and informed were affirmed by this community. Therefore, in The Gambia, the international code of informed consent is appropriate.     

Revenue, relationships and routines: The social organization of acute myocardial infarction patient transfers in the United States

Heart attack, or acute myocardial infarction (AMI), is a leading cause of death in the United States (US). The most effective therapy for AMI is rapid revascularization: the mechanical opening of the clogged artery in the heart. Forty-four percent of patients with AMI who are admitted to a non-revascularization hospital in the US are transferred to a hospital with that capacity. Yet, we know little about the process by which community hospitals complete these transfers, and why publicly available hospital quality data plays a small role in community hospitals' choice of transfer destinations. Therefore, we investigated how community hospital staff implement patient transfers and select destinations. We conducted a mixed methods study involving: interviews with staff at three community hospitals (n = 25) in a Midwestern state and analysis of US national Medicare records for 1996–2006. Community hospitals in the US, including our field sites, typically had longstanding relationships with one key receiving hospital. Community hospitals addressed the need for rapid AMI patient transfers by routinizing the collective, interhospital work process. Routinization reduced staff uncertainty, coordinated their efforts and conserved their cognitive resources for patient care. While destination selection was nominally a physician role, the decision was routinized, such that staff immediately contacted a “usual” transfer destination upon AMI diagnosis. Transfer destination selection was primarily driven at an institutional level by organizational concerns and bed supply, rather than physician choice or patient preference. Transfer routinization emerged as a form of social order that invoked tradeoffs between process speed and efficiency and patient-centered, quality-driven decision making. We consider the implications of routinization and institutional imperatives for health policy, quality improvement and health informatics interventions.     

Prenatal HIV testing in Ontario: knowledge,attitudes and practices of prenatal care providers in a province with low testing rates

OBJECTIVE: To describe the knowledge, attitudes and practices of prenatal care providers in relation to prenatal HIV testing. METHODS: A stratified random sample of 784 family physicians, 200 obstetricians and 103 midwives providing prenatal care in 3 health planning regions in Ontario received a questionnaire. RESULTS: Response was 622/1087 (57%). Almost half of participants (43%) were not aware of Ontario's prenatal HIV testing policy. Eighty-five percent of participants reported that they offered or ordered HIV testing for all pregnant women. Sixty-six percent agreed that women should have a choice about whether to test or not, and midwives were more supportive of having an informed consent process than were physicians. CONCLUSION: Knowledge about the risks and benefits of prenatal HIV testing needs to be improved, and standards for informed consent should be re-evaluated to achieve the most ethical process with the least complexity.     

Informed consent: law, clinical reality, and the role of the family physician.

Informed consent is typically seen as most relevant to surgical and other invasive specialties. Although family physicians perform fewer high-risk procedures, they are nonetheless extensively involved in the informed consent process because of the comprehensive and continuing nature of the family physician-patient relationship. Family physicians have a particularly important role in helping their patients to understand what diagnostic or therapeutic alternatives are available. Family physicians have an independent role in the informed consent process, as well as a collaborative role in the context of consultation and referral. Legal rules that require disclosure of alternatives to the patient by the treating physician are examined in the context of the family physician's role as a coordinator of patient care. Practical suggestions regarding discussion of alternatives, extent of disclosure, coordination with consulting physicians, and encouragement of patients' participation in discussions are offered.     

Best practice guidelines on informed consent for weight loss surgery patients

OBJECTIVE: To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. RESEARCH METHODS AND PROCEDURES: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. RESULTS: This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. DISCUSSION: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.     

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.     

Informed consent: court viewpoints and medical decision making

Twenty-five years of appellate court decisions about informed consent in three influential states were examined to address four issues: the criteria used to define adequate informed consent; trends in court decisions; parallels between court decision making and decision analysis; the contribution of decision analytic concepts to defining "reasonable" medical informed consent. Court standards have evolved in three phases: the "medical community" standard before 1972, the "reasonable person" standard since 1972, and recent inroads toward developing an "individual preference" standard. The latter two standards form the current basis for deciding whether a patient has been adequately informed. Decision analysis offers a framework for communication about medical outcomes and probabilities, and methods for assessing preferences. Jurists and physicians should consider whether the legal system should adopt a decision analytic perspective in the doctrine of informed consent. Researchers should address issues raised by use of decision analysis for communication between the physician and the patient.     

HIV-antibody testing in a multispecialty group practice

The authors reviewed the trends in HIV-antibody testing at a multispecialty group practice with more than 280 physicians. Based on a chart review of 243 randomly selected patient records, they judged 38% of the tests ordered to be for low-risk individuals. Forty-five percent of the records documented the patient's informed consent before testing, and only 15% noted that patient education or counseling had been given.