Patients' informed consent requires understanding of treatment risks

The need for patient consent to medical treatment derives from the idea that the patient is morally obligated to take ordinary means to preserve his or her life. The physician has only that right over the patient which the patient gives him. To ensure that patient treatment decisions are responsible, consent must be both free and informed. Free consent generally implies that the patient is under no pressure to choose a particular course of action. Informed consent suggests that the physician has a duty to give the patient sufficient information about a proposed procedure's significant risks and benefits. The patient need not receive comprehensive knowledge of the treatment, however, since overdisclosure can interfere with the freedom to decide by playing on patient fears. Though some patients simply disregard treatment information or rely on other factors in their decision making, physicians should not abandon attempts to attain patient understanding. They must develop communication skills and exercise patience in their efforts to explain treatments and obtain consent. Proxies and patient advocates also may be requested, and physicians may consult with their colleagues to guarantee that the patient's best interests are met.     

Beyond the informed consent procedure: continuing consent in human research

An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were able to document that only some of the proposed types took place at the site of our study. The most frequent practice involved the researchers' re-consent of their subjects for major protocol revisions. Only one subject dissented and chose to withdraw even though he was technically eligible to continue in the study. Two other types of continuing consent were not observed. We discovered an additional type of continuing consent not described in the typology whereby subjects gave implied consent through their cooperation and adherence to the on-going requirements of the protocols. Implications for the informed consent process and the need for further research are presented.     

Ethical considerations of informed consent: a case study

Presentation is made of a case study concerning a patient with chronic obstructive pulmonary disease who was also discovered to have small cell carcinoma. The patient had indicated many years prior to his hospitalization that if he ever had cancer he would not want to receive chemotherapy. He also indicated to his physician he did not want to hear any 'bad news'. The dilemmas posed by the ethical relationship between consultant and primary care physician and between consultant and patient in such a case are explored. The role of a hospital ethics committee in advising the parties involved is also reviewed.     

The informed consent procedure in epidemiological research

After a brief introduction on the beginning and subsequent developments of informed consent (IC), this paper analyses its ethical, legal, medical and scientific implications and its specific applications to epidemiological research. The aim is to highlight how IC principles should be fulfilled through different procedures responding to the ethical and scientific requirements of epidemiological research. At least two improper applications, in fact, can deprive IC of its meaning: referring to ethical principles without discernment, or following IC guidelines without critical evaluation. Attempts to improve IC procedures adapting them to specific needs and scientific developments should be evaluated carefully and without preconceptions.     

临床医学科研中的知情同意之我见

结合临床医学科研伦理管理中的经验,对知情同意的要素、知情同意的方式、知情同意的主体、知情告知的主要内容、知情告知的过程、知情同意书的签署、知情同意书的保存等方面进行了探讨,提出了一些见解、体会和经验,供广大医学科学研究工作者和医学科研管理人员参考.     

Record linkage research and informed consent: who consents?

Background  

Linking computerized health insurance records with routinely collected survey data is becoming increasingly popular in health services research. However, if consent is not universal, the requirement of written informed consent may introduce a number of research biases. The participants of a national health survey in Taiwan were asked to have their questionnaire results linked to their national health insurance records. This study compares those who consented with those who refused.     

Prior informed consent is also a requirement of 'no-risk' scientific research

The right to decide for oneself about participation in medical research is the foundation of informed consent. If the requirement of informed consent is dropped for research that is considered free of risk to the individual participant, then participation becomes involuntary. The absence of risk is an insufficient argument to ignore an individual's right to free choice.     

Survival and cause of death after myocardial infarction:: The Danish MONICA study

As part of the Danish WHO MONICA study, a register of patients with myocardial infarction was established in 1982, covering 11 municipalities in the western part of Copenhagen County, Denmark. During the period 1982–91, all cases of myocardial infarction among citizens aged 25–74 years were registered and validated according to the criteria set up for the WHO MONICA project. Short-term (28 days) and long-term (up to 15 years) survival in three periods were compared. The rate of mortality after a non-fatal myocardial infarction was compared with that of the general population, and causes of death were analyzed. Short-term survival did not change during the study period, whereas long-term survival improved for men but did not change for women. The excess mortality rate among female patients over that of the general population was due to ischemic heart disease, other cardiovascular diseases, cancer and other diseases. The excess mortality among male patients was due only to cardiovascular diseases.     

Risk management, public policy and informed consent: a case study

The present guidelines on the use of hepatitis B vaccine in mental handicap hospitals dictate the need for an a priori identification of occupational risk, but fail to clarify how this risk should be defined. The ethical requirement of a respect for autonomy however demands that in offering vaccine as a means of protection, the choice of options must be "informed'. The determinants of institutional transmission have not been clearly defined and it is therefore difficult to inform client groups as to the degree or nature of their occupational risk. It is questionable whether the literature can support the recommendations in their present form, and supposedly "cost-effective' solutions to the problem, pay scant regard to the fact that in risk management, the relative desirability of options is conditional on the alternatives considered, how they are framed, what evidence is consulted and how consequences are weighed. In informing the policy making process, it is imperative that the values of those whose voice is seldom heard, are considered.     

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC).     

Changing constructions of informed consent: qualitative research and complex social worlds

Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.     

Ethics of medical scientific research: informed consent and the therapeutic misconception

--Ethical approval of research involving human beings is based on two pillars: supervision of the scientific merit of the research and the risks and burdens for participants by an institutional review board (IRB) or the Dutch Central Committee on Research Involving Human Subjects (CCMO), and obtaining informed consent from the participant or his or her legal guardian. --Discussions on the ethical acceptability of a study generally focus on the first pillar, assessment by an IRB. The second pillar, obtaining informed consent, is often neglected. --Some ethical concepts play a role in obtaining informed consent, especially the concept of the 'therapeutic misconception', i.e. that participating in a study is the same as receiving individualised treatment from a physician. --Of importantance in this matter is the fundamental difference between the research relationship (between investigator and participant) and treatment relationship (between physician and patient). --Understanding the concept of therapeutic misconception is essential to explaining why it is often difficult to obtain valid informed consent from patients for medical research.     

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.     

医疗技术人体试验中受试者的知情同意权

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则.受试者知情同意权包括知情权和同意权.对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担.     

Patients' perceptions and experiences of transitions in diabetes care: a longitudinal qualitative study

Objective  To examine patients' perceptions and experiences over time of the devolvement of diabetes care/reviews from secondary to primary health-care settings.
Design  Repeat in-depth interviews with 20 patients over 4 years.
Participants and setting  Twenty type 2 diabetes patients recruited from primary- and secondary-care settings across Lothian, Scotland.
Results  Patients' views about their current diabetes care were informed by their previous service contact. The devolvement of diabetes care/reviews to general practice was presented as a 'mixed blessing'. Patients gained reassurance from their perception that receiving practice-based care/reviews signified that their diabetes was well-controlled. However, they also expressed resentment that, by achieving good control, they received what they saw as inferior care and/or less-frequent reviews to others with poorer control. While patients tended to regard GPs as having adequate expertise to conduct their practice-based reviews, they were more ambivalent about nurses taking on this role. Opportunities to receive holistic care in general practice were not always realized due to patients seeing health-care professionals for diabetes management to whom they would not normally present for other health issues.
Conclusions  It is important to educate patients about their care pathways, and to reassure them that frequency of reviews depends more on clinical need than location of care and that similar care guidelines are followed in hospital clinics and general practice. A patients' history of service contact may need to be taken into account in future studies of service satisfaction.     

论生物医学研究中受试者知情同意权的保护

保护生物医学研究中受试者的知情同意权具有重要意义.本文从国内外法律依据、研究者的义务、伦理委员会的作用及受试者自身的维权等方面,探讨如何保护受试者的知情同意权.