Risk perception and decision processes underlying informed consent to research participation

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.     

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.     

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.     

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.     

Compliance, conscious participation, and informed consent in tumor screening programs

Compliance and coverage are supposed to be indicators of effectiveness in screening activities. Yet effectiveness is a necessary but not sufficient condition for a screening programme: adverse effects are intrinsic to screening practice; to persuade to comply to screening programme should imply that the advantages overwhelm the disadvantages; if at community level the balance is in favour of the screening, it is not possible to predict the weight for each individual of any potential harms. To accomplish individual values is fundamental from ethical point of view: we must avoid non responsible participation or uninformed refusal, through a reliable information on screening benefits and harms to the invited population. Therefore the concept of compliance should be abandon: "participation" should be used instead. The consequence of a different approach to participation in screening evaluation should be appreciated: new indicators and standards have to be defined. The following ones are proposed: prevalence of informed target population; prevalence of consent to invitation within the informed population; ratio consent/refusal to invitation; prevalence of participation in the invited group. It is unrealistic to expect an informed participation, to screening programme, from all population but incorporation of patient values and preferences is seen as the next frontier in attempts to devise valid practice guidelines. Research is needed to develop instrument on risk communication and informed consent, taking into account the current organisation of screening programs.     

Beyond informed consent

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.     

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.     

No prior informed consent required for 'no-risk' scientific research

Recent research has shown that prior informed consent not only leads to a lower response but also distorts the results of the study. The concern about the protection of the individual may not be given preference over the importance of participation in a study, in particular for those studies that carry a very limited or non-existent risk or that are not burdensome to the patient.     

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.     

Personal autonomy and informed consent

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.