Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process

The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.     

Are research participants truly informed? Readability of informed consent forms used in research

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent form.     

Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.     

Protecting Sexual Minority Youth from Research Risks: Conflicting Perspectives

We describe the dilemmas we encountered in the informed consent process for an HIV prevention project targeting Black gay, bisexual, and non-gay identified young men. We highlight the complexities of applying informed parental consent procedures to sexual minority youth and identify some of the challenges that researchers who work with sexual minority youth face when they must balance the needs and rights of this population against the needs and rights accorded to parents by federal guidelines for protecting minor participants in research.     

纸质与视频补充材料对手术知情同意体验的影响：以腹腔镜胆囊切除手术为例

知情同意书在医患沟通中起着间接传递信息的重要作用。以159名大学生为被试,通过操纵不同的知情同意方式,考察了纸质或视频补充信息对患者知情同意满意度、理解程度以及患者信息需求的满足程度影响。结果发现,接受纸质补充知情同意或视频补充知情同意的被试对知情同意过程的满意度、对手术信息的理解程度与知情同意信息需求的满足程度显著高于接受普通知情同意的被试。同时,纸质补充知情同意使得“治疗信息需求的满足程度”最高。这表明,纸质补充知情同意更能满足患者对治疗信息的需求。     

‚Mirroring‘ the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?

Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors’ participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor’s autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.     

Ethical practices and beliefs of psychopathology researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.     

Collecting Informed Consent with Juvenile Justice Populations: Issues and Implications for Research

Researchers must provide participants with opportunities to make informed decisions about whether to participate in research studies. Investigators conducting research with youth in the juvenile justice system face unique ethical, legal, and practical challenges to obtaining informed consent. Juvenile justice researchers must navigate multiple legal and ethical standards for collecting informed consent, take into account youths’ dual vulnerabilities as children and prisoners, and overcome practical limitations to obtaining parental/guardian permission. Given the challenges and complexity of obtaining standard informed consent of youth in juvenile justice facilities, this paper provides suggestions for overcoming obstacles to recruiting these youth for research participation. It offers guidance for fostering the enrollment of juvenile justice youth in research studies using procedures that comply with ethical and legal standards for research with this dually vulnerable population. Copyright © 2013 John Wiley & Sons, Ltd.     

Ethical Practices and Beliefs of Psychopathology Researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.     

Internet research: an opportunity to revisit classic ethical problems in behavioral research

The Internet offers many new opportunities for behavioral researchers to conduct quantitative and qualitative research. Although the ethical guidelines of the American Psychological Association generalize, in part, to research conducted through the Internet, several matters related to Internet research require further analysis. This article reviews several fundamental ethical issues related to Internet research, namely the preservation of privacy, the issuance of informed consent, the use of deception and false feedback, and research methods. In essence, the Internet offers unique challenges to behavioral researchers. Among these are the need to better define the distinction between private and public behavior performed through the Internet, ensure mechanisms for obtaining valid informed consent from participants and performing debriefing exercises, and verify the validity of data collected through the Internet.     

Psychology of the Informed Consent Process: A Commentary on Three Recent Articles

In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.     

Informed Consent and the Requirement to Ensure Understanding

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it.     

浅议侵害患者知情同意权的性质及赔偿

知情同意是患者自主权的重要体现,侵害患者知情同意权是引发医惠纠纷的常见原因。知情同意权是患者身体权、隐私权、财产权和支配权的集中体现,对患者知情同意权的侵害直接表现为对患者身体权、隐私权或财产权的侵害,医疗机构应该承担相应的精神损害赔偿、财产损害赔偿的责任。     

对知情同意书和知情同意过程的探讨

在《医疗事故处理条例》实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程。签字的知情同意书不等于知情同意,知情同意书不等于“生死契约”。知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得。因此知情同意过程应该重要于知情同意书。医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式。     

知情同意在中国不适用吗——“文化差异论”的认知错误

知情同意是在当代生命伦理学中最有影响的概念,在大多数西方国家它已成为医疗实践和涉及人体的医学科学研究的一个基本的伦理要求。不少西方和中国学者认为,由于中西文化显著而根本的差异,知情同意不适宜于中国。指出了“文化差异论”的三个认知错误,即,文化差异论是建立在对中国文化和医学道德、西方文化以及知情同意的一系列误解之上的。基于文化的差异而拒绝知情同意在中国的适用性和必要性,显然不能成立。     

Neuropsychological Functioning and Recall of Research Consent Information Among Drug Court Clients

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures.     

美国医疗知情同意案例评介

在美国的医疗活动中,知情同意是规范医患关系的一项伦理道德原则,同时,美国司法活动也在医疗事故背景下适用知情同意说,并形成一些司法适用的医疗知情同意的标准和告知责任的范围,介绍和讨论对涉及到这些问题的三个有影响的判例。     

急诊医疗中的知情同意问题

急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除。这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同。其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步。真正的原因是,知情同意在急诊治疗中往往以特殊或不同的形式表现出来。     

论知情同意的中国本土化--中国文化视野中的知情同意走向

知情同意原产于西方,移植到中国后被"家文化"、"功利论"、"简单化"等中华传统文化彻底改造过以后,浓缩成了手术前一味要求病人家属或单位领导签字的行为模式,远离了知情同意的主旨,但曾一度非理性地普遍流行.现在,又出现了一种照搬欧美知情同意的倾向,在一线医务人员中引发了诸多困惑和不满.在实施知情同意时,离开中华文化语境,或者在本土化中化掉其本质的做法,都是不可行的.正确的取向只能是立足于中国当代医学实践,以正在形成中的中国现代文化去整合西方知情同意的本质、理念和规范,构建成一套适合中国国情的知情同意机制.