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.     

Participants' Understanding of the Process of Psychological Research: Informed Consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

Participants' understanding of the process of psychological research: informed consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41% were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

Protection of children's rights to self-determination in research

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.     

Justifying Deception in Social Science Research

The use of deceptive techniques is common in social science research. It is argued that the use of such techniques is incompatible with the standard of informed consent, which is widely employed in the ethical evaluation of research involving human subjects. A number of proposals to justify the use of deceptions in social science research are examined, in the face of its apparent incompatibility with the standard of informed consent, and found to be inadequate. An alternative method of justification is outlined, which enables some deceived participants in social science research to rationally and autonomously choose to participate in that research. The alternative method of justification appeals to the idea of indirect consent , which is introduced. It is argued that research subjects who receive reliable testimony regarding research procedures can sometimes be placed in a position to rationally and autonomously consent indirectly to participation in experiments and studies, even if these involve significant deceptions.     

The Effect of Emotion on Visual Attention to Information and Decision Making in the Context of Informed Consent Process for Clinical Trials

The aim of this study was to examine the influence of emotion on visual information processing and decision making in the context of informed consent. Researchers are ethically obligated to ensure informed consent in clinical trials; however, many volunteers have unrealistic expectations about the value of an experimental therapy. Moreover, suboptimal participation rates for clinical trials may be partially attributable to perceptions that ethical obligations to volunteers are not met. This study examines whether discrete negative emotions (fear, anger, and sadness) differentially influence information processing, visual attention, and decisions in the context of clinical trial informed consent. Community participants completed a standard emotion induction (or control) and then read an actual consent form from a clinical trial while eye movements were tracked. Fear and anger produced the most prominently different patterns of systematic processing and visual attention, such that fear induced longer fixations to information presented, whereas anger induced shorter fixations. Moreover, among women only, fear increased decisions to participate, compared with anger and neutral emotion. Examinations of associations between eye‐tracking variables and self‐reported outcomes indicated that for angry participants only, less systematic processing was associated with greater decisions to participate. Negative emotions of any kind decreased accurate perceptions of trial benefit. These patterns suggest a complex interplay among emotion, processing style, and decision making. Future research is necessary to further probe these effects among potential clinical trial volunteers. Published 2016. This article is a U.S Government work and is in the public domain in the USA.     

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.     

The structure of informed consent in psychiatric research

The manner in which the informed consent process is structured was explored by means of intensive interviews with 17 experienced psychiatric researchers. Despite differing views on informed consent, investigators displayed a commonality of practice. Most investigators were themselves not usually involved in obtaining consents, relegating the process to lower-level assistants. They did not closely monitor the process and generally were unaware of problems that may have arisen. Most protocols called for repeat contact with patients so that a relationship would develop and information could be provided before obtaining a formal consent. The actual signing of a consent form often reflected a decision that had been made much earlier in the process. These findings have significance for both sides in the dispute over informed consent in research. Those who favor tighter controls over psychiatric research will have to consider the implications of monitoring, without destroying, a prolonged and complicated process. Those who argue for a reliance on investigators' integrity must deal with the apparent lack of involvement most investigators have in the consent process.     

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。     

Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry

This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.     

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.     

Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population

Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5 %), and agreed that it provided enough information to make an informed decision (89.5 %). Those who thought it would be more important to know the severity of the conditions being screened (p?=?.002) and range of symptoms (p?=?.000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.     

Comprehension of Online Informed Consents: Can It Be Improved?

This study examined possible ways to ensure that participants provide fully informed consent for online surveys. Participants were randomly assigned to read either a traditional informed consent or one of three modified versions: enhanced (e.g., images, bullet points), consent for each key element, or a combination of these two. Those who read the combination version scored higher on a comprehension quiz, guessed at fewer questions, and were more likely to read all of the informed consent than those who received the traditional version. These findings suggest that comprehension can be improved by adopting alternatives to the traditional informed consent.     

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.     

Goodness-of-fit ethic for informed consent to research involving adults with mental retardation and developmental disabilities

This article reviews current theory and research on informed consent policies for adults with mental retardation within a relational ethics framework that re-conceptualizes consent vulnerability in terms of the goodness-of-fit between participant decisional capacities and the specific consent context. Conceptualizing informed consent competence as a product of the relationship between person and consent context shifts assessment of decisional capacity away from an exclusive focus on a research participant's cognitive deficiencies to (a) an examination of those aspects of the consent setting that are creating or exacerbating consent vulnerability and (b) consideration of how the setting can be modified to produce a consent process that best reflects and protects the hopes, values, concerns, and welfare of adults with developmental disabilities.     

Conducting Health Disparities Research with Criminal Justice Populations: Examining Research,Ethics, and Participation

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision (e.g., parole and/or probation). Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation (i.e., the informed consent process, confidentiality, compensation, what is meant by human subject and clinical trials) among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies.     

Do Undergraduate Student Research Participants Read Psychological Research Consent Forms? Examining Memory Effects,Condition Effects,and Individual Differences

Although research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information.     

Experimenter Characteristics and Word Choice: Best Practices When Administering an Informed Consent

The present research seeks to better understand research conditions in laboratory research, with special attention paid to the informed consent process and experimenter characteristics. The first study tested the impact of language perspective and experimenter demeanor upon participant retention of the informed consent information, attitudes toward the research project, and performance on experimental tasks. The second study examined the impact of experimenter attire. Across the two studies, our results suggest that there was no impact of language perspective, whereas the number of other participants in the laboratory, experimenter attire, and experimenter demeanor influence participant behaviors in the laboratory.     

Informed consent in the psychosis prodrome: ethical,procedural and cultural considerations

Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts.