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.     

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.     

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.     

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.     

When clinical care is like research: the need for review and consent

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.     

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.     

“Not Tied Up Neatly with a Bow”: Professionals’ Challenging Cases in Informed Consent for Genomic Sequencing

As the use of genomic technology has expanded in research and clinical settings, issues surrounding informed consent for genome and exome sequencing have surfaced. Despite the importance of informed consent, little is known about the specific challenges that professionals encounter when consenting patients or research participants for genomic sequencing. We interviewed 29 genetic counselors and research coordinators with considerable experience obtaining informed consent for genomic sequencing to understand their experiences and perspectives. As part of this interview, 24 interviewees discussed an informed consent case they found particularly memorable or challenging. We analyzed these case examples to determine the primary issue or challenge represented by each case. Challenges fell into two domains: participant understanding, and facilitating decisions about testing or research participation. Challenges related to participant understanding included varying levels of general and genomic literacy, difficulty managing participant expectations, and contextual factors that impeded participant understanding. Challenges related to facilitating decision-making included complicated family dynamics such as disagreement or coercion, situations in which it was unclear whether sequencing research would be a good use of participant time or resources, and situations in which the professional experienced disagreement or discomfort with participant decisions. The issues highlighted in these case examples are instructive in preparing genetics professionals to obtain informed consent for genomic sequencing.     

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。     

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.     

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.     

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.     

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.     

Conducting industrial and organizational psychological research: institutional review of research in work organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Web-based research: Methodological variables’ effects on dropout and sample characteristics

Previous research has made a beginning in addressing the importance of methodological differences in Web-based research. The present paper presents four studies investigating whether sample type, financial incentives, time when personal information is requested, table design, and method of obtaining informed consent influence dropout and sample characteristics(both demographics and measured attitudes). Undergraduates were less likely to drop out than nonstudents, and nonstudents offered a financial incentive were less likely to drop out than those offered no incentive. Complex tables, tables that were too wide, requests for personal information on the first page, and the imposing of additional informed consent procedures each provoked early dropout. As was expected, nonstudents and those presented with complex tables showed more measurement error and attitude differences. Asking for personal information and imposing additional consent procedures affected the demographic makeup, raising challenges to external validity.     

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.     

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.