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.     

The fair transaction model of informed consent: an alternative to autonomous authorization

The doctrine of informed consent in bioethics has relied on the view that consent is valid when it represents a patient or research subject's autonomous authorization. In this article we challenge this reigning conception of the validity of informed consent in clinical research, focusing in particular on the problem of the therapeutic misconception. We argue that the autonomous authorization model of informed consent suffers from four defects: (1) it fails to do justice to the relevance of risk-benefit considerations in shaping the criteria for the validity of consent, (2) it compromises the interests of subjects by preventing them from consenting to research participation with less than substantial understanding when doing so would likely be consistent with their preferences and beneficial to them or at least be unlikely to cause them harm, (3) it jeopardizes the interests of investigators by denying them fair notice regarding when the consent of research subjects can be considered valid and thus make it permissible for them to be enrolled in research, and (4) it threatens the reasonable limits on the responsibility of investigators to assure the adequacy of subjects' understanding of what research participation involves. In place of the autonomous authorization model, we present and defend a fair transaction model of informed consent, which better reflects the values served by consent.     

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 Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

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.     

A Study of the Impact of Informed Consent Procedures on Participant Responses in Trauma-Related Research

Researchers and ethics board members are often concerned about the possibility of adverse reactions to trauma-related research. While research has shown that participants in trauma-related studies rarely experience adverse reactions, mild short-term emotional distress is common. While a number of protections have been suggested to minimize risks for more vulnerable subgroups of participants, no research to date has tested how modifications to informed consent procedures may affect the data collected and participant reactions to the research. One-hundred and forty-five college students were separated into five conditions with different modifications to the informed consent procedures. Participants completed surveys on trauma experience, posttraumatic stress, coping, and reactions to research participation. The results showed no differences among the conditions on all outcome measures. It appears that modifications to informed consent procedures geared toward minimizing risk do not affect the quality of the data collected nor change reactions to participating in trauma-related research.     

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.     

Genetic research,adolescents, and informed consent

The participation of adolescents in genetic research engenders unusual problems concerning the nature of their informed consent. In this study we analyze 70 consent documents collected from genetics investigators in the United States who conduct research with children and adolescents. We find that many consent documents do not reflect either the current or the developing ethical and legal standards for research with adolescents and that in many cases the documents are simply confusing or unclear. We make recommendations for change to reflect more adequately the changing perspective concerning the autonomous decision-making capacity of adolescents.     

"There is no evidence to suggest...": changing the way we judge information for disclosure in the informed consent process

Feminist health activists and medical researchers frequently disagree on the adequacy of the informed consent processes in clinical trials. I argue for an informed consent process that reflects the central importance of patient-participant autonomy. Such a standard may raise concerns for medical researchers about their capacity to control the quantity and quality of the information they disclose to potential participants. These difficulties might be addressed by presenting potential participants with differently sized disclosure packages.     

知情同意：从纽伦堡到赫尔辛基

知情同意被视为临床伦理学与研究伦理学的基本原则。大量的文献倡导提高同意的必要条件。据说,同意应当更加明确、具体。经验主义的证据显示,满足任何一方标准是极其困难的,有时是不可能的,因此,这些目标很难行得通。倡导知情同意不实际与不可能的要求,有极小的价值。讨论告知不能作为临床伦理学与研究伦理学的基本标准,知情同意可以最好视为病人与受试者以及其他人所能选择性放弃其他的义务,而不采取侵害性行为的一种方法。它提供了一种调节根本的义务的重要方式,这一义务是由尊重真正执行同意所需要的伦理标准与认识力的双方提供。     

Routine HIV testing of hospital patients and pregnant women: informed consent in the real world

The Centers for Disease Control and Prevention (CDC) has recommended that HIV testing be routinely offered to certain patients in hospitals with a high prevalence of HIV infection and on all pregnant women. The CDC does not, however, offer implementation level guidelines for obtaining informed consent. We provide a moral justification for requiring informed consent for HIV testing and propose guidelines for securing such consent. In particular we argue that genuine informed consent can be secured without elaborate counseling, such as that currently used at Counseling and Testing Sites, provided that sufficient written notice is given to the patients before testing and that they are specifically asked for permission.     

The “Ought-Is” Problem: An Implementation Science Framework for Translating Ethical Norms Into Practice

Abstract

We argue that once a normative claim is developed, there is an imperative to effect changes based on this norm. As such, ethicists should adopt an “implementation mindset” when formulating norms, and collaborate with others who have the expertise needed to implement policies and practices. To guide this translation of norms into practice, we propose a framework that incorporates implementation science into ethics. Implementation science is a discipline dedicated to supporting the sustained enactment of interventions. We further argue that implementation principles should be integrated into the development of specific normative claims as well as the enactment of these norms. Ethicists formulating a specific norm should consider whether that norm can feasibly be enacted because the resultant specific norm will directly affect the types of interventions subsequently developed. To inform this argument, we will describe the fundamental principles of implementation science, using informed consent to research participation as an illustration.     

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。     

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.     

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.     

Doctors,Patients, and Nudging in the Clinical Context—Four Views on Nudging and Informed Consent

In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.     

Democracy as Uninformed Non‐Consent

Carol Gould argues that democratic institutions can serve as mechanisms of informed consent or could at least facilitate creating regulations and other structures which facilitate informed consent in bioethics, medicine, and elsewhere. I am sceptical. I argue that democracies cannot serve as vehicles of consent, let alone informed consent. Further, the problems of democratic ignorance and irrationality created significant barriers to democratic deliberation helping to produce better regulations or conditions for informed consent. Democracy is not a good surrogate for consent.     

Sign on the Dotted Line: The Informed Consent Process (ICP) as Induced Compliance1

We investigated the social implications of signing an informed consent form (ICF) on participant behavior. ICF research fails to consider that the decision to participate in research is a process that occurs in a social and cultural context. Understanding the meaning of giving consent in this social context is critical. In separate experiments, we found significantly greater agreement to return to complete a study and persistence at a task in participants who signed the ICF versus those who did not. Signing the ICF may be putting participants at risk of induced compliance with study protocols, rather than empowering them to withhold consent or withdraw. Future research should investigate the psychosocial factors affecting participants' decision making in the informed consent process.     

Facilitating Informed Consent: A Multicultural Perspective

Respect for the dignity and autonomy of patients has long been a fundamental principle of ethical decision making. As a practical matter, a primary way of maintaining this ethical standard is by obtaining an individual’s informed consent prior to intervening or collecting data. By giving individuals clear information about alternative treatments and potential risks and benefits, the practitioner tries to ensure that the patient can make an informed choice. However, there are cases in which those seeking informed consent have very different values and belief systems from those whose consent is being sought. In this article we explore such discrepancies using informed consent with Navajo clients as an example, illustrate potential challenges with case examples, and propose ways in which ethical dilemmas may be successfully navigated.     

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.