Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: (1) Address the role of history and experience on trust, (2) engage concerns about potential group harm, (3) address cultural values and communication barriers, and (4) integrate patient values and expectations into oversight and governance structures.     

Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled “The Ethics of Research in Emergency Medicine”. An earlier version of this paper was presented at: The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Children's competence for assent and consent: a review of empirical findings

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identifies several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interest approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence and comparison of children's competence for treatment and research decisions.     

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.     

On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. This revised version was published online in August 2006 with corrections to the Cover Date.     

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role 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.     

Sexual Health Research Among Youth Representing Minority Populations: To Waive or Not to Waive Parental Consent

Human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) significantly burden youth 13–24 years of age in the United States. Directly engaging youth in sexual health research is a public health priority and urgently needed to develop targeted, youth-friendly, and culturally relevant HIV/STI prevention interventions. Controversies arise, however, regarding informed assent and consent, parental permission or consent, and the definition of “child”/“minor” as it relates to medical, legal, and ethical issues. In this article, we describe challenges in the human subjects review processes that were undertaken before beginning an HIV/STI prevention research project with sexually active youth in an urban setting. These findings provide important contextual information to facilitate youth sexual health research and care, and Institutional Review Board approval processes with fewer delays.     

Informed consent as a prescription calling for debate between analysts and researchers(1)

This article is a review of the international scientific literature on informed consent and its use in some of the constituent organizations of the International Psychoanalytical Association (IPA). Because psychoanalysis comprises a theory based on practice, the dearth of clinical material for study, training and research purposes is a serious problem for analysts. Supervisions, presentations at scientific societies and congresses, publications and teaching material involve patients to an extent that goes beyond the work done in their sessions. Should consent be requested in these cases? This contribution addresses controversial and long‐standing issues such as informed consent and confidentiality, audio recording of treatments, knowledge production, the ambivalence of participating subjects over time and the perspective of analysts and patients respectively. The authors consider the various alternative approaches available for the handling of these ethical dilemmas without losing sight of the patient’s dignity and personal rights, while also taking account of the position of the analyst.     

Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health.     

Ethical and legal issues in conducting research involving elderly subjects

Older people are increasingly the focus of biomedical and behavioral research not only because the elderly constitute the fastest growing segment of our population but because there is a societal concern to improve the elderly's quality of life. The profound need to advance that research carries with it an equally profound obligation to protect the rights and welfare of elderly research subjects, and thus raises difficult ethical and legal issues. Against a background of foundational principles for the protection of human subjects, we discuss whether older subjects should be treated as a special class, the ethical and legal issues over informed consent, capacities for consent, and special problems related to cognitive impairment. We discuss surrogate/proxy consent procedures in research, recruitment of elderly subjects, conflicts of interest, special problems regarding institutional research, and risk/benefit analyses. We offer recommendations and practical guidelines for conducting current and future research involving elderly participants.     

The Limitations of “Vulnerability” as a Protection for Human Research Participants

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.     

Rethinking Research Ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

美国对受试者研究中特殊挑战的观点:遗传研究中的伦理问题

虽然基因研究比其他任何时候更有望了解人类疾病及其在世界各类人群中的表现形式,并且对预防和治疗疾病产生了深远影响,但是它的应用也会极大地改变我们对个体及群体特征。从个体属性及群体意识的角度来看,特别是关于知情同意这个议题,我们会非常清楚地看到遗传研究所面临的挑战。阐述了在美国遗传研究所面临的挑战,讨论了遗传研究进行过程中出现的一系列伦理问题,如：如何正确执行知情同意;研究中可能对受试者产生的标签和歧视行为;遗传流行病研究中出现的伦理问题以及需要关注的社区和民族的伦理问题;对人类组织样本的储存和使用中所出现的伦理问题。强调了知情同意和社区参与遗传研究及在研究中社区代表性的重要性;强烈主张在遗传研究中建立多民族的合作是确保研究的顺利进行的基础。     

So You Want to Do an Online Study: Ethics Considerations and Lessons Learned

The use of the Internet in conducting psychological research has become increasingly common over the past few decades, as Internet access has become more widespread. Although web-based work has a number of benefits, including lower cost, easy access to large samples, and strict standardization of administration, the limitations must also be considered. Among these limitations are the ethics concerns related to conducting psychological research online. These concerns include limitations in maintaining confidentiality, conducting thorough informed consent, and conducting valid assessment. Particular focus is given to the limitations inherent in conducting a fully automated online study. All of these limitations are discussed in detail through both a review of existing literature and the brief review of a recent study. The recent study identified areas in which participants struggled with completing a fully automated online task. This article discusses the ethics implications of Internet research as well as offering suggestions for researchers who intend to conduct web-based research, and thoughts on future directions as psychology moves forward in web-based research and assessment.     

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.     

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.     

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.     

‚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.     

Evaluating single-case research data for systematic review: A commentary for the special issue

The purpose of this commentary is to provide observation on the statistical procedures described throughout this special section from the perspective of researchers with experience in conducting systematic reviews and meta-analyses of single-case research to address issues of evidence-based practice. It is our position that both visual and statistical analyses are complimentary methods for evaluating single-case research data for these purposes. Given the recent developments regarding the use of single-case research to inform evidence-based practice and policy, the developments described in the present issue will be contextualized within the need for a widely accepted process for data evaluation to assist with extending the impact of single-case research. The commentary will, therefore, begin with providing an overview of the conceptual underpinnings of a systematic review of single-case research and will be followed by a discussion of several features that are essential to the development of a conceptually sound and widely used statistical procedure for single-case research. The commentary will conclude with recommendations and guidelines for the use of both visual and statistical analyses within primary research reports and recommendations for future research.