Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

Disclosure Issues in Neuroscience Research

Issues of disclosure arise in neuroscientific research during the informed consent process, whenever incidental findings are identified, and when study results are generated. The possibility of disclosure of incidental findings and/or research results may raise informational expectations on the part of subjects and may alter a study's risk:benefit ratio. We recommend that the informed consent process address this potential consequence of research participation, and specify the conditions under which particular types of information will be offered, the conditions under which information may not be disclosed, and any provisions for helping subjects make sense of the information to be disclosed.     

The protection of unrepresented patients in emergency care research

In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations.     

EXCLUDING PARTICULAR INFORMATION FROM CONSENT FORMS

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor’s name on the consent form may allow the form to serve as a surrogate for subjects’ HIV status.

There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.     

Ethical Sharing and Reuse of Qualitative Data

The objective of this paper is to attempt to move beyond the impasse of ethical objections to reusing qualitative data. In doing so, there is no intention of dismissing the importance of ethical debates, in fact, quite the opposite. The debate about ethical reuse needs to be deepened and broadened. First, the current terrain of research ethics will be summarised and situated in the context of broader philosophical ethical frameworks. In contrast, the debates around ethics of archiving have often been narrowly focused on participants' rights. The framework of debate should be broadened first by recognising other entities traditionally deemed within the scope of research ethics, namely the scholarly community and the public. The second useful broadening of the framework is provided by a deontological ethical stance with its focus on duties. In the final section, this expanded framework will be used to rebut several common ethical arguments against archiving qualitative data: archiving violates confidentiality; informed consent for reusing data is impossible; reusing data violates trust between researcher and participant; and, archiving creates an unacceptably high risk of data misrepresentation. If a more general philosophical debate on ethics has something to contribute, the central message must be that no single ethical claim is incontestable. The conclusion will position these debates in a wider context by asking what is at stake when the boundaries of ethical discourse about sharing data are drawn too narrowly.     

The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

Informed consent comprehension among vulnerable populations in Ecuador: video-delivered vs. in-person standard method

The informed consent comprehension process is key to engaging potential research subject participation. The aim of this study is to compare informed consent comprehension between two methods: standard and video-delivered. We compared the in-person and video-delivered informed consent process in the Familias Unidas intervention. We evaluated comprehension using a 7-item true/false questionnaire. There were a total of 152 participants in the control group and 87 in the experimental. General characteristics were similar between both groups (p > 0.05). First-attempt informed consent comprehension was higher in the intervention group but was not statistically significant (80% and 78% respectively p = 0.44). A video-delivered informed consent process did not differ from the standard method of informed consent in a low educational and socioeconomic environment.     

What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

Ethical Challenges in International HIV Prevention Research

Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics training, mechanisms to support community-wide benefit from research, and expanded dialog on the ethics surrounding HIV prevention and public health research.     

Effective Practices in the Delivery of Research Ethics Education: A Qualitative Review of Instructional Methods

In order to delineate best practices for courses on research ethics, the goal of the present effort was to identify themes related to instructional methods reflected in effective research ethics and responsible conduct of research (RCR) courses. By utilizing a qualitative review, four themes relevant to instructional methods were identified in effective research ethics courses: active participation, case-based activities, a combination of individual and group approaches, and a small number of instructional methods. Three instructional method themes associated with less effective courses were also identified: passive learning, a group-based approach, and a large number of instructional methods. Key characteristics of each theme, along with example courses relative to each theme, are described. Additionally, implications regarding these instructional method themes and recommendations for best practices in research ethics courses are discussed.     

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of “informational manipulation”; that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers’ and their sponsors’ financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings

ABSTRACT

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of “text work” as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees’ (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.     

Perceptions of Academic Health Science Research Center Personnel Regarding Informed Consent Processes and Therapeutic Misconception

Introduction: Instrumentation exists to measure voluntariness and misunderstanding in informed consent processes. However, research personnel’s perspectives about using instrumentation to measure therapeutic misconceptions in research participants has not been reported. We designed a workshop to promote research personnel knowledge of emerging instrumentation and to study the perceptions of research personnel regarding such instruments.

Methods and Findings: Two nationally recognized experts who have developed psychometric instruments to measure aspects of informed consent presented their recent findings to research personnel of the Medical University of South Carolina at a one-day workshop. Following the presentations, workshop attendees divided into two focus groups and shared their perceptions regarding the presentation content. Inductive thematic analysis detected themes related to informed consent processes including: investigator/provider role clarity; investigator transparency; therapeutic misconception; and screening subjects for understanding.

Conclusion: Our findings suggest future directions in applied, proactive empirical research to better understand investigator perceptions and practices related to transparency in research, and to develop instrumentation to detect risks to the integrity of informed consent in order to promote voluntariness and autonomy and minimize therapeutic misconception in research practices.     

Research as Profession and Practice: Frameworks for Guiding the Responsible Conduct of Research

Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims. By elucidating these features, these perspectives can serve to guide the development of RCR education programs.     

Physicians' understanding of consent requirements for phase I clinical trials in cognitively impaired or highly vulnerable populations

We investigated physicians' attitudes about entering patients who cannot give informed consent or who are of a vulnerable population into clinical trials. A survey instrument asked a nationwide sample of practicing physicians about whether ten hypothetical patients could be enrolled in a phase I clinical trials. The impact of demographic variables on the number of scenarios viewed as completely or somewhat acceptable was analyzed via student's T tests or analysis of variance (ANOVA) as applicable. All significant (p<0.01) variables were entered into a multiple logistic regression model. Eighty-four percent of respondents indicated that at least one case scenario was acceptable. A majority of those who conduct clinical trials (62%), who had training in the ethics of clinical research (78%), and who sit on institutional review boards (IRBs) (83%) approved of at least one case scenario. Physicians approved of the entry of some patients who cannot give informed consent or who are of a vulnerable population into clinical trials. More effective education on the guidelines involving clinical research should be available to practicing physicians, residents, and medical students. There should also be assurance that physicians who conduct clinical trials or who sit on IRBs have the requisite knowledge about the ethics of clinical research.     

Working Group on Ethical Considerations in Science and Scholarship∗

Persons can be subject to involuntary treatment for mental illness or substance abuse in a variety of circumstances. The ability of such persons to give a valid informed consent for research often has been called into question, because the coercive nature of the treatment is thought to impair the voluntariness of their decision making. A careful consideration of the nature of coercion from a “moralized”; perspective focuses attention on two elements that determine the acceptability of consent: the fairness of the proposal to which consent is sought, and the moral baseline from which the proposal is made. Even when coercion is not present, disproportionate rewards offered for participation in research can impair the voluntariness of consent, as can the unintended effects of the social structure of the system in which the research is taking place. When coercion, defined as a moralized concept, is not present, however, and other conditions do not substantially impair voluntariness, consent to research legitimately may be sought from involuntarily treated populations.     

Ethical Beliefs of Social Work Researchers

Abstract

The purpose of this study is to examine the beliefs of social work researchers about ethical practices. Surveys were mailed to a random sample of 240 members of the Society for Social Work and Research (SSWR) to elicit their views about ethical practices in social work research. Responses from 160 members (67% response rate) yielded information regarding the appropriateness of dual relationships, authorship practices, informed consent procedures, and other conduct in social work research. Age, gender, educational level, years of social work research experience, and current teaching of social work research were related to respondents' ethical views about practices with students and sexual relationships with research subjects. The need for additional resources on ethics in social work research is highlighted.