Reassessing the Role of the Biomedical Research Ethics Committee

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review.     

Should protections for research with humans who cannot consent apply to research with nonhuman primates?

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent?     

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.     

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning

Implantable brain–computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.     

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.     

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.     

Statistical Power,the Belmont Report,and the Ethics of Clinical Trials

Achieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense—it is ethically required in experiments when participants are at risk of harm. This paper argues that doing a power analysis effectively contributes to ensuring that a trial design is good. The ethical importance of good trial design has long been recognized for trials in which there is risk of serious harm to participants. However, whether the quality of a trial design, when the risk to participants is only minimal, is an ethical issue is rarely discussed. This paper argues that even in cases when the risk is minimal, the quality of the trial design is an ethical issue, and that this is reflected in the emphasis the Belmont Report places on the importance of the benefit of knowledge gained by society. The paper also argues that good trial design is required for true informed consent.     

The placebo phenomenon and medical ethics: Rethinking the relationship between informed consent and risk–benefit assessment

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment and informed consent.     

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.     

Conducting behavioral research on Amazon’s Mechanical Turk

Amazon’s Mechanical Turk is an online labor market where requesters post jobs and workers choose which jobs to do for pay. The central purpose of this article is to demonstrate how to use this Web site for conducting behavioral research and to lower the barrier to entry for researchers who could benefit from this platform. We describe general techniques that apply to a variety of types of research and experiments across disciplines. We begin by discussing some of the advantages of doing experiments on Mechanical Turk, such as easy access to a large, stable, and diverse subject pool, the low cost of doing experiments, and faster iteration between developing theory and executing experiments. While other methods of conducting behavioral research may be comparable to or even better than Mechanical Turk on one or more of the axes outlined above, we will show that when taken as a whole Mechanical Turk can be a useful tool for many researchers. We will discuss how the behavior of workers compares with that of experts and laboratory subjects. Then we will illustrate the mechanics of putting a task on Mechanical Turk, including recruiting subjects, executing the task, and reviewing the work that was submitted. We also provide solutions to common problems that a researcher might face when executing their research on this platform, including techniques for conducting synchronous experiments, methods for ensuring high-quality work, how to keep data private, and how to maintain code security.     

Genetic Counselors’ Experiences Regarding Communication of Reproductive Risks with Autosomal Recessive Conditions found on Cancer Panels

The development of hereditary cancer genetic testing panels has altered genetic counseling practice. Mutations within certain genes on cancer panels pose not only a cancer risk, but also a reproductive risk for autosomal recessive conditions such as Fanconi anemia, constitutional mismatch repair deficiency syndrome, and ataxia telangiectasia. This study aimed to determine if genetic counselors discuss reproductive risks for autosomal recessive conditions associated with genes included on cancer panels, and if so, under what circumstances these risks are discussed. An on-line survey was emailed through the NSGC list-serv. The survey assessed 189 cancer genetic counselors' experiences discussing reproductive risks with patients at risk to carry a mutation or variant of uncertain significance (VUS) in a gene associated with both an autosomal dominant cancer risk and an autosomal recessive syndrome. Over half (n = 82, 55 %) reported having discussed reproductive risks; the remainder (n = 66, 45 %) had not. Genetic counselors who reported discussing reproductive risks primarily did so when patients had a positive result and were of reproductive age. Reasons for not discussing these risks included when a patient had completed childbearing or when a VUS was identified. Most counselors discussed reproductive risk after obtaining results and not during the informed consent process. There is inconsistency as to if and when the discussion of reproductive risks is taking place. The wide variation in responses suggests a need to develop professional guidelines for when and how discussions of reproductive risk for autosomal recessive conditions identified through cancer panels should occur with patients.     

Ethical and Legal Guidance for Mental Health Practitioners Who Wish to Conduct Research in a Private Practice Setting

Mental health practitioners, even when they have research training, rarely contribute to the scientific literature. One reason for this may be that they need help addressing the ethical and legal issues they encounter as they contemplate undertaking research in a clinical practice setting. To address that need, we offer several types of guidance for conducting research in a private practice setting in a way that meets high ethical and legal standards. We describe the situations in which ethical review of a research proposal by a federally registered institutional review board (IRB) is legally required, and identify alternate mechanisms that practitioners can use to obtain an ethical review when a formal IRB review is not required by law. We discuss legal and ethical requirements of conducting single-case studies in a practice setting. We provide a rationale, and free and inexpensive options, for obtaining a formal certificate of training in human subjects research. And we offer guidance for obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from research participants. We conclude with a brief discussion of other legal and professional issues to consider when conducting research in private practice.     

Limits on risks for healthy volunteers in biomedical research

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.     

Ethical considerations for neuropsychologists as functional magnetic imagers

This discussion highlights ethical and practical issues potential neuropsychologist-imagers should consider in conducting functional magnetic resonance imaging (fMRI). While fMRI is not currently approved for clinical use, research is ongoing which has implications for clinical practice, from refining brain-behavior relationships, to assisting with diagnosis and treatment decisions. To protect the welfare of cognitively impaired populations requires special care with respect to MR risks and informed consent. Competent functional imaging requires an understanding of the strengths, limitations, and appropriate domain of applications of the measure.     

The affect heuristic in early judgments of product innovations

According to the affect heuristic, people often rely upon their overall affective impression of a target to form judgments of risk. However, innovation research has largely characterized risk perception as a function of what the consumer knows rather than how they feel. In three studies, this research investigates the use of the affect heuristic in consumer judgments of product innovations. The findings indicate that judgments of risks and benefits associated with product innovations are inversely related and affectively congruent with evaluations of those innovations. Additionally, more affectively extreme evaluations are associated with increasingly disparate judgments of risk and benefit. This research contributes to our theoretical understanding of both consumers' evaluations of product innovations and the affect heuristic. Implications and suggestions for future research are also discussed. Copyright © 2014 John Wiley & Sons, Ltd.     

The long-term risks in the short-term benefits: perceptions of potentially addictive activities.

It is generally assumed that individuals who take risks with their health either underestimate the magnitude of those risks or seek some benefit. This study assessed whether risk taking might also result from underestimating the benefits. In Study 1, lower estimates of the pleasure of drug use and risk of addiction were significantly related to increased self-reported experimentation and problems with drug use. This relationship remained significant even after controlling for preexisting psychosocial factors. In Study 2, perceptions of these "risks-in-the-benefits" were shown (a) to be distinct from perceptions of immediate benefits and (b) to serve as a protective factor against future alcohol use. Results are discussed in terms of creating improved interventions.     

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.     

An existential view of adolescent development

In clinical work with adolescents there is a stark similarity between what they experience and the concepts of existentialism. However, surprisingly very little has been written in terms of how the concepts of existentialism can or should be applied to this age group. Rather, existentialism seems to be a concept reserved for its application to the adult population. In fact, a search of the literature included in PsychINFO under "existentialism" and "adolescent development" results in only 5 hits. Perhaps by avoiding the use of these ideas as they might apply to adolescents, for various reasons a disservice is being done. Drawing on ideas posited in existential literature will not only benefit adolescents, it will assist caring adults in their work with them and encourage professionals to expand on existing ideas when conducting research and developing theories that apply to this age group.     

Harms and deprivation of benefits for nonhuman primates in research

The risks of harm to nonhuman primates, and the absence of benefits for them, are critically important to decisions about nonhuman primate research. Current guidelines for review and practice tend to be permissive for nonhuman primate research as long as minimal welfare requirements are fulfilled and human medical advances are anticipated. This situation is substantially different from human research, in which risks of harms to the individual subject are typically reduced to the extent feasible. A risk threshold is needed for the justification of research on nonhuman primates, comparable to the way risk thresholds are set for vulnerable human subjects who cannot provide informed consent. Much of the laboratory research conducted today has inadequate standards, leading to common physical, psychological, and social harms.