Human participants challenges in youth-focused research: perspectives and practices of IRB administrators

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals an Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives.     

Conflict and Convergence: The Ethics Review of Action Research

The article is based on the author’s experience as an administrator of three primarily social science institutional review boards (IRBs) to which researchers presented research protocols that purported to be minimal risk studies of teacher practice where the “teacher–researcher” was the “research subject.” Recently, educational, social, and behavioral science researchers encounter many problems with regard to their methodologies and the oversight mandate of the IRBs. There is a divergence between the IRB’s role and assumed bio-clinical predisposition and the ability of behavioral and social science researchers to have their research methodologies and research understood and appreciated by IRB members. The article explores some of the dilemmas confronting IRB members and administrators in the review and administration of the action research protocols, particularly those that involve vulnerable populations and which, from the practitioner–researcher’s perspective, focus on the practitioner–researcher as the object of the research.     

Impact of Institutional Review Boards on cancer research

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board (IRB) are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of the clinical investigator.     

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.     

A commentary on Dr. Kennedy's perception of the impact of Institutional Review Boards on cancer research

The Institutional Review Board is a committee of the institution responsible for carrying out the institution's responsibilities for the protection of human research subjects. Since it is a local committee, most of the complaints about the IRB can be resolved locally provided it is borne in mind that the IRB is the champion not only of the human research subject but also of the investigator. National or regional cooperative research protocols present problems that are not insurmountable.     

Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities.     

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.     

Victor Frankenstein’s Institutional Review Board Proposal, 1790

To show how the case of Mary Shelley’s Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries’ scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from “dead” tissues. In Mary Shelley’s Frankenstein, Victor failed to consider his creature’s autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself.     

The School Counselor as Perceived by School Counselors and Their Principals

This study was designed to ascertain the perceptions of school counselors and school administrators of the school counselor's activities and the attributes necessary for him to be effective in his role. The findings were interpreted to suggest that differences that exist between the perceptions of counselors and administrators tend to be in the degree to which they view certain activities or attributes as important. Ranking of activities and the attributes by both groups tended to be similar but differences were found to exist between the mean scores of counselors and administrators in various areas. Sources of discrepancy were discussed as possibly relating to the need for counselors to establish clearer priorities for their activities and the administrators' perception of the counselor as fundamentally a quasi-administrator of guidance services.     

Institutional Review Boards and Professional Counseling Research

Institutional review boards (IRBs) are responsible for regulating and safeguarding research with human participants in academic institutions in the United States. The authors explore (a) the historical impetus for IRBs, (b) the ethical values and principles as core components of the review process, and (c) the American Counseling Association's (2005) standards for ethical research. In many ways, IRB review and counseling research are complementary, yet some challenges and obstacles unique to counseling research also exist and are elaborated in the article. Implications for counselors initiating research projects and suggestions for implementation are provided.     

Human participants challenges in youth tobacco cessation research: researchers' perspectives

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver.     

Do IRBs Pass the Minimal Harm Test?

ABSTRACT— We describe examples of institutional review board (IRB) actions that have delayed or thwarted research that could not conceivably be considered to pose more than minimal risk to participants. We propose three changes to improve the IRB process and reduce both human and financial costs.     

Motivational underpinnings of social influence in work settings: Bases of social power and the need for cognitive closure

This research explored the notion that the use and efficacy of influence tactics launched from different social power bases depends on influence agents' and recipients' need for cognitive closure. In three separate studies conducted in diverse organizational contexts, it was found that, while overall participants exhibited a preference for soft over hard social influence tactics, this preference becomes less pronounced for supervisors high (versus low) on need for closure and becomes more pronounced for supervisors low on the need for closure. Overall, soft tactics were more beneficial for subordinates' performance than hard tactics; however, the benefits of soft tactics decreased as a function of subordinates' need for closure. Finally, organizational outcomes were improved when recipients who were high (versus low) on the need for closure were exposed to “hard” power tactics and those low (versus high) in the need for closure were exposed to “soft” tactics. Copyright © 2011 John Wiley & Sons, Ltd.     

Person–Job Fit and Work-Related Attitudes Among Chinese Employees: Need for Cognitive Closure as Moderator

The current research examined the moderating role of employees' need for cognitive closure in the relationship between their perceived person–job fit and their work-related attitudes. In Study 1, a survey was conducted among 176 Chinese employees from various organizations, and the results confirmed that both demand–ability fit and need–supply fit were positively related to employees' job satisfaction; moreover, these relations were stronger among people with higher need for closure than those scoring lower in need for closure. In Study 2, a survey was conducted among 242 employees from a Chinese city government, and the results replicated the findings of Study 1, but also found that need for closure moderated the relation between demand–ability fit and turnover intention. These results have important implications for research in organizational psychology and human resource management.     

Financially motivated transfers and discharges: Administrators' ethics and public expectations

In response to a competitive environment, hospital administrators are pressuring physicians to discharge Medicare patients “sicker and quicker” and to transfer indigent patients from their emergency rooms. This paper compares health administrators' ethics to public expectations regarding financially motivated hospital transfers and discharges. Health administrators use balancing strategies: code morality, survivalism, mission dependency, and tithing. Public expectations, exemplified in P.L. 99–272, P.L. 99–509, and recent case law, are based on norms of potential for patient harm and patient occupancy. These norms are morally preferable to those of health administrators; they reinforce the value of identified lives and the reliability of the health care system.     

Research on familial Creutzfeldt-Jakob disease (FCJD) resulting in presymptomatic testing: Implications for the human genome project

A research study to identify the priori gene mutation in a family with familial Creutzfeldt-Jakob disease (FCJD) evolved into presymptomatic diagnostic testing. Our experience with one case raises concerns regarding similar studies that will ensue as a result of the Human Genome Project. Technological advances in human molecular genetics make it difficult for Institutional Review Boards (IRB) to adequately evaluate proposed studies. Additionally, changes in the implications of the study may occur after initial IRB approval, due to technological progress. While FCJD, like Huntington's disease (HD), has adult onset and causes progressive dementia and ataxia, protocols established for presymptomatic testing of HD were not included in the FCJD study design. It is thus recommended that IRB committees include a genetics professional and that IRB-approved research studies be reevaluated on a regular basis to monitor the impact that technological advances may have on participating human subjects.     

Children's conceptions of Jesus

This paper presents findings from a recent study investigating young children's (aged 10–11) conceptions of Jesus in England. The overall picture revealed by the study is that whilst there was a general assent amongst pupils in our sample towards an ethical and humanistic conception of the historical Jesus, there was less of a consensus about those issues which previous research claims children find difficult to understand, namely: the divinity of Jesus; the miracles of Jesus; and Christian beliefs pertaining to Jesus' continued presence in people's lives today. The paper concludes by arguing that the variety of conceptions of Jesus which are encountered in religious education (RE) may be seen by children as a barrier to learning rather than an opportunity to grow in understanding and highlights the need for further research into the relationship between children's hermeneutical horizons and RE curriculum content.     

Perceived organizational support and perceived external prestige: predicting organizational attachment for university faculty, staff, and administrators

The present article introduces a social-exchange model of organizational attachment incorporating both direct exchange and indirect exchange. Participants were 325 university employees. The present results indicated that perceived organizational support (POS) and perceived external prestige (PEP) both contribute to organizational attachment. Further, the results showed that the extent to which POS and PEP are related to organizational attachment is moderated by occupational proxies of cosmopolitan-local role orientation. POS was more strongly related to the affective commitment and withdrawal cognitions of staff and administrators than to those of faculty. PEP was more strongly related to affective commitment and withdrawal cognitions of university faculty than to those of university staff and administrators. The authors discussed the need to incorporate relational variables such as PEP into other social-exchange frameworks.     

Self-esteem,need gratification,and work satisfaction: A test of competing explanations from consistency theory and self-enhancement theory

A sample of 112 administrators provided self-report data used to test two hypotheses derived from Korman's consistency model of work behavior. As predicted, those with high self-esteem experienced significantly greater need gratification than did those with low self-esteem, and self-esteem also significantly positively moderated the relationship between n gratification and work satisfaction. Need gratification was assessed for only those needs that were most salient for each person, thus eliminating a rival interpretation of the findings derived from the self-enhancement model of self-esteem. The moderating effect of self-esteem on the n gratification-work satisfaction relationship was limited to those experiencing low levels of n gratification, indicating a possible “boundary condition” of consistency theory. A problem with the use of moderator variables in behavioral science was also discussed.