The Low Risk Research Ethics Application Process at CQUniversity Australia

The CQUniversity Australia Human Research Ethics Committee (HREC) is a human ethics research committee registered under the auspices of the National Health and Medical Research Council. In 2009 an external review of CQUniversity Australia’s HREC policies and procedures recommended that a low risk research process be available to the institution’s researchers. Subsequently, in 2010 the Human Research Ethics Committee Low Risk Application Procedure came into operation. This paper examines the applications made under the Human Research Ethics Committee Low Risk Application Procedure during the course of 2010 and 2011. The paper contributes to the literature analyzing the decision-making processes of research review committees through an analysis of the quantitative data relating to the low risk research applications made and through discourse analysis of the qualitative data represented by the assessment comments of the members of the Committee.     

Determining risk in pediatric research with no prospect of direct benefit: time for a national consensus on the interpretation of federal regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" ( section sign 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition ( section sign 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations section sign section sign 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than “minimal risk” (§ 45CFR46.404); or 2) no more than a “minor increase over minimal risk” if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1977. Report and recommendations: Research involving children, Washington, DC: U.S. Government Printing Office.  [Google Scholar] report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

The CIOMS view on the use of placebo in clinical trials

Based on worldwide consultations with experts in science and ethics the revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects provide guidance on when the use of placebo as a comparator in clinical research is ethically acceptable. The article reviews the main points of the CIOMS Guidelines and commentaries including the use of placebo in situations where the best current method is available and the relation of placebo to established effective intervention. It discusses the use of placebo in externally sponsored research in low-resource countries and requirements for informed consent related to placebo studies. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

人类干细胞研究的伦理学争论

关于干细胞研究的伦理学争论越来越成为热门话题。2000年8月23日,美国卫生研究所颁布了涉及人类多能胚胎干细胞研究的指南。指南允许联邦政府资助的研究者进行干细胞研究,但是按照布什总统2001年8月9日的决定,政府只资助有限制的干细胞研究。而在英国、法国、日本、澳洲、以及其他国家,干细胞研究不仅在私人的实验室里而且也在政府的实验室里进行着。无论如何,人类干细胞研究应该按照一定规范谨慎进行。     

"Lost in a shopping mall" -- a breach of professional ethics

The "lost in a shopping mall" study has been cited to support claims that psychotherapists can implant memories of false autobiographical information of childhood trauma in their patients. The mall study originated in 1991 as 5 pilot experiments involving 3 children and 2 adult participants. The University of Washington Human Subjects Committee granted approval for the mall study on August 10, 1992. The preliminary results with the 5 pilot subjects were announced 4 days laters. An analysis of the mall study shows that beyond the external misrepresentions, internal scientific methodological errors cast doubt on the validity of the claims that have been attributed to the mall study within scholarly and legal arenas. The minimal involvement -- or, in some cases, negative impact -- of collegial consultation, acadmic supervision, and peer review throughout the evolution of the mall study are reviewed.     

Improving the peer-review process for grant applications: reliability, validity, bias, and generalizability

Peer review is a gatekeeper, the final arbiter of what is valued in academia, but it has been criticized in relation to traditional psychological research criteria of reliability, validity, generalizability, and potential biases. Despite a considerable literature, there is surprisingly little sound peer-review research examining these criteria or strategies for improving the process. This article summarizes the authors' research program with the Australian Research Council, which receives thousands of grant proposals from the social science, humanities, and science disciplines and reviews by assessors from all over the world. Using multilevel cross-classified models, the authors critically evaluated peer reviews of grant applications and potential biases associated with applicants, assessors, and their interaction (e.g., age, gender, university, academic rank, research team composition, nationality, experience). Peer reviews lacked reliability, but the only major systematic bias found involved the inflated, unreliable, and invalid ratings of assessors nominated by the applicants themselves. The authors propose a new approach, the reader system, which they evaluated with psychology and education grant proposals and found to be substantially more reliable and strategically advantageous than traditional peer reviews of grant applications.     

The Dilemma of Dual Use Biological Research: Polish Perspective

Biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security is termed dual use. In Poland there are adequate conditions for conducting experiments that could be qualified as dual use research, and therefore, a risk of attack on Poland or other countries exists. Optimal solutions for limiting such threats are required, and the national system of biosecurity should enable early, reliable, and complete identification of this type of research. Scientists should have a fundamental role in this process, their duty being to immediately, upon identification, report research with dual use potential. An important entity in the identification system of dual use research should also be the Central Register of Biological and Biomedical Research, which gathers information about all biological and biomedical research being conducted in a given country. Publishers, editors, and review committees of journals and other scientific publications should be involved in evaluating results of clinical trials. The National Council of Biosecurity should be the governmental institution responsible for developing a system of dual use research threat prevention. Its role would be to develop codes of conduct, form counsel of expertise, and monitor the problem at national level, while the Dual Use Research Committee would be responsible for individual cases. In Poland, current actions aiming to provide biological safety were based on developing and passing an act about genetically modified organisms (GMO’s) and creating a GMO Committee. Considering experiences of other nations, one should view these actions as fragmentary, and thus insufficient protection against dual use research threats.     

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.     

Institutional animal care and use committees: a flawed paradigm or work in progress?

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past.     

Institutional Animal Care and Use Committees: A Flawed Paradigm or Work in Progress?

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and (c) the committee's operational base of authority is alien to academic culture and violates essential aspects of academic freedom. In addition, he found that the system is burdensome, requiring enormous expenditures of time and money that inappropriately diverts resources away from the business of scientific discovery. We dispute several aspects of Steneck's historical account and the coherence of his proposals. We believe his proposals, if followed, would be a step back into a failed past.     

Disability and rehabilitation research. Opportunities for participation,collaboration, and extramural funding for psychologists

The National Institute on Disability and Rehabilitation Research (NIDRR) funds research and related activities that promote new knowledge that helps individuals with disabilities to perform regular activities in the community and increases the capacity of society to provide full opportunities and supports for individuals with disabilities. NIDRR achieves this goal by promoting interdisciplinary research and related activities. Psychologists play a key role in many of these activities and assist with improving understanding of disability and rehabilitation by participating in peer review of research proposals or by reviewing NIDRR's proposed research priorities. Psychologists also contribute by taking advantage of training and the many other opportunities for support outlined in this article.     

The India Experience

This article featuring India constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream program funded by the Fogarty International Center for Advanced Study in the Health Sciences. Research ethics is a growing area of work and interest in India. Ethics review remains the weakest component in the mechanism of good clinical practice, and there is a severe dearth of professionals trained in ethics who can provide leadership. Although the Indian Good Clinical Practice Guidelines, the Indian Medical Council Act, and the Drugs and Cosmetics Act require that the Indian Council of Medical Research’s ethical guidelines be followed as a mandatory requirement for physicians who conduct research, there is a pervasive lack of awareness of basic requirements guiding the ethical conduct of research. There is a great need to strengthen India’s research ethics capacity and regulatory framework for research.     

医疗损害赔偿费用的探讨

《医疗事故处理条例》与《民法通则》确定的赔偿范围和标准不一致。通过《医疗事故处理条例》与《民法通则》的对比,提出医疗损害赔偿的三个原则,即全面赔偿原则、限额赔偿原则、衡平赔偿原则,以及建立医疗损害赔偿费用的统一标准,希望对司法实践有所借鉴意义。     

关于地区机构伦理委员会的调研与思考

通过对辽宁地区29家机构伦理委员会的机构设置情况、工作内容、伦理审查工作的管理等状况的调研,为了解我国医学伦理委员会的发展现状,存在的问题及发展方向提供局部的现实依据,为进一步完善我国医学伦理委员会建设提出建议。     

美国人体研究的监督：科学发展中的伦理与规定

美国保护人体受试者的制度建立在伦理学基础之上,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益,确保研究的有效性,整体性,以及科学与社会更大范围的利益,监督审查机构是联邦卫生部下属的两个机构-食品与药品管理局（FDA）和人体研究保护办公室（OHRP）,大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会（IRB）及知情同意,IRBU电在提供一种机制,以进行客观的审查,同意和研究过程听持续监督;知情同意意在保证个人在了解与实验相关的风险,不适,收益后能自由做出参加与否的决定,美国人体研究保护制度正面临着挑战。美国也为促进人体受试者保护在进行新的努力。     

Peer Experiences of Anxious and Socially Withdrawn Youth: An Integrative Review of the Developmental and Clinical Literature

Prior research indicates that both anxious youth and socially withdrawn youth tend to experience challenges and difficulties in various aspects of their peer relationships and social functioning. While clinical psychology researchers have examined how anxiety relates to peer experiences using normative and clinically anxious samples, developmental psychologists have focused primarily on the peer experiences of shy and withdrawn children. Research from these two fields has progressed on related yet separate paths, producing similar results despite using different terminology and assessment techniques. The purpose of this review is to bring together the developmental and clinical bodies of literature on the peer experiences of anxious and socially withdrawn youth by identifying common themes and unique contributions of each discipline. Studies reviewed focus specifically on the peer constructs of acceptance, friendship, peer victimization, social skills, and social-cognitive processes. Limitations including methodological inconsistencies and insufficient examination of age-, gender-, and ethnicity-related issues are identified. Recommendations for future collaborations between developmental and clinical researchers as well as implications for interventions targeting the peer relations of anxious and withdrawn youth are discussed.     

Oversight framework over oocyte procurement for somatic cell nuclear transfer: comparative analysis of the Hwang Woo Suk case under South Korean bioethics law and U.S. guidelines for human embryonic stem cell research

We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under governmental auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea.     

The role of adolescent peer affiliations in the continuity between childhood behavioral adjustment and juvenile offending

This research reports on a structural equation model analysis of the relationships between childhood behavioral adjustment, adolescent peer affiliations, and adolescent offending using data gathered during the course of a 16-year longitudinal study of a birth cohort of New Zealand children. The model developed contained parameters that estimated (a) the continuities between early behavior and later offending, (b) the associations between early behavior and adolescent peer affiliations, and (c) the potentially reciprocal relationship between adolescent peer affiliations and adolescent offending behaviors. This analysis suggested that, when due allowance was made for reporting error, there was evidence of relatively strong continuity (r= .50) between early behavior and later offending. The model estimates suggested that these continuities arose from both direct continuities in behavior over time and from the effects of adolescent peer affiliations in reinforcing and sustaining earlier behavioral tendencies. The implications of the analysis for the understanding of the role of adolescent peer affiliations in behavioral continuities and discontinuities are discussed. These research has been funded by grants from the Health Research Council of New Zealand, the National Child Health Research Foundation, and the Canterbury Medical Research Foundation.     

Revising the history of Cold War research ethics

President Clinton's charge to the Advisory Committee on Human Radiation Experiments included the identification of ethical and legal standards for evaluating government-sponsored radiation experiments conducted during the Cold War. In this paper, we review the traditional account of the history of American research ethics, and then highlight and explain the significance of a number of the Committee's historical findings as they relate to this account. These findings include both the national defense establishment's struggles with legal and insurance issues concerning human experiments, and the medical profession's perspective on human experimentation in the years following the Nuremberg Medical Trials. We conclude that the Committee's work both enriches the traditional view of the history of research ethics and opens important new areas for study.