Medical research-ethics applied to social sciences: relevance, limits, issues and necessary adjustments

Social sciences are concretely concerned by the ethics of medical research when they deal with topics related to health, since they are subjected to clearance procedures specific to this field. This raises at least three questions: - Are principles and practices of medical research ethics and social science research compatible? - Are "research subjects" protected by medical research ethics when they participate in social science research projects? - What can social sciences provide to on-going debates and reflexion in this field? The analysis of the comments coming from ethics committees about social science research projects, and of the experience of implementation of these projects, shows that the application of international ethics standards by institutional review boards or ethics committees raises many problems in particular for researches in ethnology anthropology and sociology. These problems may produce an impoverishment of research, pervert its meaning, even hinder any research. They are not only related to different norms, but also to epistemological divergences. Moreover, in the case of studies in social sciences, the immediate and differed risks, the costs, as well as the benefits for subjects, are very different from those related to medical research. These considerations are presently a matter of debates in several countries such as Canada, Brasil, and USA. From another hand, ethics committees seem to have developed without resorting in any manner to the reflexion carried out within social sciences and more particularly in anthropology Still, the stakes of the ethical debates in anthropology show that many important and relevant issues have been discussed. Considering this debate would provide openings for the reflexion in ethics of health research. Ethnographic studies of medical research ethics principles and practices in various sociocultural contexts may also contribute to the advancement of medical ethics. A "mutual adjustment" between ethics of medical research and social sciences is presently necessary: it raises new questions open for debate.     

Biology, ethics, and public policy: deliberations at an unstable intersection

Biology, ethics, and politics intersect in many public policy issues. The unique features of the meeting point in each case are affected by changes in scientific and technological knowledge, moral analysis in a pluralistic society, and political relations. No one of the three can be ignored without repercussions. This essay, however, concentrates on ethics. The ethical dimension must allow for genuine differences in fundamental moral stance, which always persist alongside scientific developments. Two scientific/medical issues with considerable ethical and political implications are discussed: (1) application of human embryonic stem cell research in regenerative medicine and (2) neuroscientific reductionism in the context of behavioral research and moral responsibility. Public advisory committees and other governmental structures for pursuing public policy should not rely merely on cost-benefit analysis to form policy, as if it were uniquely objective, but should also recognize the necessity of considering science and ethics together as two separate yet complementary foundations of policy. Minimizing the distinctness of the biological and ethical dimensions will make any conclusions unstable and their later implementation more difficult.     

Electronic medical record systems at academic health centers: advantages and implementation issues.

The growth of managed care has fueled expectations for a more coordinated delivery of clinical services and a reduction of unnecessary utilization. Among the most important issues that constrain these expectations is the transfer of medical information. Electronic medical record (EMR) systems appear to offer substantive advantages over paper records for both containing costs and improving the quality of care. However, incorporation of EMR systems into practice settings has languished. Among the barriers to implementation are software problems of codification and entry of data, security issues, a dearth of integrated delivery systems, reluctant providers, and prohibitive costs. The training programs of academic health centers (AHCs) are optimal environments for testing and implementing EMR systems. AHCs have the expertise to resolve remaining software issues, the components necessary for integrated delivery, a culture for innovation in clinical practice, and a generation of future providers that can be acclimated to the requisites for computerized records. The authors critically review these and other issues of implementing EMR systems at AHCs and propose four necessary steps for financing their implementation.     

Differences and structural weaknesses of institutional mechanisms for health research ethics: Burkina Faso,Palestine, Peru,and Democratic Republic of the Congo

Background

Regardless of national contexts, the institutions responsible for research ethics, founded on international regulations, are all expected to be structured and to operate in a common way. Our experience with several countries on different continents, however, has raised questions in this regard. This article examines the differences and structural weaknesses of ethics committees in four countries (Burkina Faso, Palestine, Peru, and the Democratic Republic of the Congo) where we have conducted the same socio-anthropological study in the field of reproductive health.

Methods

In addition to recording our observations during field surveys for this study, we performed a documentary review and interviewed expert members of ethics committees, research participants, and researchers who had experience with requesting ethics approvals for research protocols in the field of social sciences and health.

Results

The results of this study showed that, despite having the same mandate, the committees functioned differently, while they all exhibited the same weaknesses. Thus, the universalization and standardization of institutional conditions for applying ethical standards in research still present problems that are, at the very least, relevant.

Conclusion

This study on ethics committees in four countries demonstrated the profound influence of context on the ways in which different institutions function and enforce regulations. In effect, in all social fields, every innovation is infused by its context.

     

The International Society for Stem Cell Research (ISSCR): history and perspectives

The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit organization founded in 2002 to foster professional and public communication and education regarding stem cell research. Under the leadership of prominent stem cell scientists from around the world, the ISSCR membership has grown exponentially, creating a diverse, international community of researchers who have expertise in many facets of stem cell biology. The ISSCR is dedicated to promoting the exchange of ideas and has developed two major forums for dissemination of stem cell research and related issues, an annual meeting and an information-rich website. With the field of stem cell research and technologies rapidly advancing, discourse is more critical than ever to maintain high standards across the full spectrum of research.     

The activity of French Research Ethics Committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study

Background  

Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis.     

The functional magnetic resonance imaging (fMRI) procedure as experienced by healthy participants and stroke patients – A pilot study

Background  

An important aspect in functional imaging research employing magnetic resonance imaging (MRI) is how participants perceive the MRI scanning itself. For instance, the knowledge of how (un)comfortable MRI scanning is perceived may help institutional review boards (IRBs) or ethics committees to decide on the approval of a study, or researchers to design their experiments.     

Genetics researchers' and IRB professionals' attitudes toward genetic research review: a comparative analysis

PurposeGenetic research involving human participants can pose challenging questions related to ethical and regulatory standards for research oversight. However, few empirical studies describe how genetic researchers and institutional review board (IRB) professionals conceptualize ethical issues in genetic research or where common ground might exist.MethodsParallel online surveys collected information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight for genetic protocols.ResultsA range of opinions were observed within groups on most issues. In both groups, a minority thought it likely that people would be harmed by participation in genetic research or identified from coded genetic data. A majority of both groups agreed that reconsent should be required for four of the six scenarios presented. Statistically significant differences were observed between groups on some issues, with more genetic researcher respondents trusting the confidentiality of coded data, fewer expecting harms from reidentification, and fewer considering reconsent necessary in certain scenarios.ConclusionThe range of views observed within and between IRB and genetic researcher groups highlights the complexity and unsettled nature of many ethical issues in genome research. Our findings also identify areas where researcher and IRB views diverge and areas of common ground.Genet Med 2012:14(2):236–242     

Beyond the horizon: the role of academic health centers in improving the health of rural communities.

Academic health centers (AHCs) face increasing pressures from federal, state, and community stakeholders to fulfill their social missions to the communities they serve. Yet, in the 21st century, rural communities in the United States face an array of health care problems, including a shortage of physicians, health problems that disproportionately affect rural populations, a need to improve quality of care, and health disparities related to disproportionate levels of poverty and shifting demographics. AHCs have a key role to play in addressing these issues. AHCs can increase physician supply by targeting their admissions policies and educational programs. Specific health concerns of rural populations can be further addressed through increased use of telemedicine consultations. By partnering with providers in rural areas and through the use of innovative technologies, AHCs can help rural providers increase the quality of care. Partnerships with rural communities provide opportunities for participatory research to address health disparities. In addition, collaboration between AHCs, regional planning agencies, and rural communities can lead to mutually beneficial outcomes. At a time when many AHCs are operating in an environment with dwindling resources, it is even more critical for AHCs to build creative partnerships to help meet the needs of their regional communities.     

Diversity in Public Views Toward Stem Cell Sources and Policies

Studies of public views on stem cell research have traditionally focused on human embryonic stem cells. With more recent scientific research on developing other stem cell sources, a series of focus group studies was undertaken with Canadian adults to examine their views on different stem cell sources (adult, umbilical cord blood, human embryonic stem cells, somatic cell nuclear transfer or SCNT, and interspecies nuclear transfer, or iSCNT). Views on three different policy models—a permissive, middle-of-the-road and restrictive policy approach—were also explored. Participants were recruited from several different social groups including patients, young adults, seniors, members of two ethnic communities, and a mixed group of adults. Participants were generally supportive of the use of adult stem cell sources. While there was also majority support for the use of hESC and SCNT, this was conditional on strict regulatory oversight. There was also majority support for a permissive policy which allows research on hESC and SCNT. General themes that cut across different groups included the potential cost of new technologies to the health care system, issues around who would gain access to these technologies, and trust in the scientific establishment and regulatory systems. A diversity of viewpoints was found as participants justified their positions on stem cell sources and policy approaches, showing more complexity and nuance than has been generally portrayed. The authors acknowledge support for this study from the project “Towards the clinic: ethical, legal, and social issues relevant to emerging stem cell therapies” funded by the Stem Cell Network of Canada.     

Suggested approaches for research protocols involving the potential for life-threatening reactions

These guidelines are intended to reduce the potential for serious or life-threatening reactions when clinical research is conducted. The following issues were addressed: identifying the risks involved in the research, providing adequate safeguards in the protocol design and during withholding of medication, anticipating risks, minimizing the chances for human error, providing resuscitative equipment sufficient to deal with the most serious anticipated life-threatening reactions, planning for medical support in case of a life-threatening emergency, and optimizing the use of medical personnel and expertise to handle emergency situations. The guidelines also discuss important general issues about protocol design and implementation and the human subject consent form, which should facilitate the approval of protocols by the governing institutional review board.The guidelines are not meant to be inflexible or applicable to all research situations. However, it is our hope that they will allow for clinical research to be conducted in a manner that affords the research subjects a high degree of protection from unnecessary and possibly fatal injuries.     

Aligning the goals of community-engaged research: why and how academic health centers can successfully engage with communities to improve health

Community engagement (CE) and community-engaged research (CEnR) are increasingly viewed as the keystone to translational medicine and improving the health of the nation. In this article, the authors seek to assist academic health centers (AHCs) in learning how to better engage with their communities and build a CEnR agenda by suggesting five steps: defining community and identifying partners, learning the etiquette of CE, building a sustainable network of CEnR researchers, recognizing that CEnR will require the development of new methodologies, and improving translation and dissemination plans. Health disparities that lead to uneven access to and quality of care as well as high costs will persist without a CEnR agenda that finds answers to both medical and public health questions. One of the biggest barriers toward a national CEnR agenda, however, are the historical structures and processes of an AHC-including the complexities of how institutional review boards operate, accounting practices and indirect funding policies, and tenure and promotion paths. Changing institutional culture starts with the leadership and commitment of top decision makers in an institution. By aligning the motivations and goals of their researchers, clinicians, and community members into a vision of a healthier population, AHC leadership will not just improve their own institutions but also improve the health of the nation-starting with improving the health of their local communities, one community at a time.     

Clinical research in India: great expectations?

India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-na?ve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society's cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.     

The policies of ethics committees in the management of biobanks used for research: an Italian survey

Gaps in regulations pertaining to the collection and storage of biological materials in a biobank, at least in the European context, have made the writing of local guidelines essential from an ethical point of view. Nevertheless, until recently, the elaboration of local guidelines for the collection, use and storage of biological materials in a biobank has been the exception in Italy and all European countries. In this context, it is of value to know the policies, even if they are unwritten, of local ethics committees (ECs) engaged in the evaluation of research protocols involving biobanks and biological materials. This paper presents the results of a survey carried out among local Italian ECs (229) to document their attitudes and policies regarding the management of the ethical issues related to biobanks and the use of biological materials. A questionnaire was developed to investigate the areas regarded as critical from an ethical–legal point of view: informed consent and information to the subjects; protection of confidentiality; communication of research results; access/transfer of biological materials and related data; ownership of samples and data and intellectual property rights; and subjects'' remuneration and benefit sharing. Twenty-six ECs from the Italian Institutes for Research and Care (62%) and 26 other ECs (14%) participated in the survey.     

Seeking ethical approval for an international study in primary care patient safety

Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a further layer of complexity. This paper draws on the experiences of the LINNAEUS Collaboration, an international group of primary care researchers, in obtaining ethics approval to conduct an international study investigating medical error in general practice in six countries. It describes the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada, England, the Netherlands, New Zealand, and the US. Wide variation in ethics review responses to the research proposal occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The authors'' experiences demonstrated that ethics committees operate in their own historical and cultural context, which can lead to radically different subjective interpretations of commonly-held ethical principles, and raised further issues such as ‘what is research?’. This first LINNAEUS study started when patient safety was a particularly sensitive subject. Although it is now a respectable area of inquiry, patient safety is still a topic that can excite emotions and prejudices. The LINNAEUS Collaboration now extends to more countries and continues to pursue an international research agenda, so reflection on the influences of history, social context, and structure of each country''s ethical review processes is timely.     

A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take before the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.     

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

Background  

Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.     

胚胎干细胞研究的伦理和心理学问题

背景：胚胎干细胞研究具有重要的医学价值,在基因治疗、组织工程学、药学等许多领域都具有广泛的应用,使人们看到了治疗疾病的新希望,而其相关研究成果也引发了许多伦理和心理学问题。 目的：综述目前胚胎干细胞研究中的伦理和心理学问题。 方法：应用计算机检索2001-01/2010-12 PubMed数据库、维普数据库及万方数据库有关干细胞研究产生的伦理和心理学问题相关文献,英文检索词“embryonic stem cells,morality,psychological”,中文检索词“胚胎干细胞,伦理学,心理学”。检索文献量总计122篇,最终纳入符合标准的文献33篇。 结果与结论：胚胎干细胞究中伦理学问题的焦点主要包括：干细胞来源的伦理学问题,干细胞“克隆”的伦理学问题,干细胞与生命的伦理学问题,干细胞研究存在和需要解决的问题及干细胞研究中伦理学规范问题。干细胞研究中的心理学问题主要是人们对干细胞研究特别是“克隆”技术的认识。相关研究多涉及造血干细胞移植患者的心理变化。胚胎干细胞的研究目前已取得了突破性成果,给医疗、卫生健康等方面带来了革命性影响。