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At least 19 recordsLinked to original sources
PubMed2002

The absent professor: why we don't teach research ethics and what to do about it.

Research ethics education in the biosciences has not historically been a priority for research universities despite the fact that funding agencies, government regulators, and the parties involved in the research enterprise agree that it ought to be. The confluence of a number of factors, including scrutiny and regulation due to increased public awareness of the impact of basic research on society, increased public and private funding, increased diversity and collaboration among researchers, the impressive success and speed of research advances, and high-profile cases of misconduct, have made it necessary to reexamine how the bioscience research community at all levels provides ethics education to its own. We discuss the need to and reasons for making ethics integral to the education of bioscientists, approaches to achieving this goal, challenges this goal presents, and responses to those challenges.

Biomedical Research↗
PubMed2002

Law, ethics and research ethics committees.

This paper examines the view of the operational management of the UK Research Ethics Committee (REC) system that RECs may not reject applications on purely legal grounds. Two arguments are offered for this view: the first rests on the contention that being lawful and being ethical are not the same thing; the second is that RECs lack expertise and authority to base their decisions on legal considerations. However, whatever the philosophical standing of the first argument, it is contrary to published guidance, the basis of RECs' official authority, unethical, and politically imprudent to permit RECs not to consider conformity with the law to be at least a necessary condition for REC approval. In any event, RECs can obtain competent and authoritative advice on the law (though the Department of Health has been remiss in this regard), and they do not exceed their authority by applying the law, because this is within their ethical remit. When current guidance to RECs about advising researchers on whether or not breaches of confidence are permissible in the public interest is linked to the view of the REC management that the role of RECs is to facilitate research (albeit ethical research), this raises serious doubts about the integrity of the system of ethical review currently in place, which is illustrated by a recent "agreement" of the Chairmen of the MRECs not to consider the Data Protection Act 1998 in their ethical review.

Confidentiality↗
PubMed2001

Ethics committees. Research ethics: beyond the guidelines.

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.

Committee Membership↗
PubMed1997

The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs.

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants.

Attitude of Health Personnel↗
PubMed2005

Gonorrhea and the beginnings of clinical research ethics.

Research on ocular inflammation associated with gonorrhea began in conjunction with the entry of trachoma into Europe during the Napoleonic wars. The initial questions involved the cause of the contagiousness of gonorrhea and how the contagion spreads from the genitalia to other sites. Because efforts to infect animals with gonorrheal matter were unsuccessful, all experiments were conducted on human subjects. Once these two causes of blindness were tentatively differentiated, attempts to restore vision in an eye that had been blinded by a trachomatous membrane over the cornea by instilling gonorrheal pus began to be practiced. In 1841, Joseph Piringer described his use of this method to determine infectiousness decades before the discovery of pathogenic bacteria, as well as ethical concerns about the associated endangerment of patients. Beginning in the 1880s, research focused on the identification of the gonococcus and assessment of its pathogenicity. The ethical dilemma of inducing a disease with an unpredictable outcome persisted until the 1940s, when gonorrhea could be reliably cured by penicillin.

Blindness↗
PubMed1998

Developing a Code of Research Ethics for research with a Native community in Canada: a report from the Kahnawake Schools Diabetes Prevention Project.

This paper describes the background and evolution of a Code of Research Ethics that was developed for a primary diabetes prevention project in the Native Mohawk community of Kahnawake in Canada. Embodying the principles of participatory research, this code was written by the researchers in conjunction with the community in the first year of the three-year project. The code ensures that the community is a full partner for the entire research process. For this project a Community Advisory Board is representative of the community.

Canada↗
PubMed1995

Primary care research ethics.

Research activity in primary care is increasing rapidly, and raises a range of specific ethical issues. Many of these relate to the involvement of individuals in the community who are not seeking medical care and to the impact of research participation on relationships between general practitioners and their patients. The ethical issues pertinent to a range of quantitative and qualitative research methodologies in primary care are identified and considered.

Ethics, Medical↗
PubMed2000

Should local research ethics committees monitor research they have approved?

The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is under review. This paper suggests that increasing the monitoring role of ethics committees in the present climate would be inappropriate. This is due to the large workload of the committees, their voluntary nature and the change a monitoring role might cause to the relationship between researcher and ethics committee, which might herald an increasing recourse to judicial review. A radical overhaul of the system would be necessary in order for ethics committees adequately to fulfil a monitoring function.

Clinical Protocols↗
PubMed1995

[Ethics and research: ethical considerations in clinical research].

Two subjects are discussed: the use of placebo controls in clinical trials and informed consent. Particularly in trials of drugs for disorders for which there exist effective treatments, the use of placebo is still controversial, although anyhow in violation of the Declaration of Helsinki. Informed consent aims at giving a subject all the necessary information to allow him to decide, with full knowledge, whether to accept a particular treatment or experimental protocol. Its importance would seem, albeit essential, to be rather illusory.

Clinical Trials as Topic↗
PubMed2006

Oncologists' opinions about research ethics committees in Italy: an update, 2004.

While there is general consensus about the basic features of ethical research, the explosion of information from technology, genetics and clinical research, and the desire to accelerate the translation of preliminary findings into clinical research and practice have created space for conflicts between the aims of research, medical ethics and human rights. Research ethics committees (RECs) play a crucial role. In 2004, a short standardized questionnaire was sent to 110 Italian oncologists. The questionnaire explored aspects of the interaction between oncologists and RECs, including reports on personal experience with RECs, and the oncologists' opinions and level of satisfaction with important functions of RECs, such as bureaucratic, ethics, scientific, and educational and training aspects. The findings are compared with those from the previous surveys. Eighty-three out of the 91 oncologists returned the questionnaire. Responders were working in 67 hospitals (60 RECs). The level of satisfaction with REC activities was high for ethical and scientific aspects (87 and 80% were satisfied or very satisfied, respectively); somewhat lower for bureaucratic and secretarial aspects (61%); and much lower for educational and formation activities (33%). Comparison with other surveys does not show any important difference. The main findings of this survey are the stable figures concerning oncologists' opinions and the low ratings given to education and training aspects. This latter finding clearly identifies the need for educational activities, and the possibility of using this approach to foster interactions between RECs and researchers.

Attitude of Health Personnel↗