Ethical Conduct for Research Involving

Code of Ethical Conduct for Research Involving Humans, Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, 1998. http //www. nserc.ca/programs/ethics/english/policy.htm. 

Tri-Council Policy Statement Ethical Conduct for Research Involving Humans... 

Tri-Council Policy Statement Ethical Conduct for Research Involving Human Subjects, Public Works and Government Services, Canada, 1998, Catalogue No MR21-18/1998E. ISBN 0-662-27121-1. 

A principal committee of the NHMRC, the Australian Health Ethics Committee (AHEC), provides guidance and support for HRECs in Australia, and is responsible for developing and publishing the National Statement on the Ethical Conduct of Research Involving Humans 1999, which replaced the previous NHMRC Statement on Human Experimentation and Supplementary Notes 1992. ... 

As a consequence of these and other developments, in 1979 the USA issued its own policy document on the ethical conduct of research involving human subjects. Known as the Belmont Report, it is the basis for the complex regulatory framework that governs human subject research in the United States. The report maybe viewed online at http //ohsr.od.nih.gov/guidelines/belmont.html. 

Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects... 

Over the years, scientific research with human subjects has provided valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. As an example, studies carried out for the authorization of a medical product, have to be conducted in line with the World Medical Association s Declaration of Helsinki, which describes the general ethical principles for medical research involving human subjects (World Medical Association 2004). The Helsinki Declaration was first issued by the World Medical Association in 1964 and has been revised several times since then. 

The principles of medical research are based on the Declaration of Helsinki. The general assemblies of the World Medical Association (WMA) have, since 1964, made recommendations for guiding physicians in clinical research involving human subjects. Although not legally binding, the Declaration forms the foundation of all other significant international documents on the ethical conduct of biomedical research. 

Bioethics is a relatively new field of study concerning the investigation of ethical issues in medicine, health care, and the life sciences. From the standpoint of bioethics, clinical pharmacy research presents no novel ethical questions however, the type and scope of issues involved differ from those faced by other practitioners. It is important for pharmacists to be aware of the ethical issues, give thoughtful consideration to them, and be sensitive to how they may affect their involvement in research. The current Code of Ethics for the practice of pharmacy virtually neglects issues encountered by pharmacists as they conduct clinical research. ... 

If local institutions receive any federal research money, all human research must be approved by the IRB. This is not the basis for IRB review but provides the incentive for local institutions to conduct studies that are ethical. The committee becomes involved in matters such as confidentiality, anonymity, and moral issues related to experimental activities. Approval from an IRB, however, does not relieve the principal investigator from the basic responsibility of safeguarding the health and welfare of participating individuals. This is a moral and professional responsibility that cannot be delegated. 

The ethical conduct of all clinical researchers is of supreme importance. Participants in all clinical trials are volunteers while the word "volunteers" is typically exclusively used to describe participants in human pharmacology studies, all participants in all clinical trials are, by definition, volunteers (see Turner, 2007). Individuals participate in clinical trials for the greater good, not specifically to benefit themselves. Everyone involved in clinical research has an obligation to conduct all aspects of this research to the highest ethical standards. 

Article 3 of 2005/28/EC stipulates that clinical trials shall be conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving humans adopted by the General Assembly at the World Medical Association in 1996. Principle 9 states that ... 

Royal College of Paediatrics and Child Health Ethics Advisory Committee (2000). Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 82 177-182. 

Clinical trial A formal study of a treatment conducted in patients with a specific disease indication. Such studies usually involve comparison with placebo or an alternative treatment and a randomisation process is used to determine the allocation of treatments. Ideally, they also involve blinding of patients and clinicians (i.e. they are double-blind ) to treatment allocations. Conducting a clinical trial involves intervening in patients treatments for research purposes and therefore informed consent from each patient and ethical committee approval are essential (see p. 31). 

My own involvement started m May 2001 with an unexpected phone call from Tieutenant Colonel Bolton from the Ministry of Defence (MoD), who asked for advice about the development of ethics standards in the conduct of research at Porton Down. Although I considered myself an unlikely candidate to act as a consultant to the MoD, and I did not in fact do so, I asked Bolton to put his request in writing. His letter gives a rare insight into the position of the UK government at a critical juncture in its dispute... 

McIntosh, N., Bates, R, Brykczynska, G., Dunstan, G., Goldman, A., Harvey, D., Larcher, V., McCrae, D., McKinnon, A., Patton, M., Saunders, J. and Shelley, R, Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics and Child Health Ethics Advisory Committee. Arclt. Dis. Child., 82, 177-182 (2000). 

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