Ethics clinical research

Emanuel, E., et al., "What Makes Clinical Research Ethical " JAMA, 283, 2701-2711... 

Emanuel E, Wendler D, and Grady C. What Makes Clinical Research Ethical JAMA 2000 283(20) 2701-2711. 

The field of clinical research ethics is no more immune from the reinvention of the wheel than any other quasiscientific discipline. The desire for improvement is both laudable and counterproductive. It is fueled by the reality of policy versus practice. 

The WMA went on to adopt an International Code of Medical Ethics (1949). This was an attempt to develop international standards of medical ethics and sought to summarize the most important principles. It did not specifically address clinical research ethics. That topic was brought to the attention of the WMA Medical Ethics Committee in 1953. After several years of discnssion and research a draft declaration was finally tabled in 1961. It was adopted at the 18th WMA General Assembly, held in Helsinki in 1964. The main points in the declaration are ... 

To become a CRP, you need to talk to and network with current CRPs and let them know you are interested in the discipline. Start to become familiar with the terminology, regulations, standards, and clinical research ethical history, for... 

The Oxford textbook of clinical research ethics. Oxford Oxford University Press. 

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

Levine, R., Ethics and Regulation of Clinical Research, 2nd ed.. Urban and Schwarzenberg, Baltimore, MD, p. 42. 

The basic ethical questions raised by clinical research should never be underestimated. The pharmaceutical physician will need to be aware that failure, intentionally or because of misguided enthusiasm, to protect the health and well-being of each study subject can have very serious consequences. In an age where the medical profession is constantly under scrutiny, the drug industry is heavily criticised and the communication industry extremely active, mistakes in clinical trials are pimished. Therefore, before a study is commenced, a review should be made that the scientific approach is current, the motivation is clear, the processes are imambiguous, and there should be sufficient data to judge the safety and effectiveness of the interventions proposed. 

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. 

The conduct of clinical research in humans raises numerous legal and ethical issues of significant importance. After a lengthy process of gestation, the European Commission has now officially... 

Clinical trials in which registered or listed medicines (or medical devices) are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence. 

Research Ethics Committees (RECs) should be invited to review all materials used to recruit subjects for all phases of clinical trials, including, but not limited to ... 

The IRB, also known as the ethics committee or human subjects committee, originally was established to protect people confined to hospitals, mental institutions, nursing homes, and prisons who may be used as subjects in clinical research. In the United States any institution conducting clinical studies supported by federal funds is required to have proposed studies reviewed and approved by an IRB. 

The mission of clinical research is to provide scientifically appropriate and accurate information about new treatments in patients, keeping the safety of the patient as absolute priority referring to the law of Hippocrates Nil nocere (Not to harm). An additional ethical aspect of clinical research is the demand of high scientific standards. Therefore ... at the start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed (Freedman, 1987). 

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

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