Ethical considerations informed consent

Regulatory authorities stipulate the need for ethical principles to be observed when conducting clinical trials. Clinical trials should never be conducted to gain knowledge per se. They should be based on risk-benefit considerations, informed consent, and respect for human individuals. Furthermore, subjects should be protected without being taken advantage of. 

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. 

The Helsinki Declaration covers all the important ethical considerations, such as the involvement of a qualified physician in any clinical trial, putting the well-being of the study subject before science and society, the use of scientific principles in the design of the study, the need for informed consent and a review by an ethics review committee in fact, all areas covered by the ICH GCP. 

Informed consent is in some sense the ethical cornerstone on which human subjects protection rests. It requires that individuals understand their part in a study and the potential consequences, and are free to choose to participate. As Levine has argued, the consent process should include specific elements an invitation to participate a statement of the purpose of the study the basis of participant selection and explanation of procedures, risks, and discomforts how untoward consequences will be handled the benefits of participation alternatives to participation financial consideration confidentiality opportunities for continuing disclosure and measures for ensuring that a person s decision to participate is voluntary (Levine, 1981). 

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

Legislation that ensures the protection of human research subjects in the United States includes the 1979 publication of the Belmont Report on the Ethical Principles and Guidelines for the Protection of Human Subjects of Research.f This report concerns the fine line between biomedical research and the routine practice of medicine and explores the criteria that determine the risk-benefit ratio in the consideration of conducting clinical research. It also addresses basic guidelines for the proper selection of human research subjects and further defines the elements of informed consent. 

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. 

Research involving human participants is typically governed by policies on ethical practices underpinned by a number of principles, eg, merit of the research, informed consent of participants, issues related to vulnerable subjects, privacy of participants, minimization of harm, limitation of deception, avoidance of conflicts of interest, cultural and social sensitivity, and publication of results. Ethics committees routinely require that consideration be given to a range of factors, and require prior decisions on ... 

Reviewers should not use or disclose unpublished information, arguments, or interpretations contained in a manuscript under consideration, except with the consent of the author. If this information indicates that some of the reviewer s work is unlikely to be profitable, the reviewer, however, could ethically discontinue the work. In some cases, it may be appropriate for the reviewer to write the author, with copy to the editor, about the reviewer s research and plans in that area. 

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