Abstract
Peru has made great strides in clinical trials (CTs) regulation in recent years. However, by 2008, Peru did not have guidance on how to review the ethical and scientific aspects of clinical trials for use by research ethics committees (RECs). In 2009, REC inspections by the Peruvian National Institute of Health (NIH) indicated that there were serious deficiencies in their ability to perform their moral functions, mainly because it appeared that the ethical-scientific reviews had become a mere administrative formality. This project developed and validated a guide for reviewing the ethical and scientific aspects of CTs to be used as an institutional standard for the Peruvian RECs. We took the following steps: (a) Review-synthesis of relevant bibliography on the ethics of research with human subjects and analysis of their applicability in the local Peruvian context; (b) development and validation of the format and content of a guide for reviewing the ethical-scientific aspects of CTs, and (c) identification and analysis of the ethical and scientific issues which surfaced during CT reviews by RECs that were included in their decision reports. The guide described here is the result of a collaboration of multinational experts in ethics and clinical research, Peruvian NIH officials and members of 12 RECs. The guide has been available at http://www.ins.gob.pe/insvirtual/hcnsopde.aspx?87 since August 2010.
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Notes
- 1.
Profit-making RECs exist in Latin America that have been established to facilitate the approval of clinical trials in centre founded directly or indirectly by the pharmaceutical industry.
- 2.
As Alan Wertheimer suggests, a fully voluntary transaction between A and B is exploitative if the division of the benefits and burdens created though the transaction is distributively unfair. In developing countries’ research, the worries about the standard of care, the quality of informed consent procedures and the post-trial availability of interventions that have proved to be useful, all relate to exploitation (Hawkins and Emanuel 2008).
- 3.
Content analysis is defined as a research method for the subjective interpretation of the content of text data through the systematic classification process of coding and identifying themes or patterns (Hsieh and Shannon 2005).
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Quispe, S.O. et al. (2012). The Development and Validation of a Guide for Peruvian Research Ethics Committees to Assist in the Review of Ethical-Scientific Aspects of Clinical Trials. In: Schildmann, J., Sandow, V., Rauprich, O., Vollmann, J. (eds) Human Medical Research. Springer, Basel. https://doi.org/10.1007/978-3-0348-0390-8_9
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