By Nuria Homedes, Antonio Ugalde
ISBN-10: 3319013629
ISBN-13: 9783319013626
ISBN-10: 3319013637
ISBN-13: 9783319013633
The outsourcing of scientific trials to Latin the United States through the transnational leading edge pharmaceutical begun approximately 20 years in the past. utilizing archival info and box paintings in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors talk about the regulatory contexts and the moral dimensions of human experimentation within the zone. greater than eighty% of all medical trials within the quarter happen in those international locations, and the eu medicinal drugs business enterprise has outlined them as precedence international locations in Latin the USA. The authors bring up questions about the standard of knowledge bought from the pains and the violation of human rights in the course of their implementation. Their findings are provided during this quantity, the 1st in-depth research of scientific trials within the sector.
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Extra info for Clinical Trials in Latin America: Where Ethics and Business Clash
Sample text
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits.
Guideline 10 establishes that the sponsor or investigator must do everything possible to ensure that the studied procedure, within reason, is accessible and 16 N. Homedes and A. 2: Summary of the Rules for Informed Consent, Council for International Organizations of Medical Sciences (CIOMS) • Discuss the study objective and the reason why the individual is asked to participate • Assure that participation is voluntary • Explain that a study participant may withdraw from the study at any time • Explain the objective of the study in greater detail • Describe the study design in a way that the participant can understand it • Discuss the length of time necessary for study participation • Discuss any compensation provided to participants • Describe how participants can learn about the study results • Explain that personal information is confidential, with safeguards to prevent access to information on individuals • Confirm that an ethics committee has approved the study • Give information about possible risks • Discuss the potential benefits for the individual and the community • Discuss the possibility of access to treatment after the conclusion of the clinical trial • Present alternative treatment or medication options to the study material • Explain any possible future use of information or samples obtained in this study • Explain the role differences between a personal physician and a physician conducting research • Describe the medical treatment to be provided during the study • Explain the measures to be taken if the participant suffers any adverse effects as a result of study participation • Explain the compensation to be offered to the participant if he or she suffers an adverse event attributable to his/her participation in the study Source: Adapted from Macrae (2007).
Clinical Trials in Latin America: Where Ethics and Business Clash by Nuria Homedes, Antonio Ugalde
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