The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 5 of 5


Declaration of HelsinkiPart 5: Conclusion

The most relevant change in the new Revision of the Declaration relates to the rights of vulnerable people. Differently than in previous versions, specific groups are not mentioned. The document leaves to those adopting the declaration to consider the circumstances that might make a group particularly vulnerable and the special protection that should apply. “All vulnerable groups and individuals should receive specifically considered protection.” In consequence, special attention should be directed towards the preparation and review of the informed consent process and its relevant documents. The informed consent process should be completed in a way as to adequately highlight the rights, benefits, and harms involved to the subjects, and the alternatives to willingly participate, such as withdrawing from the investigation. Additionally, a new principle considers appropriate compensation for subjects harmed as a result of their participation in research.

As the Declaration continues to be a cornerstone of the ethics of medical research and the protection of subjects, it should continue adapting to new issues and evolving problems surrounding the process of medical research, bioethics and human rights that will be the object of new revisions in the mediate future.

About the Author:
Dr. German Roges, Regxia’s Clinical Research Services Manager, possesses over 15 years of drug development and clinical research experience in the Life Sciences’ and Biotechnology industries. Dr. Roges brings insights from direct experience with contract negotiations, clinical research, phases I-IV, and trial management, in therapeutic areas such as Oncology, Dermatology, and Immunology.

(1)     WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
(2)      Snežana, Bošnjak (2001). “The declaration of Helsinki: The cornerstone of research ethics”. Archive of Oncology 9 (3): 179–84.
(3)     WMA Publishes its Revised Declaration of Helsinki.
(4)     Code of Federal Regulations: General requirements for informed consent

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