The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 3 of 5

Declaration of HelsinkiPart 3: Vulnerable Persons and Consent

Another distinctive modification in this new revision is the expansion of considerations on vulnerable populations and their needs of specifically considered protection according to the case.

With respect to the Informed Consent Process, the Declaration preserves the essential principle that the granting of this consent must only be given by the study subject unless he or she is a minor, or incapable of acting on his/her behalf. With this consideration however, the Declaration expands considerably on describing how this process should be conducted. In brief, the Declaration outlines: the simplicity and adequacy of the language to be used, the inclusion of all the risks and benefits foreseen as a result of the investigation and all rights that affect the patients, including the right to know about the aims, methods and sources of funding for the study, in addition to potential conflicts of interests affecting the investigator and post-study provisions.

The New version of the Declaration of Helsinki was approved by the WMA General Assembly in Fortaleza, Brazil in October 2013.

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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