The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 4 of 5

Declaration of HelsinkiPart 4: Human Material and Consent

For the first time ever, the new revision of the Declaration of Helsinki makes explicit mention that no human material obtained from the subject during the study protocol procedures should be included in data, or sample banks, without his/her consent. This implies that for those studies in which this type of sampling of mining of data is pursued, a separate consent form and process should be conducted; unless the obtainment is impossible or impracticable, in which case approval must be sought by a research ethics committee.

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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