Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: B razilian Regulation

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent ( IC ) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new B razilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 M ay 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the B razil Ministry of Health, approved on 14 S eptember 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form ( ICF ). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although B razilian and international regulations identify the main aspects to be included in the IC , efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.