WHAT CONSENT IS REQUIRED FOR THE USE OF HUMAN TISSUE SPECIMENS?
IRBs are responsible for determining whether or not informed consent is required from the subjects from whom the specimens were obtained. The IRB may waive the requirement for informed consent if the risk to the subjects is minimal and if certain other conditions are met.(3) You should not assume that your research poses minimal risk just because it involves tissue specimens. Loss of confidentiality can cause harm to patients and their relatives; IRBs will consider whether privacy and confidentiality protections are adequate. IS MY RESEARCH EXEMPT FROM IRB REVIEW? Research with specimens and data from living persons is exempt from the requirement for IRB approval when it is determined that the research either does not involve human subjects as defined in the Code of Federal Regulations (CFR) or the only involvement of human subjects is in one of the “exempt” categories listed in the Code. The exemption that is most pertinent to work with human tissue specimens is exemption #4.
