Indiana Specimen Repository Agreement
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FAQ
Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other ?primary? or ?initial? activity. In other words, data that were not collected for the purpose of the specific proposed study.
While the HIPAA Privacy Rule does not apply to biospecimens directly, it may affect biospecimen resources that are considered covered entities, or business associates of covered entities, in that human specimens often are accompanied by identifiable protected health information (PHI).
Biospecimen. A quantity of tissue, blood, urine, or other biologically derived material. The NHLBI Biologic Specimen Repository stores human biospecimens. Portions or aliquots of a biospecimen are referred to as samples (NCI Best Practices working definition).
This means that you allow your personal information and samples to be used for a variety of future medical research approved by an ethics committee, but which cannot be specified at the present time. - If applicable, specify types of medical research that will use the biobank (e.g. specific disease/ research area).
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
Our current understanding of informed consent is that it is the full disclosure of the nature of the research and the participant's involve- ment, adequate comprehension on the part of the potential participant, and the participant's voluntary choice to participate [1].
However, prior informed consent would be required in cases where biospecimens are collected from human research participants for research purposes or when the procedure for collecting biospecimens for clinical purposes is changed to meet a research need unless an IRB grants a waiver of the requirements for obtaining ...
