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Biospecimen Confidentiality

March 1, 2021
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WRITTEN BY Dr. Joshua Mueller

Research involving human participants can include the collection of biospecimens, such as blood or tissue, that can be analyzed for diagnostic purposes or evaluation of clinical treatments. Regulatory requirements at the institutional, state, and federal level provide protections for both the health and privacy of research participants. In particular, current law lays out requirements for informed consent, removal of identifiable information for anonymized study, and confidentiality of health records. In addition to these standards, HB 995 would require laboratories to obtain consent from individuals before releasing any biological specimen for anonymous scientific study. It would also allow individuals to direct the laboratory to return or destroy the sample upon completion of testing. This bill would apply retroactively. Failing to adhere to this rule would be a class A felony.

Highlights

  • Federal regulations known as the “Common Rule” establish protections, such as informed consent, for the well-being and privacy of patients who participate in clinical trials or donate biospecimens for research purposes.
  • In certain instances, biospecimens may be “de-identified” for use in future research. In these cases, specimens cannot be associated with personal information such as the donor’s name.
  • Informed consent protocols currently require that donors be informed at the time of collection if their specimens may be de-identified for future research, but no state requires that informed consent be obtained for the use of de-identified samples in particular studies.
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