Author: Erin Odor

Re-post: How should a “reasonable” person approach key information?

The Revised Common Rule requires informed consent documents to begin with a concise summary of information that a “reasonable” person would want to know when deciding to participate or not participant in a research study. At the 2018 Advancing Ethical Research conference, panelists from the Office of Human Research Protections (OHRP), National Institutes of Health (NIH), and two research institutions discussed considerations for implementing the key information requirement.
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Re-post: Minding the (db)GaP: Age of Majority and the NIH’s GDS Policy

The National Institutes of Health Genomic Data Sharing (GDS) Policy recognizes participants’ informed consent as integral to responsible sharing of genomic data, stating that consent processes must “explicitly discuss future research use and broad data sharing, even if the data are generated from specimens that are de-identified” before such information may be deposited in publicly available databases. Minors are unable to legally consent, however, and parental permission is valid only until the child turns 18. Do researchers have an ethical obligation to re-contact of-age participants to obtain consent, perhaps years after their genetic data was collected?

 

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Re-post: Less (Tissue) is More (Complicated): Rethinking Research Involving Archival Specimens

photo-of-person-using-magnifying-glass-while-holding-a-glass-4149041.jpgDemand for archival tissue for both clinical care and research is growing, especially in the field of precision medicine. But advancements in diagnostic and sampling procedures have reduced the supply of leftover specimens available for research use — raising ethical questions for investigators, patient-participants, and IRBs.

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