As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking.
Indeed, the significant lack of progress... suggests a failure of leadership in [Duke's] human subject protection system".
Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results.
Usually it includes explicit human subject protection clauses, authorship expectations, reporting requirements and other guidelines regarding how the data can be used.
It should include sample storage performed in biobanks, and the necessary frameworks of human subject protection that includes informed consent, and institutional review of the studies being performed.
Exploratory assay development using human samples, for example, tissues or body fluids, are usually conducted under general human subject protection and privacy provisions implemented by academic institutions.
We use research administration data on human subject protection, animal use management, and grant funding applications to construct new measures of collaboration formation and success.
