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Last Updated: 10/02/17

Patient Views on Broad Consent

The Biospecimen Pre-analytical Variables Program (BPV) was created to improve the quality of collected biospecimens by investigating the effects that pre-analytical factors (preservation methods, storage conditions, and time from tissue removal to processing) have on the molecular characteristics of donated biospecimens. Results of these studies have been used to develop evidence-based best practices protocols for biospecimen collection and processing.

Biospecimens were collected for BPV with the consent of cancer patients. A broad consent model was utilized to enable the use of the BPV biospecimens for future research. A BPV sub-study was conducted to explore the ethical, legal and social implications (ELSI) related to consent for broad future research use of the donated biospecimens. Patients who had been asked to donate biospecimens to the BPV study were later asked to participate in the BPV ELSI study. The study addressed comprehension, attitudes, and potential concerns regarding broad consent and return of results across the diverse BPV research participant population. Results of the study can be found below:

Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers. Warner TD, Weil CJ, Andry C, Degenholtz HB, Parker L, Carithers LJ, Feige M, Wendler D, Pentz RD. J Empir Res Hum Res Ethics. 2018 Jan 1:1556264617751204. doi: 10.1177/1556264617751204. [Epub ahead of print] PMID: 29390947