Collaboration Details

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Title of Collaborative Activity:

Ethical, Legal and Social Issues (ELSI) Sub-study in the Biospecimen Pre-Analytical Variables (BPV) Project

Description of Collaborative Activity:

This Substudy is part of ongoing efforts by the Cancer Human Biobank (caHUB) program to improve effectiveness and generate best practices for the biospecimen research community. The Biospecimen Pre-Analytical Variables (BPV) Ethical Legal and Social Implications (ELSI) Substudy is a study of the ethical, legal and social implications related to the informed consent process for biobanking. The ELSI study is designed to address current issues related to informed consent for biobanking, particularly the issues of consent for broad future research use and return of research results. The objective of the ELSI Substudy is to assess research participant comprehension and concerns related to informed consent and data sharing for biobanking across the diverse patient populations included in the BPV program. The intent of this evaluation is to improve our understanding of the issues that impact donor participation in such programs and to identify factors that may result in decreased rates of donor participation. This study provides a unique and unprecedented opportunity to address these issues in a diverse patient population of actual biospecimen contributors approached for consent using a highly harmonized informed consent document. Each Biospecimen Source Site (BSS) collecting tumor tissue from surgical procedures is participating in the ELSI study. To date, 247 interviews with BPV participants have been submitted for analysis.  Data collection will conclude in May of 2015 and data analysis will begin at that point.

Type of Collaborative Activity:

Research Initiative

Year the Collaborative Activity Originated:

2012

NIH Participating Institutes/Centers/Office of the Director:

CC, NCI

HHS Agency Collaborators on this Activity:

OS