 |
|
One-Time General Consent for Research on Biological Samples
Is It Compatible With the Health Insurance Portability and Accountability Act?
David Wendler, PhD
Arch Intern Med. 2006;166:1449-1452.
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
|
|
INTRODUCTION
The collection and storage of human biological samples has become integral to clinical research.1 These samples, estimated to be in the hundreds of millions in the United States alone, have enormous potential.2 However, requiring individuals' informed consent each time collected samples are used for new research could thwart this potential, increasing costs, decreasing response rates, burdening individuals, and precluding some studies altogether.
Several commentators have argued that these problems might be avoided by obtaining, at the time samples are collected, a 1-time general consent for research.3-4 Although 1-time general consent offers significant benefits, it seems to be inconsistent with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule,5 which requires investigators to obtain study-specific authorization to use individuals' biological samples and associated personal information for research.
Analysis reveals that the HIPAA Privacy Rule's authorization requirements can be reconciled with general consent using a 2-step decision procedure. . . . [Full Text of this Article]
THE HIPAA PRIVACY RULE
PRIVACY RULE AUTHORIZATION REQUIREMENTS
STUDY-SPECIFIC AUTHORIZATION
INDIVIDUALS’ VIEWS
1-TIME GENERAL CONSENT IN THE CONTEXT OF HIPAA
WAIVER OF STUDY-SPECIFIC AUTHORIZATION
IMPLEMENTATION OF 1-TIME GENERAL CONSENT
AUTHOR INFORMATION
Author Affiliation: Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, Md.
|
