Human Subject Guidelines

Human Subject Guidelines
By Denise Casey.
Human Genome News, July-September 1996; 8:(1)DOE, NCHGR Issue.

On August 19, Aristides Patrinos, Director of the DOE Human Genome Program, and Francis Collins, Director of the NIH National Center for Human Genome Research, issued a document providing investigators with guidance in the use of human subjects for large-scale sequencing projects. The guidance recommends the following principles:

Derive the initial version of the complete human DNA sequence from multiple donors,
Ensure that donors can make informed, unpressured decisions about DNA contributions,
Protect donor privacy and confidentiality,
Obtain institutional review-board approval before work is initiated, and
Rapidly introduce new libraries constructed in accordance with this guidance.

The guidance emphasizes numerous ways to preserve anonymity of donors and suggests that they should be selected from diverse pools of individuals, including females as well as males. Recruiting from laboratory staff is discouraged.A copy of the guidance is available from HGMIS or via WWW (http://www.ornl.gov/hgmis/archive/nchgrdoe.html).