Protecting Human Subjects in Research
(505) 845-9171 or treser@sandia.gov
Conducting research on fellow human beings is both a privelege and a serious responsibility.
All
human subject research that involves SNL facilities, funds, or personnel must be
reviewed and approved (or determined to
be exempt) by the HSB.
About the HSB
The Human Studies Board is an independent body that reviews proposed SNL research to assess risks and benefits to human subjects, and to
assure that subject participation is both voluntary and informed. Review by such a board (known generically as Institutional Review Boards
or IRBs) is mandated by the requirements listed below.
Protocols that involve more than minimal risk must be reviewed by the full board at a convened meeting. These occur quarterly,
typically in January, April, July, and October. The next HSB meeting is October 15, 2008 and the deadline to submit protocols
for review at that meeting is September 26, 2008.
Protocols involving minimal risk require less review rigor and are scheduled as necessary.
The HSB is registered (IORG0000793) and operates under a Federal Wide Assurance (FWA00003764) with the Office for Human Research
Protections (OHRP), a division of the U. S. Department of Health and Human Services.
Basic Information
Brief, general information about what constitutes human subject research, who serves on the HSB, and what to submit for review is found
on our FAQs page.
Detailed information on topics such as HSB authority and jurisdiction, basic principles, definitions, procedures, review rigor and
frequency, adverse events, conflicts of interest, and responsibilities of everyone involved in reviewing or conducting human subject
research is contained in the
HSB Procedures Manual (MN-MED026).
From Paper to People: After IRB Approval of Research Studies
is a quick read that emphasizes the interactive and dynamic nature of the review process and provides a useful look at what happens after
a proposal has been approved.
Additional resources are linked below. If the information you seek isn't in any of these places, or elsewhere on this site, please
contact the HSB Administrator, Terry Reser, at (505) 845-9171 or treser@sandia.gov.
Requirements
The following federal regulations, DOE Directives, and SNL policy describe the current protections for research volunteers:
Mandatory Training
Protecting the rights and welfare of human research subjects at SNL is primarily the responsibility of the Principal Investigator (PI).
However, accountability for ensuring that protection is shared by the HSB and Sandia. To fulfill these roles, the Institutional Official
(Executive Vice President), each member of the HSB, and each PI must be familiar with HSB procedures and understand their
responsibilities as defined in the HSB Procedures Manual. Additionally, each of these individuals** must also complete the mandatory Cooperative IRB Training Initiative (CITI) online training. Contact the HSB Administrator at 845-9171 for web site and instructions.
**PIs whose research qualifies for the lowest level of review rigor are not required to complete CITI
Related Web Resources
Contact the HSB Administrator, Terry Reser, at
(505) 845-9171
Sandia National Laboratories
Medical Clinic Department (3333), MS-1019
Albuquerque, NM 87185-1019
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