Protecting Human Subjects in Research
(505) 845-9171 or treser@sandia.gov
| The next HSB meeting is October 10, 2007. The deadline to
submit protocols for review at that meeting is September 26, 2007. |
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 (HSB) is an independent body that reviews proposed SNL research to assess risks and benefits to human subjects. The HSB also works with researchers to ensure that consent to participate is both voluntary and informed from all subjects.
Convened meetings are held quarterly (3rd Monday in January, April, July, and
October), and expedited review sessions for specific protocols are scheduled
as necessary.
Basic Information
Authority and composition of the board, basic principles, definitions, responsibilities (of the HSB, researchers, management, and SNL), procedures, and other detailed information is contained in the HSB Procedures Manual (OP-MED026). If the information you seek isn't there, or available from this page, please contact the HSB Administrator, Terry Reser, at (505) 845-9171 or treser@sandia.gov.
Requirements
Conducting research on fellow human beings is both a privelege and a serious responsibility.
The following federal regulations, DOE Directives, and SNL policy describe the current protections for research volunteers:
- 10 CFR 745, the federal "Common rule" for protection of human research subjects
- 45 CFR 46, Subparts B, C, and D provide additional protections for vulnerable subject populations
- DOE Policy Statement
- DOE O 443.1, Protection of Human Subjects in DOE funded work
- DOE O 481.1, Work for Others (Protection of Human Subjects in non-DOE funded work)
- CPR 300.5.2, SNL policy for protection of human subjects
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.
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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