• What is human subject research?
  
• Who serves on the HSB?
  
• What are Sandia's responsibilities?
  
• What does this apply to?
  
• What must be submitted for review?
  
• Where will I find more information?
  

What is human subject research?

Research is any systematic investigation (including research development, testing, and evaluation) that is designed to contribute to generalizable knowledge. Data collected during a study becomes generalizable when new information is added to a body of existing knowlege or is applied to different populations or settings from which it is gained.

If research involves living human beings about whom a researcher obtains either (a) data through intervention or interaction, or (b) identifiable, private information or materials, then the activity constitutes human subject research.

Information is private if an individual can reasonably expect it not to be made public (such as a medical record) or if the information concerns behavior that the individual can reasonably expect not to be observed or recorded. (For example, we act differently at home than we do in public because at home we expect not to be observed or recorded by anyone other than family.)

Examples:
The following activities constitute human subject research and require HSB approval:

• The use of bodily materials such as cells, tissue samples, blood, urine, hair or nail clippings, even if these materials were collected previously for a purpose other than the current research.
  

• The use of humans to test devices, products, or materials with the express purpose of investigating human-machine interfaces or evaluating environmental alterations when humans are the subjects being tested
  

• Studies conducted to gain knowledge that can be generalized about classes of subjects (such as DOE workers, fast food restaurant workers, women of child-bearing age, etc.).
  

• Research in which information is obtained either directly from the subject (e.g., oral histories, videos of subjects, interviews, surveys) or indirectly (e.g., observation of human subjects or access to identifiable private records).
  

• Analysis of identifiable private information such as genetic data or medical or exposure records, even if these materials were collected previously for a purpose other than the current research.
  

• Collaborative studies in which material or information related to human subject research is collected at another institution and sent to researchers at SNL.
  

• Any classified research involving human subjects.
  

• Projects or pilot studies in which the investigator is the only subject.
  

The following do not constitute human subjects research:

• Any research involving information or material from subjects who are deceased before the study begins.
  

• Studies intended to gather data solely for program improvement (not generalizable)
  

When in doubt about whether your activities constitute human subject research, contact the HSB.

Who serves on the HSB?

HSB members represent SNL engineers, lawyers, medical staff, and management. They include scientists and non-scientists, men and women, from NM and CA sites, and also several community members who have no affiliation with Sandia other than serving on the HSB. Linda Duffy, Director of Sandia's Health, Benefits and Employee Services Center, is Chair.

What are Sandia's responsibilities?

• Protect rights and welfare of human subjects in research
• Review all SNL projects for compliance with human subject protection requirements
• Maintain an institutional review board (HSB) according to federal regulations
• Ensure that no human subjects are involved until research approval by the HSB is complete

What does this apply to?

The HSB must review any research involving human subjects, or their data or specimens that:

• is sponsored by SNL, or
• is conducted by or under the direction of any SNL employee,or
• is conducted using any SNL property or facility, or
• involves the use of SNL's nonpublic information to identify or contact human research subjects or prospective subjects

What must be submitted for review?

In order for the HSB to review a proposed study, the Principal Investigator must submit a Proposal Review Package. This package includes the following:

1. A signed Review Request form;
   
2. A 1-2 page abstract of the proposed research, (including a description of risks and benefits;
   
3. A complete research proposal, including provisions for the protection of human subjects in accordance with all applicable laws and regulations and other related paperwork (e.g., an Activity Specific Standard Operating Procedure);
   
4. Proposed informed consent form;
   
5. Any proposed advertisement for human volunteers.
   

Where will I find more 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 recently revised HSB Procedures Manual (OP-MED026).

Also, you may contact the HSB Administrator anytime. See information below.

HSB Administrator:
Terry Reser, (505) 845-9171
Sandia National Laboratories
Medical Clinic Department (3333)
PO Box 5800, MS-1015 Albuquerque, NM 87185-1015
treser@sandia.gov

Back to top of page
HSB Manual | HSB Home | Forms & Templates
© Sandia Corporation | Terry Reser | Site Map | Privacy and Security