PNNL in the Community

The Need and Importance of Human Subjects Research and Community Outreach

It is widely known and understood that many of the modern advances in medicine rely upon human subject research in order to decide which new treatments are effective and which, although promising, pose unwarranted risks or are simply ineffective.

What is not as widely known is the importance of human subjects research in the social and behavioral sciences. Battelle, operator of the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy, has been involved in performing such research for over 40 years. Although Battelle occasionally provides technical support for medical research, it is much more common for its scientists and engineers to study the impact of technology on how people function and interact. An example of a project that falls into that category is the development of millimeter wave imaging systems. They can identify non-metallic weapons concealed on a person for security purposes or they can help select the best fit for clothing, using a beam of energy comparable to an automatic door sensor at a retail store. Other human subject research programs look at governmental policies to learn how the public will respond to changes that are being proposed in energy usage.

The Institutional Review Board (IRB) is the primary mechanism to identify risks to human subjects and to reduce or eliminate any potential harm to volunteers. The IRB is responsible to approve all aspects of the research to make sure that the benefits outweigh the risks of participation. Members of the IRB are trained to evaluate scientific and ethical issues and to oversee the process of informed consent. Occasionally those duties require changes to the way that research is conducted. The goal is to have high-quality research that is not tainted by concerns that it was obtained without respect for the individuals' rights while ensuring that the benefits are equitably shared with society.

At PNNL, the IRB is made up of twelve people, of whom eight are community members, even though Federal regulations in Title 45 of the Code of Federal Regulations, Part 46, only require one community member to be on the committee. Of those, two are retired physicians; two are retired biologists, a practicing clinical psychologist, a retired administrative professional with a degree in biology, a technical editor, and a hospital chaplain. Their involvement is vitally important to ensure that decisions taken by the IRB reflect the values of this community. Together, they have lived and worked in this community over 300 years.

In addition, PNNL occasionally draws human subject volunteers from this community. An example was a recent project where volunteers were needed to ride as passengers in a large truck as it drove through a Radiation Portal Monitor (RPM) at the HAMMER facility. PNNL designed and is deploying RPMs throughout the United States at border crossings for the Department of Homeland Security. This detector system is so sensitive that it can measure the natural radioactivity in a cargo of bananas or kitty litter. The volunteers needed to come from patients who were treated with radiation for medical procedures to characterize the type and level of radioactivity so that the RPM operators would be able to differentiate between radioactive materials that were being smuggled into the U.S. by terrorists and radiation that might be present in truck drivers who had medical procedures. The IRB monitored this project to ensure that the subjects were consented properly and were comfortable and did not experience fatigue or stress from their participation.

If you would like to know more about the Pacific Northwest National Laboratory's Human Research Protection Program or would like to discuss problems, concerns or questions or offer input regarding the program, please contact the IRB Program Manager at (509) 375-3610, for further information. The PM will be glad to discuss the program with you and answer any questions or pass your comments and concerns on to the appropriate person.