Sneak Preview: NIH Evaluating Life Sciences Research Threats

January 8, 2015 | By Jerry Ashworth | Post a Comment

xgran_bookshot(The following was excerpted from an article in the Federal Grants Management Handbook.) Institutions with researchers conducting dual use research of concern (DURC) under Department of Health and Human Services (HHS), National Institutes of Health (NIH) grants and cooperative agreements must establish an institutional review entity (IRE) by September 2015 to evaluate the benefits and risks of such research, according to a new NIH policy.

This policy addresses, in particular, science safety and security concerns, and may be in addition to any Institutional Review Board (IRB) processes that generally address the ethics of scientific research, the protection of rights (such as informed consent) of  human subjects participating in the research project and protection of personally identifiable information.

Dual use research of concern is defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel or national security.” The concerns, therefore, relate to significant public safety and security risks. NIH officials said that the goal of its new policy is to “preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products or technologies provided by such research.”

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