DURC/PEPP Research

Dual Use Research is research that is conducted for legitimate purposes, but which could potentially generate knowledge, technologies, or products that could be used for both beneficial and harmful applications. Dual Use Research of Concern(DURC) is a small subset of life science research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm, with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.

A pathogen with pandemic potential (PPP) is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.

“Reasonably anticipated” describes “an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur and excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.”

This definition captures important features of the outcome assessment that are further explained in section B3 of the DURC-PEPP Implementation Guide(link is external):

• "Relevant scientific expertise" refers to the scientific expertise required to anticipate the potential and plausible results of an experiment.
  • Scientists may have differing views on possible and likely outcomes of any particular experiment, so the general assessment of multiple individuals is likely to be more robust than the views of any single individual. The PI is not required to seek assessment from a group of individuals, but rather to use the PI’s individual expertise and experience to consider the range of assessments that individuals with relevant scientific expertise would likely make.
• "Expect this outcome to occur:" While it is impossible to know for certain the result of any experiment in advance, experiments are typically conducted to test specific hypotheses. These hypotheses constitute expectations about the possible results of an experiment, and should be included in the range of results that are “reasonably anticipated” may occur. The PI may consider, if applicable, leveraging existing literature that may have analogous experimental design and/or similar pathogens or toxins to determine potential expectations.
• “Non-trivial likelihood”: A “reasonably anticipated” outcome is not necessarily the most likely outcome, nor is it necessarily an outcome with greater than 50% likelihood. Rather, it is an outcome that has a reasonable, non-negligible chance of occurring. For example, consider an experiment on pandemic influenza that experts anticipate is most likely to result in a loss of function, but that experts also believe could possibly increase transmissibility of the pathogen. An indication of generating a pandemic influenza virus with enhanced transmissibility represents a risk of high consequence to the public if that agent were to be accidentally released. Such a study should therefore undergo Category 2 oversight because, despite the fact that generating a PEPP is not the likeliest outcome, it has a non-trivial likelihood of resulting in a PEPP.
• “Excludes experiments in which an expert would anticipate the outcome to be technically possible, but highly unlikely”: For many experiments it may be possible to imagine a scenario, however unlikely, in which a genetic mutation surprisingly results in an increase in virulence or transmissibility against all reasonable expectations and prior evidence. The purpose of the Policy is to prioritize oversight for experiments that may pose the greatest risks. Technically plausible outcomes with very low likelihoods, as assessed based on pre-existing evidence, are not subject to Category 2 oversight. As per the Policy, if such a result unexpectedly arises during the conduct of research, the study should be halted, immediately be flagged for the IRE and funding entity, and be subject to Category 2 assessment and risk mitigation.

The ICDUR is a designated individual at a research institution responsible for coordinating the institution’s response to potential Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). This person serves as the primary point of contact between the institution, researchers, and federal agencies regarding DURC/PEPP policies and compliance.

The IRE is a committee or designated body within a research institution that reviews proposed or ongoing research to assess whether it falls under Category 1 or Category 2 of the DURC/PEPP policy. The IRE is responsible for conducting risk assessments and determining appropriate actions, including creating and evaluating risk mitigation plans. The IRE ensures that all relevant policies and safety measures are followed for research with potentially high risks.