You read and hear in the news about the government issuing new regulations or passing bills about any number of things that pertain to a million different facets of life, but the questions constantly in the back of your mind—whether you’re aware of it or not—are how does this affect me, and, as a professional in the publishing industry, why should I care? Christine Casey led a well-organized and informative panel that answered those questions.
The primary government issue that should currently interest those of us in the publishing world, especially in the lifesciences field, is something called dual-use research of concern (DURC). Ori Lev introduced session attendees to this topic and explained that DURC refers to the possibility that a piece of research could have more than one application; the problem is that scientific, and more often specifically medical, findings, if placed in the wrong hands, no matter how good the original intention, could be used in negative ways.
In 2004, the US government established the National Science Advisory Board for Biosecurity (NSABB), which reports to the secretary of health and human services and advises 15 departments and agencies. The following extract is from the government policy defining DURC as follows:1
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.
Lev went on to explain that the NSABB was charged with recommending strategies for mitigating the potential for misuses of DURC. The NSABB established seven categories of experiments for which such strategies should be considered:1
Does the experiment
- Enhance harmful consequences of a biologic agent or toxin?
- Disrupt immunity or effectiveness of an immunization without clinical or agricultural justification?
- Confer on a biologic agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection?
- Increase the stability of, the transmissibility of, or the ability to disseminate a biologic agent or toxin?
- Alter the host range or tropism of a biologic agent or toxin?
- Enhance the susceptibility of a host population to a biologic agent or toxin?
- Generate or reconstitute an eradicated or extinct biologic agent or toxin?
The NSABB formed a working group on journal review policies. Through its research, it found that few manuscripts had been flagged as reporting potential DURC. But in talking with editors, the working group discovered that most editors were not even aware of the policy or that DURC was a problem. That resulted in the NSABB recommendations of steps that journal editors and staff can take to mitigate the risk of publishing a paper with potential DURC. The recommendations include adding a section in the instructions for authors and providing them with information about DURC and allowing them the opportunity to notify editors at the time of submission if any part of a paper has potential for meeting DURC criteria.
David Carr, policy adviser at the Wellcome Trust, spoke from the perspective of a research funding agency. In line with the NSABB recommendations that Lev discussed, Carr said that, as a funder, the Wellcome Trust has an obligation to promote self-governance in the scientific community. To meet that obligation, the Biotechnology and Biological Sciences Research Council, Medical Research Council, and Wellcome Trust devised a joint policy in 2005 that established a guideline specifying that a checkbox be added to application forms that authors must check if anything in their research may meet the DURC criteria. The joint policy also established a guideline for referees that explicitly mentions research misuse as an issue to consider and a guideline for funding committees that spells out the process for assessing cases that raise concern. Carr noted that in his experience most authors applying for funding and questioned about potential DURC respond forthrightly, and only a few cases have been flagged; nothing has been of such great concern that it affected a decision to fund a project.
Mary Ari echoed Carr’s assertion that in the big picture of day-to-day processes, few articles produced by the Centers for Disease Control and Prevention (CDC) have been flagged for DURC, but CDC has a clearance process that is overseen by the Institutional Biosecurity Board and follows the NSABB guidelines. Ari also said that CDC now requires all its scientists to receive Web-based DURC training. CDC uses an electronic system to track compliance, which requires authors to obtain a DURC ID number from the system and to include it in the submitted manuscript.
Ari discussed the importance of data sharing. Although it is not a requirement in the United States, CDC was an early user of data-sharing Web sites. It has discovered that using such Web sites as ArrayExpress, GenBank, and Dryad increases use of and interest in the journal and increases transparency and credibility. Such challenges as choosing which Web site to use, protecting data to avoid DURC, and ensuring confidentiality are involved in requiring authors to share data, but the incentives and rewards, such as receiving grant funding, tend to outweigh the burdens.
The take-home message: For data sharing to work at its optimal level, everyone needs to be on board—editors, authors, funders, and publishers. Funders would like to see more discipline-specific databases available. Authors want to make sure that their research is protected, and they do not want to be responsible for publishing anything that violates the DURC policy and could lead to a national-security or public-health threat; but they want access to other researchers’ data that may help them to further research in their fields. All arms of academic and scientific publishing must continue to have joint policy-making discussions about DURC and data sharing.
- United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. Accessed 2012. http://oba.od.nih.gov/oba/biosecurity/pdf/united_states_government_policy_for_oversight_of_durc_final_version_032812.pdf