Decisions about what data are covered, what constitutes publication, what is meant by a policy or rule, and what time limits apply will have enormous implications for bench scientists. Until these questions are resolved, many scientists will have to proceed with extreme caution. The laboratory environment will be drastically altered as concerns about possible future disclosure dominate and replace the current ethos of openness and the enthusiasm for exploration. The proposed rule raises serious questions about what types of information will be covered and for what periods of time. In many cases, the answers to these questions cannot be known at the onset of the research project and therefore the effort to limit the scope of the new rule will be ineffective.
Most research data require additional supporting documentation for interpretation.
Decisions about the extent and adequacy of the supporting materials will be needed. A request for data that included a broad definition of supporting material could become a crushing burden for a laboratory. Uncertainty about the ultimate use of every piece of research data, no matter how peripheral, will be costly. Moreover, it will discourage research subjects and collaborators from joining federally-funded projects, currently the most open and accountable venue for research. Replication and validation are important to progress in science, and we support efforts to encourage greater access to research tools and analytic databases.