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II. Agreements Not To Disclose: Trade-Secrets and the "CDA"

B. Secrets and the Government

Under FOIA, 20

5 U.S.C. § 552.

all Government records must be disclosed upon request, unless the Government can demonstrate that the information in the record falls into a specific, narrow exception on a short list set out by Congress -- and even then, the Government must disclose a redacted version if feasible. Of the exceptions on that list, five are routinely relevant to the Government’s biological and medical research. They are exceptions for trade secrets, 21 internal decision-making, 22 personal information of a private nature, 23 unfiled patent applications in which the Government owns an interest, 24 and certain research information generated under a "Cooperative Research And Development Agreement," or "CRADA" 25 (a topic discussed in more detail below). This arrangement presents a dilemma for the NIH.

On the one hand, from a scientific perspective, data should be meticulously collected, organized, and carefully analyzed before drawing bold conclusions; it is potentially irresponsible to release such conclusions that have not been grounded in properly collected data, particularly if the conclusions have not undergone some substantive review. This is especially true where the premature release of unsifted information would be misleading. Further, NIH acknowledges that private research facilities have a legitimate need to protect their trade secrets and individuals have the right to privacy; NIH understands that these parties will not cooperate with NIH if the confidentiality of their information will not be protected.

On the other hand, even apart from the commands of FOIA, NIH has strong reasons to support disclosure of all research results as quickly as possible. For example, because the most talented scientists cannot advance their careers if impediments block their ability to publish important results in a timely manner, they will instead work in a more publication-friendly environment. More importantly, the bedrock mission of the NIH is to uncover new knowledge that will lead to better health for everyone. NIH depends on the rapid communication of research results to advance that mission. As a policy, NIH is strongly committed to the principle that scientific advancement relies on the unfettered and rapid dissemination of information. NIH will never approve any agreement in which a private entity has substantive control or veto power over the research publication of one of its scientists, lest valuable information which was developed by taxpayer funds be stifled to further private interests. On this point NIH will not negotiate.

As a compromise, NIH strives to draw a line between the information provided to NIH, and the research results derived from that information. NIH will work with collaborators to protect legitimate trade secrets from inadvertently being disclosed in publications. Specifically, NIH will delay disclosures enough to give collaborators a reasonable opportunity to file patent applications on discoveries. Also, NIH will seriously consider any requests by collaborators to redact or edit manuscripts and other disclosures before they are made public. Nonetheless, NIH must retain final authority to decide whether to go ahead with a given disclosure.

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Page Last Updated: 12-02-2008