The Public Access Provisions from 1978 to 2020

The muckety mucks at NIH, here meeting in late 1977, were quite clear about what kinds of records Institutional Biosafety Committees are required to release to the public. God bless them. (National Library of Medicine)

The Public Access Provisions of the NIH Guidelines, as they apply to records, are short and simple. Consisting of a single paragraph, they say that Institutional Biosafety Committees (IBCs) must release to the public their meeting minutes and all other related records that their funders are required to release. Like so:

Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. If public comments are made on Institutional Biosafety Committee actions, the institution shall forward both the public comments and the Institutional Biosafety Committee’s response to the Office of Science Policy, National Institutes of Health ...
– NIH Guidelines at Section IV-B-2-a-(7)

In simple terms, what this obviously means is that, in addition to minutes, if the institution holds other records* related to rDNA research that can be obtained from a government agency under the Freedom of Information Act (or other law), then the IBC has to release those records on request. And that such records exist is effectively always the case, because nobody gets a federal grant or contract without paperwork.

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An introduction

If the Federal Register is involved, it’s going to be riveting!

I am a student of history, but I don’t profess to be a historian of the NIH Guidelines nor of biotech research in the United States. Although I do hope that if a history of this obscure topic is one day written that I will earn at least some mention for the work I’ve put in, on and off for twenty years, to preserve the public right to know about the research that it funds at American universities, research institutes and, sometimes, private companies.

The starting point is, really, a deal that was cut over a period of years in the mid to late 1970s between the US government, represented mainly by the National Institutes of Health (NIH), and an assortment of leading biologists representing their disciplines. The deal was about how to govern the safety of genetic engineering experiments, which were starting to happen in earnest at the time.

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