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.
In the past, I have focused on the minutes aspect of the public access provisions. And so have other requesters under the Guidelines that I am aware of.
For me, focusing on IBC minutes has stemmed from practical considerations. If they are well kept, and that’s a big issue for later, minutes enable reading the “pulse” of the IBC. They tell you how often it is meeting, what it is discussing, and if those discussions are serious. They should also tell you if there have been lab accidents or controversies in the committee. This is important information that shows how well the committee is working.
And if the minutes don’t tell you those things, then it might be surmised that the pulse of the patient is weak. That is a matter that can be raised in public and with government funders. And in further requests.
When it comes to the scope of the records covered by the Public Access Provisions, the creators of the Guidelines described their intent in quite clear terms in 1978 in the Federal Register, when the language of the Public Access Provisions was introduced.
While the Guidelines had always required IBC minutes to be made available, following 1977-78 consultations with the public, with experts, and with other government agencies, a decision to expand public access was made. The key paragraph in the notice that accompanied the publication of the updated Guidelines on 22 December explicitly states the intent of the Public Access Provisions to create local accountability:
In addition, the IBC is to forward to NIH any public comments made on its actions and the committee’s response to them. And all IBC documents that NIH must make available to the public, such as the funded research proposals, are also to be made available, upon request, at the local level. These include reports of serious accidents and of problems with and violations of the Guidelines; also all NIH reports to institutions when MUAs (including modifications of ongoing projects) are not in compliance. Likewise, minutes of the IBC meetings and inspection reports will be made available. The intention of the Guidelines in all these changes is to enhance public accountability at the local level.
(43 FR 60095, 22 Dec 1978)
The paragraph is most important in that the intended scope of the disclosure requirement clearly extends to all rDNA-related records that NIH releases to the public (i.e. under FOIA), without limitation. The paragraph further makes clear that this specifically includes research proposals, and records related to lab accidents and violations. Another type of record, not mentioned explicitly but which clearly falls within scope, are the reports made on funded research, which are records that NIH must release under FOIA.
“MUAs”, or “Memorandums of Understanding and Agreement” were, at the time, the signed statements from research institutions assuring their compliance with the NIH Guidelines. Today, to my knowledge, MUAs are no longer used – at least by NIH – because the compliance statement has been incorporated into the contracts that funding recipients sign. So, MUAs are now part of funding contracts. Here then, is another specific class of document that IBCs must release upon request – contracts for research involving rDNA.
(The question of research compliance assurances is interesting in relation to other federal funders. Several years ago, USDA was still using a separate statement that was to be signed alongside the contract forms. When I asked USDA’s Agricultural Research Service for these statements under FOIA, however, ARS could not produce them for most of the rDNA research it funds. What about DOD, DOE, EPA, and others? These agencies purportedly required Guidelines compliance the last time I checked, but are they actually doing it? An enterprising grad student or activist might investigate.)
Further, while it is not a focus of my own work, the language would appear to potentially encompass some animal (IACUC) and human (IRB) committee records related to federally-funded rDNA research.
Of course, even in the 1970s, commercial interests were at work in biotechnology, and the Guidelines’ drafters acknowledged that records can be redacted to protect “privacy” or “proprietary” interests. Here the obvious standard is NIH practice under FOIA. And any alleged need for proprietary redactions by local institutions must also consider the commitment that scientists made to be personally responsible and transparent with rDNA research.
“Proprietary” in this context is fairly straightforward. If it is something that NIH releases under FOIA, then the IBC must do so too. The Guidelines are national and varying standards of disclosure cannot exist. NIH publishes grant details and summaries, and releases quite a bit of information, including reports, under FOIA. (At its own pace.)
Thus, sorting out what is proprietary is fairly straightforward and revolves around established practices at NIH. General counsels at institutions receiving federal rDNA funding would do well to study up on pertinent FOIA disclosure requirements.
Personal privacy issues rarely appear in IBC records. Every once in a while somebody’s personal cell number or the name of grad student might appear in an accident report. Such instances are few and far between and can be readily dealt with by simple and short redactions.
One thing that institutions sometimes try to get away with – and cannot – is redacting the names of principal investigators and/or committee members from records they release. Of course, PI names are published by NIH (e.g. here), and PIs publish their own names in research in journal articles. Not to mention that the Guidelines system is supposed to be based on personal responsibility.
The Public Access Provisions as birthed in 1978 read as follows:
IV-D-2-h. Upon request, the Institution shall make available to the public all minutes of IBC meetings and any documents submitted to or received from funding agencies which the latter are required to make available to the public (e.g., MUAs, reports of Guideline violations and significant research-related accidents, and agency directives to modify projects). If comments are made by members of the public on IBC actions, the Institution shall forward to NIH both the comments and the IBC’s response.
And that is functionally identical language, mostly literally identical language to the Guidelines today. (See quote at the beginning of this entry.) The only real change made was to delete the outdated list of examples. Otherwise, apart from the editorial change of making “all minutes of IBC meetings” to now read “all Institutional Biosafety Committee meeting minutes“, and updating the means by which IBCs can contact NIH to account for the internet, the Public Access Provisions of today’s Guidelines are identical to those of 1978.
As the pandemic swirls and new attention centers on safety issues such as gain of function research, it’s time to see what can be done with this neglected but potentially very important part of federal research rules.
* At this website I use “records”, a more modern term in open government than “documents”, which is the 1970s-era language of the Guidelines.