The NIH is funded by Congressional appropriation so you should be aware in a very general sense that much of what we NIH-funded investigators do is a mandate of Congress. I also mention now and again that there are Congressional (I guess properly "Legislative") mandates that seem to delve a little more deeply into specifics than most scientists expect.
The NIH Guide has recently published a reminder Notice for some of these Legislative Mandates that have been around since forever*.
NOT-OD-10-040 is a reminder that even though authorizing legislation for FY2010 has not been passed, six Legislative Mandates from the 2009 bill are still in effect. At least three of them are of specific interest to our audience here at the blog.
(3) Anti-Lobbying (Section 503)
"(a) No part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself. (b) No part of any appropriation contained in this Act shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature. "
There are two implications of relevance for us. First, when I say "Call your CongressCritter", technically you'd better not be doing it with anything funded by NIH direct costs. Your phone line is generally payed for by your University but I suppose if you are using a grant-funded computer to send an email, you are in violation. If you are clocked into the NIH Grant dime for your time, ditto.
The second one is slightly more interesting and gets into the difficulty in writing legislation that accounts for all situations. What if your research has significant public policy implications? Hold that thought for just one second...
(4) Restriction on Distribution of Sterile Needles (Section 505)
" None of the funds contained in this Act may be used to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution."
Right, so if you want to do research on whether needle-exchange programs reduce the transmission of HIV you have to obtain the permission of your local legal authorities. If they are agin' it, you can't use the power of your NIH Grant award to do it anyway. I'm not aware of how many times this has been a serious issue but I do know many local jurisdictions are opposed to needle-exchange. It grates me to think that this whole "We think it causes harm and we're not going to let you generate evidence that might test our respective hypotheses, so there" is supported at the Congressional level. When you think about it, this mandate is a specialized case of #3 above. You can't do research which might actually, gee I dunno, inform public policy on the NIH dime? Right? And what possible use would needle-exchange evaluation be, save to "influence legislation"? Well, I suppose if needle-exchange is a purely local thing, this doesn't say you can't influence your local City Council, right? Phew...
Okay, now on to the red meat for my legalize-eet friends...
(9) Limitation on Use of Funds for Promotion of Legalization of Controlled Substances (Section 510)
"(a) None of the funds made available in this Act may be used for any activity that promotes the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act except for normal and recognized executive-congressional communications. (b)The limitation in subsection (a) shall not apply when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage."
This could be really nasty, couldn't it? When you are doing actual science, many studies that you conduct are going to have mixed results. And who knows what outcome is going to "promote" the legalization of schedule I drugs, right? I mean have you seen the stuff thrown up by the legalize-eet crowd in support of cannabis or Ecstasy? They are quite delighted to cherry pick out any study or finding which they think has a prayer of supporting their legislative aims. Right? So if you are doing research on schedule I substances, every study you do runs the risk of running afoul of this mandate! last bit is hilarious, isn't it? I mean one of the very best ways to generate "significant medical evidence of a therapeutic advantage" that we have is the combined body of a diversity of research studies ranging from the pre-clinical to the clinical.
With respect to schedule I drug research, it is very likely that I have done such in the past, may be doing such currently and/or am actively seeking NIH awards for future study. I totally ignore this mandate in my proposals, work and publication of results. As do all other substance abuse scientists from what I can tell. The only time I've seen this seem to raise its head in an ugly way was this incident. Given that incident, it is very possible that this mandate does have a subtle or not-subtle quelling effect on scientists** who are not even aware of the effect on their decisions. So as with the needle-exchange mandate, I think this is a BadThing for Congress to mandate.
It all just smacks of being afraid to know what the truth is, in case it contradicts your opinion. This is offensive to the enterprise of science.
*the duration of my postgraduate science career at the least.
**sure, me too.