NIH took two steps down the road that leads to more ME/CFS research funding last week, but it’s important to understand what those steps actually mean at this point in time.
First, NIH issued a Request for Information: Soliciting Input for New Research Strategies for ME/CFS. A Request for Information (or RFI) is used by federal agencies to gather public comment on a particular topic. A few things stand out about this RFI:
- The RFI was issued by the Trans-NIH ME/CFS Working Group and sixteen Institutes.
- The Working Group wants input on: emerging needs and opportunities; challenges or barriers to progress; and gaps and opportunities across the continuum from basic to clinical studies.
- “[T]he Trans-NIH ME/CFS Working Group will review and consider the comments received under this RFI with regard to current and future needs and direction for ME/CFS research and research training.”
- The deadline for response is June 24, 2016.
I can’t emphasize enough how important it is for us to respond to this RFI. To my knowledge, it is the first time our opinions have been solicited as part of a planning process. There is no reason that I can see for us not to offer our best input in response to the request.
Second, Dr. Vicky Whittemore presented a “funding concept” for an ME/CFS RFA to the Council of the National Institute for Neurological Diseases and Stroke on May 26th. But what does that actually mean?
A funding concept “describes the basic purpose, scope, and objectives of a potential solicitation of grants or contracts.” “According to law, experts in the field, usually Council members, must approve a concept before we can announce an initiative.” Approval of a concept by Council does not guarantee that it will become an RFA. In other words, Council approval of a funding concept is a bureaucratic hurdle that must be cleared before detailed work on the potential RFA can proceed.
So what did Dr. Whittemore present to the NINDS Council? Fundamentally, “our concept is that we would put in place a consortium with multiple sites utilizing common protocols across the clinical projects who can also then develop studies across the sites that would address etiology, potentially imaging, potentially biomarkers studies, genetics, that would all work together.” These sites will be at academic centers, and will also include a data-management coordinating center. Another goal of the consortia is to gather a large subject cohort who could eventually participate in clinical trials. Participating NIH Institutes will jointly fund the consortia and data center. After only two questions, the concept was approved by the NINDS Council with no objections or abstentions.
There are several critical things to understand about where we are in the process, now that Council has approved the concept:
- Dr. Whittemore is now able to proceed with drafting the RFA itself. However, there is no guarantee that an RFA will actually be approved and issued.
- We have no information on how many sites will be funded in this consortia.
- We have no information on the amount of money that will be allocated to this RFA.
- We have no information about whether the RFA will fund research directly. It’s possible that it will provide funding for the costs of getting a site up and running, not covering the cost of research projects.
- We have no information about the timeline. Dr. Whittemore said at CFSAC that she hoped to issue the RFA in June or July and make awards next year. But at least one Institute describes the process as taking six months after concept clearance.
- We don’t know if these sites will provide clinical care, so we should not assume that these will be Centers of Excellence as CFSAC recently recommended.
- We don’t know if NIH will wait for the responses to its RFI before issuing this RFA.
- We don’t know if there will be any other RFAs for research grants.
In other words, there are a lot of blanks that still need to be filled in. This RFA could be spectacular, it could be dreadful, or it could be somewhere in between. We simply do not know. Interestingly, one of the RFAs NIH issued this week was for Diabetes Research Centers. That RFA specifically requires participating Centers to already have at least $3,000,000 in peer-reviewed research underway, and the RFA does not fund research projects; only administrative and core activities are supported. This RFA for Diabetes Research Centers will provide a total of $13,500,000 for up to nine sites in 2018, approximately $1,500,000 per site.
It remains to be seen whether the steps taken by NIH last week will ultimately get ME/CFS research where we need it to go. In the meantime, the RFAs for other research areas keep rolling upwards.
- Total RFAs Issued by NIH: 231 (October 2015 to date)
- Total Dollars Committed to RFAs: $2,074,240,000 (October 2015 to date)
- Total RFAs for ME/CFS: ZERO (October 2015 to date)
|Week Beginning||RFAs Issued||Total Commitment||RFAs for ME/CFS|
If you want more background on the RFA Ticker, read the inaugural post.