Tuesday, April 6, 2010

The NIH SBIR proposal submission process SUCKS!

There. I said it. And I meant it.

Over the last few weeks I coached five companies through the intimidating, arduous, and demeaning NIH SBIR proposal submission process for the April 5th deadline. A few of them may need therapy, but by and large, they all survived the process. The jury's still out on me! What's the treatment for "craniac arrest"? I'm getting too old to work this hard!

Why does the NIH's SBIR process have to be so difficult? Required registrations on THREE websites, with multiple registrations on two of them. Just that alone may take a week or two. One of the websites, the NIH's eRA Commons, requires a faxed signature page! Even the IRS eschews that now.

Then, if that wasn't enough, one has to deal with an Adobe Form system with eleven major subforms (one mandatory subform marked "optional") and at least a dozen PDF attachments needed for those subforms, some with page limits, others not. There are dozens of fields and buttons to be filled in and selected, and you'd better do it just so. Or else.

Yes, the NIH provides an Application Guide. Only 234 pages. Shallow Table of Contents. No index.

Once you get the registrations done, all the forms filled out, and the various and sundry documents attached, you still have to endure the submission process. Take a deep breath...

First, upload the completed Adobe Form to Grants.gov (my favorite website...NOT!). Pray you've registered properly and that they'll pass it on to the eRA Commons. If not, fix the AOR credential, and upload again. Don't forget to use the Grant Tracking Number -- but it's called the Federal Identifier in the form. Huh? If it's passed on to the NIH, then the SO and PI can go to the eRA and check the eSub. Alphabet soup anyone?

And, better not have Firefox as your default browser. Grants.gov uses JavaScript. Firefox doesn't. You need JavaScript enabled to "Sign" the application. Aaargh! If JavaScript isn't enabled, you just sit and watch a screen that doesn't change. No message. Nada happens.

Then the eRA Commons does what I call the Nit-Pick Check. If everything's not perfect, you get ERRORS, and have to go back to the start, fix the Adobe Form and resubmit through Grants.gov. You may only get WARNINGS, which do not require a re-submit, but scare the bejezus out of you.

The most ridiculous field that can trip you up is the "Congressional District". Collected for statistical purposes only, it's needed on two different subforms. The format is XX-nnn where XX is the state abbreviation and nnn is the District as a 3-digit number. The use of 3 digits is required even for Wyoming which only has one district. Come to think of it, California has the most Congressional Districts of any state - 53. Why do they require a 3-digit number? That's what I call a Walter Cronkite - "That's the way it is." Put it in wrong? ERROR! Fix and re-submit!

But the Walter Cronkite that really frosts my cookies, is the question that requires you to LIE to answer it right. Yes, LIE. I wanted to do a Joe Wilson when I first read it. It's in the Vertebrate Animals Use section. Here's the quote from page I-69 of the Guide: "Applicants should check “Yes” to the question “Is the IACUC review Pending?” even if the IACUC review/approval process has not yet begun at the time of submission." Then they want you to put "None" in the field for the Animal Welfare Assurance Number. (Isn't that obvious?) If you don't -- go all the way back to the start, put it in, and re-submit. (I know this because we had to do it yesterday!) A button for "Not yet" would make it so much clearer - and truthful!

The DOD's Spring SBIR solicitation will be out in a couple of weeks. Their Guide is only ~40 pages. One website with a 5-minute registration process. You write your proposal and upload one (1) PDF file. Three forms: a cover page, a budget, and a company information form. If you've had prior Phase IIs there's one more form. That's it. And NO submission process! They close the website at the deadline. Anything there gets evaluated. Period. So clean. So simple. Thank you DOD!

So, I'll say it again: The NIH's SBIR proposal submission process sucks. It's so tied up in administrivia it's easy for the applicants to neglect paying attention to the objective: clearly articulate an innovative solution to an important health-related problem. And the agency is so wrapped up in its process that it seems more time (and taxpayer money) is spent on bureaucratic enforcement of policies than on enabling innovation for solving serious health-related problems.

And now, the NIH is campaigning to eliminate the "Error Correction Window", the five extra days (used to be only two but they had to increase it because of recent policy/procedure changes) they give you to fix all the Nit-Pick problems they find. DON'T LET THEM DO THIS! You can weigh in until April 19th at this weblink: http://grants.nih.gov/cfdocs/era_process_changes_rfi/add.htm. Read the NIH's view on why they should be allowed to do this in the Federal Register (page 11889, 12 March 2010). Again: DON'T LET THEM DO THIS!

Remember, the NIH is part of HHS -- our National Health Care agency. They'll be administering ObamaCare. And the IRS will be enforcing it.

Oy Vey! What are we in for?


Anonymous said...

Wait for the Summary Statements! Appreciating the humor requires some professional background, but once this condition is met, you will consider Alice in the Wonderland boring, comparing to the pure nonsense produced by the NIH institutional culture.

Carl Nelson said...

The sad part is that SBIR was supposed to be a gateway for tiny companies into the federal handout machine. Short simple proposals followed by a small Phase I funding to check out the idea and the company. Somehow the fed machine got the idea that SBIR was to be like all the other federal handouts with competition rules suitable for sophisticated entities competing in a narrow range of known dimensions.

Why? Procurement law, defensive management, diffused decision making, pressure for results and success rates. The federal machine just isn't set up to do what SBIR could best do.

If SBIR is ever to be an innovation generator and exploiter, it has to change its attitude. Favor first timers, disfavor repeated awards to the same technology, recognize that first timers and real innovators don't think federal, for Phase II favor ideas and companies with an independent and profitable future after federal support, etc.

Make it easier for the feds to adopt such approach. Cut the size of the program dramatically to remove the internal pressure to convert the program to mainline program support. Make it invisible at budget time. Stop the political temptation to make it ever bigger on the old Army theory that if a little bit is good, a whole lot is better.

Sue Kristoff said...

I totally agree, I swear half the work I do with my clients on NIH proposals is navigating the registration and submission process.

And I also agree with one of the respondents that the summary statements are crazy. I always prep my clients before they receive them so they aren't shocked. I had one colleague note that the only thing the summary statement didn't do was insult his grandmother.

Anonymous said...

Too bad for me my application will be going to the NIH... At least I decided to give myself until the DEC 5 deadline now. And I've received a NIDA fellowship before so I have my own ERAcommons account, but registering the business 3 different ways is pretty ridiculous. I guess we'll wait and see...
It does have some of the highest funding rates though!

Anonymous said...

Maybe they are using the submission process itself to weed out the unqualified candidates. After all, how can you have the brains needed to succeed as an innovative small business if you can't even figure out a submission process?

- Fred Patterson - said...

I was once told (off the record of course) that indeed, the hoops NIH makes applicants jump through were designed specifically to weed out the casual applicant. Only serious researchers need apply.