SBIR Proposal Writing Basics

SBIR Proposal Writing Basics: Caution if you are using Human Subjects in your SBIR/STTR project

Gail & Jim Greenwood, Greenwood Consulting Group, Inc.

For unknown reasons, the agencies have gotten a lot more sensitive about SBIR/STTR proposals involving both human and animal subjects. NIH has always had a sensitivity, but agencies like DOD and NASA also are making a big deal out of this aspect of a research project.

“What do I care?” you ask. “We’re not going to poke or drug or abuse anyone, so ‘human subject’ regulations don’t apply to our SBIR project.” Boy, are you naïve! Human subject regulations pertain to much more mundane and innocent situations than these.

Consider, for example, the discussion of human subjects in the website of the Department of Health and Human Services (the department under which the NIH fall), www.hhs.gov/ohrp/policy/checklists/decisioncharts.html. The flow chart found here first asks if you are doing research—chances are real good that your answer is yes if you are submitting for SBIR/STTR funding. If you are doing research, then the chart asks if you will be “obtaining information about living individuals.” Again, the chances are good that, if you are working with people in your SBIR/STTR project, then they are alive. The chart next asks if DHHS is supporting the research; if you are getting an SBIR contract or grant from NIH, Centers for Disease Control or Food and Drug Administration, then again your answer will be “yes.” Then, unless your research falls under one of the five relatively narrow and specific exemptions listed on the chart, your project is deemed to involve human subjects and you must comply with the regulations that are designed to protect them. That will involve approval of your research protocols by an Institutional Revenue Board (IRB), which will ensure your project does not adversely impact the safety, privacy or welfare of its human subjects.

The DoD also warns you about the use of human subjects in its Phase 1 solicitation. For example, in Section 2.8 of DOD’s FY11.3 solicitation, proposers are warned that human use regulations pertain to “any research involving an intervention or interaction with a living person that would not be occurring or would be occurring in some other fashion” if it weren’t for this project, as well as “any research involving identifiable private information” about a person. Again, that’s casting a pretty broad net around a lot of research plans that SBIR/STTR proposers are contemplating. DoD goes on, in section 3.7 of that same solicitation, to require proposers who contemplate using human subjects to be in compliance with all Federal and state policy, guidelines and laws pertaining to human subjects. While suggesting that the aforementioned DHHS/NIH compliance is one way to do this, DOD adds that “additional measures” may be required.

“Whew,” you say, “that sounds like a lot of effort. I guess I’d better build a little extra time into my Phase 1 work plan with DOD to get the necessary approvals.” Well, we’ve got some bad news for you: DOD stated in its FY11.3 solicitation that the time required to get the IRB approvals could be 1-3 months, and then DOD needs another 3-6 months to review your human subject plan and the IRB approval—if you’re doing the math, that means it could take 9 months to get all the approvals in place BEFORE you can begin any research involving those human subjects. Given Phase 1 SBIR projects typically are 6-9 months in duration, you have spent the entire time allotment to just getting the human subject background work done, and haven’t done any of the actual research involved in your feasibility study. Therefore, DOD has stated that Phase 1 proposals should NOT be for research that includes human subjects. NASA issued similar guidance in its last SBIR/STTR solicitation, presumably for the same reason.

We’ll conclude with several take aways from this discussion.

First, recognize the much higher level of scrutiny by the Federal government of research involving human subjects, and be prepared to do more than you have in the past to avoid such research, justify being under one of the exemptions, or taking precautions to protect your human subjects.

Second, if you are proposing to DOD or NASA, do not define a Phase 1 work plan that includes human subjects. This may require some rethinking of your proposal, and a discussion with the topic author and other agency representatives to ensure that your proposal avoids human subject involvement.

Third, if you plan to claim that you are exempt to the human subject regulations in your project, you should be prepared to thoughtfully and thoroughly justify that claim.

Finally, do not take treatment of the human subjects topic lightly. In an era of increased whistle blowing by former employees of SBIR/STTR companies, and of increased scrutiny in the SBIR/STTR reauthorization of “waste, fraud and abuse” among companies getting awards, such light treatment could lead to heavy consequences.