See the Glossary for more terms.
Complying with human subject rules is a legal imperative, but it's easier said than done. It's always a good idea to reflect on your work, consider every possible way your research could fall under the human subjects banner, and take steps to avoid a bar to award.
To help you get in the right frame of mind, here are the five most common reasons NIAID applicants get human subjects bars to award, plus some questions you can ask when completing your application.
1. Sources of materials are not specified.
You and others working on your grant may conduct all your research in a lab, where you deal with data and specimens rather than patients. But have you carefully traced and can you clearly specify where the data and specimens come from? Is there any possibility that they could come from sources NIH considers "human subjects," for example, individually-identifiable private information?
For more on this and the topics below, read Are You Conducting Human Subjects Research? and the other links at the end of this article.
2. Human subjects section is missing or incomplete.
Even if you think you’re not engaging in human subjects research, consider each person working on your grant, his or her role, and the potential for identifying coded specimens and data. For example, could your statistician have access to a code that links identifiers to subjects?
Though you and your staff don't intend to have the key to decipher a code, think about whether the potential exists. If you determine that you are engaged in human subjects research, you'll need to address all the human subjects elements in your application.
3. Risks or protections are not adequately addressed.
In your application, did you describe the research risks of a drug you're using in a clinical trial, or the risks of any procedures you use, for example, radiation from x-rays, biopsies, or other complications? Did you outline possible psychological risks for your participants—for example, if you’re testing for HIV and a person finds out he or she is positive? Is there any risk of someone’s confidentiality being compromised? Did you describe what you are doing to protect participants?
4. Informed consent issues.
Did you include all informed consent information, describe your process for providing it, and fully address informed consent issues in your application? This is a must—no ifs, ands, or buts.
5. Confidentiality and human genetic issues.
In the confidentiality section of your application, did you thoroughly describe plans for protecting the privacy of and data on people in your study? Pay particular attention to foreign research, which can raise confidentiality issues because local regulations may differ from your institution's. Ask: are samples allowed to be shipped outside the country for genetic research?
If you’re dealing with genetic issues, think through how genetic data and samples will be used. Who will have access to this information? Is it integral to your study, or can a subject opt-out and still participate?
Remember, even if no one on your grant works directly with patients, you might still be conducting human subjects research. Visit the links below for more information, and stay tuned to NIAID Funding Newsletter for advice on how to approach a human subjects application.
This is the latest in a series of articles highlighting resources for researchers from NIAID's Division of Microbiology and Infectious Diseases (DMID).
Get more out of NIAID's preclinical product development services, even if you're not one of our grantees. We recently expanded our lineup of pathogens and products to help you move your discoveries along the product development pathway.
If we couldn't help you with your pathogen before, take another look—we added a broader range of pathogens, including bacteria, viruses, parasites, fungi, toxins, and prion proteins.
On the service end, you get a broader choice of products. Services for therapeutics now include those for developing in vivo diagnostics, such as imaging and skin test reagents, and for monoclonal antibodies, recombinant proteins, peptides, and nucleic acid based vectors.
Does any of that pique your interest? Look at the following programs to take advantage of these offerings. Support comes at no cost, provided you're eligible:
NIAID evaluates requests according to our Standard Criteria, which include having sufficient preliminary data.
Stay tuned for more services in 2012, when we add manufacturing, characterization, evaluation, and testing services for vaccines and other biologics to the Vaccine Development Services program.
See Resources for Researchers for a full listing of services. Note each program's rules for eligibility, assurances, preliminary data, user requirements, applications, and approvals.
If you want to bone up on animal care and use, check out the following events.
To stay on top of workshops and other news, follow NIH's Office of Laboratory Animal Welfare Listserv.
Comment on Future of Biomedical Research Workforce. What does it take to build a sustainable, diverse, and productive U.S. biomedical and behavioral research workforce? The advisory committee to the NIH director wants to know—and it wants your input. Read the August 17, 2011, Guide notice for issues to address, and send your comments by October 7, 2011.
Do you have an unresolved appeal yet want to resubmit your application?
Changing your mind is fine, but be aware—you cannot have an appeal and a resubmission in the system at the same time. You have to pick one or the other.
If you are unhappy with your current choice, have your authorized organizational representative (AOR) send your program officer a request to withdraw your appeal, then go ahead and resubmit.
In the event you sent in both an appeal and a resubmission, your program officer will notify you and give you five days to submit a written request, signed by your AOR, indicating your choice. For more details, see our Appeals of Scientific Review of Grant Applications SOP.
Feel free to send us a question at email@example.com. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"For an NRSA Postdoctoral Fellowship application, can I include my time spent teaching as an activity during my F32?"—Sungwhan Oh, Brigham and Women's Hospital and Harvard Medical School
"For an R21/R33 phased innovation award, does NIAID accept unsolicited applications?"—anonymous reader
No. NIAID accepts R21/R33 applications only in response to a program announcement or request for applications. For more information, see our R21/R33 Phased Innovation Award SOP.
"In my title, can I use an ampersand instead of the word ‘and’?"—anonymous reader
We suggest following NIH’s SF 424 instructions, which say to use only standard characters in the descriptive title: A through Z, a through z, 0 through 9, and underscore ( _ ).
Following that rule is the safest approach for form fields such as the title. Also, type the title in rather than copying and pasting since pasting text will sometimes bring unusual characters over from whatever program you’re using.
You should be fine if your application makes it through validations without issues and the title appears properly when you view the application image.
See these and older announcements at NIAID Funding Opportunities List.
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Last Updated August 31, 2011
Last Reviewed August 31, 2011