A number of recent applications to Fogarty grant programs have been disqualified for being in violation of the new NIH appendix policy. The guidelines, which took effect in January 2017, provide detailed instructions for when an appendix is allowed and what it may contain. Unless specified, all publications, manuscripts, abstracts and other materials must be summarized in the research strategy portion of the application and not submitted in the appendix.
Photo by David Snyder for Fogarty/NIH
Reviewers are not required to consider appendix materials as part of their review unless those appendix materials are stated as required in the Funding Opportunity Announcement (FOA), according to Dr. Cathleen Cooper, Director of the NIH Center for Scientific Review's Division of Receipt and Referral.
"It does create a problem because some reviewers will review the appendix anyway, particularly when an applicant refers to the appendix material repeatedly, and oftentimes they're referring them out for data or other information that really needed to be in the research strategy itself," Cooper said in a podcast on the topic. "Because appendices can be significantly abused, we're watching them very closely."
There is also confusion about hyperlinks, which are only allowed in very limited parts of the application and only when they're specified either in the FOA or the form field instructions, Cooper noted. "So basically, hyperlinks are allowed in the biosketch and the references section and no place else; certainly not in the research strategy or the appendix."
Unless otherwise specified in the FOA, the only allowable appendix materials are clinical trials protocols, brochures from the FDA's Investigational New Drug program, blank informed consent forms, and blank surveys or other data collection tools.
"It's really very unfortunate, but we're not able to modify the applications in any way that are submitted to us," said Cooper. "So, it's not a simple matter of saying Appendix A is not compliant; let's just get rid of it and send the application forward to review. Our choice is to send it to review as non-compliant, which we can't do based on our policy, or withdraw that application, in which case the applicant misses a council round and has to start over again."
In the case of some Fogarty programs that would mean a five-year delay.