Frequently Asked Questions for Pediatric Cardiac Genomics Consortium (U01 - Clinical Trial Not Allowed) (RFA-HL-20-015)
Q1: Can one of our investigative partners be in Canada?
A1: Yes. For this RFA, although foreign institutions are not eligible to apply as the primary awardee, foreign investigators may serve as co-investigators and receive funds through a subaward.
Q2: Can my application propose to collect new DNA samples, or should the proposed project use existing DNA collections only?
A2: Using either existing DNA or collecting DNA is within bounds of the RFA and depends upon the question asked and design of the study.
Q3: We are interested in proposing a project that would use phenotype data paired with genomic data from the Pediatric Heart Network (PHN). Should we get a letter of support from the PHN?
A3: The PHN has rich phenotype data on patients with congenital heart disease that have been recruited in their prospective clinical studies. A subset of those patients have genetic data (SNP array, exome sequence), as well. To learn more about what is available within the PHN, please contact them at PHNmailbox@neriscience.com. To initiate a collaboration, please request a letter of support through the PHN Mailbox at PHNmailbox@neriscience.com. It will be helpful if you can provide a general description of the type of collaboration you are seeking, so that the PHN can provide as useful a letter as possible.
Q4: Is there an enrollment target that each participating center needs to make?
A4: There is no enrollment target or minimum for each center. The enrollment target for your proposed protocol should be sufficient sample size to answer the proposed scientific question. That enrollment will be spread over 4-5 centers and your center should be able to enroll its fair share of that target.
Q5: Is it permitted within the scope of the PCGC renewal to do mechanistic translational studies that involve tissue (as one of several aims)?
A5: Yes, mechanistic translational studies involving tissue are allowed as long as the ultimate goal is “translating discoveries of the genetic architecture of CHD into optimized diagnosis, management, and therapeutic strategies.” (from RFA-HL-20-015). We are trying to shift focus from gene discovery.
Q6: We are currently one of the PCGC sites, if we want to apply for RFA-20-015, is this technically a competitive renewal (it was a UM1 and is now a U01)?
A6: You can come in as a competitive renewal. Even though there is a change of activity code, renewals are allowed by the RFA.