Frequently Asked Questions about RFA-HD-17-004 and RFA-HD-17-005

Links to funding opportunity announcements for "Assessing Human Placental Development and Function Using Existing Data":

RFA-HD-17-004 (R01)
RFA-HD-17-005 (R21)

The RFAs do not explicitly prohibit animal research. Are animal studies allowed if they may be able to provide insights that inform the Human Placenta Project?
These RFAs are intended for evaluation of human data and samples. Animal studies will be considered non-responsive.

Do all studies need to use preexisting data, or may there also be some new scientific tests performed on preexisting samples (e.g., new DNA/RNA/etc. analysis of serum samples or placental tissue blocks)?
Applications may propose new tests on preexisting samples.

May collection and analysis of non-placental data be included in the application?
These RFAs are for development of profiles that reflect placental development and function. For this reason, we require the use of placentally derived samples. However, we recognize the potential value of augmenting these samples with non-placental data, and so they may be proposed as supplementary to the primary dataset.

Are applications from foreign organizations allowed? Do foreign PIs have to be partnered with someone in the U.S.?
Applications from foreign organizations are allowed, and there is no requirement to be partnered with a U.S. institution. Please be sure to follow the instructions and links provided in the funding announcement.

The title of the RFA refers to “existing data” but does not mention existing biospecimens. Does that mean we can’t develop an application that focuses on the use of biospecimens?
The application may propose use of data and/or biospecimens. We include an example of this as the first bullet under “Scope of Research to be Performed,” as shown below:

Applications that would be responsive to this FOA include but are not limited to:

  • Application of omics to placental specimens (e.g., cells, vesicles)
  • Analysis of placental imaging data
  • Development of predictive tools which incorporate data analytics and electronic medical records

We have extensive data (medical records, blood work, vaginal swabs, etc.) from across pregnancy, and we have placental specimens taken at delivery. Would analysis of these data be responsive to the RFA?
The purpose of this funding opportunity announcement is to advance the overall goal of understanding placental development and function across pregnancy in real time. While it is true that associations could be made between a variety of pregnancy data and the pathology of the placenta at term, such an analysis would not be able to provide any insight as to what was happening to the placenta during those earlier stages of pregnancy. Therefore, as described, this proposal would not be considered responsive. However, analysis of existing placental data (images, omics, etc.) or placental-specific samples (placental RNAs, proteins, etc.) from across pregnancy that would be combined with other non-placental data to develop such an understanding would be acceptable.

We are trying to use all Human Placenta Project RFAs to advance our understanding of placental development and function across pregnancy—that should be the litmus test for any proposed studies. Note the instruction in the Research Strategy section of these RFAs, stating that “for all samples and data, their value for advancing the goal of safe, real-time assessment of human placental development and function across gestation must be detailed in the application.”

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