Frequently Asked Questions about RFA-HD-15-034: Developing Paradigm-Shifting Innovations for in vivo Human Placental Assessment in Response to Environmental Influences (U01)

Link to the FOA: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-15-034.html.
Link to the Notice of Clarification: http://grants.nih.gov/grants/guide/notice-files/NOT-HD-15-014.html

  1. Are multi-PI and multi-institution applications allowed? Required?

    Because we are encouraging development of novel teams, multi-PI and multi-institution applications are allowed, though they are not required.

  2. Are applications from foreign organizations allowed? Do they 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.

  3. Given the human focus of the goals, are studies that are carried out exclusively in animal models allowed?

    We recognize that the development of novel technologies will have to be worked out in model systems first and, depending on the technology, there may be hurdles to testing in humans. Therefore, animal model-based applications are allowed; however, applicants must outline a clear path in the application for translation into humans.

  4. The RFA states that biomarker studies are not responsive. How are we going to validate our novel technology if we cannot correlate it with known biomarkers? Also, biomarkers have tremendous potential to provide insights into placental structure/function, so why don't you support those studies?

    Applications whose primary focus is on biomarker discovery and validation will be considered nonresponsive. It is understood that investigators will need to be able to validate novel technology that they are developing, and this may involve some biomarker use. NICHD is very supportive of biomarker discovery and validation – the upcoming Human Placenta Project workshop in April will include extensive discussions of omics (e.g., genomics, proteomics, etc.), which may lead to identification of such biomarkers. However, this specific RFA is for technology development.

    NICHD is very supportive of basic placental research and encourages investigators to submit investigator-initiated applications to support those studies for separate consideration, apart from the Human Placenta Project.

  5. The RFA states that nonresponsive applications include those with little potential for utility in the first trimester. There are some exciting, imaging-based methods that are not permitted within the first trimester.

    This funding opportunity is to facilitate development of novel technology that may be used across pregnancy for assessment of placental structure and/or function. Achievement of this goal may require the use of multiple approaches, and some may not be able to be utilized within the first trimester at this time.

    Projects that are directed at development of technologies with little potential for use in the first trimester will be accepted for review, provided:
    • The reason(s) it cannot be used in the first trimester is detailed.
    • The potential for use in the first trimester is addressed.
    • The value of the technology to the goals of the Human Placenta Project is justified.

  6. What constitutes "real-time"? Does assessment have to be instantaneous?

    The placenta is a dynamic organ, which changes over the course of pregnancy. To be helpful, assessments need to yield results within a time frame that reflects the placenta's current structural/functional status. However, real-time is not meant to imply instantaneous results. For any proposed technology, the application should outline:
    • The expected time frame from applying the technology to return-of-results.
    • The potential for shortening the time frame.
    • The expected utility of the proposed technology for determining placental structure and/or function status at the time that results are returned.

  7. Why is there a requirement for an obstetrician on the application? Does he or she have to be directly involved in the technology development?

    That requirement was included to ensure that there is someone with the appropriate clinical expertise to provide input into the research design, and a reality check that what is being developed would be feasible in a clinical setting.

  8. The application requires testing of an environmental component. Does this include important medical conditions that affect women, such as autoimmune disorders? What sorts of exposures are allowed?

    Chronic medical conditions are not considered environmental exposures for the purposes of this RFA. There are a number of acceptable categories of exposures outlined in the RFA, such as alcohol, cigarette smoke, nicotine, prescribed medications, indoor/outdoor air pollution, maternal diet, exercise, or stress. The selection of an environmental exposure to examine must be scientifically justified based on its known or suggested effects on placental or fetal development.

  9. What is the role of the working group described in the RFA? Will it act as a steering committee to direct the course of research across the grantees?

    The working group is intended to facilitate the exchange of ideas across the funded projects, provide useful feedback, and stimulate new ideas and collaborations. The working group members will not serve as a steering committee that has a vote in what individual grantees do. Each submission should be a complete project application on its own.

  10. Could you clarify the budget limits for the application?

    The RFA states that applicants may request up to $3 million in direct costs plus applicable Facilities & Administrative (F&A) costs for the entire project period. It is not $3 million per year.

  11. What portions of the funding announcement do reviewers use in their assessment of the application?

    Reviewers are instructed to evaluate the applications based on the review criteria in Section 5 of the funding announcement. This is generally boilerplate language. However, for this funding opportunity, we put specific language into three review criteria – Significance, Investigators, and Approach.
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