Opportunity Information: Apply for PA 08 104
Apply for PA 08 104
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Adverse Outcomes of Assisted Reproductive Technologies (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Apr 27, 2011 and posted on Mar 6, 2008.
- Applicants must submit their applications by Sep 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Independent school districts City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses County governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized).
- Foreign institutions are eligible to apply.
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Opportunity Summary:
The Adverse Outcomes of Assisted Reproductive Technologies (R01) funding opportunity (PA 08-104) is an NIH grant announcement from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) that supports investigator-initiated research focused on potential negative health effects associated with Assisted Reproductive Technologies (ART). The core goal is to generate solid empirical evidence on how specific ART procedures and protocols might influence the biology of eggs, sperm, and preimplantation embryos, and how those early effects could translate into adverse outcomes later on. The announcement reflects the view that, although most children conceived through ART appear healthy and develop normally, the field has reported some adverse outcomes and continues to raise questions because ART encompasses many different interventions, laboratory conditions, and clinical practices that may not be biologically equivalent.
Research supported under this FOA is aimed at understanding whether and how ART-related exposures could contribute to problems across multiple life stages. The scope is intentionally broad, spanning possible impacts during fetal development, the perinatal period, childhood, and adulthood, with explicit interest in the possibility of effects that might appear in subsequent generations as well. In practical terms, applicants are encouraged to investigate mechanisms and pathways by which ART could alter developmental trajectories, including changes that begin at or before implantation. The FOA is open to a wide range of scientific approaches, including basic laboratory research, clinical studies, and epidemiological investigations. It also allows for studies in both human subjects and animal models, recognizing that some mechanistic questions may be best answered experimentally in animals while others require well-designed human observational or clinical research.
This opportunity uses the NIH Research Project Grant (R01) mechanism, meaning it is designed for discrete, hypothesis-driven projects led by a principal investigator (or multiple PIs, if appropriate) with a defined set of aims, methods, and outcomes. The FOA notes that it runs in parallel with a companion announcement of identical scientific scope that uses the P01 (Program Project) mechanism (PA 08-103), which typically supports larger, multi-project programs. Applicants should choose the mechanism that best matches the size and structure of their proposed work, with PA 08-104 specifically intended for standard R01 projects rather than multi-component program project structures.
Funding decisions under this FOA are contingent on NIH funds being available and on the receipt of a sufficient number of scientifically strong applications. The announcement does not promise a fixed number of awards; instead, it emphasizes merit-based funding consistent with NIH peer review and budget realities. Overall, the expected payoff is a stronger evidence base for understanding ART outcomes, clarifying which aspects of ART (if any) contribute to risk, and helping the field refine practices to support healthier short- and long-term outcomes. The FOA also frames this work within a broader public health context, emphasizing that reproductive health is closely tied to overall health and quality of life.
Eligibility is broad and includes many organization types such as public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special districts), as well as tribal governments and tribal organizations. Importantly, foreign institutions are also eligible to apply, which allows international teams to propose studies that may leverage unique ART practices, registries, populations, or research infrastructure outside the United States.
Key administrative details include the NIH as the issuing agency, the CFDA listing under 93.865 (Child Health and Human Development Extramural Research), and a posted date of March 6, 2008, with the final application due date listed as September 7, 2011 (with the opportunity archived October 7, 2011). The full announcement was made available through the NIH grants guide, and technical help for accessing or linking to the announcement was directed to the NIH Office of Extramural Research webmaster.
FAQs: Adverse Outcomes of Assisted Reproductive Technologies (R01) - PA 08-104
What is the Adverse Outcomes of Assisted Reproductive Technologies (R01) opportunity?
It is an NIH funding opportunity announcement (FOA) titled "Adverse Outcomes of Assisted Reproductive Technologies (R01)" (PA 08-104), issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It supports investigator-initiated research focused on potential negative health effects associated with Assisted Reproductive Technologies (ART).
Which NIH institute is associated with this FOA?
This FOA is associated with NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development).
What is the main purpose of this funding opportunity?
The core goal is to generate solid empirical evidence about whether specific ART procedures and protocols affect the biology of eggs, sperm, and preimplantation embryos, and whether those early effects could translate into adverse outcomes later in life.
Why is NIH funding research on adverse outcomes in ART?
The FOA reflects the view that most children conceived through ART appear healthy and develop normally, but some adverse outcomes have been reported and questions remain because ART includes many interventions, lab conditions, and clinical practices that may not be biologically equivalent.
What kinds of outcomes or time periods does the FOA care about?
The scope is broad and includes potential impacts during fetal development, the perinatal period, childhood, and adulthood. It also explicitly notes interest in the possibility of effects that could appear in subsequent generations.
Does this FOA focus on mechanisms, outcomes, or both?
Both. Applicants are encouraged to investigate mechanisms and pathways by which ART-related exposures could alter developmental trajectories, including changes that begin at or before implantation, and how those changes might relate to later adverse outcomes.
What study approaches are allowed under PA 08-104?
The FOA is open to a wide range of scientific approaches, including basic laboratory research, clinical studies, and epidemiological investigations.
Can research be conducted in humans, animals, or both?
Both. The FOA allows studies in human subjects and animal models, recognizing that some mechanistic questions may be best answered in animals while other questions require well-designed human observational or clinical research.
What grant mechanism does PA 08-104 use?
PA 08-104 uses the NIH Research Project Grant (R01) mechanism, which is designed for discrete, hypothesis-driven projects led by a principal investigator (or multiple PIs, if appropriate) with defined aims, methods, and outcomes.
How is this R01 FOA different from the companion P01 announcement?
The FOA notes it runs in parallel with a companion announcement of identical scientific scope using the P01 (Program Project) mechanism (PA 08-103). Applicants should choose the mechanism that matches the size and structure of their work; PA 08-104 is intended for standard R01 projects rather than multi-component program project structures.
Is the scientific scope narrow or broad?
The scope is intentionally broad. It covers many possible ART-related exposures, interventions, laboratory conditions, and clinical practices, and supports research that connects early biological effects (including preimplantation) to outcomes across multiple life stages.
Does the FOA assume ART is harmful?
No. The FOA acknowledges that most children conceived through ART appear healthy, while also emphasizing that reported adverse outcomes and continuing scientific questions justify careful, empirical investigation of specific procedures and protocols.
Who can apply (what types of organizations are eligible)?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and government entities such as state, county, city/township, and special district governments. Tribal governments and tribal organizations are also eligible.
Are foreign (non-U.S.) institutions eligible to apply?
Yes. The FOA states that foreign institutions are eligible, allowing international teams to propose studies that may leverage unique ART practices, registries, populations, or research infrastructure outside the United States.
Does the FOA specify a fixed number of awards?
No. The FOA does not promise a fixed number of awards. Funding decisions are contingent on NIH funds being available and on receiving a sufficient number of scientifically strong applications.
How are applications expected to be selected for funding?
The FOA emphasizes merit-based funding consistent with NIH peer review, along with budget realities and the availability of NIH funds.
What is the expected impact or payoff of this research?
The FOA expects the research to strengthen the evidence base on ART outcomes, clarify which aspects of ART (if any) contribute to risk, and help refine practices to support healthier short- and long-term outcomes.
How does the FOA frame this research in a public health context?
It frames the work within a broader public health context by emphasizing that reproductive health is closely tied to overall health and quality of life.
Who is the issuing agency for this opportunity?
The issuing agency is the National Institutes of Health (NIH).
What is the CFDA number associated with this FOA?
The CFDA listing provided is 93.865 (Child Health and Human Development Extramural Research).
When was the FOA posted, and what were the key dates listed?
The posted date is March 6, 2008. The final application due date listed is September 7, 2011, and the opportunity was archived on October 7, 2011.
Where was the full announcement made available?
The FOA indicates the full announcement was made available through the NIH grants guide.
Where was technical help directed for accessing or linking to the announcement?
Technical help for accessing or linking to the announcement was directed to the NIH Office of Extramural Research webmaster.
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