Adverse Outcomes of Assisted Reproductive Technologies (P01) | Apply Online

FAQs: Adverse Outcomes of Assisted Reproductive Technologies (ART) (P01) - PA 08-103 (NICHD/NIH)

What is this funding opportunity?

This is a National Institutes of Health (NIH) grant announcement titled "The Adverse Outcomes of Assisted Reproductive Technologies (ART) (P01)" (PA 08-103), issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It supports coordinated research programs focused on understanding potential adverse health outcomes associated with assisted reproductive technologies (ART).

What is the central goal of the program?

The central goal is to support coordinated, multi-project research programs that examine whether, how, and why ART could introduce changes in eggs, sperm, or preimplantation embryos that later appear as adverse health outcomes. The emphasis is on careful investigation of reported risks and unresolved concerns across the range of ART procedures and laboratory protocols.

Is the intent to question whether ART works or whether ART-conceived children are generally healthy?

No. The announcement explicitly frames the work as investigating reported risks and lingering concerns, not as challenging the overall success of ART. It notes that most children conceived through ART appear healthy, while still highlighting the need for rigorous evidence about potential risks tied to specific procedures and protocols.

What NIH grant mechanism does this opportunity use?

This opportunity uses the NIH Program Project Grant (P01) mechanism, which is designed to support multidisciplinary, interactive, and synergistic research teams rather than isolated single-project studies.

What does a P01 "multi-project" program mean in practice?

Applicants are expected to propose an integrated program composed of multiple interrelated research projects that benefit from shared leadership, shared resources, and active scientific cross-talk. The intent is that the whole program is more impactful than a set of independent projects submitted side by side.

What kinds of research approaches does NICHD want to see?

The FOA signals interest in empirical, mechanistic, and population-level evidence. It encourages combinations of basic science, clinical research, and epidemiology that reinforce each other, such as pairing laboratory studies testing biological mechanisms with clinical cohorts or registry-based analyses assessing real-world outcomes.

Are both human studies and animal models allowed?

Yes. NICHD explicitly expresses interest in both human studies and animal models. The rationale described is that some questions (for example, early developmental biology, epigenetic changes, and intergenerational effects) may require experimental systems, while other questions require careful human follow-up and population research.

What types of adverse outcomes are within scope?

The scientific scope includes adverse outcomes that could emerge during fetal development, around birth (the perinatal period), throughout childhood, into adulthood, and potentially into subsequent generations. The underlying premise is that effects on gametes or preimplantation embryos may not be immediately visible but could influence later development and health.

What ART-related factors or steps could be studied under this FOA?

Based on the description, the program may address how specific ART procedures and laboratory or clinical steps might influence downstream outcomes. Examples referenced include embryo culture conditions, ovarian stimulation protocols, intracytoplasmic sperm injection (ICSI) and related micromanipulations, cryopreservation approaches, and other protocol variations that could plausibly affect development.

What biological themes are suggested as relevant?

The FOA points toward topics such as altered developmental programming, imprinting or epigenetic modifications, and early biological changes that could later affect placentation, growth trajectories, metabolic outcomes, or reproductive health over the lifespan.

Is the FOA focused on generating anecdotal observations or rigorous evidence?

The stated intent is to move beyond anecdotal reports by generating rigorous data. A key aim is to distinguish true ART-related effects from confounding factors and to identify which protocol differences might meaningfully change risk.

What confounding factors does the FOA highlight as important to account for?

The description specifically mentions confounding factors such as underlying infertility, parental age, multiple gestation, and differences in prenatal care. The program is framed as needing study designs and analyses capable of separating ART-related effects from these influences.

What kinds of questions is NICHD trying to answer through this program?

The announcement is framed around clarifying which aspects of ART may matter, under what circumstances, and what downstream consequences could occur across the lifespan. It also emphasizes understanding biological pathways that might explain risks, how risks vary by protocol or patient subgroup, and what follow-up or clinical adjustments could reduce harm while preserving benefits.

Who is the sponsoring NIH Institute?

The sponsoring Institute named in the opportunity is the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

What is the program area / CFDA listing associated with this opportunity?

The opportunity is described as a discretionary grant in the health domain and is associated with CFDA 93.865, Child Health and Human Development Extramural Research.

What organizations are eligible to apply?

The eligibility described is broad. Eligible applicants include public and private institutions of higher education, state governments, tribal governments and tribal organizations, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses). The FOA also lists designated institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.

Can a foreign organization apply as the prime recipient?

No. Foreign organizations cannot receive the overall P01 award as the prime institution under this FOA.

Can foreign institutions participate in any way?

Yes. The FOA allows component projects to be located at foreign institutions when there is strong justification, such as access to specialized cohorts, unique clinical expertise, or model systems not available domestically.

Is cost sharing or matching required?

No cost sharing or matching requirement is stated for this FOA.

When was this opportunity posted and what is its status?

The opportunity was posted on December 3, 2008. It lists an original closing date of May 7, 2011 and a later listed closing date of September 7, 2011. It was archived on October 7, 2011.

If the FOA is archived, is the description still useful?

Yes. Even though it is archived, the description is presented as a clear statement of NICHD priorities at the time, especially the priority to build strong, collaborative programs that can produce reliable evidence about ART safety and long-term outcomes.

What kind of overall program does this FOA encourage applicants to assemble?

It encourages an integrated, multidisciplinary research program capable of producing mechanistic and real-world evidence on ART-related risks and long-term outcomes, with the goal of informing understanding of reproductive health and health across the lifespan.

What is the broader significance of the research focus described?

The FOA frames the work as addressing high-stakes questions relevant to families, clinicians, and policymakers: whether certain ART approaches carry avoidable risks, why those risks might occur biologically, how they differ by protocol or subgroup, and what changes in practice or follow-up could reduce harm without undermining ART benefits.