Opportunity Information: Apply for RFA HG 11 003
Apply for RFA HG 11 003
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of a Preliminary Evidence Base to Inform Decision making about Returning Research Results to Participants in Genomic Studies (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172 Human Genome Research 93.173 Research Related to Deafness and Communication Disorders.
- This funding opportunity was created on Dec 17, 2010 and posted on Dec 17, 2010.
- Applicants must submit their applications by Mar 10, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- Eligible applicants include: Small businesses Public and State controlled institutions of higher education Private institutions of higher education Special district governments Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses State governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIH funding opportunity RFA-HG-11-003, titled "Development of a Preliminary Evidence Base to Inform Decision making about Returning Research Results to Participants in Genomic Studies (R01)," was a discretionary grant program designed to push the field beyond debate and into practical, data-driven guidance on returning individual genomic research results to participants. Its central aim was to stimulate empirical research that could help investigators, institutions, and oversight bodies make better decisions about whether results should be offered back to people who take part in genomic studies, when such offers are appropriate, and how the return of results should be carried out in real-world research settings. While the topic broadly applies to many kinds of genomics, the announcement put special emphasis on whole exome sequencing and whole genome sequencing because these approaches generate large volumes of information, including findings that may be unexpected, uncertain, clinically relevant, or personally meaningful to participants.
A key feature of the opportunity is that it was not primarily looking for laboratory discovery projects or technology development. Instead, it was aimed mainly at behavioral and social science research, including projects that involve direct interaction with research participants and other stakeholders tied to active genomics studies or genomic repositories. In practice, this means NIH was seeking studies that examine how people understand and value different kinds of genomic results, how they want those results communicated, what harms or benefits can arise from receiving them, and what processes lead to informed, ethically sound decision making. The announcement also explicitly included individuals who contributed samples or data to repositories such as biobanks and databases like dbGaP, recognizing that returning results is especially complicated when data are stored, shared, and reused across multiple studies over time and when the original relationship between participant and researcher may be limited or indirect.
The overall policy problem behind the FOA is that returning research results sits at the intersection of ethics, clinical relevance, participant autonomy, psychological impact, privacy risk, and logistical feasibility. Genomic findings can range from clearly actionable variants to results of uncertain significance, and even when a finding is medically important, delivering it responsibly may require confirmation, counseling, follow-up care pathways, and careful communication to avoid misunderstanding or unnecessary distress. This FOA was designed to support early-stage evidence building so the research community could move toward more consistent, defensible practices rather than relying on assumptions or one-off institutional preferences. Projects responsive to this kind of program would typically generate data on participant preferences and comprehension, compare different methods of disclosure, evaluate the outcomes of returning versus not returning certain categories of results, and explore how context changes decisions (for example, adult versus pediatric studies, rare disease cohorts versus population studies, or direct study enrollment versus repository contribution).
Administratively, the program used the NIH R01 grant mechanism, indicating support for substantial research projects rather than small pilot awards. The estimated total funding available was $2,000,000, with an award ceiling of $500,000, and there was no cost sharing or matching requirement. The opportunity was posted and created on December 17, 2010, and it had an original and current closing date of March 10, 2011, with an archive date of April 10, 2011, meaning it was a time-limited solicitation rather than an open-ended standing program. The funding activity category was Health, and the CFDA numbers listed were 93.172 (Human Genome Research) and 93.173 (Research Related to Deafness and Communication Disorders), reflecting its placement within NIH program areas that intersect genomics and human subjects considerations.
Eligibility was broad and included many types of domestic organizations that typically apply for NIH grants. Eligible applicants included public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses), and multiple levels of government (state, county, city or township, special district governments, and independent school districts). The eligibility language also called out a range of mission-based and community-rooted institutions and organizations, including Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and tribal organizations, including federally recognized tribal governments. This broad eligibility aligns with the idea that research on returning results benefits from diverse settings and populations and from investigators who can engage communities directly, particularly given that views on genomics, privacy, and medical information can vary significantly across groups and contexts.
In practical terms, the FOA can be understood as NIH encouraging research that brings stakeholders into the study design and evidence generation process. Stakeholders might include research participants, family members in certain contexts, clinicians who may receive or act on returned results, genetic counselors, IRB members, biobank administrators, and researchers managing ongoing sequencing studies. Because the announcement specifically highlights interaction with participants or other stakeholders in current genomics projects or repositories, it implicitly favors study designs that can observe or test return-of-results approaches in realistic workflows rather than purely hypothetical survey-only exercises. It also signals interest in the special challenges posed by repositories, such as how to recontact contributors, how to manage consent and expectations over time, and how to handle findings that emerge long after the original sample collection.
The sponsoring agency was the National Institutes of Health, and the official announcement was available through the NIH grants guide at the link provided in the notice. For technical access issues, the contact listed was the NIH Office of Extramural Research (OER) Webmaster (FBOWebmaster@OD.NIH.GOV), which is typical for older postings that were mirrored or indexed across federal opportunity portals.
Overall, this funding opportunity was about building the early empirical foundation needed to guide policy and practice on returning individual genomic research results, especially in the high-data, high-uncertainty environment created by exome and genome sequencing and in the complex governance environment of biobanks and genomic data repositories.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-HG-11-003?
RFA-HG-11-003 is an NIH funding opportunity titled "Development of a Preliminary Evidence Base to Inform Decision making about Returning Research Results to Participants in Genomic Studies (R01)." It is a discretionary grant program intended to generate empirical evidence that helps the research community make better decisions about returning individual genomic research results to study participants.
What is the main purpose of this FOA?
The central purpose is to move the field beyond debate and toward practical, data-driven guidance on whether genomic research results should be offered to participants, when offering results is appropriate, and how results should be returned in real-world research settings.
What kinds of genomic research does this FOA emphasize?
While broadly relevant to many forms of genomics, the FOA places special emphasis on whole exome sequencing and whole genome sequencing because these methods generate large volumes of findings, including unexpected results, uncertain findings, clinically relevant variants, and results that may be personally meaningful to participants.
Is this opportunity intended for laboratory discovery or technology development projects?
No. The FOA is not primarily looking for laboratory discovery projects or technology development. It is aimed mainly at behavioral and social science research related to returning genomic research results.
What types of research activities are encouraged under this FOA?
The FOA encourages empirical studies that examine how people understand and value different kinds of genomic results, how participants want results communicated, what benefits or harms may arise from receiving results, and what processes support informed and ethically sound decision making about return of results.
Does the FOA encourage studies involving direct interaction with participants and stakeholders?
Yes. The FOA highlights research that involves direct interaction with research participants and/or other stakeholders connected to active genomics studies or genomic repositories, supporting evidence generation in realistic research workflows.
Who are considered "stakeholders" in the context of this FOA?
Stakeholders may include research participants, family members in certain contexts, clinicians who may receive or act on returned results, genetic counselors, IRB members, biobank administrators, and researchers managing sequencing studies or repositories.
Does this FOA include research involving biobanks or genomic repositories?
Yes. The FOA explicitly includes individuals who contributed samples or data to repositories such as biobanks and databases like dbGaP, recognizing that returning results can be especially complicated when data are stored, shared, and reused across multiple studies over time.
Why are repositories like biobanks and dbGaP specifically relevant to return-of-results research?
Repositories create practical and ethical challenges such as how to recontact contributors, manage consent and expectations over time, and handle findings that may arise long after original sample collection, particularly when the original participant-researcher relationship may be limited or indirect.
What problem is NIH trying to address with this FOA?
The FOA addresses the policy and practice challenges of returning research results at the intersection of ethics, clinical relevance, participant autonomy, psychological impact, privacy risk, and logistical feasibility. It seeks evidence that supports more consistent and defensible practices across institutions and studies.
What kinds of genomic results are relevant to the questions this FOA supports?
The FOA recognizes that genomic findings vary widely, including clearly actionable variants, results of uncertain significance, unexpected findings, and information that may be clinically relevant or personally meaningful to participants.
What are examples of research questions or outcomes this FOA is meant to support?
Examples include generating data on participant preferences and comprehension, comparing different disclosure methods, evaluating outcomes of returning versus not returning certain categories of results, and assessing how study context affects decisions (for example, adult versus pediatric studies, rare disease cohorts versus population studies, and direct enrollment versus repository contribution).
Why does the FOA mention that returning results may require confirmation and counseling?
The FOA notes that even when findings are medically important, responsible return may require confirmation, counseling, follow-up care pathways, and careful communication to reduce misunderstanding or unnecessary distress.
What grant mechanism does this FOA use?
This opportunity uses the NIH R01 grant mechanism, which is typically intended to support substantial research projects rather than small pilot awards.
How much total funding was estimated to be available?
The estimated total funding available under this FOA was $2,000,000.
What is the award ceiling for individual awards?
The award ceiling listed for this opportunity was $500,000.
Is cost sharing or matching required?
No. The FOA states there was no cost sharing or matching requirement.
What were the key dates for this opportunity?
The opportunity was posted and created on December 17, 2010. The original and current closing date was March 10, 2011, and the archive date was April 10, 2011.
Is this an open, ongoing program?
No. The dates indicate it was a time-limited solicitation rather than an open-ended standing program.
What is the funding activity category?
The funding activity category listed for this FOA is Health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.172 (Human Genome Research) and 93.173 (Research Related to Deafness and Communication Disorders).
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, such as public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and multiple levels of government (state, county, city or township, special district governments, and independent school districts).
Are community-rooted and mission-based institutions explicitly included in eligibility?
Yes. The eligibility language calls out Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and tribal organizations, including federally recognized tribal governments.
Why does the FOA emphasize broad eligibility across many institution types?
The broad eligibility aligns with the idea that research on returning results benefits from diverse settings and populations, particularly because views on genomics, privacy, and medical information can vary across groups and contexts.
What does the FOA suggest about preferred study settings or designs?
Because it highlights interaction with participants or stakeholders tied to current genomics projects or repositories, it implicitly favors study designs that observe or test return-of-results approaches in realistic workflows rather than relying only on hypothetical scenarios.
Which agency sponsored this FOA?
The sponsoring agency was the National Institutes of Health (NIH).
Where was the official announcement posted?
The official announcement was available through the NIH Grants Guide (as referenced in the notice).
Who is listed as the contact for technical access issues?
The contact listed for technical access issues was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What is the overall takeaway of this opportunity?
This FOA was designed to build an early empirical foundation to guide policy and practice on returning individual genomic research results, especially in the high-data and high-uncertainty environment created by exome and genome sequencing and the governance complexities of biobanks and genomic data repositories.
Browse more opportunities from the same category: Health
Next opportunity: Ethical, Legal, and Social Implications of Returning Research Results to Genomic Research Participants (R21)
Previous opportunity: Clinical Sequencing Exploratory Research (U01)
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