Opportunity Information: Apply for RFA HG 11 004
Apply for RFA HG 11 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ethical, Legal, and Social Implications of Returning Research Results to Genomic Research Participants (R21)" 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 $750,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Independent school districts Special district governments For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) County governments Native American tribal governments (Federally recognized) City or township governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education Private institutions of higher education Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- 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-11-004, titled "Ethical, Legal, and Social Implications of Returning Research Results to Genomic Research Participants (R21)," is a discretionary grant program designed to spark focused, analytical work on one of the most difficult questions in modern genomics: what responsibilities researchers and data stewards have when they uncover information about an individual that could matter to that person. The program is centered on the ethical, legal, and normative dimensions of deciding whether individual research findings should be offered back to participants, and if so, under what conditions and through what processes. Although it is framed broadly, it is especially concerned with findings that arise from whole exome sequencing and whole genome sequencing, as well as results associated with people who contributed specimens or data to large-scale repositories such as biobanks and databases like dbGaP. In practice, the FOA is trying to move the field beyond general debate and toward concrete, defensible frameworks that researchers, institutions, and repositories can actually use.
The emphasis on "normative and legal issues" signals that the work sought is not primarily laboratory science or clinical trials, but careful reasoning and analysis that clarifies obligations, rights, and policy tradeoffs. Projects under this FOA would typically grapple with questions like when a genomic finding rises to a level that creates a duty to offer disclosure, how to balance potential benefits against possible harms (anxiety, stigma, discrimination, family conflict, misunderstanding), and how to handle results that are uncertain, evolving, or not clinically actionable. It also implicitly invites work on how informed consent should address the possibility of returning results, what governance structures are appropriate for biobanks that did not originally plan for return of results, and how legal regimes (privacy law, liability, research regulations, and state-by-state variation) shape what is feasible or required. Another important theme is the logistical and procedural reality: even if returning results is ethically attractive, doing it responsibly may require confirmatory testing, clinical interpretation, genetic counseling, and mechanisms to recontact participants years after enrollment, all of which raise cost, feasibility, and fairness concerns.
The grant mechanism is an R21, which is typically used for exploratory or developmental projects that are narrower in scope and can be completed without the scale of a large multi-site research effort. Consistent with that, the FOA is aimed mainly at sole investigators or small teams proposing modest legal and normative research projects. That could include rigorous conceptual analysis, comparative legal research, policy analysis, development of model guidelines, or structured evaluation of existing frameworks for returning results in different research settings. The overall intent is to build a stronger foundation for decision-making in genomic research where the line between research and clinical relevance can blur, especially as sequencing becomes more comprehensive and more likely to generate incidental or secondary findings.
From an administrative standpoint, this opportunity was posted on December 17, 2010, with an original and current closing date of March 10, 2011, and it was archived on April 10, 2011. The estimated total funding amount was $750,000, with an award ceiling of $200,000 per award, and there was no cost sharing or matching requirement. The activity category is health, and the CFDA numbers listed are 93.172 (Human Genome Research) and 93.173 (Research Related to Deafness and Communication Disorders), reflecting the broader NIH portfolio connections where genomics and communication-related outcomes, interpretation, and counseling can intersect.
Eligibility is broad and includes many types of domestic organizations and governmental entities: public and state-controlled institutions of higher education, private higher education institutions, nonprofits (including both 501(c)(3) and certain non-501(c)(3) organizations), small businesses, and for-profit organizations other than small businesses, as well as state, county, city/township, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The FOA also explicitly notes additional eligible applicants such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions, among others. The sponsoring agency is the National Institutes of Health, and the funding instrument type is a grant.
In plain terms, this FOA is about helping the genomics research community sort out the rules and ethical reasoning for a real-world dilemma that keeps getting harder as genomic datasets grow: researchers and repositories can discover information that might matter deeply to individuals, but returning it can introduce medical, legal, and social complications. NIH used this R21 opportunity to encourage smaller, targeted projects that could clarify responsibilities, propose workable policies, and anticipate unintended consequences, with a particular focus on the increasingly common setting of whole-genome or whole-exome sequencing and large repository-based research.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-HG-11-004 about?
RFA-HG-11-004 is an NIH discretionary grant opportunity focused on the ethical, legal, and social implications of returning individual research results to participants in genomic research. It is designed to support analytical work that clarifies what responsibilities researchers, institutions, and data stewards may have when they discover information that could matter to an individual participant.
What is the official title of this funding opportunity?
The official title is: "Ethical, Legal, and Social Implications of Returning Research Results to Genomic Research Participants (R21)."
What grant mechanism is being used?
This opportunity uses the NIH R21 mechanism, which is typically intended for exploratory or developmental projects that are relatively modest in scope and do not require the scale of a large multi-site effort.
What kinds of research does this FOA prioritize?
The FOA prioritizes normative, ethical, and legal analysis rather than laboratory science or clinical trials. Examples described include rigorous conceptual analysis, comparative legal research, policy analysis, development of model guidelines, and structured evaluation of existing frameworks for returning results across different research settings.
What core question is this FOA trying to address?
The central question is when (and how) individual research findings from genomic studies should be offered back to participants, including what conditions and processes would make return of results ethically defensible, legally feasible, and practically workable.
What types of genomic findings are especially relevant here?
Although framed broadly, the FOA places particular emphasis on findings arising from whole exome sequencing and whole genome sequencing, where the likelihood of discovering unexpected or secondary information is higher.
Does this FOA include research involving biobanks or large data repositories?
Yes. It is especially concerned with research results associated with specimens or data contributed to large-scale repositories such as biobanks and databases like dbGaP.
Why is returning research results considered difficult in this context?
The FOA highlights that returning results can involve complex tradeoffs: potential benefits to participants must be weighed against possible harms such as anxiety, stigma, discrimination, family conflict, or misunderstanding. It also raises challenges around uncertain or evolving findings and results that are not clinically actionable.
What kinds of harms or risks are mentioned as concerns?
The FOA mentions potential harms including anxiety, stigma, discrimination, family conflict, and misunderstanding. It also notes the broader complications that can arise when results are uncertain, evolving, or not clinically actionable.
What does the FOA mean by focusing on "normative and legal issues"?
It signals that the work sought is centered on careful reasoning and analysis about obligations, rights, and policy tradeoffs, including how laws and regulations shape what is feasible or required when considering whether to return individual research results.
What topics related to informed consent are in scope?
The FOA implicitly invites work on how informed consent should address the possibility of returning individual results, including how to explain these possibilities to participants and how consent choices might relate to later decisions about disclosure.
What governance issues for biobanks does the FOA point to?
It raises questions about what governance structures are appropriate for biobanks and repositories, particularly when they did not originally plan to return results and may not have procedures or resources in place to do so.
What legal considerations are explicitly mentioned?
The FOA references privacy law, liability, research regulations, and state-by-state legal variation as key factors that can affect whether returning results is feasible, required, or risky.
Does the FOA address practical or logistical challenges?
Yes. It notes that responsible return of results may require confirmatory testing, clinical interpretation, genetic counseling, and mechanisms to recontact participants years after enrollment, all of which raise cost, feasibility, and fairness concerns.
Is this FOA aiming for general discussion or concrete outputs?
It is explicitly trying to move the field beyond general debate toward concrete, defensible frameworks that researchers, institutions, and repositories can use in real-world decision-making.
What is the expected scale of projects under this R21 FOA?
The FOA is aimed mainly at sole investigators or small teams proposing modest, targeted legal and normative research projects rather than large multi-site efforts.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding instrument type?
The funding instrument type is a grant.
What is the activity category for this opportunity?
The activity category 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).
How much total funding was estimated for this FOA?
The estimated total funding amount was $750,000.
What was the award ceiling per grant?
The award ceiling was $200,000 per award.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
When was the opportunity posted, and what were the close dates?
The opportunity was posted on December 17, 2010. The original and current closing date was March 10, 2011.
Is this funding opportunity still open?
No. The FOA was archived on April 10, 2011, and the closing date listed was March 10, 2011.
What types of organizations are eligible to apply?
Eligibility is broad and includes public and state-controlled institutions of higher education, private higher education institutions, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), small businesses, and for-profit organizations other than small businesses.
Are government entities eligible to apply?
Yes. Eligible governmental entities include state governments, county governments, city/township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are specific institution types explicitly called out as eligible?
Yes. The FOA explicitly notes additional eligible applicants including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions, among others.
What research settings does this FOA seem most concerned with?
It is particularly concerned with modern genomic research contexts where sequencing is comprehensive (whole exome/genome) and where data and specimens may be held and reused in large repositories, creating ongoing questions about responsibilities to participants over time.
What is the broader goal of the FOA for the genomics research community?
The broader goal is to strengthen the foundation for decision-making about returning individual genomic research results by clarifying responsibilities, proposing workable policies, and anticipating unintended consequences in real-world research and repository settings.
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