Opportunity Information: Apply for RFA OD 14 002
Apply for RFA OD 14 002
- The National Institutes of Health in the education food and nutrition health income security and social services sector is offering a public funding opportunity titled "Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (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 93.213 Research and Training in Complementary and Integrative Health 93.233 National Center on Sleep Disorders Research 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.399 Cancer Control 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.859 Biomedical Research and Research Training 93.865 Child Health and Human Development Extramural Research 93.879 Medical Library Assistance.
- This funding opportunity was created on Feb 12, 2014 and posted on Feb 12, 2014.
- Applicants must submit their applications by Apr 18, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,300,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Independent school districts Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State governments For profit organizations other than small businesses County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government 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 Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
This National Institutes of Health (NIH) funding opportunity, titled "Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01)" (Funding Opportunity Number RFA-OD-14-002), supports empirical research aimed at informing policy in two fast-moving areas of human subjects oversight. The announcement calls for Research Project Grant (R01) applications that generate real-world evidence, not just conceptual argument, about (1) what central Institutional Review Boards (central IRBs) should look like and how they should operate, and (2) how people understand, value, and prefer different consent approaches when their clinical records and clinical data are used for research. The overall theme is practical ethics: producing data that can directly guide governance, protections, and best practices across the health research system.
A major focus is central IRBs, which review studies conducted across multiple sites. As research increasingly spans many hospitals, clinics, and universities, central review is often proposed as a way to reduce duplicative reviews, streamline study start-up, and create more consistent decisions. At the same time, it raises ethical and operational questions that have direct consequences for participant protections and institutional accountability. This FOA is designed to support studies that examine the underlying principles central IRBs should uphold (such as independence, transparency, expertise, fairness, and responsiveness to local context), and the practical characteristics that make central review effective and trustworthy. Projects might look at how central IRBs handle local cultural considerations, differences in institutional risk tolerance, variations in state laws and institutional policies, communication between a central IRB and relying sites, mechanisms for reporting and addressing noncompliance or unanticipated problems, and how responsibility is shared among institutions when review is centralized. The emphasis is on generating evidence that can shape policy choices rather than relying on assumptions about efficiency or protection.
The second priority area is consent and participant preferences for research uses of clinical records and clinical data. Health systems and researchers increasingly rely on information collected in routine care, including electronic health records, clinical registries, laboratory results, imaging, billing data, and other data that may be linkable over time. This creates major opportunities for discovery, quality improvement, and public health research, but it also creates hard questions about when consent should be obtained, what kind of consent is meaningful, and what people consider acceptable or unacceptable uses of their information. This FOA encourages studies that measure and analyze what participants and patients actually want, how preferences vary across populations and contexts, and how different consent models influence trust, willingness to participate, and perceptions of privacy and respect. Research under this topic could address broad consent, study-specific consent, opt-in versus opt-out approaches, notification-only models, re-consent for new uses, preferences around data sharing and secondary research, and whether certain types of data (for example, sensitive diagnoses or behavioral health information) change what people expect. It can also include work on comprehension and communication, such as how consent materials are interpreted, what information people view as essential, and which disclosure strategies best support informed choices.
Because the announcement is framed around policy development, competitive projects would typically be designed to produce findings that are generalizable and actionable for regulators, IRBs, health systems, and researchers. That can include quantitative surveys and experiments, qualitative interviews and focus groups, mixed-methods approaches, comparative case studies of different central IRB models, analysis of outcomes such as review timelines and consistency, or evaluations of participant-facing consent processes in real clinical environments. The FOA sits at the intersection of research ethics, health services research, and the practical governance of multi-site studies and large-scale data research.
Administratively, the opportunity uses the NIH R01 mechanism and falls under the discretionary grant category. The total estimated funding listed is $1,300,000. There is no cost-sharing or matching requirement. The opportunity was posted and created on February 12, 2014, with an original and current closing date of April 18, 2014, and an archive date of May 19, 2014, meaning it is a historical funding notice rather than an open competition today. The eligible applicant pool is broad and includes public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education), state, county, and city or township governments, special district governments, independent school districts, small businesses, for-profit organizations other than small businesses, public housing authorities/Indian housing authorities, and federally recognized tribal governments as well as certain tribal organizations. The eligibility language also explicitly includes several institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and U.S. territories or possessions. Foreign institutions and non-U.S. components of U.S. organizations are not eligible, and foreign components are not allowed under NIH policy as referenced in the announcement.
The FOA is associated with NIH and lists multiple CFDA program areas, reflecting the cross-cutting relevance of the topic across many institutes and centers. In practical terms, the work NIH sought to fund would be applicable across disease areas, because questions about centralized ethical review and consent for data-based research show up everywhere: cancer, cardiovascular disease, infectious diseases, mental health and substance use, child health, rare disease, and more. The announcement directs applicants and readers to the full solicitation on the NIH grants website, and it provides an NIH Office of Extramural Research (OER) webmaster contact for access or linking issues.
Frequently Asked Questions (FAQs)
1) What is the title of this NIH funding opportunity?
The funding opportunity is titled "Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01)."
2) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-OD-14-002.
3) What type of grant mechanism does this opportunity use?
This opportunity uses the NIH Research Project Grant (R01) mechanism.
4) What is the main purpose or goal of this FOA?
The FOA supports empirical research intended to inform policy in two fast-moving areas of human subjects oversight: (1) central Institutional Review Boards (central IRBs) for multi-site research, and (2) consent approaches and participant preferences when clinical records and clinical data are used for research. The emphasis is on practical ethics and real-world evidence rather than conceptual argument alone.
5) What does NIH mean here by "empirical research"?
In this FOA, empirical research refers to studies that generate real-world evidence (data) that can directly guide governance, protections, and best practices, rather than relying only on theoretical or conceptual arguments.
6) What are the two priority research areas in this announcement?
The two priority areas are: (1) ethical and operational issues related to central IRBs and how they should operate, and (2) how people understand, value, and prefer different consent approaches for research use of clinical records and clinical data.
7) What is a central IRB in the context of this FOA?
A central IRB is an IRB model used to review studies conducted across multiple sites (for example, across multiple hospitals, clinics, and universities), with centralized review proposed to reduce duplicative reviews, streamline start-up, and increase consistency.
8) What kinds of questions about central IRBs does this FOA encourage applicants to study?
The FOA encourages studies examining both ethical principles and practical operating characteristics of central IRBs, including how central IRBs should be structured and how they should function in real multi-site settings.
9) What principles or values does the FOA highlight for central IRBs?
The FOA highlights principles such as independence, transparency, expertise, fairness, and responsiveness to local context as important considerations for what central IRBs should uphold.
10) What operational issues related to central IRBs are specifically mentioned?
Examples include how central IRBs handle local cultural considerations; differences in institutional risk tolerance; variations in state laws and institutional policies; communication between a central IRB and relying sites; mechanisms for reporting and addressing noncompliance or unanticipated problems; and how responsibility is shared among institutions under centralized review.
11) Does the FOA assume central IRBs are always more efficient or more protective?
No. The FOA emphasizes generating evidence that can shape policy choices rather than relying on assumptions about efficiency or participant protection.
12) What is the second major topic area: consent for clinical records and clinical data?
The FOA supports research on how participants and patients understand and value different consent approaches when clinical records and clinical data collected in routine care are used for research.
13) What kinds of clinical records and clinical data are in scope?
The FOA describes routine-care data such as electronic health records, clinical registries, laboratory results, imaging, billing data, and other data that may be linkable over time.
14) What consent models or approaches are mentioned as potential research topics?
The FOA mentions broad consent, study-specific consent, opt-in versus opt-out approaches, notification-only models, re-consent for new uses, and preferences around data sharing and secondary research.
15) Does the FOA encourage work on how preferences differ across populations or contexts?
Yes. It encourages studies that measure what participants and patients actually want and examine how preferences vary across populations and contexts.
16) Does the FOA address trust, privacy, and willingness to participate?
Yes. It encourages research on how different consent models influence trust, willingness to participate, and perceptions of privacy and respect.
17) Are sensitive data types part of the consent-related research scope?
Yes. The FOA explicitly raises the possibility that certain types of data (for example, sensitive diagnoses or behavioral health information) may change what people expect and prefer.
18) Does the FOA include research on comprehension and communication in consent?
Yes. It includes work on how consent materials are interpreted, what information people view as essential, and which disclosure strategies best support informed choices.
19) What kinds of study designs or methods does NIH describe as relevant?
The FOA lists methods such as quantitative surveys and experiments, qualitative interviews and focus groups, mixed-methods approaches, comparative case studies of different central IRB models, analysis of outcomes (such as review timelines and consistency), and evaluations of participant-facing consent processes in real clinical environments.
20) What types of outcomes might central IRB research analyze according to the FOA?
The FOA mentions outcomes such as review timelines and consistency, along with other evidence relevant to whether central review is effective and trustworthy.
21) What does NIH mean by "practical ethics" in this FOA?
It refers to producing empirical findings that can directly guide governance, participant protections, and best practices across the health research system.
22) Who is the intended audience for the findings from funded projects?
The FOA frames findings as being actionable for regulators, IRBs, health systems, and researchers.
23) Are projects expected to be generalizable and policy-relevant?
Yes. Because the announcement is framed around policy development, competitive projects are described as those designed to produce findings that are generalizable and actionable.
24) How much total funding is estimated for this opportunity?
The total estimated funding listed is $1,300,000.
25) Is cost sharing or matching required?
No. The FOA states there is no cost-sharing or matching requirement.
26) Is this a currently open funding opportunity?
No. The FOA is historical. It was posted and created on February 12, 2014, with a closing date of April 18, 2014, and an archive date of May 19, 2014.
27) What are the key dates listed in the announcement?
Posted/created date: February 12, 2014. Original/current closing date: April 18, 2014. Archive date: May 19, 2014.
28) Who can apply (what types of applicants are eligible)?
The eligible applicant pool is broad and includes public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education); state, county, and city or township governments; special district governments; independent school districts; small businesses; for-profit organizations other than small businesses; public housing authorities/Indian housing authorities; federally recognized tribal governments; and certain tribal organizations.
29) Does the FOA explicitly encourage applications from specific institution types?
Yes. The eligibility language explicitly includes, among others, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also mentions faith-based or community-based organizations and U.S. territories or possessions.
30) Are foreign institutions eligible to apply?
No. Foreign institutions and non-U.S. components of U.S. organizations are not eligible.
31) Are foreign components allowed under this FOA?
No. The FOA states that foreign components are not allowed under NIH policy as referenced in the announcement.
32) Which federal agency is associated with this opportunity?
This funding opportunity is associated with the National Institutes of Health (NIH).
33) Is the topic limited to a specific disease area?
No. The FOA describes the relevance as cross-cutting across many institutes and centers, and notes that centralized ethical review and consent for data-based research apply across disease areas (for example, cancer, cardiovascular disease, infectious diseases, mental health and substance use, child health, rare disease, and more).
34) What broad fields does this FOA sit at the intersection of?
The FOA is described as sitting at the intersection of research ethics, health services research, and the practical governance of multi-site studies and large-scale data research.
35) Where does the FOA direct applicants for the full solicitation details?
It directs applicants and readers to the full solicitation on the NIH grants website.
36) Is a contact mentioned for website access or linking issues?
Yes. The announcement provides an NIH Office of Extramural Research (OER) webmaster contact for access or linking issues.
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