Opportunity Information: Apply for RFA OD 15 002
Apply for RFA OD 15 002
- The National Institutes of Health in the education 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 93.233 National Center on Sleep Disorders Research 93.273 Alcohol Research Programs 93.307 Minority Health and Health Disparities Research 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 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research 93.867 Vision Research.
- This funding opportunity was created on Dec 18, 2014 and posted on Dec 18, 2014.
- Applicants must submit their applications by Feb 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,700,000.00 to eligible and selected applicants.
- Eligible applicants include: 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 Special district governments Independent school districts Public housing authorities/Indian housing authorities County governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education City or township governments Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) 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:
The NIH funding opportunity "Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01)" (Funding Opportunity Number RFA-OD-15-002) invited Research Project Grant (R01) applications focused on generating real-world evidence to inform policy in two fast-moving areas of human research protections. First, it called for empirical studies that clarify the principles, operating characteristics, and performance features of central Institutional Review Boards (IRBs), including how central IRB models function in practice and what makes them effective, trustworthy, and appropriate across different types of multi-site research. Second, it sought empirical research on consent and participant preferences when research uses clinical records and health data, with an emphasis on understanding what people want, what they understand, and what consent approaches are ethically acceptable and workable when studies rely on information collected in health care settings.
This FOA was issued by the National Institutes of Health and categorized as a discretionary grant opportunity using the Grant funding instrument type. The activity area was listed broadly across Education, Health, and Income Security and Social Services, reflecting the cross-cutting relevance of ethics and oversight to many NIH-supported research domains. The listed CFDA program numbers span a wide range of NIH institutes and centers (for example, human genome research, communication disorders, sleep, alcohol research, minority health and health disparities, cancer, cardiovascular and lung diseases, arthritis and skin diseases, neurosciences, child health and development, aging, and vision research), which signals that NIH expected proposals to be relevant across biomedical and behavioral research rather than tied to a single disease area.
The practical thrust of the announcement was to move beyond purely conceptual debate and instead produce data that can guide decision-making. For central IRBs, this implies studies that examine how central review affects review quality, consistency, efficiency, coordination across sites, local context considerations, investigator burden, and protection of participants. For consent and clinical-data research, the emphasis implies work that measures participant attitudes and preferences, evaluates different consent models (for example, opt-in vs. opt-out approaches, broad consent concepts, tiered choices, or notification and transparency strategies), and tests communication methods that improve understanding and trust when electronic health records, biospecimens linked to records, or other clinical datasets are used for research.
The opportunity did not require cost sharing or matching. NIH estimated total funding of about $3.7 million for the competition. Key dates were posted and created on December 18, 2014, with an original and current closing date of February 19, 2015, and the opportunity archived on March 22, 2015, meaning it was a time-limited call and is no longer accepting applications.
Eligibility was intentionally broad and included many types of domestic organizations that could carry out rigorous empirical ethics research. Eligible applicants included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); state, county, city/township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; small businesses and some for-profit organizations; and tribal governments and tribal organizations. The eligibility list also explicitly encompassed a range of mission-focused and minority-serving institutions and community-rooted organizations, such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, the FOA clearly restricted foreign involvement: non-U.S. entities were not eligible to apply, non-U.S. components of U.S. organizations were not eligible, and foreign components (as NIH defines them) were not allowed.
For applicants seeking full details, NIH directed readers to the official announcement page on the NIH Grants Guide (link provided in the source). Administrative help for accessing or linking to the electronic announcement was routed through the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV), which is consistent with NIH practice for technical issues related to FOA access.
FAQs: Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01)
What is the official title of this NIH funding opportunity?
The opportunity is titled "Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-OD-15-002.
What type of grant mechanism does this opportunity use?
This opportunity invited applications under the NIH Research Project Grant (R01) mechanism.
Which agency issued the opportunity?
The opportunity was issued by the National Institutes of Health (NIH).
What kind of funding opportunity is it categorized as?
It was categorized as a discretionary grant opportunity and used the Grant funding instrument type.
What was the main purpose of the FOA?
The FOA aimed to support empirical (real-world, data-driven) research that could inform policy and decision-making in two fast-moving areas of human research protections: (1) central IRBs and (2) consent for research using clinical records and health data.
What topic areas did the FOA prioritize?
The FOA focused on two primary areas: empirical studies of central Institutional Review Boards (IRBs), and empirical studies on consent and participant preferences when research uses clinical records and health data.
What did NIH mean by "empirical research" in this FOA?
Based on the FOA description, NIH emphasized moving beyond purely conceptual debate to produce real-world evidence and data that can guide policy and oversight decisions.
What kinds of questions about central IRBs was NIH interested in?
NIH sought studies that clarify the principles, operating characteristics, and performance features of central IRBs, including how central IRB models function in practice and what makes them effective, trustworthy, and appropriate across different types of multi-site research.
What aspects of central IRB performance were highlighted?
The FOA highlighted examining how central review affects review quality, consistency, efficiency, coordination across sites, attention to local context considerations, investigator burden, and the protection of participants.
What kinds of consent-related research was NIH interested in for clinical records and data?
The FOA sought empirical research on consent and participant preferences when research uses clinical records and health data, emphasizing what people want, what they understand, and what consent approaches are ethically acceptable and workable when studies rely on information collected in health care settings.
What data sources or materials were specifically mentioned for the consent/clinical-data research area?
The FOA referenced research uses of electronic health records, biospecimens linked to records, and other clinical datasets collected in health care settings.
Did the FOA suggest specific consent models to evaluate?
Yes. The FOA described evaluating different consent models such as opt-in versus opt-out approaches, broad consent concepts, tiered choices, and notification and transparency strategies.
Did the FOA emphasize communication and participant understanding?
Yes. The FOA emphasized testing communication methods that improve understanding and trust when clinical records and health data are used for research.
How broadly applicable was this FOA across research areas?
The FOA was positioned as cross-cutting across biomedical and behavioral research rather than tied to a single disease area, as reflected by its broad activity area listing and wide span of CFDA program numbers across many NIH institutes and centers.
What activity areas were listed for this opportunity?
The activity area was listed broadly across Education, Health, and Income Security and Social Services.
What did the range of CFDA program numbers imply?
The wide range of CFDA program numbers (spanning many NIH institutes and centers) signaled that NIH expected proposals to be relevant across many domains of NIH-supported research, not limited to one specific institute or disease topic.
Was cost sharing or matching required?
No. The FOA stated that it did not require cost sharing or matching.
How much total funding did NIH estimate for this competition?
NIH estimated total funding of about $3.7 million for the competition.
When was the opportunity posted?
The key dates were posted/created on December 18, 2014.
What was the application deadline?
The original and current closing date listed for the FOA was February 19, 2015.
Is this FOA still open for applications?
No. The opportunity was archived on March 22, 2015, which indicates it was time-limited and is no longer accepting applications.
Who was eligible to apply?
Eligibility was broad and included many types of U.S.-based (domestic) organizations, including public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); state, county, city/township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; small businesses and some for-profit organizations; tribal governments and tribal organizations; U.S. territories or possessions; eligible federal agencies; and a range of community-rooted and minority-serving institutions.
Did the FOA explicitly include minority-serving institutions and community-based organizations?
Yes. The eligibility list explicitly encompassed institutions and organizations such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, and faith-based or community-based organizations.
Were for-profit entities allowed to apply?
Yes. The eligibility list included small businesses and some for-profit organizations.
Could tribal governments or tribal organizations apply?
Yes. Tribal governments and tribal organizations were listed as eligible applicants.
Were non-U.S. (foreign) organizations eligible to apply?
No. The FOA restricted foreign involvement: non-U.S. entities were not eligible to apply.
Could a U.S. organization apply if the project involved a non-U.S. component?
No. The FOA stated that non-U.S. components of U.S. organizations were not eligible.
Were foreign components allowed under NIH definitions?
No. The FOA stated that foreign components (as NIH defines them) were not allowed.
Where could applicants find the full official announcement details?
NIH directed readers to the official announcement page on the NIH Grants Guide (the link was provided in the source description).
Who should be contacted for technical or administrative help accessing the electronic announcement?
For administrative help related to accessing or linking to the electronic announcement, NIH routed inquiries through the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
What does it mean that the FOA is "archived"?
Based on the information provided, "archived" indicates the FOA was a time-limited call and is no longer accepting applications after the listed closing date.
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