Opportunity Information: Apply for PAR 10 096

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Multi Site Clinical Trials (Collaborative R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
  • This funding opportunity was created on Jan 27, 2010 and posted on Jan 27, 2010.
  • Applicants must submit their applications by May 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Independent school districts For profit organizations other than small businesses Small businesses Public and State controlled institutions of higher education County governments Public housing authorities/Indian housing authorities City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education Special district 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 Eligible Agencies of the Federal Government 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.
Apply for PAR 10 096

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:

Opportunity Summary:

The Investigator Initiated Multi Site Clinical Trials (Collaborative R01) funding opportunity (PAR-10-096) is a National Institutes of Health grant announcement designed to support investigator-driven, multi-site clinical trials that are ready to be run as Phase II or Phase III randomized, controlled studies. The core aim is to give researchers a clear route to propose and conduct rigorous trials across multiple locations when the scientific question fits within the mission of the National Heart, Lung, and Blood Institute (NHLBI). These trials can evaluate either clinical interventions (such as drugs, devices, procedures, or care strategies) or behavioral interventions (such as lifestyle, adherence, or risk-reduction programs), as long as the study is testing an intervention in a randomized, controlled design and is conducted across more than one site.

A key point of this announcement is what it does not fund. It is not meant for single-center studies, and it is not intended for multi-center observational research that does not involve testing an intervention. In other words, NHLBI is using this mechanism specifically for intervention trials where multiple sites are needed to recruit enough participants, ensure diverse representation, improve generalizability, or meet other scientific and operational needs that justify a multi-site randomized design.

The award mechanism is the NIH Research Project Grant (R01), which is the standard NIH grant for investigator-initiated research projects. However, the announcement notes that NHLBI may convert awards to cooperative agreements (U01). That matters because an R01 generally implies that the investigator has primary responsibility for the study’s direction and execution, while a U01 cooperative agreement typically involves more substantial scientific or programmatic involvement from the NIH institute. Practically, this signals that funded projects may involve closer coordination with NHLBI than a typical independent R01, especially given the complexity, cost, and oversight requirements of multi-site Phase II and III trials.

Applicants are directed to consult NHLBI’s Guidelines for Investigator Initiated Clinical Trials for detailed instructions on how to prepare and submit multi-site clinical trial applications. That reference is important because multi-site randomized trials usually require extensive operational planning, including coordinating centers, site management plans, standardized procedures across locations, data and safety monitoring approaches, recruitment and retention strategies, regulatory compliance, and clear governance structures for collaboration among participating sites.

The scientific scope is broad as long as it aligns with NHLBI priorities, which cover heart and vascular diseases, lung diseases, blood diseases and resources, and sleep disorders research. The opportunity is tied to multiple CFDA program areas, including 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), 93.839 (Blood Diseases and Resources Research), and 93.233 (National Center on Sleep Disorders Research). Applicants are encouraged to align their proposed trial with NHLBI’s mission, goals, strategic plan, and research interests, which are available through NHLBI’s website.

Eligibility is broad and includes many types of organizations. Eligible applicants listed include public and private institutions of higher education, nonprofit organizations (including those with 501(c)(3) status and certain nonprofits without it), small businesses and for-profit organizations other than small businesses, local and state governmental entities (such as county and city governments and special district governments), public housing authorities/Indian housing authorities, independent school districts, and tribal governments and organizations (including federally recognized tribes and other tribal entities). The eligibility information also explicitly mentions categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, U.S. territories or possessions, regional organizations, eligible federal agencies, and even non-U.S. entities (foreign organizations). The announcement states there is no cost sharing or matching requirement.

Administratively, the opportunity was posted on January 27, 2010, with an original and final closing date of May 7, 2013, and it was archived on June 7, 2013. The official full announcement was hosted through the NIH grants guide under the provided link (PAR-10-096). For technical access issues, the contact provided is the NIH Office of Extramural Research (OER) webmaster.

In plain terms, this FOA was built for research teams that have a well-developed intervention they want to test in a robust, randomized, controlled way across multiple sites, and whose question falls squarely within NHLBI’s heart, lung, blood, and sleep portfolio. It emphasizes true clinical trial testing rather than observational work, uses the R01 structure while allowing for added NIH involvement via potential U01 conversion, and expects applicants to follow NHLBI’s specific clinical trial guidance to address the operational and oversight realities of large, multi-site Phase II or III trials.

Frequently Asked Questions (FAQs)

What is PAR-10-096 (Investigator Initiated Multi Site Clinical Trials - Collaborative R01)?

PAR-10-096 is a National Institutes of Health (NIH) funding opportunity designed to support investigator-initiated, multi-site clinical trials that are ready to be conducted as Phase II or Phase III randomized, controlled studies, when the research question fits within the mission of the National Heart, Lung, and Blood Institute (NHLBI).

What types of studies are intended for this funding opportunity?

This opportunity is intended for rigorous, multi-site randomized, controlled clinical trials (Phase II or Phase III) that test an intervention and require more than one study site.

Does the trial have to be conducted at more than one site?

Yes. The announcement is specifically for multi-site trials. It is not intended for single-center studies.

What kinds of interventions can be tested?

Trials may evaluate clinical interventions (for example, drugs, devices, procedures, or care strategies) or behavioral interventions (for example, lifestyle programs, adherence interventions, or risk-reduction approaches), as long as the study is a randomized, controlled intervention trial conducted across multiple sites.

Are observational multi-center studies eligible?

No. The announcement is not intended for multi-center observational research that does not involve testing an intervention in a randomized, controlled design.

What phase of clinical trial does this FOA support?

The FOA is aimed at trials that are ready to be conducted as Phase II or Phase III randomized, controlled studies.

What is the funding mechanism for this opportunity?

The award mechanism is the NIH Research Project Grant (R01), which is the standard NIH grant mechanism for investigator-initiated research projects.

Can NHLBI change the award mechanism from an R01 to something else?

Yes. The announcement notes that NHLBI may convert awards to cooperative agreements (U01).

What does a potential conversion to a U01 imply for the project?

The FOA indicates that funded projects may involve closer scientific or programmatic involvement from NHLBI than a typical independent R01, reflecting the complexity, cost, and oversight needs of multi-site Phase II/III trials.

What scientific areas does NHLBI consider within scope for this FOA?

The scope is broad as long as the proposed multi-site randomized, controlled intervention trial aligns with NHLBI priorities in heart and vascular diseases, lung diseases, blood diseases and resources, or sleep disorders research.

Which CFDA program areas are associated with this opportunity?

The opportunity is tied to multiple CFDA program areas, including 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), 93.839 (Blood Diseases and Resources Research), and 93.233 (National Center on Sleep Disorders Research).

Who is eligible to apply?

Eligibility is broad and includes many organization types, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain nonprofits without 501(c)(3) status), small businesses, for-profit organizations other than small businesses, and various government entities.

Are state and local government entities eligible?

Yes. The eligible applicants listed include local and state governmental entities such as county governments, city or township governments, and special district governments.

Are tribal governments and tribal organizations eligible?

Yes. Eligibility includes tribal governments and organizations, including federally recognized tribes and other tribal entities.

Are public housing authorities or Indian housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are listed among eligible applicants.

Are independent school districts eligible to apply?

Yes. Independent school districts are included in the eligibility list provided.

Are minority-serving institutions explicitly included as eligible applicants?

Yes. The eligibility information explicitly mentions categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.

Are U.S. territories or possessions eligible?

Yes. The eligibility information explicitly includes U.S. territories or possessions.

Are foreign organizations eligible to apply?

Yes. The eligibility information explicitly mentions that non-U.S. entities (foreign organizations) are included.

Are federal agencies eligible to apply?

Yes. The eligibility information includes eligible federal agencies.

Is cost sharing or matching required?

No. The announcement states there is no cost sharing or matching requirement.

What planning or guidance does NHLBI expect applicants to follow for multi-site trials?

Applicants are directed to consult NHLBI's Guidelines for Investigator Initiated Clinical Trials for detailed instructions on preparing and submitting multi-site clinical trial applications. This is emphasized because multi-site randomized trials typically require extensive operational planning and oversight.

What kinds of operational elements are implied for a multi-site randomized trial application?

Based on the announcement, applicants should be prepared to address typical multi-site trial needs such as coordinating centers, site management plans, standardized procedures across locations, data and safety monitoring approaches, recruitment and retention strategies, regulatory compliance, and governance structures for collaboration among participating sites.

How should applicants ensure the project fits NHLBI priorities?

Applicants are encouraged to align the proposed trial with NHLBI's mission, goals, strategic plan, and research interests, which are available through NHLBI resources.

When was this funding opportunity posted and when did it close?

The opportunity was posted on January 27, 2010. The original and final closing date was May 7, 2013.

Is this funding opportunity still active?

No. The opportunity was archived on June 7, 2013.

Where was the official announcement published?

The full announcement was hosted through the NIH grants guide under the identifier PAR-10-096.

Who is listed as the contact for technical access issues related to the announcement?

For technical access issues, the contact provided is the NIH Office of Extramural Research (OER) webmaster.

In practical terms, who was this FOA built for?

This FOA was built for research teams with a well-developed intervention they want to test in a robust Phase II or Phase III randomized, controlled design across multiple sites, where the scientific question clearly falls within NHLBI's heart, lung, blood, and sleep research portfolio.

Browse more opportunities from the same agency: National Institutes of Health

Browse more opportunities from the same category: Health

Next opportunity: Special Focus Competition Program for North American Mobility in Higher Education CFDA 84.116N

Previous opportunity: Purchase, Distribution and Tracking of Cotrimoxazole, HIV/AIDS Related Laboratory Commodities and Supplies in the Republic of Uganda Under the Presidents Emergency Plan for AIDS Relief (PEPFAR)

USGrants.org Applicant Portal:

Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.

Apply for PAR 10 096

 

[Watch] how do funding administrators access proposals?

Applicants also applied for:

Applicants who have applied for this opportunity (PAR 10 096) also looked into and applied for these:

Funding Opportunity
Support for a National Monitoring and Evaluation System, Strategic Information Coordination, Data Synthesis, and Data Use to Strengthen the Multi Sector HIV/AIDS Response in the United Republic of Tanzania Under PEPFAR Apply for CDC RFA PS10 1069

Funding Number: CDC RFA PS10 1069
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent
Support for the Ministry of Healths Monitoring and Evaluation System, Surveillance, Blood Safety and Laboratory Infrastructure in the Republic of the Ukraine under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 1090

Funding Number: CDC RFA PS10 1090
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent
Providing HIV Prevention, Treatment, and Care Services to Injecting Drug users, Incarcerated Population, and other Vulnerable Populations in Central Asian Republics of Kazakhstan, Kyrgyz Republic, Tajikistan, Turkmenistan, and Uzbekistan under PEPFAR Apply for CDC RFA PS10 10156

Funding Number: CDC RFA PS10 10156
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent
NEI Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) for Statistical Genetics and Genome Informatics Apply for RFA EY 10 001

Funding Number: RFA EY 10 001
Agency: National Institutes of Health
Category: Health
Funding Amount: Case Dependent
Building the Capacity of Regional Health Management Team to Coordinate, Manage, and Support HIV/AIDS Clinical Services in the United Republic of Tanzania under the President s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 10127

Funding Number: CDC RFA PS10 10127
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $500,000
Improving Access to and Delivery of HIV/AIDS Services by Strengthening Community and Health Center Linkages in the Eastern Province of the Republic of Zambia Under the President s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 10108

Funding Number: CDC RFA PS10 10108
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $4,000,000
Strengthening Health Information Systems Implementation, Capacity, and Infrastructure in the Republic of Mozambique Under the President s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 1086

Funding Number: CDC RFA PS10 1086
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $1,000,000
Pediatric Pulmonary Centers (PPC) Apply for HRSA 10 103

Funding Number: HRSA 10 103
Agency: Health Resources and Services Administration
Category: Health
Funding Amount: Case Dependent
HIV Prevention for Most at Risk Populations (MARPs), Republic of Mozambique, Under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 1085

Funding Number: CDC RFA PS10 1085
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $1,946,000
Strengthening the Blood Transfusion Services in the Republic of Mozambique under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 1079

Funding Number: CDC RFA PS10 1079
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent
Prevention of Suicidal Behavior through the Enhancement of Connectedness (U01) Apply for RFA CE 10 006

Funding Number: RFA CE 10 006
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $400,000
Impact of Japanese Encephalitis Vaccination in Cambodia (U01) Apply for RFA CK 10 003

Funding Number: RFA CK 10 003
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent
Research on Alcohol and HIV/AIDS (R03) Apply for PA 10 104

Funding Number: PA 10 104
Agency: National Institutes of Health
Category: Health
Funding Amount: Case Dependent
Developing and Improving HIV/AIDS Clinical Nursing Capacities and Institutional Structural Support in India Under the President s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 10139

Funding Number: CDC RFA PS10 10139
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: $800,000
AIDS Education and Training National Resource Center Apply for HRSA 10 131

Funding Number: HRSA 10 131
Agency: Health Resources and Services Administration
Category: Health
Funding Amount: Case Dependent
Capacity Building to Develop Standard Electronic Client Information Data Systems Apply for HRSA 10 082

Funding Number: HRSA 10 082
Agency: Health Resources and Services Administration
Category: Health
Funding Amount: Case Dependent
Strengthening Local Government Response to Vulnerable Children (SLGRVC) Apply for RFA 617 10 000004

Funding Number: RFA 617 10 000004
Agency: Uganda USAID Kampala
Category: Health
Funding Amount: $20,000,000
Research on Alcohol and HIV/AIDS (R01) Apply for PA 10 103

Funding Number: PA 10 103
Agency: National Institutes of Health
Category: Health
Funding Amount: Case Dependent
Research on Alcohol and HIV/AIDS (R21) Apply for PA 10 105

Funding Number: PA 10 105
Agency: National Institutes of Health
Category: Health
Funding Amount: $200,000
Knowledge Synthesis Center for Evaluating Genomic Application in Practice and Prevention (U18) Apply for RFA GD10 001

Funding Number: RFA GD10 001
Agency: Centers for Disease Control and Prevention
Category: Health
Funding Amount: Case Dependent

 

Grant application guides and resources

It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!

Apply for Grants

 

USGrants.org applicant portal membership

 

Premium leads for funding administrators, grant writers, and loan issuers

Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.

If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.

Subscribe to Leads

 

Request more information:

Would you like to learn more about this funding opportunity, similar opportunities to "PAR 10 096", eligibility, application service, and/or application tips? Submit an inquiry below:

Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.