Questions and Answers for U.S.-South Africa Program for Collaborative Biomedical Research - Phase 3 (HIV/AIDS)

Each time we add new questions or revise, we will revise the dated note shown at the top of this page to describe the latest update.

The deadline is 5:00 p.m. local time on March 12, 2025, but you may submit your application to Grants.gov starting February 12, 2025. We advise that you give yourself plenty of time to submit, so you can resolve validation issues that may arise. To learn more, go to Pass Electronic Validations on the Submit an Application webpage.

There is currently one NOFO available for this program, targeting applications that have HIV/AIDS relevance.

Yes. For more information, check Organization Registrations.

No. Investigators from both countries will work together to prepare and submit one application, which may follow the multiple program director/principal investigator (PD/PI) approach. The contact PD/PI should be from South Africa and the application should be submitted by the South African institution.

Note: Phase 1 was the first funding cycle of the U.S.-South Africa Program for Collaborative Biomedical Research, supported during the period fiscal year (FY) 2015 to FY 2019. Phase 2 was the second funding cycle of the U.S.-South Africa Program for Collaborative Biomedical Research, supported during the period FY 2020 to FY 2024.

All applications submitted under this NOFO should be new applications. Renewal applications will not be accepted for review.

Investigators who received a grant under Phase 1 or Phase 2 of the program can use their results as preliminary data and are expected to address new hypotheses in their next application. They are not allowed to propose the same Specific Aims as their previous grant. They also may not include a progress report in their application. Contact the Scientific/Research Contact(s) listed in the NOFO if you have any questions about new versus renewal applications.

All applications require a Collaboration Plan which is not limited to the PDs/PIs; rather, it should include everyone, e.g., all collaborators and other key personnel, involved in the project, and describe the coordination of multiple sites in which the work is being conducted.

If there are multiple PD/PIs from South Africa, then a Multiple PD/PI Leadership Plan is also required. Note that there may be some redundancy between the Collaboration Plan and Leadership Plan.

If your two plans are essentially the same, state that this is the case in your Collaboration Plan, which goes in Other Attachments of the Research & Related Other Project Information section of your application.

Key personnel are contributors who provide intellectual input to the research program. They contribute substantively to the scientific development or execution of a project. Key personnel contribute a specified level of time (in contrast to other significant contributors) whether or not they are earning a salary.

Key personnel include the principal investigator as well as any consultants who meet the definition above. For more information, refer to Frequently Asked Questions: Senior/Key Personnel.

Check the Biosketch Biosketch Format Pages, Instructions, and Samples page.

There is no form for facilities. Simply label your PDF file as Facilities and Other Resources. The South Africa (SA) PD/PI should describe the site for work in SA and the U.S. collaborator should describe the site for work in the U.S. Keep in mind that since investigators from both countries submit a single application, this attachment should include both the U.S. and South African information and be clearly labeled.

No.

Reviewers for these applications will be scientists who 1) demonstrate appropriate scientific expertise and breadth of perspective, 2) demonstrate geographic expertise as it relates to the science, and 3) do not have conflicts of interest.

Reviewers consider the following core review criteria, as well as other criteria that may apply specifically to the NOFO.

• Factor 1: Importance of Research (Significance and Innovation)
• Factor 2: Rigor and Feasibility (Approach)
• Factor 3: Expertise and Resources (Investigator[s] and Environment)

For more information, refer to Section V. Application Review Information of the NOFO.

No. Only one letter of intent is needed for each application, and the South African contact PD/PI is the one who should submit it.

A letter of intent is not required or binding, but if you choose to submit one, include:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

Contact the Scientific/Research Contact(s) listed in the NOFO under “Section VII. Agency Contacts.”

Institutions must be a “National Research Foundation (NRF) South African Institution,” which is a recognized South African public higher education or research institution such as a university, university of technology, science council, museum or other research institution as declared by the Department of Science and Innovation.

For help determining whether your organization or institution is eligible to apply, contact Michelle Mulder (michelle.mulder@mrc.ac.za) at the South African Medical Research Council (SAMRC).

Though you cannot be a PD/PI, you can still be part of a proposed project as key personnel.

Yes. NIH encourages new investigators, especially early-stage investigators (ESIs), to apply.

To find out whether you qualify as new or ESI, go to Who Qualifies for New and Early-Stage Investigator Status on our Information for New Investigators webpage.

You may qualify for an ESI extension. For information on requesting permission for an extension, go to How do I request an extension of my ESI status? on NIH's Frequently Asked Questions: Early Stage Investigators page.

No. If the PD/PI is a full-time employee of an eligible South African institution or under a long-term contract for the duration of the award, they are eligible. Keep in mind that it's important to document this in the application.

No. The program is open to both new and previously established collaborations.

Yes, all South African investigators that are at eligible National Research Foundation (NRF) South African Institutions, as listed in Section III of the NOFO, are eligible for the program. Prior participation is not required.

No. You can serve as a collaborator and/or multiple PD/PI with a South African scientist at a South African institution who qualifies as stated above. However, the South African PD/PI must serve as the contact PD/PI for the award.

There must be a minimum of one PI from South Africa and one collaborator from the U.S.

Yes. South African PIs can also have an affiliation with a U.S. institution; however, the application must be submitted from the South African institution. Applications submitted by U.S. institutions will be considered nonresponsive and will not be reviewed.

No. However, you can serve as a collaborator.

Scientists from countries other than South Africa cannot be included as PD(s)/PI(s) on the application. However, scientists from other countries may be included as collaborators. If PD(s)/PI(s) anticipate the need to transfer funding to scientists from countries other than the United States and South Africa, it may be possible depending on the policies of the associated NIH institute or center (IC). Consult with the appropriate IC point of contact for further information.

No. The contact PD/PI must be an eligible investigator from the South African institution, and therefore the South African institution must submit the application.

For a multiple PD/PI application, reference NOT-OD-07-017. You should know that:

• All PIs are designated by the applicant institution (see definition of PI below).
• All PIs share the responsibility and authority for leading and directing the project.
• The first PI listed must be affiliated with the institution submitting the application and will serve as the contact PI.
• The contact PI will be responsible for communication between NIH and the rest of the leadership team.
  • Note: for this opportunity, the contact PD/PI must be an eligible investigator from the South African institution.
• The application must include a Leadership Plan. Check NIH’s Examples of Project Leadership Plans for Multiple PI Grant Applications.
• For this NOFO, applications must also include a Collaboration Plan. Read the NOFO for more information.

For more information, check NIH’s Multiple Principal Investigators webpage.

Yes. Check the International Applications webpage for more information.

For the R01 NOFO, the NIH and SAMRC plan to commit approximately $3.8 million per year to fund up to 8 to 10 awards.

Budgets are not expected to exceed $400,000 each year in direct costs, and at least 50 percent of the total budget must support activities in South Africa, regardless of how many sites are included.

No. The $400,000 does not include F&A costs.

Yes. You should apply with a budget that fits the scope of research that you intend to complete.

South African institutions are entitled to 8 percent F&A costs of modified total direct costs (all requested costs except for equipment and alterations and renovations, including 8 percent F&A on the U.S. site costs).

For more information, refer to What is the difference between allowable direct costs and allowable facilities & administrative (F&A) costs? on the Develop Your Budget webpage.

Yes. Funds can be budgeted for individuals who will be working on the proposed research project.

When recipients draw funds from PMS, the system converts the amount from U.S. dollars using the most current exchange rate.

At least 50 percent of the total costs of the collaborative research must support activities conducted in South Africa.

For research areas that are of interest, read the examples in the Research Objectives section of the NOFO. Keep in mind that these are broad topics under which your proposed project may fall.

This program supports basic/molecular, epidemiological, clinical, and implementation science research, as well as other areas of research described in the NOFO. In general, research funded through this program may lead to improvements in community health, such as public health practice or clinical medicine.

If you'd like to know whether your research is appropriate for the NOFO, contact the Scientific/Research Contact(s) listed in the announcement. Consider submitting an optional letter of intent (LOI), which is due a month before the application. Learn more about LOIs on our Letters of Intent webpage.

The following clinical research guidance outlines what would be appropriate. Check NIH’s Definition of a Clinical Trial:

• Clinical studies to conduct formative research needed to develop a new low-risk behavioral or behavioral/biomedical integrated intervention (only with approved drugs).
  • Research could include tests of feasibility, acceptability, support for intervention development, and piloting of the intervention in nonrandomized designs.
• Implementation science studies that use a previously demonstrated efficacious intervention.
  • Research could include randomization to compare proven interventions as well as adapting or pilot testing interventions with demonstrated efficacy for use in new populations.
  • Implementation science could include investigations into the acceptability, coverage, and fidelity for efficacious interventions, barriers to intervention delivery and strategies to overcome these barriers, cost-effectiveness outcomes, and impact on health systems or the community.

As for what would be considered nonresponsive: clinical trial stages III and IV.

Clinical trial stages I and II are allowed through this NOFO. Applications proposing stage III and IV clinical trials are not allowed, will be deemed nonresponsive, and will not be reviewed. Note that proposed clinical trials will need to fall within the budget limit. Check NIH’s Definition of a Clinical Trial.

No. Applications that include the use of select agents will be nonresponsive to this NOFO and will not be reviewed.

For a list of what is considered a select agent, go to HHS and USDA Select Agents and Toxins List. To determine if an agent is exempt or excluded, check Select Agents and Toxins Exclusions. Find other resources at NIH's Select Agent Information.

Collaborators can be identified by conducting a publication search on the research topic of interest to identify leaders in the field, at scientific conferences, and by networking with current contacts.

Investigators are encouraged to reach out to the SAMRC for assistance in identifying potential collaborators at HDIs and Universities of Technology. They may also contact the Scientific/Research Contact(s) listed in the NOFO to identify collaborators at NIH. All NIH-funded research can be accessed at NIH RePORT.

Successful collaborations have shared scientific interests and provide mutual benefit. The benefit to each party should be defined and a clear communication strategy should be established between the investigators, as well as their institutions. In a successful collaboration, each party understands their strengths and weaknesses. In addition, they acknowledge the skills and/or resources they can use to contribute to the research project. Visit Build Your Team for more information.

Check Section VII of the NOFO for NIH scientific/research, peer review, and financial/grants management contacts.