Questions and Answers for RFA-AI-19-023 and RFA-AI-19-025, U.S.-South Africa Program for Collaborative Biomedical Research, Phase 2 (U01 Clinical Trial Optional)

Updated April 11, 2019. We updated the question and answer about PIs from countries other than the U.S. and South Africa in the Eligibility section. We also corrected the budget figures in the Funding and Budget section.

NIH published two U01 funding opportunity announcements (FOA) on March 15, 2019:

  • RFA-AI-19-023 for research on HIV/AIDS and HIV/AIDS-associated malignancies
  • RFA-AI-19-025 for research on other infectious diseases

The questions and answers below cover the U01 FOAs. We also published two associated R01 FOAs; learn more about the R01s at Questions and Answers for RFA-AI-19-022 and RFA-AI-19-024, U.S.-South Africa Program for Collaborative Biomedical Research, Phase 2 (R01 Clinical Trial Optional).

Table of Contents

Application

When is the application deadline?

The deadline is 5:00 pm local time on July 26, 2019. You may submit your application to Grants.gov starting on June 26, 2019. We advise you to submit well in advance so you have plenty of time to resolve any validation issues that may arise. Learn more in the Pass Electronic Validations section of NIAID’s Submit an Application guide.

How many FOAs are there for the U.S.-South Africa Program for Collaborative Biomedical Research?

There are four FOAs available for this program. Two of them target applications that have HIV/AIDS relevance. The other two are for infectious diseases excluding HIV/AIDS.

Must academic institutions register with NIH or Grants.gov to apply or receive an award?

Yes. Follow the instructions at eRA Commons Accounts: Who and How and Where and Grants.gov Organization Registration Instructions.

Do investigators from each country submit individual applications?

No. Investigators from both countries will work together to prepare one application. The application must follow the multiple PI approach. The contact PI must be from South Africa and the South African institution submits the application.

Should investigators who received a grant under Phase 1 of this collaborative grant program submit a new or renewal application?

Note: Phase 1 was the first funding cycle of the U.S.-South Africa Program for Collaborative Biomedical Research, supported during the period FY 2015 to FY 2019.

You must submit a new application for these FOAs. We will not accept renewal applications for review.

Investigators who received a grant under Phase 1 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 FOA if you have any questions about new versus renewal applications.

Do NIH intramural PIs need an eRA Commons account to apply?

Yes. The NIH intramural investigator needs an eRA Commons account even though the South African investigator is responsible for submitting the application.

The intramural investigator must enter his or her eRA Commons ID in the “Credential, e.g., agency login” field of the Senior/Key Person Profile section.

To obtain an eRA Commons account, NIH intramural investigators should contact the following staff members:

NIAID intramural investigators can learn more about NIAID’s internal procedures at NIAID Staff-Only: Outside Funding for Intramural Investigators.

Is a Multiple PI Leadership Plan required in addition to the Collaboration Plan?

Yes. If your application consists of only two PIs (one from South Africa and one from the U.S.), the Leadership Plan and Collaboration Plan would basically be the same.

That said, the Collaboration Plan is normally not limited to the PIs. It should include everyone involved in the project (e.g., all collaborators and other key personnel) and describe the coordination of multiple work sites. 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.

Who qualifies as key personnel?

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 they earn salaries or not.

Key personnel include the principal investigator as well as any consultants who meet the definition above. Learn more at Frequently Asked Questions: Senior/Key Personnel.

As the intramural investigator, how should I list my current support in the Senior/Key Person Profile section? Must my junior colleagues list their government salaries?

Include a statement that you are an intramural scientist and that all support comes from NIH. Junior colleagues may do the same; they don't need to list their salaries.

As the intramural investigator, do I need to get letters or approval (e.g., from Institutional Review Board (IRB)) for anything before I submit?

You'll need to get a letter from your scientific director or designee that confirms you'll be able to collaborate on the project. You will include the letter in your application as a Letter of Support.

You do not need to get certification of IRB approval before you submit your application. It is one of the items NIH requests "just-in-time," i.e., after an application has been peer reviewed and is within a range of possible funding. Therefore, you may note IRB approval as "pending."

For more information visit For Grant Applications - Submit Just-in-Time.

Where can we find biographical sketch forms? Is there a facilities form or a special format we should use?

Visit NIH’s Biosketch Format Pages, Instructions, and Samples.

There is no form for facilities. Label your PDF file as Facilities and Other Resources. As the U.S. PI, designate your site for the work of the U.S. part. Keep in mind that since investigators from both countries submit a single application, include and clearly label both the U.S. and South African information in this attachment.

Are references part of the 12-page limit for the Research Plan?

No.

Who will serve on the peer review panel?

Reviewers for these applications will be South African and U.S. scientists who 1) demonstrate appropriate scientific expertise and breadth of perspective and 2) do not have conflicts of interest.

What review criteria are used to evaluate applications?

Reviewers consider the following core review criteria:

  • Significance
  • Investigator(s)
  • Innovation
  • Approach
  • Environment

They also consider any other criteria that may apply specifically to the FOA.

For more information, see Section V. Application Review Information of the FOA.

If we decide to submit a letter of intent, do you need one from both the U.S. and South African collaborating investigators?

No. Only one letter of intent is needed for each application. The South African contact PI should submit it.

If we decide to submit a letter of intent, what should we include?

A letter of intent is not required or binding, but if you choose to submit one, include at least the title of the research project, names of PIs, and institutions.

Eligibility

How do I know whether my South African institution is eligible?

Eligible South African organizations and institutions are legal entities that perform research and development as part of their functions.

For help determining whether your organization or institution is eligible to apply, contact Arlene Smith (arlene.smith@mrc.ac.za) at the South African Medical Research Council (MRC).

If I am not at an eligible National Research Foundation (NRF) South African institution, may I still contribute to the grant's project?

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

What are South African historically disadvantaged institutions?

South African historically disadvantaged institutions (HDIs) were either historically black and/or have been held back by a lack of training in research, research experience, and research funding. They are generally located in previously disadvantaged communities and have the potential to address important health priorities in the population. Compared to HDIs which have more of an academic focus, Universities of Technology provide vocational training.

Who are South African underrepresented scientists?

Underrepresented scientists are members of previously disadvantaged ethnic groups in South Africa who were denied the right to vote before 1994 and suffered from a lack of educational and funding opportunities.

In this FOA underrepresented scientists are defined African, Coloured, and Indian population groups, and all scientists who work at historically disadvantaged institutions (HDIs) and Universities of Technology. This group of scientists has been identified as underrepresented by the South African Medical Research Council.

The goal of this FOA is to increase the number of underrepresented scientists engaged in research collaboration in support of emerging health needs.

What role should the underrepresented scientist have?

The underrepresented scientist may serve as a program director/principal investigator (PD/PI) for the grant or as a collaborating investigator.

May new investigators apply to this FOA?

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 in our Information for New Investigators guide.

I finished my Ph.D. in 2003 but took time off to have children. Would I still qualify as an early-stage investigator (ESI)?

Yes. Since you had children after completing your terminal degree, you would likely get an ESI extension of one year (six months for each child). 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 About NIH ESI Policies.

Does the PD/PI at the South African institution have to be a citizen of South Africa?

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, he or she is eligible. It is important to document this in the application.

Must the collaboration between the U.S. and South African scientists have been previously established?

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

Are investigators who were not part of Phase 1 of the U.S.-South Africa program eligible to apply for Phase 2?

Yes, all South African investigators are eligible for the program. Prior participation is not required.

May there be two PIs from one country?

Yes. However, at a minimum, you must have one PI from the U.S. and one from South Africa. For the U01 FOA, the U.S. PD/PI must be an NIH intramural investigator.

Are there affiliation requirements for the PD/PI?

Yes. Applications must include at least one PD/PI who is an NIH intramural investigator (i.e., someone conducting research within an NIH lab or clinic) and one PD/PI who is affiliated with an eligible South African institution. If they do not, applications will be considered nonresponsive and will not be reviewed.

For research partnerships involving South African researchers and U.S. extramural investigators, refer to the R01 FOAs:

  • RFA-AI-19-022 for research on HIV/AIDS and HIV/AIDS-associated malignancies
  • RFA-AI-19-024 for research on other infectious diseases

Learn more about the R01s at Questions and Answers for RFA-AI-19-022 and RFA-AI-19-024, U.S.-South Africa Program for Collaborative Biomedical Research, Phase 2 (R01 Clinical Trial Optional).

May applications include multi-PD/PIs affiliated with countries other than South Africa and the U.S.?

You may not include scientists from countries other than South Africa and the U.S. as PD(s)/PI(s) on the application.

Although we specifically encourage including scientists from Kenya, Lesotho, Uganda, and Zimbabwe as collaborators, no country is prohibited from participating. These collaborations are intended to be scientific in nature and to stimulate regional excellence in biomedical research. Collaborative activities may include, but are not limited to, data analysis, technical expertise, sample sharing, and training.

Note: Applicants must use the majority of funds to support work to be performed at the South African institution(s), with no less than 50 percent of the total budget costs directly supporting the South African component(s) of the research project. The 50 percent minimum applies to the entire project, not each budget year. Intramural (NIH IRP Project Scientist) costs may not exceed $50,000 total costs per year and the combined total cost for intramural and extramural components cannot exceed $250,000. Therefore, applicants need to include funding for research activities taking place in other countries under the remaining budget.

(Question and answer updated on April 11, 2019.)

A multiple PI application needs a contact PI. May the contact PI from either the U.S. or South African institution?

The contact PI must be an eligible investigator from the South African institution, and therefore the South African institution must submit the application. For more on multi-PI applications, see This FOA requires multiple PI applications. What are some key points to know about multiple PI applications? below.

This FOA requires multiple PI applications. What are some key points to know about multiple PI applications?

For a multiple PI application:

  • All PIs have the same status and are responsible for their research.
  • Each PI must have a leadership role.
  • One person serves as contact PI, coordinating communication between all PIs and NIH and coordinating the progress report. For this opportunity, the contact PI must be an eligible investigator from the South African institution.
  • The application must include a Leadership Plan. See NIH’s Examples of Project Leadership Plans for Multiple PI Grant Applications.
  • For this FOA, applications must also include a Collaboration Plan. Read the FOA for more information.

For more information, read the October 5, 2016 NIAID Funding News article “Tips for Writing a Strong Multiple PI Leadership Plan.”

Since this FOA requires collaboration with researchers in South Africa, do you have online resources for foreign investigators?

Yes. Visit NIAID’s International Applications page for more information.

I am a U.S. PI. May I apply for this opportunity?

No. If you are an NIH intramural researcher, you may serve as a collaborator and/or multiple PI with a South African scientist at a South African institution. The South African PI must serve as the contact PD/PI for the award and the South African institution applies.

If you are not an NIH intramural investigator, refer to the R01 funding opportunities:

  • RFA-AI-19-022 for research on HIV/AIDS and HIV/AIDS-associated malignancies
  • RFA-AI-19-024 for research on other infectious diseases

Learn more about the R01s at Questions and Answers for RFA-AI-19-022 and RFA-AI-19-024, U.S.-South Africa Program for Collaborative Biomedical Research, Phase 2 (R01 Clinical Trial Optional).

I am a U.S. intramural scientist. May I apply for this opportunity?

No. You may serve as a collaborator and/or multiple PI with a South African scientist at a South African institution. The South African PI must serve as the contact PD/PI for the award and the South African institution applies.

Funding and Budget

What is the amount of funds available for awards? How many awards will be made?

For the R01 and U01 FOAs together, the NIH and MRC plan to commit approximately $8 million per year to fund up to 25 awards.

Is there a budget limit?

Yes. Budgets are limited to a total cost of $250,000 each year with a limit of $200,000 each year for the South African institution.

NIH intramural investigators are limited up to $50,000 in costs each year. They may not include salary or overhead in the proposed budget.

(Question and answer updated on April 11, 2019.)

May we apply for an amount less than the maximum allowable budget?

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

In developing our joint budgets, how much can be used for facilities and administrative (F&A) costs?

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).

U.S. institutions are entitled to their full negotiated F&A rates. F&A will not be paid for any NIH intramural research program costs or services.

For more information, see What is the difference between allowable direct costs and allowable facilities & administrative (F&A) costs? in NIH’s Develop Your Budget guide.

May I include salaries for postdoctoral fellows and graduate students in the budget?

Yes. You may budget funds for individuals who will be working on the proposed research project. However, you may not budget salary support for any intramural scientist.

What exchange rate is used when South African grantees draw funds from the Payment Management System (PMS)?

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

Research

There are four FOAs available for Phase 2 of the U.S.-South Africa Program for Collaborative Biomedical Research. Which FOA should I use to submit my proposal?

There are two U01 FOAs for collaborations between South African and U.S. intramural scientists at the NIH. If you wish to submit an application with an NIH intramural scientist, you should use one of the following U01 FOAs based on the research topic of interest:

  • RFA-AI-19-023 for research on HIV/AIDS and HIV/AIDS-associated malignancies
  • RFA-AI-19-025 for research on other infectious diseases

There are two R01 FOAs for collaborations between South African and U.S. scientists who are not affiliated with the NIH. If you wish to submit an application with a U.S. scientist outside of the NIH, you should use one of the following R01 FOAs based on the research topic of interest:

  • RFA-AI-19-022 for research on HIV/AIDS and HIV/AIDS-associated malignancies
  • RFA-AI-19-024 for research on other infectious diseases

How much research should be completed in South Africa?

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

What types of research projects would be appropriate?

See example research areas of interest in the Research Objectives section of the FOA. Keep in mind that these are broad topics under which your proposed project may fall.

This research program supports basic/molecular, epidemiological, clinical, and implementation science. 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 (i.e., responsive) for one of these four FOAs, contact the Scientific/Research Contact(s) listed in Section VII of your chosen FOA.

Consider submitting an optional letter of intent (LOI), which is due a month before the application. Learn more about LOIs from our July 20, 2016 NIAID Funding News article “A Useful Reminder: Contact Us Early, Write a Letter of Intent.”

What clinical research would be considered responsive to this FOA?

Check the NIH definition of a clinical trial. The following clinical research guidance outlines what would be responsive:

  • 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.

Clinical trial stages III and IV would be considered nonresponsive.

I see that clinical research is acceptable, but what about clinical trials?

Clinical trials stage I and II are allowed through this FOA. 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. Review the NIH definition of a clinical trial.

Is select agent use acceptable for this FOA? What is considered a select agent?

No. Applications that include the use of select agents will be nonresponsive to this FOA 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 see if an agent is exempt or excluded, see Select Agents and Toxins Exclusions. Find other resources at NIH's Select Agent Information.

How can investigators in South Africa identify potential collaborators at HDIs and/or the NIH?

Find potential collaborators 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.

We encourage investigators to reach out to the South African Medical Research Council for assistance in identifying potential collaborators at HDIs and Universities of Technology. They may also contact the Scientific/Research Contact(s) listed in Section VII of the FOA to identify collaborators at the NIH. Access information on all NIH-funded research at NIH RePORT.

How might we achieve a successful research collaboration?

Successful collaborations have shared scientific interests and provide mutual benefit. Define the benefit to each party and establish a clear communication strategy 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 to contribute to the research project. Refer to NIAID’s Build Your Team for more information.

Contacts

Whom should I contact if I have additional questions about a FOA?

Contact the Scientific/Research Contact(s) listed in Section VII of your chosen FOA.

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