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Questions and Answers for RFA-AI-14-018, U.S.-South Africa Program for Collaborative Biomedical Research (U01)

NIH published this funding opportunity announcement (FOA) in a January 24, 2014, Guide notice.

The questions and answers below are for the U01 opportunity. For those applying for the R01 or R21 companion FOA, see the following:

Questions Added on March 25, 2014

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:

As the intramural investigator, how should I list my current support in the Senior/Key Person Profile section? Can my junior colleagues ignore this or do they need to list their government salaries?

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

I'm an 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 on just-in-time, read the Just-in-Time SOP and Just-in-Time questions and answers.

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

Go to the Biographical Sketch Format Page.

There is no form for facilities. Simply label your pdf file as Facilities and Other Resources. As the U.S. PI, designate your site for the work as the U.S. part. 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.

Questions Added on March 13, 2014

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; 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. 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.

Where can I find slides from the grantsmanship workshops that took place in South Africa from February 3 to 7, 2014?

Go to MRC-NIH Grant Writing Workshop Presentations.

Do academic institutions have to be registered with NIH to receive an award?

Yes. See Grants.gov Registration Instructions for Domestic and Foreign Institutions.

When is the application deadline?

The deadline is 5 p.m. local time on April 22, 2014, but you may submit your application to Grants.gov starting March 22. 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 Passing Validations in the Strategy for NIH Funding.

What constitutes key personnel?

Key personnel are contributors who provide intellectual input to the research program. See our glossary term key personnel.

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.

For more information, see Facilities and Administrative Costs in the Grants Policy and Management Training for Foreign Investigators.

What is an allowable cost?

See What Are Allowable Costs? in the Grants Policy and Management Training for Foreign Investigators.

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.

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

No.

How much research should be completed in South Africa?

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

Can there be two PIs from one country?

Yes. However, there must be a minimum of one from the United States and one from South Africa.

Who serves 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 any conflicts of interest.

What review criteria are used to evaluate applications?

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

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

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

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.

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

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.

Question Revised on March 11, 2014

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.

These include units performing research with the provincial and national government departments, as well as other research-performing public and private institutions and entities supporting those departments in fulfilling their mandates.

The organization or institution is not required to be listed as a “declared research institution” in Schedule 1 of Government Gazette No. 37123. That list was established for funding directly from the South African National Research Foundation, not for funding in general, so it is not relevant to this opportunity.

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).

Question Revised on March 11, 2014

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.

These include units performing research with the provincial and national government departments, as well as other research-performing public and private institutions and entities supporting those departments in fulfilling their mandates.

The organization or institution is not required to be listed as a “declared research institution” in Schedule 1 of Government Gazette No. 37123. That list was established for funding directly from the South African National Research Foundation, not for funding in general, so it is not relevant to this opportunity.

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).

Questions Added on March 10, 2014

I understand that for a multiple PI application, there must be a contact PI. Can he or she be from either the U.S. or South African institution?

No. 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 What are some key points to know about multiple PI applications (which this FOA requires)?, below.

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, and the South African contact PI is the one who should submit it.

What clinical research would be considered responsive to this RFA?

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.

As for what would be considered nonresponsive: clinical trials involving experimental interventions (drugs, devices, biologics, behavioral) and unapproved uses of approved agents.

Question Revised on March 10, 2014

What are some key points to know about multiple PI applications (which this FOA requires)?

For a multiple PI application, you should know that:

  • 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.
    • Note: 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 Multiple PI Facts in the Strategy for NIH Funding, but note that the Facts refer to investigator-initiated applications so some of the information does not apply in this case.

Question Added on February 20, 2014

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

Questions Added on February 12, 2014

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 How to Qualify for New and Early-Stage Investigator Status in our New Investigator Guide to NIH Funding.

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 the NIH ESI Policy page.

Questions From February 11, 2014, or Earlier

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

Yes. See the International Awards section of our Questions and Answers as well as other resources on our International Awards portal.

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. (See the next questions.) 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, see the related R01 and R21 Guide notices.

What type of NIH intramural PD/PIs are eligible to apply in collaboration with eligible South African investigators?

NIH intramural PD/PIs who present at site visits are allowed to apply for funding under the program if they provide a letter of support from their scientific director. Other permanent scientific staff (e.g., staff scientists and clinicians) are also eligible to apply if they provide a letter of support from their scientific director and (if applicable) from their branch chief.

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

No. As long as 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. Keep in mind that it's important to document this in the application.

Do investigators from each country submit an application?

No. Investigators from both countries will work together to prepare one application, which the South African institution must submit and which should follow the multiple PI approach. See next question.

What is the amount of funds available for awards, and how many awards will be made?

NIH plans to commit approximately $0.6 million to fund up to four awards in FY 2015.

Is there a budget limit?

Yes. Budgets are limited to a total cost of $225,000 each year with a limit of $175,000 each year for the South African institution.

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

What types of research projects would be appropriate?

To see what research areas related to HIV/AIDS and TB are of interest, read the examples in the Research Objectives section of the FOA. Keep in mind that these are broad topics under which your proposed project may fall.

If you'd like to know whether your research is appropriate (i.e., responsive) for this FOA, 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 in our December 19, 2013, Funding Newsletter article "Why Writing Letters of Intent Helps Us Help You."

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

Clinical trials (stage I, II, III, or IV) are not allowed through this FOA. Applications proposing trials will be deemed nonresponsive and will not be reviewed.

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

No. As with applications that propose clinical trials, those 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, and to see if an agent is exempt or excluded, see Select Agent and Toxin Exclusions. Find other resources at NIH's Select Agent Information.

Whom should I contact if I have additional questions about this announcement?

Contact the Scientific/Research Contact(s) listed in the FOA.

Last Updated April 09, 2014

Last Reviewed April 09, 2014