Questions and Answers for NIH’s HIV/AIDS Clinical Trials Units FOA, RFA-AI-19-045

Updated October 7, 2019. We added one new question at the end of the Grants Management and Budget section.

NIAID published the funding opportunity announcement (FOA) for HIV/AIDS Clinical Trials Units, RFA AI-19-045, on May 1, 2019.

Review the Suggested Table Formats for NIH’s HIV/AIDS Clinical Trials Units FOA, RFA-AI-19-045.

We posted a separate page of questions for the other six FOAs at Questions and Answers for NIH’s HIV/AIDS Clinical Trials Network LOC, LC, and SDMC FOAs.

Find more information about NIH’s HIV/AIDS Clinical Trials Networks on the main Refining the HIV Clinical Trials Enterprise page.

Table of Contents

General

Will NIAID post additional questions and answers or revise the current ones?

Each time we add new questions or revise, we will replace the dated note at the top of this page.

Do these questions and answers modify or add instructions?

No, these questions and answers do not modify or add any instructions. These answers are intended to help you understand and follow the instructions in the RFAs.

(Question and answer above added on June 26, 2019.)

Is this FOA limited to previous CTU grantees?

No. This is not a limited competition. New and renewal applications are welcome.

(Question and answer above added on June 26, 2019.)

What is a UM1 and how is a UM1 application structured?

NIH uses the UM1 activity code to support cooperative agreements involving large-scale research activities with complicated structures that cannot be appropriately categorized into an available single component activity code. A UM1 application is structured as a single application with multiple elements representing a variety of supporting functions.

(Question and answer above added on June 26, 2019.)

How many Clinical Trials Units (CTUs) does NIAID intend to award?

RFA AI-19-045 indicates that NIAID plans to award between 30 and 35 CTUs through this FOA. However, we will fund the number of CTUs necessary to ensure that each NIAID HIV/AIDS Clinical Trials Network has the clinical research sites needed to accomplish its scientific agenda.

NIAID will consider the scientific and technical merit of the proposed applications as determined by scientific peer review, availability of funds, programmatic priorities, and geographic distribution of the proposed Clinical Research Sites (CRSs) to determine awardees. As for all grant applications, NIAID reserves the right to partially fund an application, as described by the FOA.

Will CTU applicants know which Clinical Trials Network applicants are successful prior to submitting their CTU applications?

No, NIH Clinical Trials Network grant awardees will not be known by CTU applicants prior to the CTU application deadline. CTU applicants should propose CRSs and affiliations with the clinical research priority areas as posted in the Network Leadership Group FOAs:

RFA AI-19-003: HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center
RFA AI-19-004: HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network Leadership and Operations Center
RFA AI-19-005: HIV Prevention Clinical Trials Network Leadership and Operations Center
RFA AI-19-006: HIV Vaccines Clinical Trials Network Leadership and Operations Center

Can an institution submit more than one CTU application?

A sponsoring institution may submit more than one CTU application, provided that each application is scientifically distinct. CTU applications should provide adequate scientific justification for proposing more than one CTU from a single institution in each of the applications proposed. NIAID reserves the right to combine components submitted in multiple applications from a single institution into a single award. NIAID may elect not to fund one or more components within an application if that need has already been met (and thus is duplicative) within another application from that same institution/organization.

Should each CRS have its own community advisory board (CAB)?

The number and composition of CABs within a given CTU is a decision best made by the CTU applicant. This decision should take into account the role of the CAB in representing the local community participating in the clinical research, and the geographic and cultural diversity of the CRSs.

Can a person be named as the CTU PD/PI and at the same time be a CRS leader of a CRS at the CTU?

The determination of whether or not to designate the CTU PD/PI as a CRS Leader for any given CTU will depend on the size and scope of the CTU. An individual is not prohibited from serving simultaneously in both roles within the same application; however, the experience, qualifications and extent to which the PD/PI and /or CRS Leader is committed to the proposed role(s) and other activities should guide that decision. The proposed level of effort should be commensurate with the size and scope of the CTU.

Should I solicit and include a letter of commitment or support from a current NIH HIV/AIDS Clinical Trials Network(s) in my CTU application?

No. Do not include a letter of commitment or support from a current NIH HIV/AIDS Clinical Trials Network or seek them from a proposed applicant to the NIH HIV/AIDS Clinical Trials Network FOAs.

Is it acceptable to name my current Program Officer in my CTU application?

Do not name NIH extramural staff, including NIAID extramural staff, in the application.  Naming NIH staff may constitute a conflict of interest according to NIH and NIAID policy. 

Is there something extra I need to do for NIH intramural collaborations in my CTU application?

NIH intramural staff with roles in the research should be designated in the same manner as any other investigator in a grant application.  Applications that include NIH Intramural scientists need to provide the signed letter of collaboration from NIH in their application.  Refer to NIAID’s Intramural Scientist Collaboration on Extramural Funded Grants and Contracts SOP for details.  Allow sufficient time to obtain the required documentation.

For existing Clinical Trials Units grantees, is this considered by NIAID to be a renewal application or is this a new application?

A CTU application would be a renewal application if the research represents a continuation of the same long-term goals as those of the prior CTU.   The applicant organization could be the same as the prior CTU, or different (a new organization for the PI/PD, or a subcontracted organization and a new PI/PD or a new contact PI/PD), as long as the application can show continuity from the prior competing segment to the new.

As such, an application can be considered a renewal even if the composition of the CTU and proposed Network affiliations differ from the current configuration and/or if the title changes.  Finally, if two current CTUs combine, only one award can be considered the renewal application.  The other award must Close Out at the end of its project period.

Is the progress report I submit with my competing renewal application in response to the RFA sufficient to meet the progress report requirement for the last year of my current award, due October 1, 2019? If not, what portion of the progress report should be included in the response to the RFA?

For current awards, the annual Research Performance Progress Report (RPPR) should include the information described in the RPPR instructions. The RPPR should be submitted by the due date, October 1, 2019.

Section IV (Application and Submission Information) instructions under “PHS 398 Research Plan” for RFA-AI-19-045 state the following: “For renewal applications: Progress Report should be included.” The progress report to be included in the competing renewal application is due November 18, 2019 with the application submission.

The NIH How to Apply - Application Guide offers the following instructions under Research Strategy:

Progress Report for Renewal and Revision Applications:

Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:

  • Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
  • Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
  • Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research. Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.

Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

(Question and answer above added on May 28, 2019.)

I won’t be able to submit my application on time. May I have permission to submit a late application?

No matter how reasonable the excuse is, we do not have authority to grant advance permission for late submissions. Refer to Late Applications for additional details.

(Question and answer above added on July 8, 2019.)

We are getting an error, warning, or technical issue when we try to submit our application. What should we do?

Your application must pass validations at the Grants.gov and eRA Commons with no errors. If an error message describes an issue in the application, Submit a Changed/Corrected Application before the deadline. Warnings won’t stop your application, but you may wish to address them in the same way. Learn more about errors and warnings at NIH’s Submit, Track, and View Your Application.

If you encounter an error you are unable to resolve or technical System Issues, contact the help desk for the system in question:

(Question and answer above added on July 8, 2019.)

A system issue is preventing me from submitting my application. Help!

Please contact the eRA Commons Service Desk for assistance.

(Question and answer above added on July 8, 2019.)

Where do I find information about other grant application submission issues?

Please refer to Submission Policies.

(Question and answer above added on July 8, 2019.)

For “Attachment 2. CRS Site Characteristics” under the “Other Attachments” section of “SF 424 (R&R) Other Project Information,” are we required to check the table fields only if the relevant categories or population characteristics apply, or do you require actual numbers and percentages?

Applicants should identify the participant cohort(s) that the CRS has demonstrated experience recruiting into clinical trials by entering either a check mark or “X” for each of the categories listed in the FOA for each site. Actual numbers and percentages are not required.

If they wish, applicants may use the Suggested Table Formats for NIH’s HIV/AIDS Clinical Trials Units FOA from the Refining the HIV Clinical Trials Enterprise website.

(Question and answer above added on July 8, 2019.)

It is understood that a CTU application may propose multiple PDs/PIs as long as it’s accompanied by a Multiple PD/PI Leadership Plan. Are there any such restrictions for other roles, e.g., can there be more than one CTU Coordinator or co-CRS Coordinators?

As defined in Section IV. Application and Submission Information, SF424(R&R) Senior/Key Person Profile, each CTU must designate individuals in the following roles as 'Senior/Key Personnel': CTU PD(s)/PI(s), CTU Coordinator, CRS Leader(s), CRS Coordinator(s), and Pharmacist(s) of Record. NIAID recognizes one single CTU Coordinator per CTU, one single CRS Leader per CRS, and one single CRS Coordinator per CRS.  Applicants may designate multiple PD/PIs (along with the required leadership plan as described in the SF424 application guide) and may designate multiple Pharmacists of Record.

(Question and answer above added on July 30, 2019.)

Is it possible for NIAID to make the scientific research agendas of the Network Leadership and Operations Center (LOC) applications available to CTU applicants?

NIH policy prohibits NIH institutes from sharing application information. Therefore, NIAID will not provide public access to the content of the LOC applications. We encourage CTU applicants to review the clinical Network Research Priority Areas for each planned HIV/AIDS Clinical Trials Network.

(Question and answer above added on August 16, 2019.)

In reference to NOT-AI-19-066, are we required to respond to Attachment 3 “Ending the HIV Epidemic: A Plan for America”, under SF 424 (R&R) Other Project Information?

While attachments 1 (“Proposed Clinical Trials Network Affiliation per CRS”) and 2 (“CRS Site Characteristics”) are required, attachment 3 is optional and separate from the NIH HIV/AIDS Clinical Trials Network Research Priority Areas. This attachment is intended to allow interested and eligible applicants with the appropriate linkages to domestic institutions/sites the opportunity to provide NIAID with statements of capability relevant to the Ending the HIV Epidemic: A Plan for America (EHE) initiative, as described in the FOA. Attachment 3 is limited to 12 pages and should be organized as outlined in the FOA. Information provided in this optional attachment will not affect overall impact/priority score for the application.

(Question and answer above added on August 16, 2019.)

In reference to NOT-AI-19-066 Attachment 3 “Ending the HIV Epidemic: A Plan for America,” are we required to submit budgets, collaborator biosketches, or any other information in addition to what is already requested in the instructions for the Attachment?

No. Do not submit budgets, collaborator biosketches, or any other information beyond what is requested in the Attachment 3 instructions.

(Question and answer above added on August 30, 2019.)

Under PHS 398 Research Plan, subsection K “Quality Management,” there are instructions under “Pharmacy Quality Management” and “Laboratory Quality Management” that indicate applicants should address requirements and processes only “if applicable.” Under what circumstance does the “if applicable” apply?

For “Pharmacy Quality Management,” the “if applicable” refers only to pharmacies that conduct participant counseling activities. Not all site pharmacists interact with and counsel participants.

For “Laboratory Quality Management,” the “if applicable” applies only to non-U.S. sites which must ship materials into the country and ship specimens out of the country.

(Question and answer above added on August 30, 2019.)

Are letters of support required for my CTU application?

Applicants may include letters of support demonstrating commitment of collaborators, institutions, and other relevant affiliates in support of their CTU application. However, applicants must not include letters of support from any existing or applicant NIH HIV/AIDS Clinical Trials Network.

(Question and answer above added on September 27, 2019.)

Grants Management and Budget

Can U.S. or international CRSs receive funding for alterations and renovations (A&R) under this FOA?

The CRSs proposed in applications are expected to have  appropriate infrastructure in place to initiate participant enrollment upon award. In rare cases, minimal costs may be requested for "minor" alterations, renovations or repairs with adequate justification.  Refer to the NIH Grants Policy Statement for more details.

How are CTU protocol-funds and core funding amounts determined?

Core funding amounts are determined by NIAID based on the size and scope of the CTU.

Protocol funding amounts are recommended by the corresponding Leadership and Operations Centers (LOCs) based on specific study requirements.

Are CTUs allowed to re-budget core or protocol funds (PF) between CTU components or networks?

A grantee is expected to re-budget existing funds to meet legitimate needs across their grant. However, in rare circumstances, specific funds (including PF)  may be restricted in a Notice of Award (NOA) to be used only for the purpose stated in the restriction.

Will applications requesting funding amounts above the suggested amounts ($1 to 2 million [PR([3] direct costs for a CTU with three or four sites and two or three networks) be considered non-responsive?

The funding amounts in the example are representative of what NIAID expects to provide to CTUs of that size and scope. CTUs will not be considered non-responsive for exceeding the suggested amounts. Extensive departure from this guidance may suggest that the CTU is not well aligned with the scope and complexity of the Network(s) and could have a negative impact on the application as a whole, which can result in recommendations of budget changes.

The instructions in the RFA state that we should only include a budget for Core funding and not for protocol funds (PF). Should we interpret this to mean that we should not include CTU/CRS salary PF in our renewal application budget?

You should not request CTU/CRS salary PF in an application for RFA AI-19-045. As stated in Section IV.2 (R&R Budget) of the FOA:

The applicant should request only Core funding.... Protocol Funds (PF) should not be requested; PF will be determined and provided as protocols are initiated through a collaborative process between the NIAID and awardees.

Study and Trial Issues

Must an application propose a fully developed clinical trial to be responsive to these FOAs?

No. Definite plans for fully developed clinical trials will not be possible at the time of application. You must not propose a fully developed clinical trial or complete a Study Record. Instead, you must add and complete at least one delayed onset study record in FORMS-E, as instructed in the FOAs.

(Question and answer above added on June 26, 2019.)

Do I need to include a Study Record for each ongoing clinical study?

No. For renewal applications with ongoing clinical studies, follow the FOA-specific instructions listed under Other Requested Information.

(Question and answer above added on June 26, 2019.)

The applicant instructions under “PHS Human Subjects and Clinical Trials Information” say:

Other Requested Information

For Renewal applications with ongoing clinical studies, applicants must include a list of all ongoing clinical studies and/or the unique ClinicalTrials.gov identifiers. All information must be combined in one single attachment using the file name "ongoing Clinical Studies". If appropriate, please indicate for each study the NIAID Division of AIDS (DAIDS)-defined study status (https://rsc.niaid.nih.gov/networks-protocol-teams/developing-protocols).

Would you clarify which DAIDS-defined study statuses are considered “ongoing” and the timeframe for which this information is requested?

In the “Ongoing Clinical Studies” attachment, renewal (type 2) applicants should include any ongoing clinical studies for which they anticipate continuing support will be necessary in the next funding cycle, starting in December 2020.

Studies that may be considered “ongoing” are those that are projected to be in DAIDS-defined study status “In Development” through “Participants Off Study & Primary Analysis Completed”, as outlined here: https://rsc.niaid.nih.gov/networks-protocol-teams/developing-protocols

Include clinical trials, sub-studies, and any clinical research studies that aren’t clinical trials. NIAID will work with the grantees at the time of award to make changes to this list as necessary.

(Question and answer above added on July 16, 2019.)

Do I need to provide a single IRB plan in the application?

No. Follow the instructions for delayed onset studies for how you will comply with NIH's Single Institutional Review Board (sIRB) Policy.

(Question and answer above added on June 26, 2019.)

Scientific Review

Is there a mechanism to request that a particular reviewer who may be in conflict be excluded from the review of a specific CTU application?

The NIH peer review process has well-established conflict of interest management processes to avoid real or potential conflicts of interest during the peer review of applications. A sponsoring institution has the option to submit the PHS Assignment Request Form with their submission identifying specific individual(s) who might be in conflict with their application. For any questions about the peer review process, applicants can contact the Peer Review Contact(s) listed in the FOA.

NIAID offers advice on how to Use the PHS Assignment Request Form.

Will reviewers have access to CTU and CRS performance data from prior NIAID grantees?

Reviewers will base their review on the information contained in the application. NIAID may, however, consider past performance data from previous grant cycles in making funding decisions.

Will the number of Clinical Trials Network affiliations proposed influence the overall score of the CTU application?

Applicants are required to include at least two HIV/AIDS Clinical Trials Networks. Proposing the maximum number (four) of Network affiliations may not be the optimal configuration for every a CTU. Successful applicants will adequately justify the number and specific selection of Network affiliations reflected in their CTU.

Will the number of CRSs proposed influence the overall score of the application?

Applicants are required to include at least one, but no more than eight, CRSs. Applicants should adequately justify the number of CRSs reflected in their CTU.

Contact Information

Whom do I contact for more information about this FOA?  

Find NIH scientific/research, peer review, and financial/grants management contacts listed in the FOA.  You may submit any general questions about this FOA to NIAIDNetworkRefinement@mail.nih.gov.

Please include your name, email address, and institution.

Learn more about NIH’s HIV/AIDS Clinical Trials Networks on the main webpage, Refining the HIV Clinical Trials Enterprise.

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