Frequently Asked Questions for RFA-AR-13-010 (R01) and RFA-AR-13-011 (R21):
Ancillary Studies to Large Ongoing Clinical Projects

PDF Version of This Document

Updated June 28, 2012

Q: Does the focus of the ancillary study have to be within the mission of the NIAMS? What about the focus of the parent study?

Q: Does the parent study have to be funded by the NIH?

Q: Can the parent study be a non-U.S. trial?

Q: Can the ancillary study be used to extend the parent study?

Q: Am I allowed to recruit the appropriate controls using ancillary study funds?

Q: The RFA states that, "All ancillary study applications must include a letter or statement from one of the parent study leadership committees documenting that the required patients, samples, data, and materials from the parent project are accessible to the ancillary study." Does this mean that the ancillary study cannot collect samples/data in addition to those being collected by the parent study?

Q: How large does the parent study have to be?

Q: If I am the PI for the parent study am I eligible to be the PI on the ancillary studies application?

Q: How do I know which mechanism (R01 or R21) is more appropriate for my research?

Q: What is the definition of "time-sensitive?"

Q: When is the Letter of Intent (LOI) due? Are LOIs required? What information should be provided in the LOI?

Q: How long can the research section be?

Q: What supporting documentation must be included in the application?

Q: Can supplemental material be submitted after the application receipt date?


Q: Does the focus of the ancillary study have to be within the mission of the NIAMS? What about the focus of the parent study?
A: The focus of the proposed ancillary study must be within the scope of the NIAMS mission. In contrast, the objectives of the parent study do not need to be related to the NIAMS mission.

Q: Does the parent study have to be funded by the NIH?
A: No. The parent study can be funded by non-NIH funding sources such as industry, private sponsors, or other governmental agencies. It must be independently funded and will not receive support from this FOA.

Q: Can the parent study be a non-U.S. trial?
A: Yes. The parent trial can be sponsored by a foreign organization. Foreign institutions are eligible to apply for this FOA, if the ancillary study presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Q: Can the ancillary study be used to extend the parent study?
A: No.  Ancillary study funds may not be used to augment or extend the parent study.  The ancillary studies may extend beyond the end of the parent project, provided that all of the parent study information needed to complete the ancillary studies has already been obtained, or will remain available to the ancillary studies after completion of the parent project.  However, the parent work cannot rely on support from ancillary study funds.

Q: Am I allowed to recruit the appropriate controls using ancillary study funds?
A: In general, this FOA will not support the recruitment of patients who are not already enrolled in the parent study. However, recruitment of a small number of normal controls is acceptable provided that there is a strong scientific justification and the cost is minimal.

Q: The RFA states that "All ancillary study applications must include a letter or statement from one of the parent study leadership committees documenting that the required patients, samples, data, and materials from the parent project are accessible to the ancillary study." Does this mean that the ancillary study cannot collect samples/data in addition to those being collected by the parent study?
A: No. The purpose of this letter is to assure that the ancillary study will have access to the parent study's patient cohort to obtain any additional samples or data required to complete the proposed ancillary studies.

Q: How large does the parent study have to be?
A: There are no minimum or maximum sample sizes specified in this RFA. However, the sample sizes must be large enough to allow for appropriate statistical power of the proposed ancillary studies.

Q: If I am the PI for the parent study am I eligible to be the PI on the ancillary studies application?
A: Yes. If you are the PI for the parent study you are still eligible to be the PI on the ancillary studies application.

Q: How do I know which mechanism (R01 or R21) is more appropriate for my research?
A: The NIH Exploratory/Developmental Research Grant (R21) award mechanism is intended to support highly innovative exploratory research projects with potential for significant impact. These projects are funded for a two-year period and do not require preliminary data. Projects that do not meet these characteristics of the R21 mechanism are more suitable for the Research Project Grant (R01) mechanism. The R01 mechanism provides funding for up to four years and typically appreciates support of preliminary data to demonstrate feasibility.

Q: What is the definition of "time-sensitive"?
A: The intent of this RFA is to fund applications that require an accelerated peer review and award process in order to take advantage of the parent study. If the proposed research does not need to be concurrent with the parent project, or if the investigators could complete the same work using the standard application process, it will be determined as non-responsive to this FOA.

All applications must include a paragraph entitled “Time-Sensitivity” under the Approach section that justifies the time-sensitive nature of the ancillary study and clearly explains why an expedited review and award process is essential to its feasibility. Additionally, applications must include a timeline demonstrating that the parent study has adequate time left to carry out the proposed ancillary study.

Examples of characteristics that do support the case for time-sensitivity:

  • The need for support to collect samples or data prior to the end of recruitment of the parent grant
  • The need to perform analysis on soon-to-be-collected fresh specimens
  • The need for collecting post-intervention data in a trial that will soon be ending.

Examples of characteristics that do not support the case for time-sensitivity:

  • Secondary analyses of existing datasets
  • Sample collection that is already part of the parent study, unless the existing data set has to be analyzed at the same time with soon-to-be-collected samples
  • Completion of data collection by the parent study before the ancillary study would begin, unless the existing data set has to be analyzed at the same time with soon-to-be-collected samples .

Q: When is the Letter of Intent (LOI) due? Are LOIs required? What information should be provided in the LOI?
A: The LOI is due 30 days before the application receipt date. Although it is not required, the information provided in the LOI is very helpful for NIAMS staff in setting up the most adequate review for your application.

The following pieces of information are recommended to be included in the LOI:

  • Title of the proposed ancillary study
  • Title of the parent study
  • Brief description of the ancillary study
  • Relationship between ancillary and parent studies and rationale for time-sensitivity and need for expedited review
  • Name, address, and telephone number of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institutions
  • Number and title of this funding opportunity.

Q: How long can the research section be?
A: The page limit for the Research Strategy section of the application is 12 pages for an R01 application and 6 pages for an R21 application. These page limits do not include the 1-page Specific Aims section or the Protection of Human Subjects section. Additional information on the SF424 application is available at http://grants.nih.gov/grants/funding/424/index.htm.

Q: What supporting documentation must be included in the application?
A: Each application must include the following supporting documentation:

  • A compelling rationale for the time-sensitivity of the proposed ancillary study, clearly explaining why an expedited review and award process is needed (Approach section)
  • An integrated timeline for the parent and ancillary studies demonstrating that the parent project has adequate time left to carry out the proposed ancillary studies (Approach section)
  • Letter(s) of support from the PI and/or governing body of the parent study, documenting approval of the proposed ancillary study (Item 14 of the PHS398 components).

Q: Can supplemental material be submitted after the application receipt date?
A: No. Due to time constraints associated with the expedited review and award process, no supplemental materials will be accepted after the application receipt date.

Applicants with additional questions are highly encouraged to contact their Program Director (http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp).