Does the focus of the ancillary study have to be within the mission of the NIAMS? What about the focus of the parent study?
The focus of the proposed ancillary study must be within the scope of the NIAMS mission. However, the objectives of the parent study do not need to be related to the NIAMS mission.
Does the parent study have to be funded by the NIH?
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 RFA.
Can the parent study be a non-U.S. clinical study?
Yes. The parent study can be sponsored by a foreign organization. However, foreign institutions or non-domestic components of U.S. organizations are not eligible to apply for this RFA.
Can the ancillary study funds be used to extend the parent study?
No. Ancillary study funds may not be used to augment or extend the parent study. The parent study cannot rely on support from ancillary study funds. However, the ancillary study project period 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.
Am I allowed to recruit the appropriate controls using ancillary study funds?
In general, this RFA 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.
Can ancillary study collect samples/data in addition to those being collected by the parent study?
Yes, the ancillary study can collect samples/data from the already enrolled parent study patient cohort if they have been authorized and do not unduly burden participants. All ancillary study applications must include a letter or statement indicating that the required patient cohorts, samples, data, and biological materials from the parent project are accessible to the ancillary study. As described above, collection of normal controls from a small number of newly recruited normal controls is acceptable, provided that there is a strong scientific justification and the cost is minimal.
What clinical studies are appropriate for me to use as parent projects?
The objective of this FOA is to provide a flexible mechanism to leverage established resources and maximize the return on existing investments in parent projects. The “parent” clinical project should be ongoing, and can be an interventional clinical trial, or/and a clinical study such as an observational study that will be actively collecting patient samples or clinical data. There are no required 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.
If I am the PI for the parent study, am I eligible to be the PI on the ancillary study application?
Yes. If you are the PI for the parent study, you are still eligible to be the PI on the ancillary study application.
How do I know which mechanism (R01 or R21) is more appropriate for my research?
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.
What is the definition of "time-sensitive"?
The intent of this RFA is to fund applications that require an accelerated peer review and award process in order to take advantage of and leverage 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 RFA.
All applications MUST include a paragraph titled "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.
When is the Letter of Intent (LOI) due? Are LOIs required? What information should be provided in the LOI?
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 and the mechanistic insight to be gained by the 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.
How long can the research section be?
The page limit for the Research Strategy section of the application is twelve pages for an R01 application and six pages for an R21 application. These page limits do not include the one-page Specific Aims section or the Protection of Human Subjects section. Additional information on the SF424 application is available at https://grants.nih.gov/grants/funding/424/index.htm.
What supporting documentation must be included in the application?
Each application must include the following supporting documentation specific to the RFA:
- A clear description of the ancillary study’s mechanistic rationale and premise, as well as the new mechanistic insight to be gained from the proposed study (Significance section)
- A paragraph titled "Time-Sensitivity" with compelling justification 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).
- A three-page or less synopsis of parent clinical projects, providing a summary of the parent project with sufficient information for the reviewers to assess the choice of the parent project to provide appropriate, sufficient, and well-characterized patients, biological samples and/or clinical data necessary for the ancillary study (Appendix).
Can supplemental material be submitted after the application receipt date?
No. Due to time constraints associated with the expedited review and award process, no supplemental materials will be accepted after the application receipt date.