If you plan to conduct Research Using Human Subjects, you must also check if it fits NIH’s definition of a clinical trial. All NIAID-funded clinical trials must follow the rules we describe and link below. For investigator-initiated clinical trials, follow NIAID’s required process as described at Investigator-Initiated Clinical Trial Resources.
Table of Contents
- Clinical Trial: NIH’s Definition
- How NIAID Funds Clinical Trials
- What’s Special About Clinical Trial Applications?
- Budgeting for Your Planned Clinical Trial
- Learn More About NIAID and NIH Requirements
Clinical Trial: NIH’s Definition
NIH has a specific definition of what’s considered a clinical trial:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
This may sound straightforward, but what if your research involves nontherapeutic interventions for data or sample collection? Mechanistic studies that support larger, non-clinical research projects? Small-scale, routine interventions that entail no risk to human subjects?
In some cases, NIH will consider your research a clinical trial, even if you and your institution don’t think it is.
NIH’s Definition of a Clinical Trial webpage provides additional context.
Use NIH’s decision-making tool, Does your human subjects research study meet the NIH definition of a clinical trial? to determine whether your research qualifies as a clinical trial. You can also ask your program officer for his or her thoughts.
How NIAID Funds Clinical Trials
NIAID funds most of our clinical trials through Networks and collaborations where NIAID determines the research topic and project scope.
However, you can apply for funding for your own clinical trials–called investigator-initiated clinical trials (IICT)–outside of these networks. If you plan an IICT application to NIAID, you must follow our required process or we will not accept your application. Learn more at Investigator-Initiated Clinical Trial Resources.
What’s Special About Clinical Trial Applications?
If your planned research qualifies as a clinical trial, it matters for three reasons:
- You cannot include any research considered a clinical trial – no matter the scope – in any application you submit to any notice of funding opportunity (NOFO) that says “Clinical Trial Not Allowed.” This means if you don’t check whether your research fits, NIH may reject your application, even if you don’t think your proposed research includes a clinical trial.
- Even if you correctly submit a clinical trial to a NOFO that allows clinical trials, you must provide all the necessary documents. If you don’t, NIH will reject your application.
- If you plan an investigator-initiated clinical application to NIAID, you must follow our required process or we will not accept your application. Learn more at Investigator-Initiated Clinical Trial Resources.
Regarding the necessary documents in item 2, follow the instructions in your NOFO and NIH’s guidance on the Human Subjects and Clinical Trials Information Form, the Clinical Trials Protocol Template, and other key documents described further at NIH’s Clinical Trial Requirements for Grants and Contracts.
We will attach the NIAID Clinical Terms of Award to your grant, which specify the actions we require grantees to take when conducting clinical research.
- NIAID Clinical Terms of Award – Guidance for Compliance
- NIAID Clinical Terms of Award Restriction for China
For more application advice and instruction, check NIAID’s Plan and Write Your Human Subjects Application and Four Tips for Investigator-Initiated Clinical Trial Applications.
Budgeting for Your Planned Clinical Trial
You need to consider several clinical trial-related factors to develop an appropriate budget. We describe some of those factors below, but first, a quick word about the importance of making sure your budget fits the scope of your research.
Don’t Ask for Too Little or Too Much: Here’s Why
Though reviewers do not use your budget request to assess scientific merit, they will check if it is reasonable, appropriate, and fully justified. What’s more, they will use it as a gauge of how well you understand the cost of your project and what it takes to accomplish the research you propose.
If you significantly over- or underestimate, reviewers may conclude that you don't grasp the scope of the work. That, in turn, will count against you. Therefore, it’s essential you take the time to prepare your budget request by thoroughly thinking of all expenses.
Factors When Developing a Clinical Trial Budget
Taking all expenses into account may be more difficult for a clinical trial. You’ll need to figure in factors such as costs associated with appropriate oversight and regulatory compliance activities and appropriate support for investigational products.
In your application, include all the necessary activities and budget them appropriately. We notice that applicants often budget for personnel costs but miss the costs of other essential items. Though this list of examples is not all inclusive, consider the following potential costs.
- Site payments based on subjects—costs for screen failures, screening activities, and any non-routine care activities that need to be paid, such as data entry, preparing institutional review board (IRB) documents, scheduling assessments, and follow up for participants
- Site costs—site startup, payment for single IRB (if applicable) and IRBs on site, site personnel (if not paid per subject), adding or removing sites, storage fees for clinical trial records, site overhead and administrative costs, and closeout
- Safety oversight costs—evaluating adverse events, evaluating serious adverse events and reporting them to regulatory agencies, safety oversight committees (including generating reports and ad-hoc meetings), independent consultants, and costs that result from adverse events such as medical follow ups and evaluations
- Data and quality management costs—clinical monitoring (including site initiation visits, ongoing site monitoring visits, and site closeout visits), biostatistician, project management, data management, and quality management
- Regulatory costs—submissions to the regulatory authority (e.g., application for investigational new drug/investigational device exemption, annual reports, and final reports) and clinicaltrials.gov registration and results posting
- Other costs—laboratory operations, medical monitors, investigator training, staff meetings, travel, translations and translators, advertising, shipping and storing investigational products, and any other miscellaneous expenses as appropriate for your project
Lastly, remember to plan for the unexpected, such as potential costs associated with slow enrollment, protocol amendments, and other contingencies.
If you have budget-related questions, reach out to the scientific/research contact(s) or financial/grants management contact(s) listed under Section VII. Agency Contacts of your chosen NOFO.
For general information on budgeting, see NIAID’s Plan Your Budget & Personnel and NIH’s Develop Your Budget.
Learn More About NIAID and NIH Requirements
NIAID applicants and staff should review the following links for more information:
- NIAID Research Using Human Subjects—includes training requirements
- NIAID Clinical Terms of Award
- Guidance for Compliance on using the Terms
- Trans-NIAID Clinical Research Toolkit
- NIAID Clinical Research Policies
- ClinRegs—for country-specific clinical research regulatory information, including comparison information, presented in plain language
- Research Methods Resources