NIH Clinical Trials
If you are conducting studies involving human subjects funded by NIH, it is very important that you understand the NIH definition of a Clinical Trial to determine if additional requirements apply to your research.
In recent years, NIH has broadened its definition of clinical trial, and it may impact NIH sponsored research and awards (new submissions, resubmission, or revised submissions). NIH’s definition of clinical trial now includes some research approaches not traditionally considered clinical trials. For example, many behavioral or biobehavioral studies that focus on underlying mechanisms of development may now be considered clinical trials. Also, conducting experiments that involve human subjects may be considered a clinical trial. More discussion of the reasons for the policy changes is at: https://grants.nih.gov/policy/clinical-trials/why-changes.htm.
NIH Definition of 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. health-related biomedical or behavioral outcomes.”
How do I know if my study is a clinical trial?
NIH has four questions that researchers need to answer to determine whether their study is a clinical trial:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…
- You are studying healthy participants
- Your study does not have a comparison group (e.g., placebo or control)
- Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
- Your study is utilizing a behavioral intervention
Studies intended solely to refine measures are not considered clinical trials.
Studies that involve secondary research with biological specimens or health information are not clinical trials.
See the NIH website section at https://grants.nih.gov/policy/clinical-trials/definition.htm for additional resources, including case studies and FAQs, to assist in determining if your study meets NIH’s definition of a Clinical Trial.
Why is this important? What are the implications if my study is considered a clinical trial?
Beginning with applications (new, resubmissions, or revisions) submitted on or after January 25, 2018, if your application involves a clinical trial, some additional requirements include:
- Submit the application through a Funding Opportunity Announcement (FOA) that accepts clinical trials.
- Provide additional information in the application, which will be subject to different and distinct review criteria for clinical trials.
- Fulfilling requirements for registering and reporting results on ClinicalTrials.gov
- Ensure Good Clinical Practice (GCP) training is completed for applicable study personnel
- For applicable domestic, multi-site clinical trials, provide plans for use of a single Institutional Review Board (sIRB) to conduct the ethical review for human subjects in research
Additional details regarding NIH’s Clinical Trial Requirements for Grants and Contracts, including NIH’s policy and policy updates, are available at https://grants.nih.gov/policy/clinical-trials.htm.
Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov
All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after 1/18/2017.
As part of their applications or proposals, applicants and offerors seeking NIH funding will be required to submit a plan for the dissemination of NIH-funded clinical trial information that will address how the expectations of this policy will be met. NIH-funded awardees and investigators conducting clinical trials funded in whole or in part by the NIH will be required to comply with all terms and conditions of award, including following their plan for the dissemination of NIH-funded clinical trial information.
In addition, informed consent documents for clinical trials are to include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.
See NIH’s “Steps to Compliance for NIH Awardees” at https://grants.nih.gov/policy/clinical-trials/reporting/steps.htm for more information.
Good Clinical Practice Training
All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical must be trained in Good Clinical Practice (GCP).
Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. NIH also offers GCP training.
UO offers on-line Good Clinical Practices (GCP) training through the Collaborative Institutional Training Initiative (CITI). CITI’s GCP courses are acceptable GCP training for the NIH policy. Learners will receive a completion report documenting the successful completion of CITI Program training. To access the training click HERE (insert link /content/Good-Clinical-Practice).
Single IRB Policy for Multi-site Research
For NIH applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.
This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards.
Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).
Please contact Research Compliance Services when developing a plan for the use of a sIRB in proposals.
Clinical Trials Protocol Template
Applicants conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with instructional and sample text to help write protocols. Note that the use of the tool is voluntary and is not required for NIH applications or contract proposals. More information can be found on the NIH website at https://osp.od.nih.gov/clinical-research/clinical-trials/
FDA Clinical Trials
Applicants and recipients should familiarize themselves with the requirements of 42 U.S.C. 282(j), also known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA), as implemented in regulation by 42 CFR Part 11, with respect to registration and results reporting requirements that apply to certain clinical trials. Of particular note is that, in general, results of applicable clinical trials are due not later than 12 months after the primary completion date. If this date occurs after the period of performance has ended, results reporting is still required in accordance with FDAAA and the terms and conditions of grant awar