MSU HRPP Manual Section 7-9-E
ClinicalTrials.gov Requirements: National Institutes of Health
The United States National Institutes of Health (NIH) Policy on Dissemination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH, will ensure that their NIH-funded clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting. (NOT-OD-16-149).
See HRPP Manual Section 7 for ClinicalTrials.gov regulatory requirements and MSU processes and requirements for ClinicalTrials.gov.
Definitions
For the purposes of the NIH Policy on Dissemination of NIH-funded Clinical Trial Information, the following definitions apply:
Clinical Trial. A "clinical trial" means "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 definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and studies of any intervention not regulated by the FDA, e.g., behavioral interventions.
- This definition of "clinical trial" is broader than the term "applicable clinical trial" as defined in the ClinicalTrials.gov regulation (42 CFR 11).
Responsible Party. The awardee or the investigator is responsible for meeting the expectations of the NIH Policy on Dissemination of NIH-funded Clinical Trial Information.
- In the ClinicalTrials.gov regulation, a "responsible party" means, in part, "with respect to a clinical trial, the sponsor of the clinical trial, as defined in 21 CFR 50.3 (or any successor regulation); or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under [42 CFR Part 11] for the submission of clinical trial information."
Primary Completion Date. This term has the same meaning as the term "primary completion date" in the ClinicalTrials.gov regulation.
- In the ClinicalTrials.gov regulation, this is "the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated."
Registration Information. This term has the same meaning as the term "registration information" in the ClinicalTrials.gov regulation.
- In the ClinicalTrials.gov regulation, registration information consists of descriptive information, recruitment information, location and contact information, and administrative data.
Results Information. This term has the same meaning as the term "results information" in the ClinicalTrials.gov regulation.
- In the ClinicalTrials.gov regulation, results information includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.
In addition, the following definitions are applicable:
Basic experimental studies involving humans (BESH).Studies that meet both the definition of basic research and the NIH definition of a clinical trial.
- This definition is not limited to manipulations that improve health-related endpoints in a long-term fashion.
- Many experimental manipulations are considered to be interventions even if the manipulation is being used to study the normal function of a physiological system and the effects are short-lived, reversible, and/or benign.
Basic Research. A systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (32 CFR 272.3)
Applicability
The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or whether they are subject to the ClinicalTrials.gov regulation.
This requirement applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy's effective date (January 18, 2017) that request support for the conduct of a clinical trial that is initiated on or after the policy's effective date (January 18, 2017).
However, NIH has delayed the enforcement for ClinicalTrials.gov registration and results reporting through September 24, 2025 for BESH studies. BESH studies are subject to NIH clinical trials policies such as registration and results reporting.
This delayed enforcement is only applicable to BESH studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title. It does not apply to applications submitted under a clinical trials required or clinical trials optional funding opportunity.
During this period of delayed enforcement, NIH continues to expect registration and results reporting for studies submitted to BESH funding opportunities, but with the additional flexibility to register and report results on alternative publicly available platforms.
Responsibility
The responsibilities of NIH awardees and investigators is determined by whether, under ClinicalTrials.Gov regulation (42 CFR 11), the clinical trial is also an "applicable clinical trial" and the awardee or investigator is the "responsible party."
Each NIH-funded clinical trial should have only one entry in ClinicalTrials.gov that contains its registration and results information. Awardees and investigators need not and should not create a separate record of the applicable clinical trial to comply with this policy.
|
Applicable Clinical Trial Under ClinicalTrials.gov Regulation? |
Is the Awardee or investigator the Responsible Party? |
Who is Responsible for ClinicalTrials.Gov Requirements? |
|
Yes |
Yes |
Awardee or investigator will ensure all ClincialTrials.gov regulatory requirements are met |
|
Yes |
No |
Awardee or investigator will coordinate with the Responsible Party to ensure that all ClinicalTrials.gov regulatory requirements are met. |
|
No |
Yes |
Awardee or investigator will be responsible for carrying out the tasks and meeting the timelines described in ClinicalTrials.gov regulation |
Informed Consent
Informed consent documents for clinical trials are to include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.
See HRPP Manual 7-9, ClinicalTrials.Gov Requirements for specific informed consent language.
Responsible Party
The determination of the Responsible Party is made based on whether the clinical trial is an "applicable clinical trial" and what institution is the primary awardee.
|
Applicable Clinical Trial Under ClinicalTrials.gov Regulation? |
Primary Awardee |
Responsible Party Determination |
|
Yes |
NA |
ClinicalTrials.gov regulation is used to determine the Responsible Party. See HRPP Manual 7-9-A, ClinicalTrials.Gov Requirements: General Requirements under 42 CFR 11 for the determination of who is the responsible party. |
|
No |
Michigan State University |
Responsible Party is typically the Principal Investigator of the NIH award. |
|
No |
Not Michigan State University |
Primary awardee would typically determine who is designated as the Responsible Party. |
Penalties
If the clinical trial is NIH-funded in whole or in part, expectations for clinical trial registration and summary results submission will be included in the terms and conditions of the award.
Failure to comply with the terms and conditions of the NIH award may provide a basis for enforcement actions, including termination, consistent with 45 CFR 75.371 and/or other authorities, as appropriate.
If the NIH-funded clinical trial is also an applicable clinical trial, non-compliance with the requirements specified in 42 USC 282(j) and 42 CFR Part 11 may also lead to the actions described in 42 CFR 11.66.
Approved By
Vice President for Research and Innovation on 4-30-2025.
This policy and procedure supersedes those previously drafted.