What Is a Clinical Trial? | Policy Statement | Reporting Requirements | Consent Form Posting | Comparison of Requirements | Responsibilities for Registration & Reporting

Clinical Trials

WHAT IS A CLINICAL TRIAL?

Brown University complies with the federal definition of a clinical trial.

“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 the interventions on biomedical or behavioral health-related outcomes.” [45 CFR 46.102(b)]

Brown University’s Policy Statement

Brown is committed to complying with all applicable laws, regulations and policies governing registration and submission of results information in ClinicalTrials.gov. This includes, but is not limited to:

• Food and Drug Administration Amendments Act, Section 801 (FDAAA 801)
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
• International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy

All Brown University investigators conducting a clinical trial are required to comply with the consent form posting requirements included in the federal law. Follow the Comparison of Requirements as applicable to the study and act in accordance with the Requirements of Registration and Reporting outlined below.

REPORTING REQUIREMENTS

*NEW* Change to good cause extension requests on ClinicalTrials.gov for ACT results reporting

“As of January 25, 2022, the [ClinicalTrials.gov Protocol Registration and Results System] PRS no longer permits responsible parties to submit good cause extension requests late (i.e., on or after the results information submission deadline) for ACTs with a primary completion date on or after January 18, 2017.” (ClinicalTrials.gov FAQ). Failure to submit required results information can result in penalties.

*NEW* Enhanced NIH noncompliance checks for registering and reporting clinical trials

New electronic Research Administration (eRA) Research Performance Progress Report (RPPR) submission system validations for clinical trial registration and results reporting have been implemented by NIH as of 10/01/2021. These checks will impact NIH funded recipient’s ability to submit the RPPR. Those who are noncompliant with clinical trial registration and reporting will receive errors preventing submission of the RPPR. In order to submit your RPPR, you must take action and bring your clinical trials into compliance.

Consent Form Posting

The federal regulations [45 CFR 46.116(h)] includes consent form posting requirements for clinical trials conducted or supported by any Federal department or agency. For such studies, one IRB-approved version of a consent form, or an IRB approval documenting a waiver of consent [45 CFR 46.116(e)(1) or 45 CFR 46.116(f)(1)] if applicable, that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms. The informed consent form must be posted after recruitment closes and no later than 60 days after the last study visit. It is the responsibility of the Principal Investigator to comply with this requirement.

Which websites can be used? 

There are two approved sites for posting consent forms:

1. ClinicalTrials.gov
   This is likely the easiest choice if the researcher has already registered the clinical trial at ClinicalTrials.gov. Specific instructions on how to register with ClinicalTrials.gov and upload documents (including consent forms) can be found on the ClinicalTrials.gov website. If the study is already registered, see Appendix A.1 of the ClinicalTrials.gov Results Data Elements Definitions document for information on posting consent forms.
2. Regulations.gov
   Upload the consent form to the Nonrulemaking Docket folder “Clinical Trial Informed Consent Form Posting (sec. 116(h) of the revised Common Rule)” [ID: HHS-OPHS-2018-0021] created by the Department of Health and Human Services (DHHS). Instructions are located on the DHHS Office of Human Research Protections webpage Clinical Trial Informed Consent Form Posting.

Additional consent guidance:

• *NEW* The HHS Office for Human Research Protections (OHRP) provides consent form posting instructions and guidance, found here.
• If the study has more than one consent form (for example, there may be different consent forms for each study group), only one consent form is required to be posted. The PI may decide which one to post.
• If the study has assent and/or parental permission forms, the study is only required to post one of these two forms. If the study has a consent form, assent form, and parental permission form, the PI may choose which one to post.
• If the consent form is revised during the study, only one version of the consent form should be posted. It is not required to replace an already-posted consent form with the revised version, although this can be done voluntarily.
• A HIPAA authorization form is not a consent form. Posting a HIPAA authorization form will not satisfy the federal consent posting requirement.
• If the study’s consent process received a waiver of consent by an IRB [45 CFR 46.116(e)(1) or 45 CFR 46.116(f)(1)] and there is no consent form to post for this study, then no documentation is required to be posted. Instead it is recommended that the PI include information in the study record “Detailed Description” section about receiving a waiver of consent.

Reporting requirement variations

The U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) definitions of a “clinical trial” vary slightly. Each has its own requirements for registration in ClinicalTrials.gov. While some of the requirements overlap, it’s important to know which definition(s) you’re operating under as you determine compliance requirements, particularly as they relate to reporting.  

• FDA: (i) A prospective clinical study of health outcomes that compares an intervention of an FDA-regulated device against a control in human subjects (other than a small clinical trial to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes), and (ii) a pediatric postmarket surveillance, and (iii) a controlled clinical investigation, other than a Phase 1 clinical investigation of an FDA-regulated drug.
• NIH: 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. (Click here for more information about NIH clinical trials.)
• ICMJE: Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. (ICMJE journals will not accept for publication any study that meets its definition of a clinical trial that is not registered. Studies must be registered prior to informed consent of the first subject. More information about the ICMJE requirements can be found here.)

Comparison of Requirements

Responsibilities for Registration & Reporting

Principal Investigator

For investigator-initiated clinical trials, it is the responsibility of the Principal Investigator to:

1. Register the clinical trial before the first subject is enrolled;
2. Update the record at least once every 12 months (Recruitment Status and Primary Completion Date). It is recommended that the Record Verification Date be updated at least every 6 months for studies that have not yet been completed, even if there were no changes to the record;
3. Posting the informed consent form on a publicly available website.
4. Close-out any studies before leaving Brown University, including ensuring that studies are properly closed or transferred to another investigator; and
5. Submit summary results (applicable clinical trials only).

Register a Study on ClinicalTrials.gov

Brown's Human Research Protection Program

1. The Brown University Human Research Protection Program is responsible for general oversight and support of ClinicalTrials.gov registration and enforcement of Brown’s statement of compliance. Please note that Brown's HRPP reserves the right to take appropriate action against a party that has not obtained IRB approval from the Brown University IRB for a clinical trial, but registers a clinical trial identifying Brown University as the sponsor.