The HRPP team reserves the right to take appropriate action against a party that has not obtained approval from Brown’s Institutional Review Board (IRB) for a clinical trial but registers a clinical trial identifying Brown University as the sponsor.
Division of Research
Clinical Trial Reporting Requirements
Defining a Clinical Trial
Brown University complies with the federal definition of a clinical trial, as outlined in federal regulations for the protection of human subjects:
“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)).
Federal Regulations for the Protection of Human Subjects (45 CFR 46)
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, policies outlined by the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the International Committee of Medical Journal Editors (ICMJE).
Consent Form Posting Requirements
Federal regulations require the principal investigator (PI) to post consent forms 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 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.
The federal government has approved two sites for posting consent forms: ClinicalTrials.gov and Regulations.gov.
ClinicalTrials.gov
ClinicalTrials.gov uses a web-based data entry system called the Protocol Registration and Results System (PRS) to allow researchers to register clinical studies and submit results. You must have a PRS account to register study information on the website. Specific instructions on how to register with ClinicalTrials.gov and upload documents (including consent forms) can be found on the website.
Regulations.gov
Regulations.gov is an official U.S. government website designed to facilitate public review of and comment on federal rules and regulations. Federal departments and agencies use the website’s docket structure to post and share information, including consent forms for clinical trials. Upload consent forms to the site’s Nonrulemaking Docket folder “Clinical Trial Informed Consent Form Posting.” Instructions can be found on the U.S. Department of Health and Human Services (HHS) website.
PI Responsibilities
For investigator-initiated clinical trials, the PI has the following responsibilities:
- Register the clinical trial before the first subject is enrolled.
- 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 six months for studies that have not yet been completed, even if there were no changes to the record.
- Post the informed consent form on a publicly available website.
- Close out any studies before leaving Brown University, ensuring that studies are properly closed or transferred to another investigator.
- Submit summary results (applicable clinical trials only).
Additional Guidance for Clinical Trial Reporting
Multiple Consent Forms
If a 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.
Assent and Parental Permission Forms
If the study has assent and/or parental permission forms, the PI 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.
Mid-Study Revisions
If the consent form is revised during the study, only one version of the consent form should be posted. The PI is not required to replace an already-posted consent form with the revised version, although this can be done voluntarily.
HIPAA Authorization Form
A HIPAA authorization form is not a consent form. Posting a HIPAA authorization form will not satisfy the federal consent posting requirement.
Waiver of Consent
If the study’s consent process received a waiver of consent by an IRB and there is no consent form to post for this study, then the PI is not required to post documentation. Instead it is recommended that the PI include information in the study record “Detailed Description” section about receiving a waiver of consent.
Recent Updates to Clinical Trial Reporting Requirements
‘Good Cause’ Extension Requests
As of January 25, 2022, the ClinicalTrials.gov PRS no longer permits responsible parties to submit good cause extension requests late (i.e., on or after the results information submission deadline) for applicable clinical trials with a primary completion date on or after January 18, 2017. Failure to submit required results information can result in penalties.
Enhanced NIH Noncompliance Checks
As of October 1, 2021, the NIH has implemented new validations in the electronic Research Administration (eRA) Research Performance Progress Report (RPPR) submission system for clinical trial registration and results reporting. These checks will impact NIH-funded recipients’ 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.
Agency-Specific Definitions
The FDA, NIH and 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 Definition
The FDA defines a clinical trial as:
(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 Definition
The NIH defines a clinical trial as:
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.
Planning for NIH Clinical Trials
ICMJE Definition
The ICMJE defines a clinical trial as:
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.
Comparison of Reporting Requirements
This information is provided to help in understanding the differences in clinical trial reporting requirements among Brown University, the FDA and the NIH.
Brown University Policy
Applies to all clinical trials conducted under the auspices of Brown University, based solely on scientific design of the study
Not applicable
One IRB-approved consent form used to enroll participants or an IRB approval documenting a waiver of consent must be posted on a publicly available federal website (ClinicalTrials.gov or Regulations.gov) after the study is closed to recruitment, but no later than 60 days after the last study visit by any participant.
May lead to suspension or termination of grant or contract
(Effective January 21, 2019)
FDA Rule
Applies to all FDA-regulated clinical trials (drug, biological, device products and pediatric post-market device surveillance studies under the Federal Food, Drug and Cosmetic (FD&C) Act
Does not include Phase 1 studies or small-device feasibility studies
(Effective January 18, 2017)
Registration must occur within 21 days of enrollment of the first participant.
PI must submit results no later than one year after the completion date. This is referred to as the “primary completion date” of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.
- If federally funded, grant funding can be withheld
- Civil monetary penalties of up to $12,000 per day
- Study record in ClinicalTrials.gov will be marked as noncompliant
NIH Policy
Applies to all clinical trials funded wholly or in part by the NIH
Does include Phase 1 studies
(Effective January 18, 2017)
Registration must occur within 21 days of enrollment of the first participant.
PI must submit results no later than one year after the completion date. This is referred to as the “primary completion date” of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.
- May lead to suspension or termination of grant or contract
- Can affect future funding decisions
- Study record in ClinicalTrials.gov will be marked as noncompliant