135. Requirements for clinical trials | Research integrity
Updated May 26, 2021
Clinical trials must comply with a variety of requirements that do not apply to other types of human research. These requirements are designed to address the increased vulnerability of participants and the risks of many clinical trials relative to other research. They also aim to guarantee significant results. Here are some of the main requirements for clinical trials.
Requirement to publish consent form
Under the revised Human Research Protection Regulation (known as the revised “Common Rule”) which came into effect on January 21, 2019, an IRB-approved consent form used to register participants must be posted on a publicly accessible federal website for each clinical trial. funded by any federal agency or department that has adopted the common rule. For the purposes of this consent form display requirement, a “clinical trial” is defined in 45 CFR 46.102 (b) as: a research study in which one or more human subjects are prospectively assigned to one or more procedures (which may include a placebo or other controls) to assess the effects of interventions on biomedical or behavioral health outcomes.
Social, behavioral, and educational research studies funded by a Common Rules department or agency that meet the above definition of clinical trial must comply with the posting requirement. The informed consent form must be posted on the federal website after the clinical trial has closed upon enrollment, and no later than 60 days after participants’ last study visit, as required by protocol. If the federal department or agency that supports or is conducting the clinical trial determines that certain information should not be made public on a federal website (e.g., Confidential Business Information), the federal department or agency may authorize or require redactions of published information.
Recording and communication of clinical trial results
ClinicalTrials.gov is a publicly accessible registry and database of federally and privately funded clinical trials conducted in the United States and around the world. The purpose of ClinicalTrials.gov is to disclose to the public key information about clinical trials currently available or already conducted. ClinicalTrials.gov captures summary protocol information before and during the trial as well as summary results and adverse event information from a completed trial. Federal laws, regulations, and leading medical journal publishers require registration of a clinical trial, as described below.
An academic or affiliate researcher conducting a clinical trial must comply with these requirements if:
- She or he is the Principal Investigator (PI), AND
- The study is initiated by the investigator (the clinical trial is not an industrial trial in which the protocol is developed, owned and sponsored by a company. Industrial sponsors are responsible for registering their trials.)
Food and Drug Administration (FDA) Requirements
Registration is mandatory for studies that meet the definition of an “applicable clinical trial” (ACT) and that were initiated after September 27, 2007 or were initiated on or before that date and were still ongoing as of September 26, 2007. December 2007. Studies must be registered no later than 21 days after the registration of the first participant. The holder of any FDA IND, IDE, or HDE must ensure that these requirements are met.
National Institutes of Health (NIH) Requirements
Regardless of study phase or type of intervention, all NIH-funded clinical trials are expected to register and submit outcome information to Clinicaltrials.gov, in accordance with the “NIH Policy on Disclosure of Information. NIH-Funded Clinical Trials Information ”for competing applications and contract proposals. submitted on or after January 18, 2017. The Principal Fellow must ensure compliance. Studies must be registered no later than 21 days after the registration of the first participant. The NIH Principal Fellow is responsible for ensuring that these requirements are met.
International Committee of Medical Journal Editors (ICMJE)
For studies that plan to publish in medical journals, the ICMJE requires registration of clinical trials. Studies must be registered at the time of registration of the first participant at the latest
All investigator-initiated clinical trials that fall into one or more of the above categories must register with ClinicalTrials.gov to comply with the federal FDA requirements outlined in FDA 42 CFR 11 (final rule) and / or other federal agencies and departmental policy or requirements. Studies that fall under more than one registration requirement need only be registered once. Information published on ClinicalTrials.gov should be updated throughout the trial, checked at least every 12 months, and results should be provided at the end of the study.
Note: Even if a researcher-initiated clinical trial does not meet NIH or FDA clinical trial registration requirements, researchers are urged to read and consider registering your trial to comply with the additional requirements. of the International Committee of Medical Journal Editors (ICMJE). for publication purposes and other research funders who now need recording and reporting of results.
In the case of multi-site clinical trials, the primary PI for the entire study is the person responsible for meeting the requirements. If the University or Affiliate Researcher is the Principal Investigator only for the local site and is not the Principal Fellow or Principal Investigator of the study, then the Principal Investigator of the University or Affiliate is not responsible of the publication on ClinicalTrials.gov.
For more detailed guidance on clinical trial requirements, please visit the information page titled, Registration of Clinical Trial Information and Results Reporting Requirements available on the Research Integrity website.