CLINICAL TRIAL REQUIREMENTS
Clinical trials must comply with many requirements that do not apply to other types of human subjects research. These requirements are designed to address the increased participant vulnerability and risks of many clinical trials compared with other research. They also are meant to ensure meaningful results. Some of the major requirements that apply to clinical trials are described below.
Consent Form Posting Requirement
Under the revised human subjects protection regulations (known as the revised “Common Rule”) that took effect on January 21, 2019, one IRB-approved consent form must be posted on a publicly-available federal website for each clinical trial funded by any federal agency or department that has adopted the Common Rule. Twenty federal agencies and departments, including DHHS, have adopted the Common Rule. For a complete list of federal agencies and departments that have adopted the Common Rule, see here.
For purposes of this consent form posting requirement, a “clinical trial” is defined 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 the interventions on biomedical or behavioral health-related outcomes [45 CFR 46.102(b)].
Social, behavioral, and educational research studies funded by a Common Rule department or agency that fit the definition of clinical trial in 45 CFR 46.102(b) must also comply with the posting requirement.
Good Clinical Practice Training
Per NIH Policy, all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP).
While FDA regulation do not specifically address GCP training, LSUHSC-NO (LSUNO) HRPP policies require GCP training for all investigators participating in studies involving FDA-regulated drugs, biologics and devices. Sometimes sponsors of such studies also require GCP training.
LSUNO investigators can meet the GCP training requirement by completing the relevant basic and refresher GCP courses at CITI Program. CITI GCP courses are tailored to different types of clinical research including:
- Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- Clinical Investigations of Devices
- Social and Behavioral Research Best Practices for Clinical Research
Instructions for LSUNO investigators to log in to CITI are available here.
Please note that the CITI Human Subjects Protections course does not fulfill the GCP training requirement.
Registration and Reporting of Clinical Trial Results