Clinical Trials

Conducting a clinical trial carries additional requirements which are outlined here. What is a “clinical trial”? The Penn IRB utilizes the NIH definition, regardless of funding source. 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.”

Clinical trials are used to determine whether a new biomedical or behavioral intervention is safe, efficacious, and effective.

• Biomedical “Interventions” may include, but are not limited to a drug or device product, a treatment procedure or surgery, etc.
• Social-Behavioral “Interventions” to modify behavior may include, but are not limited to dietary changes, physical activity, cognitive or other psychological therapies, etc. Social behavioral clinical trials may be referred to as “controlled trials.”

If you are unsure whether your research is a clinical trial, the NIH has published case studies to help investigators identify whether a study would be considered by NIH to be a clinical trial.

Registration on ClinicalTrials.gov

ClinicalTrials.gov is a public registry and results database of both privately and publicly supported clinical studies maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

The Department of Health and Human Services’ (HHS), Food and Drug Administration (FDA) and National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) all require the public registration of clinical trials. NIH Policy, effective January 2017, requires the public registration of all fully or partially NIH funded clinical trials, regardless of phase to ClinicalTrials.gov.

In particular, ICMJE, as a condition of publication, requires the public registration of “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.”

The public registration includes the publication of results and posting of the consent form. Failure to comply with registration requirements can lead to penalties for Responsible Parties under federal law. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

Clinical Trial Consent Requirements

1. Elements of Consent

   1. The following regulatory language must be placed into the consent form: “A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.” This language may not be edited.

2. Informed Consent Form Posting [§46.116(h)]

   1. The revised Common Rule requires posting of an unsigned clinical trial consent form for any research supported by federal funding. This applies to all clinical, educational, and social-behavioral research meeting the NIH Definition of a Clinical Trial. The prime awardee is responsible for compliance.
      
      

Details on Consent Form Posting Requirements

• For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved [unsigned] informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Website.
• The informed consent form must be posted on the Federal Website, after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
• The Penn HRPP recommends posting unsigned, IRB-approved stamped copy on either ClinicalTrials.gov or Regulations.gov. For studies that are registered on ClinicalTrials.gov, the consent form must be posted on ClinicalTrials.gov.

Good Clinical Practice Requirements

1. Trial Conduct

   1. Good Clinical Practice (GCP) is an international standard provided by the International Conference for Harmonisation (ICH). It is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.
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2. GCP Training

   1. Studies meeting the NIH definition require study teams to complete Good Clinical Practice training. GCP training is an available curriculum in CITI and expires every 3 years. The IRB does not monitor compliance with this requirement. Penn Medicine researchers should continue to reach out to OCR Operations regarding GCP training. Researchers from non-Penn Medicine schools are responsible for compliance with these requirements.
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IRB Operation within ICH Harmonized Tripartite Guidelines

Click below to view a letter for Sponsors describing the Penn IRB’s position on compliance with ICH GCP, including disclosing the names of IRB members to sponsors.

IRB Requirements

The IRB has incorporated some checks within the review process to ensure compliance with the above requirements.

• Initial Review:
  • Investigators will be required to provide the NCT registration number, or an explanation of why the study does not require posting, before final IRB approval will be given. Penn Medicine researchers may require consultation with OCR compliance for concurrence of studies not posted on CT.gov.
  • Consent Review: The IRB will check if the required CT.gov language is included in the consent form.
• Closure: At the time of closure with the IRB, the study team will be asked to confirm that results have been posted on CT.gov. A copy of the confirmation that results were received must be submitted. Closure with the IRB will not be accepted without this confirmation.