Industry-Funded Clinical Trials

Industry-funded Clinical Trials Submitted to an External (Commercial) IRB

Industry-funded clinical trials submitted for review by an external (commercial) IRB are subject to TTUHSC El Paso study management fees. Investigators should inform potential sponsors of this fee during contract negotiations.

All industry-funded clinical trial agreements will be assessed an up-front, non-negotiable Study Management Fee of $1,300 as noted in the TTUHSC El Paso IRB Administrative Fee Structure. It is separate from any applicable Department-specific fees associated with conducting the trial. TTUHSC El Paso will begin charging Study Maintenance Fees of $1000 for new and/or ongoing trials that switch to a reliance agreement. The yearly maintenance fee will be due each year on either the anniversary date of the study’s contract execution or the continuing review, and is applicable until the study is in a status of ‘Completed/Cancelled’ with the TTUHSC El Paso IRB. All relevant fees may be found on the IRB Website under the Single IRB Process.

The Study Management Fee addresses costs associated with reviews and work conducted on industry-funded protocols by several areas involved in the activation process which includes the following:

  • the TTUHSC El Paso IRB retains the authority to decide whether to participate in a study and/or to limit the investigator’s involvement (i.e. experience, non-compliance issues);
  • the IRB performs a pre-review of the protocol for TTUHSC El Paso IRB and CIRB requirements prior to submission and review by the commercial IRB;
  • the TTUHSC El Paso IRB stores, maintains, and updates the research documents within iRIS, as well as assists the reviewing IRB with local matters, through the life of the protocol at TTUHSC El Paso.

These include, but are not limited to ensuring that the investigators have:

  • obtained required local ancillary approvals, etc.;
  • completed local training and Conflict of Interest disclosures;
  • complied with local recruitment policies for non-English speakers, limited- and non-readers, etc.;
  • incorporated locally-reviewed boilerplate language into the consent form i.e. relevant state laws, institutional concerns, compensation for research-related injury, institutional contact information, costs, and the placeholder for the IRB stamp;
  • post-approval monitoring that must be coordinated with the relying institution, including both for-cause and not-for-cause audits.