Relying Institution Study Team Responsibilities

Relying Institution Study Team Responsibilities

Reliance is unlikely to result in less work, even for those sites which are not designated as lead. At TTUHSC El Paso, we require a submission through iRIS, as with a local review request. In addition, the reviewing IRB often has additional forms that must be completed by each site and may even need local IRB input.

All sites must be prepared to follow the policies and procedures of the reviewing IRB. There is no standard set of IRB policies and procedures, although many IRBs may have similar requirements. Each site is responsible for understanding the policies and procedures of the reviewing IRB and conducting the research accordingly. Specifically, it is important for sites to understand the reviewing IRB’s expectations for reporting adverse events, deviations, noncompliance, and other problems to the reviewing IRB, as well as expectations for updating personnel and enrollment status, submitting amendments, and tracking subject enrollment and status, among other things. The lead site should provide this information to the sites and help study sites comply with reviewing IRB requirements.

In addition, the TTUHSC El Paso Relying Principal Investigator has a responsibility to update the TTUHSC El Paso IRB according to the policies and procedures. The TTUHSC El Paso Human Research Protection Program (HRPP) Manual requires notification of study related items when another IRB will conduct the review. These include, but are not limited to:

Addition of Boilerplate Language on Consent Form

The TTUHSC El Paso relying study team staff will be responsible for ensuring that institutional requirements related to boilerplate language have been included in the consent form document that is submitted for review by an academic or commercial IRB. These would apply to compensation for subject injury, local contact information, location where the research will take place, HIPAA authorization language, placeholder for IRB stamp of approval, etc.).

Other Approvals

The TTUHSC El Paso relying study team staff are reminded that there are several other institutional approvals that may be required for a research study to be conducted at TTUHSC El Paso. It is the responsibility of the TTUHSC El Paso relying study team staff to ensure that all these approvals have been obtained before the research is initiated at TTUHSC El Paso.  

  • UMC El Paso research compliance approval, as applicable
  • EPCH research compliance approval, as applicable
  • Conflict of Interest in Research Management Plan, as applicable
  • Execution of Contract/Clinical Trial Agreement, as applicable
  • Safety Committee approvals, as applicable

Post Review Updates/Correspondence

It is the responsibility of the TTUHSC El Paso Principal Investigator to submit copies of renewal letters, amendments, study closures, as well as updated study documents, through iRIS, to the TTUHSC El Paso IRB in order to keep our records up to date. Failure to submit this correspondence may be deemed as noncompliance.

HIPAA authorizations/Waivers

Some IRBs will not or do not approve HIPAA authorization forms or waivers. If the Reviewing IRB does not review/approve our institutional authorization forms, the investigator must submit the external authorization form for review by the Institutional Privacy Officer and subsequent documentation to the TTUHSC El Paso IRB for review and approval. This information may be covered by the local context form. Please ask the reviewing IRB what their policy is regarding HIPAA authorization forms.

Renewal periods

If the project is significant risk and has a renewal requirement, the renewal period is determined by the reviewing IRB. The TTUHSC El Paso IRB does not issue approval periods when relying and will use the expiration date assigned by the reviewing IRB.

Reportable Items

The TTUHSC El Paso IRB requires that all local unanticipated problems (UP) or reportable items be submitted through iRIS to maintain the study files. This is submitted on the ‘Unanticipated Event Form’ (available in iRIS) along with copies of the materials submitted to the reviewing IRB. This is so the TTUHSC El Paso IRB can maintain local knowledge regarding our participants and problems with the study. If the TTUHSC El Paso IRB needs to engage in a serious event that has occurred, we will do so as required to ensure ongoing compliance with local policies for any single IRB study. Please contact the IRB when an Unanticipated Problem or local reportable item arises.

Completing the study

Investigators are responsible for concluding all human research activities as soon as possible after the project is completed or no longer involves human research participants. This is done by submitting the study closure form through iRIS, attaching any closure documentation from the reviewing IRB so that the TTUHSC El Paso IRB can close the study at the local site and complete their records.