Lead Study Team Responsibilities

Lead Study Team Responsibilities

Collecting all the required information about multiple sites can be time- and resource-intensive. Under the NIH’s proposed business model for sIRB, a lead site (usually the awardee institution) is responsible for communications between the research sites (i.e. relying institutions) and the reviewing IRB (e.g. collecting the required information from sites and compiling it for the reviewing IRB, making IRB submissions on behalf of sites, and communicating IRB decisions and approved documents back to sites).

For those that have not participated in this process before, it can be difficult and time intensive to handle this level of coordination and communication. Some larger research networks may have resources available to lead sites through these tasks. However, in many cases, lead sites will need to be ready to handle this additional work themselves and may need to consider budgeting for additional staff. Either way, reliance studies require an increase in research responsibilities.

The Lead Study Team Principal Investigator is responsible for managing the process for identifying sites and initiating the process for establishing the reliance agreement between each relying institution and the single IRB. There is a nationwide reliance agreement electronic system called “SMART IRB” to facilitate this process which the Lead Study Team will have to learn how to use.

The Lead Study Team Principal Investigator is responsible for tracking and communicating with each site’s investigator any requirements of the TTUHSC El Paso IRB; including but not limited to renewal requirements, reporting obligations, and sharing any IRB determinations. All requirements to conduct research at the TTUHSC El Paso apply to each site where the TTUHSC El Paso IRB will be the IRB of record. Each site will be required, via signed reliance agreements, to agree to these terms before the TTUHSC El Paso IRB will assume oversight.

The Lead Study Team Principal Investigator is responsible for maintaining appropriate documentation of site approvals and consent forms, and must produce documentation upon request to the HRPP.

Increased responsibilities of the Lead Study Team

The Lead Study Team becomes the liaison between the single IRB and the local study teams at all other sites, and must communicate requirements for:

  • submitting to the single IRB for initial site approval
  • providing continuing review information
  • reporting unanticipated problems, deviations, etc. to the single IRB
  • all determinations of the single IRB
  • the overall protocol and site-specific consent forms and recruitment material, including any changes resulting from amendments
  • study specific duties assigned