IRB Processes

In addition to GPC’s collaboration efforts for researchers, the GPC network includes a best practice consortium for IRB representatives from network institutions.

All research involving human data meets one of four determination definitions:

  1. Non-Human Subject Research (NHSR) 
  2. Exempt (note: this is an IRB determination, and does not refer to whether an IRB submission is needed) 
  3. Minimal Risk 
  4. Greater than Minimal Risk

Projects that meet the definition of Exempt, Minimal Risk, or Greater than Minimal Risk require IRB submissions at GPC network institutions.  Non-Human Subject Research may not require a submission, but an investigator must follow the policy of their own institution.  Additionally, an IRB submission may be recommended for NHSR in order to obtain documentation of the determination for journal submissions.  Many of the projects utilizing clinical or existing data sources meet the definition of NHSR or Exempt human subject research.     

 Single IRB Review:

Single IRB review refers to the review of a multi-center protocol by only one IRB.  When a single IRB review process is used, each investigator is still required to submit an application or request to their local site for HRPP (Human Research Protections Program) review as per the individual site’s process.  Single IRB review is not always required and is not always recommended depending on the protocol.  For example, single IRB review is not utilized for review of NHSR or Exempt research.  Most institutions require the IRB to make these determinations and do not permit the investigator to do so on their own, meaning it is important to consult the IRB prior to any IRB review process planning.  

Before Submitting a Grant or Proposal:

In most cases, there are review fees associated with single IRB review regardless of funding source. Prior to the submission of a grant application or project proposal of a multi-center project, it is recommended the principal investigator discuss the project with an IRB representative from their institution or the GPC IRB group to determine the regulatory path and if single IRB review is appropriate. The investigator will also need to select an IRB to conduct the single IRB review. IRBs have different requirements for when they can act as the single IRB. The Principal Investigator can ask their own site’s IRB to act as the single IRB or can ask another IRB to perform this service. Most grant submissions require the single IRB be named, meaning 18 the PI should obtain a commitment from an IRB to act as the reviewing IRB prior to grant/proposal submission. Additionally, the reviewing IRB will provide the PI with the costs related to IRB review for submission as part of the project budget. IRBs have different processes and procedures for evaluating the request, determining if they are willing to serve as sIRB, providing a quote for service, and providing a letter of support. Submit your request to the potential reviewing IRB as early in the process as possible as this process could take anywhere from a few days to a few weeks. GPC Network IRBs generally utilize the SMART IRB Master Joinder Agreement for ease of reliance on one another. The reliance process is managed by the IRB and each institution has its own process for relying on external IRBs. Contact your IRB to determine your role and responsibilities for utilizing the single IRB process.

Data Transfer/Data Use Agreements (DTA/DUA):

A data transfer agreement (DTA) or data use agreement (DUA) may be required regardless of the IRB requirements for a project. For example, your institution may require a DTA/DUA to share data even for a project that has been determined to be Non-Human Subject Research. All participating GPC sites have signed a data sharing agreement to permit the sharing of standard clinical data. However, specific project usage of data may not be covered by the main data sharing agreement. Investigators should work with their local site contact for DTAs/DUAs to determine if a project specific DTA/DUA is needed. If you are unsure of who to contact at your institution, your sponsored programs officer or an IRB representative can assist you in identifying the appropriate department or process to being the DTA/DUA process.