MinerAlert
MinerAlert
Once your protocol is approved, the work truly begins! Protocol approval periods vary based upon the type of protocol submission (Exempt, Expedited, Full Board) and IRB determination. Prior to expiration of a study, a continuing review must be submitted through eProtocol . The maximum allowable interval for projects that expire is 1 year. The IRB may determine that continuing review needs to be more frequent based on the risk of the project.
Any changes to the study must, of course, be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population. You may submit an amendment to the protocol through eProtocol.
Researchers may encounter certain types of unanticipated problems, adverse events or protocol deviations. It is vital that researchers report these incidents to the IRB. These can be reported through eProtocol.
It is vital that investigators keep accurate and up-to-date records. All approved versions of protocol documents (e.g., survey instruments, consent forms, advertisement materials, etc.), recruitment logs, signed consent forms, participant withdrawal records, and participant incentive payment records must be kept for the life of the protocol plus three years.
The IRB has an obligation set forth by federal regulations to oversee and continually review all aspects of UTEP’s human subjects research program. The Post-Approval Verification and Education (PAVE) team are one aspect of that program. Their role in reviewing protocol activity is meant to be a collegial experience with a focus on education and an exchange of information. The spirit of PAVE is to review human subjects research as it is occurring in real time and encourage transparency between the researcher and the IACUC.
For further information visit the PAVE website.
