Protocol ID

 
Starting from the academic year 2015-16, the protocol IDs will resemble the following format:
 
##-####
 
This new system will replace the previouly used format (##-###).  Like in the previous system, the first 2 numbers would still denote the academic year (16 for this academic year).  The third number (immediately after the dash) would now denote the type of review mechanism (1 for EXEMPT, 2 for EXPEDITED and 3 for FULL REVIEW).  The last three numbers would just be assigned sequentially like we did before.  Additionally, no two protocols within each academic year will share the same sequential number.  
 
In addition, the third digit with a zero (0) implies an exclusion from IRB oversight when a proposed activity does not meet the OHRP's requirement for "research."  Moreover, studies for which IRB approval was obtained from a non-MTSU IRB and an IRB Agreement Authorization (IAA) was executed to allow that research to take place at MTSU are also assigned "0" in the third digit of the protocol ID.  
 
Starting from AY 2018, class projects and standing protocols assigned to a class are assigned with the third digit to have "4" 
 
The above format is further explained below:
  • Protocol ID 16-0033 is either an activitiy that is excluded from IRB oversight or it was approved by a non-MTSU IRB but permitted to be conducted at MTSU through an IRB Authorization Agreement (IAA)
  • Protocol ID 16-1077 is an EXEMPT protocol that was sequentially assigned a number 77
  • Protocol ID 16-2120 is an EXPEDITED protocol with a sequential number 120
  • Protocol ID 16-3330 is a protocol reviewed under the FULL REVIEW process and assigned a sequential number 330
  • Protocol ID 18-4012 is a protocol that specifically oversees Class Projects (Starting from academic year 2018)
 
In addition to the easy recognition of a review mechanism from the protocol ID, this system will also help us to move studies from one mechanism to another.  
 

Scenario 1

An investigator submits a study to be reviewed as exempt and the protocol was assigned an ID 16-1077.  After review, it was determined that this protocol needs to be reviewed as expedited due to the nature of this research.  Then, instead of assigning a totally new ID, the protocol will just be changed to 16-2077.  Also a point to note is that the sequence 110 will not be assigned to any other protocol.  
 

Scenario 2

An investigator submits a study to be reviewed under the full member review mechanism.  It was assigned an ID 16-3330.  After pre-screening, it was found that the research does not pose more than minimal risk and the study qualifies to be considered under the expedited mechanism.  Then, the ID will just be changed to 16-2330 thereby all original applications will be retained for future reference.  
 

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