Subject: Modifications to Previously Approved Research

Procedure:

1. Investigator Responsibilities.
   1. The Investigator shall submit to the IRB all proposed modifications in the form of a revised protocol, consent form, and other documents associated with the requested change along with justification for the change.
   2. The Investigator shall assess whether the proposed modification will change the risk/benefit ratio and/or require the currently active subjects to undergo any new or revised procedures. In either case, the Investigator shall submit a revised consent form in order to re-consent currently active subjects.
   3. The Investigator shall submit to the IRB any proposed changes to exempt research as set forth in IRB Policy III. C^[1].
   4. If the Investigator has modified research activity without IRB approval to avoid apparent immediate hazards to the subject, the modifications shall be promptly reported to the IRB.
2. IRB Committee Responsibilities.
   1. The IRB will determine whether the proposed modification is a minor modification or a major modification to a previously approved research project during the period of one year or less for which approval is authorized.
      1. Any proposed modification determined to be minor may be reviewed as set forth in IRB Policy III. D^[2].
      2. Any proposed modification determined to be major will be reviewed as set forth in IRB Policy III. E^[3].
   2. The IRB will determine whether re-consenting of currently active subjects is necessary as set forth in IRB Policy III. H^[4].
3. IRB Specialist Responsibilities.
   1. Upon receipt, the Specialist will determine the type of review for which the research is eligible as set forth in IRB Policies III.D ² and III.E ³ within two working days and will assign it to the next available agenda.
   2. The Specialist will record the discussions of the IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution will be provided via written notification to the Investigator of the IRB’s determinations.
   3. The Specialist will ensure that all relevant information has been entered into the IRB database in an accurate and timely manner.
   4. The Specialist will ensure that all IRB approved documents are provided to the Investigator in an accurate and timely manner.

^[1] IRB Policy III.C

^[2] IRB Policy III.D

^[3] IRB Policy III.E

^[4] IRB Policy III.H