IRB Manual
      IRB Records
 
   
Each IRB is responsible for maintaining comprehensive documentation of its activities, membership, and procedures. Listed below are the records that must be kept:


  6.1 Documentation for each Product
   


Records relating to each project reviewed by the IRB must be kept for a minimum of three (3) years after the termination of the last IRB approval period for the project. The file(s) for each project should include all the documentation received or produced by the IRB in relation to the research. For example:

 
(1)   
the protocol;
 
(2)   
consent form(s);
 
(3)   
statements of significant new findings provided to subjects;
 
(4)   
scientific evaluations/consultants reports;
 
(5)   
cross reference to the minutes of the meeting at which the study was approved.
 
(6)   
progress report(s);
 
(7)   
reports of monitoring activities (these may be kept separately if they are readily accessible and are cross referenced);
 
(8)   
correspondence with the researcher and/or other interested parties;
 
(9)   
reports of research related injuries, adverse reactions and/or unanticipated problems involving risks to subjects;
 
(10)   
decisions, conditions and recommendations of the IRB, including continuing reviews;
 
(11)   
required approvals e.g. Director, RFMH, OMH or OPWDD, DOH.
     
   
OMH Researchers are required to retain documentation of their research projects for ten years from the close of the project. This includes, but is not limited to: IRB approvals; consent forms, data sheets; coding sheets; abstracts of patient records; reports; etc. One copy of each research report must be transferred to the State Archives after 10 years. (Section 8.000 of the OMH Policy Manual)
     
   


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