IRB Manual
      6.4 Procedures
 
Each IRB must follow a set of written procedures which have been reviewed by the RFMH and checked for compliance with relevant Federal, State and Departmental regulations and policies. Written procedures must include:

 
(1)   
initial and continuing review of research, including expedited review procedures, primary reviewers, sub-committees, etc.;

 
(2)   
reporting decisions, conditions and recommendations to the investigator and the institution. The IRB must report, in writing, to the principal investigator or authorized co-investigator and the institution:
  • the decision(s) of the IRB (including conditions placed on the research).
  • Reasons for conditions or disapproval of research.
 
(3)   
criteria for determining which projects require review more often than annually and which projects need verification from sources other than the investigator's that no material changes have occurred since the previous IRB review:

 
(4)   
prompt reporting by the investigator to the IRB of:
  • proposed changes in a research activity (changes must not be implemented until IRB approval has been given except when it is necessary to eliminate apparent immediate hazards to subjects);
  • unanticipated adverse events or injuries to subjects or others;
  • newly available information that may affect a subject's willingness to continue  participation or the IRBs decision to continue approval of a study or to require  changes in an ongoing study.
 
(5)   
prompt reporting by the IRB to the director of the institution and to RFMH of: injuries and unanticipated risks to subjects, instances of serious or continuing non-compliance, or suspension or termination of IRB approval.;

 
(6)   
forwarding IRB minutes, approved protocols (including consent forms) and disposition forms to RFMH.
     
   


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