IRB Manual
      5.3 Inclusion of Research Records In Subject's Medical Records
 

In situations where participation in research may effect treatment or diagnostic procedures, a copy, or the original, of the signed consent form and any information which is likely to be needed by the subject's treatment team should be included in the subject's medical record. (This is required for OMH facilities).

The IRB and the researcher, in conjunction with the subject's doctor, etc., are responsible for determining exactly what information should be included in the medical record, the method of informing the subject, and the method of transmitting the information. The subject should be notified in the consent form when information will be shared with the treatment team.

OMH facilities - When involvement in a research protocol has the potential to significantly affect the patient's treatment, the investigator and the treating physician should assess the advantages/disadvantages and document accordingly. When the research lends itself to a treatment related goal then it should be included in the Comprehensive Treatment Plan. More important than a documented goal however, is a mechanism to insure ongoing communication between the treatment team, the investigator and the patient so that issues relevant to the patient's well being can be resolved. When the research involves more than minimal risk the treatment team must certify that the research does not come into substantial conflict with the patient's individual service plan.
   
 


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