Section 7
Responsibility of Investigators Conducting CORIHS-Approved Activities

Once his/her project is approved by CORIHS, the investigator must:

• conduct every aspect of the project as approved by CORIHS
  
• promptly report any revisions or amendments to the research activity for review and approval by CORIHS prior to commencement of the revised protocol. (The only exception to this policy is in situations where changes in protocol are required to eliminate apparent, immediate hazards to the subject)
  
• promptly report any unanticipated problems involving risks to subjects or others
  
• assume full responsibility for selecting subjects in strict accordance with the inclusion/exclusion criteria outlined in the application materials
  
• use only CORIHS-approved, stamped forms in the consent process (where consent/permission/assent form(s) have been approved for the research activity), and
  
• assume full responsibility for assuring that all personnel who s/he has delegated to obtain informed consent from subjects has complete understanding of the research protocol and of the consent process (including assessment of the subject to give consent for participation)

Section 8
CORIHS Disapproval

Disapproval of an activity is determined at meetings of the full committee only.

If CORIHS does not approve a research activity, the principal investigator has the right to appeal that decision either in writing or in person at a CORIHS meeting. If the investigator is not satisfied with the decision subsequently reached by CORIHS, s/he may request that CORIHS review the protocol again whenever significant changes are made to the research protocol or significant new information becomes available.

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Last Updated: 2004-04-28