Responsibilities of Research Investigators and Study Coordinators

Research Investigator

The following are the general responsibilities of investigators:

1. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Institution’s IRB. The Principal Investigator is responsible for the compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements.
   
   
2. Research investigators are responsible for conducting studies in accordance with the protocol.
   
   
3. Research investigators are required to complete periodic training in the protection of human subjects, as required by Federal regulations and IRB policy.
   
   
4. Research investigators are responsible for obtaining consent and for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent.
   
   
5. Research investigators are responsible for ensuring that only authorized research staff will conduct the consent process.
   
   
6. Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.
   
   
7. Research investigators are responsible for reporting progress of approved research to the IRB, as often as and in the manner prescribed by the IRB, on the basis of risks to subjects, but not less than once per year.
   
   
8. Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others no later than 5 working days after their occurrence.
   
   
9. Research investigators are responsible for notifying the IRB and providing a final report when a study is closed.
   
   
10. Research investigators are responsible for ensuring, whenever necessary, that the trial is properly registered with clinicaltrials.gov.
    
    

Study Coordinator

The duties of Study Coordinators are delegated by the Principal Investigator and may include the consenting of research subjects, ensuring accuracy of the data recorded, acting as liaison between the study sponsor and the Institution, acting as liaison between the Principal Investigator and the IRB and other Institutional officials and committees, and general oversight of conduct of protocols. The Study Coordinators serve as impartial safety monitors; the IRB requires all interventional protocols to have a Study Coordinator to ensure safety of research participants and compliance with regulations.