3.4 - Responsibilities of Investigators

Researchers assume certain responsibilities:


  1. To inform subjects of all risks and benefits of research;
  2. To provide subjects with information necessary to decide whether they will participate in a study, and to obtain and document voluntary consent, provided that the IRB may waive the requirement of documentation;
  3. To inform subjects of conditions which may affect risks, benefits, or willingness to continue in a study.


  1. To learn, acknowledge, and accept the responsibilities for protecting the welfare and rights of human subjects as set forth in the Federalwide Assurance (FWA00008602) established between The University of Mississippi and the DHHS, and to comply with all provisions of the Assurance;
  2. To submit all protocols involving research with human subjects to the IRB for determination of status (Exempt from Review, Expedited Review, or Full Review);
  3. To be informed concerning all federal, state, local, and university regulations that pertain to a study, and to comply with them.

During the Application Process

  1. To provide clear and accurate information in the IRB application, and to clarify the questions raised by the IRB;
  2. To modify research protocols when the IRB requests modification.

During the Research Process

  1. To begin subject recruitment only after notification that a protocol has been approved by the IRB;
  2. To report to the IRB promptly any injuries or other unanticipated problems involving risks to subjects or to others;
  3. To monitor research, and to inform the IRB of findings that may affect risks and benefits to subjects;
  4. To inform the IRB of developments in the literature that may affect risks and benefits to subjects;
  5. To inform the IRB of significant changes in research procedures;
  6. To submit research reports to the IRB as requested;
  7. To allow IRB observation of research procedures;
  8. To retain signed informed consent forms for at least three (3) years past completion of the research activity.