Version
2.1
Date Updated
Sunday, April 29, 2012
Descripton

Approved by Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 176
AAHRPP Elements: I.1.E., I.6.B., III.1.B.


POLICY


  1. The UIC HSPP includes ongoing educational requirements for the research community (i.e., investigators, department heads, faculty, staff and students).  The HSPP education program consists of initial and continuing mandatory training sessions for all individuals who are engaged in the research, including but not limited to, being involved in the conduct, review, or oversight of human subject research as well as a HIPAA research training requirement for all individuals involved in research using PHI.
  2. No individual identified as key research personnel on a project will be allowed to conduct research activities involving human subjects without meeting the HSPP training requirements.
    1. Key research personnel are engaged in the research and include:
      1. Principal investigators;
      2. Co-investigators;
      3. Individuals listed on the grant or contract application;
      4. Individuals listed on a FDA form 1572 (for UIC sites);
      5. Individuals who are named as contact persons in the informed consent documents or recruitment materials for research;
      6. Individuals who provide supervision of the persons who are obtaining informed consent to participate in research;
      7. Individuals who obtain informed consent or authorization; and
      8. Individuals who have access to PHI.
    2. PIs are responsible for the ongoing monitoring of the educational requirements of all research personnel, paying special attention when research personnel are promoted or are given additional responsibilities.  A promotion or broadening of duties may trigger new educational requirements from which personnel were previously exempt. 
    3. Key research personnel are listed on the IRB application and Appendix P and must be reviewed and approved according to their role in the research by the IRB. 
    4. If students or other individuals are not engaged in the research and are not listed in Section II.A above, then they are not required to be listed on the research protocol.  However, the Principal Investigator is responsible to ensure that these individuals receive both adequate training, including human subjects protection training, and oversight in accordance to the roles these individuals perform in the research.
    5. Individuals who are designated as “RiSC Web View Only” must be listed on Appendix P with this designation, but human subjects protection education is not required for these individuals.
    6. Individuals who use research information/data from a study for their own research must be included as key research personnel on the original protocol application or must submit a separate application.
    7. Applications will not be accepted by OPRS for IRB review if a PI or faculty sponsor lacks the required human subject protection training.  Key research personnel will be excluded from participating in the conduct of the research until they have met the training requirements. 
    8. Final approval may be withheld if it is determined that an individual, who has not met the HSPP training requirements, is key to the conduct of the research.
    9. For further information on who is required to take HSPP training, see OPRS Website Education and Training page
  3. Other entities that are components of the UIC HSPP (UIC Medical Center, JBVAMC, College of Medicine, etc.) have their own research training mandates that are separate from those described in this policy and procedure.  UIC OPRS is not responsible for the management or record-keeping for these courses. IV.
  4. The educational program at UIC OPRS also extends to UIC OPRS staff and IRB members.