Version
1.1
Date Updated
Monday, February 13, 2017
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
 AAHRPP REF#:  124
AAHRPP Elements:   II.2.D.


POLICY


  1. The UIC Environmental Health and Safety Office (EHSO) has a policy (Radiation Safety:  Human Subject Research Protocols) that defines when research protocols involving human subjects require review by the EHSO prior to IRB review and approval. Protocols requiring review by EHSO include:
    1. Research protocols involving radiation exposure for research purposes and that involve increased exposure for the subject versus standard of care due to additional procedures or more frequent procedures;
    2. Research protocols that require review by the Radioactive Drug Research Committee (RDRC) as they involve the use of a radioactive labeled drug as defined by the FDA;
    3. Protocols with an estimated equivalent does below 100 mrem per year do not require review by the Radiation Safety Office (RSO).  (For information on estimating radiation exposure, please refer to the following website: http://www.doseinfo-radar.com/RADARDoseRiskCalc.html);
    4. Protocols with an estimated effective equivalent dose above 25 rem per year whole body, 250 rem per year individual organs and tissues, and 75 rem per year eyes require RSO review.  These effective equivalent doses are for patient research subjects only.  The RSO will not approve an effective equivalent dose greater than 5 rem/yr to any health human research subject; 
    5. Research protocols with an estimated effective equivalent dose above 25 rem per year whole body, above 250 rem per year individual organs and tissues, or 75 rem per year eyes require review by the Human Use Radiation Safety Subcommittee;   
    6. Protocols involving the use of investigational medical devices emitting ionizing radiation (i.e., not having FDA approval) also require review by the Human Use Radiation Safety Subcommittee.
    7. Administration of radioactive research drugs or radiopharmaceuticals that are not New Drug Application (NDA) approved by the FDA or that have NDA approval but are being used for off-label purposes require review by the Radiation Safety Radioactive Drug Research Subcommittee. 
    8. Administration of radioactive biologicals including blood and blood products, living cell extracts, insulin, antibodies, and vaccines require review by the RSO and Biosafety Officer (BSO).
    9. Administration of radioactive recombinant DNA products or radioactive infectious agents require review by the RSO and Institutional Biosafety Committee (IBC).
    10. Exposure levels of 1/10 of the above levels will apply to protocol reviews for minors under the age of 18.
  2. The EHSO review provides the IRBs with a risk assessment and a determination regarding the research prior to IRB review and approval to ensure that the IRB has the information required in order to make the necessary determinations as required by the approval criteria outlined in the regulations [45 CFR 46.111 (a) (1)(2), 21 CFR 56.111 (a) (1) (2)].
    1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purpose.
    2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
  3. For protocols requiring EHSO review, approval notification from EHSO must be received prior to IRB review and approval. Typically, this approval should be obtained before IRB submission. If it is not, IRB review will not proceed until this is obtained.