Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 103
AAHRPP Elements: II.2.D.
- The UIC 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:
- 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;
- Research protocols that require review by the RDRC as they involve the use of a radioactive labeled drug as defined by the FDA;
- Protocols involving greater than 100 mrem exposure per year and having an estimated effective equivalent dose below 25 rem per year whole body, 250 rem per year individual organs and tissues, and 75 rem per year eyes. These protocols require RSO review. These effective equivalent doses are for patient research subjects only. The Radiation Safety Office will not approve an effective equivalent dose greater than 5 rem/yr to any healthy human research subject;
- 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; and
- Protocols involving the use of investigational medical devices emitting ionizing radiation (i.e., not having FDA approval).
- The JBVAMC RSO must review research protocols involving:
- Any radiation exposure to healthy clinical research volunteers;
- Uses of radiation sources that do not meet the criteria for “medically indicated” and are therefore regarded as “indicted for research;”
- Administration of radioactive research drugs or radiopharmaceuticals that are not NDA approved by the FDA;
- Use of radiopharmaceuticals that are NDA approved but are being used for off-label procedures;
Investigator Conflict of Interest Disclosure Policy for Human Subjects Research,
Version 1.1 DRAFT
- Administration of radioactive biologicals (e.g., monoclonal antibodies, insulin, penicillin, blood and blood products, vaccines, derivatives or natural substances, and extracts of living cells); and
- Medical devices emitting ionizing radiation that have not received FDA approval.
- The EHSO and the JBVAMC RSO 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), 38 CFR 16.111 (a) (1) (2)].
- 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.
- 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.
- For protocols requiring EHSO and/or JBVAMC RSO review, approval notification from EHSO and/or JBVAMC RSO 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.
If the OPRS/IRB receives a report of an event that meets the reporting requirements within the EHSO/JBVAMC RSO policy, the EHSO/JBVAMC RSO will be notified promptly and will be copied regarding any IRB determinations.