Ascension Wisconsin places the highest priority on its responsibility to mitigate risks and to protect the health and safety of research personnel, research participants and the general public.
Institutional Biosafety Committee (IBC)
Federal Guidelines established by the National Institute of Health, require that institutions conducting or sponsoring research using recombinant or synthetic nucleic acid molecules covered by the NIH Guidelines, be responsible for ensuring that the research is conducted in full conformity with the provisions of the NIH Guidelines.
Ascension Wisconsin currently works with WIRB IBC services to provide IBC review. Clinical Research staff can assist researchers with their IBC submission. Researchers working on studies requiring IBC review must also complete training, such as the CITI IBC courses. Note that IBC approval is required prior to final IRB approval.
Radiation Safety at each facitlity is involved in the review of research studies involving exposure to ionizing radiation for research. Most of the radiation-use program currently consists of exposure to additional CTs or X-rays specificly for research, outside of normal care parameters. Radiation Safety provides input to the IRB regarding the safety, risks and benefits to subjects.
Research studies which expose subjects to ionizing radiation for research purposes require a variance approved by the State of Wisconsin State Department of Health Services (DHS). Under the DHS regulations, no persons may be exposed to x-ray radiation except for the purposes of diagnosis and treatment, without this variance. Research studies which expose subjects radiation as part of standard clinical imaging or which are therapeutic in nature, do not require a variance from DHS. Before a variance request may be submitted to DHS, you must have IRB approval in place for your study.
Note that IRB approval conditioned upon DHS’s issuance of a variance is acceptable. Radiation and AWRI staff are also available to assist researchers in submitting the variance (Appendix M) to the state.