Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. Experimental treatments or tests are novel or unproven approaches that are outside accepted standards of care. Research involving human subjects raises many potential ethical concerns. To ensure that these ethical concerns are addressed—and to improve the overall quality of research—Gundersen Clinic, Ltd., Gundersen Lutheran Medical Center, Inc., and the Gundersen Medical Foundation have established a review process. This review process applies to all employees of Gundersen Health System.
Any research that involves human subjects or medical information about individuals and any treatments or tests that are experimental (unproven), including retrospective reviews of medical records, must be approved by the Human Subjects Committee/Institutional Review Board (HSC/IRB) before the research or experiment begins. In a few limited instances, the Director of Research, the Chair of the HSC/IRB, or the IRB Coordinator may determine that a project is exempt from review. This decision will be communicated to the researcher in writing.
Once it is clear that a research or experimental protocol needs to be reviewed, there are several possible responses. Projects that pose only minimal risks for the subjects may receive expedited review. Expedited reviews are conducted by only one or two members of the HSC and usually can be completed within a week. The Director of Research reserves the right to have such proposed projects reviewed by the Research Committee if this might improve the research methods or if funding issues need to be addressed. If a proposal does not receive expedited approval, the researcher has the right to submit the project for full review.
Full review requires review by both the Research Committee and the HSC. The Research Committee must review and approve the proposed project prior to the HSC’s review. Projects cannot advance to review by the HSC until the Research Committee has given its approval. Thus, researchers must satisfactorily address all Research Committee concerns and objections before the HSC will put the proposal on the agenda.
No other group or individual can overturn the decisions of the Research Committee or the HSC if a proposal or request is disapproved. But even when these Committees approve a project, it may be stopped because of lack of funding or by a decision of the Board of Governors.