Human Subject Determinations
Sometimes it is difficult to discern whether a proposed activity constitutes as human subject research. The Marshfield Clinic Health System's IRB is the sole body designated to make human subject research determinations for Marshfield Clinic Health System. The MCHS IRB has created a form to assist with this determination. The information provided will be reviewed to determine whether the proposed activity would require review and approval by the MCHS IRB.
- Print out the IRB Review Determination Request, complete the form, sign and then send to the IRB Office at 1R-4. Please review the definitions provided to assist you in completing this form.
Within 5 working days the submission will be reviewed and a determination provided to the investigator as to whether IRB Review is not required as the project is not research, not human subject research, is Quality Improvement or Other. You will also be informed if the project requires IRB review and the level of review.
An exempt research project is still subject to HIPAA Privacy Rule as well as institutional policies and ethical standards of MCHS Human Research Protections Program (HRPP). Research involving prisoners is not exempt, nor is research regulated by the Food and Drug Administration (FDA).
MCHS IRB Review Process
If your project is "less than minimal risk" and meets one or more of the exempt categories listed in the IRB Exemption Request form, fill out this form, sign and then submit to the IRB at 1R-4 along with all applicable materials.
Upon receipt the IRB Analyst will preview the submission and then provide to the IRB Chair, IRB Administrator or designee for review and determination within 5-7 working days. A determination letter will then be sent to the investigator.
If your project is "not greater than minimal risk" and meets one or more of the Expedited review categories, in the IRB Application - New Research form, fill out this form, sign and submit to the IRB at 1R-4 along with all applicable materials.
Upon receipt the IRB Analyst will preview the submission and then provide to the IRB Chair, IRB Administrator or designee for review and determination within 7-10 working days. A determination letter will then be sent to the investigator.
For human subject research projects that are "more than minimal risk" to participants/subjects, fill out the IRB Application - New Research form, sign and submit to the IRB at 1R-4 along with all applicable materials (e.g. protocol, informed consent, recruitment materials, etc.)
Submission for convened/full board review are requested 3 weeks prior to the bi-monthly scheduled IRB meeting date that the investigator wished to have the project reviewed. Upon receipt the IRB Analyst will preview the submission for completeness and accuracy. It will then be placed on the appropriate IRB meeting agenda and assigned to two primary reviewers with at least one being a clinician. After a thorough review from the primary reviewers, the study will be provided to all board members to review prior to the meeting. During the meeting the study will be discussed and members will vote on a determination of approval, request modifications to secure approval, table the study or disapprove. Approximately within a week the investigator will receive a determination letter.
See also: Ten Steps to Get Started page