Any person interested in conducting research at Marshfield Clinic Health System involving human subjects, their data or specimens must receive approval from the Marshfield Clinic Research Institute's Institutional Review Board (IRB), in accordance with the policy/procedure, “Human Participants in Research & the Human Research Protection Program.” ORIP provides investigators with decision charts designed to aid investigators in deciding whether their studies meet the definition of human subjects research, or whether they meet one of the exemptions from IRB review.

If a study qualifies as human subjects research, investigators and research staff must complete computer-based training through CITI, complete conflict of interest (COI) training/disclosure and are to familiarize themselves with MCRI IRB policies and forms.

Frequently Asked Questions

Q. What is Research?

A. A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

  • Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question (s), testing a specific hypothesis (es) or developing theory
  • Generalizable knowledge means the intent or purpose of the systematic investigation is dissemination of findings. Common ways of disseminating results include publishing or presenting

Q. What is Human Research?

A. Dept. of Health & Human Services (DHHS) defines it as a living individual about whom an investigator conducting research obtains (possess), uses studies, generates or analyzes: 1) information or biospecimens through intervention or interaction with the individual or 2) identifiable private information or identifiable biospecimens.

  • Intervention: includes both physical procedures (e.g. venipuncture) by which data are gathered and manipulation of the participant or the participant's environment performed for research purposes.
  • Interaction: includes communications or interpersonal contact between investigators (or research team) and participant.  Examples include interviews, questionnaires, surveys, observations, manipulations subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue) and administration of experimental drugs or devices.

For details on Human Subject Determinations and IRB Review click here.