Human Research Subject Protection

Marshfield Clinic Health System is committed to the protection of the rights and welfare of each person enrolled in research at its institution. To this end, Marshfield Clinic Health System subscribes to the ethical principles outlined in The Belmont Report, requires compliance with federal regulations pertaining to the protection of the rights and welfare of human subjects, and has formally designated the Marshfield Clinic Research Institute's Institutional Review Board (IRB) as the body to approve, monitor, and review research conducted at Marshfield Clinic Health System. Investigators engaged in research and IRB members are to familiarize themselves with all applicable regulations, policies, forms, and guidance documents.

Potential research participants should be aware that being in a study is entirely voluntary. Anyone asked to take part may refuse to do so, and this decision will not be held against them. Participants can also decide to join a research study but then stop at any time without being penalized or without losing benefits they would otherwise receive. Decisions about research participation will not affect a patient’s relationship with their Marshfield Clinic Health System physician or the Marshfield Clinic Health System in general.

What's an Institutional Review Board?

An institutional review board (IRB) is a group of individuals who are responsible for reviewing a research study to make sure that the research participant's rights and welfare are protected.  Most clinical research studies cannot begin without a review board's approval. Board members generally include health care personnel such as doctors, nurses, pharmacists, and scientists.  The Board also includes other members who aren't of the scientific community, non-scientists such as clergy, legal counsel, information systems/security, business associates, social workers and community members.

The IRB/Ethics Board protects the rights and welfare of research participants by reviewing the research project to ensure that:

  • Risk to participants are minimized
  • Risks are acceptable in light of the possible benefits
  • The informed consent document is accurate and complete in describing the study and its risks and benefits
  • The clinical research study is conducted in an ethical manner 

If the board believes that these conditions have been met, it may approve the study and allow it to begin.

Once the clinical research study begins, the board is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected.

The informed consent document should provide the research participants with a phone number to contact the clinical investigator or the IRB if the participant has a question or concern about how the study is being conducted.

For additional human research subject protection details, see the following webpages

    Background

Questions, concerns or complaints about research participation can be addressed to Marshfield Clinic Research Institute's Institutional Review Board (IRB) office at 1 800-782-8581 ext. 9-3022. This same number can be called to obtain answers to questions, express concerns, or convey suggestions about the human research protection program.