Medical College of Wisconsin IRB (MCWIRB) – A Short Introduction

Understanding the role and function of the Institutional Review Board (IRB) at the Medical College of Wisconsin (MCW) is essential for anyone involved in medical research. Established in 1974, the IRB system was introduced by the US federal government to address ethical issues in research, ensuring the protection of participants’ rights and safety.

IRB Committee Composition

IRB committees must have at least five members, including a diverse mix of men and women, scientists, and non-scientists. This diversity ensures a comprehensive review process. The application process for IRB approval is rigorous, involving detailed scrutiny to ensure research is conducted safely and ethically. For example, suggestions might include limiting the age range of participants to enhance safety.

Guiding Principles

The IRB operates based on three guiding principles:

1. Respect for Persons: Ensuring informed consent so participants are fully aware and voluntarily involved in the research.
2. Risk-Benefit Analysis: Identifying and minimizing risks to participants.
3. Fairness and Justice: Ensuring equitable distribution of research risks and benefits across the population.

MCWIRB’s Active Role

MCWIRB is a highly active research organization, overseeing around 6,000 protocols with six IRB committees meeting weekly. Oversight is conducted by external agencies like the FDA and other federal bodies. Additionally, a nonprofit accreditation organization performs site visits, and internal monitors randomly check documentation to ensure compliance.

Accreditations and Oversight

MCWIRB’s human research protection program includes random checks by monitors to ensure proper documentation and adherence to protocols. This rigorous oversight reassures the public that MCWIRB prioritizes patient safety, privacy, and well-being in all research projects.

Useful Resources

• PRIM&R – https://www.primr.org
• IRB FORUM – https://www.irbforum.org/
• MCW (Medical College of Wisconsin) IRB – https://www.mcw.edu/departments/human-research-protection-program/irb-committees-and-members
• MCWRIB – http://mcwirb.org