This monthly program focuses on educating research faculty and staff on current research processes or new developments within MCW and Froedtert. The presentation is generally held on the last Tuesday of the month. Attendees are welcome to bring their lunch. A beverage and dessert are provided.
Beginning January 2014 registration for this and all other Human Research Protection Grand Rounds course presentations must be filed in EthosCE.
- If you previously created your EthosCE profile and registered for the Human Research Protection Grand Rounds course no additional registration is necessary.
- If you have not created your EthosCE profile or registered for the Human Research Protection Grand Rounds course in EthosCE please create your EthosCE profile now and register for the Human Research Protection Grand Rounds course.
Next Human Research Professionals Meeting
||March 27, 2018
Medical College of Wisconsin
||11:30 a.m.: Announcements
12 p.m. - 1 p.m.: Presentation
Human Research Protection Program's Annual Report: A Review of the Past Year and Expectations Moving Forward
David Clark, PhD, Director, Human Research Protection Program
1. Provide an overview of the anticipated changes to MCW HRPP policy based on the revised Common Rule
2. Discuss the impacts of the revised Common Rule on research operations and procedure at MCW
3. Discuss upcoming changes to HRPP operations apart from the revised Common Rule
4. Determine the requirements for subject safety monitoring in research
Questions? Send an email to IRB Office.
Everyone interested in the review or conduct of research is welcome.
The Medical College of Wisconsin is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Program ID: 18026
Designation of Credit Statement
The Medical College of Wisconsin designates this live activity for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim credit commensurate with the extent of their participation in the activity.
Hours of Participation for Allied Health Professionals
The Medical College of Wisconsin designates this activity for up to 1.0 contact hour of continuing education for allied health professionals.
Upcoming Human Research Professionals Meeting
Date: May 29, 2018
The Human Research Series is intended for MCW employees whose job responsibilities include any aspect of human research, are optional modules that can be taken in any order. Individuals are welcome to choose which modules to attend, according to their job needs.
There are currently three modules held quarterly on a rotating monthly basis, lasting 60 minutes each:
- Module A - IRB Processes
- Module B - Research Banks at MCW & Froedtert Hospital
- Module C - Conducting Human Research at Froedtert Hospital: What You Need to Know
Sessions are typically small in size, allowing time for questions, interaction and networking.
View more information on our Human Research Series here
The IRB Lunch & Learn meetings are generally held on the third Tuesday of every month, from noon - 1 p.m. in the MACC Fund building meeting room 3075.
Several IRB staff members will be available on a walk-in basis to help you with the IRB review process. The first 20 minutes will be devoted to brief presentations on issues of general interest; the remaining 40 minutes is your time for questions and direct assistance.
In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program. The program requirements include reading the Belmont Report and key MCW research documents and policies, completing the required modules of the Collaborative IRB Training Initiative (CITI) Program, maintaining CITI certification and additional annual educational requirements.
View more MCW Certification Program (CITI) information
The purpose of this educational event is to provide resources to the human research team member in the coordinator role that will expedite his/her ability to perform his/her job responsibilities in a manner consistent with federal requirements and guidance and other applicable policy. The focus of this course is the very basic day to day functions of conducting research with an emphasis on providing practical information and tools that can be used immediately.
Human Research Team members including: Clinical Research Coordinators, Clinical Research Assistants, Research Nurses, and other individuals responsible for the conduct of human research protocols. Course content is geared toward those with limited experience in their roles. Experienced human research team members seeking to broaden their knowledge base and acquire additional human research management skills are welcome.
The Department of Defense (DOD) module must be successfully completed by all research staff (investigator and research staff) involved in the conduct of human subject research supported by the DOD including its components (Army, Navy, Air Force, Marine Corps, or recruiting DOD personnel). This includes human subject research that is funded by DOD or one of its components and/or recruits from the DOD or a DOD component through a contract, grant, cooperative agreement or other arrangement.
Successful completion of the module includes completing the quiz with a passing score of 80% or higher.
IRB training is required for personnel involved in the development and/or maintenance of a local bank/repository established for the purpose of future research. Individuals who have access to the local bank/repository database, obtain informed consent for banking of data or specimens in the local bank or have record keeping or other administrative responsibility for the local bank must complete the in-person or online training. The in-person training is offered approximately every 3 months; the online module is available for those who cannot attend the in-person training. Successful completion of this module includes completing the quiz with a passing score of 80% or greater.
Visit our IRB FAQ page for an archive of questions that have been answered for investigators and study teams. Topics included HIPAA, FWA, Exempt projects, Informed Consent, etc.
Visit our Quality Improvement Program FAQ page for an archive of questions that have been answered for investigators and study teams on the subject of informed consent.