Medical College of Wisconsin Human Research Protection Program
The primary mission of the Medical College of Wisconsin Human Research Protection Program (HRPP) is to protect the rights, welfare, and privacy of all individuals participating in research conducted at MCW, Children's Wisconsin, Froedtert Health, and Versiti Blood Center of Wisconsin.
Children's Wisconsin IRB Transition
The Children's Wisconsin Human Research Protection Program is transitioning to MCW as the IRB or record for pediatric studies. This transition will take place through 2023. Read more about the Children's Wisconsin transition to the MCW IRB. Researchers can find information on Children's Wisconsin HRPP on the CW HRPP Internal Website (CW Connect access required) and the CW HRPP Standard Operating Procedures webpage (CW Connect access required).
HRPP Training & Events
Research Connection Series
Rotating modules for training based on work role and responsibilities. Beginner and Intermediate/Advanced trainings are available. Offered the second Thursday of the month from 12-1 p.m. via Zoom.
Beginner Series:
Thursday, June 12 | OCRICC
Thursday, July 10 | IRB Submissions Part 1
Thursday, Aug. 14 | IRB Submissions Part 2
Thursday, Sept. 11 | OCRICC
Thursday, Oct. 9 | IRB Submissions Part 1
Thursday, Nov. 13 | IRB Submissions Part 2
Thursday, Dec. 11 | OCRICC
Intermediate/Advanced Series:
Thursday, June 12 | Reliance Part 2
Thursday, July 10 | MCW QA/I Team & Post Approval Monitoring
Thursday, Aug. 14 | Consent & Enrollment of Vulnerable Research Participants
Thursday, Sept. 11 | Reliance Part 1
Thursday, Oct. 9 | Reliance Part 2
Thursday, Nov. 13 | MCW QA/I Team & Post Approval Monitoring
Thursday, Dec. 11 | Consent & Enrollment of Vulnerable Research Participants
Human Research Professionals Meetings
Topical and discussion presentation series covering a variety of topics in Human Subject Research. Offered the fourth Tuesday of the month from 12-1pm via Zoom.
Tuesday, June 24 | OnCore Clinical Trials & Financials
Tuesday, July 29 | Luau with the HRPP
Tuesday, August 26 | The CRDW and CBMI Services
Tuesday, September 30 | Custom Devices, Compassionate Use, & HDE/HUDs
Tuesday, October 28 | QA/QI, Case Reports and NHSR Projects
Tuesday, December 2 | TBD
HRPP News and Announcements
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12.2.2024 Revisions to MCW IRB SOPs for Recruitment & Enrollment of Non-English Speaking subjects
Describes the changes to the process for the recruitment & enrollment of non-English speaking subjects either planned or when using a ShortForm consent process.
Learn More -
10.12.2024 Changes to IRB Funding Review Process
Describes changes to the IRB funding review process for research projects with for-profit funding effective 10/12/2024
Learn More -
8.2.2024 Update to CITI Course, Learner Group 3
Information regarding CITI training for IRB Members and IRB staff effective 7/2/2024
Learn More -
12.13.23 Amendment SmartForm Submission Changes
Describes changes to the layout and functionality of the Amendment SmartForm being implemented on 12/16/23
Learn More -
12.1.2022 IRB Guidance for REDCap Consenting
Summarizes three options the IRB has identified for obtaining signatures via REDCap
Learn More -
7.1.2022 Children's Wisconsin IRB Transition
Information regarding the Children's Wisconsin transition to the MCW IRB
Learn More -
9.29.2020 Single IRB Submission Process Update
Enhanced submission process for single IRB submissions effective 11/1/2020
Learn More -
9.29.2020 IRB Fee Billing Moves to iLab
New process for IRB Fee collection and billing for reviews 10/1/2020 and later
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7.24.2020 IRB Consent Guidance During COVID-19 Pandemic
Guidance for obtaining and documenting informed consent during COVID-19 Pandemic.
Learn More -
7.24.2020 IRB Informed Consent Decision Tree
Decision aid for informed consent during COVID-19
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06.20.2020 COVID-19: Back to Basics CITI Training
New CITI training modules to introduce safety protocols and procedures for returning to campus during COVID-19
Learn More -
06.20.2020 IRB Reliance Process in eBridge
Reliance Requests (allowing an MCW protocol to rely on an external IRB) will now be submitted and processed through eBridge
Learn More -
04.28.2020 MCW IRB Lunch and Learn Recording
Listen to the meeting "A Living Room Conversation with the HRPP Office: Answers to your COVID-19 related questions"
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01.21.2019 Common Rule Goes Live!
On January 21, 2019 the Revised Common Rule went live. This includes the changes to IRB policies in light of these changes.
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01.02.2019 MCW Revised Common Rule Transition Plan
With HHS adoption of the Revised Common Rule, MCW IRB Office has developed the following transition plan for all currently approved projects
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01.02.2019 HHS Revised Common Rule
An overview of the Revised Common Rule changes and how MCW will be navigating those changes
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11.18.2018 Common Rule Revisions and Consent Form Templates
With the Revised Common Rule fast approaching, you may need to revise your Consent Form Templates to ensure compliance with the Revised Common Rule
Learn More -
07.17.2018 3 Year Review of IRB SOPs
MCW HRPP's review of all IRB SOPs
Learn More -
07.01.2018 2018 IRB Fees
Notice regarding a change in IRB Fees effective July 1 2018
Learn More -
01.26.2018 Revised ICF templates
MCW HRPP has revised our ICF templates to incorporate required changes per the Revised Common Rule
Learn More -
01.19.2018 Delay of Revised Common Rule
HHS announces the implementation of the Revised Common Rule will be delayed
Learn More
HRPP Contact Information
Call, email, or visit our offices in the MACC Fund Building, #MFRC 3040
Medical College of Wisconsin
IRB Office
MACC Fund Research Center #3040
8701 Watertown Plank Rd.
Milwaukee, WI 53226
(414) 955-8422
(414) 955-6575 (fax)
General IRB Questions:
IRBOffice@mcw.edu
Reliance Agreements & Deferral Requests:
MCWIRBReliance@mcw.edu
Quality Improvement Office
(414) 955-8422
(414) 955-6575 (fax)
Post-Approval Monitoring Questions:
HRPP-QIOffice@mcw.edu
