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 Change is Coming: Meeting Potential Challenges

Wednesday, November 15, 2017






The breakfast is independently sponsored by Governors State University.

Performing Arts Center Foyer

8:30 – 8:45

Welcome/Agenda/General Housekeeping

Deborah Bordelon, Provost, GSU

Performing Arts Center Auditorium

8:45 – 10:15

Overview of the Revised Common Rule with a Focus on Exemptions

Misti Ault Anderson, OHRP

Performing Arts Center Auditorium

10:15 – 10:35

                            SESSION BREAK

Performing Arts Center Foyer


Overview of the Changes to Informed Consent in the Revised Common Rule

Jaime O. Hernandez, OHRP

Performing Arts Center Auditorium

11:50 – 1:00

The lunch is independently sponsored by Governors State University.

Performing Arts Center Foyer


Panel Discussion on Single IRB Review

Mary Jane Welch, Moderator, Rush University
Michael Bingham
University of Wisconsin-Madison
Jaime O. Hernandez, OHRP
Marcella Oliver, Northwestern University
Eileen Yates, Northwestern University

Performing Arts Center Auditorium

2:15 – 2:35

The snacks are independently sponsored by Governors State University.

Performing Arts Center Foyer

2:35 –


Let’s Review a Protocol Together

Misti Ault Anderson, OHRP

Performing Arts Center Auditorium

Let’s Review a Protocol Together

Jaime O. Hernandez, OHRP

Engbretson Hall

This workshop meets the criteria in the Certified IRB Professional (CIP) recertification guidelines for a maximum of 5.7 hours of accredited continuing education credits.  This workshop is being presented without bias or commercial support.

PRESENTATION SLIDES: The following links below will provide you with access to the presentation slides.

Applying the Revised Common Rule Regulations

Overview of the Changes to Informed Consent in the Revised Common Rule

OHRP Education Workshop Protocol Review


Single IRB-Panel Discussion

Single IRB for Cooperative Research

SMART IRB Agreement Overview

Reliance Agreements



  • Registration



     Fee: $75 (Registration fee includes full day program, continental breakfast, and a box lunch.)
    Registration Deadline:  November 8, 2017

    By Mail:

    GMT Bldg. Room 162
    Governors State University
    1 University Parkway
    University Park, IL 60484



  • OHRP Presenters


     Misti Ault Anderson


    Misti Ault Anderson, M.S., M.A.

    Ms. Anderson serves as a Senior Advisor for Public Health Education in the Division of Education and Development of the HHS Office for Human Research Protections (OHRP).

    Prior to joining OHRP, Ms. Anderson was a Senior Policy and Research Analyst at the Presidential Commission for the Study of Bioethical Issues, where she served as staff lead for the Bioethics Commission’s educational materials and for both volumes of the Bioethics Commission’s Gray Matters report on neuroscience and ethics. She holds an M.S. in Biomedical Science Policy and Advocacy from Georgetown University, an M.A. in Science Education from UNC-Chapel Hill, and a B.S. in Microbiology from Clemson University.


     Michael Bingham

    Michael Bingham, J.D.

    Michael Bingham serves as an IRB Facilitator for multisite research for the University of Wisconsin-Madison Health Sciences IRB Office. In addition, Mr. Bingham serves as a Regulatory Affairs Officer & Ambassador for the National Center for Advancing Translational Sciences (NCATS) funded Streamlined, Multisite, Accelerated Resources for Trials (SMART IRB) initiative, as well as the IRB Facilitator for the Greater Plains Collaborative (GPC) PCORnet Clinical Data Research Network.

    Prior to that, he was the Human Research Protection Program Specialist at ProHealth Care of Southeastern Wisconsin and the Assistant Director of the Education Research IRB at the University of Wisconsin-Madison. Mr. Bingham obtained his Juris Doctorate (J.D.) at Suffolk University Law School in Boston and a B.S. in Criminal Justice from the University of Massachusetts at Lowell.


    Jaime Hernandez  

    Jaime Hernandez, J.D., M.Be.

    Jaime Hernandez is an attorney and bioethicist who is currently a Public Health Advisor with the Division of Education and Development at the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services.  Before joining OHRP, Mr. Hernandez was a Senior Research Investigator at the University of Pennsylvania, Department of Medical Ethics and Health Policy.  Prior to that, he was a Litigation Associate at Hughes Hubbard & Reed, L.L.P.  He also served as an Administrator for the social and behavioral science IRB at the University of Pennsylvania, Office of Regulatory Affairs.

    Mr. Hernandez obtained his Juris Doctorate (J.D.) at the University of California, Berkeley School of Law (Boalt Hall) and his Masters in Bioethics (M.Be.) at the University of Pennsylvania, Perelman School of Medicine.  He also holds a Bachelors in Philosophy from the University of Miami.


    Marcelle Oliver 3 

    Marcella Oliver

    Marcella Oliver has worked in Clinical Research for 12 years, first starting at the Institutional Review Board office at Northwestern University in 2005, then in managing the Regulatory/Compliance aspects of research.

    In her previous position as manager of Regulatory within the Northwestern University Clinical and Translational Sciences Institute, she was in charge of providing training/education and supervision for the Regulatory Unit staff who work with investigator teams on IRB and FDA submissions. Marcella also took the lead on a pilot study starting the Northwestern University IRB on the path of ceding review to external IRB’s.  Following the success of this pilot, there was expanded use of external IRB’s throughout the entire institution.  

    Marcella currently serves as the IRB Reliance and Education lead serving as the key liaison between Northwestern University IRB, principal investigators, clinical study sites, individual study teams and external organizations and IRBs regarding IRB reliance issues.  She is also responsible for facilitating the reliance agreement negotiation process, including working with the Northwestern University legal counsel to address legal and institutional requirements related to reliance agreements.  Marcella holds a Bachelor’s of Science in Political Science from Northwestern University.

       mary Jane


    Mary Jane Welch, DNP, APRN, BC, CIP

    Mary Jane Welch is the Associate Vice-President of Research Regulatory Operations and an Associate Professor at Rush University Medical Center. In this role she has regulatory oversight of the Rush IRBs, IBC, Biohazard Committee, DURC committee and the research arm of the Rush radiation committee. She currently serves as a steering committee member of the Chicago Area Patient Centered Outcomes Research Network (CAPriCORN) and as the Chair of the Ethics and Regulatory Workgroup of that group.

    Dr. Welch led the implementation of the electronic research submission and management system at Rush and the successful preparation and application to the Association for the Accreditation of Human Research Protection Programs, IncÒ. While leading these projects, as part of her doctoral work, she invented the aggregation program Master Project©, and the business concept, Study Centered Research™.

    Dr. Welch earned her Doctor of Nursing Practice from Rush University with a focus on executive leadership and systems theory and management. She has published numerous articles, chapters and presentations on the subjects of research ethics, research administration and multiple topics related to serious mental illness.


    Ellen Yates - Revised 

    Eileen Yates, M.S., CIP

    Ms. Yates serves as the Compliance Manager at Northwestern University (NU) in the IRB Office. In this role, she is mainly responsible for overseeing the conduct of for-cause auditing and post approval monitoring on behalf of the NU IRB. In her role, she also works closely with research participants to follow up with any concerns or allegations of non-compliance.

    Prior to coming to NU, Ms. Yates worked for 7 years at Rush University, the last 3 serving as Director of the IRB office.  Ms. Yates holds an M.S. in Clinical Research and Regulatory Administration from Northwestern University and maintains certification as an IRB professional since 2000.


  • Hotel Information



    Hampton Inn & Suites Chicago Southland Matteson
    20920 Matteson Avenue
    Matteson, IL 60443
    (708) 748-4102 or 1-800-HILTONS

    Holiday Inn Chicago Matteson Conference Center
    500 Holiday Plaza Drive
    Matteson, IL 60443
    (708) 747-3500

    Can provide transportation to GSU campus between 9 a.m. and 9 p.m.
    Pre-book when you need the shuttle.
    Send a confirmation of the reservation.

  • Transportation



    www.flychicago.com provides information about Chicago's O'Hare International Airport and Midway International Airport. Both airports are accessible by many modes of transportation including public, taxi, limo service, and rental car. O'Hare is 49.4 miles from Governors State University. Midway is 29.2 miles from Governors State University.

  • Sponsors


    OHRP Sponsors