Institutional Review Board s4

Marywood University Institutional Review Board Annual Report Fiscal Year 2010 - 2011

The Marywood University Institutional Review Board was comprised of the following members from July 2010 through June 2011.

Name Position Karen Arscott, DO Chair; Physician Representative of the College of Liberal Arts and Sr. Margaret Gannon, IHM, Ph.D. Sciences; Non-Scientist Sr. Susan Hadzima, IHM Prisoner Advocate: Review of prisoner research only Representative of the Reap College of Education and Brooke Cannon, Ph.D. Human Development Asst. VP for Research; Added as Voting Member in Maria Montoro Edwards, Ph.D. January of 2010; Non-Scientist Representative of the College of Health and Human Christine Kessen, D.S.W. Services; Non-Scientist Representative of the Insalaco College of Creative and Joan McCusker, IHM, Ph.D. Performing Arts; Non-Scientist Non-Affiliated Member Moses Prabu, Ph.D. Member at Large Robert Shivers, Ph.D. Non-Affiliated Member

Administrative Staff throughout the academic year included Dr. Maria Montoro Edwards, Ms. Courene M. Loftus, Mr. Ryan Houser and Mrs. Laurie Camlet Houser.

Meetings were held monthly and there have been 11 meetings held between July 2010 and June 2011.

Accomplishments include:

 New IRB Application Review: N=47 o Full Review: N=10 o Expedited Review: N=36 o Not Research with Human Participants: N=1  Renewal Application Review: N=15 . Full Review: N=1 . Expedited Review: N=11 . Exempt Review: N=3 Exempt reviews which were originally performed by the IRB remained with that board throughout the life of the project.  Review of Revisions to Previously Approved Research Protocols: N=17 . Full Review: N=5 . Expedited Review: N=11 . Exempt Review: N=1  Completion of online CITI training program for the Human Research Curriculum by researchers, sponsors, IRB members and staff: N=367

 Ongoing training of IRB members, sponsors and students on various aspects of the review process, regulations and/or IRBNet submission procedures: o Via workshop, classroom presentation or one-on-one meetings: N=47 o Training of 1 New IRB Committee Member o Continuous responses to e-mail, telephone and in-person inquiries

 Online application submission and management via IRBNet.org o New site registrants: N=282

 Routine update of IRBNet training instructions and website information

 Additions or Changes to IRB policies and procedures concerning:

o International Research – Created o Dietary Supplements – Created o Reproductive Risk in Clinical Research – Added o Copyrighted Instruments – Removed o Professional Review of Researcher-Developed Instruments – Revised

 Attendance at Public Responsibility in Medicine and Research’s (PRIM&R) 2010 Advancing Ethical Research Conference by the Director

 Renewed Certification as an IRB Professional (CIP) by the Director

Submitted by: Ms. Courene M. Loftus, MPA, CIP