Institutional Review Board s2

Marywood University Institutional Review Board Annual Report Fiscal Year 2014-2015

The Marywood University Institutional Review Board was comprised of the following members from July 2014 through June 2015.

Position Name Maria Montoro Edwards, Ph.D. Administrator of the Office of Research and Sponsored Programs; Non-Scientists Laura Ann Camlet Houser, Ph.D.

Member at Large Ying-Ju Sung, Ph.D.

Non-Affiliated Member Jennifer Boardman, Ph.D. Physician/PA/Medical Professional Steven S. Reggie, D.C. Representative Prisoner Representative (Review of prisoner Sr. Susan Hadzima, IHM research only); Non-Scientist Representative of the College of Health and Alexander Dawoody, Ph.D. Human Services; Non-Scientist; Chair Representative of the Insalaco College of Barbara Parker-Bell, Psy.D., ATR-BC, LPC Creative and Performing Arts; Non-Scientist Representative of the Munley College of Thomas Kent, Ph.D. Liberal Arts and Sciences; Non-Scientist Representative of the Reap College of Tracie Pasold, Ph.D. Education and Human Development

Administrative staff throughout the academic year included:

. Dr. Maria Montoro Edwards – Assistant Vice-President for Research . Dr. Laura Ann Camlet Houser – Director of Research and Sponsored Programs . Ms. Courene M. Loftus – Director of Human Participants Protection and Research Compliance . Mr. Ryan Houser – Research Administrator . Mr. Yash Bhambhani – Research Graduate Assistant

Accomplishments include:

 Number of convened meetings held at which a quorum was present: N=6  Total submissions processed by the IRB: N=151 Page 1 of 3  New Projects Review: N=39 Note: Because most new projects take two to three submissions to reach initial approval, the actual number of new submissions reviewed is substantially higher (i.e., at least 78 or more). Exempt research is ordinarily reviewed by the Exempt Review Committee; however, projects erroneously submitted to the IRB and reviewed by IRB staff have been included here. . Full Review: N=9 . Expedited Review: N=27 . Exempt (Administratively Reviewed by Staff): N=2 . Not Research with Human Participants: N=1

 Annual Renewals (Continuing Review): N=11 . Full Review: N=1 . Expedited Review: N=10

 Review of Revisions to Previously Approved Research (Researcher Initiated Changes): N=22 . Full Review: N=0 . Expedited Review: N=22

 Withdrawn Prior to Review: N=1  Adverse Event or Deviation/Violation Reports Received: N=1  Review and Acknowledgement of Six-month Status Reports: N=43  Closure Submissions or Administrative Closures Processed: N=34  Research Compliance Issues: N=10  New Site Registrants at IRBNet (www.irbnet.org): N=219  Updates to IRB policies and procedures concerning: . Closure or Withdrawal . Continuing Review . Mandatory Reporting . Mandatory Training . Submission of Applications

 Completion of online training via the CITI Program by researchers, sponsors, IRB members and staff: N=247

 Ongoing training of researchers, sponsors and IRB members about various aspects of the review process, regulations and/or IRBNet submission procedures: N=313

Note: This figure does not include exempt research training conducted by the Director of Research Compliance.

. Via classroom presentation and personal meetings: N=30 . Via IRBNet Workshops and Open Labs: N=11 Page 2 of 3 . Via presentation during Faculty Development Day: N=225 . Via Graduate Assistant Responsible Conduct of Research Training as requested by Mr. Frank Falcone: N=45 . New IRB Committee Members: N=2 . Continuous responses to e-mail, telephone and in-person inquiries  Attendance at the Secretary’s Advisory Council for Human Research Protections’ webcast, Exploring Ethical and Regulatory Issues in Interventional Social Media Research, by the Director in July, 2014  Attendance at WIRB Copernicus Group’s Webinar, Early Access to Investigational Drugs by the Director in October, 2014

 Attendance at Health Advocate’s Webinar, Enhancing Managerial Interpersonal Skills by the Director in October, 2014

 IRB professional certification (CIP) held by the Director of Human Participants Protection

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