2012 State of the IRBBoston University

Charles River Campus (CRC)

Cynthia J. Monahan, MBA, CIPDirector, Institutional Review Board

Role of the IRB

•Review and approve human subjects research•Assist researchers with IRB

submissions• Education and training

The CRC IRB

• The IRB Committee • Meets the 3rd Tuesday of the month• Reviews all full board studies. This includes

new studies, continuing reviews, amendments, deviations, adverse events, and unanticipated problems• 11 Committee members• Committee members include representatives

from: (Social Work, CAS, Sargent, Anthropology, Education, Theology, Fine Arts)

The CRC IRB

• The IRB Advisory Committee• Meets periodically (5-6 times/year)• Meets to discuss policies and procedures and

any problems• Members are faculty, IRB members, and deans

who represent the research community (Social Work, CAS, Sargent, Anthropology, Education, Theology, Fine Arts)

Staff Updates

• Cynthia Monahan—Director, CRC IRB• Edward Szkutak—Senior IRB Analyst• Sonia Chawla—IRB Analyst• Mary McCabe—IRB Analyst• Julie Cullinane—IRB Coordinator• LaNeia Thomas—IRB Educator

All expedited and exempt reviews are conducted in the office by an Analyst or the Director

CRC Facts

• 818 Active Studies • 568 Investigators

CRC Facts

CRC Facts

CRC Facts

Average Turnaround Time (March)*

• New Full Board Studies 51 days• New Expedited Studies 54 days• New Exempt Studies 24 days• Amendments 19 days• Progress Reports/Final 25 days• Deviation Reports 30 days

*Turnaround time is calculated using calendar days (this includes weekend days and holidays)

Education and Outreach

• School/Department-focused education sessions• In-class presentations• Individual meetings•Open Office hours (Mondays and

Thursdays: 11:30-1:00)

Continuous Quality Improvement through Post-Approval Monitoring

• Conduct requested and random educational reviews• Assist investigators with:• Navigating the IRB process • Implementing study management practices

• Assist IRB with:• Investigating issues of non-compliance• Providing data to guide future education programs• Improving the human subjects protection program

Continuous Quality Improvement through Post-Approval Monitoring

New Education Service• Goals• Enhance protection of human subjects• Enhance the quality of research data• Enhance the education program• Ensure research is being conducted in

accordance with the IRB-approved protocol and applicable regulations and policies

CRC Changes

•Revised Policies/Procedures•Website http://www.bu.edu/irb/•Application Forms•New templates (consent, assent, etc.)

Goals

• Decrease turnaround time• Increase customer satisfaction• Collaborate with departments,

researchers, and research study staff• Increase efficiency and consistency• Continually assess the program in order to

improve practices

CRC Contact Information

• IRB Office Main Number: 617-358-6115• IRB Office E-mail: irb@bu.edu• Post-Approval Monitoring/ LaNeia Thomas: 617-358-6346• IRB Director/ Cynthia Monahan: 617-358-6345