Office of Research Compliance Supports and promotes ethical research practices. Provides assistance and guidance to researchers to ensure compliance in the following areas: Human subjects protection Animal care and use Use of hazardous agents in laboratories Research integrity Export control Conflict of interest Coordinates institution-wide research compliance policy and procedures ensuring that the Rowan University is compliant with federal, state and local and institutional policies.

Research Compliance Human Subject Research Research Activity Type Number (%) Total Number of Active Studies 681 Number of Minimal Risk Studies* 361 (53.0%) Number of No risk studies 304 (44.6%) Number of More than Minimal Risk Studies 15 (2.3%) Active Clinical Trials** 1 *The risk is no more than what participants experience in their daily life or research is almost like things participants do in their routine life. ** Reviewed by an outside IRB with expertise on reviewing clinical trials. Industry indemnifies Rowan from risk of injury. Investigators receive assistance from the Office to design their study to minimize risks. As a result of this, the overall risk is minimized to minimal or no risk level in 97.6% of Rowan faculty-initiated research. Over 1150 (2419 in last two years) students and faculty have completed required training the last fiscal year. Only those who have completed training are approved to conduct research. Conflicts associated with research are reviewed and approved by appropriate committees prior to approving a research study. Routine Internal Audits yielded no significant findings or issues There have been no regulatory violations. There have been no complaints from participants. Program is compliant with federal, local and state regulations. Compliance Office is in the process of implementing new rules and regulations effective January 21, 2019. IRB members’ and researcher’s input is taken to implement new regulations.

Office of Research Compliance Summary of Rowan IRBs Glassboro/CMSRU IRB: Social & Behavioral board covering studies from Glassboro campus and non-medical studies from CMSRU faculty RowanSOM IRB: Medical Research board covering all studies from SOM students, faculty, & residents. Western IRB: Clinical Trials board. All clinical trials studies are contracted out to Western IRB for review and management Facilitated Reviews: Studies which have already been approved by other IRBs. Review includes Inter-Intuitional Agreements and simplified review to only address any local concerns

Office of Research Compliance IRB Composition Composed in accordance with Common Rule regulations Harriet Hartman (Chair)- Sociology Burt Sisco (James Coaxum III to replace)- Education Adarsh Gupta- Family Medicine SOM Eric Gregory- Division of Research Sreekant Murthy- Research Compliance Cindi Hasit- Community Member Robert Weaver – Exercise Science James Hogan (John Mills- Social Justice as alternate)- Prisoner Advocate/Community Member Jiwook Shim- Biomedical Engineering Valerie Davis-LaMastro- Psychology Ane Johnson (MaryBeth Walpole as alternate during sabbatical)- Education Jeffrey Lenz- Research Compliance Darren Nicholson- Marketing and Business

Office of Research Compliance Glassboro – Approved studies by College

Office of Research Compliance Approved studies at RowanSOM

Office of Research Compliance Approved studies by Review

Office of Research Compliance Glassboro IRB Review Timeline

Office of Research Compliance Recent Changes to Reduce IRB Burden As a result of Common Rule Changes Continuing Reviews for most Glassboro Campus projects are reduced to Progress reports minimizing the time required to complete a lengthy form into one page Efforts are on the way to reduce submission of progress reports/continuing reviews when the study is in the analysis state. https://sites.rowan.edu/officeofresearch/compliance/irb/submissions/crsandfrs/index.html. Reduced IRB burden for Pedagogy and Methodology Activities This is for course directors to submit any pedagogical or methodological training activities that involve information collection from human subjects but with no intent to use information collected to contribute to generalizable knowledge. https://sites.rowan.edu/officeofresearch/compliance/irb/submissions/pedagogy-policy/index.html.