IRB Committee & Policies

IRB Committee & Policies

The Franklin University IRB complies with the federal regulations detailed in 45 CFR 46 - Protection of Human Subjects. All IRB policies and procedures are structured around these guidelines and ethical research principles generally. This section contains information about Franklin's IRB Committee as well as federal and institutional policies.

IRB Committee

The IRB committee consists of faculty and staff from across the University and at least one community member who is not otherwise affiliated with Franklin University. These individuals provide expertise in a variety of disciplines and have the necessary training to assess protocols submitted to the IRB for review. The committee adheres to the federal regulations that guide the development of its operating procedures.

The Franklin University IRB convenes on the third Thursday of each month and conducts meetings in accordance with applicable federal requirements for full review of protocols (i.e., 45 CFR 46.108). 

The agenda is set at least seven (7) calendar days prior to the scheduled meeting. Protocols requiring review by the convened IRB will be scheduled on a first-come, first-served basis.

Committee Members

 

Brett Tozer
IRB Chair

Dr. Brett Tozer is a Department Chair in the School of Education.

See Dr. Tozer's faculty profile page for more information.

Denise Bergstrom, Ph.D.
Program Chair, B.S. Cybersecurity & M.S. Cybersecurity and CPSCE Cyber Lead

Dr. Bergstrom has almost 30 years’ experience in cybersecurity managing and contributing to projects that include cleaning up a nuclear facility after it was infected with malware; secure code development projects, over 150 risk assessments/security assessments/gap analysis; and digital forensics cases for companies, local law enforcement, and FBI task forces. She has been an educator for students at the associates through doctorate levels serving as their teacher, coach, and mentor. Her expertise has led to textbooks, cybersecurity awareness books, and many conference and research papers. She is the Vice Chairman of the Colloquium for Information System Security Education (CISSE); a senior editor for the CISSE Journal; a reviewer for the Journal of Digital Forensic Science and Law and many conferences. She holds 23 industry certifications including the CISSP, C|CISO, PMP, and Security+.

Melanie Brewer
Department Chair, School of Nursing, Chief Nursing Administrator, Program Chair, DNP

Dr. Melanie Brewer is the Department Chair of Nursing and Chief Nursing Administrator, and Program Chair of the Doctor of Nursing Practice Program at Franklin University. As a nurse for over 30 years and family nurse practitioner for over 20 years, she has held several positions in clinical practice and academia. As Director of Research in a hospital system and Professor of Clinical Nursing, Dr. Brewer has mentored numerous clinicians and doctoral students to conduct research and implement evidence to improve patient outcomes. With an interprofessional team, she led the development of a Center for Evidence-Based Practice and Research in a children’s hospital, mentoring healthcare providers to develop new guidelines and standards for practice with children and their families. Dr. Brewer led the successful submission and directed a multi-million-dollar Centers for Medicare and Medicaid Services Graduate Nurse Education Demonstration Project to increase access to care with academic-practice partners. She is a Fellow of the American Association of Nurse Practitioners and a Hartford Geriatric Institute Research Scholar. The focus of her clinical practice is oncology phase I clinical trials, previously internal medicine and movement disorders. Dr. Brewer holds a Doctor of Nursing Science from Johns Hopkins University. Her research interests include improving psychosocial and physiological outcomes for patients with cancer and their families. In addition, her research focuses on improving educational outcomes for students across all levels of nursing.

Sarah Christian

Sarah Christian serves as an accreditation specialist within the Office of Accreditation and Authorization for Franklin University. Her work includes coordinating various applications and reports to both the Higher Learning Commission and the Ohio Department of Higher Education. In addition, she oversees compliance efforts for the University’s specialized accreditor, the International Accreditation Council for Business Education (IACBE). Through her background in institutional compliance, Sarah understands the importance of upholding standards to ensure the ethical research of human subjects.

Rachel Fant

Rachel is retired from the United States Navy and serves as our community member.

Natalya Koehler

Dr. Natalya Koehler joined Franklin University in 2013 and is an instructional design faculty member.

See Dr. Koehler's faculty profile page for more information.

Tracie Miller

Dr. Tracie Miller joined Franklin University in 2022 and serves as Program Chair for MS and BS Accounting.

You can read more about Dr. Miller here. 

Betty Mitchell

Betty Mitchell is Franklin University's site director and academic advisor at London Correctional. She is a longstanding member of OPEC (Ohio Penal Education Consortium).

Amiee Wagner

Dr. Amiee Wagner is an IRB Administrator as well as the Program Chair of Science at Franklin University.

See Dr. Wagner's faculty profile page for more information.

Alternate Members

 

Alisa Blazek

Dr. Alisa Blazek is an experienced scientific researcher, project manager, and operations manager with demonstrated success in managing projects and in multidisciplinary team building in health care and software development industries. Her formal training consists of a master’s degree in Exercise Science and a Ph.D. in Molecular, Cellular, and Developmental Biology, both from The Ohio State University. Her M.A. thesis focused on altitude's effects on the mucosal immune system of athletes, and her Ph.D. dissertation focused on molecular mediators of bone and muscle crosstalk with exercise. She also obtained a certificate in Data Science from Thinkful online. Dr. Blazek spent much of her career as a biological scientist and program manager in various positions at Battelle Memorial Institute in Columbus, OH, and has also held positions in data science and analytics. She is developing Kinesight Fitness, LLC, a company that aims to use machine learning and molecular biomarkers to program fitness and perform exercise science research. Dr. Blazek has been teaching Exercise Science courses at Franklin University since 2020, and has experience teaching courses and labs in Kinesiology, Exercise Physiology, Exercise Testing, and other Exercise Science classes both at Franklin and The Ohio State University. She enjoys using novel technologies to study exercise and appreciates the importance of understanding molecular mechanisms in exercise research.

Joel Gardner

Dr. Joel Gardner is currently serving as the Assistant Dean of Instructional Design within the International Institute for Innovative Instruction.

See Dr. Gardner's faculty profile page for more information.

Marnie Shaffer

Dr. Marnie Shaffer manages the Institutional Review Board (IRB) Office and the Office of Academic Scholarship (OAS). 

Todd Whittaker

Dr. Todd Whittaker serves as the Department Chair for Computing Sciences and Mathematics and as Program Chair for the BS and MS in Cybersecurity at Franklin University.

See Dr. Whittaker's faculty profile page for more information.

IRB Policies & Procedures

Franklin University relies on the U.S. Department of Health and Human Services Code of Federal Regulations (45 CFR 46, last updated in 2018) to guide development of our Standard Operating Procedures (SOPs). Our policies and procedures were adapted by Franklin University’s IRB Office from IRB staff in the Office of Research Integrity (ORI) at the University of Kentucky.

Federalwide Assurance (FWA)

The Franklin University Institutional Review Board (IRB) is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) as IRB00011340 and complies with the terms of the Federalwide Assurance FWA00026525, expiring February 21, 2028.