Debra McKeehen

Oversight of human research protection program (HRPP), including two IRBs Managed institutional FWA, including submission, implementation, and maintenance Ensured compliance with OHRP and FDA human subjects protection regulations

IRB Administrator at Children's Minnesota (2010-12 – 2025-08)

• Oversight of human research protection program (HRPP), including two IRBs
• Managed institutional FWA, including submission, implementation, and maintenance
• Ensured compliance with OHRP and FDA human subjects protection regulations
• Performed substantive administrative reviews of research protocols and identified projects that are either 'not human subjects research' or 'exempt'
• Promptly reported unanticipated problems involving risks to subjects, serious non-compliance, or IRB suspensions to Institutional Official and federal agencies
• Ensured compliance of research studies with privacy and confidentiality of research subjects
• Oversaw training and trained IRB members, investigators, and research staff in human subjects protection regulations, privacy, and other compliance topics
• Acted as primary liaison for FDA audits
• Provided leadership and guidance as basic protocol activities are administered, such as submissions, reports, renewals, and revisions
• Provided support to all aspects of workflow and support for the IRB, as needed
• Supported research endeavors by helping researchers understand their obligations and ensure compliance with Children's MN policies and federal/state regulations
• Served as the subject matter expert and advised and provided input to IRB and other stakeholders regarding regulations and policies
• Collaborated with senior leadership, faculty, staff, students, medical professionals, and external agencies in communicating federal and organizational requirements to stakeholders
• Assisted in program and policy development in response to government agency updates
• Handled multiple projects with competing deadlines

IRB Administrator at Minneapolis VA Medical Center (2005-07 – 2010-12)

• Coordinated and managed AAHRPP accreditation of IRB
• Oversight of human research protection program (HRPP), including two IRBs
• Managed institutional FWA, including submission, implementation, and maintenance
• Ensured compliance with Common Rule
• Provided leadership and guidance as basic protocol activities are administered, such as submissions, reports, renewals, and revisions
• Provided support to all aspects of workflow and support for the IRB, as needed
• Supported research endeavors by helping researchers understand their obligations and ensure compliance with Department of Veterans Affairs policies and federal/state regulations
• Served as the subject matter expert and advised and provided input to IRB and other stakeholders regarding regulations and policies
• Collaborated with senior leadership, faculty, staff, students, medical professionals, and external agencies in communicating federal and organizational requirements to stakeholders
• Assisted in program and policy development in response to government agency updates
• Managed multiple projects with competing deadlines

National Project Coordinator, PIVOT Study at Minneapolis VA Medical Center (1996-07 – 2005-07)

• Coordinated all research activities of 150 participating sites from Study Chairman's office of VA Cooperative Study
• Reviewed all data submissions for consistency
• Responsible for ongoing training of study personnel on study protocol, privacy, and compliance issues
• Led quality assurance activities for participating sites
• Ensured regulatory compliance of all participating sites
• Developed recruitment materials both in print form and on-line

Pancreas Transplant Registry Liaison at University of Minnesota (1994-09 – 1996-07)

• Responsible for communication with and data collection from pancreas transplant centers globally
• Analyzed data and prepared manuscripts for publication of Registry outcomes in medical journals

Research Coordinator, Cardiology at Harper Hospital (1992-05 – 1994-08)

• Conducted study activities and collected data per multiple research protocols
• Analyzed data and prepared manuscripts for publication of research data

Free-lance research services at Self-Employed (1988 – 1992)

• Provided various services to investigators, including grant writing, data analysis, and manuscript and presentation preparation

Research Coordinator at Mount Carmel Mercy Hospital (1978-05 – 1988-11)

• Conducted study activities and collected data per multiple research protocols in both animal and human research in transplantation and surgical research

Master of Science in Biology – Wayne State University

Bachelor of Science in Biology – University of Michigan

Biology – University of Windsor