Ethical Research Solution, Inc is the foremost provider of research ethics consultations, analysis, and solutions for all areas of research administration, facilitation, compliance, and oversight. Also, ERS specializes in Critical Research Infrastructure Development and Sustainability. ERS enables new and existing businesses to develop and expand. Our duties include developing research protocols, advising on research administration matters, regulatory oversight, policy development, and identifying areas for growth within a company, organization, institution, or research team.Mission: To protect the rights, safety, and welfare of human participates in research.

Responsibilities include reviewing and improving syllabi, understanding students’ needs, developing engaging lesson plans, and ensuring the relevant learning resources are available. You should also be able to evaluate student performance and address any issues promptly.• Creates, distributes, and reviews the ethics course syllabus.• Utilizes a variety of instructional strategies to engage students, including cooperative and experiential learning.• Meets with the academic department chair to develop courseware and curriculum.• Presents prepared materials and supervises organized activities.• Evaluates student performance promptly and accurately based on departmental rubrics.• Maintains records of student attendance, involvement, and progress.• Teaches assigned class material per learning objectives that the ethics department develops.• Communicates with students outside of class to provide supplementary instruction.• Participates in faculty meetings involving departmental updates.• Survey students to obtain information about their wants and needs in specific courses.

As the Executive Director, within the Office of the Vice President of Research and Innovation, is responsible for oversight of the human research protections program, including but not limited to the administration of the Institutional Review Board (IRB) as well as implementation and management of policies and procedures related to research involving human subjects. I serve as a senior advisor to the Institutional Official. Essential Duties & Responsibilities are as follows: • Oversight of the review of protocols submitted for approval by IRB for completeness and compliance with the Office of Human Research Protections (OHRP) regulations, other Federal regulations, state and local laws, and IRB Policy and Procedures.• Oversight and support for the VCU IRB, including evaluating and monitoring submissions for appropriate assignment of review category under Federal guidelines (e.g., Exempt, Expedited, Full Review).• Maintain IRB Policy and Procedures Manual and recommend revisions and updates.• Develop and facilitate education/outreach/training for the research community, as needed, regarding the overall HRPP, including, but not limited to: (a) determining when IRB review is necessary and (b) identifying appropriate categories of review.• Built relationships with internal stakeholders (including consulting with researchers) and liaised with Virginia Commonwealth University Health System, Office of Ethics and Integrity, and other respective colleges as appropriate; worked with various stakeholders to build a culture of compliance.• Oversee the Quality Assurance Monitoring, IRB Operations, IRB Reliance, and Education of the HRPP, including investigation of matters of noncompliance, and ensure implementation of corrective action, as needed, in accordance with the policies and procedures of VCU and the IRB.• Represent VCU HRPP as a liaison with regulatory agencies, accrediting bodies (as applicable), and funding agencies.

As the chief of ethics policy, I led the policy and regulatory initiatives surrounding pivotal ethical topics such as informed consent, life-sustaining treatment, and advanced directives at a national level for the U.S. Department of Veteran Affairs. I led and mentored a virtual team of four senior advisors and technical experts in policy revisions, policy development, and system support of the medical record that facilitated the implementation of these policies.•Advisor to the Executive Director of the National Center for Ethics in Health Care regarding policies on Advance Directives, Life-Sustaining Treatment, and Informed Consent. • Oversee the creation, management, and documentation of HSR records, including protocols, questionnaires, consent forms, IRB review, standard operating procedures, and Agency approvals.• I provide oversight on the ethical and regulatory conduct of human subjects research (HSR) to ensure compliance with the Common Rule and VA-specific policies and guidance.• Coordinate with internal and external stakeholders and organizations to contribute to the development of research policies, guidelines, and procedures governing HSR.• Develop, evaluate, and improve policies and guidelines regarding the ethical conduct of human studies.• Develop and present reports and publications in forums and journals to address issues related to the conduct of human studies.• Develop policies, procedures, and regulations related to the detection, investigation, and prevention of clinical misconduct and the responsible conduct of clinical care.• Serve as a special projects officer and conduct comprehensive research, review, and analysis on a wide variety of public health-related programs to provide a wide variety of staff papers that address multi-functional issues.

As the Research Ethics and Compliance Officer for the Air Force Surgeon General Office was charged with the preparation and remediation of human research protection programs at Air Force Medical Facilities prior to transitioning authority to the Defense Health Agency. In addition, I oversaw the human research protection program of federally funded research and development centers and led the site assessment visits of Air Force Human Research Protection Programs.Essential Duties & Responsibilities • Advised the Air Force Surgeon General on human subjects research (HSR) protections, including the principles, criteria, methods, and body of data used in developing human subjects research projects to ensure participant safety.• Provided leadership and oversight in planning, managing, and establishing requirements for protocol review and processes that support regulatory science research and application.• Worked collaboratively with all team members (scientific, regulatory, and management) to develop project plans, including negotiating time frames, milestones, and an agreed-upon endpoint.• Led U.S Air Force Institutions in preparing for The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) process by aligning policies and procedures to AAHRPP accreditation standards and requirements.• Analyzed review status concerning project plan variance and determined the impact on established project goals.• Identified and coordinated the resolution of conflicting resource needs, availability, and scheduling.• Developed, evaluated, and improved policies and guidelines regarding the conduct of human studies and provide oversight of HSR programs and activities. • Oversaw the creation and management of tracking, coordinating, and archiving systems for records related to human research studies and provided recommendations to U.S. Air Force, Surgeon General Executive-Compliance Office management on HSR records documentation.

The Human Protections Administrator and Program Director of the Human Research Protection Program (HRPP) at Walter Reed National Military Medical Center is charged with ensuring that the human research protections program complies with applicable laws, regulations, and policies as the Human Protection Administrator within the Department of Research Programs is responsible for oversight of the human research protections program, including but not limited to the administration of the Institutional Review Board (IRB) as well as implementation and management of policies and procedures related to research involving human subjects.Essential Duties & Responsibilities• Oversight of the review of protocols submitted for approval by IRB for completeness and compliance with the Office of Human Research Protections (OHRP) regulations, other Federal regulations, state and local laws, and IRB Policy and Procedures.• Oversight and support for the WRNMMC IRB, including evaluating and monitoring submissions for appropriate assignment of review category under Federal guidelines (e.g., Exempt, Expedited, Full Review).• Review of IRB membership with responsibilities for Exempt determinations and Expedited reviews, as commensurate with the level of knowledge and expertise.• Maintain IRB Policy and Procedures Manual and recommend revisions and updates.• Develop and facilitate education/outreach/training for the research community, as needed, regarding the overall HRPP, including, but not limited to: (a) determining when IRB review is necessary; (b) identifying appropriate categories of review; (c) protocol submission process and procedures including use of, and technical support for, the electronic submission system; and (d) the institutional HRPP education/training program (CITI).• Built relationships with internal stakeholders (including consulting with researchers) and liaised within the DHA as appropriate; worked with various stakeholders to build a culture of compliance.

As a policy analyst and ORISE Fellow, I supported the drafting of federal regulations regarding the protection of human subjects, directed strategic planning for the Secretary Advisory Committee on Human Research Protections on ethical issues concerning informed consent, randomization of group samples, the participation of vulnerable populations, and bio-specimen and genomic research. I also analyzed qualitative data collected and proposed new guidelines, led training modules, developed manuals on applying consistency, standardization, and error reduction, and issued guidance on using prisoners as human subjects, and verified institutional certification of engaging in research enrolling prisoner subjects.