Sharp Human Research Protection Program
Ensuring participant safety and ethical research
Sharp HealthCare’s Human Research Protection Program (HRPP) goal aligns with the organization’s mission by ensuring the protection of the rights and welfare of human research participants in all Sharp HealthCare research:
The rights and welfare of human research participants are adequately protected.
Research is conducted with expertise and integrity, guided by the ethical principles of respect for persons, beneficence, and justice as outlined in the Belmont Report.
Research complies with applicable laws.
HRPP ensures the protection of human research by:
Monitoring and improving protection processes.
Overseeing research activities.
Educating investigators and staff on ethical responsibilities.
Intervening and addressing participant concerns when needed.
Building strength with support systems
In 2014, research support activities were consolidated within the Sharp Center for Research to strengthen the Human Research Protection Program, maximize efficiency of resources, and enhance collaboration among various research areas and Sharp operational departments.
Sharp’s Institutional Review Board (IRB) seeks to promote a culture of safety and respect for those participating in research for the greater good of the community. All proposed research studies with human participants must be reviewed by the IRB to protect participant safety and maintain responsible research conduct.
The responsibilities of regulatory specialists include ensuring that research staff are properly trained, as well as drafting, tracking, and maintaining essential trial documents that comply with all requirements. The regulatory specialists serve as a liaison between the IRB, sponsors and sites and assist staff with preparing for and participating in internal and external audits of sites.
Sharp’s Legal Affairs department ensures that research agreements define relationships and the scope of work, protect all involved parties, and mandate compliance with all institutional and regulatory requirements. Sharp’s clinical trials billing and compliance specialists manage budget development and negotiation tasks in accordance with standardized pricing schedules to achieve fair market value for services.
The purpose of the coverage analysis is to complete a systematic review of all procedures detailed in the study protocol to determine how each service and procedure at each visit time point should be billed to ensure institutional billing compliance.
The Investigational Pharmacies at each entity are responsible for managing all investigational drugs and biologics. All investigational drugs and biologics used in human subjects’ research are stored, handled, and dispensed in full compliance with regulations or requirements of the ICH GCPs, FDA, the Joint Commission (TJC), the California State Board of Pharmacy, other applicable organizations, and Sharp HealthCare institutional policies and guidelines.
The Administrative Review Committee at each entity is a high-level, multi-disciplinary group that evaluates human subject research protocols for financial or administrative risks. The ARC is comprised of representatives from entity administration, finance, Service Lines, Supply Chain Services, Investigational Pharmacy, Laboratory, Radiation Safety, and other entity experts as appropriate.
Sharp HealthCare’s marketing and digital services support clinical trials by preparing and reviewing promotional materials that inform potential study participants, medical staff, and the community about ongoing research activities.
The Office of Corporate Compliance reviews Financial Disclosures that the Institutional Review Board (IRB) committee has deemed significant and requires additional input regarding the appropriateness or adequateness of any proposed conflict of interest management plan.
The Legal Affairs Department is responsible for addressing all legal issues at Sharp. These include regulatory compliance, participant protection, contracting and contract compliance, intellectual property management, and formulation of policies and guidance documents.