Mary Holloway Richard
ANNOUNCING HLO’S IRB AND CLINICAL RESEARCH REGULATORY CONSULTANTS (ICRRC)
Health Law Oklahoma is pleased to introduce a new service.
ICRRC is designed to meet the needs of systems or facilities lacking legal counsel, providing expertise in this uniquely regulated area on a contractual basis. HLO counsel has successfully joined hospital system administrative research teams serving as regulatory counsel where recruiting such talent proved difficult. We are able to fill that gap both in the short-term and for longer periods as well.
ICRRC offers the unique capability to quickly answer the need for legal services supporting clinical research activities and institutional review boards tasked with oversight of the research. These services include document review, attendance and counsel at IRB and pre-IRB meetings, and drafting and review of policies and procedures in compliance with HHS and FDA statutes and regulations, counsel regarding vulnerable populations and diversity, and regulatory updates. In addition, HLO can prepare staff for IRB audits and assist with corrective actions if necessary. ICRRC is also available to provide training to in-house counsel newly hired or currently in place assigned to the IRB and clinical research along with training materials for board members and staff.
- Knowledge of applicable HHS and FDA policies and procedures
- Ability to transfer federal regulations into local IRB policies and procedures
- Ability to quickly familiarize ourselves with existing internal structure and work well with staff
- Effective communication skills and efficient response times and accessible to IRB staff
- Significant experience in reviewing clinical trial agreements, amendments, consent forms, requests for waivers, and non-disclosure agreements
- Skilled in preparing for governmental audits, responding to requests for information and preparing plans of correction
- Experienced in accessing OCR staff and procedures on behalf of clients as necessary
It is our experience that institutions engaged in clinical research desiring to hire in house counsel, or with newly hired counsel in place, often find recruiting the necessary legal expertise challenging. We welcome the opportunity to discuss how ICRRC can support your research program by providing qualified legal support or assist in training your legal staff in this area.