Independent QA/QI Program: An Indispensable Entity of a Human Research Protection Program

1. Independent QA/QI Program: An Indispensable Entity of aHuman Research Protection Program Delia Wolf, M.D. Director, Partners Quality Improvement and Human Subjects Protection Program Partners HealthCare System E-mail; dwolf@partners.org

2. Vice President, Partners Research Management Director, Human Research Affairs G.C.O. Director, QI Program Director, IRBs PCAC Investigator QA/QI IRB QA/QI Education

3. General Goals • Create an institutional culture that embraces the principle of responsible research review and conduct • Establish a process of continuous review and oversight of all human research activities

4. Specific Goals • Ensure investigator compliance and improve study site performance • Assess IRB review and approval process • Facilitate communication between investigator and IRB • Improve existing and recommend new policies and procedures

5. QA/QI Program Activities • Conduct routine QI on-site review • Assist investigator to conduct self-assessment • Provide consultation to study site • Assist study site in preparation for an external audit • Review IRB files and evaluate IRB review process

6. QA/QI Program Activities • Provide IRB with feedback from study site • Conduct inspections and investigations in response to inquiries or complaints received from IRBs, regulatory agencies, sponsors or research participants • Make recommendations to institution official (e.g. draft policies and procedures)

7. Ensuring Study Site Compliance and Improving Performance • Informed consent process • Record keeping • Continuing review application • Corrective actions • Quality Improvement tips (developing user friendly tools)

8. Assessing IRBReview/Approval Process • Policy enforcement • AE reporting • Deviation/violation reporting • Study lapse • Continuing review submission • Database accuracy • Record keeping • Corrective actions

9. Facilitating Communication • Inform investigators about current institutional policies and procedures • Make investigators aware of submission requirements for initial and continuing review • Present common IRB-related findings from study site to the IRB chairs, administrators, and protocol administrators • Serve as a “middle person”

10. Improving Written P & P • Revise existing policies/procedures and guidance documents • AE reporting guidelines • Continuing review submission deadlines • Violation/deviation reporting guidelines • IRB initial/continuing review forms • Providing template with instructions • Protocol • Protocol summary • Consent form

11. Key Elements for a Successful QA/QI Program • Institutional support • Experienced, knowledgeable, and enthusiastic staff • Collaboration rather than confrontation • Be responsive and flexible • Be tough • Be fair