Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance

What is Quality Assurance? Quality assurance is a systematic, internal process that is meant to increase compliance with federal, state and institutional requirements, and promote human subjects protections through the ethical conduct of research. The objective of the University's Quality Monitoring Program for human subjects protection is to measure and improve human research protection effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.

Why do we have Quality Assurance? It helps to protects human subjects, the researchers, and the institution. It helps to identify areas for improvement to build a stronger program. Our accrediting body, AAHRPP, requires it.

What is Non-Compliance? RIO Policy 15D describes it as: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with the research plan as approved by a designated IRB, or federal regulations or institutional policies governing such research. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times. Noncompliance includes but is not limited to deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of research participants or others, or the integrity of the study. Complaints or reports of noncompliance from someone other than the research investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed.

Levels of Non-Compliance Minor Serious Continuing Levels may be combined such as Serious, Continuing Non- compliance.

Minor Non-Compliance Any behavior, action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations or institutional policies but because of its nature, the research project or the subject population, does not place, or have the potential to place, participants and others at greater risk than previously anticipated; does not have a substantive effect on the value of the data collected; and does not result from willful or knowing misconduct on the part of investigators or study staff. Examples of minor noncompliance may include but are not limited to, when such noncompliance does not create additional risks to subjects: changing study personnel without notifying the IRB; shortening the duration between planned study visits; implementing minor wording changes in study questionnaires without first obtaining IRB approval; or routine lab missed at scheduled visit and re-drawn later.

Serious Non-Compliance Any behavior, action or omission in the conduct or oversight of human research that has been determined to: affect the rights and welfare of participants and others; increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio; compromise the integrity or validity of the research; or result from the willful or knowing misconduct on the part of investigators or study staff. Examples include, but are not limited to the following: failing to obtain Informed consent before enrolling a participant in a research study; conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval; enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened Committee, places the participant(s) at greater risk; or failing to report adverse events, unanticipated problems, or substantive changes to the proposed protocol to the IRB in accordance with IRB policy.

Continuing Non-Compliance A pattern of noncompliance that, in the judgment of the IRB Chair, designee or convened Board, indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others, compromises the scientific integrity of a study such that important conclusions can no longer be reached, suggests a likelihood that noncompliance will continue without intervention, or involves repeated or frequent instances of minor noncompliance. Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.

Why would my study be selected for review? Random Scheduled (Most Common): File is randomly selected for review Directed/Emergency (Very Rare): Ordered by the IRB chair, IRB committee, or RIO director. Usually triggered by an issue or event that indicates risks to subjects may have increased. Investigation/Allegation of Non-compliance (May or may not trigger a full review): Complaint Reportable Event RIO File

Process Key: = Will occur ? = May occur Random Directed Emergency Investigation Written Notification ( or Campus Mail) ? Phone call or to schedule pre-review meeting ? Pre-review Meeting: less than an hour to discuss process and preparation for review. Researchers are given the option of having the QIO Briefly review study materials to give guidance. ? Review: QIO will review administrative files and study files, verify where and how study materials are stored, review consent documents, may interview research personnel and subjects, etc. ? Post-review: The QIO will prepare a report of the visit that includes any findings that were made and recommendations for corrective actions, if applicable. A draft is sent to the researcher. A copy is sent to the RIO Director and IRB chair per SOPs. ? Final report: Once the researchers and QIO agree to the content of the report, the researchers will be asked to submit a corrective action plan for any findings. The QIO sends the report and corrective action plan to the IRB chair and RIO director with a recommendation as to the level of non-compliance, if any.

Process If the QIO, director, and chair agree that minor, non-continuing non- compliance occurred, the matter will be handled outside full committee, between the QIO and researchers. The researchers will be sent a determination letter directing them to implement the corrective action plan. The researchers must provide a letter to the QIO indicating whether or not the corrective action plan has been implemented within 30 days of the date of the determination letter. Once the process is completed, the IRB will be notified on the next meeting agenda.

Process If the QIO, director, and chair agree that more than minor, non- continuing non-compliance may have occurred, the matter will be sent to the full committee for review. The researchers will be sent a determination letter directing them to implement the corrective action plan. The researchers must provide a letter to the QIO indicating whether or not the corrective action plan has been implemented within 30 days of the date of the determination letter.

Consequences Better protected subjects More compliant protocols Better prepared for study monitors or audits Better trained researchers

Contact The Research Integrity Office 218 Ross Hall ~ Mail Stop 0331 Reno, NV (775)