Transcript Tough L ve (Random Reviews and Investigations of Non

Tough Love:
Understanding the Purpose and Processes of Quality Assurance
Michelle Groy Johnson
Quality Improvement Officer
Research Integrity Office
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 Noncompliance.
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
Written Notification (Email or Campus Mail)
?
Phone call or email 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.
?
Investigation
? = May occur
Directed
= Will occur
Random
Key:
Emergency
Process
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 noncompliance 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, noncontinuing 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 89557-0331
(775) 327-2368