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Quality Improvement Program (QIP)

The Purpose of the Quality Monitoring Program for Human Subjects Protection is Twofold:

1. To provide a systematic, internal process that will increase compliance with federal, state and institutional requirements, and promote human subjects protections through the ethical conduct of research.
2. To create opportunities to educate and support the research community.

Objective

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.

Selection of Studies

The majority of studies will be selected at random for review. However, consideration may also be given to:

1. Higher risk studies
2. Investigator-initiated protocols
3. Studies that include vulnerable populations such as University of Nevada, Reno employees and students, terminally-ill and decisionally-impaired, or identified in 45CFR46 subparts C and D, pregnant women/fetuses/neonates, prisoners, and children
4. Potential for conflict of interest
5. "Directed" interests of the IRB or University of Nevada, Reno RIO

Types of Reviews

1. Random Scheduled: This type of review is considered a full review. The focus of the review includes roles and responsibilities of research team members, regulatory and IRB compliance, consent form elements, recruitment, eligibility and consenting process, case review for protocol adherence, source documentation and data collection, adverse events, file security, and other suitable aspects of the study. It is unlikely this type of review would occur more than once in a twelve month period.
2. Directed (Emergency): This review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or University of Nevada, Reno RIO. This is considered a full review. This type of review may occur more than once in a twelve month period if concerns about the protocol were brought to the attention of the IRB on multiple occasions. Additional reviews or continued monitoring may result from a review in which corrective actions were prescribed by the IRB.
3. Informed Consent: This type of review is intended to support researchers in assuring that adequate informed consent is obtained from human subjects participating in their studies. They are performed at the request of the IRB and may be requested by researchers as an educational experience. This type of review includes observation of the consenting process; verification that the person consenting the subject is qualified and designated by PI; review of the consent form for valid version date, signatures and date signed; confirmation that a copy of the consent documents were given to subject, if applicable; review of the consent form for basic elements of consent according to the Common Rule, and observation and review of HIPAA consenting process. It is unlikely this type of review would occur more than once in a twelve month period unless continued monitoring was a corrective action prescribed by the IRB as the result of a Directed review.

Arranging a Review

Written notification of pending review will be sent from the Quality Improvement (QI) Officer. It is the responsibility of the QI Officer to schedule the visit after notice has been sent.

The following is an estimate of the timeframe for notification depending on the type of review being employed:

1. Random reviews will be scheduled in advance in conjunction with the researchers.
2. Directed reviews may be scheduled with 24 hours notice, or without notice if there is concern for safety of human subjects.
3. Informed consent reviews may be scheduled by mutual convenience since it involves observing the consent process.

Review Procedures

Reviews may include, but are not limited to the following activities:

• Interviews of the principal investigator, co-investigators and/or research staff
• Review of randomly selected participant files to:
  • Determine whether the approved inclusion/exclusion criteria were met
  • Determine that participants were not enrolled until after all appropriate approvals were obtained
  • Determine whether the correct informed consent document(s) was utilized and that informed consent was obtained in the manner approved by the IRB
  • Determine whether the approved dose ranges of the study drug were administered
• Review of study files to:
  • Determine whether all of the amendments were reported before changes were implemented unless it was necessary to eliminate apparent immediate hazard
  • Determine whether adverse events and unanticipated problems were reported in a timely manner
  • Determine if the advertisements and other recruiting materials in use are the versions approved by the IRB
  • Determine whether the informed consent document complies with federal regulations
  • Determine whether IRB (RIO) and VA R&D administrative file(s) contain all modifications and adverse events submitted by the investigator
  • Determine whether IRB review was timely
  • Review projects to verify from sources other than the researcher that no unapproved changes have occurred since previous review
  • Monitor conflict of interest concerns to assure the consent documents include the appropriate information and disclosures
  • Determine if continuing reviews were completed within one year (or more often if appropriate)
  • Observe the consent process as determined necessary by the convened IRB (i.e., considered when a complaint is received regarding the informed consent process, or when investigator veracity is doubted)
  • Conduct any other monitoring or review activities as deemed appropriate by the IRBs
  • Confirm completion of compliance education for PI and research staff
  • Compare list of subjects (# enrolled/accrued) provided by the Investigator with continuation review report for consistency

Report of Review Findings

Based on the Quality Monitoring Review (aka Q-Review), identified serious or continuing noncompliance will be verbally reported immediately to the University of Nevada, Reno RIO Director. The chair of the IRB will be verbally informed within five business days.

• Examples of review observations that may be considered serious or continuing noncompliance:
• A pattern of no documentation or no evidence of informed consent from subjects enrolled in the research.
• A pattern that subjects did not meet eligibility criteria as stated in the IRB approved protocol.
• A pattern of changing or altering the IRB approved practices and procedures.
• The IRB approved practices and procedures not completed.
• Evidence of a serious adverse event or unexpected adverse event of moderate or greater severity that appears to be associated with the research intervention and was not reported to the IRB.
• Inadequate supervision of study conduct, study staff, oversight of subjects that puts subjects at increased risk.
• Initiating research activity prior to IRB approval.
• Enrolling or continuing to engage subjects in research related activities after approval of the study has expired.
• Misrepresentation of information related to the human subjects research protocol or performance of the research.
• Apparently intentional violation of laws, regulations or institutional policies governing the conduct of human subjects research.

A draft of the Report of Review Findings, prepared by the QI Officer who conducted the review, will be sent to the Principal Investigator, the Director of the Research Integrity Office, and the chair of the IRB within twenty business days of completing the review. The PI will have five business days, or a mutually agreed upon duration, to provide an explanation of the circumstances (extenuating or otherwise) that could account for certain findings, and an acknowledgement of findings requiring correction.

The response to the draft Report of Review Findings from the PI will be reviewed by the QI Officer, the RIO Director, and the chair of the IRB. The PI's response will also be reviewed by the IRB, which may include a discussion of any corrective actions that may be required. The PI will receive the final Report of Observations within ten business days after review by the IRB. This final report will also be sent to the IRB. Other invested parties such as the Principal Investigator's department chair and the Vice President for Research may receive copies at the discretion of the University of Nevada, Reno RIO Director.

Response to Review Findings

If a corrective action is indicated in the Final Report of Review Findings, the PI will be expected to submit a corrective action plan with ten business days of receipt of the Final Report of Review Findings, or on a mutually agreed upon date. University of Nevada, Reno RIO will review the Corrective Plan within ten business days of its receipt from the PI. The Corrective Plan must be approved prior to implementation.

After the QI Officer or other RIO staff confirms that the Corrective Plan has been successfully implemented, a close-out letter will be sent to the PI and to the IRB.

Educational Outreach

The Quality Improvement Officer is charged with developing, implementing and hosting educational opportunities for research personnel. Activities may include but are not limited to the following:

Study Start-up Visits: Close to the time that a study is approved or approved contingent by the IRB, the PI may request an education session for his/her research team tailored to his/her specific protocol. The QI Officer will educate the research team on what would be looked for in a review and will also review the plans for study conduct (e.g. plans for storage of investigational articles, plans for recruitment etc.) to ensure that all planned activity is consistent with the approved protocol, policies and regulatory requirements.

Brown-Bag Lunch Sessions: These sessions will be developed based on input from the research community as to their interest and needs and from the IRB, RIO staff, and QI Officer based on common errors that are seen. The sessions will be implemented at regular time intervals so that research personnel can plan accordingly to allow for attendance.

As Requested: The QI Officer is available to provide tailored educational sessions on human subject protections.