800. Quality Improvement Program (QIP)

Updated Oct. 4, 2019

The mission of Research Integrity and the IRB is to verify and promote the continual ethical conduct of research.  The HRPP has a quality improvement plan that periodically assesses compliance with organizational policies, applicable laws, regulations and ethical principles. The Quality Improvement Program (QIP) is committed to providing on-going support and services aimed to update and educate the research community of applicable regulations and University policies and procedures governing the conduct of human subjects research. QIP shall focus on key areas of the HRPP including IRB operations, investigator activities, study subject comprehension, IRB member review activities and recordkeeping.

Purpose

The purpose of the Quality Improvement 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.
  1. To create opportunities to educate and support the research community.

Objective

The objective of the University’s Quality Improvement 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. Quality Improvement Program is to educate researchers on the mechanisms by which human subjects are protected. In keeping with this intent, results of routine Post Approval Investigator Reviews or Internal Reviews are not shared with the Institutional Review Board (IRB) unless significant or serious deficiencies in human subject protections are found. QIP consists of four overall objectives, 1) compliance, 2) quality, 3) effectiveness and 4) efficiency.

Selection of Studies

The majority of studies will be selected at random for review. However, consideration for selection of projects or for increased frequency of reviews may be given to:

Higher risk studies

Investigator-initiated protocols

Studies that include vulnerable populations such as UNR employees and students, terminally ill and decision-impaired, or identified in 45CFR46 subparts C and D, pregnant women, fetuses, neonates, prisoners, and children.

Potential for conflict of interest

“Directed” interests of the IRB or UNR RI

Investigator history of noncompliance that suggests a lack of understanding about the protection of human participants

Research involving investigational drugs or devices for which a new safety warning or changes in labeling suggest increase risks

Data confidentiality or security concerns

Types of Quality Reviews of Research Team Files and Activities

Administrative Internal Assessment Review:  Administrative assessment reviews are conducted by the Research Compliance Officer (RCO) and are initiated at the discretion of the Director of RI, and/or Chair IRB. Any IRB member of Research Integrity (RI) staff member may suggest procedures or process for internal review.  A thorough examination of the IRB records may be conducted for improvement of management or to evaluate the procedures applied and/or issues addressed by the RI staff and the IRB for protection of human subjects in research. The review may be specific to the IRB member completing the regulatory review. The results of an administrative assessment are shared with the RI Director. The results may affect current practices and may require additional educational activities for RI staff, IRB members.  The purpose of the review is to monitor internal practices by RI staff and/or IRB members but possible noncompliance may be discerned regarding the investigators/study personnel. The RI Director and/or Chair may request a directed on-site review or a consent conference review.

Random Scheduled Investigator Post Approval Review: 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.

Directed On site Review:  This review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or RI. 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.

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 or RI Director 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.

Periodic Assessment of Outreach Activities: The IRB Chairs, Director and RI staff will meet at least once a year to evaluate the IRB outreach to participants, researchers and IRB members. Assessments may include interviews, surveys, focus groups, written evaluations and website feedback.

VA Research: 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. If the RCO identifies apparent serious or continuing noncompliance, RCO must report it directly to the facility director and copy for ACOS Research, the R&D Committee and the IRB no later than 5 business days after the discovery of the potential non-compliance.

Methods to Assess Compliance

These audits and reviews are designed to assess compliance with local, state, and federal laws; research participant safety; and HRPP policies and procedures. Audits and reviews are designed to identify standards of excellence and potential areas for improvement in order to promote a solid foundation for the conduct of human subjects research, while maintaining compliance with the federal regulations.

Annually, a meeting is held by the Research Compliance Officer, Director and RI staff members in which a quality improvement plan with specific focus on 1) quality, 2) effectiveness and 3) efficiency of the HRPP is delineated.  The annual plan is developed and put into place, to be carried out by an assigned RI staff member to assess compliance and measure targeted levels of quality, efficiency, and effectiveness of the HRPP during the fiscal year. Each quality improvement focus for the fiscal year will be recorded in IRBNet with access for all RI staff members. The conduct of the audit/review for the focused quality improvement focus will be monitored at monthly RI staff meeting. 

The plan will, at a minimum, contain:

  • The goals of the quality assessment/improvement plan with respect to measuring effectiveness, identifying opportunities for improvement and achieving and maintaining targeted levels of quality, efficiency, effectiveness and compliance
  • At least one objective to achieve or maintain compliance is defined
  • At least one measure of compliance is defined
  • The methods to assess compliance and make improvements are described
  • At least one objective of quality, efficiency, or effectiveness is defined
  • At least one measure of quality, efficiency, or effectiveness is defined
  • The methods to assess quality, efficiency, or effectiveness and make improvements are described

Results of the plan are reviewed by the Research Compliance Officer and RI Director to identify trends and to determine if systemic changes are required. If so, the Research Compliance Officer, RI Director and other relevant parties (such as the IO, the IRB Chair) will collaborate in the development of a corrective action plan, its implementation, and evaluation of its effectiveness. Documentation of the assessment and improvement (if any) will be documented in IRBNet.