Marshall University

Huntington, WV

  

SUBJECT:  Quality Assurance/Quality Improvement

 

PURPOSE:  To provide guidance on the Quality Assurance/Quality Improvement Program for the Marshall University Human Research Protection Program (HRPP).   The goal is to increase the quality and performance of the HRPP as well as to ensure compliance with federal regulations.  The Quality Assurance portion of this program will assess the strengths and weaknesses of the HRPP and the Quality Improvement portion of the program will continually improve the performance of the HRPP. 

 

POLICY:  Our policy is to assess, monitor, and improve the performance of the HRPP, IRB, and the research activities.   The key to performance improvement is the concept of continually striving to improve outcomes.  The Office of Research Integrity is subject to periodic assessment for purposes of assuring the protection of human research subjects through compliance and quality improvement activities.  Such assessments will determine the extent to which the HRPP complies with Federal regulations and its SOPs, and the adequacy of its processes and documentation.

 

SCOPE:  This policy covers all aspects of Human Research Protection Program as well as research investigators and their staff.  All research involving human subjects conducted at Marshall University, whether funded or unfunded, are within its purview.

 

RESPONSIBILITY:

 

The Office of Research Integrity is responsible to the Institutional Official for maintaining high standards throughout the facility’s HRPP.  These standards include those assuring the scientific quality of the research projects and the protection of human rights and safety.  The Director of the Office of Research Integrity conducts ongoing monitoring of the IRB by reviewing the IRB monthly minutes and conducting independent reviews.

 

The IRB Chairman and the Director, Office of Research Integrity are jointly responsible for taking an active leadership role in performance improvement of the HRPP.  They are responsible for developing an effective and systematic approach to assessing and improving the HRPP performance.  The Director, Office of Research Integrity (ORI) has the overall responsibility for the planning, development, staff orientation/education, conduct, validation and reporting of the outcomes of the quality improvement program for the MU HRPP.  He/she is responsible for evaluating performance and adherence to applicable federal regulations, state laws and accreditation standards, which govern human research.  The Director, ORI will also conduct an annual review of the organization's participant outreach activities and consider any changes that may be needed.

 

IRB members, research staff, investigators and their staff are responsible for identifying opportunities for improvement and for participating in performance improvement activities.

 

The IRB Coordinator maintains a file of quality improvement projects/activities.  The data includes the area identified needing improvement, what action(s) taken to improve, and any results of QI activities.  Where possible pre- and post-evaluation measurements are included.

 

 

Programs - Quality Assurance/Quality Improvement

 

The MU HRPP Quality Assurance Program periodically performs self-assessments, audits the research activities, and surveys human subjects.  The Quality Assurance approach includes the systematic collection and analysis, review of adverse outcomes, and resolution of individual problems.  The QA program covers the utilization of self-assessment tools, the review of SOPs, and other monitoring tools to assess the performance in relation to the federal guidelines.  The IRB evaluates effectiveness and conducts quality improvement activities on a continual basis.  Research Satisfaction Surveys will be sent to participants in one ongoing and one completed study on a semi-annual basis.  These studies will be selected at random and a summary of the results will be provided to the principal investigator of the study. 

 

Any problems identified are addressed and appropriate corrective action (e.g., change policy, procedure, communication, implements education or other such intervention) is taken to improve the process.  The effects of the corrective action are assessed within a reasonable time frame to assure the action taken was effective.  Any changes to the research activity, SAEs, Safety reports, protocol violations and non-compliance issues are reported and discussed at the IRB monthly meeting.  Any urgent concerns are discussed immediately with the IRB Chairman and the Director, ORI for their immediate attention.  The ProIRB tracks the information and the ProIRB History of each protocol is reported at least annually.

 

When the research protocol involves an investigational device, the IRB will monitor the storage, security, and dispensing of investigational devices to ensure compliance with policies.  Any compliance violations will be investigated, corrected, and reported at the next monthly IRB meeting.

 

 

Procedure – IRB

 

The IRB activities that may be monitored include but are not limited to:

1)      Informed Consent Documents

2)      IRB Minutes

3)      IRB SOPs

4)      Education

5)      Protocol and Application Packets

 

1)      Informed Consent Documents

The informed consent document review will be conducted on an annual basis.  The informed consent process including appropriate filing and documentation will be evaluated by the Director, ORI or his designee.  The following items will be reviewed in the informed consent:

      ·  Presence or absence of all required elements

      ·  Consent obtained prior to initiating research

      ·  Consent signed, dated and documented in patient’s record

      ·  Use of exculpatory language

      ·  Presence or absence of discrepancies between the protocol application and the informed  

          consent document regarding the purpose, risks, and benefits of the research.

       

When evaluating the informed consent document the Director, ORI or his designee will give special consideration to documents approved for the following populations:

      ·  Employees

      ·  Homeless

      ·  Subjects likely to need surrogate consent

      ·  Subjects participating in high risk studies

 

2)      IRB Minutes

The Director, ORI or his designee reviews the IRB minutes monthly and a thorough monitor is conducted semi-annually.  The minutes are monitored to assure compliance with regulations.  The regulations require that minutes of IRB meetings be in sufficient detail to show:

            ·  Attendance at the meetings

            ·  Actions taken by the IRB

            ·  The vote on these actions including the number of members voting for, against, abstaining and number recused

            ·  The basis for requiring changes in or disapproving research

            ·  A written summary of the discussion of controverted issues and their resolution

            ·  Consideration of additional safeguards for vulnerable subjects

            ·  Documentation of risk assessment and approval period

 

3)      IRB SOP

The Director, ORI  or his designee will monitor new regulations and update the appropriate SOP accordingly.  The Director ensures the newly updated SOP remains in compliance with the applicable federal regulations and institutional policies.  This will be done on a continuing basis and documented in the SOP.  All SOPs will be reviewed and approved by the IRB annually.

 

4)      Education

The IRB Coordinator will review the training records of the IRB members and the investigators and his/her research staff on a semi-annual basis to assure compliance with the educational requirements.

 

5)      Protocol and Application Packets

The IRB Coordinator will review individual IRB protocol files to ensure that there is documentation within each file of the IRB’s actions and activities for that protocol.  He/she will annually monitor the following:

  ·  Initial Review and Approval of protocol prior to initiating research study

  ·  Monitoring Ongoing Research – SAEs and miscellaneous document notifications

  ·  Continuing Review conducted prior to expiration of previous approval period

  ·  Study Closure

 

 Procedure - Investigators

 

The principal investigator (PI) is responsible for the conduct of the research study.   He/she has the authority to delegate responsibility to members of the research team; however, the PI is ultimately responsible for the overall conduct of the study.  If during routine QA/QI activities a PI or his staff is found to be in non-compliance with the federal regulations or institutional policies, the non-compliance will be reported to the IRB, the Director, ORI, and the Institutional Official.

 

The investigators and their staff are subject to periodic assessment for purposes assuring the protection of human research subjects.  Monitors will include (1) consent process,  (2) study conduct, and (3) compliance with applicable regulations, policies and guidelines.  The results of these reviews will be used for purposes of quality improvement and actions taken, as needed.

 

(1) Consent Process

 

The ethical conduct of human research is based upon the voluntary consent of the subject who has been appropriately informed about a study’s risks and benefits.  It is the responsibility of the investigator to ensure that all federal and state regulations have been met through the language of the informed consent document, and that informed consent itself has been properly obtained from the subject or the subject’s legal representative.  Documentation of the informed consent process is required to establish that the subject was accurately and adequately informed and that no study-related procedures were initiated prior to obtaining informed consent.  The Director, ORI or his designee will audit and evaluate the effectiveness of the consent process on a yearly basis, on selected active project.  This evaluation will include documentation that the following procedures have been followed:

 

            ·  Consent has been obtained prior to initiating any research related procedures

            ·  Only the IRB-approved consent form has been used

            ·  The consent form has been signed and dated by the subject (or subject’s legally authorized

                representative) and the individual providing the information to the subject

            ·  The subject’s case history documents the consent process with an appropriate note and

                original signed consent document

            ·  There is documentation that the subject or the subject’s legally authorized representative was

                provided a copy of the consent form

 

The survey and monitoring of informed consent is designed to improve the consent process, ensure compliance with federal regulations on informed consent and educate investigators and study staff about the informed consent process.

                                                                                                                                                                          

(2)  Study Conduct

Human subject selection must be in accordance with the inclusion/exclusion criteria to ensure maximal subject safety during the protocol.  The safety and well-being of subjects is the primary concern.  Close monitoring and careful assessment of subjects will enable the investigator to detect adverse events in the earliest stages and respond immediately with appropriate treatment.  The research investigator and his staff must pay close attention to the subject’s safety as well as to the integrity of the data collected.  The Director, ORI or his designee monitors the protocols annually by reviewing the following:

 

            ·  Use of only IRB-approved advertisements and subject recruitment materials

            ·  Adherence to inclusion/exclusion criteria

            ·  Adherence to IRB-approved protocols and conditions

            ·  Obtaining IRB approval prior to initiating changes to the protocol or consent form, except

                where necessary to eliminate apparent immediate hazards to subjects

            ·  Reporting adverse events

            ·  Reporting all unanticipated problems involving risks to human subjects

            ·  Reporting all protocol deviations

            ·  Reporting of protocol modifications

           

Special consideration is given to studies involving the following:

            ·  Investigators with numerous studies

            ·  New investigators

            ·  Investigators with studies outside their normal therapeutic interest

            ·  Vulnerable subjects

            ·  Subjects likely to need surrogate consent

            ·  Subjects participating in high risk studies

 

(3) Compliance

The Principal investigator has the authority and responsibility for the ethical conduct of the study and compliance with federal regulations.  Part II of the Initial Protocol Application contains the Certification and Assurance document that specifies the PI’s compliance responsibilities.  By signing the application, the PI agrees to comply with the federal guidelines upon which this document is based.  The PI has the authority to delegate responsibility to members of his research team; however, he is ultimately responsible for the conduct the study and compliance with federal regulations.  If during QA/QI activities the PI is found not to be in compliance, the non-compliance will be reported to the IRB, Director of the Office of Research Integrity, the Institutional Official, and other appropriate University officials.

 

 

The Process Improvement Outcomes

The results of the process improvement investigation are reported on the Performance Improvement Report form (Attached).  This report is critical to communicating the Director’s findings and the ability to properly demonstrate the results of process improvements or the needs for additional improvements.  The report identifies the process targeted for improvement and:

·  Why it was important to improve this process (i.e. high risk area or problem prone area)?

·  What was measured (i.e. timeliness, effectiveness, safety, direct compliance)?

·  What was the level of performance at baseline?

·  Why the process was not performing at the desired level?

·  Relationship to external or internal benchmarks (i.e. other organizations, accreditation standards, federal regulations)?

·  What interventions or changes were made?

·  What were the outcomes or results of the changes?

·  What actions are now required to maintain or sustain the positive change?

·  Other actions that may be necessary to make additional improvements to the process.

 

 

 

 

FOLLOW-UP RESPONSIBILITY: Director, Office Research Integrity

 

 

 

Revised 5-1-2007

 

 

Marshall University

Office of Research Integrity

Huntington, West Virginia

 

PERFORMANCE IMPROVEMENT REPORT

 

Function:  Human Research Protection Program

 

Plan:

What is the process targeted for improvement?

What is being measured and why [high  risk/problem prone]?

 

Measure	Baseline or Previous Results/Date	Current Results/Date	Benchmark
Informed Consent
Required (8) elements present
Consent obtained prior to initiating research
Signed and dated
Consent documented in patient’s record
Patient received a copy of consent
No use of exculpatory language
Membership
Appropriate for research reviewed
Community member present at all meetings
All members completed required education
Members with conflict of interest abstain from voting
Membership meets federal requirements
Minutes
Attendance – alternates substituting for identified   Member
Vote illustrates for, against and abstain
Summary of discussion
Consideration of additional safeguards for vulnerable subjects
Documentation of risk assessment and approval period
Discussion/Analysis of risks and benefits
Complaints/Noncompliance/Misconduct
Complaints were addressed timely and appropriately
Allegations of misconduct/improprieties are reported immediately
Allegations of misconduct/improprieties are   investigated and resolved satisfactorily
Measure	Previous Results/Date	Current Results/Date	Benchmark
Investigational Drugs
Receipt