Post-Approval Compliance Monitoring: A Responsibility of the Human Research Protection Program (but how to do it?)

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1 Post-Approval Compliance Monitoring: A Responsibility of the Human Research Protection Program (but how to do it?) Monika S. Markowitz, PhD Director, Office of Education and Compliance Oversight Office of the Vice President for Research Virginia Commonwealth University June 26, 2008

2 Objectives This presentation will discuss: Post approval compliance monitoring (PACM) conducted on behalf of the Human Research Protection Program. Requirements and guidance for PACM by regulatory and accreditation agencies Purposes of PACM and some examples Taking the police out of PACM, and fostering an education and ethics approach VCU s s model

3 What is PACM? Monitoring the conduct of the research after the IRB has issued initial approval. Does the research adhere to the IRB-approved terms? Required post-approval monitoring exists in IRBs: Continuing Review, at least annually for non- exempt research Review of amendments or modifications Review of reported problems Monitoring beyond the IRB submissions: Site visits?

4 A PACM Process Is it QA? Is it QI? - for the IRB? - for the institution s s human research protection program?

5 A PACM system may maintain or improve IRB function: Audit of IRB records Audit of the conduct of the research Does (or should) the purpose of PACM go beyond assessing or evaluating the IRB?

6 Facilitating a trusting environment Education, education, education Researchers need to know what to do in order to do it right! - To all research constituencies - Varied programming with required baseline training (e.g., CITI) Availability of experts for questions IRB consultations, research ethics consultations Taking investigators/research staff at their word, unless evidence to the contrary Does PACM undermine trust?

7 Reliance on trust: How much do you trust, how much do you verify? Trust Assured reliance on the character, ability, strength, or truth of someone Applying the Belmont principle of respect for persons to investigators >>>> ought they be trusted to fulfill their responsibilities? Role of professional ethics?

8 How is PACM described in federal regulations? Common Rule Additional FDA regs for complete documentation and sponsor-required required monitoring

9 The Common Rule 17 signatory agencies, including including DHHS, FDA, and DoD 45 CFR (e), 21CFR (f), 32CFR219 An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research. 45CFR46.111(a)(6), 21CFR56.111(a)(6), 32CFR219 IRB ensure that when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

10 Findings of Noncompliance by OHRP

11 Additional FDA regulations 21CFR (drug) An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator agreement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator s s care; 21CFR (a) (device) accurate, complete, and current records for all subjects in a device study 21CFR Sponsors are responsible for. ensuring proper monitoring of the investigation

12 Guidance about PACM From regulatory agencies ICH Good Clinical Practice (GCP) Guidelines AAHRPP

13 OHRP QA Self-Assessment Tool Date Completed: SECTION A. INSTITUTION S S HUMAN SUBJECTS PROTECTION PROGRAM This section collects information to assess your institution s s or independent IRB s s overall human subjects protection program. 1. Name of Institution or Organization: 3. Institutional Review Board (IRB) Organization Number (IORG #): This number, assigned by OHRP, can be found on the OHRP website at 4. a) Name of Contact Person: b) Title: c) Phone: d) Fax: e) E General Administrative Information on the IRB Component of the Human H Subjects Protection Program 5. How many IRBs are operated or supported by your institution? Include special situation IRBs (e.g., prisoner research, emergency use, etc.). 6. Who oversees the day-to to-day operations of the human subjects protection program? 7. To whom does the IRB(s) report? 8. Does the IRB(s) have its own budget? 9. Who authorizes budget support for the IRB(s)? 10. Does the IRB(s) have a written Charter or Charge? 11. Does your institution or organization have an organizational chart for your human subjects protection program? 12. Who appoints the IRB Chair(s)? 89. Does the IRB monitor or require monitoring of any studies? If yes, please describe when and how. Total 19 pages

14 IRB Guidebook 1993 The responsibility for continued monitoring of approved research is as important as the initial review and approval. It is only after research has begun that the real risks can be evaluated and the preliminary results used to compute the actual risk/benefit ratio; the IRB can then determine the correctness of the initial judgment. Some IRBs have set up a complaint procedure that allows subjects to indicate whether they believe that they were treated unfairly or that they were placed at more risk than was agreed upon at the beginning of the research. A report form available to all researchers and staff may be helpful for informing the IRB of unforeseen problems or accidents. The IRB may find that scheduled progress reports are an effective means of monitoring some research.

15 U. S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) TERMS OF THE FEDERALWIDE ASSURANCE (FWA) OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with,, the following: relevant ethical principles; relevant federal regulations; written IRB procedures; OHRP guidance; other applicable guidance, state and local laws; and institutional policies for the protection of human subjects.

16 INFORMATION SHEETS Guidance for Institutional Review Boards and Clinical Investigators 1998 Update A Self-Evaluation Checklist for IRBs DOES THE INSTITUTION HAVE WRITTEN POLICIES OR PROCEDURES THAT DESCRIBE: I.THE INSTITUTIONAL AUTHORITY UNDER WHICH THE IRB IS ESTABLISHED AND EMPOWERED.æ II.THE DEFINITION OF THE PURPOSE OF THE IRB, i.e., THE PROTECTION N OF HUMAN SUBJECTS OF RESEARCH. III.THE PRINCIPLES WHICH GOVERN THE IRB IN ASSURING THAT THE RIGHTS AND WELFARE OF SUBJECTS ARE PROTECTED. IV.THE AUTHORITY OF THE IRB. A. The scope of authority is defined, i.e., what types of studies s must be reviewed. B. Authority to disapprove, modify or approve studies based upon consideration of human subject protection aspects.4 * C. Authority to require progress reports from the investigators and oversee the conduct of the study.5 * D. Authority to suspend or terminate approval of a study.6 * E. Authority to place restrictions on a study.7

17 GUIDELINE FOR THE MONITORING OF CLINICAL INVESTIGATIONS U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs January 1988 (Minor editorial and formatting changes November 1998) Purpose The purpose of this guideline is to present acceptable approaches to monitoring clinical investigations. Existing requirements for sponsors of clinical investigations involving new drugs for human and animal use (including biological products for human use) and medical devices under 21 CFR Parts 312 and 511, and 812 and 813, respectively, require that a sponsor monitor the progress of a clinical investigation. igation. The monitoring functions may be delegated to a contract research organization as defined under 21 CFR Proper monitoring is necessary to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted to the Food and Drug Administration (FDA).

18 Good Clinical Practice Quality Assurance Audits In-house audits: sponsor/monitor audits, investigator file audits, informed consent audits Site Audits auditing case report forms (CRFs) and source docs, auditing informed consent forms, auditing study article conditions, auditing facilities and equipment, auditing site personnel qualifications and training

19 STANDARD I-2: I The Organization assures the availability of resources sufficient t to protect the rights and welfare of research participants, taking into consideration the research activities in which they are asked to participate. I.2.C. The Organization provides resources that are necessary for human research protection, care of research participants, and safety during the conduct of the research. STANDARD I-3: I The Organization monitors compliance of all those involved in the research process. I.3.L. The Organization implements a plan to measure and improve Human Research Protection Program effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.

20 PACM is permitted, even encouraged but what should it look like? IRB has the opportunity to re-review review the study when re-submitted >>> revisit risk/benefit assessment, informed consent process, recruitment plan Monitor investigator s s adherence to terms of IRB approval

21 Sampling of terminology used for PACM nationally Compliance review Quality Assurance activities Audit Compliance Monitoring and Audit Process Quality Improvement Reviews Post approval monitoring and education: IRB Support Visits

22 Principles contributing to a successful PACM site visit program Adapted from Bankert & Amdur, IRB: Management & Function,, 2006 Immediate objectives and long term goals fit the institution and its needs Obtain administrative endorsement and support, including adequate resources Adequate staff, experience, and superior interpersonal skills

23 More principles PACM program is proactive and educational in approach. All investigators and research staff are educated about the goals of the PACM program. Engage researchers in development of the program. Perform ongoing quality control of the PACM program and adjust as needed.

24 VCU s s Model for PACM VCU employs a comprehensive approach to post-approval monitoring through: 1. Continuing Review (including review of modifications and Unanticipated Problems 2. Voluntary Post-Approval Study Evaluations (PASE); 3. Post-Approval Monitoring & Education Visits - Not for Cause ( Random( Random ) and - For cause (Requested, a a feeling ) Problems involving Risk to Subjects or Others);

25 Post-Approval Monitoring and Education Visits at VCU Emphasis on education and support IRB Support Visits - Not-for for-cause - For cause

26 Tools/resources for PACM VCU Human Research Protection Program Policy Written Policies & Procedures HRPP Quality Assurance/Improvement Elements Post-Approval Monitoring of IRB-Approved Protocols Post-approval self-evaluation evaluation tool

27 Post-Approval Self-Evaluation Tool Specific Uses Include: Study Site or Investigator Use for the purposes of: Training new research personnel Preparing for institutional, sponsor, or regulatory site visits A Routine Quality Improvement exercise. By, or at the request of, the OECO as part of a random or for-cause IRB Support Visit (or Site Visit).

28 VCU IRB Post-Approval Study Evaluation SECTION NAVIGATION: click to go directly to the following sections: [based on GCP requirements] Regulatory Documentation IRB Documentation Subject Recruitment Procedures Informed Consent Process Subject Selection Criteria Unanticipated Problem (a.k.a. AE/SAE) Reporting Protocol Violations/Deviation Reporting Drug/Device Accountability Recordkeeping

29 Priority research elements targeted for PAME/IRB Support Visits Full Board studies >>>greater than minimal risk Expedited studies if quite complex Vulnerable subjects involved Non-WIRB review No review by Cancer Center or GCRC No external funding or no other review Difficulty with appropriate submissions Referral by the IRB

30 How qualifying studies identified Continuing review agenda Amendment review agenda Frequent calls with questions Submitting non-current documents Continued tabling due to apparent PI confusion Identified issues at CR low enrollment, frequent amendments, changes to risk

31 General steps for IRB Support Visit Preparatory Identify qualifying studies Ascertain approval and funding status Contact investigator and coordinator with invitation, proposed schedule options, goal of Visit; target 1 hour When confirmed, invite IRB reviewers, coordinator, Chair to attend Visit Investigator is apprised of additional visitors, optional completion of PASE tool, conversational focus, availability of records IRB file read in advance record of initial review, CR s, changes in research, reported problems

32 General steps for IRB Support Visit During the Visit A member of OECO is the lead Visitor. Other Visitors also ask questions, make comments. Walk through conversation about recruitment, enrollment, study visits, follow-up; other issues of IRB interest Problem solve concerns/irritations with conduct of study (low enrollment, space, follow-up with subjects) Recommendations and/or reinforcement Verbal summary of Visit, findings identified, recommendations made

33 General steps for IRB Support Visit After the Visit Draft report shared with other Visitors for accuracy and clarity Edited draft shared with investigator for comment Final sent to PI, Chair, reviewers, IRB file Process evaluation form sent for optional completion Listed on convened Panel agenda as IRB Support Visit Report given to reviewers at CR

34 Initiating the PAME: IRB Support Visit program Structure of Visit and PASE tool developed Proposed to IO and IRB chairs Brought before IRB members IRB member/ investigators piloted the process Broadcast announcement to investigators, coordinators, administrators; 4 th Friday program for research coordinators; listed under IRB News; VP of Research announced to leadership

35 Assessment and Follow-Up Findings of concern or those needing correction directed to IRB and reviewers Summary spreadsheet of Visits and findings Followed by University s s Internal Audit program Monitoring time spent, evaluations received

36 Positive Aspects of IRB Support Visits Visibility of IRB and HRPP to investigators/ departments PI and IRB reviewers/coordinator meet IRB reviewers develop context for PI s s research with appreciation of constraints Educational; problem solving PIs enjoy talking about their research; appear to appreciate the IRB as a partner in ethics and compliance Investigators have increased comfort level in later seeking advice or guidance Highly respectful toward investigators; well-received by investigators

37 Constraining Aspects Very time-consuming Limited number of Visits can be conducted

38 Resources at VCU for PACM VCU IRB Homepage VCU Human Research Protection Program Policy VCU IRB WPP X-3: X Post-Approval Monitoring of IRB-Approved Protocols Post-Approval Study Evaluation (PASE) VCU IRB WPP VIII-4: Continuing Review VCU IRB WPP II-4 HRPP Quality Assurance/Improvement Elements

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