Good Clinical Practice: A Question & Answer Reference Guide - May 2011 - (Page 275)

Section 8: Institutional Review Boards 8.1 Q. In recent years, several experts—including Koski (2008), Levine, and Frost among others—have spoken about increasing pressure for reform in the U.S. IRB system. Has such pressure and have similar calls for reform continued more recently? A. Yes. In a 2011 article entitled, “Are IRBs Ripe for an Overhaul?” (Korieth), CenterWach noted that, “as frustration with the expansive mission and bureaucracy of Institutional Review Boards (IRBs) builds, it has become clear that the current system for protecting research subjects needs a radical overhaul… As criticism of inefficient IRB processes grows, the oversight system for protecting volunteers has begun to lose credibility and respect among some investigators, IRBs, institutions and the public.” While acknowledging the growing challenges facing IRBs in the face of a rapidly evolving clinical research landscape, Christine Grady, R.N., Ph.D., of the NIH’s Department of Bioethics recently called for new efforts to address concerns over the state and effectiveness of the IRB system. In a September 2010 commentary in the Journal of the American Medical Association (JAMA), Grady noted that, “multisite research, expansion into international and community settings, novel scientific opportunities, freezers of stored samples, expanded categories of researchers, and entities including contract research organizations, data and safety monitoring committees, clinical trial coordinating centers, and commercial IRBs have transformed the clinical research enterprise. Concurrently, the number of, investment in, and responsibilities of IRBs have increased… In addition to compliance with human subjects regulations, IRBs are often responsible for review of scientific merit, conflicts of interest, and compliance with privacy regulations. “Institutional review boards are described as dysfunctional, in crisis, and ‘…more concerned with protecting the institution than research participants.’ Researchers, institutions, and some IRB members complain about burden and ‘mission creep’—the excessive paperwork, inflexible interpretation of regulatory requirements, attention to inconsequential details, and expanding obligations of IRBs that seem to have little to do with protection of research participants… Over decades, scores of studies have concluded that IRBs are inconsistent in their judgments and variably apply a standard set of regulations… Although available data suggest a need for more efficiency and less variation in IRB review, neither efficiency nor consistency gauges effectiveness in protecting research participants… Serious efforts are needed to address these concerns and provide evidence of IRB effectiveness….” Grady noted that the clinical research ethics group of the NIH-funded Clinical and Translational Science Awards Consortium has started work to identify measures of IRB quality “to investigate how well IRBs protect the rights and welfare of research participants while promoting ethical research.” Such efforts should be supported, Grady emphasizes, “to determine how effective IRBs are at achieving their goals and whether they are worth the substantial investment of time and resources.” 8.2 Q. Although there have been significantly fewer IRB inspections by the FDA in recent years given the limitations of agency resources (see Q8.23), are there any signs of greater oversight of IRBs in light of the new requirement for IRB registration (see Q8.15) and the fallout from the Coast IRB case? A. There are several signs. Specifically, CDER’s Division of Scientific Investigations (DSI) has undertaken a number of recent steps to provide a greater focus on IRBs: • As DSI officials first discussed in 2009, the division has now reconstituted its Human Subjects Protection (HSP) team within DSI. The HSP team will “provide a focus for our IRB inspections and other human subject protection issues,” noted Leslie Ball, M.D., DSI’s director, during a 2010 interview. Another focus for the HSP team has been inspecting Radioactive Drug Research Committees (RDRC), for which CDER maintains an inspectional compliance program, Ball adds. • CDER’s DSI has also received additional funding to develop a “quantitative risk-based site selection tool” for IRB inspections, similar to the one that has been developed for clinical investigator inspections. When developed, says Ball, the tool will support a “more quantitative approach to selecting IRBs for inspection,” and will be based on selected risk factors. 275

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2011

Good Clinical Practice: A Question & Answer Reference Guide - May 2011
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2011