Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 157)

Section 5: Informed Consent 5.1 Q. FDA officials continue to discuss the agency’s development of a new and general guidance on informed consent. What is the focus of the new guidance, and what is its status? A. During 2010, FDA officials confirmed that a new informed consent draft guidance document had been developed and was in the government clearance process. “The informed consent document is still in the clearance process, in large part because we wanted this document to be as comprehensive as possible,” said Joanne Less, director of the FDA’s Good Clinical Practice Program. “We combined a number of information sheets, and so it turned into a rather robust guidance. In addition, during the clearance process, new issues/questions came up, so we made additional modifications to include those. We’re hoping to issue this guidance very soon.” Agency officials note that the new draft guidance will address a wide range of broad and special consent-related issues, including the elements involved in the consent process, recruiting clinical subjects, pediatric assent/parental consent in pediatric clinical trials, obtaining consent in non-English speaking participants, how the agency reviews informed consent documents submitted in INDs, and common misconceptions regarding the informed consent requirements and process. FDA officials now hope to issue the informed consent guidance in 2011. In its December 2010 Annual Guidance Agenda for 2011, the FDA noted that the new guidance “describes in detail basic and additional elements of informed consent and includes topics such as review of patient records, children as subjects, and subject participation in more than one study.” The FDA’s guidance agenda offered no timeline for the new draft guidance. 5.2 Q. In January 2011, the FDA issued a final regulation making the first change to its “basic,” or “essential,” elements of informed consent in years. What is the purpose and what are the implications of the proposed change? A. The change was mandated by The Food and Drug Administration Amendments Act of 2007 (FDAAA), which required the FDA to update its informed consent regulations to mandate that informed consent documents and processes for certain clinical investigations include a statement that information on such trials has been or will be submitted for inclusion in the U.S. government’s “clinical trial registry databank” (www.clinicaltrials.gov). The new statement now becomes the ninth basic element of informed consent (21 CFR 50.25). Under the final rule, the new, simplified statement (i.e., compared to the version published in a 2009 proposed regulation) in the informed consent document must read as follows: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” This statement will be required for any controlled clinical investigation, other than a Phase 1 clinical investigation, for any drug subject to sections 505 or 351 of the Federal Food, Drug, and Cosmetic Act. The new requirement will apply to any relevant clinical trials initiated on or after March 7, 2012. The FDA had noted that there will be several “benefits” to the new statement’s inclusion in informed consent documents, including the following: • It will increase public awareness of the existence of the database and thereby increase the transparency of clinical trials. • It will provide greater accountability and responsibility of investigators for outcomes and adverse events and improve the transparency of all clinical trials outcomes information. • It will increase public confidence in the validity of the research process. 5.3 Q. FDA regulations (Section 50.27(a)) establish that a copy of the informed consent form “shall be given to the person signing the form,” meaning the subject or the subject’s legally authorized representative. In certain trials, however, some subjects will sometimes not accept a copy of the form, due perhaps to the fact that the form documents that they have been diagnosed with the disease (e.g., they do not want to take it home, to work, or elsewhere and have others see that they have been diagnosed with a particular 157 http://www.clinicaltrials.gov http://www.ClinicalTrials.gov

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
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, Ukraine, 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 2012