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Adverse Event Reporting
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Clinical Trial Design
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Clinical Trial Monitoring
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Human Data and Specimens in Research
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Human Subjects Regulations
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Informed Consent
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Models of IRB Review
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Adverse Event Reporting
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Department of Health and Human Services
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Department of Health and Human Services: Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46
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OHRP Draft Guidance on "Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others"
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Food and Drug Administration:
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Adverse Event Reporting Requirements
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National Institutes of Health:
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NCI CTEP Adverse Event Reporting Guidelines
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Clinical Trial Design
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Food and Drug Administration:
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Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff (May 23, 2006) - This draft document discusses important statistical issues and provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods; it does not describe the content of a medical device submission.
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Guidance on Emergency Use of an Investigational Drug or Biologic (1998) - The emergency use of test articles frequently prompts questions from Institutional Review Boards (IRBs) and investigators. This information sheet addresses three areas of concern: emergency Investigational New Drug (IND) requirements; IRB procedures; and informed consent requirements.
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International Conference on Harmonization:
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Harmonized Tripartite Guideline: Statistical Principles for Clinical Trials (E9)
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IHarmonized Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials (E10)
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Clinical Trial Monitoring
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European Medicines Agency:
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Guideline on Data Monitoring Committees
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Food and Drug Administration:
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Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006
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National Institutes of Health:
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Policy for Data and Safety Monitoring (June 10, 1998)
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Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000)
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Office of Human Research Protections:
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Guidance on Continuing Review, Including Considerations for DSMBs and Similar Committees
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World Health Organization:
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Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Board
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Human Data and Specimens in Research
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Department of Health and Human Services
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Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46
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HIPAA Privacy Rule (Standards for Privacy of Individually Identifiable Health Information) at 45 CFR Parts 160 and 164
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OHRP: Engagement of Institutions in Research, guidance memorandum issued October 16, 2008
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OHRP: Guidance on Research Involving Coded Private Information or Biological Specimens, issued October 16, 2008
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Food and Drug Administration:
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Protection of Human Subjects. Code of Federal Regulations, 21 CFR Parts 50 and 56
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Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
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National Institutes of Health:
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Guidance on "Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule" (April 14, 2003; revised 7/13/04)
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Guidance on "Research Repositories, Databases and the HIPAA Privacy Rule" (July 2, 2004)
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Guidance on "Institutional Review Boards and the HIPAA Privacy Rule" (July 8, 2004)
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Office of Human Research Protections:
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Guidance on "Issues to Consider in the Research Use of Stored Data or Tissues" (November 1997)
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Guidance on "Engagement of Institutions in Research" ( January 26, 1999)
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Guidance on "Research Involving Coded Private Information or Biological Specimens" (August 10, 2004)
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International Compilation of Human Subject Research Protections
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Human Subjects Regulations
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Department of Health and Human Services
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Department of Health and Human Services: Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46
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Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations
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Office of Human Research Protections: 1993 IRB Guidebook
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Food and Drug Administration:
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Protection of Human Subjects. Code of Federal Regulations, 21 CFR Parts 50 and 56
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Significant Differences in FDA and HHS Regulations for the Protection of Human Subjects"
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Informed Consent
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Department of Health and Human Services:
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Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46
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Office of Human Research Protections (OHRP) Policy Guidance - Informed Consent (Provides a variety of useful OHRP reports and documents on the informed consent process, including tips for researchers and a checklist of elements to include in informed consent documents)
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OHRP FAQs - Informed Consent
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Food and Drug Administration:
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Protection of Human Subjects. Code of Federal Regulations, 21 CFR Parts 50 and 56
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Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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A Guide to Informed Consent (1998 - This document provides guidance on the informed consent process and the information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25(b), for studies that are subject to the requirements of the FDA regulations)
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Exception from Informed Consent For Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble (1998 - This document provides guidance on the narrow FDA regulatory exception to the requirement for informed consent to allow research on life-threatening conditions for which available treatments are unproven or unsatisfactory, and where it is not possible to obtain informed consent, while establishing additional protections to provide for safe and ethical studies)
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Exception From General Requirements for Informed Consent-FDAÂ’s Interim Final Rule at 21 CFR 50.23(e) (The Food and Drug Administration (FDA) issued this interim final rule to amend its medical devices regulations to establish a new exception to the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The exception applies when investigational in vitro diagnostic devices are used and the investigator is unable to obtain timely informed consent from subjects (or their legally authorized representatives) whose specimens are being tested, and delay in diagnosis could be life-threatening to the subject)
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Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDAÂ’s Interim Final Rule at 21 CFR 50.23(e) (This document addresses how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug AdministrationÂ’s (FDAÂ’s) interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent" (21 CFR 50.23(e)). This guidance only applies to clinical investigations that are conducted or supported by HHS)
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Models of IRB Review
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Department of Health and Human Services:
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Office of Human Research Protections Guidance on "Knowledge of Local Research Context"
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Office of Protections from Research Risks Report on "Local IRB Review of Multicenter Clinical Trials"
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Office of Human Research Protections Guidance on "The Use of Another InstitutionÂ’s IRB"
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Food and Drug Administration:
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Guidance on "Non-local IRB Review" (1998)
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Food and Drug Administration Guidance on Using a Centralized IRB Review Process in Multicenter Clinical Trials (2006)
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