RESOURCES
HISTORICAL & REGULATORY
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Belmont Report
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The Office of Human Research Protections (OHRP) considers it unethical for anyone involved in human subject
research not to have read the Belmont Report. It describes and explains the ethical principles that should be followed by such investigators: respect for persons,
beneficence and justice.
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Council for International Organizations of Medical Sciences
(CIOMS)/World Health Organization (WHO) -
Created International Ethical Guidelines for Biomedical Research Involving Human
Subjects and includes 21 Guidelines and focuses on the need for Scientific
Review, Ethical Review and the responsibilities of the IRB.
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Declaration of Helsinki
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Reinterpretation of
Nuremburg code and set the stage for IRB’s/Ethics Review Boards.
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Food & Drug Administration (FDA)
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Home page includes forms, Guidance documents, Federal Regulations, for the use
of Investigational drugs, biologics and devices.
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Biological Products (21 CFR 600)
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Bioresearch Monitoring Program
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Sample
Warning Letters
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Conflict of Interest regulations (21 CFR 54)
- FDA requires investigators to document their financial
interests for every study they are working under FDA jurisdiction.
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Information Sheets
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A publication of the Food and Drug Administration (FDA), that provides guidance
to both the Institutional Review Board (IRB) and research investigators in
carrying out their responsibilities relative to the protection of human research
subjects. It covers clinical investigation requirements for research on drugs
and biologicals, and medical devices.
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Institutional Review Boards (21 CFR 56)
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Investigational New Drug Applications (21 CFR 312)
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Applications for FDA Approval to Market a New Drug
(21 CFR 314)
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Investigational new drug application Guidance
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Conducting investigational drug trials
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FDA brochures for
clinical investigators.
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Investigational
Device Exemptions (21 CFR 812)
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Pre-Market Approval of Medical Devices (21 CFR 814)
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Device Advice
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Provides information to Sponsors, Institutional Review
Board (IRB) and research investigators on clinical trials and devices.
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Protection of Human Subjects (21 CFR 50)
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Sponsor/Cooperative Group Monitoring
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Sponsor (CRA) responsible
for monitoring each clinical site on a regular basic to ensure that the study
site staff conduct, record, and report the study according to the protocol,
sponsor’s standard operating procedures (SOPs), Good Clinical Practice
(GCP), ICH Guidelines and FDA requirements and looks
at Case Report Forms (CRF), verification of source data, regulatory documents
and help make corrections
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Historical Background
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Timeline
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Nuremberg Code
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Stemmed from Nazi
trials for research experiments that occurred in concentration camps in German
during WWII, focuses on the need for
Informed consent, prior animal work, risks should be justified by the
anticipated benefits, qualified scientists must conduct research, physical and
mental suffering must be avoided and research in which death or disabling injury
is expected should not be conducted.
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Good Clinical Practice: Consolidated Guidance
- Brings
together the regulatory authorities of Europe, Japan and the United States and
experts from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of product registration.
This is a publication of the DHHS, FDA, Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER) which describes the international ethical and scientific quality
standard for conducting research in human subjects. This document was endorsed
by the International Conference on Harmonisation (ICH) in April 1996 and
published in the Federal Register May 1997. This document addresses issues
relative to IRBs, investigators, sponsors, clinical trial protocols,
investigator brochures, and essential documents for the conduct of a clinical
trial.
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Health Insurance Portability and Accountability Act
(HIPAA) in Research
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National Institutes of Health (NIH)
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Conflict of Interest Code of Federal regulations (42
CFR 50)
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Office for Human Research Protections (OHRP)
- Includes
information on IRB Registration and Assurances, Regulations, Guidance,
Educational resources, compliance oversight, conferences, etc.
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45CFR46
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Code of Federal
Regulations Title 45: Public Welfare. Department of Health and Human Services,
National Institutes of Health, Office for Protection from Research Risks. Part
46: Protection of Human Subjects. Revised November 13, 2001. Effective December
13, 2001.
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Engagement in Research Guidance
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International Compilation of Human Subject
Protections
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Lists about 900 laws, regulations, and guidelines
from 84 countries on human subject protections. Many of the listings include the
web address, allowing the reader to link directly to the law, regulation, or
guideline of interest.
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OHRP Monitoring and Site Visits
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MA State/Local Regulation
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M.G.L. c. 94C §8(Controlled Substances in Research)
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105 C.M.R. 700.009 (Controlled Substances in
Research)
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M.G.L. ch. 111L (Human Embryonic Stem Cell Research)
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105 C.M.R. 960.000 (Human Embryonic Stem Cell
Research)
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M.G.L. ch. 111, §70E (Patients Rights/Informed
Consent)
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M.G.L. c.111 §70F (Consent to HIV/AIDS Testing)
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M.G.L. c.111 §70G (Genetic Privacy)
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M.G.L. c.112, §12F (Consent by Minors)
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M.G.L. c.112, §12J (Experimentation on Fetuses)
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M.G.L. c.201, §§6-6B (Guardianships)
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Section 6. Mentally ill persons
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Section 6A. Mentally retarded persons
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Section 6B. Persons unable to make or communicate
informed decisions
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M.G.L. c.201D,6; 2-1-2 to 201-4 (Health Care Proxies)
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104 C.M.R. 31.00 (Department of Mental Health
Research)
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115 C.M.R. 10.00 (Department of Mental Retardation
Research)
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