| Department of Health and Human Services (DHHS) |
| Department of Health and Human Services (DHHS) | The principal government agency responsible for both the protection of American's health and the provision of human services. |
| DHHS Office of Research Integrity (ORI) | U.S. Dept. of Health and Human Services (DHHS), Office of Research Integrity (ORI) guide to the responsible conduct of research integrity |
| Office for Human Research Protections (OHRP) | With the aim of strengthening protection of human participants, the OHRP grants "assurances," meaning the institute assures/ commits to following their policies, regulations and guidance regarding compliance, education and quality improvement |
| Code of Federal Regulations (CFR) Title 45 CFR 46 | Protection of Human Subjects (also known as "the common rule") |
| Food and Drug Administration (FDA) |
| Food and Drug Administration (FDA) home page | The FDA is a government agency (under DHHS) responsible for protecting the public health by assuring the safety of drugs, medical devices, food, cosmetics, biological products and products that emit radiation. The agency also advances public health through aid to innovation that ensures the safety of these products while promoting public access to accurate information concerning them. |
| FDA Good Clinical Practice (GCP) Guidelines | A Division of the FDA responsible for good clinical practice issues that arise in human research trials regulated by the FDA. |
| FDA Information Sheet Guidance | FDA information sheet guidance for Institutional Review Boards, Clinical Investigators and Sponsors. |
| FDA Information Sheet Guidance to Frequently Asked Questions about the IRB | Answers to questions frequently asked by clinical investigators about the role of the IRB |
| FDA Center for Drug Evaluation and Research (CDER) | The FDA Division responsible for New Drug Development and Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities. |
| CFR Title 21, Part 11 | Electronic Records; Electronic Signatures |
| CFR Title 21, Part 50 | Protection of Human Subjects |
| CFR Title 21, Part 54 | Financial Disclosure |
| CFR Title 21, Part 56 | Investigational Review Boards |
| CFR Title 21, Part 312 | Investigational New Drug Applications |
| CFR Title 21, Part 314 | New Drug Applications |
| CFR Title 21, Part 812 | Investigational Device Exemptions |
| CFR Title 21, Part 814 | Pre-market Approval Applications |
| CFR Title 45, Parts 160 & 164 | HIPAA/ Privacy rule |
| Center for Medicare and Medicaid | Formerly the Health Care Financing Administration, this federal agency is responsible for the administration of Medicare, Medicaid, SCHIP, HIPAA, CLIA, and a number of other health related programs |
| National Institute of Health (NIH) | Part of the U.S. Department of Health and Human Services, NIH is the primary federal agency for conducting and supporting medical research. |
| NIH Road Map | The Roadmap provides an overview of the NIH's goals in creating a more efficient and productive system of medical research |
| NIH Bioethics Resources | |
| Nuremberg Code | The conduct of biomedical research was addressed in 1947 at The Nuremberg Military Tribunal where the Nuremberg Code was created. This code included the absolute requirement for informed Consent and placed the primary responsibility of ethical conduct on the investigators. The Nuremberg Code suggested subject voluntary consent, power of free choice, and knowledge of study detail. The Nuremberg Code is the basic foundation for The Declaration of Helsinki. |
| Declaration of Helsinki | In 1961 the World Medical Assembly adopted the Declaration of Helsinki (an extension of the Nuremberg code) which is considered the guiding doctrine in conducting ethical clinical research. This document is essentially a bill of rights for study participants and focuses on the informed consent as the foundation for all ethical research. This declaration provides the actual procedures to ensure the subjects safety, including Informed Consent procedures and the ethics committee review. Adopted in 1964; most recently updated in 2004. Basis for FDA policy. |
| The Belmont Report | The National Research Act of 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Their charge was to Identify basic ethical principles that should underlie conduct of biomedical and behavioral research involving human subjects. This commission published the Belmont Report which summarizes the ethical principles and guidelines when conducting research with human subjects. These ethical principles include: Respect for Persons, Beneficience, Justice |
| International Conference on Harmonization (ICH) | In 1990, government agencies and pharmaceutical trade organizations from Europe, Japan and US joined forces to create common standardized guidelines for conducting clinical drug trials. The International Conference on Harmonization (ICH) released the Good Clinical Practice Guideline in May 1996. ICH GCP (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve participation of subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected. |
