The references on this page are cited on this website and in many of the NIAID Division of Microbiology and Infectious Diseases (DMID) documents. They are some of the most referred to in clinical research. There are many other sources of information available on line, and this list should not be considered inclusive.
- Assent - NCI guidance
- ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.
- Data and Safety Monitoring
- NIH Policy For Data And Safety Monitoring
- NIH Guidance On A Data And Safety Monitoring For Phase I And Phase II Trials
- NIAID Policy on Data and Safety Monitoring Board (DSMB) Operations
- FDA - The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors - Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees
- NIAID Policy for Identifying Potential Conflict of Interest for Individuals Serving on Advisory Committees or Independent Safety Monitors Responsible for Data and Safety Monitoring of Clinical Trials
- DMART
- DMID Clinical Research Operations and Management Support (CROMS) provides support for DMID staff and clinical investigators; authorized users
- EMMES Statistical and Data Coordinating Center—provides statistical and data management support for DMID clinical trials—authorized users
- Ethics Codes and Standards
- Belmont Report
- CIOMS International Ethical Guidelines—Council for International Organizations of Medical Sciences
- Declaration of Helsinki
- International Conference on Harmonization – Guideline for Good Clinical Practice
- Nuremberg Code
- International Compilation of Human Research Standards—contains by country key organizations, legislation, regulations, and guidelines
- NIH Bioethics Websites—Information and links for research ethics, human subjects research, IRBs, international issues, conflict of interest, use of human tissue, neuroethics, genetics/genomics, gene therapy, and training
- Fogarty Center Bioethics Information and Resources
- Federal Wide Assurances
- Federal Wide Assurance - OHRP website
- NIAID FWA SOP
- Food and Drug Administration (FDA) Guidances, Regulations, and Information sheets
- Computerized Systems Used in Clinical Trials Electronic Source Documentation in Clinical Investigations
- Electronic Records; Electronic Signatures (21 CFR Part 11)
- Electronic Source Documentation in Clinical Investigations
- FDA IRB Registration Rule (21 CFR 56.106) (printable PDF version)
- FDA Inspections of Clinical Investigators
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)
- Form 1572 Q & As
- Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
- Guidance on Establishment and Operation of Clinical Trial Data Monitoring Committees
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are not Individually Identifiable
- Investigational Device Exemption (IDE) Regulations (21 CFR part 812)
- Investigator Responsibilities & Protecting the Rights, Safety, and Welfare of Study Subjects, Guidance for Industry
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors—represents the agency's current thinking on protection of human subjects in research including IRB guidance and interactions, charging for investigational product, screening prior to enrollment, recruitment, payment of volunteers, off-label use
- Informed Consent Elements (21 CFR 50.25(c))
- Institutional Review Boards (21 CFR Part 56
- Investigational New Drug Application (21 CFR Part 312)
- Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
- Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
- Race and Ethnicity Data in Clinical Trials
- Running Clinical Trials
- Structure And Content Of Clinical Study Reports
- Statistical Principles for Clinical Trials
- Grant Capture
- Human Subjects Protections
- Certificates of Confidentiality
- HIPAA Privacy Rule - (also see 45 CFR Part 160 and Subparts A and E of Part 164 and NIAID heading)
- 45 Code of Federal Regulations part 46—HHS Human Subjects Protections Regulations
- 21 CRF Part 50 - FDA Human Subjects Protection
- Informed Consent for Genomic Research
- Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects, FDA Guidance for Industry
- Genetic Privacy Laws
- Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
- NIH Office of Extramural Research Human Subjects Research Protections
- Office for Human Research Protections (OHRP)—Comprehensive information on human subject research including regulations, policy, guidance for research supported by Health and Human Services. The site also includes international human subjects regulations.
- Institutional Review Boards and Ethics Committees
- FDA IRB Registration Rule (21 CFR 56.106)
- Guidance on IRB Continuing Review of Research (OHRP)
- Guidance on IRB Approval of Research with Conditions (OHRP)
- IRB Continuing Review after Clinical Investigation Approval, Guidance for IRBs, Clinical Investigators, and Sponsors
- IRB Registration, Frequently Asked Questions, Guidance for Institutional Review Boards (IRBs) (FDA)
- International Conference on Harmonisation. Below are some of the most frequently used ICH guidance. Some of the guidance also have concept papers, frequently asked questions and examples associated with them on the main ICH page.
- Good Clinical Practices (GCP) E6
- Clinical Safety - E1-The Extent Of Population Exposure To Assess Clinical Safety
- For Drugs Intended For Long-Term Treatment Of Non-Life-Threatening Conditions
- Clinical Safety - E2A- Clinical Safety Data Management: Definitions and Standards For Expedited Reporting
- Clinical Safety Data Management-E2b(R2): Data Elements For Transmission Of Individual Case Safety Reports
- Clinical Safety - E2E-Pharmacovigilance Planning
- Clinical Study Reports E3
- Clinical Safety – E4- Dose-Response Information To Support Drug Registration
- Clinical Safety- E2F -Development Safety Update Report
- Studies In Support Of Special Populations E-7: Geriatrics
- Guidance on General Considerations for Clinical Trials E8
- Statistical Principles for Clinical Trials E9
- Choice Of Control Group And Related Issues In Clinical Trials- E10
- Clinical Investigation Of Medicinal Products In The Pediatric Population- E-11
- Definitions For Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data And Sample Coding Categories- E15
- Biomarkers Related To Drug Or Biotechnology Product Development: Context, Structure And Format Of Qualification Submissions- E16
- Quality Risk Management Q9
- International Research
- International Clinical Sciences Support Center provides support for DMID international investigators
- International Compilation of Human Research Standards contains by country key organizations, legislation, regulations, and guidelines.
- 2015 Edition of International Compilation of Human Research Standards Now Available
- NIAID References
- NIH References
- NIH-Information on Certificates of Confidentiality
- NIH Extramural Human Subjects Protection
- NIH Office of Extramural Programs (OEP)
- NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research
- NIH Policy And Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects
- NIH Office of Bioethics
- NIH—Further Guidance on Data and Safety Monitoring for Phase I And Phase II Trials
- NIH—Policy on Data and Safety Monitoring Boards
- Record Retention
- Safety Reporting
- Guidance for Industry and Investigators - Safety Reporting Requirements for INDs and BA/BE Studies
- Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Vaccine Adverse Event Reporting System (VAERS)
- Specimens—see FDA and Human Subjects Headings