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  | 40 CFR 9 & 26 Amendments – Protections for Subjects in Human Research Final Rule | |
| | AAHRPP Accreditation Standards (2009) | |
| | AAHRPP Accreditation Standards 2010 | |
| | AAHRPP Principles, Domains and Standards | |
| | AAPP Code of Ethics | |
| | AAUC – Academic Freedom and the IRB | |
| | AHRQ - Horizon Scan: Affect of Changes in Third-Party Payment on Clinical Trials and the Evidence Base? | |
| | AHRQ - Registries for Evaluating Patient Outcomes | |
| | AMA Principle E-2.071 - Subject Selection | |
| | AMA Principle E-2.075 - Placebos | |
| | AMA Principle E-8.0315 - Managing Conflicts of Interest | |
| | AMA Principles of Medical Ethics | |
| | ASSERT Statement | |
| | The Belmont Report | |
| | California – Disclosure of Medical Information | |
| | California - Protection of Human Subjects | |
| | CDER MAPP 7700.2 for In-House Human Subject Research Conduct | |
| | CIOMS – International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) | |
| | CMS – Medicare Payment of Routine Costs in a Clinical Trial | |
| | CMS Decision Memo - Clinical Trial Policy | |
| | CMS Decision Memo CAG-00071R2 | |
| | CMS Letter – Primary Payor | |
| | CMS National Coverage Decision 2007 | |
| | Code of Ethics for Investigative Sites | |
| | CONSORT Checklist | |
| | CONSORT Flowchart | |
| | CTEP Handbook Appendices | |
| | Culturally and Linguistically Appropriate Services in Health Care | |
| | DHHS - Report of the Equivalent Protections Working Group | |
| | DOJ Antitrust Letter for CEO Roundtable on Cancer | |
| | EPA Expanded Protections for Subjects in Human Studies Research | |
| | FDA – CDER CIIL Code Definitions | |
| | Federal Register – 21 CFR Part 11 – Electronic Signatures & Submissions | |
| | Federal Register – Breach Notification for PHI (Interim Final Rule) | |
| | Federal Register – CMS –Physicians_Payment_Act_Proposed_Rule | |
| | Federal Register – Consent Elements | |
| | Federal Register – Information Sheet Initiative | |
| | Federal Register – Informed Consent Elements (Proposed) | |
| | Federal Register – IRB Expedited Reviews | |
| | Federal Register – Review of Post-Inspection Responses | |
| | Federal Register – Safety Reporting for INDs and BA/BE Studies | |
| | GAO Report – FDA’s Debarment & Disqualification Processes | |
| | GPP - Good Publication Practice Guidelines | |
| | HHS NPR – HIPAA Privacy Rule Accounting of Disclosures | |
| | Hippocratic Oath | |
| | ICMJE Editorial - Clinical Trial Registration | |
| | ICMJE Requirements for Manuscripts | |
| | IFPMA – IFPMA Code of Practice 2012 | |
| | ISO – Biological Evaluation of Medical Devices | |
| | Joint Position on Disclosure of Clinical Trial Information | |
| | Joint Position on the Disclosure of Clinical Trial Information (2008) | |
| | Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2002) | |
| | Maine – Proposed Reporting Requirements | |
| | Medicare Coverage - Clinical Trials | |
| | Medicare Coverage of Imaging Tests for Cancer Trials | |
| | National Commission – Disclosure of Research Information under the Freedom of Information Act | |
| | National Commission - Research Involving Prisoners | |
| | National Commission – Research on the Fetus | |
| | NBAC - Clinical Trials in Developing Countries | |
| | NBAC Ethical and Policy Issues in Research Involving Human Participants | |
| | NCI – Best Practices for Biospecimen Resources | |
| | NCI - Essential Elements of a Data and Safety Monitoring Plan | |
| | NCI CTEP - Manual for Participants in Clinical Trials | |
| | NCI Guideline – Expedited Adverse Event Reporting | |
| | NCPHS - Research Involving Children | |
| | NIAID - Good Clinical Practices Handbook | |
| | NIH – Institutional Conflicts of Interest | |
| | NIH – PHS 398 and PHS 2590 – More Information | |
| | NIH – Protection Initiatives in Gene Therapy Trials | |
| | NIH - REVISED PHS 398 AND PHS 2590 | |
| | NIH Guidance – Impact of HIPAA | |
| | NIH Guidance – IRB Review in Grant Applications | |
| | NIH Guidance – Notices from the FDA | |
| | NIH Guidance - Questionable Capacity to Consent | |
| | NIH Guidance – Research with Persons at Suicidality Risk | |
| | NIH Guidance on Reporting Adverse Events | |
| | NIH Guideline – Children in Research | |
| | NIH Guidelines – Conduct of Research (Gray Booklet) | |
| | NIH Guidelines – Women and Minorities | |
| | NIH Notice – Approvals for Human Stem Cell Research | |
| | NIH Outreach Notebook - Women and Minority Subjects | |
| | NIH Policy - Certificates of Confidentiality Background Information | |
| | NIH Policy - Certificates of Confidentiality FAQs | |
| | NIH Policy – Data and Safety Monitoring | |
| | NIH Policy – Data and Safety Monitoring for Phase I & II | |
| | NIH Policy – Reporting Communicable Diseases | |
| | NIH Policy – Reporting Race & Ethnicity | |
| | NIH Policy – Required Education | |
| | NIH Policy – Required Education - FAQs | |
| | NIH Revised Policy for IRB Review | |
| | NIH Statement – Certificates of Confidentiality | |
| | NIMH Guidance - Clinical Care in a Research Setting | |
| | NIMH Guidance - Recruitment and Retention | |
| | NIMH Meeting - Research in the Aftermath of Disaster | |
| | NIMH Policy - Data and Safety Monitoring | |
| | NIMH Policy – Recruitment of Participants | |
| | OCR – Fact – Sheet – Privacy Complaints | |
| | OCR – Fact Sheet – Protecting Patient Privacy | |
| | OCR – Guidance – HIPAA Privacy | |
| | OHRP – Approval of Research with Conditions | |
| | OHRP – Exempt Research Determination FAQs | |
| | OHRP – Federalwide Assurance Terms | |
| | OHRP – FWA Individual Investigator Sample Statement | |
| | OHRP – FWA Sample Text | |
| | OHRP – IRB Guidebook | |
| | OHRP - Quality Improvement Activities: Frequently Asked Questions | |
| | OHRP - Recent Compliance Oversight Determinations | |
| | OHRP Filing - IRB Registration | |
| | OHRP Guidance – Adverse Event Reporting | |
| | OHRP Guidance - Certificates of Confidentiality | |
| | OHRP Guidance - Coded Private Information | |
| | OHRP Guidance - Coded Private Information and Biological Specimens | |
| | OHRP Guidance – Compliance Oversight of Institutions | |
| | OHRP Guidance - Emergency Medical Care of Subjects | |
| | OHRP Guidance - Engagement of Institutions in Research | |
| | OHRP Guidance - Engagement of Pharmaceutical Companies in Research | |
| | OHRP Guidance - Exculpatory Language in Informed Consent | |
| | OHRP Guidance – Exculpatory Language in Informed Consent (Draft) | |
| | OHRP Guidance - Exemption for Public Benefit and Service Programs | |
| | OHRP Guidance - Exempt Research and Expedited Review | |
| | OHRP Guidance - Expedited Review Categories | |
| | OHRP Guidance – Expedited Review Procedures | |
| | OHRP Guidance - Fetal Tissue Transplantation | |
| | OHRP Guidance - Financial Relationships and Interests | |
| | OHRP Guidance – FWA Instructions – International | |
| | OHRP Guidance – FWA Instructions – U.S. Institutions | |
| | OHRP Guidance – FWA Instructions – U.S. Institutions | |
| | OHRP Guidance - Human Embryonic Stem Cells | |
| | OHRP Guidance - Human Subject Regulations Decision Charts | |
| | OHRP Guidance - Individual Investigator Agreement | |
| | OHRP Guidance - Informed Consent - Legally Effective | |
| | OHRP Guidance – Informed Consent Checklist | |
| | OHRP Guidance - Informed Consent in Emergency Research | |
| | OHRP Guidance – Informed Consent of Subjects Who Do Not Speak English | |
| | OHRP Guidance – Informed Consent Tips | |
| | OHRP Guidance – International Federalwide Assurance | |
| | OHRP Guidance – IRB Approval of Research with Conditions | |
| | OHRP Guidance – IRB Continuing Review of Research | |
| | OHRP Guidance –IRB Continuing Review of Research | |
| | OHRP Guidance - IRB Knowledge of Local Research Context | |
| | OHRP Guidance - IRB Meetings via Telephone | |
| | OHRP Guidance – IRB Review of Applications for HHS Support | |
| | OHRP Guidance - IRB Review of Clinical Trial Websites | |
| | OHRP Guidance – IRBs for AIDS Studies | |
| | OHRP Guidance - Local IRB Review of Multicenter Clinical Trials | |
| | OHRP Guidance - Local IRB Review of NIAID Multicenter Clinical Trials | |
| | OHRP Guidance – Medical Devices - Exception from Informed Consent | |
| | OHRP Guidance – Obsolete Guidances | |
| | OHRP Guidance - Prisoners in Research | |
| | OHRP Guidance - Reporting Incidents to OHRP | |
| | OHRP Guidance - Special Protections for Children | |
| | OHRP Guidance - Special Protections for Children – Review Process | |
| | OHRP Guidance - Summary of Basic Protections | |
| | OHRP Guidance - When Participation of Subjects in Research is Discontinued (Draft) | |
| | OHRP Guidance – Withdrawal of Subjects | |
| | OHRP Guidance - Written IRB Procedures | |
| | OHRP Guideline – Financial Conflicts of Interest | |
| | OIG – Clinical Trial Websites | |
| | OIG - FDA Oversight of Clinical Investigators | |
| | OIG – FDA Oversight of Clinical Trials | |
| | OIG - Globalization of Clinical Trials | |
| | OIG - Institutional Review Boards: A Time for Reform | |
| | OIG - Institutional Review Boards: Promising Approaches | |
| | OIG - Investigational Devices: Four Case Studies | |
| | OIG - Low-Volume Institutional Review Boards | |
| | OIG - Protecting Human Research Subjects: Status of Recommendations | |
| | OIG - Recruiting Human Subjects | |
| | OIG - Recruiting Human Subjects in Industry-Sponsored Clinical Research | |
| | OIG - The Emergence of Independent Boards | |
| | OIG Work Plan Fiscal Year 2009 | |
| | OMB Information Collection - Financial Disclosure by Clinical Investigators – Supporting Statement | |
| | ORHP FAQs – Assurance Process | |
| | PhRMA Communication of Clinical Trial Results | |
| | PhRMA Communication of Clinical Trial Results (2009) | |
| | President’s Commission - Protecting Human Subjects | |
| | PrRMA Principles on Clinical Trials | |
| | Supporting Statement - Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens | |
| | Treasury – Discrimination on Genetic Information: Interim Final Rules | |
| | U.S. Common Rule – CFR Sections | |
| | U.S. PHS Policy on Partner Notification | |
| | UNAIDS – Ethical considerations in HIV preventive vaccine research | |
