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First Clinical Research Laws, Regulations & Guidelines

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 AAHRPP Principles, Domains and Standards 
 AAPP Code of Ethics 
 AAUC – Academic Freedom and the IRB 
 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 
 CMS – Transparency Reports and Reporting of Physician Ownership or Investment Interests Final Rule 
 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 
 DHHS - Report of the Equivalent Protections Working Group  
 Federal Register – 21 CFR Part 11 – Electronic Signatures & Submissions 
 Federal Register – Information Sheet Initiative 
 Federal Register – IRB Expedited Reviews 
 GPP - Good Publication Practice Guidelines 
 Hippocratic Oath 
 ICMJE Requirements for Manuscripts 
 ISO – Biological Evaluation of Medical Devices 
 Joint Position on Disclosure of Clinical Trial Information 
 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 - 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 – 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 
 OCR Guidance –Methods for De-identification of Protected Health Information 
 OHRP – Federalwide Assurance Terms 
 OHRP – FWA Individual Investigator Sample Statement 
 OHRP – FWA Sample Text 
 OHRP – IRB Guidebook 
 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 - 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 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 - 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 
 PhRMA Code on Interactions with Healthcare Professionals 
 PrRMA Principles on Clinical Trials 
 U.S. Common Rule – CFR Sections 
 U.S. PHS Policy on Partner Notification 
 UNAIDS – Ethical considerations in HIV preventive vaccine research 
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