First Clinical Research Laws, Regulations & Guidelines


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 AAHRPP Accreditation Standards (2009) 
 AAHRPP Accreditation Standards 2010 
 AAHRPP Principles, Domains and Standards 
 AAPP Code of Ethics 
 AAUC – Academic Freedom and the IRB 
 ABPI – Clinical Trial Compensation Guidelines 
 AHRQ – Horizon Scan: Affect of Changes in Third-Party Payment on Clinical Trials and the Evidence Base? 
 AHRQ – Registries for Evaluating Patient Outcomes 
 Air Force – Protection of Human Subjects in Research 
 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 
 Army – Regulation AR 70-25 Use of Volunteers as Subjects of Research 
 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 – Decision Memo – Clinical Trial Policy –CAG-00071R2 
 CMS – Final National Coverage Decision – Clinical Trials 
 CMS – Letter – Primary Payor 
 CMS – Medicare Coverage of Imaging Tests for Cancer Trials 
 CMS – Medicare Payment of Routine Costs in a Clinical Trial 
 CMS – National Coverage Decision 2007 
 CMS – Transparency Reports and Reporting of Physician Ownership or Investment Interests Final Rule 
 CONSORT Checklist 
 CONSORT Flowchart 
 CTEP Handbook Appendices 
 Culturally and Linguistically Appropriate Services in Health Care 
 Department of Defense – Protection of Human Subjects in the Performance of Surveillance, Public Health Practice, and Research 
 Department of Homeland Security – Protection of Human Subjects  
 DHHS – Report of the Equivalent Protections Working Group  
 DoD – Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research 
 DoD –Protection of Human Subjects in DoD-Sponsored Research 
 DoD – Protection of Human Subjects in Research Supported by USAID  
 DOE Notice 443.1 – Protection of Human Subjects in Classified Research 
 DOJ Antitrust Letter for CEO Roundtable on Cancer 
 EPA – Scientific and Ethical Approaches for Observational Exposure Studies  
 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 – Acceptance of Data from Clinical Studies for Medical Devices Proposed Rule 
 Federal Register – Breach Notification for PHI (Interim Final Rule) 
 Federal Register – CFR40.9&26 Amendments – Protections for Subjects in Human Research Final Rule 
 Federal Register – Clinical Trials Registration and Results Information Submission: Final Rule 
 Federal Register – Consent Elements 
 Federal Register – Federal Policy for the Protection of Human Subjects 
 Federal Register – Federal Policy for the Protection of Human Subjects; Notice of Proposed Rulemaking 2015 
 Federal Register – Information Sheet Initiative 
 Federal Register – Informed Consent Elements (Proposed) 
 Federal Register – IRB Expedited Reviews 
 Federal Register - Medical Device Data Systems 
 Federal Register – Review of Post-Inspection Responses 
 Federal Register – Safety Reporting for INDs and BA/BE Studies 
 Federal Register – Strengthened Protections for Human Subjects of Classified Research 
 GAO Report – FDA’s Debarment & Disqualification Processes 
 GPP – Good Publication Practice Guidelines 
 HHS – Guidance on HIPAA & Cloud Computing 
 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 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 
 National Commission – Disclosure of Research Information under the Freedom of Information Act 
 National Commission - Research Involving Prisoners 
 National Commission – Research on the Fetus 
 Navy – Human Research Protection Program 
 NBAC – Clinical Trials in Developing Countries 
 NBAC – Ethical and Policy Issues in Research Involving Human Participants 
 NCI – Best Practices for Biospecimen Resources 
 NCI – CTEP – Manual for Participants in Clinical Trials 
 NCI – Essential Elements of a Data and Safety Monitoring Plan 
 NCI – Guideline – Expedited Adverse Event Reporting 
 NCPHS – Disclosure of Research Information under FOIA 
 NCPHS – Research Involving Children 
 NIAID – Good Clinical Practices Handbook 
 NIH – Clinical Trials Registration and Results Information Submission 
 NIH – Institutional Conflicts of Interest 
 NIH – Notice of Changes to Policy for Issuing Certificates of Confidentiality 
 NIH – PHS 398 and PHS 2590 – More Information 
 NIH – PHS 398 AND PHS 2590 Forms (Revised) 
 NIH – Policy on the Dissemination of NIH-Funded Clinical Trial Information 
 NIH – Protection Initiatives in Gene Therapy Trials 
 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 – Reporting Adverse Events 
 NIH Guidance – Research with Persons at Suicidality Risk 
 NIH Guidelines – 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 – IRB Review (Revised) 
 NIH Policy – Reporting Communicable Diseases 
 NIH Policy – Reporting Race & Ethnicity 
 NIH Policy – Required Education 
 NIH Policy – Required Education - FAQs 
 NIH Policy –Use of a Single Institutional Review Board for Multi-Site Research 
 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 – 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 FAQs – Assurance Process 
 OHRP Filing – IRB Registration 
 OHRP Guidance – Adverse Event Reporting 
 OHRP Guidance – Certificates of Confidentiality 
 OHRP Guidance – Coded Private Information and Biological Specimens 
 OHRP Guidance – Compliance Oversight of Institutions 
 OHRP Guidance – Continuing Review 
 OHRP Guidance – Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft) 
 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 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 
 OMB – Information Collection – Financial Disclosure by Clinical Investigators – Supporting Statement 
 PhRMA – Code on Interactions with Healthcare Professionals 
 PhRMA – Communication of Clinical Trial Results 
 PhRMA – Communication of Clinical Trial Results 
 PhRMA – Principles on Clinical Trials 
 PhRMA/EFPIA – Principles for Responsible Clinical Trial Data Sharing 
 PHS – Policy on Partner Notification 
 President’s Commission – Protecting Human Subjects 
 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 
 VHA – Requirements for the Protection of Human Subjects in Research 
 VHA – Research Compliance Reporting Requirements 
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