LEADER 05456nam 2200685 450 001 9910797243603321 005 20200520144314.0 010 $a0-12-420065-6 035 $a(CKB)3710000000431002 035 $a(EBL)2069958 035 $a(SSID)ssj0001540482 035 $a(PQKBManifestationID)11906687 035 $a(PQKBTitleCode)TC0001540482 035 $a(PQKBWorkID)11533923 035 $a(PQKB)10179687 035 $a(MiAaPQ)EBC2069958 035 $a(Au-PeEL)EBL2069958 035 $a(CaPaEBR)ebr11066330 035 $a(CaONFJC)MIL799182 035 $a(OCoLC)911196739 035 $a(PPN)198685815 035 $a(EXLCZ)993710000000431002 100 $a20150628h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aResearch regulatory compliance /$feditors, Mark A. Suckow, Bill J. Yates 210 1$aLondon, England ;$aSan Diego, California :$cAcademic Press, an imprint of Elsevier,$d2015. 210 4$dİ2015 215 $a1 online resource (345 p.) 300 $aDescription based upon print version of record. 311 $a0-12-420058-3 320 $aIncludes bibliographical references and index. 327 $aFront Cover; RESEARCH REGULATORY COMPLIANCE; Copyright; Contents; Contributors; Preface; Chapter 1 - Human Subjects Research Protections; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. KEY REGULATORY AGENCIES AND MANDATE; 4. COMMON CHALLENGES; 5. CURRENT INFLUENCES SHAPING THE FUTURE OF HUMAN RESEARCH SUBJECT PROTECTION; Chapter 2 - Investigational New Drug and Device Exemption Process; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES [1]; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. REGULATORY MANDATES 327 $a5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 3 - The Institutional Animal Care and Use Committee; 1. INTRODUCTION; 2. REGULATORY HISTORY; 3. RELEVANT REGULATORY AND OVERSIGHT LAWS, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES FOR THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE; TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; 8. FINAL COMMENTS; Chapter 4 - Biological Hazards and Select Agents; 1. INTRODUCTION 327 $a2. HISTORICAL PERSPECTIVES3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 5 - Radiological Hazards and Lasers; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES 327 $a6. COMMON COMPLIANCE CHALLENGES7. ADDRESSING NONCOMPLIANCE; 8. CONCLUSION; Chapter 6 - Controlled Substances: Maintaining Institutional Compliance; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 7 - Export Controls and US Research Universities; 1. SUMMARY; 2. KEY DEFINITIONS; 3. INTRODUCTION; 4. HISTORICAL PERSPECTIVES 327 $a5. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS6. REGULATORY MANDATES; 7. KEY PERSONNEL AND UNIVERSITY COMMITTEES; 8. COMMON COMPLIANCE CHALLENGES; 9. ADDRESSING NONCOMPLIANCE; Chapter 8 - Data Management and Research Integrity; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 9 - Intellectual Property 327 $a1. SUMMARY 330 $a Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users 606 $aResearch$xGovernment policy$zUnited States 606 $aResearch$xMoral and ethical aspects 606 $aMedicine$xResearch$xMoral and ethical aspects 607 $aUnited States 607 $aUnited States$2fast 615 0$aResearch$xGovernment policy 615 0$aResearch$xMoral and ethical aspects. 615 0$aMedicine$xResearch$xMoral and ethical aspects. 676 $a338.97306 702 $aSuckow$b Mark A. 702 $aYates$b Bill 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910797243603321 996 $aResearch regulatory compliance$93702556 997 $aUNINA