| Acknowledgments |
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xiii | |
| Foreword: Jesse's Intent |
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xv | |
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| Preface |
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xxv | |
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| Contributing Authors |
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xxvii | |
| PART 1 Background and Overview Topics |
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2 | (31) |
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An Ethics Primer for IRBs |
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3 | (6) |
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Reflections from the Office of the Inspector General |
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9 | (4) |
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A Unified Human-Research Protection Program |
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13 | (4) |
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A Shared Responsibility for Protecting Human Subjects |
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17 | (5) |
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The Tension Between Science and Ethics |
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22 | (2) |
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A Brief History of PRIM&R and IRB Education |
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24 | (3) |
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The IRB: Definition and Federal Oversight |
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27 | (3) |
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The Limits of IRB Authority |
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30 | (3) |
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| PART 2 Organizing the Office |
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33 | (44) |
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Administrative Reporting Structure for the IRB |
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35 | (2) |
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Documenting Compliance with Federal Regulations |
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37 | (6) |
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IRB Policies and Procedures |
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43 | (7) |
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50 | (8) |
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58 | (8) |
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66 | (9) |
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75 | (2) |
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| PART 3 Organizing the IRB Committee |
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77 | (32) |
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Reflections on Chairing an IRB |
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79 | (3) |
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82 | (4) |
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The IRB Administrative Director |
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86 | (5) |
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91 | (5) |
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Committee Size, Alternates, and Consultants |
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96 | (3) |
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Length, Frequency, and Time of IRB Meetings |
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99 | (2) |
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101 | (4) |
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Social Science Versus Biomedical IRBs |
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105 | (4) |
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| PART 4 Review Categories Other Than Full Board Review |
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109 | (32) |
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111 | (3) |
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114 | (4) |
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Identifying Research Intent |
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118 | (7) |
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IRB Triage of Projects That Involve Medical Record Review |
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125 | (4) |
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``Compassionate Use'' and Emergency Exemption from IRB Approval |
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129 | (3) |
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Waiver of Consent in Emergency Medicine Research |
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132 | (9) |
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| PART 5 Initial Protocol Review and the Full-Committee Meeting |
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141 | (90) |
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Overview of Initial Protocol Review |
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143 | (9) |
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Evaluating Study Design and Quality |
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152 | (3) |
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The Study Population: Women, Minorities, and Children |
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155 | (5) |
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Community Consultation to Evaluate Group Risk |
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160 | (5) |
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Requiring Birth Control to Participate in Research |
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165 | (4) |
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Privacy and Confidentiality |
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169 | (7) |
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Recruitment of Research Subjects |
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176 | (4) |
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Advertisements for Research |
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180 | (5) |
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185 | (6) |
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Provisions for Data Monitoring |
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191 | (6) |
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Conflict of Interest: Researchers |
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197 | (7) |
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Conflict of Interest: Recruitment Incentives |
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204 | (4) |
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Conflict of Interest: IRBs |
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208 | (6) |
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Administrative Tasks Before the Meeting |
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214 | (5) |
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Guidelines for Review, Discussion, and Voting |
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219 | (7) |
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Administrative Tasks After Each IRB Meeting |
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226 | (5) |
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| PART 6 Informed Consent |
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231 | (56) |
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The IRB's Role in Editing the Consent Document |
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233 | (3) |
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236 | (3) |
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Exculpatory Language in Informed Consent Documents |
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239 | (3) |
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Requiring a Witness Signature on the Consent Form |
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242 | (2) |
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Deception of Research Subjects |
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244 | (6) |
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Research Without Consent or Documentation Thereof |
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250 | (6) |
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Active Versus Passive Consent |
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256 | (2) |
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Selecting a Surrogate to Consent to Medical Research |
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258 | (7) |
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Research-Related Injuries |
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265 | (3) |
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Informing Subjects About Research Results |
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268 | (4) |
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Explaining the Cost of Research Participation |
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272 | (5) |
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Improving Informed Consent |
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277 | (5) |
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Informed Consent Evaluation Feedback Tool |
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282 | (5) |
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| PART 7 Continuing Review |
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287 | (24) |
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Revisions of an Approved Protocol |
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289 | (4) |
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293 | (4) |
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IRB Review of Adverse Events |
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297 | (6) |
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Christopher J. Kratochvil |
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Data and Safety Monitoring |
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303 | (3) |
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Noncompliance/Complaint Procedure |
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306 | (5) |
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| PART 8 Administrative and Regulatory Issues |
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311 | (60) |
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OHRP Federal-Wide Assurance |
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313 | (3) |
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International Conference on Harmonisation |
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316 | (5) |
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321 | (2) |
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Understanding the FDA's IND Process |
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323 | (6) |
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Differences Between DHHS and FDA Regulations |
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329 | (2) |
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Veterans Administration Research Guidelines |
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331 | (8) |
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339 | (3) |
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342 | (3) |
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Certificates of Confidentiality |
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345 | (2) |
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347 | (2) |
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349 | (4) |
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353 | (3) |
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Certification of IRB Professionals |
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356 | (3) |
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Preparing for an FDA Audit |
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359 | (6) |
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Preparing for an OHRP Site Visit |
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365 | (6) |
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| PART 9 Issues Based on Study Population |
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371 | (30) |
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Research Involving Fetuses and In Vitro Fertilization |
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373 | (7) |
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Research Involving Pregnant Women |
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380 | (3) |
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Research Involving Children |
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383 | (6) |
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Research Involving Adults with Decisional Impairment |
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389 | (5) |
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Research Involving Prisoners |
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394 | (5) |
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Christopher J. Kratochvil |
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Research Involving College Students |
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399 | (2) |
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| PART 10 IRB Issues Based On Study Design or Category |
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401 | (86) |
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Qualitative Social Science Research |
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403 | (4) |
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407 | (8) |
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415 | (4) |
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419 | (5) |
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Epidemiology/Public Health Research |
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424 | (4) |
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428 | (6) |
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Research Involving a Medical Device |
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434 | (7) |
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441 | (2) |
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Banking of Biological Materials for Research |
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443 | (7) |
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The Placebo-Controlled Clinical Trial |
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450 | (8) |
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Research Involving Sham Surgery |
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458 | (3) |
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Treatment-Withholding Studies in Psychiatry |
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461 | (4) |
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465 | (11) |
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Research Involving Genetic Testing |
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476 | (5) |
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481 | (2) |
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Alternative Medicine Research |
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483 | (4) |
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| PART 11 Reference Material and Contact Information |
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487 | (84) |
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489 | (12) |
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490 | (2) |
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492 | (7) |
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World Medical Association Declaration of Helsinki |
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499 | (2) |
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Selected U.S. Government Regulations |
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501 | (33) |
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Code of Federal Regulations: Title 45, Part 46 |
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502 | (15) |
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Code of Federal Regulations: Title 21, Part 50 |
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517 | (6) |
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Code of Federal Regulations: Title 21, Part 56 |
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523 | (9) |
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Expedited IRB Review Criteria |
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532 | (2) |
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U.S. Government Guidance and Resources |
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534 | (1) |
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535 | (1) |
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536 | (1) |
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Periodicals and IRB Forum |
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537 | (1) |
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538 | (1) |
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539 | (1) |
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540 | (31) |
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| Index |
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571 | |
Other versions by this Author
