Policies & Procedures - Emory IRB - Emory University

More documents

Recommendations

Info

Emory University IRB P&Ps Revised 1/18/2013 provide oversight to Human Subjects Research conducted or supported by a U.S. department or agency that has adopted the Common Rule that is carried out under its jurisdiction and it shall provide this oversight in accordance with the terms and conditions of the Emory FWA. In addition, for DOD supported research, Emory University shall adhere to the terms and conditions of the DOD Addendum. Emory University-Related Components Covered by the Emory FWA: The components of Emory University that are covered by the Emory FWA are as follows: Emory University; the Carter Center; Emory University Midtown Hospital; the Emory Clinic; Emory University Hospital Clifton; Emory Johns Creek Hospital, the Hope Clinic, and Wesley Woods Geriatric Center and Hospital. The IO must grant approval to any additions or withdrawals of the components covered by the Emory FWA. The IRB Director shall be responsible for filing any necessary documentation with Office of Human Research Protections (OHRP) for the addition/withdrawal of a component from the Emory FWA. Other Institutions that Rely on the Emory FWA: Per agreement with Emory University, all institutions that rely on the Emory FWA are subject to the terms thereof and to these P&Ps. Emory FWA Renewal: The Emory FWA must be renewed every thirty-six months, even if no changes have occurred, in order to maintain an active OHRP-approved FWA. The IRB Director is responsible for ensuring that the Emory FWA is renewed in a timely fashion and is not permitted to expire. A copy of the complete current Emory FWA shall be kept in the IRB offices. DOD Addendum Renewal – The DOD Addendum shall be renewed and kept in effect for so long as any DOD supported research is being carried out in or at Emory University. A copy of the DOD Addendum shall be kept at the IRB offices. Applicable Regulations: 45 CFR §§ 46.I03 & .I07. 56 CFR § 56.I07. 38 CFR §§ 16.I03 & .I07. 32 CFR § 219.103; DOD Directive 3216.2 E2.1.1 DOD Addendum Page 16 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 5 ROLES AND RESPONSIBILITIES UNDER THE EMORY HRPP The IO is ultimately responsible for ensuring that all responsibilities are carried out under the Emory HRPP, which includes the Emory FWA. The IO is responsible for ensuring that the Emory IRB upholds and carries out its responsibilities under the Emory FWA. Other persons and committees within Emory University also have responsibilities in fulfilling the requirements of the HRPP. It is incumbent upon all faculty and staff who play a role in the administration of the Emory HRPP, or in the conduct or administration of Human Subjects Research subject to the jurisdiction of the Emory HRPP including the Emory FWA, to carry out all responsibilities that are assigned to those roles. PROCEDURES: Principal Investigator (PI) Responsibilities: In fulfilling Emory University’s responsibilities under the Emory HRPP, each PI is responsible for: Training and Knowledge: Ensuring, prior to initiating any Human Subjects Research, that he/she, and all study staff/key personnel involved in his/her Research protocol, have acquired the appropriate knowledge and training regarding protections, ethical conduct of Research, and applicable federal regulations, as well as the specific knowledge needed to properly conduct his/her specific protocol(s). Completion of Required Training Programs: Ensuring, prior to beginning any Human Subjects Research that he/she, and all study staff/key personnel involved in his/her Research protocol, have each completed any training programs mandated by the Emory IRB or by other Emory University departments or committees that have jurisdiction over the Research in which the PI is participating (e.g., CITI Training Course, HIPAA training, radiation safety training, blood borne pathogens training), including individually, without any assistance from others, attaining a passing score on any required examinations or tests covering the training materials. DOD Addendum: For protocols conducted under the auspices of a DOD Addendum, PIs shall insure that they, and the research personnel who work on their studies, complete the following training: (a) initial and continuing research ethics education offered by the Office for Research Compliance, the Emory Ethics Center, the School of Medicine, or equivalent programs offered by other Emory University schools or units; and (b) any specific education or certification required by a particular DOD funding unit. The IRB may request written documentation of completion of any required training or certification. Knowledge of Protocol and Related Documentation: Prior to initiating work under any Research protocol, thoroughly reading and understanding the Research protocol and any informed consent document and HIPAA Authorization, and understanding and properly completing the IRB Protocol Application (including all appropriate materials) submitted to the Emory IRB for review and approval. All PIs are also responsible for Page 17 of 370
Page 1 and 2: EMORY UNIVERSITY INSTITUTIONAL REVI
Page 3 and 4: Emory University IRB P&Ps Revised 1
Page 15: Emory University IRB P&Ps Revised 1
Page 67 and 68:
Emory University IRB P&Ps Revised 1
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Approval Pending Modification (spec
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
Page 205 and 206:
Page 207 and 208:
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
Page 223 and 224:
Page 225 and 226:
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Page 245 and 246:
Page 247 and 248:
Page 249 and 250:
Page 251 and 252:
Page 253 and 254:
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261 and 262:
Page 263 and 264:
Page 265 and 266:
Page 267 and 268:
Page 269 and 270:
Page 271 and 272:
Page 273 and 274:
Page 275 and 276:
Page 277 and 278:
Page 279 and 280:
Page 281 and 282:
Page 283 and 284:
Page 285 and 286:
Page 287 and 288:
Page 289 and 290:
Page 291 and 292:
Page 293 and 294:
Page 295 and 296:
Page 297 and 298:
Page 299 and 300:
Page 301 and 302:
Page 303 and 304:
Page 305 and 306:
Page 307 and 308:
Page 309 and 310:
Page 311 and 312:
Page 313 and 314:
Page 315 and 316:
Page 317 and 318:
Page 319 and 320:
Page 321 and 322:
Page 323 and 324:
Page 325 and 326:
Page 327 and 328:
Page 329 and 330:
Page 331 and 332:
Page 333 and 334:
Page 335 and 336:
Page 337 and 338:
Page 339 and 340:
Page 341 and 342:
Page 343 and 344:
Page 345 and 346:
Page 347 and 348:
Page 349 and 350:
Page 351 and 352:
Page 353 and 354:
Page 355 and 356:
Page 357 and 358:
Page 359 and 360:
Page 361 and 362:
Page 363 and 364:
Page 365 and 366:
Page 367 and 368:
Page 369 and 370:
show all

Policies & Procedures - Emory IRB - Emory University

Create successful ePaper yourself

Delete template?

Save as template?