Policies & Procedures - Emory IRB - Emory University

More documents

Recommendations

Info

Emory University IRB P&Ps Revised 1/18/2013 POLICY: 16 LOCAL RESEARCH CONTEXT; RESEARCH CONDUCTED AT NON-EMORY SITES In reviewing Research protocols that will be conducted at international or other non-Emory University sites, the Emory IRB must obtain sufficient knowledge of the local Research context in order to fulfill its responsibilities under its FWA and to comply with all applicable required standards. In particular, the IRB must be sensitive to community attitudes and be able to ascertain the acceptability of proposed Research in terms of institutional commitments and regulations; applicable law; and standards of professional conduct and practice. All policies and procedures that are applied to research conducted domestically will be applied to research conducted in other countries, as appropriate, including oversight of the following: initial review, continuing review, and review of modifications; post‐approval monitoring; and handling of complaints, noncompliance and UPs. For protocols subject to a DOD Addendum, the Emory IRB must ensure that DOD-mandated additional safeguards are in place. PROCEDURES: Requirements of Federal Regulations: In accordance with federal regulations [45 CFR §46.103(d), 45 CFR §46.107(a), 45 CFR §46.111(a)(3),(a)(4),(a)(7),(b), 45 CFR §46.116, 21 CFR §56.107(a), 21 CFR §56. 111(a)(3),(a)(4),(a)(7),(b)], the Emory IRB, in reviewing Research protocols that will be conducted at a non-Emory site, must have obtained sufficient knowledge about the local research context to ensure that adequate protections are in place for the conduct of the Research in that geographic location. Federal Regulations require that IRBs be knowledgeable about the local Research context as demonstrated by fulfillment of the following criteria: The IRB’s composition must be adequate in light of the scope of the institution’s Research activities, types of subject populations, appropriateness of proposed review procedures in light of probable risks, and the size and complexity of the institution. [45 CFR §46.103(d)] The IRB’s members must be sufficiently qualified through the experience and expertise and diversity, including race, gender, cultural background, and sensitivity to such issues as community attitudes to promote respect for the IRB’s advice and counsel. [45 CFR §46.107(a)] The IRB must be able to evaluate Research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. [45 CFR §46.107(a)] The IRB must also be capable of ensuring that the selection of subjects is equitable, privacy and confidentiality of subjects is maintained, informed consent is sought in language understandable to the subject and in circumstances that minimize the Page 46 of 370
Emory University IRB P&Ps Revised 1/18/2013 possibility of coercion, and that there are appropriate safeguards protecting vulnerable subjects. [45 CFR §46.111(a)(3),(a)(4),(a)(7),(b) and 46.116] Requirements of FDA Regulations: For the purposes of Research that may be subject to regulation by the FDA, the FDA Regulations contain essentially the same requirements as those set forth above in the provision entitled Requirements of HHS Regulations. [21 CFR 561.07, 56.111(a)(3),(a)(7) and (b)]. Both HHS and FDA Regulations, as well as other Federal regulations may apply to the same Research protocol. Alternatively, either HHS or FDA Regulations may apply to a Research protocol. Demonstration of Sufficient Knowledge of Local Research Context: In reviewing Research to be conducted at an international or other non-Emory site, the Emory IRB must demonstrate that it has obtained sufficient knowledge about the local Research context to review the Research to be conducted in that geographic location in accordance with the standards established by OHRP. The level of local knowledge required is based on the degree of risk presented by the Research. The OHRP standards include the following: Minimal Risk: When the Research involves Minimal Risk to the participants, the IRB should obtain the necessary information about the Research context through written materials or discussion with appropriate consultants. Greater than Minimal Risk: When the Research involves greater than Minimal Risk and the Investigator and/or study personnel will have Interaction or Intervention with the participants, the IRB should obtain the necessary information about the local Research context through one or more of the following mechanisms or through other mechanisms deemed appropriate by OHRP for the proposed Research and local Research context: Personal knowledge of the local Research context on the part of one or more IRB members; Participation (physically or by telephone conference) by one or more appropriate consultants in a convened IRB meeting. Such consultant(s) should have personal knowledge of the local Research context; Prior written review of proposed Research by one or more appropriate consultant(s), in conjunction with participation (physically or by telephone conference) by the consultant(s) in convened IRB meetings; Systematic, reciprocal, and documented interchange between the IRB and elements of the local Research context. [See, OHRP Guidance Document: Knowledge of Local Research Context, July 21, 2000] Other Factors that May be Considered by the Emory IRB in its Review of the Research and Consideration of Local Research Context: Page 47 of 370
Page 1 and 2: EMORY UNIVERSITY INSTITUTIONAL REVI
Page 3 and 4: Emory University IRB P&Ps Revised 1
Page 45: Emory University IRB P&Ps Revised 1
Page 97 and 98:
Emory University IRB P&Ps Revised 1
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?