who tool benchmarking ethics oversight of health …
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Working document REC tool Rev. 1
November 2021
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WHO TOOL 1
BENCHMARKING ETHICS OVERSIGHT OF HEALTH-RELATED 2
RESEARCH WITH HUMAN PARTICIPANTS: 3
INDICATORS AND FACTSHEETS 4
Final Draft – 26 November 2021 5
6
Please send your comments to Alireza Khadem, Regulatory System Strengthening, Regulation and
Safety Unit ([email protected] ), with a copy to Andreas Reis ([email protected] ), Health Ethics
& Governance Unit, before 28 January 2022. Please use the “Table of Comments” document for this
purpose.
Our working documents are sent out electronically and they will also be placed on the WHO Health Ethics & Governance Unit’s (https://www.who.int/health-topics/ethics-and-health#tab=tab_1 ) and RPQ’s websites (https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss ) for comments under the “Working documents in public consultation” link.
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© World Health Organization 2021 8 All rights reserved. 9 This is a draft. The content of this document is not final, and the text may be subject to revisions before 10 publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, 11 translated or adapted, in part or in whole, in any form or by any means without the permission of the World 12 Health Organization. 13 14 Please send any request for permission to: Andreas Reis, Co-Unit Head, Health Ethics & Governance, 15 Department of Research for Health, World Health Organization, CH-1211 Geneva 27, 21 Switzerland, email: 16 [email protected]. 17 The designations employed and the presentation of the material in this draft do not imply the expression of any 18 opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, 19 territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted 20 lines on maps represent approximate border lines for which there may not yet be full agreement. 21 The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed 22 or recommended by the World Health Organization in preference to others of a similar nature that are not 23 mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital 24 letters. 25 26 All reasonable precautions have been taken by the World Health Organization to verify the information 27 contained in this draft. 28 29 However, the printed material is being distributed without warranty of any kind, either expressed or implied. 30 The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World 31 Health Organization be liable for damages arising from its use. 32 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 33
Description of Activity Date
Working document REC tool Rev. 1
November 2021
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Preparation of first draft working document December 2020
Working Group discussions among experts of Research Ethic
Committess & National Regulatory Authorities to develop this tool March - May 2021
Consolidation of comments received.
Preparation of working document for public consultation June to November 2021
Public consultation 30 November 2021 –
28 January 2022
Consolidation of comments received and review of feedback. February 2022
Any other follow up action as required
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OBJECTIVES 35
The tool is intended to assist WHO Member States in evaluating their existing capacity to 36
provide appropriate ethical oversight of health-related research with humans by identifying 37
strengths and limitations in their laws and in the organizational structures, policies, and 38
practices of the bodies responsible for research ethics oversight. It is also intended to guide 39
the development of recommendations to address the identified gaps and the assessment of 40
countries’ progress in implementing those recommendations. In addition to assisting in 41
capacity-building efforts, the tool is intended to promote policy convergence and best 42
practices in research ethics oversight and to enhance public trust in health research. 43
44
SCOPE 45
This tool is designed for all entities involved in the ethical oversight of health-related research 46
involving humans, including research ethics committees (RECs) at the national, sub national, or 47
institutional levels, and institutions whose employees or agents conduct health-related research 48
involving humans. The tool covers all health-related research involving humans, including research 49
involving biospecimens or data derived from humans. 50
51
USING THESE INDICATORS 52
While some of these indicators can be measured at the system-wide level, others must be measured 53
at the level of individual RECs or individual research institutions. In countries with multiple RECs 54
and/or research institutions, national assessors should seek to obtain assessments of a representiatve 55
sample of RECs and insitutions. They can then aggregate this information to generate country-level 56
results. Further information on this process is provided in the accompanying manual. 57
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Indicator: EC 01: Legal provisions defining the mandates, roles and authority 59
of RECs to oversee ethical issues in health-related research with humans 60
61
Objective: The objective of this indicator is to determine whether RECs have explicit legal 62
authority to provide ethical oversight of health-related research involving humans, as required by 63
internationally accepted ethical standards. 64
Category: Legal provisions 65
66
Subindicator: EC 01.01: Legal provision requiring health-related research with humans to be 67
reviewed and approved by RECs. 68
Description: As required by internationally accepted ethical standards, countries should have legal 69
provisions that explicitly require the ethical review and approval of health-related research with 70
humans prior to the commencement of those studies. Countries may choose to exempt specified 71
categories of low-risk studies from this requirement. 72
Objective: The objective of this subindicator is to determine whether there are legal provisions 73
requiring health-related research with humans to be reviewed and approved by RECs. 74
Evidence to review: The assessor should ask for and review: 75
1. Legal provisions requiring RECs to review and approve health-related research with humans 76
in accordance with internationally accepted ethical standards. 77
2. Any relevant guidance documents. 78
Framework: Structure/Foundation/Input 79
Rating Scale: 80
- NOT IMPLEMENTED (NI): There are no legal provisions requiring health-related research with 81
humans to be reviewed and approved by RECs. 82
- ONGOING IMPLEMENTATION (OI): Legal provisions requiring health-related research with 83
humans to be reviewed and approved by RECs have been drafted, but they have not yet been adopted. 84
- IMPLEMENTED (I): Legal provisions requiring health-related research with humans to be 85
reviewed and approved by RECs have been fully adopted. 86
Remarks: Application level: 1. National 87
88
Subindicator: EC 01.02: Legal provision ensuring that RECs have the authority to function 89
independently. 90
Description: In order for RECs to function effectively, they need to have the authority to act 91
independently of research sponsors and free of political pressures. This independence is essential to 92
maintaining public trust in the integrity of health-related research. In order to ensure RECs’ 93
independence, legal provisions should require that REC members do not participate in the review of 94
studies in which they have conflicts of interest. In addition, they should ensure that it is not possible 95
to overrule RECs’ decisions to disapprove research. 96
Objective: The objective of this subindicator is to ensure the existence of legal provisions 97
ensuring that RECs have the authority to function independently. 98
Evidence to review: The assessor should ask for and review: 99
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1. Legal provisions ensuring that RECs have the authority to act independently from researchers, 100
sponsors, and other outside influences, including provisions requiring that REC members do not 101
participate in the review of studies in which they have conflicts of interest and provisions ensuring 102
that it is not possible to overrule RECs’ decisions to disapprove research. 103
2. Any relevant guidance guidance documents. 104
Framework: Structure/Foundation/Input 105
Rating Scale: 106
- NOT IMPLEMENTED (NI): There are no legal provisions ensuring that RECs have the authority 107
to function independently. 108
- ONGOING IMPLEMENTATION (OI): Legal provisions ensuring that RECs have the authority to 109
function independently have been drafted, but they have not yet been adopted. 110
- IMPLEMENTED (I): Legal provisions ensuring that RECs have the authority to function 111
independently have been fully adopted 112
Remarks: Application level: 1. National 113
114
Subindicator: EC 01.03: Legal provision requiring RECs to review proposed research to determine 115
that it satisfies the ethical standards articulated in WHO guidance or its equivalent. 116
Description: WHO guidance sets forth specific ethical issues that RECs should consider in their 117
review of proposed research. These include the scientific design and conduct of the study; the risks 118
and potential benefits of research; the selection of the study population and recruitment of research 119
participants; the use of inducements and issues related to financial benefits and costs; protection of 120
research participants’ privacy and confidentiality; the informed consent process; and community 121
considerations. Countries should have legal provisions that require RECs to consider all of these issues. 122
Objective: The objective of this subindicator is to ensure the existence of legal provisions 123
requiring RECs to review proposed health-related research with humans to determine that it satisfies 124
the ethical standards articulated in WHO guidance or its equivalent. 125
Evidence to review: The assessor should ask for and review: 126
1. Legal provisions setting forth the considerations RECs must take into account in reviewing 127
proposed health-related research with humans. 128
2. Any relevant guidance documents 129
Framework: Structure/Foundation/Input 130
Rating Scale: 131
- NOT IMPLEMENTED (NI): There are no legal provisions requiring RECs to review proposed 132
research to determine that it satisfies the ethical standards articulated in WHO guidance or its 133
equivalent. 134
- ONGOING IMPLEMENTATION (OI): Legal provisions requiring RECs to review proposed 135
research to determine that it satisfies the ethical standards articulated in WHO guidance or its 136
equivalent have been drafted, but they have not yet been adopted. 137
- IMPLEMENTED (I): Legal provisions requiring RECs to review proposed research to determine 138
that it satisfies the ethical standards articulated in WHO guidance or its equivalent have been fully 139
adopted 140
Remarks: Application level: 1. National 141
142
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Subindicator: EC 01.04: Legal provision requiring RECs to conduct continuing review of ongoing 143
research at intervals appropriate to the risk to humans. 144
Description: In addition to reviewing proposed research before it begins, legal provisions should 145
require RECs to provide continuing review of ongoing studies. Continuing review is intended to ensure 146
that an ongoing study continues to meet the criteria that justified its initial approval. Continuing 147
review should occur at intervals appropriate to the degree of risk to human participants and should 148
take place as long as the research remains active for long-term follow-up of participants. 149
Objective: The objective of this subindicator is to ensure the existence of legal provisions 150
requiring RECs to conduct continuing review of ongoing research at intervals appropriate to the risk 151
to humans. 152
Evidence to review: The assessor should ask for and review: 153
1. Legal provisions requiring RECs to conduct continuing review of ongoing studies at intervals 154
appropriate to the degree of risk to humans. 155
2. Any relevant guidance documents. 156
Framework: Structure/Foundation/Input 157
Rating Scale: 158
- NOT IMPLEMENTED (NI): There are no legal provisions requiring RECs to conduct continuing 159
review of ongoing research at intervals appropriate to the risk to humans. 160
- ONGOING IMPLEMENTATION (OI): Legal provisions requiring RECs to conduct continuing 161
review of ongoing research at intervals appropriate to the risk to humans have been drafted, but they 162
have not yet been adopted. 163
- IMPLEMENTED (I): Legal provisions requiring RECs to conduct continuing review of ongoing 164
research at intervals appropriate to the risk to humans have been fully adopted. 165
Remarks: Application level: 1. National 166
167
Subindicator: EC 01.05: Legal provision allowing RECs to terminate health-related research with 168
humans if they determine that the rights or well-being of participants are not adequately protected. 169
Description: Legal provision should ensure that if a REC determines that the rights or well-being of 170
research participants are not adequately protected, it has the authority to suspend or, in appropriate 171
cases, terminate the research. In situations where national regulatory authorities (NRA) are 172
responsible for suspension/termination decisions, the NRA should be required to carry out an REC’s 173
recommendation to suspend or terminate a study. 174
Objective: The objective of this subindicator is to ensure the existence of legal provisions 175
authorizing RECs to suspend or terminate health-related research with humans if they determine that 176
the rights or well-being of participants are not adequately protected. 177
Evidence to review: The assessor should ask for and review: 178
1. Legal provisions authorizing RECs to suspend or terminate health-related research with 179
humans if they determine that the rights or well-being of participants are not adequately protected. 180
2. In situations where NRAs are responsible for suspension/termination decisions, legal 181
provisions requiring NRAs to carry out an REC’s recommendation to suspend or terminate a study. 182
3. Any relevant guidance documents. 183
4. Evidence of situations in which an REC has suspended or terminated, or considered 184
suspending or terminating, health-related research with humans. 185
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Framework: Structure/Foundation/Input 186
Rating Scale: 187
- NOT IMPLEMENTED (NI): There are no legal provisions authorizing RECs to suspend or 188
terminate health-related research with humans if they determine that the rights or well-being of 189
participants are not adequately being protected. 190
- ONGOING IMPLEMENTATION (OI): Legal provisions authorizing RECs to suspend or terminate 191
health-related research with humans if they determine that the rights or well-being of participants 192
are not adequately being protected have been drafted, but they have not yet been adopted. 193
- IMPLEMENTED (I): Legal provisions authorizing RECs to suspend or terminate health-related 194
research with humans if they determine that the rights or well-being of participants are not 195
adequately being protected have been fully adopted. 196
Remarks: Application level: 1. National 197
198
Subindicator: EC 01.06: Legal provision ensuring that research participants have access to medical 199
treatment for any injuries that directly result from their participation, and that participants and 200
their dependants are protected from any financial consequences that could directly result if they 201
suffer injury or death as a result of their participation. 202
Description: Consistent with internationally accepted ethical guidelines, legal provisions should 203
require the provision of appropriate treatment and compensation for humans who are harmed as a 204
result of participating in research. Compensation should be sufficient to cover the costs of medical 205
care and any wages or other income lost as a direct result of the participant’s injury or death. One 206
way to satisfy this requirement is to require research sponsors to provide insurance, a guarantee, or 207
a similar arrangement, as appropriate to the nature and the extent of the risk. 208
Objective: The objective of this subindicator is to ensure the existence of legal provisions 209
ensuring that participants have access to treatment for any injuries that directly result from their 210
participation, and that participants and their dependents are protected from any financial 211
consequences that could directly result if they suffer injury or death as a result of their participation. 212
Evidence to review: The assessor should ask for and review: 213
1. Legal provisions ensuring that participants have access to treatment for any injuries that 214
directly result from their participation, and that participants and their dependents are protected from 215
any financial consequences as a direct result of their participation is available, such as requirements 216
for sponsors to provide insurance, a guarantee, or a similar arrangement, as appropriate to the nature 217
and the extent of the risk. 218
2. Any relevant guidance documents. 219
3. Evidence of mechanisms undertaken to in particular studies to implement these provisions, 220
such as insurance policies or other relevant documents. 221
Framework: Structure/Foundation/Input 222
Rating Scale: 223
- NOT IMPLEMENTED (NI): There are no legal provisions ensuring that participants have access 224
to treatment for any injuries that directly result from their participation, and that participants and 225
their dependents are protected from any financial consequences that could directly result if they 226
suffer injury or death as a result of their participation. 227
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- ONGOING IMPLEMENTATION (OI): Legal provisions ensuring that participants have access to 228
treatment for any injuries that directly result from their participation, and that participants and their 229
dependents are protected from any financial consequences that could directly result if they suffer 230
injury or death as a result of their participation have been drafted, but they have not yet been 231
adopted. 232
- IMPLEMENTED (I): Legal provisions ensuring that participants have access to treatment for 233
any injuries that directly result from their participation, and that participants and their dependents 234
are protected from any financial consequences that could directly result if they suffer injury or death 235
as a result of their participation have been fully adopted.. 236
Remarks: Application level: 1. National 237
238
Subindicator: EC 01.07: Legal provisions creating mechanisms to suspend or revoke the authority 239
of RECs that do not adhere to applicable laws, regulations, and guidelines. 240
Description: Legal provisions should provide a mechanism for suspending or revoking an REC’s 241
authority to review and approve research if the REC is in serious noncompliance with the laws, 242
regulations, and guidelines that govern its operations. Allowing noncompliant RECs to continue 243
functioning creates significant risks for research participants and threatens to undermine the public’s 244
trust in the integrity of health-related research. The authority to suspend or revoke RECs’ authority 245
may be given to existing governmental agencies, such as ministries of health, or to independent 246
agencies created specifically to oversee RECs. 247
Objective: The objective of this subindicator is to determine whether there are legal provisions 248
creating mechanisms to suspend or revoke the authority of RECs that do not adhere to applicable 249
laws, regulations, and guidelines. 250
Evidence to review: The assessor should ask for and review: 251
1. Legal provisions creating mechanisms to suspend or revoke the authority of RECs that do not 252
adhere to applicable laws, regulations, and guidelines. 253
2. Any relevant guidance documents. 254
3. Evidence of activities undertaken by government agencies or independent oversight agencies 255
related to the suspension or revocation, or potential suspension or revocation, of an REC’s authority 256
to review and approve research. 257
Framework: Structure/Foundation/Input 258
Rating Scale: 259
- NOT IMPLEMENTED (NI): There are legal provisions creating a mechanism to suspend or 260
revoke the authority of RECs that do not adhere to applicable laws, regulations, and guidelines. 261
- ONGOING IMPLEMENTATION (OI): Legal provisions creating a mechanism to suspend or 262
revoke the authority of RECs that do not adhere to applicable laws, regulations, and guidelines have 263
been drafted, but they have not yet been adopted. 264
- IMPLEMENTED (I): Legal provisions creating a mechanism to suspend or revoke the authority 265
of RECs that do not adhere to applicable laws, regulations, and guidelines have been fully adopted. 266
Remarks: Application level: 1. National 267
Indicator: EC 02: REC structure and composition 268
269
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Objective: The objective of this indicator is to determine whether RECs have an effective 270
structure and composition. 271
Category: Structure and composition 272
273
Subindicator: EC 02.01: The REC’s membership satisfies the requirements of relevant ethical 274
guidelines. 275
Description: According to internationally accepted ethical guidelines, RECs must have a 276
multidisciplinary and multisectoral membership that is gender balanced, that reflects the social and 277
cultural diversity of the communities from which research participants are most likely to be drawn, 278
and that includes individuals with backgrounds relevant to the areas of research the committee is 279
most likely to review. 280
Factors that should be taken into consideration when appointing members include: 281
1. RECs should consist of a reasonable number of members who collectively have the education, 282
training, skills, and experience to review and evaluate the scientific, medical and ethical aspects of the 283
proposed research. Many guidelines recommend a minimum of five members. 284
2. Members should include individuals with scientific expertise, including expertise in 285
behavioural or social sciences; health care providers; members who have expertise in legal matters 286
and/or ethics; and lay people whose primary role is to share their insights about the communities from 287
which participants are likely to be drawn. 288
3. Lay people and other members, whose primary background is not in health research with 289
human participants, should be appointed in sufficient numbers to ensure that they feel comfortable 290
voicing their views. 291
4. In order to enhance independence, committee membership should include members who are 292
not affiliated with organizations that sponsor, fund, or conduct research reviewed by the REC. In 293
addition, all REC members should declare any conflicts of interest, and the REC should ensure that 294
members do not participate in the review of studies in which they have a conflict of interest. 295
5. Committees should be large enough to ensure that multiple perspectives are brought into the 296
discussion. To this end, quorum requirements should provide that at least five people, including at 297
least one lay member and one non-affiliated member, are present to make decisions about the 298
proposed research. 299
Objective: The objective of this subindicator is to ensure that the REC’s membership satisfies the 300
requirements of relevant ethical guidelines. 301
Evidence to review: The assessor should ask for and review: 302
1. Legal provisions and guidance documents related to the composition of REC members. 303
2. Provisions in the REC’s standard operating procedures related to the recruitment and 304
selection of members. 305
3. List of REC members 306
4. CVs and/or other relevant documents establishing the background and expertise of REC 307
members. 308
Framework: Structure/Foundation/Input 309
Rating Scale: 310
- NOT IMPLEMENTED (NI): The REC’s membership does not meet the requirements of relevant 311
ethical guidelines. 312
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- ONGOING IMPLEMENTATION (OI): The REC’s membership meets some of the requirements 313
of relevant ethical guidelines. 314
- IMPLEMENTED (I): The REC’s membership meets all of the requirements of relevant ethical 315
guidelines 316
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 317
318
Subindicator: EC 02.02: The roles and responsibilities of REC members are clearly defined. 319
Description: The roles and responsibilities of REC members should be clearly defined in written 320
terms of reference. Among other things, the terms of reference should make clear who has voting 321
authority, who is authorized to conduct expedited reviews, and how any conflicts of interest should 322
be declared and managed. 323
Objective: The objective of this subindicator is to ensure that roles and responsibilities of REC 324
members are clearly defined. 325
Evidence to review: The assessor should ask for and review: 326
1. Provisions in the REC’s standard operating procedures or other governing documents related 327
to the roles and responsibilities of REC members , including provisions related to voting procedures, 328
the process of expedited review, and the declaration and management of conflicts of interests. 329
2. The terms of reference for REC members. 330
3. The REC’s organizational chart. 331
Framework: Structure/Foundation/Input 332
Rating Scale: 333
- NOT IMPLEMENTED (NI): The roles and responsibilities of REC members are not clearly 334
defined. 335
- ONGOING IMPLEMENTATION (OI): The roles and responsibilities of REC members are partially 336
defined, but important elements are missing. 337
- IMPLEMENTED (I): The roles and responsibilities of REC members are clearly defined. 338
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 339
340
Subindicator: EC 02.03: REC members and chairs are appointed for specific terms, rather than on 341
an indefinite basis. 342
Description: In order to promote the active engagement of members and ensure a diversity of 343
perspectives, REC members and staff should be appointed for fixed periods of time, rather than an 344
indefinite basis. Appointments may be renewable if the conditions justifying the initial appointment 345
continue to be satisfied. 346
Objective: The objective of this subindicator is to determine whether REC members and chairs 347
are appointed for specific terms, rather than on an indefinite basis. 348
Evidence to review: The assessor should ask and review: 349
1. Provisions in the REC’s standard operating procedures or other governing documents related 350
to the appointment of REC members and chairs, including the duration of appointments and the policy 351
for renewal of appointments. 352
2. The terms of reference for REC members and chairs. 353
3. The dates of initial appointment (and renewals, if applicable) of existing REC members and 354
chairs. 355
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Framework: Structure/Foundation/Input 356
Rating Scale: 357
- NOT IMPLEMENTED (NI): REC members and chairs are not appointed for specific terms. 358
- ONGOING IMPLEMENTATION (OI): Some REC members and chairs have been appointed for 359
specific terms, but there is no clear policy requiring that this be done in all cases. 360
- IMPLEMENTED (I): REC members and chairs are appointed for specific terms . 361
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 362
363
Subindicator: EC 02.04: REC members receive training on ethical issues in health-related research 364
with humans. 365
Description: Training on the ethical aspects of health-related research with human participants, 366
how ethical considerations apply to different types of research, and how the REC conducts its review 367
of research, should be provided to REC members when they join the committee and periodically 368
during their committee service, at a frequency adequate to ensure that the members have updated 369
knowledge. 370
371
Training for REC members should focus on: 372
1. the role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according 373
to relevant international guidelines. 374
2. the full range of ethical considerations relevant to research with human participants. 375
3. the application of such ethical considerations to different types of research 376
4. basic aspects of research methodology and design 377
5. the impact of different scientific designs and objectives on the ethics of a research study 378
6. the various approaches for recognizing and resolving the tensions that can arise among 379
different ethical considerations and modes of ethical reasoning. 380
381
The REC should have a training plan that specifies the goals of training, the methods to be used, and 382
the frequency of training activities. The plan should include mechanisms for assessment of training 383
participants and evaluation of the effectiveness of training. Records of all training activities should be 384
maintained. 385
Objective: The objective of this subindicator is to determine whether REC members receive 386
training on ethical issues in health-related research with humans. 387
Evidence to review: The assessor should ask for and review: 388
1. The REC’s training plan. 389
2. Documentation of the system used to design and approve specific training activities. 390
3. Evidence of how the REC identifies training needs. 391
4. List of trainings received by members. 392
5. Examples of assessments of training participants. 393
6. Examples of evaluations of training activities. 394
Framework: Process 395
Rating Scale: 396
- NOT IMPLEMENTED (NI): REC members do not receive training on ethical issues in health-397
related research with humans. 398
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- PARTIALLY IMPLEMENTED (PI): REC members receive some training on ethical issues in health-399
related research with humans, but the training is inadequate. 400
- IMPLEMENTED (I): REC members receive adequate training on ethical issues in health-related 401
research with humans. 402
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 403
404
Subindicator: EC 02.05: REC members and chairs are protected from being removed prior to the 405
expiration of their terms, except for good cause. 406
Description: In order to preserve the independence of REC members and chairs, members and 407
chairs should be protected from being removed prior to the expiration of their terms, unless they are 408
found to have substantially breached their duties by, for example, frequently failing to attend 409
meetings or to conduct diligent reviews, or failing to disclose conflicts of interest. 410
Objective: The objective of this subindicator is to determine whether REC members and chairs 411
are protected from being removed prior to the expiration of their terms, except for good cause. 412
Evidence to review: The assessor should ask and review: 413
1. Provisions in the REC’s standard operating procedures or other governing documents related 414
to the disqualification or removal of REC members and chairs. 415
2. The terms of reference for REC members and chairs. 416
3. Documents related to any case in which REC members or chairs have been removed prior to 417
the expiration of their terms. 418
Framework: Structure/Foundation/Input 419
Rating Scale: - NOT IMPLEMENTED (NI): REC members and chairs are not protected from 420
being removed prior to the expiration of their terms in the absence of good cause. 421
- PARTIALLY IMPLEMENTED (PI): There are some limits on the circumstances in which REC 422
members and chairs may be removed prior to the expiration of their terms, but these limits do not 423
fully protect members and chairs from being removed without good cause. 424
- IMPLEMENTED (I): REC members and chairs are explicitly protected from being removed prior 425
to the expiration of their terms unless good cause for their removal exists. 426
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 427
428
Subindicator: EC 02.06: The REC invites relevant non-members to contribute to the review of 429
research that raises issues beyond the scope of the members’ own expertise. 430
Description: When RECs review research that raises issues beyond the scope of the members’ own 431
expertise, they should invite non-members with relevant expertise to contribute to the review. Non-432
members who are invited to REC meetings may fully participate in discussions, but they should not 433
have the right to vote. Before accepting an invitation to participate in a meeting, they should declare 434
any relevant conflicts of interest; the REC should withdraw the invitation if they determine that the 435
conflict of interest would make their participation in the meeting inappropriate. The REC should 436
provide non-members invited to meetings with relevant background information on the ethics review 437
process. 438
Objective: The objective of this subindicator is to determine whether RECs invite non-members 439
to contribute to the review of research that raises issues beyond the scope of members’ own 440
expertise. 441
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Evidence to review: The assessor should ask and review: 442
1. Provisions in the REC’s standard operating procedures or other governing documents related 443
to the standards and procedures for inviting non-members to participate in meetings. 444
2. Correspondence to non-members seeking their participation in REC meetings. 445
3. Conflict of interest declarations submitted by non-members who have participated in REC 446
meetings. 447
4. Background information on the ethics review process provided to non-members who 448
participate in REC meetings. 449
Framework: Structure/Foundation/Input 450
Rating Scale: 451
- NOT IMPLEMENTED (NI): The REC does not invite non-members to contribute to the review 452
of research that raises issues beyond the scope of the members’ own expertise. 453
- PARTIALLY IMPLEMENTED (PI): The REC has policies and procedures related to the 454
participation of non-members to meetings, but there is no evidence that non-members are regularly 455
invited to meetings. 456
- IMPLEMENTED (I): The REC regularly invites non-members to contribute to the review of 457
research that raises issues beyond the scope of the members’ own expertise. 458
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 459
Indicator: EC 03: REC resources 460
Objective: The objective of this indicator is to determine whether there are adequate resources, 461
including staffing, facilities, technological support, and financial resources, to allow the REC to 462
effectively carry out its responsibilities. 463
Category: Resources 464
465
Subindicator: EC 03.01: The REC has sufficient competent staff, with appropriate education, 466
training, skills and experience, to support its activities. 467
Description: The REC has an adequate number of staff members who collectively have the 468
qualifications and experience to support the members’ work. 469
Objective: The objective of this subindicator is to determine whether the existing human 470
resources for the RECs are sufficient, in terms of numbers, experience, and specific competencies, to 471
perform all the REC’s activities. 472
Evidence to review: The assessor should ask for and review: 473
1. List of staff members 474
2. CVs and/or other relevant documents establishing the background and expertise of staff 475
members. 476
3. Advertisements and/or job descriptions for staff members 477
4. Recruitment plans for staff positions and evidence of their implementation. 478
5. Information about the specific responsibilities assigned to each staff member, including the 479
number of active studies for which each staff member is responsible at the time of the assessment 480
6. Information about staff members’ work hours 481
7. Performance evaluations of staff members. 482
Framework: Structure/Foundation/Input 483
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Rating Scale: - NOT IMPLEMENTED (NI): The REC does not have sufficient competent staff, 484
with appropriate education, training, skills and experience, to support its activities. 485
- PARTIALLY IMPLEMENTED (PI): The REC has some competent staff, but does not have a full 486
complement of staff with adequate education, skills and experience to support its activities. 487
- IMPLEMENTED (I): The REC has sufficient competent staff, with appropriate education, 488
training, skills and experience, to support its activities. 489
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 490
491
Subindicator: EC 03.02: The REC’s staff receive training on ethical issues in health-related research 492
with humans. 493
Description: REC staff members should receive initial training as needed in light of their 494
background and experience, as well as periodic training at a frequency adequate to ensure that they 495
have updated knowledge. 496
Training for REC staff should address the topics specified in EC 02.04, as well as any regulatory and 497
procedural requirements applicable to the REC’s work. 498
499
The REC should have a training plan that specifies the goals of training, the methods to be used, and 500
the frequency of training activities. The plan should include mechanisms for assessment of training 501
participants and evaluation of the effectiveness of training. Records of all training activities should be 502
maintained. 503
Objective: The objective of this subindicator is to determine whether the REC’s members and 504
staff receive training on ethical issues in health-related research with humans. 505
Evidence to review: The assessor should ask for and review: 506
1. The REC’s training plan. 507
2. Documentation of the system used to design and approve specific training activities. 508
3. Evidence of how the REC identifies training needs. 509
4. List of trainings received by members. 510
5. Examples of assessments of training participants. 511
6. Examples of evaluations of training activities. 512
Framework: Process 513
Rating Scale: 514
- NOT IMPLEMENTED (NI): The REC’s staff does not receive training on ethical issues in health-515
related research with humans. 516
- PARTIALLY IMPLEMENTED (PI): The REC’s staff receive some training on ethical issues in 517
health-related research with humans, but the training is inadequate. 518
- IMPLEMENTED (I): The REC’s staff receive adequate training on ethical issues in health-related 519
research with humans. 520
Remarks: • Application level: 1. National, 2. Sub national (regional), 3. Local 521
522
Subindicator: EC 03.03: The REC has adequate facilities and equipment 523
Description: The REC should be supported with adequate infrastructures and facilities, including 524
office space, equipment and supplies (e.g. computers, stationery, telephones, photocopying 525
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machines, shredding machine) to conduct administrative business, to store committee files, and to 526
keep documents secure and confidential. 527
Objective: The objective of this subindicator is to determine whether there are adequate 528
facilities and equipment to support ethics oversight activities. 529
Evidence to review: The assessor should ask for and review: 530
1. Working facilities used by the REC. 531
2. List of equipment available to the REC. 532
Framework: Structure/Foundation/Input 533
Rating Scale: - NOT IMPLEMENTED (NI): The REC lacks essential facilities and/or equipment. 534
- PARTIALLY IMPLEMENTED (PI): The REC has facilities and equipment that satisfy some of its 535
needs, but that are not sufficient; 536
- IMPLEMENTED (I): The REC has adequate facilities and equipment. 537
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 538
539
Subindicator: EC 03.04: The REC has adequate technological support in light of its needs. 540
Description: The REC should have sufficient technological support to manage the ethics oversight 541
process. The adequacy of the system depends on the REC’s needs. For some RECs, simple paper-based 542
systems may be adequate . 543
Objective: The objective of this subindicator is to ensure that the REC has adequate technological 544
support in light of its needs. 545
Evidence to review: The assessor should ask for and review: 546
1. Computer hardware and software systems used by the REC 547
2. Technological support services available to the REC. 548
3. Information about the adequacy of the REC’s internet access 549
4. The REC’s web site 550
Framework: Structure/Foundation/Input 551
Rating Scale: 552
- NOT IMPLEMENTED (NI): The REC lacks essential technological support. 553
- PARTIALLY IMPLEMENTED (PI): The REC has some technological support, but it is not adequate 554
to the REC’s needs. 555
- IMPLEMENTED (I): The REC has technological support adequate to its needs. 556
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 557
558
Subindicator: EC 03.05: The REC has adequate financial resources 559
Description: RECs need funding to support their operations. It is not inappropriate to charge 560
research sponsors a fee for review by the committee, but the fees should be based on the actual costs 561
of review. Funding mechanisms should be designed to ensure that committees and their members 562
have no financial incentive to approve or reject particular studies. 563
Objective: The objective of this subindicator is to determine whether the REC has adequate 564
financial resources. 565
Evidence to review: The assessor should ask for and review: 566
1. Information about the REC’s source of funding. 567
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2. The REC’s budget for the current year and at least one prior year, along with information about 568
how those budgets were determined. 569
3. Information about any budget proposals by the REC that were denied, the basis for the 570
denials, and the impact of the denials on REC operations. 571
4. The number of applications reviewed annually by the REC. 572
5. Member/staff surveys on the adequacy of budget (if any). 573
6. The REC’s annual financial report. 574
7. Information about any activities not performed due to budget constraints. 575
Framework: Structure/Foundation/Input 576
Rating Scale: - NOT IMPLEMENTED (NI): The REC’s financial resources are wholly inadequate. 577
- PARTIALLY IMPLEMENTED (PI): The REC has some financial resources, but they are insufficient 578
to fully implement the REC’s mandate. 579
- IMPLEMENTED (I): The REC has adequate financial resources. 580
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 581
582
583
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Indicator: EC 04: REC procedures 584
585
Objective: The objective of this indicator is to determine whether the REC has documented 586
procedures to carry out its ethics oversight activities. The procedures should cover the submission and 587
screening of applications, the protocol review process, the monitoring of ongoing research, and the 588
document management system. 589
Category: Process 590
591
Subindicator: EC 04.01: The REC provides adequate guidelines for the submission and screening of 592
applications for the ethical review of health-related research with humans. 593
Description: The REC should provide clear guidelines for the submission and screening of 594
applications for ethical review of health-related research with humans. 595
596
The guidelines for submission should specify the necessary content of applications, any required 597
supporting materials, relevant deadlines, any applicable application fees, the expected timeline of the 598
review process, and any other information investigators need to know in order to submit a complete 599
and timely application. 600
601
The guidelines for screening should establish a clear process for determining whether applications are 602
complete and for communicating with applicants who have submitted incomplete applications. In 603
addition, the screening guidelines should establish procedures for rapidly identifying applications that 604
are exempt from REC review or eligible for expedited review. 605
Objective: The objective of this subindicator is to determine whether the REC has well-defined 606
guidelines for the submission and screening of applications for ethical review of health-related 607
research with humans. 608
Evidence to review: The assessor should ask for and review: 609
1. Guidelines for submitting an application for ethical review of health-related research with 610
humans 611
2. Application forms 612
3. Checklists for applicants 613
4. Procedures for checking the completeness of applications and communicating with 614
investigators who have submitted incomplete applications. 615
5. Procedures for rapidly identifying applications that are exempt from REC review or eligible for 616
expedited review. 617
6. Examples of ethics review applications. 618
7. Examples of communications with investigations who have submitted incomplete 619
applications. 620
8. Examples of determinations that applications are exempt from REC review or eligible for 621
expedited review. 622
Framework: Process 623
Rating Scale: 624
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- NOT IMPLEMENTED (NI): There are no guidelines for the submission and screening of 625
applications for the ethical review of health-related research with humans. 626
- PARTIALLY IMPLEMENTED (PI): Guidelines for the submission and screening of applications for 627
the ethical review of health-related research with humans exist, but they are not fully adequate. 628
- IMPLEMENTED (I): The REC has adequate guidelines for the submission and screening of 629
applications for the ethical review of health-related research with humans. 630
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 631
632
Subindicator: EC 04.02: The REC has written procedures to ensure that it explicitly considers the 633
ethical criteria for review identified in WHO guidance or its equivalent. 634
Description: The REC should have written procedures to ensure that its decisions are based on a 635
coherent and consistent application of the ethical principles articulated in international guidance 636
documents (WHO guidance or its equivalent) and human rights instruments, as well as any national 637
laws or policies consistent with those principles At a minimum, the principles addressed should 638
include (1) scientific design and conduct of the study; (2) risks and potential benefits; (3) selection of 639
study populations and recruitment of research participants; (4) inducements, financial benefits, and 640
financial costs; (5) protection of research participant confidentiality, (6) informed consent process, 641
and (7) community considerations. 642
Objective: The objective of this subindicator is to determine whether the REC has written 643
procedures to ensure that it explicitly considers the ethical criteria for review identified in WHO 644
guidance or its equivalent. 645
Evidence to review: The assessor should ask and review: 646
1. Written procedures articulating the ethical criteria to be used in reviewing health-related 647
research with humans. 648
2. Checklists, flowcharts, or other decision tools used to ensure that the REC applies these 649
criteria in its review process. 650
3. Minutes meetings, correspondence, or other documents applying the ethical criteria to 651
specific protocols. 652
4. Any guidance documents relied on by the REC in interpreting those criteria. 653
Framework: Process 654
Rating Scale: 655
- NOT IMPLEMENTED (NI): The REC does not have written procedures to ensure that it explicitly 656
considers the ethical criteria for review identified in WHO guidance or its equivalent. 657
- PARTIALLY IMPLEMENTED (PI): The REC has written procedures that ensure that it explicitly 658
considers some of the ethical criteria for review identified in WHO guidance or its equivalent, but they 659
are not adequate or not regularly followed. 660
- IMPLEMENTED (I): The REC has written procedures that ensure that it explicitly considers the 661
ethical criteria for review identified in WHO guidance or its equivalent, and there is adequate evidence 662
to indicate that those procedures are regularly followed. 663
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 664
665
Subindicator: EC 04.03: The REC members have adequate time before and during meetings for 666
meaningful review of research proposals. 667
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Description: REC members should receive all relevant documents in advance of the meetings with 668
enough time to adequately review them. The length of meetings should be sufficient to allow for a 669
full discussion of research protocols. 670
Objective: The objective of this sub‐indicator is to determine whether the REC members have 671
adequate time before and during meetings for meaningful review of research proposals. 672
Evidence to review: The assessor should ask for and review: 673
1. Procedures for distributing meeting materials to REC members. 674
2. Correspondence indicating the dates REC members were sent meeting materials for all 675
meetings held in the prior year. 676
3. Agendas and minutes for all meetings held in the prior year, indicating the starting and ending 677
times and the number of applications discussed. 678
Framework: Process 679
Rating Scale: 680
- NOT IMPLEMENTED (NI): The REC members do not have adequate time before and during 681
meetings for meaningful review of research proposals. 682
- PARTIALLY IMPLEMENTED (PI): The REC members sometimes have adequate time before and 683
during meetings for meaningful review of research proposals, but not on a consistent basis. 684
- IMPLEMENTED (I): The REC members have adequate time before and during meetings for 685
meaningful review of research proposals. 686
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 687
688
Subindicator: EC 04.04: The REC has mechanisms to ensure that decisions are made in a timely 689
manner and that the results are promptly communicated to principal investigators 690
Description: RECs should meet regularly as a committee on dates that are announced in advance. 691
The REC’s procedures should specify the frequency of meetings, which should be based on committee 692
workload and regular enough to avoid undue delay; establish the maximum timeframe for review 693
after receipt of complete applications; and require the REC to provide written justification in situations 694
where that timeframe is exceeded. 695
696
The results of REC decisions should be promptly communicated to principal investigators. Any 697
negative decisions or requests for modifications should be accompanied by a written explanation. 698
Objective: The objective of this subindicator is to determine whether the REC has mechanisms 699
to ensure that decisions are made in a timely manner and that the results are promptly communicated 700
to principal investigators. 701
Evidence to review: The assessor should ask for and review: 702
1. Procedures for scheduling REC meetings. 703
2. Procedures establishing maximum timeframes for review after receipt of complete 704
applications, and for requiring written justifications in situations where that timeframe is exceeded. 705
3. Dates of meetings held by the REC in the prior year. 706
4. For each meeting held in the prior year, a list of applications considered; the dates on which 707
those applications were submitted; and correspondence with principal investigators of those 708
applications informing them of decisions taken at the meetings. 709
Framework: Process 710
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Rating Scale: 711
- NOT IMPLEMENTED (NI): The REC does not have mechanisms to ensure that its decisions are 712
made in a timely manner and that the results are promptly communicated to principal investigators. 713
- PARTIALLY IMPLEMENTED (PI): The REC has some procedures to ensure that its decisions are 714
made in a timely manner and that the results are promptly communicated to principal investigators, 715
but those procedures are not adequate or are not regularly followed. 716
- IMPLEMENTED (I): The REC has procedures to ensure that its decisions are made in a timely 717
manner and that the results are promptly communicated to principal investigators, and there is 718
adequate evidence to indicate that those procedures are regularly followed. 719
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 720
721
Subindicator EC 04.05: The REC has mechanisms for ensuring the rapid review of research 722
proposals in public health emergencies. 723
724
Description: The REC should have mechanisms that ensure the rapid review of time-sensitive 725
proposals for research during public health emergencies. Those mechanisms should not compromise 726
the REC’s ability to conduct a thorough assessment of the ethical issues raised by proposed research. 727
Objective: The objective of this subindicator is to determine whether the REC has mechanisms 728
for ensuring the rapid review of research proposals in public health emergencies. 729
Evidence to review: The assessor should review: 730
1. Procedures to ensure the rapid review of research proposals in public health emergencies. 731
2. Any examples of applications for research related to a public health emergency, including the 732
dates of the applications and the dates of final decisions. 733
Framework: Process 734
Rating Scale: 735
- NOT IMPLEMENTED (NI): The REC has no mechanisms for ensuring the rapid review of 736
research proposals in public health emergencies. 737
- PARTIALLY IMPLEMENTED (PI): The REC has some mechanisms for ensuring the rapid review 738
of research proposals in public health emergencies, but those mechanisms are not adequate or are 739
not regularly followed. 740
- IMPLEMENTED (I): The REC has procedures for considering relevant previous decisions in its 741
review of protocols and there is adequate evidence to indicate that those procedures are regularly 742
followed. 743
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 744
745
746
747
Subindicator EC 04.06: The REC has procedures for considering relevant previous decisions in its 748
review of protocols. 749
Description: The REC should have procedures for considering relevant previous decisions in its 750
review of protocols, in order to ensure that it can draw on relevant prior decisions and minimize the 751
likelihood of unjustified inconsistencies. 752
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Objective: The objective of this subindicator is to determine whether the REC has procedures for 753
considering relevant previous decisions in its review of protocols. 754
Evidence to review: The assessor should review: 755
1. Procedures to ensure that RECs have access to relevant previous decision in its review of 756
protocols. 757
2. The database or archiving system for REC decisions. 758
3. Minutes of REC meetings indicating consideration of relevant previous decisions. 759
Framework: Process 760
Rating Scale: 761
- NOT IMPLEMENTED (NI): The REC has no procedures for considering relevant previous 762
decisions in its review of protocols. 763
- PARTIALLY IMPLEMENTED (PI): The REC has procedures for considering relevant previous 764
decisions in its review of protocols, but they are not adequate or not regularly followed. 765
- IMPLEMENTED (I): The REC has procedures for considering relevant previous decisions in its 766
review of protocols and there is adequate evidence to indicate that those procedures are regularly 767
followed. 768
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 769
770
Subindicator: EC 04.07: The REC engages in and/or contributes to monitoring of ongoing research 771
at intervals appropriate to the degree of risk to humans. 772
Description: RECs should have procedures for monitoring studies for which a positive decision has 773
been reached, at intervals appropriate to the degree of risk to humans. At a minimum, the REC’s 774
procedures should address continuing review, review of amendment requests, review of protocol 775
deviations, and adverse event review. The procedures should ensure that the REC has the authority 776
to act independently of regulatory authorities. 777
Objective: The objective of this subindicator is to determine whether the REC engages in and/or 778
contributes to monitoring of ongoing research at intervals appropriate to the degree of risk to humans. 779
Evidence to review: The assessor should ask for and review: 780
1. Procedures related to continuing review, review of amendment requests, review of protocol 781
deviations, and adverse event review. 782
2. Information about all monitoring activities conducted in the previous year. 783
Framework: Process 784
Rating Scale: 785
- NOT IMPLEMENTED (NI): The REC does not engage in and/or contribute to monitoring of 786
ongoing research. 787
- PARTIALLY IMPLEMENTED (PI): The REC has procedures for engaging in and/or contributing to 788
monitoring of ongoing research, but those procedures are not adequate or not regularly followed. 789
- IMPLEMENTED (I): The REC has procedures for engaging in and/or contributing to the 790
monitoring of ongoing research, and there is adequate evidence to indicate that those procedures are 791
regularly followed. 792
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 793
794
Subindicator: EC 04.08: The REC maintains a good document management system. 795
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Description: The REC should have documented procedures for all its activities, and the results of 796
all activities should be adequately documented. All of the REC’s documentation and communication 797
should be dated, filed, and archived according to the committee’s policies and written procedures. 798
Such policies should be consistent with any relevant local laws or institutional policies. REC records 799
may be kept in hard copy, electronically, or both. Sufficient safeguards should be established to 800
maintain confidentiality (e.g. locked cabinets for hard copy files, password protection and encryption 801
for electronic files). An adequate system should be in place for the storage, security, retrieval, and 802
eventual disposal of documents, and policies should exist regarding the duration of storage. This 803
system should enable the REC to identify and trace documents of relevant previous decisions. REC 804
staff should be sufficiently trained to understand their responsibilities related to record keeping, 805
retrieval, and confidentiality. The REC’s procedures should outline who is authorized to access 806
committee files and documents. 807
Objective: The objective of this subindicator is to determine whether the REC maintains a good 808
document management system. 809
Evidence to review: The assessor should ask for and review: 810
1. The REC’s database or archiving system. 811
2. Procedures for document storage and access. 812
3. Procedures for the maintenance of archives and related documents. 813
4. Information about staff training activities related to record keeping, retrieval, and 814
confidentiality. 815
5. Evidence that documents associated with all meetings held within the past year have been 816
properly archived. 817
Framework: Procedure 818
Rating Scale: 819
- NOT IMPLEMENTED (NI): The REC has no document management system. 820
- PARTIALLY IMPLEMENTED (PI): The REC has a document management system, but it is not 821
adequate or not consistently used. 822
- IMPLEMENTED (I): The REC has a good document management system and there is adequate 823
evidence to show that the system is regularly used. 824
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 825
826
Subindicator: EC 04.09: The REC has internal mechanisms to monitor its adherence to its standard 827
operating procedures. 828
Description: The REC should employ reliable means to evaluate whether its staff and members 829
routinely follow its policies, rules, and written procedures, with special attention to whether the 830
ethical considerations articulated in international guidelines and national standards are being 831
considered and applied consistently and coherently. 832
Objective: The objective of this subindicator is to determine whether the REC has internal 833
mechanisms to monitor its adherence to its standard operating procedures. 834
Evidence to review: The assessor should ask for and review: 835
1. Procedures for monitoring REC staff and members’ compliance with the REC’s policies, rules 836
and procedures. 837
2. Examples of monitoring activities undertaken by the REC in the prior year. 838
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Framework: Process 839
Rating Scale: 840
- NOT IMPLEMENTED (NI): The REC has no internal mechanisms to monitor its adherence to its 841
standard operating procedures. 842
- PARTIALLY IMPLEMENTED (PI): The REC has internal mechanisms to monitor its adherence to 843
its standard operating procedures, but these mechanisms are not adequate or they are not regularly 844
followed. 845
- IMPLEMENTED (I): The REC has internal mechanisms to monitor its adherence to its standard 846
operating procedures, and there is adequate evidence to show that these procedures are regularly 847
followed. 848
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 849
850
Subindicator: EC 04.10: The REC has procedures for communication and coordination with other 851
committees, regulatory authorities, and other stakeholders that are also responsible for oversight 852
of research. 853
Description: The REC should have procedures to ensure clear and efficient communication, 854
harmonization of standards, networking, and cooperation among national committees and between 855
different levels of committees, as applicable. These procedures enable RECs to learn about prior 856
decisions by other RECs that may be relevant to the proposed research under review. In addition, 857
procedures should exist for the coordinated review of multi-site research, whether within a country 858
or in more than one country. 859
Objective: The objective of this subindicator is to determine whether the REC has procedures for 860
communication and coordination with other stakeholders that are also responsible for oversight of 861
research. 862
Evidence to review: The assessor should ask for and review: 863
1. Procedures for communication and coordination with other stakeholders (e.g.: other REC, 864
NRA, etc) that are also responsible for oversight of research. 865
2. Examples of communication and coordination with other stakeholders. 866
Framework: Process 867
Rating Scale: 868
- NOT IMPLEMENTED (NI): The REC has no procedures for communication and coordination 869
with other stakeholders that are also responsible for oversight of research proposals. 870
- PARTIALLY IMPLEMENTED (PI): The REC has some procedures for communication and 871
coordination with other stakeholders that are also responsible for oversight of research proposals, but 872
the procedures are inadequate or not regularly used. 873
- IMPLEMENTED (I): The REC has procedures for communication and coordination with other 874
stakeholders that are also responsible for oversight of research proposals and there is adequate 875
evidence to show that these procedures are regularly used. 876
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 877
878
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Indicator: EC 05: Mechanisms to promote REC transparency 879
880
Objective: The objective of this indicator is to determine whether mechanisms are in place to 881
make REC operations transparent. These mechanisms should provide the public with information 882
about the ethics review process, the sources of RECs’ funding, the composition of RECs, and all 883
research proposals that REC approves. In addition, they should enable research participants, 884
prospective research participants, and investigators to pose questions to RECs and to obtain a 885
response. 886
Category: Transparency 887
888
Subindicator: EC.05.01: Updated information on laws, regulations, and official guidelines related 889
to the ethics oversight of health-related research with humans is publicly available. 890
Description: The public should have access to updated information regarding, laws, regulations 891
and official guidelines related to the ethics oversight of health-related research with humans. 892
Objective: The objective of this subindicator is to determine whether updated information on 893
laws, regulations, and official guidelines related to the ethics oversight of health-related research with 894
humans is publicly available. 895
Evidence to review: The assessor should ask for and review: 896
1. Websites or other publicly available sources of information about laws, regulations, and 897
official guidelines related to the ethics oversight of health-related research with humans. 898
Framework: Output 899
Rating Scale: 900
- NOT IMPLEMENTED (NI): Updated information on laws, regulations, and official guidelines 901
related to the ethics oversight of health-related research with humans is not publicly available. 902
- PARTIALLY IMPLEMENTED (PI): Some information on laws, regulations, and official guidelines 903
related to the ethics oversight of health-related research with humans is publicly available, but it is 904
not complete and/or not up to date. 905
- IMPLEMENTED (I): Updated information on laws, regulations, and official guidelines related 906
to the ethics oversight of health-related research with humans is publicly available. 907
Remarks: Application level: 1. National. This subindicator should not be used in the evaluation 908
of individual RECs. 909
910
Subindicator: EC 05.02: Updated information on the REC’s own guidelines and procedures is 911
publicly available. 912
Description: The REC should have a mechanism to ensure that updated information regarding its 913
own guidelines and procedures is publicly available. 914
Objective: The objective of this subindicator is to determine whether updated information on 915
the REC’s own guidelines and procedures is publicly available. 916
Evidence to review: The assessor should ask for and review: 917
1. Websites or other publicly available sources of information about the REC’s guidelines and 918
procedures. 919
2. Procedures for ensuring that these materials are up to date. 920
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Framework: Output 921
Rating Scale: 922
- NOT IMPLEMENTED (NI): REC does not make updated information on its own guidelines and 923
procedures publicly available. 924
- PARTIALLY IMPLEMENTED (PI): REC makes some information on its own guidelines and 925
procedures publicly available, but it is not complete and/or not up to date. 926
- IMPLEMENTED (I): REC makes updated information on its own guidelines and procedures 927
publicly available. 928
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 929
930
Subindicator: EC 05.03: Information about the REC’s sources of funding is publicly available. 931
Description: RECs may be funded by a variety of sources, including national or local governments, 932
research institutions, or research sponsors. In all cases, the source of funding for the REC’s activities 933
should be made publicly available. 934
Objective: The objective of this subindicator is to determine whether REC’s sources of funding 935
are publicly available. 936
Evidence to review: The assessor should ask for and review: 937
1. Information about the sources of the REC’s funding. 938
2. Evidence that the sources of the REC’s funding are publicly available, such as publication on a 939
website, in an annual report, or in other publicly available documents. 940
Framework: Input and Output 941
Rating Scale: 942
- NOT IMPLEMENTED (NI): Information about the sources of the REC’s funding is not publicly 943
available. 944
- PARTIALLY IMPLEMENTED (PI): Some information about the sources of the REC’s funding is 945
publicly available, but the information is not complete and/or not easily accessible. 946
- IMPLEMENTED (I): Information about the sources of the REC’s funding is publicly available. 947
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 948
949
Subindicator: EC 05.04: An updated list of all RECs in the country is publicly available. 950
Description: A list of all RECs operating in the country should be publicly available. This 951
requirement could be satisfied by one of the following methods: 952
• Publication of a list of RECs by a government ministry or other official entity 953
• Publication of a list of RECs by a university or nonprofit institution 954
• In countries that require RECs to be registred, publication of a list of registered RECs by the 955
entity in charge of the registry 956
• In countries where all RECs are created by specific legal provisions, publication of a list of those 957
legal provisions 958
Objective: The objective of this subindicator is to determine whether a list of registered RECs is 959
publicly available. 960
Evidence to review: The assessor should ask for and review: 961
1. An updated list of all RECs operating in the country 962
2. Information about the mechanism used to include RECs in the list 963
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3. Information about the mechanism used to ensure that the list remains up to date 964
4. Evidence that the list is publicly available, such as publication on a website, in official 965
government documents, or in other publicly available sources. 966
Framework: Transparency 967
Rating Scale: 968
- NOT IMPLEMENTED (NI): An updated list of all RECs in the country does not exist. 969
- PARTIALLY IMPLEMENTED (PI): A list of all RECs in the country exists, but it is not publicly 970
available and/or it is not regularly updated. 971
- IMPLEMENTED (I): An updated list of all RECs in the country is publicly available. 972
Remarks: Application level: 1. National. This subindicator should not be used in the evaluation 973
of individual RECs. 974
975
Subindicator: EC 05.05: An updated list of all the REC’s members is publicly available. 976
Description: In order to promote transparency and accountability purpose, a list of the REC’s 977
members should be publicly available. 978
Objective: The objective of this subindicator is to ensure that an updated list of the REC’s 979
members is publicly available. 980
Evidence to review: The assessor should ask and review: 981
1. An updated list of the REC’s members. 982
2. Information about the mechanism used to ensure that the list remains up to date. 983
3. Evidence that the list is publicly available, such as publication on a website, in an annual 984
report, or in other publicly available documents. 985
Framework: Transparency 986
Rating Scale: 987
- NOT IMPLEMENTED (NI): The REC does not provide a publicly available list of its members. 988
- PARTIALLY IMPLEMENTED (PI): Information about the REC’s members is available to the 989
public, but only on request. 990
- IMPLEMENTED (I): An updated list of the REC’s members is publicly available. 991
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 992
993
Subindicator: EC 05.06: A searchable list of the titles, principal investigators, and dates of approval 994
of all research proposals approved by the REC is publicly available. 995
Description: REC decisions, excluding confidential information, should be made publicly available, 996
through mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards. The 997
information should be presented as a searchable list of the titles, principal investigators, and dates of 998
approval of all research proposals approved by the REC. RECs should have the authority not to disclose 999
the information about a study when doing so would expose investigators and/or participants to a risk 1000
of harm (e.g., in studies involving illegal or highly stigmatized behavior, such as drug use or same-sex 1001
sexual activity). RECs should be encouraged to include short summaries of approved studies to the 1002
extent this is feasible, but doing so is not a requirement for satisfying this sub-indicator. To make it 1003
possible for RECs to publish short summaries, investigators should be encouraged to submit a brief 1004
description of the study in language understandable to a reasonable person. 1005
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Objective: The objective of this subindicator is to determine whether a searchable list of the 1006
titles, principal investigators, and dates of approval of all research proposals approved by the REC is 1007
publicly available. 1008
Evidence to review: The assessor should ask for and review: 1009
1. Standard operating procedures or other documents requiring that a searchable list of the 1010
titles, principal investigators, and dates of approval of all research proposals approved by the REC are 1011
made publicly available. 1012
2. A list of the titles, principal investigators, and dates of approval of all research proposals 1013
approved by the REC. 1014
3. Information about the mechanism used to ensure that the list remains up to date 1015
4. Evidence that the list is publicly available, such as publication on a website, in an annual 1016
report, or in other publicly available documents. 1017
Framework: Output 1018
Rating Scale: 1019
- NOT IMPLEMENTED (NI): There is no a searchable list of the titles, principal investigators, and 1020
dates of approval of all research proposals approved by the REC. 1021
- PARTIALLY IMPLEMENTED (PI): A searchable list of the titles, principal investigators, and dates 1022
of approval of all research proposals approved by the REC exists, but it is not publicly available and/or 1023
not regularly updated. 1024
- IMPLEMENTED (I): A searchable list of the titles, principal investigators, and dates of approval 1025
of all research proposals approved by the REC is publicly available. 1026
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1027
1028
Subindicator: EC 05.07: The REC has a mechanism for research participants or prospective research 1029
participants to ask questions about their rights as research participants, about studies in which they 1030
have been involved, and about the ethics review process, as well as procedrues for responding to 1031
those questions. 1032
Description: The REC should have mechanism for research participants or prospective participants 1033
to ask questions about their rights as research participants, about studies in which they have been 1034
involved, and about the ethics review process , as well as procedures for responding to those 1035
questions. This mechanism should be created and overseen by the REC and should be separate from 1036
any mechanisms for posing questions to investigators or research sponsors. Research participants 1037
and prospective research participants should be made aware of the existence of this mechanism. 1038
Objective: The objective of this subindicator is to determine whether the REC has a mechanism 1039
for research participants or prospective research participants to ask questions about their rights as 1040
research participants, about studies in which they have been involved, and about the ethics review 1041
process, as well as procedures for responding to those questions. 1042
Evidence to review: The assessor should ask for and review: 1043
1. Standard operating procedures or other documents establishing a mechanism for research 1044
participants or prospective research participants to ask questions about their rights as research 1045
participants, about studies in which they have been involved, and about the ethics review process, as 1046
well as procedures for responding to those questions. 1047
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2. Evidence that research participants and prospective participants are made aware of the 1048
existence of this mechanism through prominent notices on websites, informed consent forms, or 1049
other means. 1050
3. Evidence of all questions posed by research participants or prospective research participants 1051
in the prior year and the REC’s responses to those questions. 1052
Framework: Process 1053
Rating Scale: 1054
- NOT IMPLEMENTED (NI): The REC has no mechanism for research participants or prospective 1055
research participants to ask questions about their rights as research participants, about studies in 1056
which they have been involved, and about the ethics review process. 1057
- PARTIALLY IMPLEMENTED (PI): The REC has mechanism for research participants or 1058
prospective research participants to ask questions about their rights as research participants, about 1059
studies in which they have been involved, and about the ethics review process, but it is not adequately 1060
publicized and/or the REC does not consistently provide responses to questions. 1061
- IMPLEMENTED (I): The REC has a mechanism for research participants or prospective research 1062
participants to ask questions about their rights as research participants, about studies in which they 1063
have been involved, and about the ethics review process, as well as procedures for responding to 1064
those questions, and there is evidence that it is well publicized and that the REC consistently responds 1065
to all questions submitted. 1066
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1067
1068
Subindicator: EC 05.08: The REC has a mechanism for investigators to ask questions about the 1069
ethics review process, as well as procedures for responding to those questions. 1070
Description: The REC should have a mechanism for investigators to ask questions about the ethics 1071
review process, as well as procedures for responding to those questions. This mechanism should be 1072
created and overseen by the REC and should be separate from any mechanisms for posing questions 1073
to research sponsors. Investigators should be made aware of the existence of this mechanism. 1074
Objective: The objective of this subindicator is to determine whether the REC has a mechanism 1075
for investigators to ask questions about the ethics review process, as well as procedures for 1076
responding to those questions. 1077
Evidence to review: The assessor should ask for and review: 1078
1. Standard operating procedures or other documents establishing a mechanism for 1079
investigators to ask questions about the ethics review process , as well as procedures for responding 1080
to those questions. 1081
2. Evidence that investigators are made aware of the existence of this mechanism through 1082
prominent notices on websites, in application materials, or other means. 1083
3. Evidence of all questions posed by investigators in the prior year and the REC’s responses to 1084
those questions. 1085
Framework: Process 1086
Rating Scale: 1087
- NOT IMPLEMENTED (NI): The REC has no a mechanism for investigators to ask questions about 1088
the ethics review process. 1089
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- PARTIALLY IMPLEMENTED (PI): The REC has a mechanism for investigators to ask questions 1090
about the ethics review process, but it is not adequately publicized and/or the REC does not 1091
consistently provide responses to questions. 1092
- IMPLEMENTED (I): The REC has a mechanism for investigators to ask questions about the 1093
ethics review process, as well as procedures for responding to those questions, and there is adequate 1094
evidence that it is well publicized and that the REC consistently responds to all questions submitted. 1095
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1096
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Indicator: EC 06: Mechanisms for RECs to monitor their performance 1097
1098
Objective: The objective of this indicator is to determine whether the REC has mechanisms in 1099
place to ensure their adherence to ethical standards and to assess and improve the quality of their 1100
performance. 1101
Category: Monitoring performance 1102
1103
Subindicator: EC 06.01: The REC has mechanisms to continuously monitor its adherence to 1104
indicators EC 02, EC 03, EC 04, and EC 05. 1105
Description: In order to ensure that indicators in this tool are consistently implemented, RECs 1106
should have mechanisms to continuously monitor their adherence to indicators EC02, EC 03, EC 04, 1107
and EC 05. 1108
Objective: The objective of this subindicator is to determine whether the REC has mechanisms 1109
to continuously monitor their adherence to indicators EC 02, EC 03, EC 04, and EC 05. 1110
Evidence to review: The assessor should ask for and review: 1111
1. Standard operating procedures or other documents that specify policies and procedures for 1112
RECs to continuously monitor their adherence EC 02, EC 03, EC 04, and EC 05. 1113
2. Evidence that these policies and procedures are consistently implemented, such as internal 1114
audit reports. 1115
3. Information about how the REC uses the information generated by these monitoring 1116
mechanisms, and there is adequate evidence that these mechanisms are consistently used. 1117
Framework: Output 1118
Rating Scale: 1119
- NOT IMPLEMENTED (NI): The REC has no mechanisms to continuously monitor its adherence 1120
to indicators EC 02, EC 03, EC 04, and EC 05. 1121
- PARTIALLY IMPLEMENTED (PI): The REC has some mechanisms to continuously monitor its 1122
adherence to indicators EC 02, EC 03, EC 04, and EC 05, but these mechanisms are incomplete and/or 1123
not consistently used. 1124
- IMPLEMENTED (I): The REC has mechanisms to continuously monitor its adherence to 1125
indicators EC 02, EC 03, EC 04, and EC 05 and it is fully implemented. 1126
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1127
It is not expected that all RECs will have the capacity to institute a comprehensive monitoring system. 1128
1129
Subindicator: EC 06.02: The REC has mechanisms for research participants or prospective research 1130
participants to lodge complaints about studies in which they have been involved or about the ethics 1131
review process, as well as procedures for reviewing and responding to those complaints. 1132
Description: Research participants should have a means of lodging complaints with the REC about 1133
studies in which they have been involved or about the ethics review process, and the REC should have 1134
a mechanism for reviewing and responding to those complaints. This mechanism should be created 1135
and overseen by the REC and should be separate from any mechanisms for lodging complaints with 1136
investigators or research sponsors. Research participants and prospective research participants 1137
should be made aware of the existence of this mechanism. If a complaint reveals problems with an 1138
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ongoing study, the REC should take appropriate remedial action, which in some cases may include 1139
suspending or terminating the study. If the complaint reveals problems with the ethics review process, 1140
the REC should institute changes in the process to address the identified problems. 1141
Objective: The objective of this subindicator is to determine whether the REC has mechanisms 1142
for research participants or prospective research participants to lodge complaints about studies in 1143
which they have been involved or about the ethics review process, as well as procedures for reviewing 1144
and responding to those complaints. 1145
Evidence to review: The assessor should ask for and review: 1146
1. Standard operating procedures or other documents that specify policies and procedures for 1147
research participants or prospective research participants to lodge complaint about studies in which 1148
they have been involved or about the ethics review process, as well as procedures for responding to 1149
those complaints. 1150
2. Evidence that research participants and prospective participants are made aware of the 1151
existence of this mechanism through prominent notices on websites, informed consent forms, or 1152
other means. 1153
3. Evidence of all complaints raised by research participants or prospective research participants 1154
in the prior year and the REC’s responses to those complaints. 1155
4. Evidence of any follow-up actions the REC has taken based on complaints received, including 1156
remedial actions in ongoing studies and changes to the process of ethics review. 1157
Framework: Process 1158
Rating Scale: 1159
- NOT IMPLEMENTED (NI): The REC has no mechanism for research participants or prospective 1160
research participants to lodge complaints about studies in which they have been involved or about 1161
the ethics review process. 1162
- PARTIALLY IMPLEMENTED (PI): The REC has mechanisms for research participants or 1163
prospective research participants to lodge complaints about studies in which they have been involved 1164
or about the ethics review process, but it is not adequately publicized and/or the REC does not 1165
consistently provide responses to complaints. 1166
- IMPLEMENTED (I): The REC has a mechanism for research participants or prospective research 1167
participants to lodge complaints about studies in which they have been involved or about the ethics 1168
review process, as well as procedures for responding to those questions, and there is adequate 1169
evidence that it is well publicized and that the REC consistently responds to all complaints submitted. 1170
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1171
1172
Subindicator: EC 06.03: The REC has mechanisms for investigators to lodge complaints about the 1173
ethics review process, as well as procedures for responding to those complaints. 1174
Description: Investigators should have a means of lodging complaints with the REC about the ethics 1175
review process, and the REC should have a mechanism for reviewing and responding to those 1176
complaints. This mechanism should be created and overseen by the REC and should be separate from 1177
any mechanisms for lodging complaints with research sponsors. Investigators should be made aware 1178
of the existence of this mechanism. If the complaint reveals problems with the ethics review process, 1179
the REC should institute changes in the process to address the identified problems. 1180
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Objective: The objective of this subindicator is to determine whether the REC has mechanisms 1181
for investigators to lodge complaints about the ethics review process, as well as procedures for 1182
reviewing and responding to those complaints. 1183
Evidence to review: The assessor should ask for and review: 1184
1. Standard operating procedures or other documents that specify policies and procedures for 1185
investigators to lodge complaint about the ethics review process, as well as procedures for responding 1186
to those complaints. 1187
2. Evidence that investigators are made aware of the existence of this mechanism through 1188
prominent notices on websites, in application materials, or other means. 1189
3. Evidence of all complaints raised by investigators in the prior year and the REC’s responses to 1190
those complaints. 1191
4. Evidence of any follow-up actions the REC has taken based on complaints received, including 1192
changes to the process of ethics review. 1193
Framework: Process 1194
Rating Scale: 1195
- NOT IMPLEMENTED (NI): The REC has no mechanism for investigators to lodge complaints 1196
about the ethics review process. 1197
- PARTIALLY IMPLEMENTED (PI): The REC has a mechanism for investigators to lodge complaints 1198
about the ethics review process, but it is not adequately publicized and/or the REC does not 1199
consistently provide responses to complaints. 1200
- IMPLEMENTED (I): The REC has a mechanism for investigators to lodge complaints about the 1201
ethics review process, as well as procedures for responding to those questions, and there is adequate 1202
evidence that it is well publicized and that the REC consistently responds to all complaints submitted. 1203
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1204
1205
Subindicator: EC 06.04: The REC has mechanisms to solicit feedback from investigators and 1206
research participants about their experience of research and the system of research participant 1207
protection. 1208
Description: To assist in the REC’s ability to provide effective ethics oversight, the REC should have 1209
mechanisms to proactively solicit feedback from investigators and research participants about their 1210
experience of research and the system of research participant protection. If the feedback reveals 1211
problems with an ongoing study, the REC should take appropriate remedial action, which in some 1212
cases may include suspending or terminating the study. If the feedback reveals problems with the 1213
ethics review process, the REC should institute changes in the process to address the identified 1214
problems. 1215
Objective: The objective of this subindicator is determine whether that the REC has mechanisms 1216
to solicit feedback from investigators and research participants about their experience of research and 1217
the system of research participant protection. 1218
Evidence to review: The assessor should ask for and review: 1219
1. Standard operating procedures or other documents that specify policies and procedures for 1220
soliciting feedback from investigators and research participants about their experience of research 1221
and the system of research participant protection. 1222
2. Evidence that these policies and procedures have been implemented. 1223
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3. Feedback received from investigators and research participants as a result of these policies 1224
and procedures in the past year. 1225
4. Evidence of any follow-up actions the REC has taken based on feedback received, including 1226
changes to the process of ethics review. 1227
Framework: Process 1228
Rating Scale: 1229
- NOT IMPLEMENTED (NI): The REC has no mechanisms to solicit feedback from investigators 1230
and research participants about their experience of research and the system of research participant 1231
protection. 1232
- PARTIALLY IMPLEMENTED (PI): The REC has some mechanisms to solicit feedback from 1233
investigators and research participants about their experience of research and the system of research 1234
participant protection, but these mechanisms are inadequate and/or not consistently used. 1235
- IMPLEMENTED (I): has mechanisms to solicit feedback from investigators and research 1236
participants about their experience of research and the system of research participant protection, and 1237
there is evidence that these mechanisms are consistently used. 1238
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1239
1240
Subindicator: EC 06.05: The REC conducts internal audits of its performance on a regular basis. 1241
Description: The REC should conduct internal audits of its performance on a regular basis, in order 1242
to ensure that it is maintaining high standards of quality and productivity and that its work is having a 1243
positive impact on the protection of research participants. RECs should select criteria to audit based 1244
on applicable legal standards, ethical guidance, and internal policies and procedures. Examples of 1245
criteria that RECs could measure include the following: 1246
• Productivity metrics, such as time from submission to approval 1247
• Quality of REC deliberations, such as reviews of meeting minutes to determine whether all 1248
relevant ethical criteria are discussed and whether sufficient attention is paid to core issues like 1249
risk/benefit assessment and informed consent 1250
• Metrics comparing the REC’s assessment of studies’ risks with information about the number 1251
and type of adverse events reported in those studies 1252
• Number and nature of complaints received by the REC 1253
• Outcomes of surveys assessing participants’ comprehension of the informed consent process 1254
• Outcomes of surveys assessing participants’ experience of participating in research 1255
• Outcomes of surveys of REC members about the strengths and weaknesses of the ethics 1256
review process. 1257
The REC should use the information generated through these audits to make ongoing improvements 1258
in the ethics review system. 1259
Objective: The objective of this subindicator is to determine whether the REC conducts internal 1260
audits of its performance on a regular basis. 1261
Evidence to review: The assessor should ask for and review: 1262
1. Standard operating procedures or other documents that specify mechanisms the REC uses to 1263
conduct internal audits of its performance on a regular basis. 1264
2. A list of the criteria the REC’s internal audits are designed to measure. 1265
3. The results of all internal audits conducted in the past year. 1266
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4. Evidence of any follow-up actions the REC has taken based on these internal audits, including 1267
changes to the process of ethics review. 1268
Framework: Structure/Foundation/Input 1269
Rating Scale: 1270
- NOT IMPLEMENTED (NI): The REC has no mechanisms to conduct internal audits of its 1271
performance on a regular basis. 1272
- PARTIALLY IMPLEMENTED (PI): The REC has some mechanisms to conduct internal audits of 1273
its performance, but they are inadequate and/or not consistently used. 1274
- IMPLEMENTED (I): The REC has mechanisms to conduct internal audits of its performance on 1275
a regular basis, and there is documented evidences that these mechanisms are consistently used. 1276
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1277
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Indicator: EC 07: Responsible Research Institutions 1278
1279
Objective: The objective of this indicator is to determine whether research institutions fulfil their 1280
responsibility to ensure that any health-related research with humans affiliated with the institution 1281
adheres to internationally recognized ethical standards. 1282
1283
Subindicator: EC 07.01: The institution requires proposals for health-related research with 1284
humans to be submitted to an REC if any part of the research will be conducted by a researcher 1285
affiliated with the institution. 1286
Description: Research institutions should ensure that all proposals for health-related research with 1287
humans are submitted to an REC if any part of the research will be conducted by a researcher affiliated 1288
with the institution. In some systems, the institution may automatically fall under the jurisdiction of 1289
a particular REC. In others, institutions need to create their own RECs or establish affiliations with 1290
external RECs in order to satisfy this subindicator. 1291
Objective: The objective of this subindicator is to determine whether the institution requires 1292
proposals for health-related research with humans to be submitted to an REC. 1293
Evidence to review: The assessor should ask for and review: 1294
• Institutional policies requiring all health-related research with humans to be submitted to an 1295
REC if any part of the research will be conducted by a researcher affiliated with the institution. 1296
• Institutional policies specifying the REC(s) the institution relies on for reviewing research 1297
conducted by researchers affiliated with it. 1298
• Evidence that the institution has mechanisms for ensuring that researchers affiliated with the 1299
institution comply with these policies. 1300
• Information about any actions taken against researchers who fail to comply with these 1301
policies. 1302
• Information about all health-related research with humans conducted by researchers 1303
affiliated with the institution in the past year, along with evidence that these studies were submitted 1304
to RECs. 1305
• Evidence of the institution’s express commitment to complying with international and 1306
national ethical standards in health-related research with humans. 1307
Framework: Structure/Foundation/Input 1308
Rating Scale: 1309
- NOT IMPLEMENTED (NI): the institution does not require proposals for health-related 1310
research with humans to be submitted to an REC. 1311
- PARTIALLY IMPLEMENTED (PI): the institution requires proposals for health-related research 1312
with humans to be submitted to an REC, but it does not adequately ensure that all researchers 1313
affiliated with the institution adhere to this requirement. 1314
- IMPLEMENTED (I): the institution requires proposals for health-related research with humans 1315
to be submitted to an REC, and there is evidence that all researchers affiliated with the institution 1316
adhere to this requirement. 1317
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1318
1319
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Subindicator: EC 07.02: The institution has a mechanism for monitoring whether its researchers 1320
are in compliance with ethics policies and procedures. 1321
Description: Research institutions should have mechanisms to ensure that their researchers are in 1322
compliance with ethics policies and procedures, such as routine audits or regular self-certifications by 1323
researchers and/or department heads. 1324
Objective: The objective of this subindicator is to determine whether the institution has a 1325
mechanism for monitoring whether its researchers are in compliance with ethics policies and 1326
procedures. 1327
Evidence to review: The assessor should ask for and review: 1328
1. Institutional policies establishing mechanisms to ensure that researchers affiliated with the 1329
institution are in compliance with ethics policies and procedures. 1330
2. Evidence that these mechanisms are consistently used. 1331
3. Information about any actions taken against researchers who fail to comply with these 1332
policies. 1333
Framework: Process 1334
Rating Scale: 1335
- NOT IMPLEMENTED (NI): The institution has no mechanism for monitoring whether its 1336
researchers are in compliance with ethics policies and procedures. 1337
- PARTIALLY IMPLEMENTED (PI): The institution has a mechanism for monitoring whether its 1338
researchers are in compliance with ethics policies and procedures, but it is inadequate and/or not 1339
consistently used. 1340
- IMPLEMENTED (I): The institution has a mechanism for monitoring whether its researchers 1341
are in compliance with ethics policies and procedures and there is evidence to show that it is 1342
consistently used. 1343
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1344
1345
Subindicator: EC 07.03: The institution has policies and procedures related to the declaration and 1346
management of conflicts of interest of researchers, REC members, non-member participants in REC 1347
meetings, and the institution itself. 1348
Description: In order to protect the integrity of research and public confidence in the research 1349
system, research institutions should develop and implement policies and procedures related to the 1350
declaration and management of conflicts of interest of researchers, REC members, non-member 1351
participants in REC meetings, and the institution itself. For institutions that have their own RECs, the 1352
institution’s conflict of interest policies should be harmonized with the REC’s own conflict of interests 1353
policies. 1354
Objective: The objective of this indicator is to determine whether the institution has policies and 1355
procedures related to the declaration and management of conflicts of interest of researchers, REC 1356
members, non-member participants, and the institution itself. 1357
Evidence to review: The assessor should ask for and review: 1358
1. Institutional policies and procedures related to the declaration and management of conflicts 1359
of interest of researchers, REC members, non-member participants, and the institution itself. 1360
2. Evidence that these policies and procedures are consistently followed. 1361
3. Conflict of interest declarations submitted to the institution in the past year. 1362
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4. Information about actions taken by the institution in cases in which conflicts of interest have 1363
been declared. 1364
5. Information about actions taken against individuals who fail to disclose conflicts of interest 1365
pursuant to the institution’s policy. 1366
Framework: Process 1367
Rating Scale: 1368
- NOT IMPLEMENTED (NI): The institution does not have policies and procedures related to the 1369
declaration and management of conflicts of interest of researchers, REC members, non-member 1370
participants, and the institution itself. 1371
- PARTIALLY IMPLEMENTED (PI): The institution has some policies and procedures related to 1372
the declaration and management of conflicts of interest of researchers, REC members, non-member 1373
participants, and the institution itself, but these policies and procedures are inadequate and/or not 1374
consistently followed. 1375
- IMPLEMENTED (I): The institution has policies and procedures related to the declaration and 1376
management of conflicts of interest of researchers, REC members, non-member participants, and the 1377
institution itself, and there is documented evidence that these policies and procedures are 1378
consistently followed. 1379
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1380
1381
Subindicator: EC 07.04: The institution has a policy requiring all researchers affiliated with it to be 1382
trained on their responsibilities related to the ethical conduct of research. 1383
Description: Research institutions should have policies requiring all researchers affiliated with 1384
them to be trained on their responsibilities related to the ethical conduct of research. Institutions 1385
may either offer this training themselves or rely on training conducted by external entities. 1386
Researchers should be required to provide proof to the institution that they have complied with their 1387
training obligations. 1388
Objective: The objective of this indicator is to determine whether `the institution has a policy 1389
requiring all researchers affiliated with it to be trained on their responsibilities related to the ethical 1390
conduct of research. 1391
Evidence to review: The assessor should check and review: 1392
1. Institutional policies requiring all researchers affiliated with the institution to be trained on 1393
their responsibilities related to the ethical conduct of research. 1394
2. Institutional policies requiring researchers to provide proof of compliance with their training 1395
obligations. 1396
3. Evidence of proof of training submitted by resaerchers affiliated with the institution in the 1397
prior year. 1398
4. Information about actions taken against researchers who fail to satisfy their training 1399
obligations. 1400
Framework: Structure/Foundation/Input 1401
Rating Scale: 1402
- NOT IMPLEMENTED (NI): The institution does not have a policy requiring all researchers 1403
affiliated with it to be trained on their responsibilities related to the ethical conduct of research. 1404
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- PARTIALLY IMPLEMENTED (PI): The institution has a policy requiring all researchers affiliated 1405
with it to be trained on their responsibilities related to the ethical conduct of research, but the policy 1406
is inadequate and/or not consistently followed. 1407
- IMPLEMENTED (I): The institution has a policy requiring all researchers affiliated with it to be 1408
trained on their responsibilities related to the ethical conduct of research, and there is documented 1409
evidence to show that it is consistently followed. 1410
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1411
1412
Subindicator: EC 07.05: The institution ensures that research participants and prospective 1413
research participants have the ability to lodge complaints about studies in which they have been 1414
involved, either through the institution itself or at the national or regional level. If the complaint 1415
system is established within the institution, the institution should establish a process for reviewing 1416
and responding to complaints. 1417
Description: Research institutions should ensure that research participants and prospective 1418
research participants have a means of lodging complaints about studies in which they have been 1419
involved or about the ethics review system. If such a system does not exist at the national or regional 1420
level, the institution should establish an internal system of its own. Research participants and 1421
prospective research participants should be made aware of the existence of the complaint system. 1422
1423
When a complaint system is established within the institution, the institution should establish a 1424
process for reviewing and responding to complaints. If a complaint reveals problems with an ongoing 1425
study, the institution should take appropriate remedial action, which in some cases may include 1426
suspending or terminating the study. If the complaint reveals problems with the ethics review process, 1427
the institution should work with the relevant REC to institute changes in the process to address the 1428
identified problems. 1429
Objective: The objective of this subindicator is to determine whether the institution has a 1430
mechanism for research participants and prospective research participants to lodge complaints, either 1431
through the institution itself or at the national or regional level. 1432
Evidence to review: The assessor should ask for and review: 1433
1. Either (a) evidence that the institution has determined that a national or regional system exists 1434
for research participants and prospective research participants to lodge complaints about studies in 1435
which they have been involved; or (b) institutional policies establishing an internal mechanism for 1436
research participants and prospective research participants to lodge complaints about studies in which 1437
they have been involved, as well as a process for responding to those complaints. 1438
2. For institutions with an internal complaint system, evidence that research participants and 1439
prospective participants are made aware of the existence of this system through prominent notices 1440
on websites, informed consent forms, or other means. 1441
3. For institutions with an internal complaint system, evidence of all complaints received in the 1442
prior year and the institution’s responses to those complaints. 1443
4. For institutions with an internal complaint system, evidence of any follow-up actions the 1444
institution has taken based on complaints received, including remedial actions in ongoing studies and 1445
changes to the process of ethics review. 1446
Framework: Process 1447
Working document REC tool Rev. 1
November 2021
Page 38 of 39
Rating Scale: 1448
- NOT IMPLEMENTED (NI): The institution does not ensure that research participants and 1449
prospective participants have the ability to lodge complaints about studies in which they have been 1450
involved, either through the institution itself or at the national or regional level. 1451
- PARTIALLY IMPLEMENTED (PI): The institution has a mechanism for research participants and 1452
prospective participants to lodge complaints about studies in which they have been involved, but it is 1453
not adequately publicized and/or the institution does not consistently provide responses to 1454
complaints. 1455
- IMPLEMENTED (I): The institution ensures that research participants and prospective 1456
participants have the ability to lodge complaints about studies in which they have been involved, 1457
either through the institution itself or at the national or regional level, and, if the system exists within 1458
the instititon itself, there is evidence that it is well publicized and that the institution consistently 1459
responds to all complaints submitted. 1460
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1461
1462
Subindicator: EC 07.06: The institution has a mechanism to investigate allegations of unethical 1463
conduct by researchers and to impose consequences in cases where unethical conduct is 1464
determined to have occurred. 1465
Description: Research institutions should have a mechanism to investigate allegations of unethical 1466
conduct by researchers and to impose consequences in cases where unethical conduct is determined 1467
to have occurred. Such consequences might include a temporary or permanent prohibition on 1468
conducting further research with humans, changes in job titles or responsibilities, financial penalties, 1469
public reprimands, and/or other remedies. Any investigations conducted should provide researchers 1470
accused of misconduct with basic due process protections, including adequate notice of the 1471
allegations against them and an opportunity to be heard before penalties are imposed. 1472
Objective: The objective of this subindicator is to determine whether the institution has a 1473
mechanism to investigate allegations of unethical conduct by researchers and to impose 1474
consequences in cases where unethical conduct is determined to have occurred. 1475
Evidence to review: The assessor should review: 1476
1. Institutional policies specifying allegations of unethical conduct by researchers and to impose 1477
consequences in cases where unethical conduct is determined to have occurred 1478
2. Information about the range of consequences that may be imposed on researchers 1479
determined to have engaged in misconduct. 1480
3. Information about the due process protections provided to researchers accused of 1481
misconduct. 1482
4. Information about investigations conducted related to researchers accused of unethical 1483
conduct and the outcome of those investigations. 1484
Framework: Process 1485
Rating Scale: 1486
- NOT IMPLEMENTED (NI): The institution has no mechanism to investigate allegations of 1487
unethical conduct by researchers and to impose consequences. 1488
Working document REC tool Rev. 1
November 2021
Page 39 of 39
- PARTIALLY IMPLEMENTED (PI): The institution has a mechanism to investigate allegations of 1489
unethical conduct by researchers and to impose consequences, but it does not provide for adequate 1490
penalties and/or it does not contain adequate due process protections. 1491
- IMPLEMENTED (I): The institution has a mechanism to investigate allegations of unethical 1492
conduct by researchers and to impose consequences, and this mechanism provides for adequate 1493
penalties and contains adequate due process protections. 1494
Remarks: Application level: 1. National, 2. Sub national (regional), 3. Local 1495
1496
1497
REFERENCES 1498
1. Standards and operational guidance for ethics review of health-related research with human 1499
participants. WHO; 2011 1500
(https://apps.who.int/iris/bitstream/handle/10665/44783/9789241502948_eng.pdf;jsessionid=91501
0EC6DA1E51844CBAC88C60235511D7E?sequence=1) 1502
2. Research ethics committees: basic concepts for capacity-building. WHO; 2009 1503
(https://www.who.int/ethics/Ethics_basic_concepts_ENG.pdf) 1504
3. International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. 1505
Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016 1506
(https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf) 1507
4. ICH E6(R2) Addendum Step 4 version 1508
(https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf) 1509
5. Declaration of Helsinki. The 64th WMA General Assembly, 2013. (https://www.wma.net/policies-1510
post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-1511
subjects/) 1512