who tool benchmarking ethics oversight of health …

Working document REC tool Rev. 1

November 2021

of 39

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.

7

© 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

mailto:[email protected]


https://www.who.int/health-topics/ethics-and-health#tab=tab_1

https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss



November 2021

of 39

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

34

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

58


November 2021

of 39

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



November 2021

of 39

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


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


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


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


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


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


142


November 2021

of 39

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


requiring RECs to conduct continuing review of ongoing research at intervals appropriate to the risk 151

to humans. 152


1. Legal provisions requiring RECs to conduct continuing review of ongoing studies at intervals 154

appropriate to the degree of risk to humans. 155



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


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


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


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


4. Evidence of situations in which an REC has suspended or terminated, or considered 184

suspending or terminating, health-related research with humans. 185


November 2021

of 39


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


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


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


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


3. Evidence of mechanisms undertaken to in particular studies to implement these provisions, 220

such as insurance policies or other relevant documents. 221


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


November 2021

of 39

- 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


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


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


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


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


Indicator: EC 02: REC structure and composition 268

269


November 2021

of 39

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


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


Rating Scale: 310

- NOT IMPLEMENTED (NI): The REC’s membership does not meet the requirements of relevant 311

ethical guidelines. 312


November 2021

of 39

- 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


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


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


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


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


November 2021

of 39


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


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


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


November 2021

of 39

- 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


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



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


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


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


November 2021

of 39



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


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


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


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



November 2021

of 39

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


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


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


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


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


November 2021

of 39

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


1. Working facilities used by the REC. 531

2. List of equipment available to the REC. 532


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


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


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


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


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


1. Information about the REC’s source of funding. 567


November 2021

of 39

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


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


582

583


November 2021

of 39

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



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


Rating Scale: 624


November 2021

of 39

- NOT IMPLEMENTED (NI): There are no guidelines for the submission and screening of 625


- 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



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


1. Written procedures articulating the ethical criteria to be used in reviewing health-related 647


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


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


665

Subindicator: EC 04.03: The REC members have adequate time before and during meetings for 666

meaningful review of research proposals. 667


November 2021

of 39

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


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


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


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


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



November 2021

of 39

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


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


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


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


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


November 2021

of 39

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


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


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


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


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


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


794

Subindicator: EC 04.08: The REC maintains a good document management system. 795


November 2021

of 39

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


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


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


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


November 2021

of 39


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


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


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


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


878


November 2021

of 39

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


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


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


November 2021

of 39


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



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


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


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



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


November 2021

of 39

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


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


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


November 2021

of 39

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



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


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


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


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


November 2021

of 39

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


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


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


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


Rating Scale: 1087

- NOT IMPLEMENTED (NI): The REC has no a mechanism for investigators to ask questions about 1088

the ethics review process. 1089


November 2021

of 39

- 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



November 2021

of 39

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


to continuously monitor their adherence to indicators EC 02, EC 03, EC 04, and EC 05. 1110


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


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


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


November 2021

of 39

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


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



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


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


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


November 2021

of 39


for investigators to lodge complaints about the ethics review process, as well as procedures for 1182

reviewing and responding to those complaints. 1183



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


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


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



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


November 2021

of 39

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



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


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


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


November 2021

of 39

4. Evidence of any follow-up actions the REC has taken based on these internal audits, including 1267



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



November 2021

of 39

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


• 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


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


1319


November 2021

of 39

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


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


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


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


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


November 2021

of 39

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


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


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


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


November 2021

of 39

- 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


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


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


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




November 2021

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


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


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


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


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


November 2021

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


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

https://apps/

https://www/

https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

https://www/