In this survey, 702 emails were sent to REC chairs, 200 delivered, and 502 emails came back with a failed delivery message. Out of the 200 emails, 98 responses were received, out of which fifty were REC members, while 48 were REC chairs. Out of the total, only three responded in French. Study participants were from 16 African countries, and they were from the Eastern, South Eastern, and Southern Africa region mainly Ethiopia, Kenya, and Uganda (Table 1, Fig. 1). The mean (SD) age of REC members was 47 (SD ± 12) and over half of them were female, 27 (54%). The majority of REC members and chairs were physicians followed by biomedical scientists. Over three-fourths of REC chairs reported that the number of REC members ranges from nine to twenty. Almost half of REC members' affiliation was outside the REC’s home institution (Table 1).
Table 1
Socio-demographic characteristics of RECs
REC Members | REC Chairs |
Region and Country | | Region and Country | |
East Africa | 29 (58) | East Africa | 27 (56) |
West Africa | 12 (24) | West Africa | 12 (25) |
South Africa | 5(10) | Southern Africa | 8(17) |
North Africa | 4 (8) | North Africa | 1 (2) |
| | REC composition/regular members | |
REC members role/profession | | Medical Doctor | 41 (85) |
Physician | 13 (26) | Other medical practitioner | 38 (79) |
Other medical practitioners | 3 (6) | Biomedical scientist | 37 (77) |
Layperson/community representative | 3 (6) | Social Scientist | 36 (80) |
Biomedical Scientist | 8 (16) | Lawyer | 23 (51) |
Social scientist | 7 (14) | Layperson/community representative | 37 (82) |
REC secretary | 11 (22) | Ethicist | 24 (50) |
Ethicist | 7 (14) | Other | 12 (25) |
Others | 8 (16) | REC members are officially employed at REC home base institution (quantitative) mean %, SD | 52 (32) |
Being a member of a professional ethics organization | 26 (53) | < 5 members | 11 (34) |
| | 6–10 members | 13 (41) |
| | > 10 members | 8 (26) |
| | REC members are not officially employed at REC home base institution mean %, SD | 48 (32) |
| | < 5 members | 24 (53) |
| | 6–10 members | 10 (22) |
| | > 10 members | 6 (13) |
Nearly half (49%, n = 22) of RECs were academic institute affiliated. All of them reported having different types of Standard Operating Procedures (SOP) and forms, most of them have SOP on initial (98%) and post-approval review (92%), but only 76% have SOP on SAE review. Seventy percent of REC members have a regular monthly meeting.
Ninety percent of REC chairs claimed that their REC is accredited; however, only 70% of them (n = 30) provided the name of the organization providing accreditation. Half of them (n = 22) claimed to be accredited by a ‘’National Regulatory Authority’’ in their respective country. Only three chairs reported the recognition of their RECs by SIDCER, all based in East Africa, and one REC reported being accredited by AAHRPP.
Over 80% of REC members claimed for reviewing different types of research protocols including clinical, laboratory, public health, and socio-behavioral research. Only 58% of RECs practiced exemption of protocols from ethics review when appropriate, while 98% did an expedited review of protocols when the need arises.
Most (91%, n = 42) REC members responded to their involvement as primary reviewers for scientific and technical issues (Table 2). Majority of REC members(82%, n = 41) and Chairs (94%, n = 45) claimed to have reviewed COVID-19 related protocols. The most common protocols reviewed were public health interventions and community engagement. On the flip side, there were relatively few protocols on new drug tests, drug repurposing, and diagnostic tools.
Table 2
REC characteristics, activities, and working documents
REC members | | REC chairs | |
REC Affiliation | | REC affiliation | |
Academic Institute | 21 (42) | Academic Institute | 22 (49) |
Hospital (public/private) | 12 (24) | Hospital (public/private) | 9 (19) |
Research Institute | 17 (34) | Research Institute | 10 (21) |
Independent | 3 (6) | Independent | 9 (19) |
Other | 5 (10) | other | 8 (18) |
Items in the Standard Operating Procedure | | | |
List of international/ national guidelines & regulations, | 37 (74) | International/ national guidelines/ regulations | |
Structure and composition of the REC | 48 (96) | Declaration of Helsinki | 41 (95) |
Initial review procedures | 49 (98) | Council of the International Organization for Medical Sciences | 28 (65) |
Post-approval review (amendments, progress & final reports), | 46 (92) | International Conference for the Harmonization of GCP | 35 (81) |
Review of SAE reports | 38 (76) | World Health Organization Ethics Guidelines | 36 (84) |
Review of protocol deviation/ violation reports, | 41 (82) | Local guidelines regulations | 33 (77) |
Agenda and minutes preparation, | 42 (84) | other | 5 (12) |
Documentation of protocol files | 44 (88) | Accredited or recognized (yes) | 43 (90) |
Archiving | 42 (84) | If yes, who accredited (n = 43) | |
Standard researcher application form | 47 (94) | National Regulatory Authority | 22 (54) |
Standard assessment form of the protocol and informed consent | 42 (84) | SIDCER | 3 (7) |
Others | 4 (8) | AAHRPP* | 1 (2) |
Reviewing the following types of protocols | | | |
Clinical research | 43 (86) | | |
Socio-behavioral research | 43 (86) | | |
Laboratory research | 39 (78) | | |
Public health research | 43 86) | | |
Others | 2 (4) | | |
Did not review | 3 (6) | | |
Types of review by REC | | | |
Exempt | 29 (58) | | |
Expedited review | 47 (94) | | |
Full board review | 46 (92) | | |
Joint or centralized review of multisite protocols | 18 (36) | | |
REC meeting frequency | | | |
Weekly/fortnight | 5 (10) | | |
Monthly | 35 (70) | | |
Quarterly (Every three months) | 7 (14) | | |
Semesterly (Every six months) or annually | 3 (6) | | |
Review functions | | | |
Primary reviewer for scientific/ technical issues, | 42 (91) | | |
Primary reviewer for informed consent | 29 (63) | | |
| 9 (2) | | |
AAHRPP: The Association for the Accreditation of Human Research Protection Programs |
SIDCER: Strategic Initiative for Developing Capacity in Ethics Review |
REC: Research Ethics Committee |
REC chairs who participated in the survey reported that their REC reviewed 5860 protocols in 2019 while in 2020 the number increased by 744 (12.7%). In both years, over half of RECs reviewed less than 100 protocols each. As per REC members’ report, there was an increment in protocol amendment (79%, n = 38), deviation/violation (29%, n = 14) and early protocol termination (25%, n = 12). In reviewing COVID-19 protocols, the most common challenges faced by REC members/chairs were issues related to risk/benefit, scientific design, and informed consent.
Institutional policies for the prevention of COVID-19, such as limiting face to face meetings, limits on access to facilities, limits in the number of people in a room and others were followed by most RECs. Accordingly, RECs have shifted their meetings to either virtual platforms (47%, n = 23) or hybrid meetings (49%, n = 24), (Table 3).
Table 3
a: REC activities and demands during COVID-19 pandemic
REC members | | REC Chair | |
Participated in review of COVID-19 related protocols | 39 (81) | REC reviewed COVID-19 or related protocols | 45 (94) |
Elements reviewed by REC for COVID-19 protocol | | Types of COVID-19 protocol Reviewed | |
Qualifications of the investigator | 36 (84) | Dx. tool for COVID-19 | 24 (53) |
Conflicts of interest | 30 (70) | New drug for COVID-19 | 13 (27) |
Scientific soundness | 37 (86) | Old drug tested for COVID-19 | 15 (31) |
Informed consent | 39 (91) | Vaccine for COVID-19 | 16 (33) |
Advertisement/ recruitment materials | 23 (54) | Convalescent plasma for COVID-19 | 5 (10) |
Vulnerability | 37 (86) | Public health intervention for COVID-19 | 39 (81) |
Risks | 41 (95) | Community engagement for COVID-19 | 31 (65) |
Benefits | 40 (93) | Other | 5 (10) |
Privacy | 36 (84) | | |
Others | 4 (9) | | |
Difficult issues to review | | Issues challenging during COVID-19 | |
Risks/ benefits | 16(36) | Scientific design | 23 (48) |
Conflict of interest, | 9 (21) | Informed consent | 24 (50) |
Privacy issues | 6 (14) | Conflict of interest | 8 (17) |
Vulnerability | 7 (16) | Vulnerability | 12 (25) |
Scientific design | 11 (25) | Risks | 30 (63) |
No difficulty | 16 (36) | Benefits | 10 (21) |
Others | 2 (4) | Privacy confidentiality | 20 (42) |
Need of training in ethics review | 40 (80) | Recommended training for RECs members | |
Training Topics in ethics review interested to attend | | Online review meetings | 36 (75) |
Principles of research ethics | 14 (31) | Ethical issues COVID-19clinical trials | 36 (75) |
International guidelines and local regulations | 22 (49) | Ethical issues COVID-19vaccine trials | 36 (75) |
Review of clinical research | 25 (56) | Ethical issues COVID-19 PH research | 37 (77) |
Review of socio-behavioral research | 22 (49) | Ethical issues COVID-19 socio behavioral research | 25 (52) |
Community engagement research | 26 (58) | Types informed consent | 29 (60) |
Types of consent forms | 17 (37) | Other | 6 (13) |
Vulnerability | 20 (44) | New protocol submissions reviewed in 2019 (sum) | 5860 |
Risk/ benefit assessment | 25 (56) | < 100 per respondent (n = 1032) | 29 (64) |
Not interested for training | 4 (9) | 101–200 per respondent (n = 1332) | 9 (20) |
Others | 2 (4) | 201–500 per respondent (n = 970) | 3 (7) |
| | ≥ 500 per respondent (n = 2526) | 4 (9) |
| | New protocol submissions reviewed in 2020 (Sum) | 6604 |
| | < 100 (n = 889) | 23 (52) |
| | 101–200 (n = 1843) | 15 (34) |
| | 201–500 (n = 1377) | 4 (9) |
| | ≥ 500 (n = 1436) | 2 (5) |
| | COVID-19 cases | |
| | < 10,000 | 9 (20) |
| | > 100,000 | 21 (47) |
| | 10,001 to 100,000 | 15 (33) |
| | Adopted COVID-1919 policies | |
| | Limit face to face | 46 (96) |
| | Limit access institutional facility | 33 (69) |
| | Limit no of people in a room | 39 (81) |
| | Limit travel | 34 (71) |
| | other | 6 (13) |
| | Mode of meeting | |
| | Face to face | 2 (4) |
| | Online | 23 (48) |
| | Both/hybrid | 24 (50) |
| | COVID-19 impact on no. of protocols | |
| | Increases | 20 (42) |
| | Decreases | 15 (31) |
| | No effect | 13 (27) |
| | Protocol deviation/ violation (yes) | 14 (29) |
| | Amendments | 38 (79) |
| | Early termination of protocol | 12(25) |
| | Serious adverse events | 11 (23) |
| | Subject complaints | 7 (15) |
PH: Public Health, Dx: Diagnosis, REC: Research Ethics Committee |
Table 3
b: Knowledge and attitude of REC members towards COVID-19 protocol review
RECs knowledge towards COVID-19 reviewing protocols | Correct answer, N (%) |
RECs should review for approval unproven drugs vaccines and intervention | 8 (17) |
Participant consent should be required for COVID-19 clinical trial protocol | 49 (98) |
COVID-19 patients enrolled in clinical trials are vulnerable | 40 (80) |
Healthy volunteers enrolled in vaccine trials are vulnerable | 36 (72) |
COVID-19 patients in hospitals should not be allowed to join a clinical trial | 32 (64) |
Traditional medicine for COVID-19 therapy should undergo a clinical trial | 42 (84) |
Only patients should sign the consent forms for COVID-19 research | 25 (50) |
A drug company may appoint an employee to become the principal investigator | 35 (70) |
REC members should sign a conflict of interest and confidentiality declaration | 47 (94) |
The identity of COVID-19 participants in research should be kept confidential | 49 (98) |
RECs Attitude toward COVID-19 reviewing protocols | (strongly)Disagree | Neutral | (strongly)Agree |
RECs need training in ethics review of COVID-19 protocols | 3 (6) | 3 (6) | 44 (88) |
Multicenter COVID-1919 protocols should be reviewed by joint centralized RECs | 4 (8) | 5 (10) | 41 (82) |
Joint central RECs ensure harmonized recommendations | 2 (4) | 5 (10) | 42 (86) |
All COVID-19 protocols are high risk protocols | 22 (44) | 13 (26) | 15 (30) |
Any medical doctor can be appointed as principal investigator | 43 (86) | 5 (10) | 2 (4) |
Any medical doctor can review the technical issues | 36 (72) | 7 (14) | 7 (14) |
Majority of REC members (n = 40) recommended training in specific topics including risk-benefit assessment, community engagement, clinical and socio-behavioral research, and various types of guidelines and regulations. Similarly, REC chairs identified the need for training on the ethical issues of clinical trials, public health research, and how to conduct online review meetings.
With regards to the knowledge of REC members towards the COVID-19 protocol review, only four members responded that REC has no mandate on new drug or vaccine approval. On other knowledge questions, REC members scored from 60 to 98% (Table 3b). Forty-four percent of respondents did not believe that all COVID-19 related proposals are high-risk protocols. Only a few agree medical doctors can be the principal investigator (4%, n = 2) or reviewers of COVID-19 protocol (14%, n = 7) (Table 3b).