Training Needs Of Research Ethics Committee Members In Cameroon Regarding Research Participant Protection


 Background The capacity of the Research Ethic Committee (REC) members to review research protocol is one of the frequently raised problems. The purpose of this study was to assess training needs of members of research ethics committee in Cameroon regarding research participant protection.Methods It was a cross-sectional descriptive study conducted in all the regions of Cameroon during the last quarter of the year 2020, assessing training needs of REC members’ ethical evaluation of health research protocols. Data were collected from all eligible REC members by trained and supervised surveyors using a well designed questionnaire integrated in smartphones via ODK-collect. The data were analyzed by estimating proportions with 95% Confidence Interval using the EpiInfo software version 7.2.2.6.Findings Out of the 79 ethics committee members reached, 64 (81.01%) accepted to participate including 28 (43.75) female. The result showed that,21 (32.81%) of ethics committee members were not trained in research ethics evaluation including 68.75% not exposed to training on research participants protection during clinical trials. A given fraction of respondent was not aware of the existence of key national regulations (25%) and international guidelines like the Helsinki Declaration (32.81%). Participants identified and ranked their priorities in terms of training needs in research participant’s protection, national text regulating research in Cameroon, evaluations’ procedures of research protocol, organization of research in Cameroon, and protection of participants in research involving the transfer of biological materials. The workshop and e-learning courses were seen to be the main accessible source of training.Conclusion Not all ethics committee members received training on ethical principles regarding research ethics review, review process and monitoring of research protocols, and on ethical issues associated to each study design including clinical trials. These gaps and the needs perceived by participants are to be taken into account when setting up a training program for RECs members on ethical evaluation in Cameroon.


Abstract
Background The capacity of the Research Ethic Committee (REC) members to review research protocol is one of the frequently raised problems. The purpose of this study was to assess training needs of members of research ethics committee in Cameroon regarding research participant protection.
Methods It was a cross-sectional descriptive study conducted in all the regions of Cameroon during the last quarter of the year 2020, assessing training needs of REC members' ethical evaluation of health research protocols. Data were collected from all eligible REC members by trained and supervised surveyors using a well designed questionnaire integrated in smartphones via ODK-collect. The data were analyzed by estimating proportions with 95% Con dence Interval using the EpiInfo software version Conclusion Not all ethics committee members received training on ethical principles regarding research ethics review, review process and monitoring of research protocols, and on ethical issues associated to each study design including clinical trials. These gaps and the needs perceived by participants are to be taken into account when setting up a training program for RECs members on ethical evaluation in Cameroon.

Background
Health research activities involving human subjects are being increasingly performed in developing countries (1). During the implementation of research projects, the rights of participants have in some case be intentionally or unintentionally violated by researchers for a variety of reasons including nancial and/or career takes, exaggerated enthusiasm, in uences from various sources and even ignorance (2)(3)(4).
Members of Research Ethics Committee (REC) through Research Ethics Committees, review and monitor the implementation of research protocols involving human subjects to ensure that they comply with internationally and locally recognized ethical standards (5)(6)(7)(8). Studies conducted in African countries in recent years have revealed that many of these members are limited in playing their role because they are not properly trained (9). This may compromise the quality of ethics review by ethics committees, limiting their ability to play their role in protecting research participants.
The rst ethics committee in charge of reviewing health research protocols was set up in Cameroon in 1987, but the regulatory text organizing the ethics review system was signed by the Minister of Public Health in 2012 (10,11). The training for REC members was assessed and used to develop an online and free access course available for them in 2009(12).
Due to the fact that a certain number of ethics committees have been set up in Cameroon without bene ting from a standard and evaluated training program and due to the fact that the regulations and guidelines in terms of ethical review have evolved both at the national and international levels without necessarily being taken into account in the different training offers, it has become necessary to take stock of the training needs of the members of health research ethics committees (6,8,13).
In this light, the purpose of this study was to assess training needs of research ethics committee members in Cameroon regarding research participant protection during ethical evaluation of research projects. This was based on; evaluating the knowledge and the use of Human Health Research ethical guidelines; previous and perceived training needs of the REC members on ethical evaluation of research projects.

Study design
It was a cross-sectional descriptive study conducted in the last quarter of the year 2020 targeting all members of Research Ethic Committee in Cameroon. The data were collected by trained and supervised surveyors using a well-designed questionnaire administered face to face, to members of Research Ethics Committees in Cameroon. This questionnaire were designed from the Kobo Toolbox Platform and deployed in smartphones via the ODK-collect software. The data were analyzed by estimating the priority training needs perceived by research ethics committees' members, the training channels preferred by research ethics Committee members and their knowledge and used of the regulatory texts/guideline on research ethics.

Study Site and period
This study was carried out in the Research Ethics Committees o cially existing in Cameroon and in those located in the different Research institutes, Training institutes in Biomedical Sciences and Health institutions visited during the survey. Data were collected in the last quarter of 2020.

Study population
All members of National, Regional and Institutional Ethics Committees involved in research ethics evaluation in Cameroon were eligible to participate in the study. Those who refused to participate and those absent during the period of the study were excluded from the study.

Data collection tools
Data were collected using questionnaires designed based on a pre-existing questionnaire (9,14). It was design in both o cial languages of Cameroon on Kobo Toolbox interface and deployed in smartphones via the ODK-collect software. The used questionnaire was pre-tested on former research ethics committees' members and comments integrated before deploying the nal version in smartphones. The main variables were collected on socio-demographic characteristics, knowledge of ethical considerations in a research protocol, knowledge of research ethics regulations/guidelines; previous training received in research ethics; and priority training needs perceived by REC members

Data collection procedures
The data were collected face-to-face by trained and supervised interviewers. Four teams, each consisting of three interviewers and one supervisor were assigned to the 10 regions of Cameroon. Heads of REC were met to present objectives and targets of the survey and also to obtain their permission to collect data from their REC members. Before questionnaire administration, the interviewers submitted all relevant information about the study to the participant in simple and understandable language. Each consenting participant was invited to sign the informed consent form.
Data management Data quality control was done at two levels. All data were double checked for consistency and completeness; rstly by the eld supervisors before its transmission to the cloud server and secondly by the data manager at the central level on daily bases. Any discrepancies observed at each of these levels were corrected as soon as possible. Prior to analysis, data were screened for accuracy and a reliable system of coding data was established during data analysis. .

Data analysis
The data were keyed and cleaned with Microsoft Excel 2010 software. It was analyzed using EpiInfo version 7.2.2.6 software. Descriptive data analysis was done on all variables by ranking and estimating proportions. The values of the different indicators were estimated with a 95% con dence interval.
The Research Ethics Committee members were asked to identify in order of importance, their rst four priority themes on which they would like to be trained. At the end of the data collection, the trainings topics were coded and a list of 16 trainings was drawn up. Scores were then assigned to the different trainings topics as follows: 4 points if the REC member has chosen the training topic as his or her rst choice, 3 points for the second choice, 2 points for the third choice and 1 point for the fourth choice. The sum of points attributed to each training contents was estimated per trainings content. Training contents were ranked in descending order from highest average to sum and the rst 4 were selected as the training priority.

Ethical consideration
All REC members were informed of the survey through an explicit information notice that has been translated into the two o cial languages spoken in Cameroon and their written consent was obtained prior to the interview. The respondents' data were coded and accessible only by the data manager staff and investigators' team. The ethical approval was obtained from the Cameroon National Ethics Committee for Human Health Research (N o 2020/10/1305/CE/CNERSH/SP).

1.Characteristics of committee members
Out of the 79 ethics committee members reached, 64 (81.01%) accepted to participate in the study. Table 1 shows the distribution of participants per research ethic Committees type, sex, basic training, method of appointing a member and status of participants within the REC. Forty-four (68.75%) of the ethic committee members were from institutional ethic committee. The main primary disciplines of respondents were; medicine (37.50%) and social sciences (12.50%). The majority of participants were appointed by their institution to be a member of the ethic committee.  Table 2 below.  Table 3 shows the knowledge of REC members on some aspects covered by scienti c validity and participant's informed consent. The main aspect concerning the scienti c validity known by the REC members was "the usefulness of the results in the context of the country's health problem". "Guarantee the independence of the participant" was known for the majority of the members (89.06 %) as aspects of participant's informed consent.

Perceived Training Needs of Research Ethics Committee Members
All the REC members surveyed responded for need to be trained on research ethics. The ranking of scores attributed to the perceived importance and priority of training topics are presented in Table 5. This ranking shows that among training topics identi ed as important, the top four were: procedures for monitoring the implementation of research protocols, national text regulating research in Cameroon, evaluations' procedures of research protocol and organization of research in Cameroon. Evaluations' procedures of research protocol 32 3 Organization of research in Cameroon 28 4 Protection of participants in research involving the transfer of biological materials 24 5 Protection of research participants during eld trials 18 6 Procedure for the submission of research protocols 14 7 Roles of the Investigator in Protecting Research Participants 14 8 Protection of Research Participants in Vaccine Trials 08 9 Involvement of the community in the implementation of research projects 12 10 Protection of vulnerable persons in the implementation of research projects 08 11 Bioethics 08 12 How to sanction in case of plagiarism 8 13 Ethics of online research 8 14 Legal aspects of human health research 8 15 Evaluation of Institutional Ethics Committees 08 16 General Ethics 6 17 National and international texts regulating research 06 18 Con dentiality in research projects 06 19 Safety of therapeutic products in clinical trials 04 20 Con icts of interest 02 21 Consequences of non-compliance with research ethics standards 02 22 6. Accessible sources of training for research ethics committee(REC) members The accessible sources of training for REC members are presented in Fig. 1 below. The workshop and elearning courses were seen to be the main accessible source of training.

Discussion
The purpose of this study was to identify the training needs in research ethics of REC members in Cameroon. The results show that, twenty one (32.81%) of ethics committee members were not trained in research ethics evaluation including 68.75% not exposed to training on research participants protection International guidelines disseminate ethical principles that are contextually adjusted by national regulations to ensure the best possible protection of participants in human health research (6,8,11,15,20).Those that apply to each context and type of protocol should be accessible and used by ethics committee members to guide the ethical review and monitoring of human health research protocols. But as described in a number of studies, this is not always the case (14,21). The present study describes as in previous studies, a diversity of knowledge, reading and use of international guidelines and national regulations for the protection of research participants among research ethics committee members. It also reveals that a certain fraction of the members of the Ethics Committees are not aware of the national ethics regulations and a lesser fraction have read and used them. This situation questions the monitoring of the functioning of ethics committees by the institutions in charge and the quality of ethical evaluation.
The expected bene t of a health intervention depends on the bene ciary's perception of the proposed solutions (22). For this reason, the present study asks to prioritize their needs in research ethics training.
The ranking of the perceived training needs shows that among training topics identi ed as selected priority, the top ve were: procedures for monitoring the implementation of research protocols, existing national text regulating research in Cameroon, evaluations' procedures of research protocol by REC members, organization of research in Cameroon, and protection of participants in research involving the transfer of biological materials. These themes relatively differ from the priority themes identi ed by REC members a decade earlier (9).No data was collected that can guide the understanding of the difference but it may be related to the actual situation of participants in terms of training received or variation of type of protocol submitted to their ethics committee for evaluation. These results are to be taken into account when planning the training of ethics committee members.
Despite the fact that nearly one-fth of the participants in this study did not participate in the study, we believe that its results can be used to plan for and address the perceived needs of Cameroonian ethics committee members for research participant protection, because it covered both legally constituted and non-legally constituted ethics committees and the different categories of exiting ethics committees.

Conclusion
About one-third of responding RECs members were not trained in research ethics evaluation. Coverage of participants in terms of training received varied per training topic with 68.75% not exposed to training on research participants protection during clinical trials. The three-fourth of respondents was aware of both the existence of key national regulations and international guidelines such as the Helsinki Declaration respectively. Participants identi ed and ranked their priorities in terms of training needs in research participants' protection. We