Going paperless: the strengths and limitations of electronic Research Ethics Information Management System in a health training institution in Tanzania

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Mkumbwa, Godwin Pancras, Nathanael S. Sirili This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4102733/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Jan, 2025 Read the published version in BMC Health Services Research → Version 1 posted 4 You are reading this latest preprint version Abstract Over the years, the processing of research proposals for ethical approvals has been done manually through a review of printed proposals. The system faced many challenges which led to inefficiency of the review process, and thus longer turn-around time. To address these challenges, an electronic or web-based application for research proposal submission and processing was introduced. However, the advantages of going paperless and inherent drawbacks remain unsubstantiated. This study aimed to explore the strength and limitations of electronic Research Ethics Information Management Systems (REIMS) in a health training institution in Tanzania. An exploratory qualitative study was adopted where 16 faculty members of the Muhimbili University of Health and Allied Sciences were interviewed. The faculty were purposefully recruited to include only those who had been exposed both to the paper-based research ethics review system and electronic Research Ethics Information Management System. The faculty were stratified into two groups of researchers and members of the research ethics committee. Thematic analysis using inductive reasoning was used to analyze the gathered information. The strengths and limitations of REIMS were unveiled in this study as two important themes. The strengths included convenience in use of the system and improved records management. The imitations included demand for reliable ICT resources and limited reviewer-researcher interaction. The findings of this study underscore the strengths and limitations of transformation in handling research ethics review following an introduction of an electronic system and abandoning the paper-based system. Institutions aspiring to adapt the system can learn from this experience and devise ways to overcome the limitations. We recommend system automation, strengthening the institutional capacity and further studies to be conducted on the use of the REIMS. Research information management system research ethics Tanzania Background The conduct of human research globally must adhere to ethical guidelines and requirements. The World Health Organization (WHO) provides that all proposed health research must get an ethical approval for data collection to commence ( 1 , 2 ). Ethical approval is crucially important to ensure compliance in terms of ethical conduct of research and regulations envisioned to safeguard the dignity, rights, safety as well as well-being of research participants ( 3 ). Ethical approvals are provided by Research Ethics Committees (RECs). RECs are charged with providing an independent assessment that the proposed research is ethically acceptable, scrutinizing clinical investigators’ potential biases, and assessing compliance with guidelines and regulations intended to safeguard human participants ( 3 ). With the growing need for conduct of human health research, institutions have been looking for more advanced, time saving procedures for review of proposed research and provision of ethical approvals. Although some countries have succeeded in incorporating technology into the process of obtaining ethical approvals, studies show that there has been less progress in Africa ( 4 , 5 ). In Tanzania, the review and approval of human health research is decentralized under the auspices of the National Institute for Medical Research (NIMR). Muhimbili University of Health and Allied Sciences (MUHAS) is one of the institutions mandated to form and manage an institutional REC that has been ensuring adherence to health research ethics through provision of ethical approvals ( 6 – 8 ). Over the years, the processing of research proposals for ethical approval at MUHAS was conducted manually through a review of hard copies. But in the last two years, a research ethics information management (electronic) system (REIMS) was introduced that would enhance the management of research ethics information in a single interface, increase the efficiency and effectiveness of research information management activities and enhance data storage and reporting ( 9 , 10 ). Again, it would reduce the turn-around-time in processing and obtaining ethical approval, facilitate the submission and review process, facilitate the timely and routine generation of reports of number and type of studies conducted at MUHAS, enhance feedback mechanism between the REC and researchers and reduce costs associated with the previous paper-based system. This study informs the strengths and limitations of the use of REIMS as compared to the paper-based system. Findings from this study adds to the body of knowledge on research management information systems and which may be taken as a starting point in improving research management information systems in local and global contexts. Methods Study design and context We utilized a pre- and post-evaluation design and adopted a qualitative approach for data collection. Institutional users (researchers, REC reviewers and managers) that had been exposed to both the paper-based system and REIMS were interviewed about their experience of using each of the systems. The study was conducted at MUHAS located at Ilala Municipal in Dar es Salaam. It is one of the largest and oldest health training institutions in the country and undertakes a wide range of research. MUHAS has a research ethics review committee under the Senate that is mandated to review all research proposals and grant ethical clearances to undertake research studies under the umbrella of the institution. Study population The study population included researchers (MUHAS faculty), REC members including reviewers, the secretariat and the chairman to the committee. The aforementioned participants had been exposed to both the paper-based review system and REIMS and recruited from across the schools and institutes at MUHAS. The MUHAS REC Following the introduction of REIMS at MUHAS in May 2020, roles were defined among the system users to include managers, reviewers, and researchers. At MUHAS, the chairperson to REC is responsible for, among others, chairing online and physical REC meetings and receiving and assigning protocols to respective reviewers. Reviewers, as part of the committee, are responsible for; accepting review requests, reviewing, and recommending proposals for ethical clearance during REC meetings. The secretariat to the REC is responsible for, among others; organizing committee meetings, create, distribute meeting agendas, and plan meeting logistics, validate applications in the system as per guidelines and in line with requirements, organize and track proposals received and sent to reviewers and through the system, facilitate communication and feedback between committee members and applicants. All these collectively and within their specific roles, take part in processing ethical clearance for research conducted through MUHAS. Currently the committee is made up of more than 30 members, most from MUHAS ( 8 , 11 ) . Sampling and sample size We purposefully identified and interviewed 16 MUHAS systems users that were traced from registries and records available at the directorate of research, publications and innovations office at MUHAS, after selection based on research criteria (MUHAS faculty; researchers and members of REC that had been exposed to both systems), the PI contacted the selected participants through mobile to schedule appointments to conduct interviews based on their availability. Among them, five were researchers, nine were REC reviewers, and two were REIMS managers. Male participants were 10 and six were female participants. Research experience varied from five years to 15 years and review experience varied from three years to 10 years. Data collection was completed after reaching information saturation. Male Female Total Role Reviewer 6 3 9 Manager 2 0 2 Researcher 2 3 5 Total 16 Age 30–40 3 3 6 40–50 3 1 4 above 50 4 2 6 Total 16 Data collection We utilized in-depth interviews (IDI) to collect data from the purposefully selected participants. Data were collected between 20th and 30th June 2022. Semi structured interview guides were prepared for each category of participants (researchers, reviewers, and managers), customized to gather relevant information from each category based on their roles in using REIMS. The IDI guides were prepared in English language and later translated to Kiswahili language. Both languages were used during the interviews depending on respondent’s choice and comfortability. The IDI guides questions were prepared based on the knowledge of the researcher on the two systems (paper-based and REIMS) and theoretical knowledge on effectiveness of research management information systems as found literature ( 12 , 13 ). The tools were pretested among 3 rapidly available postgraduate (PhD) students at MUHAS who had used both systems to process ethical clearance and had obtained ethical clearance to conduct their research. The pre-testing resulted in rephrasing some of the questions in the researchers guide prior to the data collection process in order to capture the intended information. Upon obtaining ethical clearance to undertake the study, the principal investigator obtained reviewers and researchers contacts from databases available at the IRB office at DRPI. After selection based on research criteria, the PI contacted the selected participants through mobile to schedule appointments to conduct interviews based on their availability. All interviews were recorded using a digital audio recorder, carried out in the offices or designated room of the participant and took between 20 minutes and 90 minutes. Interviews were conducted by the first author and one research assistant. Data management and analysis We used a thematic analysis approach using inductive reasoning. After the verbatim transcription of recorded files, the first author coded three transcripts and obtained abstracted codes. Another author coded the same transcripts, and a comparison of codes was done. The same was done for all the 16 transcripts. The abstracted codes (that where in Kiswahili language), were translated to English language. After obtaining the abstracted codes, the authors sorted and condensed the codes to obtain level two codes. Further comparisons, checking and rechecking for similarities and differences was done to sort and cluster the codes into subthemes. The emerging subthemes were aligned into themes. The analysis process involved authors going back and forth between transcripts to identify, compare and summarize newly emerged themes. We present findings with support of succinct quotes (in English language) from the participants to reflect responses of the participants rather than the perspective of the authors. Ethical considerations Ethical clearance to conduct the study was obtained from MUHAS Research Ethics Committee (MUHAS-REC-06-2022-1206). Written informed consent was obtained from participants prior to their involvement in the study. Confidentiality was ensured for all obtained information during the conduct of the study. Results From the analysis of the 16 IDIs, two broad themes of strengths and limitations of REIMS were identified (Table 2 ). Table 2 Summary of findings Codes Sub-theme Themes • Geographical accessibility • Easy navigation Convenience Strengths in using REIMS • Tracking of documents is easy in REIMS • Less physical labor in handling documents Improved records management • Internet breakdown • Server connectivity • Electronic devises and gadgets Demands reliable ICT resources Limitations in using REIMS • Undefined standard number of proposals to reviewers • Fragmented notification • There is no integrated feedback Limited Reviewer-researcher interaction Strengths of REIMS system REIMS is convenient to use Users reported that REIMS can be accessed from any location and at any time. They stated that it has provided convenience of using the system and one can submit their proposal at any time from any location, reviews can be done at any time when the reviewer is ready, progress tracking and management can be done from anywhere. “REIMS is very convenient with me, sometimes I like to work over the weekend because I have a lot of things during the weekdays… you can do work anytime and you submit…so I think that is quite a good experience…” (IDI / R02) Some reviewers further highlighted that REIMS had simplified their work throughout the review process. They stated that despite some issues in execution, the system has simplified review and has added efficiency to their work. “I think as an idea it is excellent, the concept might be great, but the execution might have some issues here and there. REIMS as a system has been really good and it has really streamlined my review process, beforehand I would not be to do fast all the papers that I have gone through for instance and it’s so easy to make comparisons, it is very efficient” (IDI / R05) Perceived as a better record management system Improved feedback process Users reported that the system has improved the feedback process, and they are now able to receive real-time notifications of their proposal progress. Some participants reported that: “…the system is good as it gives you progress, that it has been accepted, where it is at the moment and if it has been discussed in the meeting, I knew lots of the procedures through the system, like it notifies you the REC has approved, you know, so you get such information…” (IDI / I03) In addition, some participants highlighted that REIMS has reduced the risk of documents being misplaced as documents are submitted, tracked, and stored electronically. “… it helps to keep records because also at any time a reviewer can take a look on how many works, they have reviewed, and if someone does not see their ethical clearance can take a look there, so it is technology incorporated it has become quite easier” (IDI / I05) Managers also reported that REIMS has improved record keeping and management and costs in handling proposals submitted for ethical clearance at the institution. “…Before they used to submit about 8 proposals and later they saw that it was costly since you also have to duplicate copies whenever you receive comments…as a result you end up leaving the copies in office and storing them is difficult…but now since it is online you can work on them whenever you are free you just need access to internet regardless you are on leave, on a weekend or even out of Dar es Salaam…” (IDI / M01) Limitations of using REIMS REIMS demands reliable ICT resources As one of the limitations in using REIMS, some participants highlighted that the current system necessitates the availability of adequate and reliable ICT devices (computers, laptops, tablets) especially among reviewers to ease the review process of proposals submitted for ethical clearance. “…Another challenge is working tools, sometimes my computer does not work well, I can even show you now, my computer cannot work without being in what, in charger It is almost going to die you see, so reviewing becomes a challenge, at one point it was broken, proposals stayed for quite some time, I was being asked every day and I told them I have issues with my computer, I can even show you…” (IDI / R04) Users highlighted some of the limitations to access to REIMS as being determined by institutional internet and server connectivity. They reported that access is still limited and that it is necessary to solve the problem and any reason that limits access to the use of the system. “Yah, it hasn’t happened to me, sometimes to a number of people but we recently… let’s say to me if the asking person were the ICT, I would say the internet connection. But as you say it can be a small server, small capacity or something else, take it as problematic. What I am saying, access is a problem. Whatever the reason for access that should be solved, if it’s the server capacity, internet connectivity or anything else” (IDI / R06) Limited reviewer-researcher interaction Users reported that REIMS limits the possibility for reviewers to provide detailed in text comments and inputs required to improve the proposals during the review process. They stated that the use of an electronic available template with no possibility to upload a detailed reviewed file limits the details of a review that the applicant/researcher can receive to improve their work. “Yes, in REIMS currently it’s that when the proposal comes, that even if I put track changes, I cannot upload it, the student’s proposal that I have put track changes or author that it is returned to them so as they can see where, but in REIMS currently there is like a template that you complete online based on proposal sections but to put as track changes that is not possible” (IDI / R01) Some reviewers further reported that the system does not provide the flexibility to use various review templates based on specific review requirements, thus following a structured review system. They stated that there may also be a need to have empirical templates for different categories of applicants so each can be handled based on specific research requirements. “I think REIMS does not provide a room when if it is an amendment someone is requesting for amendment there is not a specified template on how you should handle amendment …I think we also need to have an empirical template based on researcher’s category…” (IDI / R08) Users further reported that the system limits interaction among one user and another, say, a reviewer and the principal investigator. They further suggested that the system could be improved to allow for more interaction among users throughout the review process, when required so as to minimize the delays in the process of improving the proposals. “It would be good if it would reach a point where the reviewer and the one submitting are now interacting instead of having to go through the whole process back and forth….it could be within the same platform…” (IDI / R09) Some researchers further reported that the system has no feature to allow users, especially researchers, to provide their feedback and submit their claims when utilizing the system. They stated that it is not clear from the system who should be contacted when faced with usability difficulties and that more delays were experienced. “….. I think what can be improved is there should be timelines, that if you do not hear from us after certain time then contact this person, yes and should be more than one person or if also there should be a system of claims, or it should be through the system itself…there should be a system of putting complains because coming back I think paper based the issue was time and if we do not improve on REIMS it would be more or less useless in terms of your balance” (IDI / I04). Discussion The study aimed to explore the strengths and limitations of REIMS in a health training institution in Tanzania. Our findings underscore that the use of REIMS for submission and processing research proposals for ethical clearance at the institution has its strengths and limitations. Specifically, our study points; Convenience and Improved records management as the strengths of using REIMS. On the other hand, our findings points; limited reliable ICT resources and limited reviewer-researcher interaction as the limitations for using REIMS for processing ethical clearance at MUHAS. The use of an electronic submission and review system has increased access and management of proposals submitted for ethical clearance. Compared to paper-based review systems, the use of electronic systems in research institutions has often reduced workload and time in processing proposals submitted for ethical review ( 14 , 15 ). The study findings imply that users of REIMS perceived the system to be desirable for ethical clearance processing at the institution. However, findings from this study have also suggested that the system is limited in a number of ways in realizing its effectiveness. Unreliable ICT resources have been mentioned to be one of the limitations to access in other research institutions in Africa as well ( 5 , 14 , 16 ). Furthermore, limited interaction between users of the system has been mentioned to lead to delays and ineffectiveness of the process. Studies show that the interaction among users enhances a timeous and efficient process in using the system ( 17 ). As significant as it can be, clear communications between a reviewer and a researcher could alleviate areas of tension and help arrive at a shared understanding to enable the best research practice ( 17 ). This shows the importance of having interactive ways among REIMS users through the system to effectively use the system in enhancing ethical clearance processing in research institutions. The strengths of the REIMS as revealed by this study can be used for reinforcement and recognition and weaknesses of the system as perceived by users can be used as a basis for future improvement and capacity building at academic and research institutions. Study limitation The first author who also led the interviews was a student at MUHAS and a member of the directorate during the conduct of the study which may have somehow helped in understanding the system. This might have also induced desirable responses from participants. However, a detailed description of the data collection and analysis process, the use of a research assistant during data collection and triangulation of information gaining the perspectives from different groups of respondents (researchers, and members of REC), offsets this limitation. Conclusion With the fast-growing research at MUHAS and other academic and research institutions, the use of digital technology to enhance research review process and activities is unavoidable. The findings of this study underscore the strengths and limitations of transformation in handling research ethics review following an introduction of an electronic management system in place of a paper-based system, thus, going paperless. Despite the limitations, the strengths revealed have also included an increase in users’ satisfaction which is key for system use. It can be urged that the perceived benefits of an electronic research ethics information management system outweigh the limitations and institutions with similar to MUHAS can learn from this experience and adapt the same. There are a number of ways that REIMS can be improved and further enhance the processing of ethical clearance at MUHAS. We recommend; System automation and strengthening the institutional capacity, regular updates on the use of the new system. Moreover, further studies are needed to include broader perspectives from groups like students and researchers beyond MUHAS to gain a comprehensive understanding of REIMS in resource limited settings. Abbreviations DRPI Directorate of Research, Publications and Innovations IDI In-Depth Interview IS Information System MUHAS Muhimbili University of Health and Allied Sciences NIMR National Institute of Medical Research PI Principal Investigator IRB Institutional Review Board REC Research and Ethics Committee REIMS Research Ethics Information Management System WHO World Health Organization Declarations Data availability Underlying data Zenodo: [Interview transcripts]. https://doi.org/10.5281/zenodo.8382375 [97]. The project contains the following underlying data: [Interview transcripts] (Interview trancsripts of study participants). Extended data Zenodo: [Extended data]. https://doi.org/ 10.5281/zenodo.8383498 [97]. This project contains the following extended data: Interview guides. (Interview guides for strengths and limitations of electronic Research Ethics Information Management System in a health training institution) Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication). Acknowledgements We acknowledge all participants in this study for their invaluable contribution that has made this work possible. Competing Interests No competing interests were disclosed. Grant information The authors declared that no grants were involved in supporting this work. References Lolas Stepke F, WHO. Standards and operational guidance for ethics review of health-related research with human participants. Acta Bioeth. 2012;18(1):129–32. WHO. TDR/PRD/ETHICS/2000.1 i Operational Guidelines for Ethics Committees that Review Biomedical Research World Health Organization Geneva 2000. 2000. Grady C. Institutional review boards purpose and challenges. Chest. 2015;148(5):1148–55. Mokgatla B, Ijsselmuiden C, Wassenaar D, Kasule M. Mapping research ethics committees in africa: Evidence of the growth of ethics review of health research in Africa. Dev World Bioeth. 2018;18(4):341–8. Pulford J, Crossman S, Begg S, Amegee Quach J, Abomo P, El Hajj T, et al. Strengthening research management and support services in sub-Saharan African universities and research institutions. AAS Open Res. 2020;3:31. National Health Research Ethics Committee (Tanzania), Tanzania National Health Research Forum. Guidelines on ethics for health research in Tanzania. Tanzania National Health Research Forum; 2001. p. 100. National Institute of Medical Reserach. Standard Operating Procedures for the National Health Research Ethics Committee, 2nd Edition [Internet]. 2014. Available from: . Muhimbili University of Health and Allied Sciences. Research Policy and Guidelines. 2020. Elsevier. Why you need a Research Information Management System (RIMS) [Internet]. Available from: https://www.elsevier.com/research-intelligence/rims-and-cris-systems . Manu TR, Shashikumara AA, Asjola V. Research Information Management Systems: A Comparative Study. In: Research Data Access and Management in Modern Libraries [Internet]. 2019. p. 54–80. Available from: https://www.igi-global.com/chapter/research-information-management-systems/232424 . Muhimbili University of Health and Allied Sciences. Research Ethics Committee Members. 2020. Thong JYL, Yap CS. Inform Syst Effectiveness: User Satisfaction Approach. 1996;32(5):601–10. Kristianto B, Al-Raisi A, Amin S, Tahir S, Mill RC, Cyrus AW et al. Measuring the effectiveness of information systems. Management Information Systems [Internet]. 2016;2(6):601–10. Available from: . Cyrus AW. Measuring the effectiveness of information systems. 1992;71. Available from: http://hdl.handle.net/10945/30950 . Anna K, Lazaro B, Matti T. User perceptions on the use of Academic Information Systems for decision making support in the context of Tanzanian Higher Education. Int J Educ Dev Using Inf Commun Technol. 2020;16(1):72–87. Kebede D, Zielinski C, Mbondji PE, Sanou I, Kouvividila W, Lusamba-Dikassa PS. Institutional facilities in national health research systems in sub-Saharan African countries: Results of a questionnaire-based survey. J R Soc Med. 2014;107:96–104. Brown C, Spiro J, Quinton S. The role of research ethics committees: Friend or foe in educational research? An exploratory study. Br Educ Res J. 2020;46(4):747–69. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 03 Jan, 2025 Read the published version in BMC Health Services Research → Version 1 posted Editorial decision: Revision requested 18 Mar, 2024 Submission checks completed at journal 16 Mar, 2024 Editor assigned by journal 16 Mar, 2024 First submitted to journal 14 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4102733","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":280862113,"identity":"6efd495c-b326-4023-9351-9182ff9e3ed5","order_by":0,"name":"Rebecca D. 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The World Health Organization (WHO) provides that all proposed health research must get an ethical approval for data collection to commence (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Ethical approval is crucially important to ensure compliance in terms of ethical conduct of research and regulations envisioned to safeguard the dignity, rights, safety as well as well-being of research participants (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Ethical approvals are provided by Research Ethics Committees (RECs). RECs are charged with providing an independent assessment that the proposed research is ethically acceptable, scrutinizing clinical investigators\u0026rsquo; potential biases, and assessing compliance with guidelines and regulations intended to safeguard human participants (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eWith the growing need for conduct of human health research, institutions have been looking for more advanced, time saving procedures for review of proposed research and provision of ethical approvals. Although some countries have succeeded in incorporating technology into the process of obtaining ethical approvals, studies show that there has been less progress in Africa (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e In Tanzania, the review and approval of human health research is decentralized under the auspices of the National Institute for Medical Research (NIMR). Muhimbili University of Health and Allied Sciences (MUHAS) is one of the institutions mandated to form and manage an institutional REC that has been ensuring adherence to health research ethics through provision of ethical approvals (\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Over the years, the processing of research proposals for ethical approval at MUHAS was conducted manually through a review of hard copies. But in the last two years, a research ethics information management (electronic) system (REIMS) was introduced that would enhance the management of research ethics information in a single interface, increase the efficiency and effectiveness of research information management activities and enhance data storage and reporting (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Again, it would reduce the turn-around-time in processing and obtaining ethical approval, facilitate the submission and review process, facilitate the timely and routine generation of reports of number and type of studies conducted at MUHAS, enhance feedback mechanism between the REC and researchers and reduce costs associated with the previous paper-based system.\u003c/p\u003e \u003cp\u003eThis study informs the strengths and limitations of the use of REIMS as compared to the paper-based system. Findings from this study adds to the body of knowledge on research management information systems and which may be taken as a starting point in improving research management information systems in local and global contexts.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and context\u003c/h2\u003e \u003cp\u003eWe utilized a pre- and post-evaluation design and adopted a qualitative approach for data collection. Institutional users (researchers, REC reviewers and managers) that had been exposed to both the paper-based system and REIMS were interviewed about their experience of using each of the systems. The study was conducted at MUHAS located at Ilala Municipal in Dar es Salaam. It is one of the largest and oldest health training institutions in the country and undertakes a wide range of research. MUHAS has a research ethics review committee under the Senate that is mandated to review all research proposals and grant ethical clearances to undertake research studies under the umbrella of the institution.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy population\u003c/h2\u003e \u003cp\u003e The study population included researchers (MUHAS faculty), REC members including reviewers, the secretariat and the chairman to the committee. The aforementioned participants had been exposed to both the paper-based review system and REIMS and recruited from across the schools and institutes at MUHAS.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eThe MUHAS REC\u003c/h2\u003e \u003cp\u003eFollowing the introduction of REIMS at MUHAS in May 2020, roles were defined among the system users to include managers, reviewers, and researchers. At MUHAS, the chairperson to REC is responsible for, among others, chairing online and physical REC meetings and receiving and assigning protocols to respective reviewers. Reviewers, as part of the committee, are responsible for; accepting review requests, reviewing, and recommending proposals for ethical clearance during REC meetings. The secretariat to the REC is responsible for, among others; organizing committee meetings, create, distribute meeting agendas, and plan meeting logistics, validate applications in the system as per guidelines and in line with requirements, organize and track proposals received and sent to reviewers and through the system, facilitate communication and feedback between committee members and applicants. All these collectively and within their specific roles, take part in processing ethical clearance for research conducted through MUHAS. Currently the committee is made up of more than 30 members, most from MUHAS (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) .\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eSampling and sample size\u003c/h2\u003e \u003cp\u003eWe purposefully identified and interviewed 16 MUHAS systems users that were traced from registries and records available at the directorate of research, publications and innovations office at MUHAS, after selection based on research criteria (MUHAS faculty; researchers and members of REC that had been exposed to both systems), the PI contacted the selected participants through mobile to schedule appointments to conduct interviews based on their availability. Among them, five were researchers, nine were REC reviewers, and two were REIMS managers. Male participants were 10 and six were female participants. Research experience varied from five years to 15 years and review experience varied from three years to 10 years. Data collection was completed after reaching information saturation.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eRole\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReviewer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eManager\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResearcher\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e16\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e30\u0026ndash;40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e40\u0026ndash;50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eabove 50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e16\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eWe utilized in-depth interviews (IDI) to collect data from the purposefully selected participants. Data were collected between 20th and 30th June 2022. Semi structured interview guides were prepared for each category of participants (researchers, reviewers, and managers), customized to gather relevant information from each category based on their roles in using REIMS. The IDI guides were prepared in English language and later translated to Kiswahili language. Both languages were used during the interviews depending on respondent\u0026rsquo;s choice and comfortability. The IDI guides questions were prepared based on the knowledge of the researcher on the two systems (paper-based and REIMS) and theoretical knowledge on effectiveness of research management information systems as found literature (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). The tools were pretested among 3 rapidly available postgraduate (PhD) students at MUHAS who had used both systems to process ethical clearance and had obtained ethical clearance to conduct their research. The pre-testing resulted in rephrasing some of the questions in the researchers guide prior to the data collection process in order to capture the intended information.\u003c/p\u003e \u003cp\u003eUpon obtaining ethical clearance to undertake the study, the principal investigator obtained reviewers and researchers contacts from databases available at the IRB office at DRPI. After selection based on research criteria, the PI contacted the selected participants through mobile to schedule appointments to conduct interviews based on their availability. All interviews were recorded using a digital audio recorder, carried out in the offices or designated room of the participant and took between 20 minutes and 90 minutes. Interviews were conducted by the first author and one research assistant.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData management and analysis\u003c/h2\u003e \u003cp\u003eWe used a thematic analysis approach using inductive reasoning. After the \u003cem\u003everbatim\u003c/em\u003e transcription of recorded files, the first author coded three transcripts and obtained abstracted codes. Another author coded the same transcripts, and a comparison of codes was done. The same was done for all the 16 transcripts. The abstracted codes (that where in Kiswahili language), were translated to English language. After obtaining the abstracted codes, the authors sorted and condensed the codes to obtain level two codes. Further comparisons, checking and rechecking for similarities and differences was done to sort and cluster the codes into subthemes. The emerging subthemes were aligned into themes. The analysis process involved authors going back and forth between transcripts to identify, compare and summarize newly emerged themes. We present findings with support of succinct quotes (in English language) from the participants to reflect responses of the participants rather than the perspective of the authors.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eEthical considerations\u003c/h2\u003e \u003cp\u003e Ethical clearance to conduct the study was obtained from MUHAS Research Ethics Committee (MUHAS-REC-06-2022-1206). Written informed consent was obtained from participants prior to their involvement in the study. Confidentiality was ensured for all obtained information during the conduct of the study.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eFrom the analysis of the 16 IDIs, two broad themes of strengths and limitations of REIMS were identified (Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSummary of findings\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCodes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSub-theme\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eThemes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Geographical accessibility\u003c/p\u003e \u003cp\u003e\u0026bull; Easy navigation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eConvenience\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eStrengths in using REIMS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Tracking of documents is easy in REIMS\u003c/p\u003e \u003cp\u003e\u0026bull; Less physical labor in handling documents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eImproved records management\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Internet breakdown\u003c/p\u003e \u003cp\u003e\u0026bull; Server connectivity\u003c/p\u003e \u003cp\u003e\u0026bull; Electronic devises and gadgets\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDemands reliable ICT resources\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eLimitations in using REIMS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Undefined standard number of proposals to reviewers\u003c/p\u003e \u003cp\u003e\u0026bull; Fragmented notification\u003c/p\u003e \u003cp\u003e\u0026bull; There is no integrated feedback\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLimited Reviewer-researcher interaction\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStrengths of REIMS system\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003eREIMS is convenient to use\u003c/h2\u003e \u003cp\u003eUsers reported that REIMS can be accessed from any location and at any time. They stated that it has provided convenience of using the system and one can submit their proposal at any time from any location, reviews can be done at any time when the reviewer is ready, progress tracking and management can be done from anywhere.\u003c/p\u003e \u003cp\u003e\u0026ldquo;REIMS is very convenient with me, sometimes I like to work over the weekend because I have a lot of things during the weekdays\u0026hellip; you can do work anytime and you submit\u0026hellip;so I think that is quite a good experience\u0026hellip;\u0026rdquo; (IDI / R02)\u003c/p\u003e \u003cp\u003eSome reviewers further highlighted that REIMS had simplified their work throughout the review process. They stated that despite some issues in execution, the system has simplified review and has added efficiency to their work.\u003c/p\u003e \u003cp\u003e\u0026ldquo;I think as an idea it is excellent, the concept might be great, but the execution might have some issues here and there. REIMS as a system has been really good and it has really streamlined my review process, beforehand I would not be to do fast all the papers that I have gone through for instance and it\u0026rsquo;s so easy to make comparisons, it is very efficient\u0026rdquo; (IDI / R05)\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003ePerceived as a better record management system\u003c/h2\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003eImproved feedback process\u003c/h2\u003e \u003cp\u003eUsers reported that the system has improved the feedback process, and they are now able to receive real-time notifications of their proposal progress. Some participants reported that:\u003c/p\u003e \u003cp\u003e\u0026ldquo;\u0026hellip;the system is good as it gives you progress, that it has been accepted, where it is at the moment and if it has been discussed in the meeting, I knew lots of the procedures through the system, like it notifies you the REC has approved, you know, so you get such information\u0026hellip;\u0026rdquo; (IDI / I03)\u003c/p\u003e \u003cp\u003eIn addition, some participants highlighted that REIMS has reduced the risk of documents being misplaced as documents are submitted, tracked, and stored electronically.\u003c/p\u003e \u003cp\u003e\u0026ldquo;\u0026hellip; it helps to keep records because also at any time a reviewer can take a look on how many works, they have reviewed, and if someone does not see their ethical clearance can take a look there, so it is technology incorporated it has become quite easier\u0026rdquo; (IDI / I05)\u003c/p\u003e \u003cp\u003eManagers also reported that REIMS has improved record keeping and management and costs in handling proposals submitted for ethical clearance at the institution.\u003c/p\u003e \u003cp\u003e\u0026ldquo;\u0026hellip;Before they used to submit about 8 proposals and later they saw that it was costly since you also have to duplicate copies whenever you receive comments\u0026hellip;as a result you end up leaving the copies in office and storing them is difficult\u0026hellip;but now since it is online you can work on them whenever you are free you just need access to internet regardless you are on leave, on a weekend or even out of Dar es Salaam\u0026hellip;\u0026rdquo; (IDI / M01)\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eLimitations of using REIMS\u003c/h2\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003eREIMS demands reliable ICT resources\u003c/h2\u003e \u003cp\u003eAs one of the limitations in using REIMS, some participants highlighted that the current system necessitates the availability of adequate and reliable ICT devices (computers, laptops, tablets) especially among reviewers to ease the review process of proposals submitted for ethical clearance.\u003c/p\u003e \u003cp\u003e\u0026ldquo;\u0026hellip;Another challenge is working tools, sometimes my computer does not work well, I can even show you now, my computer cannot work without being in what, in charger It is almost going to die you see, so reviewing becomes a challenge, at one point it was broken, proposals stayed for quite some time, I was being asked every day and I told them I have issues with my computer, I can even show you\u0026hellip;\u0026rdquo; (IDI / R04)\u003c/p\u003e \u003cp\u003eUsers highlighted some of the limitations to access to REIMS as being determined by institutional internet and server connectivity. They reported that access is still limited and that it is necessary to solve the problem and any reason that limits access to the use of the system.\u003c/p\u003e \u003cp\u003e\u0026ldquo;Yah, it hasn\u0026rsquo;t happened to me, sometimes to a number of people but we recently\u0026hellip; let\u0026rsquo;s say to me if the asking person were the ICT, I would say the internet connection. But as you say it can be a small server, small capacity or something else, take it as problematic. What I am saying, access is a problem. Whatever the reason for access that should be solved, if it\u0026rsquo;s the server capacity, internet connectivity or anything else\u0026rdquo; (IDI / R06)\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eLimited reviewer-researcher interaction\u003c/h2\u003e \u003cp\u003eUsers reported that REIMS limits the possibility for reviewers to provide detailed in text comments and inputs required to improve the proposals during the review process. They stated that the use of an electronic available template with no possibility to upload a detailed reviewed file limits the details of a review that the applicant/researcher can receive to improve their work.\u003c/p\u003e \u003cp\u003e\u0026ldquo;Yes, in REIMS currently it\u0026rsquo;s that when the proposal comes, that even if I put track changes, I cannot upload it, the student\u0026rsquo;s proposal that I have put track changes or author that it is returned to them so as they can see where, but in REIMS currently there is like a template that you complete online based on proposal sections but to put as track changes that is not possible\u0026rdquo; (IDI / R01)\u003c/p\u003e \u003cp\u003eSome reviewers further reported that the system does not provide the flexibility to use various review templates based on specific review requirements, thus following a structured review system. They stated that there may also be a need to have empirical templates for different categories of applicants so each can be handled based on specific research requirements.\u003c/p\u003e \u003cp\u003e\u0026ldquo;I think REIMS does not provide a room when if it is an amendment someone is requesting for amendment there is not a specified template on how you should handle amendment \u0026hellip;I think we also need to have an empirical template based on researcher\u0026rsquo;s category\u0026hellip;\u0026rdquo; (IDI / R08)\u003c/p\u003e \u003cp\u003eUsers further reported that the system limits interaction among one user and another, say, a reviewer and the principal investigator. They further suggested that the system could be improved to allow for more interaction among users throughout the review process, when required so as to minimize the delays in the process of improving the proposals.\u003c/p\u003e \u003cp\u003e\u0026ldquo;It would be good if it would reach a point where the reviewer and the one submitting are now interacting instead of having to go through the whole process back and forth\u0026hellip;.it could be within the same platform\u0026hellip;\u0026rdquo; (IDI / R09)\u003c/p\u003e \u003cp\u003eSome researchers further reported that the system has no feature to allow users, especially researchers, to provide their feedback and submit their claims when utilizing the system. They stated that it is not clear from the system who should be contacted when faced with usability difficulties and that more delays were experienced.\u003c/p\u003e \u003cp\u003e\u0026ldquo;\u0026hellip;.. I think what can be improved is there should be timelines, that if you do not hear from us after certain time then contact this person, yes and should be more than one person or if also there should be a system of claims, or it should be through the system itself\u0026hellip;there should be a system of putting complains because coming back I think paper based the issue was time and if we do not improve on REIMS it would be more or less useless in terms of your balance\u0026rdquo; (IDI / I04).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe study aimed to explore the strengths and limitations of REIMS in a health training institution in Tanzania. Our findings underscore that the use of REIMS for submission and processing research proposals for ethical clearance at the institution has its strengths and limitations. Specifically, our study points; Convenience and Improved records management as the strengths of using REIMS. On the other hand, our findings points; limited reliable ICT resources and limited reviewer-researcher interaction as the limitations for using REIMS for processing ethical clearance at MUHAS.\u003c/p\u003e \u003cp\u003eThe use of an electronic submission and review system has increased access and management of proposals submitted for ethical clearance. Compared to paper-based review systems, the use of electronic systems in research institutions has often reduced workload and time in processing proposals submitted for ethical review (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). The study findings imply that users of REIMS perceived the system to be desirable for ethical clearance processing at the institution. However, findings from this study have also suggested that the system is limited in a number of ways in realizing its effectiveness. Unreliable ICT resources have been mentioned to be one of the limitations to access in other research institutions in Africa as well (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Furthermore, limited interaction between users of the system has been mentioned to lead to delays and ineffectiveness of the process. Studies show that the interaction among users enhances a timeous and efficient process in using the system (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). As significant as it can be, clear communications between a reviewer and a researcher could alleviate areas of tension and help arrive at a shared understanding to enable the best research practice (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). This shows the importance of having interactive ways among REIMS users through the system to effectively use the system in enhancing ethical clearance processing in research institutions.\u003c/p\u003e \u003cp\u003eThe strengths of the REIMS as revealed by this study can be used for reinforcement and recognition and weaknesses of the system as perceived by users can be used as a basis for future improvement and capacity building at academic and research institutions.\u003c/p\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eStudy limitation\u003c/h2\u003e \u003cp\u003eThe first author who also led the interviews was a student at MUHAS and a member of the directorate during the conduct of the study which may have somehow helped in understanding the system. This might have also induced desirable responses from participants. However, a detailed description of the data collection and analysis process, the use of a research assistant during data collection and triangulation of information gaining the perspectives from different groups of respondents (researchers, and members of REC), offsets this limitation.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eWith the fast-growing research at MUHAS and other academic and research institutions, the use of digital technology to enhance research review process and activities is unavoidable. The findings of this study underscore the strengths and limitations of transformation in handling research ethics review following an introduction of an electronic management system in place of a paper-based system, thus, going paperless. Despite the limitations, the strengths revealed have also included an increase in users\u0026rsquo; satisfaction which is key for system use. It can be urged that the perceived benefits of an electronic research ethics information management system outweigh the limitations and institutions with similar to MUHAS can learn from this experience and adapt the same. There are a number of ways that REIMS can be improved and further enhance the processing of ethical clearance at MUHAS. We recommend; System automation and strengthening the institutional capacity, regular updates on the use of the new system.\u003c/p\u003e\n\u003cp\u003eMoreover, further studies are needed to include broader perspectives from groups like students and researchers beyond MUHAS to gain a comprehensive understanding of REIMS in resource limited settings.\u003c/p\u003e\n\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\u0026nbsp;\u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eDRPI \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Directorate of Research, Publications and Innovations\u003c/p\u003e\n\u003cp\u003eIDI \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;In-Depth Interview\u003c/p\u003e\n\u003cp\u003eIS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Information System\u003c/p\u003e\n\u003cp\u003eMUHAS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Muhimbili University of Health and Allied Sciences\u003c/p\u003e\n\u003cp\u003eNIMR\u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp;\u0026nbsp;National Institute of Medical Research\u003c/p\u003e\n\u003cp\u003ePI \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Principal Investigator\u003c/p\u003e\n\u003cp\u003eIRB \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Institutional Review Board\u003c/p\u003e\n\u003cp\u003eREC \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Research and Ethics Committee\u003c/p\u003e\n\u003cp\u003eREIMS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Research Ethics Information Management System\u003c/p\u003e\n\u003cp\u003eWHO \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; World Health Organization\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eData availability\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eUnderlying data\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eZenodo: [Interview transcripts]. https://doi.org/10.5281/zenodo.8382375 [97].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe project contains the following underlying data:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e[Interview transcripts] (Interview trancsripts of study participants).\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eExtended data\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eZenodo: [Extended data]. https://doi.org/ 10.5281/zenodo.8383498 [97].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis project contains the following extended data:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eInterview guides. (Interview guides for\u0026nbsp;strengths and limitations of electronic Research Ethics Information Management System in a health training institution)\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eData are available under the terms of the Creative Commons Zero \u0026quot;No rights reserved\u0026quot; data waiver (CC0 1.0 Public domain dedication).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe acknowledge all participants in this study for their invaluable contribution that has made this work possible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo competing interests were disclosed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGrant information\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declared that no grants were involved in supporting this work.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLolas Stepke F, WHO. Standards and operational guidance for ethics review of health-related research with human participants. Acta Bioeth. 2012;18(1):129\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWHO. TDR/PRD/ETHICS/2000.1 i Operational Guidelines for Ethics Committees that Review Biomedical Research World Health Organization Geneva 2000. 2000.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGrady C. Institutional review boards purpose and challenges. Chest. 2015;148(5):1148\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMokgatla B, Ijsselmuiden C, Wassenaar D, Kasule M. Mapping research ethics committees in africa: Evidence of the growth of ethics review of health research in Africa. Dev World Bioeth. 2018;18(4):341\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePulford J, Crossman S, Begg S, Amegee Quach J, Abomo P, El Hajj T, et al. Strengthening research management and support services in sub-Saharan African universities and research institutions. AAS Open Res. 2020;3:31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Health Research Ethics Committee (Tanzania), Tanzania National Health Research Forum. Guidelines on ethics for health research in Tanzania. Tanzania National Health Research Forum; 2001. p. 100.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Institute of Medical Reserach. Standard Operating Procedures for the National Health Research Ethics Committee, 2nd Edition [Internet]. 2014. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003c/span\u003e\u003cspan address=\"http://www.nimr.or.tz\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMuhimbili University of Health and Allied Sciences. Research Policy and Guidelines. 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eElsevier. Why you need a Research Information Management System (RIMS) [Internet]. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.elsevier.com/research-intelligence/rims-and-cris-systems\u003c/span\u003e\u003cspan address=\"https://www.elsevier.com/research-intelligence/rims-and-cris-systems\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eManu TR, Shashikumara AA, Asjola V. Research Information Management Systems: A Comparative Study. In: Research Data Access and Management in Modern Libraries [Internet]. 2019. p. 54\u0026ndash;80. 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Int J Educ Dev Using Inf Commun Technol. 2020;16(1):72\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKebede D, Zielinski C, Mbondji PE, Sanou I, Kouvividila W, Lusamba-Dikassa PS. Institutional facilities in national health research systems in sub-Saharan African countries: Results of a questionnaire-based survey. J R Soc Med. 2014;107:96\u0026ndash;104.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrown C, Spiro J, Quinton S. The role of research ethics committees: Friend or foe in educational research? An exploratory study. Br Educ Res J. 2020;46(4):747\u0026ndash;69.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Research information management system, research ethics, Tanzania","lastPublishedDoi":"10.21203/rs.3.rs-4102733/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4102733/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e Over the years, the processing of research proposals for ethical approvals has been done manually through a review of printed proposals. The system faced many challenges which led to inefficiency of the review process, and thus longer turn-around time. To address these challenges, an electronic or web-based application for research proposal submission and processing was introduced. However, the advantages of going paperless and inherent drawbacks remain unsubstantiated. This study aimed to explore the strength and limitations of electronic Research Ethics Information Management Systems (REIMS) in a health training institution in Tanzania. An exploratory qualitative study was adopted where 16 faculty members of the Muhimbili University of Health and Allied Sciences were interviewed. The faculty were purposefully recruited to include only those who had been exposed both to the paper-based research ethics review system and electronic Research Ethics Information Management System. The faculty were stratified into two groups of researchers and members of the research ethics committee. Thematic analysis using inductive reasoning was used to analyze the gathered information. The strengths and limitations of REIMS were unveiled in this study as two important themes. The strengths included convenience in use of the system and improved records management. The imitations included demand for reliable ICT resources and limited reviewer-researcher interaction. The findings of this study underscore the strengths and limitations of transformation in handling research ethics review following an introduction of an electronic system and abandoning the paper-based system. Institutions aspiring to adapt the system can learn from this experience and devise ways to overcome the limitations. We recommend system automation, strengthening the institutional capacity and further studies to be conducted on the use of the REIMS.\u003c/p\u003e","manuscriptTitle":"Going paperless: the strengths and limitations of electronic Research Ethics Information Management System in a health training institution in Tanzania","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-19 08:48:14","doi":"10.21203/rs.3.rs-4102733/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-18T11:17:42+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-03-16T12:07:09+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-16T12:07:09+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2024-03-14T17:43:55+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5f75bffb-7df9-4a30-b0e4-51df98a1378e","owner":[],"postedDate":"March 19th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-01-06T15:59:15+00:00","versionOfRecord":{"articleIdentity":"rs-4102733","link":"https://doi.org/10.1186/s12913-024-12151-0","journal":{"identity":"bmc-health-services-research","isVorOnly":false,"title":"BMC Health Services Research"},"publishedOn":"2025-01-03 15:57:02","publishedOnDateReadable":"January 3rd, 2025"},"versionCreatedAt":"2024-03-19 08:48:14","video":"","vorDoi":"10.1186/s12913-024-12151-0","vorDoiUrl":"https://doi.org/10.1186/s12913-024-12151-0","workflowStages":[]},"version":"v1","identity":"rs-4102733","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4102733","identity":"rs-4102733","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}