UNIVERSITY OF GHANA COLLEGE OF HEALTH SCIENCES SCHOOL OF PUBLIC HEALTH ASSESSMENT OF THE ETHICAL STANDARDS FOR RESEARCH WITH HUMAN PARTICIPANTS DURING THE COVID-19 PANDEMIC IN GHANA BY ANGELINA CYENDY SENA ADORKOR (10875115) THIS DISSERTATION IS SUBMITTED TO THE UNIVERSITY OF GHANA, LEGON IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE AWARD OF A MASTER OF PUBLIC HEALTH (MPH) DEGREE SEPTEMBER, 2022 University of Ghana http://ugspace.ug.edu.gh i Declaration I, Angelina Cyendy Sena Adorkor, do hereby declare that except for other scholarly works, which have been duly acknowledged, the materials contained in this thesis are my original efforts and that I have not submitted this work, either in part or in whole, for the award of any degree elsewhere. Angelina Cyendy Sena Adorkor …………………………… ………………… (Student) Signature Date Professor Paulina Tindana ……………………… ………………… Supervisor Signature Date University of Ghana http://ugspace.ug.edu.gh ii Abstract Introduction: Ethical standards are important for promoting research goals and protecting human research participants from the risks associated with research. During public health emergencies such as the recent COVID-19 pandemic, adhering to ethical standards and procedures that inform the review and implementation of research presents important challenges. The main objective of this study was to assess the ethical standards for research involving human participants and the challenges faced by both researchers and ethics review committees in their work during the COVID-19 pandemic in Ghana. Methods: This study employed a concurrent mixed-methods design involving qualitative interviews with Chairpersons and Administrators of Six (6) research ethics committees and a survey of 360 researchers across Ghana. Guided by the study's objectives, the qualitative data were analyzed using thematic content analysis, while the quantitative data were analysed using SPSS, where frequency tables and figures were generated. Results: The study revealed that before the COVID-19 pandemic in 2020, IRB/RECs in Ghana held face-to-face meetings regularly and received protocols manually. However, IRB/REC operations were affected by the COVID-19 restrictions, which necessitated a transition to virtual meetings. Some IRB/RECs collaborated with other regulatory authorities, such as the Food and Drugs Authority, to streamline the ethics and regulatory review process. This included the introduction of online submissions and accelerated reviews for COVID-19- related protocols. While most of the ethics standards for research, such as informed consent, were followed strictly by researchers during the pandemic, there were challenges with implementing some research activities under COVID-19 restrictions. IRB/RECs also experienced challenges during the review process, including poor internet connectivity, the University of Ghana http://ugspace.ug.edu.gh iii workload during review meetings, protocol approval delays, inability to meet schedules and timelines, absenteeism, and inadequate funding. Conclusion: Ethical standards and procedures for research with human participants were followed by IRB/RECs and researchers during the COVID-19 pandemic. This study has highlighted important ethical challenges experienced by IRB/RECs and researchers in the review and implementation of research during the COVID-19 pandemic. There is a need to anticipate these challenges and identify innovative ways of addressing them in future pandemics to protect research participants and promote the ethical conduct of research in Ghana and beyond. University of Ghana http://ugspace.ug.edu.gh iv Acknowledgements I acknowledge the contribution of many individuals to this piece of work. I thank my supervisor Dr. Paulina Tindana of the University of Ghana School of Public Health, for her great input, contributions, and advice throughout the study period, The Principal Investigators in the persons of Dr. Paulina Tindana of the University of Ghana School of Public Health, and Dr. Dorcas Kamuya of the KEMRI Wellcome Trust Research Programme in Kilifi, Kenya who supported the research work with a grant from the Africa Academy of Sciences (AAS), I appreciate the financial support. My appreciation also goes to the Director of my Institution, Noguchi Memorial Institute for Medical Research, College of Health Sciences, the University of Ghana, for permitting me to pursue the MPH programme. My next appreciation goes to all the Directors of the study site: the Director of the Water Research Institute - CSIR, The Director of Dodowa Health Research - DHR, the Director of the West African Centre for Cell Biology of Infectious Pathogens (WACCBIP) Director, Navrongo Health Research, and Director, Kintampo Health Research. I sincerely acknowledge the effort of Mr. Prince Martin Gyekye for proofreading the entire work and providing unending support throughout the study time. Special gratitude also goes to Mr. Theodore Ahuno, the Institute Administrator of Noguchi Memorial Institute for Medical Research, for taking a keen interest in the research work and mostly encouraging me. My appreciation also goes to the following people who contributed immensely to the collection of data, Leticia Ofosu Yirenkye, Ghana Atomic Energy Commission, Celestine Sappor and Dorcas Osei-Boakye, both of Noguchi Memorial Institute for Medical Research, University of Ghana http://ugspace.ug.edu.gh v Pamela Emefa Selormey CSIR- Water Research, Zaid Haruna – CSIR - Water Research Institute, Adjoa Brenya, Dodowa Health Research, Henry Okudjeto, Dodowa Health Research, I appreciate the efforts of madam Faustina Anyetie in the Department of Health Policy, Planning and Management - University of Ghana School of Public Health, for coordinating various activities on the work. My sincere appreciation also goes to Mr. Anthony G. Akanlu, of the West African Centre for Cell Biology of Infectious Pathogens (WACCBIP), Dr. Samuel Dadzie, Head, Department of Parasitology, Noguchi Memorial Institute for Medical Research, (NMIMR) for their diverse support throughout the work. My final appreciation goes to Mr. Augustine Mensah, a Research Assistant who offered selfless assistance to the work. University of Ghana http://ugspace.ug.edu.gh vi Dedication This thesis is dedicated to the Almighty God for His continued guidance throughout the programme, to my parents Mr. and Mrs. Adorkor, My husband, Mr. Emmanuel Appiah-Kubi, and my children, Emefa, Twumwaa, Eyram, Boakyewaa, and Nana Kwadwo. Finally, to my siblings Mercy and Cosmos for their unflinching support. University of Ghana http://ugspace.ug.edu.gh vii Contents Declaration........................................................................................................................ i Abstract ............................................................................................................................ ii Acknowledgements ........................................................................................................ iv Dedication ....................................................................................................................... vi Contents ......................................................................................................................... vii List of Tables .................................................................................................................. xi List of Figures ................................................................................................................ xii CHAPTER ONE: INTRODUCTION ........................................................................... 1 1.1 INTRODUCTION .................................................................................................... 1 1.2 BACKGROUND ..................................................................................................... 1 1.3 PROBLEM STATEMENT ......................................................................................... 5 1.4 RESEARCH QUESTIONS ........................................................................................ 6 1.5 GENERAL AND SPECIFIC OBJECTIVES .................................................................. 7 1.5.1 General Objective ....................................................................................... 7 1.5.2 Specific Objectives ...................................................................................... 7 1.6 JUSTIFICATION OF THE STUDY .............................................................................. 7 1.7 OUTLINE OF THE THESIS ....................................................................................... 8 1.8 SUMMARY OF INTRODUCTION .............................................................................. 9 CHAPTER TWO: LITERATURE REVIEW............................................................ 10 2.1 INTRODUCTION .................................................................................................. 10 University of Ghana http://ugspace.ug.edu.gh viii 2.2 A HISTORICAL PERSPECTIVE OF THE EMERGENCE OF IRB/RECS ...................... 10 2.2.1 Global Ethical Standards for Conducting Research during the COVID-19 Pandemic ................................................................................................. 13 2.2.2 Informed Consent Processes in Research during COVID-19................... 22 2.2.3 Steps Taken by Researchers to Protect Participants’ Safety During Research .................................................................................................. 27 2.3 RESEARCH CHALLENGES UNDER COVID-19 RESTRICTIONS ............................. 33 2.4 OVERVIEW OF RESEARCH ETHICS COMMITTEES IN GHANA ............................... 37 2.5 CURRENT REQUIREMENTS FOR CONDUCTING RESEARCH UNDER COVID-19 IN GHANA .............................................................................................................. 41 2.6 CONCEPTUAL FRAMEWORK ............................................................................... 46 2.7 SUMMARY OF LITERATURE REVIEW .................................................................. 48 CHAPTER THREE: RESEARCH METHODS ........................................................ 50 3.1 INTRODUCTION .................................................................................................. 50 3.2 STUDY DESIGN .................................................................................................. 50 3.3 STUDY POPULATION .......................................................................................... 50 3.4 INCLUSION AND EXCLUSION CRITERIA .............................................................. 51 3.5 3.7 SOURCES OF DATA ............................................................................................. 52 3.8 DATA COLLECTION ............................................................................................ 53 3.9 DATA COLLECTION TOOLS AND TECHNIQUES .................................................... 53 3.11 DATA ANALYSIS ................................................................................................ 55 3.12 ETHICAL CONSIDERATIONS ............................................................................... 56 3.13 SUMMARY OF CHAPTER ..................................................................................... 59 SAMPLING SIZE DETERMINATION........................................................................ 51 3.6 SAMPLING TECHNIQUE ....................................................................................... 51 3.10 CONDUCTINF RESEARCH UNDER COVID-19 ANALYSIS ....................................... 54 University of Ghana http://ugspace.ug.edu.gh ix CHAPTER FOUR: RESULTS .................................................................................... 60 4.1 INTRODUCTION .................................................................................................. 60 4.2 SOCIO-DEMOGRAPHIC CHARACTERISTICS OF STUDY PARTICIPANTS ................. 60 4.3 BACKGROUND OF IRB/RECS INCLUDED IN THIS STUDY QUALITATIVE ............. 4.4 REVIEW PROCESSES BEFORE THE COVID-19 PANDEMIC .................................. 62 4.5 CHALLENGES IN REVIEW PROCESSES DURING THE COVID-19 PANDEMIC ........ 64 4.6 TIMELINES FOR ETHICAL CLEARANCE DURING THE COVID-19 PANDEMIC QUANTITATIVE RESULTS ................................................................................... 66 4.7 EFFECT OF COVID-19 RESTRICTIONS ON INFORMED CONSENT PROCESSES ...... 67 4.8 STEPS TAKEN TO PROTECT RESEARCH PARTICIPANTS DURING THE COVID-19 PANDEMIC ......................................................................................................... 67 CHALLENEGS WITH RESEARCH CHALLENGES UNDER COVID-19 RESTRICTIONS ................................................................................................... 69 CHAPTER FIVE: DISCUSSION ............................................................................... 71 5.1 INTRODUCTION .................................................................................................. 71 5.2 ETHICS REVIEW PROCESSES OF CONDUCTING RESEARCH BEFORE AND AFTER THE OUTBREAK OF COVID-19 .......................................................................... 71 5.3 INFORMED CONSENT PROCESSES IN RESEARCH DURING COVID-19 ................. 82 5.4 STEPS TAKEN BY RESEARCHERS TO PROTECT PARTICIPANTS’ SAFETY DURING RESEARCH ......................................................................................................... 82 RESULTS ............................................................................................................ 61 4.9 5.5 RESEARCH CHALLENGES UNDER COVID-19 RESTRICTIONS ............................. 83 5.6 EXPERIENCES OF RESEARCHERS AND IRB CHAIR/ADMINISTRATORS ................ 84 University of Ghana http://ugspace.ug.edu.gh x CHAPTER SIX: CONCLUSIONS AND RECOMMENDATIONS ........................ 86 6.1 INTRODUCTION .................................................................................................. 86 6.2 CONCLUSIONS .................................................................................................... 86 6.3 CONTRIBUTIONS TO KNOWLEDGE ...................................................................... 86 6.4 RECOMMENDATIONS .......................................................................................... 87 REFERENCES .............................................................................................................. 89 APPENDIX .................................................................................................................. 101 APPENDIX I: QUESTIONNAIRE .......................................................................... 101 APPENDIX II: INTERVIEW GUIDE ..................................................................... 107 APPENDIX III: ETHICAL CLEARANCE ............................................................. 113 University of Ghana http://ugspace.ug.edu.gh xi List of Tables TABLE 1: ETHICAL GUIDELINES FOR CONDUCTING RESEARCH UNDER COVID-19 RESTRICTIONS .......................................................................................................... 15 TABLE 2: SOCIO-DEMOGRAPHIC CHARACTERISTICS OF RESEARCHERS (N=372) ....................... 60 TABLE 3: REVISION OF THE INFORMED CONSENT PROCESSES DURING COVID-19................... 67 University of Ghana http://ugspace.ug.edu.gh xii List of Figures FIGURE 1: CONCEPTUAL FRAMEWORK OF THE STUDY .............................................................. 47 FIGURE 2: DURATION OF ETHICAL APPROVAL DURING COVID-19 PERIOD ............................. 66 FIGURE 3: INSTITUTIONAL STANDARD OPERATIONAL POLICIES ............................................... 68 FIGURE 4: CHALLENGES THAT EXISTED BEFORE COVID-19 ..................................................... 69 FIGURE 5: CHALLENGES WORSENED BY THE COVID-19 PANDEMIC .................................... 70 University of Ghana http://ugspace.ug.edu.gh 1 CHAPTER ONE INTRODUCTION 1.1 Introduction This chapter presents a general overview of the current study, which seeks to investigate the ethical standards for research during the COVID-19 pandemic in Ghana, based on the perspectives of researchers and members of research ethics committees. Accordingly, the research background and the research problem statement are highlighted. Further, the chapter outlines the research aim and objectives, research questions, significance of the research, research scope, structure of the research, and summary of the chapter. 1.2 Background In December 2019, the novel coronavirus SARS-CoV-2 disease (COVID-19) which was initially reported in Wuhan, China, quickly spread across the globe, infecting 48,539,872 people, and causing 1,232,791 deaths in 215 countries as at the year 2020 (World Health Organization, 2020). Since the year 2020, COVID-19 has caused widespread health challenges and socio-economic instability worldwide. The pandemic also heightened the important role of research and different types of candidate vaccines and therapeutics have been evaluated and/or are under clinical trials against the COVID-19 disease. Research involving human participants plays a vital role in advancing scientific knowledge and improving healthcare outcomes. The ethical considerations surrounding such research are of high importance to ensure the safety, respect, and justice of research participants. However, conducting ethical research presents key challenges, particularly during global health emergencies, such as the recent COVID-19 pandemic. University of Ghana http://ugspace.ug.edu.gh 2 The World Health Organization states that in order to produce high-quality research outcomes, researchers must abide by universal principles and guidelines known as ethical standards of research (Organization, 2020). Ethical standards are critical in research because they provide the framework for protecting the rights and well-being of research participants and promote the scientific and ethical merits of research (Fouka and Mantzorou, 2011). In response to the unethical use of human subjects in World War II, the World Medical Association (WMA) established the Declaration of Helsinki in 1964. Inspired by the Nuremberg Code, the Declaration aimed to safeguard the rights and welfare of human subjects involved in medical research. The Declaration serves as a blueprint for promoting the highest moral standards in studies involving human subjects. It guarantees the protection of participants' rights and welfare by placing a strong emphasis on the values of safety, respect, and fairness. Compliance with the Declaration fosters trust in the research community and facilitates the advancement of knowledge while upholding ethical responsibilities toward those who contribute to scientific progress. Continued adherence to the Declaration's principles is crucial for maintaining public trust in research and safeguarding the well-being of human participants. Further, ethical standards provide the benchmark against which common research language, characteristics, and outcomes are established by research ethics committees (Organization, 2020). They also allow researchers to determine and eliminate potential risks and dangers to guarantee voluntary participation (Akaranga and Makau, 2016). One important aspect of conducting research is the key role of Research Ethics Committees and Institutional Review Boards (REC/IRBs). The history of IRBs reflects a growing recognition of the importance of protecting human subjects in research and ensuring the ethical conduct of research. They have evolved as essential entities to review and oversee research, aiming to safeguard participant rights, minimize harm, and uphold ethical principles University of Ghana http://ugspace.ug.edu.gh 3 in scientific investigations (Arunachalam et al., 2021). Historically, REC/IRBs have faced challenges in the discharge of their duties. Workload and a lack of experience with some of the novel scientific approaches are some of these difficulties that have been highlighted in the literature (Kass et al., 2007; Boateng 2019). Several articles have also documented the challenges with ethics review processes during global health emergencies such as the Ebola Epidemic in 2014 (Hunt et al., 2016; Saxena et al., 2019). But under COVID-19 restrictions, these specific ethical issues are amplified, new ethical issues require innovative mitigation measures, whereas the safety of both researchers and participants must be guaranteed. From this foundation, researchers are expected to anticipate the ethical and social consequences of the pandemic on the processes and procedures of conducting research. To proceed with the current study, there is a need to specify working definitions for key concepts such as ethical standards, REC, and researchers. Kruger et al. (2014) define REC as a group of persons with the appropriate competencies and authorizations to review and approve research involving human participants. REC could also refer to a panel that reviews the methods proposed for research to guarantee strict adherence to research values and moral principles (Boateng, 2019). For this study, REC is defined as a recognized institution authorized to appraise the ethical virtues of research and protect the safety, anonymity, confidentiality, privacy, and security of research participants and the public in general. RECs play a significant role in the conduct of research because they ensure the scientific integrity of work, trust, accountability, mutual respect, and fairness (Ghana Health Service Ethics Review Committee, 2015). Apart from sanctioning approval for various research activities, REC also provides consistent monitoring, appraisal, resolution, accountability, and quality assurance at all stages of the research process (Agha et al., 2007). Ethical standards can be likened to the principles and processes that guide the implementation of research (Boaz and Ashby, 2003). They are offer researchers guidelines to enable them to University of Ghana http://ugspace.ug.edu.gh 4 conduct and publish responsible research (Gajjar, 2013). In this study, the World Health Organization’s definition of ethical standards would be observed as a working definition. Kothari, 2004 defines researchers as a group of scholars who follow scientific and systematic approaches in search of information, truth, and new facts in any branch of knowledge. These scholars conduct a careful investigation or inquiry to find a solution to a problem (Kothari, 2004). So, in effect, researchers are intellectuals who conduct theoretical, systematic, or empirical research. From the aforementioned definitions, it can be concluded that universal principles and the gatekeeping role of RECs, create the enabling environment for researchers to create knowledge through the outcome of theoretical, systematic, or empirical research. This will ensure that the process of contributing to the existing stock of knowledge has been accomplished by protecting the safety, anonymity, confidentiality, privacy, and security of participants. Determining the effect of COVID-19 on research is consequently difficult for Ghana's numerous RECs and researchers. It is extremely challenging for anyone or any organisation to predict how long the pandemic's effects would last. But given the important role of research, there is the need to continue implementing research projects to generate the right evidence for policy-decision making. However, there are still concerns about how such research can be carried out ethically under COVID-19 constraints. Similarly, although RECs, researchers, and project managers struggle to navigate ethical problems related to COVID-19, the integrity of all research and academic projects must be upheld. Therefore, it is highly desirable to conduct a study to evaluate the ethical requirements for research involving human subjects at COVID-19 in Ghana. University of Ghana http://ugspace.ug.edu.gh 5 1.3 Problem Statement COVID-19 has caused widespread health challenges and socio-economic instability worldwide for more than a year. As at the time of conducting this research, there was no definite line of treatment that has been approved, however, different types of potential vaccines and therapeutics have been evaluated and/or are under clinical trials against COVID-19 (Khan, 2020). COVID-19 has caused widespread health challenges and socio- economic instability worldwide for more than a year. The important role of research during disease outbreaks and pandemics in particular cannot be overemphasised (Wright et al., 2020). However, the COVID-19 pandemic altered the daily life to the extent that research had to be conducted within the confines of COVID-19 safety protocols. Ethical standards such as informed consent, non-maleficence (do no harm), respect for anonymity and confidentiality, transparency, security, and respect for privacy; underpin the conduct of any research. The above assertion is premised on the assumption of conducting research during ‘normal times. However, in times of a global pandemic such as COVID-19, crucial ethical issues, conflicting values, and lack of clarity on ethical standards, among others, are raised and may consequently affect the outcome of any research. Fortunately, in 2016, the WHO provided authoritative guidance on conducting ethical research during emergencies. This action resulted from experiences dealing with the severe acute respiratory syndrome (SARS) outbreak, the 2009-2010 H1N1 influenza pandemic, and the Ebola Epidemic between 2014 and 2016. The Nuffield Council on Bioethics also developed a set of recommendations on how research should be conducted during global health emergencies (Wright et al., 2020). However, there is paucity of data on how various research institutions and RECs are navigating the complexities involved in the conduct and review of research involving human participants during the COVID-19 pandemic. University of Ghana http://ugspace.ug.edu.gh 6 In Ghana, ethical standards that all researchers must follow in the conduct of research during a public health emergency such as COVID-19 were limited at the beginning of the pandemic. Each of the RECs designed separate ethical standards that govern the conduct of research under COVID-19 restrictions rather than a common ethical standard for all RECs in Ghana. Anecdotal reports have suggested that researchers have encountered serious challenges, particularly in recruiting participants in the context of the COVID-19 restrictions. There is a need to design and implement specific national ethical policies to guide Ghanaian researchers to guarantee privacy, transparency, confidentiality, anonymity, and security. Moreover, national and institutional requirements for conducting research under COVID-19 are not readily available, whereas the processes and steps governing informed consent, protection of participants’ safety, and the associated challenges of conducting research under COVID-19 restrictions have not been standardized in Ghana. Given the abovementioned problem, this study aimed to assess the ethical standards for research with human participants during the COVID-19 pandemic in Ghana and to identify key recommendations that can inform the review and implementation of research in future pandemics. 1.4 Research Questions The research questions to be addressed in this study are as follows: 1. What are the current policies and requirements for conducting research during the COVID-19 pandemic in Ghana? 2. How do researchers obtain informed consent under COVID-19 restrictions? 3. What steps do researchers take to ensure the safety of study participants during the pandemic? 4. What are the challenges of conducting research under COVID-19 restrictions? University of Ghana http://ugspace.ug.edu.gh 7 1.5 General and Specific Objectives 1.5.1 General Objective The main objective was to examine the perspectives of researchers and members of research ethics committees on the ethical standards for conducting research during the COVID-19 pandemic in Ghana. 1.5.2 Specific Objectives The study addressed the following specific objectives: 1. To examine the ethics review processes for research before and during the outbreak of the COVID-19 pandemic in Ghana. 2. To examine informed consent processes in research during the COVID-19 pandemic. 3. To examine the steps taken by researchers to protect participants’ safety during research. 4. To explore the perspectives of researchers and members of research ethics committees on the challenges of conducting research under COVID-19 restrictions. 1.6 Justification of the study Research is conducted to generate new information to inform policies and practices. This means that any research outcomes should contribute to the existing stock of knowledge. Hence, RECs, researchers, research participants, and the Ghanaian public stand to benefit from the outcomes of this study. Specifically, the outcome of this study will clarify the ethical issues governing research in Ghana under the COVID-19 restrictions. Furthermore, all the crucial ethical issues and conflicting values raised will be addressed by the suggested recommendations of this study. Also, the study's outcome will reliably inform researchers about reallocating research resources, participants, facilities, and equipment. University of Ghana http://ugspace.ug.edu.gh 8 In academia, a study's findings will become a source of reference for future studies. Consequently, the study's outcome would contribute to the body of knowledge in the area of Ghanaian ethical standards for any research conducted during a pandemic such as COVID- 19. Lastly, this study will contribute to the literature on ethical standards and RECs' formation, composition, and responsibilities and the measures that should be put in place to facilitate the ethical conduct of research during pandemics. 1.7 Outline of the Thesis The study is organized into six chapters as follows. Chapter One presents an overview of the study and provides a background to the general area of research. In addition, the statement of the research problem, research aims, and objectives, together with research questions, have been clearly stated in this chapter. Chapter One also highlights the significance of conducting the research, the research scope, and the research report's structure. Chapter two focused on a review of relevant literature which captures the written contributions, discussions, analyses, and findings in the research area regarding ethical standards and RECs. This chapter has therefore presented summaries of the existing theoretical and empirical literature on ethical standards related to the formation, composition, and procedures of RECs. Chapter three presents the study's methodology, highlighting areas such as the research design, approach, and setting; target population and sampling technique; sources of data, collection, and analysis. Chapter Four presents the key findings of the research. Appropriately, tables and graphs were used to organize the work coherently. Chapter 5 discusses the key findings of relevant literature. Finally, chapter six presents the research's summary, conclusions, and recommendations. University of Ghana http://ugspace.ug.edu.gh 9 1.8 Summary of Introduction The preceding chapter has set the stage for the commencement of the study, following the specification of the aim, objectives, and research questions. Additional guidance regarding the research scope and structure of the thesis have been clearly defined. It is now certain that the outcome of this study has played a significant role in setting the record straight regarding the ethical standards required for conducting research during the COVID-19 pandemic or any emergencies in Ghana. University of Ghana http://ugspace.ug.edu.gh 10 CHAPTER TWO LITERATURE REVIEW 2.1 Introduction This chapter presents a review of literature relating to ethical standards for conducting research during the COVID-19 pandemic. The chapter is therefore organized under the thematic areas as follows: global ethical standards for conducting research during the COVID-19 pandemic, informed consent processes in research during COVID-19, steps taken by researchers to protect participants’ safety during research, research challenges under COVID-19 restrictions, an overview of research ethics committees in Ghana, and current requirements for conducting research under COVID-19 pandemic in Ghana. 2.2 A Historical Perspective of the Emergence of IRB/RECs Institutional Review Boards (IRBs), also known as Research Ethics Committees in some countries, have a history shaped by several landmark events and ethical controversies which led to the development of IRB Regulations in the 1960s and 1970s, when countries started implementing regulations and guidelines for the protection of human research subjects. In the United States, the National Research Act (1974) led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, which produced the Belmont Report. This report laid the groundwork for the establishment of IRBs as the key oversight bodies for human subjects’ research (Cassell, 2000). The Belmont Report, the Tuskegee Study, and the Helsinki Declaration are all significant trials that have had a profound impact on the field of medical ethics and research practices which are the fundamentals for the emergence of Institutional Review Boards (Buxtun et al., University of Ghana http://ugspace.ug.edu.gh 11 1972; “The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,” 1979; World Medical Association, 2013). The Tuskegee Syphilis Study was a notorious case of unethical research that occurred from 1932 to 1972. It involved the mistreatment and exploitation of African American men who were not informed about the nature of the study or given appropriate treatment for syphilis. The Tuskegee Study exposed the grave violations of ethical principles and human rights in research. Therefore, in the late 1960s, concerns regarding the ethical treatment of human subjects in research led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the United States. The Tuskegee Study played a significant role in raising awareness about the mistreatment of human subjects and highlighting the need for ethical guidelines. It was one of the key events that contributed to the formation of the National Commission and the subsequent development of the Belmont Report giving way to a commission that was tasked with addressing ethical issues in research and produced the Belmont Report in 1979. The Belmont Report set forth fundamental ethical principles for the protection of human subjects involved in research: respect for persons (autonomy and informed consent), beneficence (maximizing benefits and minimizing harm), and justice (fairness in the selection of research subjects). The Belmont Report, in turn, served as a crucial document that consolidated ethical principles and provided a framework for the protection of human subjects in research. It has influenced research regulations and guidelines not only in the United States but also internationally. The Helsinki Declaration, issued by the World Medical Association in 1964, provides ethical guidelines for medical research involving human subjects. It outlines principles such as informed consent, protection of vulnerable populations, and ethical review by independent University of Ghana http://ugspace.ug.edu.gh 12 committees. The declaration has been revised multiple times, with the most recent version being the Helsinki Declaration of 2013. The Helsinki Declaration, although distinct from the Belmont Report, shares a common goal of ensuring the ethical conduct of research involving human subjects. It has provided an important international framework for ethical guidelines and has been influenced by similar historical events and concerns regarding the mistreatment of human subjects. These reports have their unique context and significance in the emergence of the formation of IRBs. They are interconnected in their mission to safeguard the rights and well-being of human subjects in research and to promote ethical standards in medical research practices (Stark, 2019). Overall, the history of IRBs reflects a growing recognition of the importance of protecting human subjects in research and ensuring ethical conduct. They have evolved as essential entities to review and oversee research, aiming to safeguard participant rights, minimize harm, and uphold ethical principles in scientific investigations (Arunachalam et al., 2021). According to international guidelines, IRB/RECs must receive all research proposals involving human participants from researchers and review them accordingly based on the required standards and principles. Further, IRB/RECs must be self-governing without associating with the research team, and they must also not benefit financially from any research outcomes to warrant compromises. However, IRB/RECs may receive funding for protocol review activities but not to coerce protocol authorization, approval, or clearance decisions. Based on records of protocol decisions kept in archives, IRB/RECs must conduct additional reviews to monitor the progress of the studies whose protocols have been approved in the past. Also, IRB/RECs must safeguard participants in a way that will guarantee that both participants and participants do not waste their valuable time and resources on unproductive research activities (CIOMS, 2002). University of Ghana http://ugspace.ug.edu.gh 13 IRB/RECs are required to select people with the requisite qualification, knowledge, and experience to deliver a comprehensive and adequate review of submitted research proposals and protocols. Individuals with qualifications and experiences in the physical sciences, social sciences, and religion, among others, are often recommended. This selection would ensure a wide range of expertise on the committee to evaluate research risks (CIOMS, 2002). Additionally, IRB/RECs must design processes to review emergencies and normal protocols. Hence, there should be expedited or unscheduled review processes and normal or scheduled review processes. The choice of which review process to use must depend on the urgency and need of the protocol (Arunachalam et al., 2021). Fundamentally, IRB/RECs are responsible for ensuring that protocols are reviewed based on competence and in an independent process. Further, IRB/RECs are expected to protect the well-being and rights of human participants involved in any research. Also, they review and oversee that all research meets the national and international ethical principles and the appropriate regulations and guidelines relating to human participant protection. Accordingly, IRB/RECs must, per the ethical principles in their guidelines, issue ethical review statements on the ethics of research plans and other associated research risks upon the request of researchers (TENK, 2019). 2.2.1 Global Ethical Standards for Conducting Research during the COVID-19 Pandemic For several decades, researchers have gained much experience dealing with infectious diseases such as HIV, SARS, H1N1, Nipah, Ebola, and others. During this period, emergency research and ethics had to be planned, research guidance had to be provided, and individuals’ rights had to be treated ethically (Kumar and Muthuswamy, 2020). Notwithstanding, the COVID-19 pandemic has shepherded a new global stage, requiring comprehensive ethical University of Ghana http://ugspace.ug.edu.gh 14 standards in research. It is because the outcomes of such research would affect policy- making, ethical investigations, and even how current and future research should be designed (Palacios and Shah, 2019). Therefore, it is not surprising to see several proposals for ethical standards from individuals and organizations in the academic and research space. To identify the ethical considerations that should guide decision-making in research during global health emergencies, the UK's Nuffield Council on Bioethics Working Group developed a number of key recommendations. These included the need for “more inclusive approach to influencing research agenda and priorities; more inclusive approach to study design and review; Consent – and the wider ‘ethics ecosystem’; equitable collaborations and partnerships; respectful and equitable sharing of data and samples and better support for front-line workers (researchers)” (Nuffield Council Report, 2020). Given the complexities of conducting research with human participants during the COVID-19 pandemic, several research institutions and organisations also developed specific guidelines and recommendations. For example, the Research Ethics Committee of the International Institute for Environment and Development Studies (IIED) came out with a COVID-19 Research Ethics Supplement in May 2020 to guide project managers and researchers as they attempt to mitigate COVID-19-related ethical issues. The supplement was also a policy response to the pandemic and was intended to ensure the responsible conduct of research while protecting the safety, health, dignity, privacy, and rights of research participants (Dodman, 2020). According to the IIED, all IIED-managed research projects undertaken by IIED staff and partner organizations could be continued after careful considerations have been made based on support and advice from IIED. Hence, all proposed changes in methods, designs, objectives, scope, and timelines, among many others, must be assessed and approved by all University of Ghana http://ugspace.ug.edu.gh 15 stakeholders (IIED Staff, partners, participants, and funders). Similarly, an outline of a feasible action plan for all research projects must be assessed. Partners undertaking research projects overseas are also advised to follow the local guidance on COVID-19 (i.e., restrictions on face-to-face interactions and movement) to lessen undesirable or unwarranted risks (Dodman, 2020). In general, the COVID -19 Research Ethics Supplement offers two options to IIED staff and partner organizations conducting research under COVID-19 restrictions which are outlined in the Table 1 below: Table 1: Ethical Guidelines for Conducting Research under COVID-19 Restrictions 1. Ethical Standards for Digital Research • Secure online data collection to prevent digital exclusion resulting from limited access to communications methods (phones and internet data). This data collection scheme could lead to bias in research findings. • Update recruitment documents to reflect online methods more readily and inform your participants about the new updates. • Perform remote data collection via telephone, Microsoft Teams, Skype, Zoom, WhatsApp, or Google Hangouts. Whichever platform is deployed must ensure data security and conform to data protection guidance. • Determine if your digital research would be a financial cost to participants and allocate appropriate resources from project funds to support them. • Use secure methods to collect appropriate data that is regulated by data-protection laws. 2. Modify Data Collection Procedures • Use discretion, responsibility, and common sense to interpret whether adjustments to data-gathering plans and activities would significantly result in deviation from the methods initially planned, the original project itself, or the potential findings. • Consider the exact impact of these modifications on the participants' dignity, welfare, and rights, and act accordingly. • You may decide to postpone or cancel data collection involving group gatherings as determined by local regulations or advice. • During face-to-face data collection, vulnerable groups must be pre-assessed to ensure that suitable physical distance University of Ghana http://ugspace.ug.edu.gh 16 between research participants and the researcher is maintained – to comply with mitigation measures. • Protective equipment (e.g., masks, face shields, gloves, among others) must be used by both research participants and researchers. A study by Barroga and Matangguilan (2020), investigating global ethical standards for conducting research during the COVID-19 pandemic, found essential alterations in ethics, peer review, and research, which have set the stage for the development of new, profitable, and extremely flexible research models. Accordingly, they proposed eight (8) ethical standards developed out of interinstitutional and interprofessional collaboration to guarantee the highest data collection and research reporting standards in both the short and long term. 1. Reframe the Research Design – The imposition of COVID-19 restrictions such as partial or total lockdowns by countries across the globe has necessitated the need for researchers to reframe their research objectives, questions, and hypotheses. They must also reexamine their modes of conducting research and reevaluate partnerships to effectively contribute to knowledge production during the COVID-19 pandemic. 2. Adapt Methodologies to Study Type - The pandemic has resulted in new research realities, such as restrictions on the conduct of quantitative and qualitative. For this reason, innovative but ethical research methodologies have been adapted and initiated. For example, mobile methods for capturing social life and interactions, online interviews and focus groups, questionnaire diaries for obtaining reflections, photo/video/voice data collection using smartphones, and video work documentation; are some of the innovative research methods that have been adopted for qualitative research. Similarly, online and phone surveys deploying paid or free online survey tools have been used for quantitative research. The additional quantitative research method adopted under COVID-19 restriction includes but is not limited to content University of Ghana http://ugspace.ug.edu.gh 17 analysis, social media analysis, spatial analysis, text mining, and digitization of traditional research methods. 3. Transition Research Mechanics - The COVID-19 restriction has overturned the traditional mechanism for conducting research. Hence, researchers must transition to the online mechanism through methodological revisions. The following online resources have become very handy to researchers and are helping researchers to formulate creative virtual research plans: Skype, Zoom, Google Meet, Microsoft Teams, Cisco WebEx, Moodle, Facebook, Telegram, Yammer, Google Classroom, WhatsApp, and WebEx. 4. Change Research Methodologies - COVID-19 has had dire consequences on participatory and operational research to the extent that changes in research methodologies are required. For example, budget and study time could be reduced, participation could be promoted, generalizability may be strengthened, and publication could be accelerated. Changes required in data collection could include using social media data, reviewing repository data, and virtual interviews. Similarly, evidence gap maps could be developed, network-based online referral strategies can be deployed, whereas electronic tools such as video chat platforms for telehealth, remote focus group platforms, and web forms for screening and enrolment could be relied upon by researchers besides leveraging on the expertise of a local consultant. 5. Overcome Data Collection and Standardization Constraints - COVID-19 protocols such as social distancing and quarantines have created data collection constraints in the form of limited direct interactions. Hence, researchers have had to resort to using online and remote tools to collect empirical data. For example, researchers have tried to overcome data collection constraints by relying on remote research and online University of Ghana http://ugspace.ug.edu.gh 18 interactions to mitigate constraints and shift priorities in research capacity and resources. 6. Uphold Research Standards and Ethics - Irrespective of the impact of COVID-19 on research and the numerous changes and shifts that have been proposed, the highest ethical standards must be maintained to lessen apprehensions about research quality brought about by changes in research designs and methodologies. It means that whatever changes are required should not be achieved at the expense of employing unvalidated substitute endpoints, using partial evidence, altering research organization and design, using smaller sample sizes, and disregarding randomization. 7. Maintain Informativeness and Social Value – There is no need for researchers to hastily produce research based on insufficient confirmed results due to time constraints and COVID-19 restrictions. Hence, any research outcome must be thoroughly verified, meet published ethical standards, and be peer-reviewed. 8. Provide Secured Peer Review Flexibility - Open access journals must embrace a more adaptable approach to the peer review process due to COVID-19-related constraints. This approach would enable researchers to respond timely to additional experiments or components required by the peer-review process. However, introducing a flexible peer review process does not mean that the reliability of peer review and ethical standards should be compromised. Kim and Grady (2020) also observed that the most difficult challenge confronting clinical researchers was how to distribute scarce resources fairly. Hence, they explored ethical standards that have remained the same and those that have changed (Kim and Grady, 2020). The authors indicated that central ethical standards for conducting clinical research had remained the same despite COVID-19 restrictions. These include, but are not limited to: University of Ghana http://ugspace.ug.edu.gh 19 • Respect for patient's wishes regarding their medical treatment (autonomy) • Patients’ wishes for end-of-life medical decisions are captured in the advance directives. • Patients’ wishes regarding end-of-life treatments are captured by the ‘values and wishes’ section. • Discrimination and stigmatization against patients are not permissible. With regards to ethical standards that have changed under COVID-19 restrictions, Kim and Grady (2020) also expressed the view that the following have resulted from the COVID-19 restrictions even though they are not universally accepted: • Guidelines must endorse the priority of short-term survival. • A long-term prognosis is permissible. • Scarce resources should be used for ‘the greater good. • Priority should be given to the young rather than the old • Research frameworks must be designed after the public has been engaged and must reflect their views. Yeoh and Shah (2021) also observed that the global clinical research community is experiencing ethical challenges due to the COVID-19 pandemic. To circumvent overlapping protocols, RECs were required to prioritize new study submissions and modify ongoing research activities while maintaining the existing ethical standards and international research guidance. The authors suggested ethical standards guide researchers during the COVID-19 pandemic for this and other reasons. They based their suggestions on the pre-COVID-19 ethical standards for research, such as the principles of, justice, beneficence, utility, respect for persons, liberty, reciprocity, and solidarity. In the view of Yeoh and Shah (2021), all University of Ghana http://ugspace.ug.edu.gh 20 clinical research conducted after the outbreak of COVID-19 must abide by the following revised research ethics: 1. RECs must expedite the reviewing of new research works without compromising the quality. • Fair consent and the safety of study participants must be maintained while ensuring the methodology's validity so that it answers the scientific question. • Good publishing practice must be emphasized by scrutinizing the publication strategy. • The benefit of expediting knowledge of study results in a rapidly developing pandemic must be balanced with the need for data transparency and peer review. 2. RECs must assess research methodologies within the context of possible scarce clinical resources such as hospital capacity, protective equipment, and staff. 3. RECs must evaluate COVID-19-related research on the same terms as research into other medical conditions. However, research into COVID-19 should be prioritized due to its clinical urgency at this abnormal time. 4. RECs must review and reassess all research works that had already been planned and were ongoing. They must base their reviews and reassessments on the related risks of the research to study participants (i.e., impact on severely ill patients before any approvals). According to Hashem et al. (2020), researchers have an ethical obligation to continue their research even when implementing COVID-19 restrictions such as stay-at-home measures, quarantines, and travel bans. This means that clinical researchers must adhere to and abide by the pre-COVID-19 ethical standards (e.g., informed consent, committee approvals, external monitoring and audits, shipping trial products, and efficiency, among others). Additionally, researchers must deploy virtual visits, and remote monitoring was necessary to reduce the University of Ghana http://ugspace.ug.edu.gh 21 risk of transmission of infection for both participants and research staff (Hashem et al., 2020). Accordingly, Kim and Grady (2020) expressed that the same core ethical standards must oversee research on human subjects regardless of COVID-19 restrictions. Any clinical research conducted within the period must obtain informed consent, ensure efficient use of resources, minimize harm, and the like (Kim and Grady, 2020). On efficient use of resources (fair allocation of scarce resources) during COVID-19 restrictions, Emanuel et al. (2020) specifically recommend four guiding principles based on the utilitarian approach of maximizing benefits as follows: • The total benefits produced by scarce resources in any research must be maximized. • Researchers must treat equivalent cases equally. • Instrumental value (benefit to others) must be promoted and rewarded. • Priority must be given to the worst off. Having realized that researchers could provide useful facts, information, and insight to help understand, manage, and control COVID-19, Tindana et al. (2020) discussed the role of community engagement in research during the COVID-19 pandemic. The authors found that the traditional community engagement approaches have been challenged by COVID-19 response strategies such as social distancing; and that the new ways of engaging communities in research are done using web-based platforms (e.g., Zoom, Skype, MS Teams, WebEx and Google HangOut), phone-based platforms (e.g., WhatsApp), telephoning and mass media (e.g., radio, tv, newspapers, mobile information vans and televisions), among others. Jowett (2020) also proposed that in conducting qualitative research under COVID-19 restrictions, researchers must resort to online data collection techniques or existing textual data rather than face-to-face interviews, focus groups, and fieldwork. Similarly, video-calling (e.g., Skype/Zoom) and text-based instant messaging (e.g., WhatsApp) could be used to replicate the face-to-face interview or focus group. This approach would ensure that the well- University of Ghana http://ugspace.ug.edu.gh 22 being of participants and researchers is prioritized over research timelines (Jowett, 2020). We have seen from the above that the traditional ethical standards for conducting clinical and social research under COVID-19 restrictions have changed slightly. Some institutions have proposed changes in research design and methodologies (i.e., revisions in data collection procedures and tools, guidelines, research frameworks, participants’ engagement, remote research, and the like). Other institutions have also recommended that research outcomes procedures be altered (i.e., publishing practice, research quality, the peer review process, and research reporting, among others). Nevertheless, some institutions have strongly advocated reviewing and reassessing research logistics (time, funds allocation, and knowledge distribution, for example). However, the above review has shown that all modifications regarding ethical standards for conducting research during the COVID-19 pandemic must be made based on informed consent, committee approvals, benevolence, efficiency, and fairness, among others. 2.2.2 Informed Consent Processes in Research during COVID-19 COVID-19 restrictions such as social distancing and lockdowns affected how researchers deployed the normal and established consent-seeking process. These restrictions necessitated revising ethical standards guidelines with alternative informed consent processes to help researchers interact with research participants under COVID-19 restrictions. However, there was a need to ensure that the processes of informed consent during normal times align with informed consent processes under the restrictions of COVID-19. When a well-informed individual, acting without compulsion or excessive enticement, willingly approves of a course of action based on adequate and applicable information, it is known as informed consent (WHO, 2020). However, in research, informed consent is a written or verbal agreement by a participant to participate and comply voluntarily in research regardless of the risks or the absence of benefits (Pickering, 2021). It means that the University of Ghana http://ugspace.ug.edu.gh 23 processes, risks, and benefits of informed consent must be clarified and agreed upon by both the researcher and the participant. Informed consent becomes a process when the researcher follows a formalized procedure to educate and recruit participants for either clinical or social research. When this process is followed, participants are accorded respect, the right of willingness, and the decision right of participation to guarantee an impartial research outcome (Pickering, 2021). According to Hoverd et al. (2021), the informed consent process aims to offer prospective participants information to make an informed decision regarding their participation in impending research. Accordingly, informed consent is a very important ethical standard that must be applied in any research because it is the basis of protection for both researchers and participants; relying on elements such as voluntariness, awareness, and information (Nembaware et al., 2020). De Vries et al. (2020) cautioned, however, that the urgency with which a research outcome is required under COVID-19 restrictions does not warrant a relaxation in the principles underpinning the informed consent processes. Similarly, the Nuffield Council on Bioethics Working Group on Research in Global Health Emergencies: Ethical Issues also highlighted the central role of culturally appropriate and respectful consent processes in research during global health emergencies. They however cautioned that consent alone is never the only requirement for research to be ethically acceptable and recommended that other parts of the ‘ethics ecosystem’ should include responsibilities of researchers and ethics committees and inclusive and collaborative engagement with communities (Wright et al., 2020). To guarantee high-quality research during the COVID-19 pandemic, Health Canada provides guidance notes and regulatory requirements for informed consent in clinical research as follows (Hashem et al., 2020): University of Ghana http://ugspace.ug.edu.gh 24 • The researcher must obtain written informed consent from participants, with specifics on the anticipated risks, benefits, and other relevant information required to enhance the participant’s decision to participate in the research. • The anticipated benefits must balance the risks and inconveniences when participating in the research. Also, participants’ health, safety, and well-being should outweigh any professional and academic research interests. • A participant must, either in person or remotely, go through the processes captured on the informed concern form before he/she is allowed to be involved in any aspect of the research procedure. • All of the participant’s questions about his/her participation in the research must be answered by the researcher. • Participants must be provided with both original and amended applicable informed consent laws approved by the Research Ethics Board (REB). Furthermore, Hashem et al. (2020) specify an informed consent process for researchers who are conducting COVID-19 clinical experiments as follows: 1. All informed-consent-process changes must be documented and maintained in the research site file. The documentation should be labelled as COVID-19 Clinical Experiments with dates, signatures, and approvals, among other factors. 2. All informed consent processes should comply with the regulations of the International Council for Harmonization and Health Canada as approved by the REB. 3. Substitute wrote informed consent with electronic methods, as the former would lead to contamination. The electronic system should be detailed and comprehensive; the processes should be validated appropriately, whereas the electronic consent version must have the capacity to keep records for 25 years. Obtain the informed consent orally by phone or videoconference in the presence of an independent witness, and University of Ghana http://ugspace.ug.edu.gh 25 document the process accordingly. Electronic consent could also be obtained from participants through the mail after it has been witnessed, reviewed, and authorized. A participant can withdraw his/her consent without written notification, but it must be documented by the researcher and captured by the investigative site file. 4. Standard Operating Procedure – SOP (step-by-step instruction) compiled by the researcher must be available for obtaining informed consent. The SOP must capture the following information: effective date, author, originality, and other related procedures. 5. The researcher must train workers at the site of the clinical experiment on the SOP compliance and documentation of the training manuals to ensure that the informed consent process has been satisfied. 6. Any new information resulting from the changing COVID-19 environment should be explained to participants (or their legitimate representatives) immediately after it becomes available. It would erase any doubt concerning the impact of the clinical experiments on participants’ health. 7. Researchers must prove that participants understand the informed consent process and the related documents. 8. The formation of IRBs was a direct response to the ethical violations witnessed in the Tuskegee Study (1964) and the Belmont Report (1979) which are the foundations of contemporary IRBs. Researchers must conform to all existing and applicable regulatory requirements, besides the already established ethical principles, particularly those that originate from the Helsinki Declaration. 9. In an emergency case where informed consent cannot be obtained, the participant’s legitimate representative must be informed about the clinical experiments immediately for he/she to consent to the research appropriately. Also, when previous University of Ghana http://ugspace.ug.edu.gh 26 informed consent cannot be obtained, the researcher must seek approval from the REB and document it accordingly. This way, the participants' well-being, safety, and rights would be protected, whereas compliance with appropriate regulatory requirements would be guaranteed. Given the challenges in obtaining informed consent from research participants, de Vries et al. (2020) suggest that researchers may also require remote telephonic or electronic proxy consent from the participants’ next of kin. In this regard, the authors proposed a simplified informed consent process under COVID-19 restrictions as follows: 1. Ascertain if the prospective participant can provide valid informed consent. 2. Determine the participant’s legitimate representative (next of kin) as an alternative source. 3. Select the appropriate mode (e.g., telephonic, electronic) of capturing the informed consent without putting workers and materials at risk of contamination. 4. Obtain informed consent from participants or their legitimate representative (next of kin). 5. Obtain delayed informed consent from participants who recovered from their ailments during the research. 6. Obtain a possible waiver of informed consent from the REC if the participant dies and for the continuous use of the deceased participant’s information for research. Therefore, the COVID-19 pandemic has warranted the review and revision of the existing informed consent processes, which are of the greatest importance to help protect prospective research participants and researchers from contamination during research. It is imperative, therefore, for researchers to be responsive to the changing environmental conditions to revise informed consent processes in a manner that can help them obtain genuine informed consent for all research carried out under COVID-19 restrictions. However, in doing so, researchers University of Ghana http://ugspace.ug.edu.gh 27 must ensure that their revised processes are detailed, documented, and conform to existing regulatory requirements. 2.2.3 Steps Taken by Researchers to Protect Participants’ Safety During Research Well-informed individuals who willingly agree to participate in research are known as participants. These individuals interact with researchers during research surveys, focus group discussions, in-depth interviews, and observations. However, there is no guarantee that participants’ rights, safety, and well-being will be protected during the research. This is because participants can be psychologically, financially, and sociologically harmed during their interaction with professional or academic researchers (Liamputtong, 2006). Hence, researchers must determine the type of harm their intended research may cause participants regardless of their good intentions. They should specifically consider their research's negative impact on participants, how they would protect themselves, and how their institutions and supervisors can be protected against a lawsuit and public condemnation. Therefore, it is not a coincidence that over the years, public and private institutions and countries across the globe have designed regulations, laws, and policies to ensure that participants, researchers, and supervisors receive the same high level of protection. These regulations, laws, and policies have been harmonized into steps or guidelines to be followed by researchers to guarantee participants’ safety during the research (Organization, 2011). Before the outbreak of the COVID-19 pandemic, individuals and institution researchers relied on ethical principles to protect participants during the conduct of social research. Specific ethical principles such as the right to autonomy, privacy, and confidentiality were applied to protect research participants from all forms of potential damage while intensifying the practical benefit of their research to the participants and the general public (Association, 1964; Beauchamp, 2008; Žydžiūnaitė, 2018). According to the author, the informed consent process allowed researchers to provide full disclosure to potential participants, explaining the University of Ghana http://ugspace.ug.edu.gh 28 benefits, dangers, possibilities, and the opportunity to ask further questions before committing themselves to research. Some RECs in some countries have designed ways of protecting research participants. For example, in 2006, the National Committees for Research Ethics in Norway (2006) and Israel and Hay (2006) presented revised guidelines for research ethics in the social sciences, law, and humanities. The guidelines ‘Respect for Individuals’ section provided details on the steps researchers can take to protect participants’ safety during research. The following are the steps that apply to individuals and institution researchers, in addition to other entities that exercise control over research and research outcomes in Norway: 1. Researchers must select topics that show respect for human dignity, whereas their research processes must also protect research participants in the areas of; confidentiality, relationships, and autonomy. 2. For research in an institution, researchers must respect participants’ integrity, anonymity, independence, and right to participate. It would ensure that nothing happens to them or their lives. 3. Researchers must not expose their research participants to harm and suffering and must weigh the risk of causing harm and suffering to participants against the benefits of the research outcome. They should subsequently give participants the chance to manage difficulties that may arise due to their participation in the research. 4. Researchers must explicitly provide participants with general information about the research, such as research purpose, approaches, risks of participation, funding sources, and the like. This way, participants would be reliably informed about the scope of the intended research, the benefits, and the risks of participating in it. University of Ghana http://ugspace.ug.edu.gh 29 5. Researchers must acquire free and informed consent from participants to guarantee them the right to withdraw from participating in the research when so desired, without necessarily resulting in negative penalties. 6. For research involving children and youth, the research's approaches, systems, design, and objectives must be adopted by the researcher to protect children’s rights of respect, dignity, and privacy, among others. Accordingly, researchers must obtain parental consent for participants aged 15 and below; however, their consent is required when young participants become old enough to express an opinion. 7. Researchers must respect participants’ close relationships and privacy to protect them against unsolicited meddling and exposure to third parties. 8. Researchers must respect participants’ confidentiality, particularly concerning the usage and circulation of information provided by participants about their private lives that could harm them. 9. Researchers must responsibly store data that could be traced to participants. Such data (e.g., field notes, lists of names, interview guide) should be stored distinctly and manually for a limited time and then expunged once it has served its original purpose. 10. Researchers must respect participants’ values and motives irrespective of public opinion concerning a subject matter. Unreasonable or undeserving motives should only be ascribed by researchers to participants with evidence and convincing arguments. Vanclay et al. (2013) conducted a study to identify existing ethical research principles involving humans from an ethical professional practice standpoint. The authors found that in addition to the above, four additional steps could be taken by researchers to protect participants’ safety during research as follows: University of Ghana http://ugspace.ug.edu.gh 30 1. Researchers are obligated to provide participants with the right to check and modify transcripts, and this would ensure that they are not misquoted in draft publications, reports, and records; and that they agree with how the information provided has been recorded. 2. Participants must be informed of the sources of funding for the research so they can make informed decisions regarding their participation or otherwise in current and future research. 3. Researchers must follow a system of ethical governance instituted by RECs to guarantee the proper functioning of ethical procedures. Accordingly, RECs must; appraise research protocols before the commencement of the research, monitor research activities, advise researchers and participants, and decide on research-related complaints. 4. Researchers must provide participants with a grievance procedure and an option for corrective action. This grievance procedure must be fair and appropriately disclosed to participants. Meanwhile, it is believed that the outbreak of the COVID-19 pandemic may have led to a revision of the above steps intended to protect research participants from contracting the disease. Having been confronted with increased practical and ethical issues regarding research during the COVID-19 pandemic, the British Psychological Society Ethics Committee created a Code of Human Research Ethics highlighting four main ethical principles. First of all, it is required for researchers to respect the independence, confidentiality, and self- respect of participants. Where there is the need to adapt the research design, methods, and data-gathering techniques to online mediums, researchers are required to document and present the intended changes for evaluation. Also, informed consent must be renewed for participants who may withdraw from the research because of a change from face-to-face data University of Ghana http://ugspace.ug.edu.gh 31 collection to online. Secondly, researchers must ensure that their research works are planned, revised, and conducted to guarantee truthfulness and value while advancing knowledge and understanding. Moreover, when online research must replace face-to-face research, researchers must submit modification requests for ethics review and approval. Also, researchers must develop protocols for dealing with sensitive issues. Thirdly, researchers must ensure that the outcome of their research meets societal needs and respect social structures. Their research must also be of high social value, clarifying who the beneficiaries are. Researchers must desist from accelerating ethics review and institutional approval by branding all research as COVID-19-related. Lastly, researchers must maximize the benefit of their research while minimizing potential harm to participants. Risks greater than participants' exposure to in their ordinary lives must be avoided. For example, if research must be conducted in a practical environment such as a hospital or a school, the burden on participants, likely students, teachers, or medical staff, must be considered and reduced drastically (Wolf et al., 2008). Accordingly, Kraft et al. (2021) proposed new guidance for protecting research participants after interviewing researchers conducting clinical research. The author recommends that researchers must consider the steps to protect themselves and participants apart from adherence to the COVID-19 protocols such as disinfection, masking, and social and physical distancing. 1. Researchers must follow established advice on new protocols regarding local infection rates, labs and shared spaces disinfection, and protocol modification. 2. For protection purposes, researchers must reduce all risks associated with every stage of the research process. For example, if the meeting room for participants is small, a bigger and more expansive room should be sought to avoid congestion and allow for observing social and physical distancing protocols. University of Ghana http://ugspace.ug.edu.gh 32 3. Researchers must design and implement new protocols for greeting participants. For example, researchers may welcome participants by using fist bumps, hand waves to make a connection and verbal compliments. 4. Apart from the research setting risks, researchers must determine risks associated with transporting research participants and how to reduce exposure among participants who use public transportation, for example. 5. Researchers must deploy ICT tools and techniques to decrease the occupancy of research settings/sites. They could, for example, share Google calendars to reserve time slots to plan their schedules. 6. Researchers must amend consent forms where necessary and specify the potential risks along with measures that can be taken to protect participants. Researchers must also let participants know they can withdraw from the research whenever they desire. 7. Researchers must be creative and devise new designs, methods, and approaches to achieve their research objectives whilst protecting participants simultaneously. They could, for example, conduct Internet instead of face-to-face research. Likewise, researchers could use open spaces outside to test rather than in the laboratories. The above indicates that various RECs, research institutions, and individual researchers have collaboratively put in place measures to protect researchers, students, teachers, medical staff, and most importantly, research participants. The measures are in the form of steps designed out of ethical issues underpinning the conduct of research. In the above steps, ethical research principles such as confidentiality, respect, autonomy, informed consent, dignity, privacy, integrity, anonymity, independence, or right to participate; were captured and explained in detail to ensure that voluntary research participants are protected from possible undesirable consequences. It is important to note that the steps for protecting participants before and during the COVID-19 pandemic were the same except for some modifications made in University of Ghana http://ugspace.ug.edu.gh 33 research designs, methods, data-gathering techniques, informed consent processes, and the review and approval protocols for managing sensitive issues. Furthermore, there was a requirement for protocols such as masking, disinfection of labs and shared spaces, and social and physical distancing to be adhered to by research conducted during the pandemic. 2.3 Challenges with research implementation under COVID-19 Restrictions Research challenges are the complexities associated with the designs, methods, techniques, and processes of conducting clinical and social research to guarantee consistent findings (Žydžiūnaitė, 2018). For example, in the conduct of social research, there is an obligation on the part of the researcher to adhere to ethical issues such as; obtaining approval from RECs, equitably selecting research participants, obtaining informed consent from potential participants regarding the nature and purpose of the research, maximizing the benefits for and at the same time minimizing the risk of harm to the research participant, among others (Wiles et al., 2006). Concerning clinical research, issues such as participant recruitment, adapting to a dynamic research environment, and accountability to national and international RECs, regulatory bodies, and funders are challenges that must be dealt with by researchers (Campbell et al., 2007). In recent years, however, these research challenges have worsened due to the outbreak of the COVID-19 pandemic. Social researchers are needed to predict the pandemic's social, moral, and economic consequences, and clinical researchers must continue with their knowledge creation without harming themselves and the participants. There is also a vital requirement for clinical researchers to conduct new therapeutic and restraining research on COVID-19. Accordingly, RECs must speedily review specific ethical issues, completely unify the RECs' supervision system, and collaborate with other institutions to improve capacity and University of Ghana http://ugspace.ug.edu.gh 34 efficiency. So, we see that the following discussed challenges from conducting research during COVID-19 restrictions have been heightened. According to Tindana et al. (2020), one challenge confronting researchers under COVID-19 restrictions is in the area of engagement methods. The COVID-19 restriction protocol, such as social distancing, has necessitated a method that would enable researchers to prevent the transmission of the pandemic while engaging with research participants. So, a web-based platform (Zoom, Skype, or Microsoft Teams) could be used to engage participants rather than a face-to-face interview. However, this method may be affected by erratic and poor internet connection, data protection threats, difficulty in controlling private messages, potential misinformation, and a limited number of participants at any time (Tindana et al., 2020). Additionally, three challenges that confront researchers under COVID-19 restrictions have been identified by (Fegert et al., 2020): 1. Compliance with Paragraph 32 of the Declaration of Helsinki (2013). This declaration requires clinical researchers to obtain informed consent for data collection, storage, and re-usage. According to Fegert et al. (2020), it would not be possible or realistic to obtain informed consent from researchers who use recognizable human data or material confined in biobanks or comparable storehouses. Such clinical research cannot be completed unless RECs are considered and approved. 2. Complying with special considerations guidelines of research ethics during a pandemic. Fegert et al. (2020) note that the responsibilities of researchers, RECs, and front-line medical staff in carrying out daily diagnosis, treatment, and scientific research are enormous. Hence, the difficulty with which these individuals and institutions must balance scientific observation record keeping and informed notification with life-saving obligations; cannot be overemphasized. For example, RECs must thoroughly measure the risk/benefit ratio and obtain informed consent by University of Ghana http://ugspace.ug.edu.gh 35 comparing social interest, personal interest, and general ethical considerations. Similarly, the severe nature of COVID-19 has necessitated the urgent need for researchers to find therapy. However, the risks involved in conducting different research, such as Randomized Controlled Trials (RCTs), could be unbearable due to the intricacies of RCTs methods and procedural requirements. 3. Overcoming existing scientific research management laws and regulations gaps during COVID-19 emergencies. To control the COVID-19 pandemic, some governments have categorized it into classes of infectious diseases, with the highest class being the most infectious. Hence, state institutions, organizations, and agencies must adhere to governments’ directives in dealing with the pandemic. However, as captured in existing government laws, there must not be discrimination in clinical research and treatment during any pandemic. This situation puts researchers and medical institutions in a difficult position where they have to choose between improving the therapy capacity in line with diagnosis ethics and meeting the therapeutic obligation of the government’s public health authority (Fegert et al., 2020). Concerning obtaining informed consent from research participants under COVID-19 restrictions, Goldman and Gelinas (2021) identified three broad categories of challenges. 1. Researchers' Challenges – These challenges confront researchers due to the rapidly evolving: decisive risk factors for condensed outcomes and genetic aspects of disease and death, daily evidence, and new data on epidemiological spread and symptomatology. In the above situation, researchers find it difficult to evaluate the possible effect of other treatments, decide on the most promising mechanisms of action in drug classes, and confirm differences in drug interactions. Also, the COVID- 19 pandemic is new, with little or no background research, making it difficult for University of Ghana http://ugspace.ug.edu.gh 36 researchers to assess the impact of new procedures, devices, and experimental drugs on participants. Similarly, the inadequate COVID-19 research background makes it difficult for researchers to obtain informed consent due to non-estimated risks, the likelihood of occurrence, non-available details on risk mitigation measures, unforeseeable risks, or distress to participants (Goldman and Gelinas, 2021). 2. Patient/Participants Challenges – these are challenges resulting from patients/participants’ inability to understand robust and clear disclosures by researchers. When it happens this way, researchers and clinicians find it difficult to adhere to rules and regulations governing disclosures under COVID-19 restrictions. Further challenges are raised by participants’ reasoning and possibly defenceless statuses, which negatively cloud their decisions at the expense of researchers. Likewise, researchers and clinicians are confronted with time and systems constraints while looking for appropriate legally authorized representatives (LARs) for patients/participants who have been incapacitated by COVID-19. When these LARs cannot give consent on behalf of patients/participants on time, further strains are placed on researchers and clinicians (Goldman and Gelinas, 2021). 3. System Challenges – these are challenges that researchers encounter due to inadequate resources in the form of limited research personnel, tools, and equipment. These challenges are even aggravated when researchers have to serve as researchers and also assist with the research consent process. Similarly, unparalleled strains are placed on researchers and healthcare systems by the increasing number of COVID-19-infected patients/participants who require resource and time-intensive care. Moreover, the COVID-19 pandemic has created urgent conditions requiring timely treatments to save lives globally. It means that the usual timeframe for conducting clinical research has been condensed for all stakeholders (researchers, sponsors, funding agencies, RECs, University of Ghana http://ugspace.ug.edu.gh 37 and regulators) who are required to remove barriers to the commencement of clinical research and the enclosure of participants (Goldman and Gelinas, 2021). However, other challenges under COVID-19 restrictions have been identified by Byrom, (2020) to be affecting researchers. First of all, the ability of researchers to gather data, discuss research findings and insights with co-equals, and publish research discoveries; has been negatively affected by the lockdown. Secondly, their institutions have restrained researchers’ access to software and other electronic research platforms. Lastly, some researchers are stressed out due to uncertainty about their research contracts. Some researchers, particularly those whose research was disrupted by the COVID-19 pandemic, are unsure if their contracts would be extended with additional funding. Others are also worried about future research plans as there is no guarantee that funds will be available to support future research. The above indicates that the COVID-19 pandemic, with its associated restrictions, has severely impacted the works of researchers, RECs, participants, and sponsors. Some of these identified challenges are methodological and procedural, whereas others are in the area of complying with research ethics guidelines. Nevertheless, other challenges have risen out of the need to meet rapidly evolving daily evidence and the need to assess the impact of new procedures, devices, and experimental drugs on participants. The good thing, however, is that most of these research challenges originated from the need to prevent participants and researchers from contracting COVID-19. 2.4 Overview of Research Ethics Committees in Ghana There are eighteen (18) RECs, ERCs, IRBs, or REBs in Ghana (Boateng, 2019). Among them is the Ghana Health Service Ethical Review Committee (GHS-ERC). This national committee evaluates and authorizes all prospective research applications for health research University of Ghana http://ugspace.ug.edu.gh 38 in Ghana, predominantly prospective research conducted in GHS facilities and by GHS staff. The GHS-ERC is one of the units under the Research and Development Division (RDD) of the GHS and can be located within the Adabraka Polyclinic. The Standard Operating Procedures (SOP) of GHS-ERC was developed in 2015, and it outlines the tasks, structure, and executive strategies of the Committee. The SOP further describes the system and procedures underlining research review protocols, categories of reviews, and modification processes. Likewise, the methods for monitoring ongoing research are contained in the SOP, together with documentation and archiving procedures (Standard Operating Procedures for GHS-2015). The Navrongo Health Research Centre Institutional Review Board (NHRC IRB) is yet another REC. It was established to appraise, assess and approve research protocols involving data collection from persons and institutions in the Upper East, Upper West, Northern, North East, and Savannah regions. The NHRC IRB is located in Navrongo and is mandated to ensure and guarantee the safety, protection, dignity, and rights of all persons and groups participating in NHRC research events (NHRC, 2022). Another popular REC in Ghana is the Kintampo Health Research Centre Institutional Ethics Committee (KHRCIEC). As its name suggests, it is located in Kintampo in the Bono East Region and was established to appraise, assess and approve the ethical qualities of KHRCIEC research protocols. It is also mandated to improve research activities and to ensure the safety, protection, dignity, and rights of all persons and groups who participate in research activities, particularly within Western, Western North, Brong Ahafo, Bona East, Ahafo, Ashanti, Oti, and Volta Regions of Ghana (KHRCIEC, 2020). For all research works that require approval and data from persons, groups, and organizations within the Eastern, Central, and Greater Accra Regions, the Dodowa Health Research Centre University of Ghana http://ugspace.ug.edu.gh 39 Ethical Review Committee (DHRC ERC) has been established to appraise and approve research protocols based on the principles of welfare, safety, protection, and dignity of research participants; and the scientific integrity of all GHS-related research works (Canadian Coalition for Global Health-Research - CCGHR, 2021). Additionally, the Korle-Bu Teaching Hospital Institutional Review Board (KBTH-IRB) and Ethical and Protocol Review Committees (EPRC) were established with their respective Research Policy Guidelines and Procedures to guide researchers, students, and their supervisors, RECs, ERCs, IRBs, or REBs. According to the Hospital, one of its core mandates is to research to advance science and technology in the areas of new or improved products, services, and processes (drugs, vaccines or diagnostic tools, new surgical techniques, and treatment protocols). It means that all research conducted at KBTH or involving their staff must follow the KBTH’s Research Policy Guidelines, which have specific procedures for using data from patients’ medical records, observations and interviews, surveys, and clinical trials, among others. The KBTH-IRB and EPRC are located at the College of Health Sciences, Korle-Bu Accra (KBTH-IRB Research Policy Guidelines and Procedures, 2016; Boateng, 2019). Most tertiary institutions in Ghana have instituted their respective RECs, ERCs, IRBs, or REBs to guide their students, supervisors, internal and external research institutions, external consultants, and the like. The University of Ghana, with its internal research institutions such as the Office of Research Innovation and Development (ORID), Noguchi Memorial Institute for Medical Research (NMIMR), and Institute of Statistical, Social and Economic Research (ISSER); have set up and developed their RECs together with Research Policy Guidelines, capturing specific details on good practice, environmental health, and safety, meeting national development priorities, among others. Hence, the ORID and ISSER collaborated and University of Ghana http://ugspace.ug.edu.gh 40 established a university-wide REC to superintend and control the integrity of research conducted within the humanities disciplines at the University of Ghana. It is known as the University of Ghana, Ethics Committee for Humanities (UG-ECH), and is located within the College of Humanities, University of Ghana, Legon (Boateng, 2019). Similarly, the Kwame Nkrumah University of Science and Technology (KNUST), together with the Komfo Anokye Teaching Hospital (KATH), has set up and operationalized the Committee on Human Research, Publications, and Ethics; Humanities and Social Sciences Research Ethics Committee (HuSSREC); and Kumasi Centre for Collaborative Research Ethics Committee (KCCREC). These institutions’ Research Ethic Policies and Standard Operating Procedures (SOP) provide the basis for conducting clinical, humanities, and social sciences research at the KNUST and KATH. They also ensure that principal researchers, students, and supervisors are properly trained on research protocols and ethics (Obiri-Danso and Agyare, 2018). Consequently, the following universities and research institutions and many others in Ghana have their respective research guidelines, protocols, SOP to guide the conduct of clinical and social research: University of Cape Coast IRB (UCC-IRB); the University of Health and Allied Sciences Research Ethics Committee (UHAS-REC); University of Education Winneba’s University Research Ethics Committee (UREC); University of Development Studies Research Ethics Committee (UDS-REC); Ghana Atomic Energy Commission Ethical Review Committee (ERC), located within the Ghana Atomic Energy, Accra; Centre for Scientific and Industrial Research Institutional Review Board (CSIR IRB), located at Airport, Accra (Boateng, 2019). University of Ghana http://ugspace.ug.edu.gh 41 2.5 Current Requirements for Conducting Research under COVID-19 in Ghana The contribution of research to the growth of individuals, corporate entities, and countries cannot be overemphasized. Ordinarily, research is conducted to inform action and produce applicable knowledge. However, in times of health emergencies, such as the outbreak of the COVID-19 pandemic, methodologically vigorous clinical and social research is conducted to provide insightful knowledge about the pandemic, protect life, and create sustainable lifetime opportunities for individuals, organizations, and nations efficiently and effectively. For example, when suggestions were made that chlorhexidine or hydrogen peroxide could be used as mouthwashes to prevent transmission of the COVID-19 virus, with no significant proof, there were calls for urgent clinical trials and laboratory analyses to be conducted accordingly (Bonney et al., 2020). To succeed in this regard, appropriate research requirements must be designed and implemented to guarantee an actual and well-organized response to such pandemics. Therefore, it is not a coincidence that the government of Ghana responded to the COVID-19 pandemic with timely crafted targets to deal with the possible effects of the virus in Ghana. The government was clear and emphasized the need to reduce and prevent the importation of the virus; quell the transmission of the virus within the country; deliver sufficient care for the infected; reduce the negative effect of the virus in communities, on trade and industry; and encourage the growth of national capacity in dealing with future infectious diseases (Ogunleye et al., 2020). The above goals have become the basis for which the various RECs, may revise their research guidelines under COVID-19 in Ghana. However, before the outbreak of the COVID- 19 pandemic, the RECs in Ghana had developed and operationalized their distinct ethical University of Ghana http://ugspace.ug.edu.gh 42 policy documents to standardize research activities within their respective institutions and also to consistently enhance the sharing of research findings among local, state and global partners. In 2013, the Food and Drugs Authority (FDA) developed Guidelines for Good Clinical Practice in Ghana and updated them in 2019. As specified in part 8 of the Public Health Act 2012 (Act 851), the guidelines were developed to support the regulatory requirements of the FDA. Similarly, the Guidelines are a partial derivative of the International Ethical Guidelines for Biomedical Research on human subjects, designed by the following organizations: International Conference on Harmonization Good Clinical Practice (ICH GCP), Council for International Organizations of Medical Sciences (CIOMS), and World Health Organization (WHO). Also, the guidelines are intended to provide researchers in Ghana with clear standards and frameworks for good clinical practice. It would provide the expected public assurances and protect trial participants' rights, safety, and well-being. Hence, to guarantee a regulated and ethical approach to clinical research implementation in Ghana, all RECs, researchers, participants, and benefactors; are required to use the guidelines developed by the REC of FDA (Food and Drugs Authority, 2015). However, none of the state agencies/authorities, research institutions, universities, teaching hospitals, and their respective RECs, mentioned in the previous section have been able to design and implement guidelines and SOPs for conducting clinical and social research under COVID-19 in Ghana. The only current reference guidelines are those developed by the Ministry of Health (MOH) in June 2020. It is the closest guideline as far as the conduct of clinical research under COVID-19 restrictions in Ghana is concern