What is Research Ethics and integrity

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DrKateBesant,United States,Researcher
Published Date:07-07-2017
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1. General 1.1 Background Research involving human participants may have existed on Earth for several millen- nia, albeit the research may have been unscientific, uncoordinated, unmonitored, and largely unethical. Some of these experiments have survived the test of time and are still used wholly or in part, in modern healthcare and services. The development and safety of health-related services and practices evolved from experiments on self, other animals, and people in the community, although the ethics were far from acceptable in most cases. On the other hand, the moral principles of ancient philosophers and practitioners are still used in modern day medicine, as well as in the field of ethics. One such example is the use of the Hippocratic Oath taken by physicians and health practitioners, though recently, the Oath has been challenged by contemporary philosophers and ethicists. In Ethiopia, health research has been and is still being carried out by various sectors including government and private organizations, bilateral and multilateral agencies including United Nations (UN) agencies, and faith-based organizations. These orga- nizations have been conducting research of their interest independently or through collaborations with institutions such as medical and paramedical schools, research institutes, drug control agencies, and others. To disseminate these research findings, the grounds for formal peer-reviewed health research publication were laid by the Ethiopian Medical Journal in 1962. Other peer-reviewed scientific journals followed suit, namely, the Ethiopian Pharmaceuti- cal Journal, the Ethiopian Journal of Health Development, the Ethiopian Journal of Health Sciences, and Ethiopian Journal of Reproductive Health. Commitment of the government towards research and research ethics has been ex- pressed in various undertakings throughout the years. These undertakings include: • Endorsement of a constitution and legal codes that protect the well-being, wel- fare, and autonomy of its citizens, while also protecting the right to intellectual and academic freedom, as well as the pursuit of knowledge • Establishment of medical and public health colleges since 1952, the Central Research Laboratory in 1942 which later was upgraded to an institute, the Institute of Pathobiology in 1966, the Armauer Hansen Research Institute in 1969, the Demographic Training and Research Center in 1982, and recently, the National Science Academy. • Introduction of Ethics Review Committees (ERC) at the university level in the 1970s to protect the rights, safety, and welfare of research participants and to en- sure independent review of protocols before commencement of research activities. • Establishment of the Ethiopian Science and Technology Commission (ESTC) in 1975, with the mandate to guide, coordinate, and facilitate all Science and Technology-related activities including health-related activities. ESTC was later National Research Ethics Review Guideline Fifth Edition 13changed to the Ethiopian Science and Technology Agency (ESTA) to lead the development and application of science, technology and innovation in Ethiopia, and further coordinate, regulate, and oversee research. On October 24, 2008, under proclamation No. 603/2008’, ESTA was formally renamed as the Min- istry of Science and Technology (MoST) by the Federal Democratic Republic of Ethiopia (FDRE). • Development of a National Research Ethics Review Committee and the now dissolved, National Health Research Council, were formed to lay the foundation for standardized protection of human participants in research. National Health Research Ethics Review Guidelines were first developed in 1995 by the former ESTC. The guidelines were revised three times since its first release in 1995. At the institutional level, standard operative procedures (SOPs) for research ethics review came into practice by organizations that include, the Addis Ababa University Medical Faculty Institutional Review Board (AAUMFIRB), Armauer Hansen Research Institute (AHRI), Ethiopian Health and Nutrition Research Institute (EHNRI) now renamed Ethiopian Public Health Institute (EPHI), and the Ethiopian Public Health Association (EPHA). • Launching a Health Science and Technology Policy in which the country’s health research priority areas were explicitly listed as policy directives. The Health Sci- ence and Technology Policy in article states the need “to enhance the monitoring and coordination of Health Science and Technology activities and the practical implementation of research outputs.” This Health Science and Technology Policy in article 4.3.5 further stresses the need to “Organize an ethical committee to review the ethical aspects and procedures of research undertakings as required” as one strategy. In addition, article 4.3.6 emphasizes the need to “encourage institutional peer reviews….”, • Founding the Drug Administration and Control Authority in 1999 which was re- cently renamed the Food, Medicine and Health Care Administration and Control Authority (FMHACA) • Declaration of the potential allocation of 1.5% of the gross national income or gross domestic product (GNI/GDP) to research in various disciplines. To regulate and provide oversight for health research in light of its increasing land- scape, complexity, and sophistication, MoST hired three consultants with expertise in the field of bioethics to review the existing guidelines. The experts reviewed local and international standards, guidelines, instruments, and procedures related to bioethics. Furthermore, opinions and suggestions were solicited from a dozen highly educated, ethically experienced, reputable professionals in the country. The shortcomings and strengths of the existing guidelines, extent of decentralization of protocol review, man- dates of the National Research Ethics Review Committee (NRERC) and Institutional Review Boards (IRB), terminology, operative procedures, and general suggestions from these dozen professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the experts’ sometimes differing opinions and suggestions for these guidelines. National Research Ethics Review Guideline Fifth Edition 14Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST, Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN agencies, and other relevant stakeholders. The comments and recommendations from this nation- wide consultative meeting were analyzed and incorporated before this guideline was endorsed and released for use to safeguard the rights and welfare of research partic- ipants and for oversight of research in Ethiopia. 1.2 Introduction “Research is a systematic investigation including research development, testing, and evaluation designed to contribute to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the well-being of the patient takes priority over the interests of society and the knowledge to be gained. “Human subject research participant is a living individual about whom an investi- gator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.” Besides, research participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data. The main purpose of health research involving human participants is for better un- derstanding of the etiology, pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic procedures and measures. st Moreover, as evidence-based practice has become necessary at the turn of the 21 century, and quite understandably, existing procedures and practices are challenged continuously for their effectiveness, efficiency, quality, accessibility, and acceptability by the community. However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception, undue influence or induce - ment, and threat or intimidation. The information shall be obtained in a private setting whenever necessary and confidentiality maintained throughout the lifetime of the re - search. This is even more important when research involves participants whose com- prehension and decision making is compromised because of age, lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders. For all research involving human participants and human biological materials/speci- mens, investigators should be aware of, and are obligated to, respect and adhere to all ethical, legal, and regulatory requirements applicable in Ethiopia. In this rapidly advancing, complex, and sophisticated era of genetic studies, preven- tive, diagnostic, and therapeutic clinical trials, as well as collaborative research and human biological material transfer being common place, oversight and regulation is imperative to properly safeguard the rights and welfare of human research subjects. National Research Ethics Review Guideline Fifth Edition 15For research to be ethical, all of the following eight criteria must be met: 1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For research to be ethical, the methods must be valid and practically feasible, the research must have a clear objective, be designed using sound scientif- ic principles, have sufficient statistical power, and be based on adequate knowledge of the scientific literature. 2. Science and social value: The proposed protocol should demonstrate valid scientific basis/ground, enhance health or generalizable knowledge, and benefit individuals and the community where the research is conducted. However, the research partic- ipants’ rights and welfare outweigh any benefit to the society or gain in knowledge. 3. Favorable risk-benefit ratio to research participants and their communities: Risks to subjects shall be minimized through using procedures that are consistent with acceptable research design and potential benefits enhanced. The maximum benefit should be provided at the lowest possible risk, and risks to research participants shall be reasonable in relation to anticipated benefits. 4. Fair selection and enrollment of human subjects: “Scientific objectives, not vul- nerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individuals…” The justification for selection and the equitable nature of selection of research subjects should be described. 5. Privacy: Privacy should be respected, confidentiality maintained, the opportunity to withdraw at anytime or refuse any component(s) of the research should be avail- able, and the well-being of research participants should be monitored, while infor- mation related to research participants should be kept confidential. 6. Independent/IRB review: “Individuals that are not affiliated with the research must review the research and approve, amend, or terminate the research.” How- ever, individuals involved in independent review with any conflicts of interest may be summoned to provide information to the IRB. 7. Informed consent process: The information provided to research participants should be complete and appropriate to the participants’ level of understanding. The partici- pant should be competent to give or refuse consent and research participants should provide their entirely voluntary informed consent without coercion, manipulation, undue influence, or intimidation. 8. Community engagement: Research is quite often generalized to the community from which individual participants are drawn from. Such generalization can result in different positive or negative impacts to the community in terms of stigma, resource drainage, health outcomes, and more. Hence, researchers are encouraged to involve the community in decision making about the design and conduct of the study. Be- sides, investigators should consider the local customs, traditions, culture and reli- gious practices of the community where the research is proposed to be conducted. National Research Ethics Review Guideline Fifth Edition 161.3 Preamble MoST attaches the highest priority to maintaining high standards of integrity, respon- sibility, and accountability in all research conducted in Ethiopia. In addition, MoST obligates that ‘Research with human subjects should be carried out only by or strictly supervised by, suitably qualified and experienced investiga- tors and in accordance with a protocol that clearly states the aim of the research, the reasons for proposing that it involves human subjects, the nature and degree of any known risks to the subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects’ consent will be ade- quately informed and voluntary. The protocol should be scientifically and ethically appraised by one or more suitably constituted review bodies, independent of the investigators.’ MoST ensures that this guidelines basically operate within the legal framework of Ethiopia and that the IRBs operate independently and without influence and coer - cion. Furthermore, MoST demands that membership of IRBs should be large enough to ensure a robust discussion of protocols. Additionally, IRB membership should have a healthy mix of representation by different genders, disciplines, sectors, and layper- sons. While this document focuses primarily on guidelines for IRBs, it emphasizes that at- tention shall be given to the wider system of human research participants’ protections of which IRBs are a part. These guidelines empower IRBs to perform effectively and efficiently with best intentions. The review guidelines are developed to operate in the existing research systems with the following objective realities: • Constitutional and legal rights, relevant policies related to health and science research exist. • These guidelines are executed under the Law of Ethiopia. IRBs operate under explicit legal authority. • All research with human participants is subject to the oversight of an IRB. • MoST has the primary responsibility for ensuring that IRBs are subject to ade- quate oversight. • Mechanisms are in place to ensure IRBs work effectively and efficiently. IRBs are part of a larger research participant protection programs that also include training of IRB members and investigators. • Procedures exist to ensure clear and efficient communication, harmonization of standards, networking, and cooperation among the NRERC and other IRBs, and between different levels of review and publication committees in departments/ units of institutions. In addition, procedures exist for the coordinated review of multi-site research within Ethiopia or international collaborative research. • Mechanisms exist to ensure that IRB activities are coordinated with national regulatory authorities’ oversight of drugs and medical devices. National Research Ethics Review Guideline Fifth Edition 17• Mechanisms are created for obtaining community input into the ethics review system. • A system exists for registration of IRBs that operate in Ethiopia. MoST attaches emphasis that this guideline is part of an effort to establish, facilitate and strengthen an effective health research system in Ethiopia. The aim of the health research system is to advance and use of scientific knowledge to improve health and health equity. The key functions of this health system research are stewardship, of which research ethics is a part, finance of the systems, creation of and sustaining resources, and production and use of knowledge. Hence, Understanding and considering • The shortcomings of the existing guidelines in the face of the widening land- scape of research areas, complexity of research procedures, and evolvement of genetic studies with the consequent biobanks, • The critical importance of establishing a strong health research system, • The relevance and responsibility of ensuring standardized research ethics review all over Ethiopia, • The need to ensure independence of IRB operations and decision-making from influence by anyone who sponsors, conducts, or hosts the research it reviews, • The need for ensuring networking and collaboration of IRBs, both local and international, • The increasing number of health teaching institutions and with them the num- ber and quality of research, • Evidence-based practice is the order of the day, and Cognizant of • The rapidly advancing and complex research related to genetic, biomedical sci- ence, and transfer of human biological materials, • The increasing number and scope of collaborative studies by numerous investi- gators and institutions within and outside of Ethiopia, and with the existing pol- icy, academic and administrative environment, the increasing interest of donors to sponsor research in Ethiopia, • Research participants’ protection, that should involve not only research protocol review, but also ethically sound research participant-investigator interactions, continuous safety monitoring, adherence to approved protocol, and quality im- provement in research, • The duty to ensure mechanisms to make IRB operations transparent, account- able, consistent, and of high quality; establishing mechanisms for IRBs to em- ploy reliable means to evaluate whether the staff and members routinely follow National Research Ethics Review Guideline Fifth Edition 18the IRB policies, rules and guidelines; the need for both internal and external evaluation; the demand to address complaints and grievances from all parties involved in research (researchers, research participants, communities, spon- sors, and others), • That research should be carried out in full compliance with, and awareness of, standards, laws, regulations of the country, as well as local customs, commu- nity, and the mix of social, traditional, and cultural diversity, MoST developed this National Research Ethics Review Guidelines to safeguard the rights, safety and welfare of all human participants in all research proposed to be conducted in Ethiopia, based upon the Health Science and Technology Policy and the responsibilities assigned to the MoST. No other guidelines and requirements are allowed to diminish or remove any of the human research participants’ protections set forth in this National Research Ethics Review Guidelines. 1.4 Scope of Application This Guideline is applicable to all types of research that involves human participants, including but not limited to: • Studies of a physiological, biomedical, biochemical, or pathological processes • Genetic research, clinical trials, pharmaceutical, and other investigational products • Research studies involving clinical records or other personal information • Public health and epidemiological research • Health systems research • Quality improvement research • Human health related behavioral research, research on medical and paramedi- cal education, and research related to traditional healing. • Research that may include one or a combination of observations; interviews, in- ternet-based, mail-based, and telephone research; focus group research; survey and research with biological samples. Furthermore, the guidelines are applicable in research proposed to be conducted by all sectors and organizations. These include, but are not limited to, public, private, faith-based, indigenous and international non-governmental organizations (NGOs), bilateral, multilateral, and United Nations’ agencies. National Research Ethics Review Guideline Fifth Edition 192. Objectives 2.1 General Objective The objective of this guideline is to safeguard the rights, values, and welfare of re- search participants through respecting the participants’ autonomy, protecting the participants from harm related to research, and ensuring that individual/community benefits and fairness are maintained. 2.2 Specific Objectives 2.2.1. To ensure the rights and autonomy of research participants are respected and that participation or otherwise in research, is entirely voluntary 2.2.2. To safeguard research participants from unnecessary/unjustifiable risk 2.2.3. To ensure fair selection of research participants and fair distribution of benefits and risks 2.2.4. To create awareness among investigators, sponsors, reviewers, decision and policy makers, and individuals/communities on basic ethics principles 2.2.5. To ensure that research holds/embraces/possesses/considers social and cultural responsiveness/sensitivities for participating individuals and com- munities 2.2.6. To ensure the scientific integrity, ethical standards, and appropriate proce- dures for the conduct of research involving human participants 2.2.7. To monitor and evaluate ongoing and post-research ethical implications to the participants and the community, at large 2.2.8. To regulate human biological materials (sample/specimen) transfer 2.2.9. To ensure rigorous and robust ethical review of research protocols 2.2.10. To ensure timely review and communication of decision of submitted proto- col to investigators 2.2.11. To facilitate cooperation and networking among IRBs at local and interna- tional levels 2.2.12. To comply with and regulate the complexity of research procedures 2.2.13. To put in place legal considerations against research investigators/ studies undertaken prior to appropriate ethics review or unethical implementation of studies. National Research Ethics Review Guideline Fifth Edition 203. Ethical Principles High ethical standards in health research can be achieved only when investigators aspire to such standards in their research activities. To safeguard the rights and wel- fare of human subjects in research, all Research Ethics Review Committees (RERCs) and IRBs, regardless of their level, shall promote three basic ethical principles: 1) respect for persons 2) beneficence and 3) justice. In general, RERCs shall ensure that investigators have thought of ethical issues, specifically that no harm will be done and no resources wasted in the name of research, regardless of the research ques- tion planned for exploration. However, in certain circumstances, the weight given to each of these three basic ethical principles may differ in accordance with the type of the research and the setting where the research is conducted. Nevertheless, the IRB should ensure that the following basic ethics principles are met. 3.1 Respect for Persons Out of respect, participants must be informed about the research and allowed to decide about participation. Research participants unable to make decisions inde- pendently deserve extra protection. 3.1.1. Autonomy - This principle aspires to protect the interests of hu- man research participants from physical, psychological, and cultural harm. It refers to the obligation on the part of the investigator to respect each research participant as a person capable of making an informed decision regarding participation in the research study. It obligates in- vestigators to respect the right of human subjects to hold their views, make choices and take actions without controlling influences. For human subjects who are not capable of making an informed decision because of age, mental, or medical capacity, the next of kin or guardian shall make the decision in the best interest of the research participant. 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension, competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the research par- ticipant. The information to be provided should be written in a way that considers the local culture and values, as well as the level of understanding of the research participant. The information provided should weigh the re- search participants’ competence. When informed consent is that of a third party (proxy; parent, next-of-kin, legally authorized representative (LAR), the reasons for the indirect approach shall be stated and become part of the protocol. Research participants or persons giving proxy consent cannot give full informed consent unless the consent process/form contains adequate information. All such information shall be expressed in a language that is understandable to the participant. Generally, the consent form should explicitly indicate the points mentioned in Section 6.13 below. National Research Ethics Review Guideline Fifth Edition 213.2 Beneficence The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to maximize benefits for the individual participant and/or community, while minimizing risk or harm to the individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible in the design and conduct of the research. Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a result of being a research participant. Risks to research participants include physical, psychological, and emotional harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical, psychological, emotional, economic, educational, legal, and social harm. In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm, remove harm, and maximize the benefit to re- search participants and to the community, or both. 3.3 Justice Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants. 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced into participating, including but not limited to, prisoners, pregnant women, people with mental and physical disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations. Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural, religious, creed, and institutional make up. 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population groups likely to benefit from the research. Distributive justice means that no segment of the population should be unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to neglect nor discriminate against individuals and groups who may ben- efit from advances in research. 3.3.3. Justice also demands balancing the benefits and burdens to the commu - nity where the research is undertaken. 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation remains confidential to protect partici - National Research Ethics Review Guideline Fifth Edition 22pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of individual participants also needs to be protected throughout the investigation by the investigators. 4. Institutional Authority and Purpose 4.1 Institutional authority NRERC and IRBs are established under the authority of the Ministry of Science and Technology, but function independently. The MoST requires all research involving human participants or human biological materials to be reviewed and approved by NRERC or one of the MoST accredited and registered IRBs prior to initiation of any research-related activities, including recruit- ment and screening of participants. 4.2 Purpose of NRERC, IRBs The NRERC and IRB’s objective is to protect the rights and welfare of human partic- ipants in biomedical and behavioral research. The IRB reviews and oversees human participant research to ensure that it meets the ethical principles cited in this guide- line, FMHACA regulations, and that it complies with legal requirements and other pertinent regulations, guidance, and local laws. 4.2.1. The NRERC and IRB’s duty is to inform and assist the in- vestigators and advisors on ethical and procedural standards related to the use of human participants in research, to facilitate compliance with this guidelines, Ethiopian law, and international regulations. However, the primary responsibility for assuring that the rights and welfare of indi- viduals are protected rests upon the investigators conducting the research. Others engaged in the conduct of the research including host institutions and sponsors share this responsibility. Faculty advisors serving as Principal Investigators (PIs) to students who conduct research have an obligation to carefully consider whether the students are qualified to safeguard adequately the rights and welfare of par ticipants. 4.2.2. The NRERC and IRB have the authority to ensure that re- search studies conducted under its jurisdiction are designed and con- ducted in a manner that protects the rights, welfare and privacy of re- search participants. Specifically: • The NRERC and IRB reviews, and has the authority to approve, require mod- ification in, or disapprove all research activities that fall within its jurisdiction. • The NRERC and IRB have the authority to conduct continuing review as it deems necessary to protect the rights, welfare, and privacy of research partici- pants, including requiring progress reports from investigators. • The NRERC and IRB may suspend or terminate approval of a study not being National Research Ethics Review Guideline Fifth Edition 23conducted in accordance with the NRERC and IRB’s requirements or that has been associated with unexpected serious harm to participants or others. • The NRERC and IRB have the authority to observe or have a third party ob- serve the informed consent process and/or audit the progress of any study in its jurisdiction as it deems necessary to protect the rights and welfare of human participants. • The NRERC and IRB may place restrictions on a study. 4.3 Use of Policies, Procedures The NRERC and IRB members and its Secretariat staff must maintain and follow all written policies and procedures consistent with Ethiopian regulations, good clinical practices, good manufacturing practices, and biomedical ethics when reviewing pro- posed research. 5. Ethics Review System The MoST through the Ministry of Justice, shall ensure that health research ethics re- view is supported by an adequate legal framework that resonates with this guideline. MoST shall strive to put in place an appropriate and sustainable system to monitor the quality and effectiveness of research ethics review. In addition, MoST is respon- sible to ensure existence of mechanisms for networking and cooperation among IRBs at different levels, as well as IRBs of international standing in collaborative research. All health research involving human participants must undergo review by the NRERC or an independent IRB. In Ethiopia, ERCs are established at three levels: National Ethics Commitee (NEC), Institutional (IRB Level A and IRB Level B). The composition and mandates of these ERCs are stated below. It is important to note that decen- tralization of the activities of the NRERC and subsequent establishment of new and empowerment of already existing Institutional IRBs, shall be realized. 5.1 Organizational Structure To effectively and efficiently deliver research ethics review services, functional and structural arrangements are established at the National, and Institutional levels as depicted in the Organogram below. National Research Ethics Review Guideline Fifth Edition 245.2 National Research Ethics Review Committee The purpose of the NRERC is to safeguard the dignity, rights, safety, and welfare of all actual or potential research participants and/or communities. The NRERC is mandat- ed to review research protocols and the supporting documents on their scientific and ethical merit. Furthermore, the NRERC is mandated to assure that proposed research resonates with the health research directives as stipulated on the Health Science and Technology Policy. 5.2.1 Composition • Shall have members with professional competence and mix of varying backgrounds, gender representation, a community representative, re- search ethics training and experience. • Minimum number of members is fifteen (15). The details are described in Section 6.3 below. 5.2.2 Mandates and Functions of NRERC Develop research review guidelines and standards Accredit and recommend licensing and registration of IRBs by MoST National Research Ethics Review Guideline Fifth Edition Solicit funds to build capacity at all levels of IRBs Organize and deliver research ethics training to IRBs at all levels using different media (classroom, on-site, internet-based); develop standardized training materials for countrywide use NRERC Protocol Review - The NRERC is responsible for giving final eth- ical decisions on: • All clinical trials involving new drugs, or new combinations of drugs, vaccines, new therapeutic regimens, and other biological products as well as invasive diagnostic procedures. For all research that involves investigational products, authorization and monitoring by FMHACA is a requirement before submitting a protocol for review and approval. • Multi-center collaborative research, including student theses (MSc, PhD, specialization studies) that inherently exhibit more than minimal risk, and experimental/clinical trials. • Research which is funded by companies producing the experimental product. • Experimental research which is carried out by a national agency or agencies with international collaboration. • Projects that require transfer of human biological materials (samples/ specimens). Umpire complaints, disputes, appeals and grievances on functions and review processes of IRBs submitted by researchers or institutions. Monitor and evaluate IRBs at all levels. Facilitate experience sharing among local and international IRBs. Facilitate international registration of Level A IRBs such that their reviews are accepted by funding agencies. Review of trials that are funded by manufacturers and pharmaceuticals, Review very urgent research projects that are of national interest and priority, and Policy-advocacy and creating community awareness on ethical principles in research, and legal and regulatory reforms, and changes related to re- search involving human participants. 5.3 Institutional Review Board, Level A These IRBs can be regional or institutional. These are IRBs that have the capacity to review, monitor, document research protocols and undertakings involving humans in the region or the institution where they are based, or other institutions that do not have their own IRBs and beyond. Similarly, Level A IRBs shall be capable of safe- National Research Ethics Review Guideline Fifth Edition 26guarding the rights, autonomy, safety, and welfare of human research participants. 5.3.1 Composition • Shall have members with professional competence and a mix of varying back- grounds, gender representation, a community representative, research ethics training, and experience similar to or equivalent with the NRERC. • Minimum number of members is five (5). 5.3.2 Mandates and Functions Organize and deliver research ethics training to researchers in the region or the institutions. Develop SOPs, that govern the IRB’s research review procedures. Submit progress report of the IRB’s functions annually to the NRERC. Inform the NRERC on occurrence of frequent, unexpected severe adverse effects (SAEs) related to research reviewed and approved by the IRB, Review and approve research protocols similar to the NRERC except: • Genetic research, stem cell research • Research involving human biological material transfer outside of Ethi- opia provided that the IRB notifies the NRERC Multicenter interna - tional collaborative research of experimental nature • Investigation of new devices, drugs or vaccines not registered for use in Ethiopia • Review of trials that are funded by manufacturers and pharmaceutical companies Solicit funds to build its own capacity 5.4 Institutional Review Board, Level B These can be regional or institutional IRBs. These are IRBs that have the capaci- ty to review, monitor, and document research protocols and undertakings involving humans from the institution where they are based or other institutions that do not have their own IRBs, according to the mandates and functions stated below. Simi- larly, Level B IRBs shall be capable of safeguarding the rights, autonomy, safety, and welfare of human research participants. These IRBs may not have the expertise and experience of Level A IRBs, in which case the protocols can be reviewed by Level A IRBs of other institutions. 5.4.1 Composition • Shall have members with professional competence and a mix of gender repre- sentation, a community representative, research ethics training, and experience, National Research Ethics Review Guideline Fifth Edition 27which may not be similar to or equivalent with NRERC or Level A IRB. • Minimum number of members is five (5). 5.4.2 Mandates and Functions Organize and deliver research ethics training to researchers in the region or the institution. Develop SOPs that govern the IRB’s research review procedures. Submit progress report of the IRB’s functions annually to the NRERC. Inform the NRERC on occurrence of frequent, unexpected SAEs related with research reviewed and approved by the IRB. Review and approve research protocols that involve minimal risk. Solicit funds to build its own capacity Responsibilities of the Secretariat: • Receive applications from other IRBs. • Ensure the completeness of application documents for ethical review. • Distribute protocols to all ethics committee members and/or external reviewers, as applicable and when directed by NRERC chairman or delegate. • Facilitate regular and extraordinary meetings in consultation with the Chairper- son of the NRERC. • Communicate decisions of the NRERC to the applying institution with a copy to the PI. • Archive all project-related protocols, correspondence, decisions and minutes of the NRERC. • Receive periodic progress reports from investigators and annual reports from other IRBs. • Facilitate the accreditation and registration of IRBs based on the recommenda- tion of the NRERC and endorsement by MoST. • Propose revision criteria for registration and accreditation of IRBs. • Support networking among the NRERC and other IRBs. • Facilitate the monitoring and evaluation of the ethical implementation of research. • Organize, support, and facilitate the conduct of research ethics training at Na- tional and Institutional levels. National Research Ethics Review Guideline Fifth Edition 28• Manage and facilitate all official correspondence of the NRERC and • Solicit funds for realization of the duties of the NRERC. 5.6 Terms of Reference Each IRB shall develop its own terms of reference. The TOR of the NRERC can be found in Appendix III. 5.7 NRERC Office 5.7.1. Physical Location and Security - The NRERC should have a dedi- cated office located in the premises of MoST. 5.7.2. Only the NRERC Secretariat should be authorized to have access to the NRERC documents unless ordered by a court of law. 5.7.3. NRERC documents should be kept secure in locked cabinets and only accessed by authorized personnel. 5.8 NRERC Operations 5.8.1. The NRERC operations office should be spearheaded by the NRERC Secretariat as per instructions from the NRERC through the Chairperson or his/her designate. 5.8.2. The NRERC operations office should be separate and independent of the administration of MoST. 5.8.3. Applications to the NRERC must be channeled through the NRERC Secretariat. 5.8.4. All decisions and communication from the NRERC to the appli- cant must be conveyed through the Secretariat. 5.9 Registration and Accreditation 5.9.1. All IRBs in Ethiopia have to be accredited by the NRERC, and registered and licensed by the Secretariat of the NRERC at MoST. 5.9.2. Registration and renewal of all IRBs shall be done every two years from the date of registration or renewal of the IRB. 5.9.3. When IRB members are replaced for any reason, these outgoing members shall be notified in writing. The reason for termination of membership shall be clearly described in the letter. 5.9.4. Review procedures, TORs, and the review forms should be standardized. 5.9.5. The minimum acceptable number of members on any IRB is five. No IRB can have even numbered members for the sake of deci- sions, particularly when there is a need to vote. 5.9.6. IRBs shall have members with a varied professional mix and there National Research Ethics Review Guideline Fifth Edition 29should be at least, one member from behavioral sciences, law, or humanities, be gender sensitive and ensure community represen- tation by a lay person. No IRB can be composed entirely of a single profession, similar gender, or without a community representative. 5.9.7. Following registration, a letter of accreditation shall be given to IRBs by the Secretariat. 6. Establishment, Functions, Review Procedures 6.1 Definition Institutional Review Boards (IRBs) are independent committees established in an in- stitution to conduct initial and continuing review of research projects with the primary goal of protecting the rights and welfare of research participants. All institutions in Ethiopia that conduct research involving humans as research participants should set up IRBs in accordance with these guidelines. Where an institution cannot set up an IRB, that institution may rely on an IRB of another institution to review their research projects, provided the IRB is registered by the National IRB. 6.2 Establishment 6.2.1 Appointing Authority • The Head of the Institution is the authority responsible for the appointment of IRB members. In cases where members come from diverse institutions, the appointment should be upon the recommendation of the institution where the potential IRB member is based. • Members are selected in their personal capacities based on their scientific knowledge and expertise, as well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function. • Appointments should consider age and gender distribution, and relevant but diverse professional representation. • The appointing authority should write an appointment letter to the prospective member inviting him/her to be a member of the IRB. • Members will sign a confidentiality agreement and conflict of interest (COI) form. 6.2.2 Applying to Establish an IRB An institution that needs to establish an IRB shall apply in writing for approval and reg- istration at the National Secretariat at MoST, and include the following requirements:- • Statement that the IRB will follow the guidelines as stipulated in this document, law, relevant regulations. • A list of IRB members identified by name, qualifications, profession, current National Research Ethics Review Guideline Fifth Edition 30CV, representative capacity; any changes, in due process or in IRB membership must be reported to the secretariat. • Written SOPs for the activities of the IRB: composition of IRB members; con- ducting initial and continuing review of research, and for reporting its sugges- tions/opinion and decisions to the investigator and the institution; expedited review process; follow-up and monitoring of approved studies. • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of the IRB. The process of application and response from MoST should not exceed three months. 6.3 Composition The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical as - pects, and ethics of the proposed research. • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in composition, including persons with relevant but diverse scientific expertise, balanced age and gender distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and medical ethics aspects of research protocols. • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one member whose primary area of expertise is in a non-scientific field. • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close family member working in the institution. • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific expertise, but may be a layperson that rep - resents the interests and concerns of members of the community and is familiar with the community’s values, customs, traditions, and culture. • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research participants. • All IRB members should at the minimum take one basic training on bioethics within one year of appointment. National Research Ethics Review Guideline Fifth Edition 31

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