No abstract available.
Ethics, Research

There is no substantial difference in conducting research that is both ethical and responsive to the health needs in developing and developed nations. Differences are in financial constraints, technological expertise in identification and addressing needs, and in the perception of equal partnership of all stakeholders. There will be differences in emphasis of research but this is slowly blurred due to globalisation. Public health emergencies in developing countries need timely and effective global collaborative research to implement control strategies. Research needs should be based on predictive models with learning from past emergencies, technological advances, strategic critical appraisal of local and global health information, and dialogue with all stakeholders. Adequate funding will be challenging and resources from national, international and aid foundations will be needed. Issues associated with such funding include deployment of international rapid response teams, collaborating researchers, transfer of technology, and intellectual property ownership. While all types of research ranging from basic, applied, clinical studies, meta-analysis, and translational research are relevant, the relative importance and specific allocation of resources to these may differ. Is the choice related to responsiveness or based on researchers’ perception of their contributions to evidence-based practice and research? Ethical issues relating to vulnerable groups, risk distribution, quality issues, research integrity and oversight are just as important. Internationally funded research including clinical trials must be sensitive to such issues to avoid allegations of exploitation. Thus the potential of utilisation and buy-in of research findings and recommendations must be considered.
Ethics, Research

In this epoch of progress in health care, when systematic generation of knowledge is considered the cornerstone of health development, there is increasing focus on the need to demonstrate the ethicalness of doing research. Stories of harm inflicted on research participants and scientific misconduct in research are rife in the history of science, even within our immediate past.1 The lessons that we have learned from these stories have shaped the ethical research guidelines that we abide by and uphold today.2 3 Within the last 15 years, since the creation of the Philippine Health Research Ethics Board (PHREB) as the country's policy-making body on research ethics, numerous mandates have been issued to ensure human research participant protection and research integrity. Taken together, these mandates push for the ethical review of researches that are proposed to be done among humans or to use human data, the establishment of research ethics committees (RECs) in institutions that produce these researches, and the maintenance of quality standards in the operation of these RECs through accreditation by the PHREB.4 The enactment of Republic Act No. 10532 in 2013, formally institutionalized the Philippine National Health Research System and tied up all these mandates that pertain to research ethics.5 In effect, all institutions that generate human research一hospitals, health facilities, pharmaceutical companies, government and private agencies, universities, colleges, and even high schools一are expected to comply with these mandates. Many institutions that produce research involving humans or human data find it very challenging to set up a series of procedures for the review of these researches. For one, submitting research protocols一after they have gone through several revisions as directed by the technical research committee or panel一to a second committee for ethics review, approval, and implementation monitoring is a relatively new practice. The extra layer of scrutiny, the intellectual disagreements of technical committees and RECs, and the additional time and effort it takes to get an REC approval all figure in the arguments of those who are against the ethics review process. Research offices or training committees may have to put a system in place to incentivize submission or discourage non-submission of research protocols for ethics review. All in all, it takes administrative political will to incorporate a procedural pathway to ethics review into the usual research generation procedures of an institution. The institutions can arrange a mechanism for external ethics committees or, more commonly一and indeed more efficiently一they can create their own in-house RECs. The demands related to the establishment and operation of in-house RECs constitute an altogether different set of challenges for the institution. REC members and staff will have to be trained to competently do ethics reviews and perform administrative tasks within the REC office. There is also the difficulty of coming up with a good roster of trained reviewers who can dedicate time for committee work. The institution will also have to allocate physical space, and finance both the cost of REC operations and the remuneration of office personnel. The REC accreditation process is meant to reduce variation of procedures and maintain the quality of operations by way of recommending certain standards in the structures, processes, and outputs of RECs. On the part of PHREB as the accrediting body, the process requires careful organization of a well-trained accreditation team that can efficiently and scrupulously evaluate the REC operations and produce helpful recommendations. The process is inherently challenging for REC managers as well since, most of the time, it requires meticulous (re)engineering of REC operations. Above all these demands in complying with the mandates on research ethics is the pervasive call for us to generate trustworthy research results in ways that are beneficial and non-harmful to humans. An ethically produced piece of knowledge is a valuable contribution to scientific progress.
Ethics, Research

Research—or the production of new knowledge—needs to be done ethically. Why is it important to factor ethics into the practice of producing new knowledge? The word “ethics” refers to “moral principles that govern a person’s behavior or the conducting of an activity.”1 Moral principles are “principles of right and wrong that are accepted by an individual or a social group.”2 If we add “research” into the term “ethics,” the phrase “research ethics” would now refer to the principles of right and wrong that govern a researcher’s behavior or the conducting of research. “Research ethics” is the principles of right and wrong in action, in practice, or in the actual implementation of knowledge production. When we conduct human research, we produce new knowledge, often with development goals in mind, for instance—to be more efficient in work, to make clients more satisfied, to diagnose more accurately, to treat more effectively, to prevent illness, to predict outcomes, or to save lives. We ask questions and answer them to produce new knowledge, which we hope will eventually inform the actions that we take in order to meet our development goals. This is a very human pattern of behavior: question-answer-knowledge-action, to strive towards development. It is human nature to work towards development—towards making existence a better experience. This is the reason why we have the propensity to marvel and to introspect, and then to question and look for answers to our questions. This is the most fundamental reason for generating more and more knowledge, for doing research. And this is good—the intention is noble because it benefits us, the people around us, and even those who will exist after us. Generating new knowledge is a conscious effort to do something that gives benefit to oneself and to others. The problem with knowledge production is that it can cause harm, especially to research participants. Harm within the context of research can either be physical, psychological, economic, sociocultural, or legal. Many researches in the past have caused direct, indirect, intentional, or unintentional harm to the participants, or even to the public.3 Asking questions, collecting and analyzing data to answer these questions, and communicating findings and interpretations to others all involve harm. That is why we have international and national guidelines, state laws, and research implementation standards that support human protection systems in research. In the Philippines, many mandates pertaining to health research order the establishment of research ethics committees, the review of all researches involving humans or human data by these committees, and the accreditation of these committees by the Philippine Health Research Ethics Board, the policy-making body in health research ethics in the country.4 These mandates should guide academic and health institutions, as well as agencies that conduct researches involving humans or human data, in providing human protection in research. Deciding to do research is an ethical act. If we decide to pursue knowledge, we affirm and celebrate the human features of introspection, examination of our actions, and pursuit of excellence in the things we do as a society. Actually doing research—i.e., asking questions, recruiting participants, giving interventions, gathering and analyzing data, to reporting findings—offers several opportunities for more ethical acts because, when we perform the tasks involved in research, we are presented with opportunities to do good for others, to prevent harm from coming their way, to show respect for and to acknowledge others as fellow humans, to actively participate in restoring or maintaining justice, and to practice professionalism, honesty, and integrity. By properly applying ethical principles in doing research, and by ensuring that a system for the oversight and guidance of research implementation is in place, we can prevent harm, minimize the risk of harm, and avoid misconduct in research. From there on, we can pursue the ethical act of doing research and positively gain from seizing the opportunities that the act offers. That is why it is important to factor ethics into the practice of producing new knowledge.
Ethics, Research

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.
Ethics Committees, Research ; Ethics, Research ; Humans ; Korea

No abstract available.
Ethics, Research ; Writing

No abstract available.
Ethics Committees, Research ; Humans

No abstract available.
Compliance ; Ethics, Research

No abstract available.
Education ; Ethics, Research

In 2003, the secretaries of the Department of Health (DOH) and the Department of Science and Technology (DOST) signed a memorandum of understanding to institutionalize the Philippine National Health Research System (PNHRS) for the management of research in the country.1 One of the groups constituted under the PNHRS was the Technical Working Group (TWG) on Ethics, which created strategies that highlight the role of ethics in a responsible health research system. Among the recommendations of the Ethics TWG was the establishment of the Philippine Health Research Ethics Board (PHREB).2 In 2006, the PHREB was formally created through DOST Special Order 2006-91 “to ensure that all phases of health research shall adhere to universal ethical principles that value the protection and promotion of the dignity of health research participants.” Since then, PHREB has become the country’s policy making body on health research ethics.2 3 In 2013, the Republic Act 10532一or the PNHRS Law一was enacted.4 The Act strengthened the mandate of PHREB to ensure protection of the welfare, rights, and safety of human research participants, and the implementing rules and regulations (IRR) of the Act specified the policies that facilitate the achievement of the PHREB mandate.5 In 2017, through DOST Special Order 2017-248, DOST established research ethics monitoring boards (REMBs) in Region I, Region VI, and Region XI to assist in the comprehensive and consistent implementation of PHREB policies at the regional level.6 The creation of PHREB in 2006 initiated several other mandates from PHREB and other agencies that implement the PNHRS. These mandates一shown in the infographic一support human research participant protection through ethical reviews of research protocols, establishment of research ethics committees, and maintenance of quality standards of these committees through accreditation. Many of these mandates are national in scope, but a few are specific to Davao Region (Region XI).
Ethics Committees, Research