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

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

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 qualitative researchers, we are actively involved in the research process. We accept the fact that we are the main instrument, thus are part of the social world we aim to understand. It entails self-awareness and as Parahoo (2006) posits, reflexivity, as a process, is an introspection on the role of subjectivity in the research that entails a continuous process of reflection by researchers on their values. It is also a process of recognizing, examining, and understanding how their “social background, location, and assumptions affect their research practice” Hesse-Biber, 2007, p.17). Reflexivity, as the abundant literature would indicate, is an elusive term, it is commonly used interchangeably with reflectivity, and even with critical reflection. In this paper, an attempt was made to rediscover how reflexivity has been utilized in various perspectives to define its position and role in the conduct of robust qualitative research. In the process, we would like to share and solicit perspectives on reflexivity as a process and as an output. This was done thru a review of literature and the integration and highlighting of reflexivity/reflexivities of various researchers arising from the various research that we have been involved with such as: the six-country multi-disciplinary team lead by the Ottawa University based in Canada that undertook participatory research across Asia, Africa, and the Pacific to learn how poverty can be defined and measured; the five-country multi-disciplinary team, led by the Australian National University, Australia; and various local interdisciplinary researches. These researches were conducted over three years or more, some in various stages using focused group interviews, key informant interviews, observations, ladder ranking using photographs, record reviews, surveys, and photovoice. We also included documented reflexivities of colleagues with whom we have worked with in various capacities. We analyzed these documents vis-à-vis the concern of the qualitative researcher to unravel how their personhood intersects with their experiences in the field. Indeed, revisiting reflexivity and research methods enlightens the rigor in traversing the pathways of knowledge generation in qualitative research.
Research Design ; Ethics

Aspergillosis ; Ethics Committees, Research ; Fungi ; Humans ; Korea ; Magnetic Resonance Imaging ; Mycetoma ; Paranasal Sinuses ; Retrospective Studies ; Sinusitis

OBJECTIVES: This study investigates the current state of consuming breakfast among elementary school students residing in Malang, East Java, Indonesia, and to identify factors that influence breakfast behavior.METHODS: The research model was set up as per the health belief model, and slightly modified by adding the subjective normative factors of the theory of planned behavior. The survey was conducted from July 17 to August 15, 2017 using a questionnaire, after receiving the permission PNU IRB (2017_60_HR).RESULTS: The subjects were 77 boys (49.4%) and 79 girls (50.6%) suffering from malnutrition with anemia (21.2%) and stunting ratio of Height for Age Z Score (HAZ) (11.5%). Furthermore, moderate weakness (14.8%) and overweight and obesity (12.3%) by Body Mass Index for Age Z Score (BMIZ) were coexistent. According to the results obtained for breakfast, 21.8% did not eat breakfast before school, with 18.8% of the reasons for skipping breakfast being attributed to lack of food. Even for subjects partaking breakfast, only about 10% had a good balanced diet. The average score of behavioral intention on eating breakfast was 2.60 ± 0.58. The perceived sensitivity, perceived severity, perceived benefits, and self-efficacy of the health belief model correlated with breakfast behavior. Of these, self-efficacy (β=0.447, R²=0.200) and perceived sensitivity (β=0.373, R²=0.139) had the greatest effect on breakfast behavior. Mother was the largest impact person among children.CONCLUSIONS: In order to increase the level of breakfast behavior intention among children surveyed in Indonesia, we determined the effectiveness by focus on education which helps the children recognize to be more likely to get sick when they don't have breakfast, and increase their confidence in ability to have breakfast on their own. We believe there is a necessity to seek ways to provide indirect intervention through mothers, as well as impart direct nutrition education to children.
Anemia ; Body Mass Index ; Breakfast ; Child ; Diet ; Eating ; Education ; Ethics Committees, Research ; Female ; Growth Disorders ; Humans ; Indonesia ; Intention ; Malnutrition ; Mothers ; Obesity ; Overweight

In this paper, I reflect on caring and witnessing through engaged ethnography of an urban poor community during the onset of the COVID19 pandemic. The urban poor are individuals and families who live below the poverty line in metropolitan areas, many of whom have little or no political voice and are insufficiently protected by social networks and other institutions. In March 2020, the government placed Metro Manila under Enhanced Community Quarantine to control the spread of COVID19. This left many an urban poor community in Metro Manila to struggle even more against an already precarious existence. By standard, nurses render different levels of care for urban poor clients in almost all health care settings. In public health nursing, we come in close contact to the realities of our clients when we see them in health centers, in the community, or whenever we do our home visits. Now, caring for vulnerable and marginalized groups such as the urban poor has changed due to minimum public health standards of wearing masks, physical distancing, handwashing, and enforcement of lockdowns. As a nurse, an academic, and as a student of anthropology, I came up for self-review while doing an article for a popular social news network derived from a virtually engaged ethnography. While this novel method requires you to see the world through the eyes of the “other,” and generates bioethical dialogue and awareness of personal biases in addressing ethical considerations and challenges, it gives voice and fulfills our roles as client advocates. In May 2020, the article was published with the urban poor organization and its partners as my coauthors. I borrowed from anthropology to arrive at a greater understanding of the socio-cultural effects and political implications of COVID19 to one of the most vulnerable nursing clientele – the urban poor.
Public Health Nursing ; Ethics, Research ; COVID-19

Neonatal hypoxic-ischemic (HI) brain injury is a major cause of neonatal mortality and long-term neurodevelopmental disabilities. Although promising neuroprotective interventions have been studied, the current management of HI brain injury has been limited to supportive measures and induced hypothermia. In addition to engrafting, migrating toward the damage sites and differentiating into multiple lineages, multipotent neural stem/progenitor cells (NSPCs) also provide trophic/immunomodulatory factors and integrate into the host neurons upon implantation into an HI-injured brain. However, NSPC-based therapies have shown poor cell survival and integration, poor differentiation or restricted differentiation into the glial lineages. Furthermore, to achieve full functional recovery following brain injury, the optimization of cell therapy is needed to recapitulate the precise migration of stem cells to the region of interest and the neural rewiring present in the brain microenvironment. Therefore, the efficacy of NSPCs in the treatment of CNS injury is currently insufficient. Human NSPCs (hNSPCs) were isolated from the forebrain of an aborted fetus at 13 weeks of gestation with full parental consent and the approval of the Institutional Review Board of the Yonsei University College of Medicine. Here, to enhance the regenerative ability of hNSPCs in HI brain injury, cells were either pretreated with pharmacological agents or engineered to serve as vehicles for gene delivery. Furthermore, when combined with a poly (glycolic acid)-based synthetic scaffold, hNSPCs provide a more versatile treatment for neonatal HI brain injury. Finally, hNSPCs transfected with zinc-doped ferrite magnetic nanoparticles for controlling both cell migration and differentiation offer a simple and smart tool for cell-based therapies.
Aborted Fetus ; Brain Injuries ; Brain ; Cell Movement ; Cell Survival ; Cell- and Tissue-Based Therapy ; Ethics Committees, Research ; Genetic Therapy ; Humans ; Hypothermia, Induced ; Hypoxia-Ischemia, Brain ; Infant ; Infant Mortality ; Nanoparticles ; Neural Stem Cells ; Neurons ; Parental Consent ; Pregnancy ; Prosencephalon ; Stem Cells ; Translational Medical Research

It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.
Bioethics ; Computer Security ; Consent Forms ; Ethics ; Ethics Committees, Research ; Humans ; Informed Consent ; Jurisprudence ; Korea ; Personally Identifiable Information ; Privacy ; Publications ; Republic of Korea ; Retrospective Studies

OBJECTIVE: Scarce literature about myoma removal without anesthesia has been published. The aim of this paper is to evaluate the feasibility of a new alternative for a hysteroscopic myomectomy in a conventional office setting, without need for anesthesia. METHODS: Step-by-step description of the surgical technique has been provided, based on video images. An office hysteroscopy was performed in a Gynecological Endoscopy Department of a tertiary European hospital. RESULTS: A 49-year-old woman was referred for management of severe hypermenorrhea. Consent and approval were received from the patient and the institutional review board, respectively. The introduction of a Truclear® hysteroscopic polyp morcellator of 5.5 mm with optic of 0 degrees into the uterine cavity did not require any kind of anesthesia or cervical dilatation. The use of saline flow helped distend the cavity and identify a submucosal myoma. Under direct vision, a full myomectomy was performed via mechanical energy with continuous cutting movements, without any complication. After the procedure was completed, the excised material was aspirated through the device into a collecting pouch. A successful complete morcellation of a Type-0 submucosal leiomyoma with a polyp morcellator device was performed in an outpatient setting. Good medical results, good tolerance by the patient besides lower surgical risks due to mechanical instead of electrical energy are shown. CONCLUSION: In conclusion, this video demonstrates that a hysteroscopic myomectomy can be performed successfully in office with lower risk of complications from the procedure and without use of general anesthesia besides good tolerance by the patient.
Anesthesia ; Anesthesia, General ; Endoscopy ; Ethics Committees, Research ; Female ; Humans ; Hysteroscopy ; Labor Stage, First ; Leiomyoma ; Menorrhagia ; Middle Aged ; Morcellation ; Myoma ; Outpatients ; Polyps ; Pregnancy ; Uterine Myomectomy