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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Strategies for resolving ethically ambiguous scenarios2

 

During the fall of 2013 and spring of 2014, I traveled to numerous universities across the United States and England to conduct in-depth interviews with physicists as part of the Ethics among Scientists in International Context Study, a project led by my colleague Elaine Howard Ecklund at Rice University(1). The study sought to find out how physicists approach ethical issues related to research integrity in their day-to-day work.

My colleagues and I began our interviews with a relatively straightforward question: “What does it mean to you to be a responsible scientist in your role as a researcher?” For many scientists, responsibility in research is a relatively black and white question: don’t falsify, don’t fabricate, and don’t plagiarize. And if one looks to the literature, scholarship and policy also tend to focus on these black and white instances of misbehavior because they are unambiguous and deserving of stern sanctions.

As our research unfolded, Ecklund and I began to question whether a black and white view of misconduct is overly simplistic. From a sociological perspective, whether scientists reach consensus about the meaning of unethical conduct in science is debatable because the same behavior in a given circumstance may be open to different ethical interpretations based on the statuses of the stakeholders involved and the intended and actual outcomes of the behavior. Our research ultimately demonstrated that the line separating legitimate and illegitimate behavior in science tends to be gray, rather than black and white—a concept we refer to as ethical ambiguity.

For the purpose of illustration, consider a scenario in which a scientist receives funding for one project and then uses a portion of that money to support a graduate student on a study unrelated to the grant. Many scientists would view this practice as a black and white instance of unethical conduct. But some scientists we interviewed view this an ethically gray scenario, indicating that the use of funds for reasons other than specified in a grant is justifiable if it means supporting the careers of their students or keeping their lab afloat. In these and other circumstances, scientists cope with ambiguity through decisions that emphasize being good over the “right” way of doing things.

What strategies help resolve these and other ethically ambiguous scenarios?

Frameworks for ethical decision-making offer some, but in my view limited, help. Kantian deontological theories assert that one should follow a priori moral imperatives related to duty or obligation. A deontologist would argue, for example, that a scientist has an obligation to acknowledge the origins of her work. And policies regarding plagiarism have a law-like quality. But how far back in the literature should one cite prior work? Deontology does not help us much in this example. Another framework, consequentialism, would suggest that in an ethically ambiguous scenario, a scientist should select the action that has the best outcomes for the most people. But like other individuals, scientists are limited in their ability to weigh the outcomes of their actions (particularly as it relates to the long-term implications of scientific research).

One ethical decision-making framework, virtue ethics, does offer some help in resolving ambiguity. Virtue ethics recognizes that ethical decision-making requires consideration of circumstances, situational factors, and one’s motivations and reasons for choosing an action, not just the action itself. It poses the question, “what is the ethically good action a practically wise person would take in this circumstance?” For individual scientists, this may require consulting with senior and trusted colleagues to think through such circumstances is always a valuable practice.

A pre-emptive strategy for helping scientists resolve ethically ambiguous scenarios is to create cultures in which ambiguity can be recognized and discussed. For their part, the physicists we spoke with do not view ethics training as an effective way to create such a culture. As one physicist we spoke with explained, “It’s the easy thing to say, oh make a course on it. Taking a physics course doesn’t make me a good physicist. Taking a safety course doesn’t make me safe. Taking an ethics course doesn’t make me ethical.”

There may be merit to this physicist’s point. Nevertheless, junior scientists must learn—likely through the watching, talking, and teaching that accompanies research within a lab—that the ethical questions that scientists encounter are more likely to involve ambiguous scenarios where the appropriate action is unclear than scenarios related to fabrication, falsification, and plagiarism. __

Contributor
David R. Johnson, a sociologist, is an assistant professor of higher education the University of Nevada, Reno, in the United States. His first book, A Fractured Profession: Commercialism and Conflict in Academic Science, is published by Johns Hopkins University Press.
davidrjohnson@unr.edu

This post may be cited as:
Johnson D. (2017, 21 June) Strategies for resolving ethically ambiguous scenarios Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/strategies-resolving-ethically-ambiguous-scenarios

(1) (National Science Foundation grant # 1237737, Elaine Howard Ecklund PI, Kirstin RW Matthews and Steven Lewis, Co-PIs)

iDARE: [innovation.design.arts.research.ethics]0

 

I dare you?

CREW Activity (iDARE conference September 2016)
Image: Caitlyn Parry

iDARE involves a team of designers and visual and performing artists and theorists from across Australia who have asked the question: How do we prepare artists for real world practice where there are no ethics committees to guide them and where and they are responsible for developing their own ethical framework in their work? In late 2015, this team won OLT funding for a University of Melbourne led project Developing new approaches to ethics and research integrity training through challenges posed by Creative Practice Research [ID15-4776].

A little context: Higher degree research (HDR) in creative practice (including creative and performing arts, and design) is a relatively new research field in the academy. The creative practice PhD has only existed since the 1990s when creative arts training became part of a unified higher education system as a result of the Dawkins reforms. As researchers, creative arts research practitioners enrolled in the creative practice PhDs have become subject to the university’s research ethics processes and procedures if their work involves human and animal subjects, while in “real world” practice this is not the case (Bolt et al, 2010: 6). The iDARE team are concerned with the question of developing “ethical know-how”: how ethical practices are enacted in creative arts research and beyond its disciplinary boundaries. Our aim is to support research and reposition “ethics” as being at the forefront and centre of innovative creative research practice rather than a problem to be avoided.

As part of the project, we held a national iDARE conference in September 2016, where around 100 creative practitioners, candidates, academics and ethics administrators and managers descended on Melbourne to discuss and debate the intersections of creative practice research and ethical “know-how”.

Over the two days of the conference:

CREW Activity round table (IDARE conference September 2016)
Image: Kate Robertson

The response to the conference was so enthusiastic that we put out a call for papers and have had over fifteen essays that address issues such as developing ethical know how, relationality and ethics, institutional ethics and creative practice research, ethics in practice and etho-aesthetics. Watch this space for the publication!When aesthetics meets ethics in artistic research and art based research

Ethics is at the forefront and centre of innovative creative research practice but how do we equip our graduate students with the ethical knowhow to make ethical decisions in their practices as creative arts practitioners? How do we shift perceptions and practice around ethics, beyond institutional ethics and risk management? How can we encourage institutions to take on the notion of “a situated ethics” that will help prepare our graduates to become ethical and innovative practitioners in the “real world”?

Over the last 18 months the research team (http://idare.vca.unimelb.edu.au/about-idare/about-the-project/researchers-and-partner-institutions/) has been working on this through the conference, a series of workshops, interviews and surveys and the development of the website iDARE (http://idare.vca.unimelb.edu.au/). Over the life of the project, we will publish on the iDARE website some of the deliverables for the project. These deliverables include:

  • a mapping of current university practices through audit and case studies
  • professional development for candidates, supervisors and ethics administrators is being developed and trialled through workshops with evaluation.
    • University of Melbourne (February 2017) as a part of VCA_MCM Staff planning day
    • RMIT (March 2017)
    • Edith Cowan University (April 2017)
    • Federation University Australia (April 2017)
    • London workshop (June 2017) Bartlett School (UCL) and Slade School of Fine Art (UCL)
    • UNSW (September, 2017)
    • University of Wollongong (September, 2017)
  • a pedagogical toolkit (in progress) http://idare.vca.unimelb.edu.au/
  • University of Melbourne ethics library guide for visual arts The University of Melbourne Lib Guide is a Library resource that can be customised to your resources by any university library using the SpringShare platform. We are keen for this to be shared across the academy and so ask you to share with your librarian. http://unimelb.libguides.com/c.php?g=402830&p=3063140
  • establishing a community of practice through engagement in the conference, workshops and the CREW http://www.aelab.org/the-crew The Creative Research Ethics Workshop (CREW) is an ethics-in-action collaboration involving creative practice researchers from multiple universities. Through a call for Expressions of Interest the group formed to explore relationships between ethics and creative practice research. Starting in August 2016 with a two-day intensive workshop, the group continued and expanded through a month of weekly gatherings inside the Occupied exhibition at RMIT’s Design Hub, leading to a series of contributions to the iDARE conference, including an exhibition, workshop/performative events and a conference bag/kit. The CREW is still in progress and working towards some more exciting ethics-in-action collaboration activities.

We would love to hear about your experiences in ethics and advising creative practices researchers, if you would like to contribute we invite you to fill in our ethics administrator/manager survey: https://www.surveymonkey.com/r/ethics_admin_survey

The final report will be published on the iDARE website after lodging and the funding body’s approval and publishing. We expect this report to be published by mid 2018.

Activity prompt and response (IDARE conference September 2016)
Image: Caitlyn Parry

Support for this project has been provided by the Australian Government Office for Learning and Teaching.  The views in this project do not necessarily reflect the views of the Australian Government Office for Learning and Teaching.

CREW Activity (IDARE conference September 2016)
Image: Caitlyn Parry

Contributor
Megan McPherson
Project Manager | Developing new approaches to ethics and research integrity training through challenges posed by creative practice research
Professor Barbara Bolt | Associate Dean of Research
Bios – http://idare.vca.unimelb.edu.au/about-idare/about-the-project/researchers-and-partner-institutions/
Enquiries – mcpherson.m@unimelb.edu.au

This post may be cited as:
McPherson M and Bolt B . (2017, 22 May) iDARE: [innovation.design.arts.research.ethics]. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/idare-innovation-design-arts-research-ethics

Cracking the Code: Is the Revised Australian Code likely to ensure Responsible Conduct of Research?0

 

The Australian Code for the Responsible Conduct of Research is presently under review. Issued jointly in 2007 by the National Health and Medical Research Council, the Australian Research Council and Universities Australia, the current code is a 41-page document divided into two parts. Part A, comprising some 22 pages, sets out the responsibilities of institutions and researchers for conducting sponsored research responsibly. Part B, comprising approximately 11 pages, provides advice on procedures for identifying and investigating instances of the conduct of research in which those responsibilities have not been fulfilled.

The current proposal is to replace this document with a five-page statement of eight principles of responsible research conduct and two lists of responsibilities, again of institutions and researchers, together with a 25-page guidance document (the first of several) of preferred procedures for the identification and investigation of research conduct that has not adhered to the responsibilities set out in the five-page code.

Among the innovations in these changes, other than a significant reduction in the size of the document, is the proposal that the expression ‘research misconduct’ not be used in the guide on identification and investigation but be replaced by the expression ‘breach’. An important reason given for this proposal is the avoidance of conflict with the requirements of institutional enterprise bargaining agreements (EBAs).

The scale of the proposed changes is likely to generate extensive debate and this will have been disclosed in the course of the consultation period that closed earlier this year. The consultation process conformed to the minimal requirements of sections 12 and 13 of the NHMRC Act. This is a process that publicises, by formal means, drafts of proposed changes to which responses are sought. Current practice is to prefer provision of responses by electronic means and to require responders to answer questions determined by the Council. The passivity and formality of the process tends to attract and privilege better resourced interests. In some of the published debate that occurred during the consultation period, there was much attention to the change in scale and to the proposal not to refer to research misconduct but only to breach. This level of discussion risks ignoring several underlying systemic questions, or assuming the answers to them. It is the purpose of this brief opinion to tease out these questions.

The key premise of these remarks on the existing Code and any revision is that the Code constitutes a form of regulation of research conduct. With this premise comes a centrally important question: what are the aims of the regulation of this activity?

The apparent aims of the revision are the definition of responsible research conduct and relevant responsibilities, the identification, disclosure and investigation of failures to conduct research responsibly.

Underlying these aims lie some broader and deeper considerations. These include whether the purpose to be served by regulation of research is to:

  • protect the reputation of research;
  • prevent waste and misguided work that can follow from relying on irresponsible and inaccurate research;
  • protect the reputation of research institutions; to prevent the waste – or even the risk of waste – of public research funds;
  • penalise those who fail to fulfil their research responsibilities, whether the failures are on the part of institutions or individual researchers;
  • protect the public interest in research by promoting productive use of public research funds, and rewarding responsible researchers and institutions.

It is a regulatory situation not unlike that which faced environmental protection through the 1990s and later and other areas such as oil rig and building safety in the UK. One lesson from these experiences is that where the aims of regulation are the protection of the environment, the safety of buildings or oil rigs, they are more likely to be achieved by giving those who conduct relevant activities the opportunity to devise their own methods to achieve those regulatory aims, methods that are then assessed by a responsible authority against a set of standards. The shift from the tight prescription of safety standards to some form of well-defined and supervised self-regulation appears to have been successful in achieving regulatory aims.

The choice of which of the above purposes is to be served will have a direct and profound effect on the methods to be used. For example, if the purpose were the protection of the reputation of research institutions, it would not be surprising to extend a significant degree of autonomy to institutions to set up their own procedures and methods for promoting responsible conduct and so establishing their good reputation. However, there would be an incentive for institutions not to publicly disclose instances of irresponsible research but to manage these institutionally. Reliance on the need to conform to enterprise bargaining agreements might lend support to justification of such non-disclosure.

If the purpose were to penalise those institutions or researchers who fail to fulfil relevant responsibilities for responsible research conduct, the system would need to define those responsibilities with some precision, so that the definitions could be made enforceable, and to establish an agency with appropriate investigation powers and sanctioning authority to identify, investigate and reach decisions as to whether relevant responsibilities had or had not been fulfilled.

A relevant regulatory model may not be that of criminal prosecution but rather of corruption investigation. There is a public interest that motivates the establishment and operation of anti-corruption agencies. The outcomes of their enquiries can lay the foundation for individual punishment of those found ‘guilty’ of corrupt behaviour, and those proceedings are then taken up by different state agencies. Research integrity policy can be seen to have similar aims: first, to protect the public interest by empowering an independent agency to uncover corrupt conduct, and, second, following such a finding, to prosecute individuals by a separate process. A research integrity agency could be given the task of investigating and finding research misconduct, leaving to employers of those individuals the responsibility to impose consequences. Although remaining autonomous in following their own procedures, and so conformingh to EBAs, institutions would be likely to find it difficult to conceal the process because of the public finding of research misconduct that they are implementing.

The debate so far appears to have left most of these underlying questions either unanswered or to have assumed answers to them. Because this has not been explicit, those answers are unlikely to be consistent. For example, the chosen terminology discloses some of these assumptions. The responsibilities described in the five-page code are in very general form that would present considerable difficulties if they were to be used to determine whether they had been fulfilled. For example, what evidence would constitute a failure on the part of an institution to fulfil the obligation to develop and maintain the currency and ready availability of a suite of policies and procedures which ensure that institutional practices are consistent with the principles and responsibilities of the Code? Or, what evidence would constitute a failure on the part of a researcher to fulfil the obligation to foster, promote and maintain an approach to the development, conduct and reporting of research based on honesty and integrity? The very breadth and generality of the language used in these statements suggest that the purpose is not their enforcement.

A further example is the proposal not to use the expression research misconduct in the document, but to refer to breaches of the Code. The language of breach is applied better to duties, rules or standards that are drafted with the intent of enforcement so that it can be clear when evidence discloses a breach and when it does not. Casting the substantive document in the form of responsibilities makes this difficult. In common language, responsibilities are either fulfilled or they are not and where they are not, it is common to speak of a failure to fulfil the responsibility rather than a breach. The use of the language betrays a confusion of underlying purposes.

The advocates of an enforcement approach have argued for a national research integrity agency, like that in some other Western nations. There may, however, be a simpler, more politically and fiscally feasible model available.

If the underlying purposes are to protect the reputation of research as a public interest, to prevent waste and misguided work that can follow from relying on irresponsible and inaccurate research and to prevent waste or the risk of waste of public research funds, then the mode of regulation would be more likely to resource the training of researchers, the guidance of institutions in establishing appropriate research environments and the public promotion of responsible and effective research. The response to irresponsible research conduct would be directed at the withdrawal from the public arena of unsupported and inaccurate results, appropriate disclosure of these (e.g. to journal editors and research funding agencies) and appropriate apologies from responsible institutions and researchers supported with undertakings for reform of faulty procedures and practices.

In implementing these purposes, it would not be surprising for the system to give significant authority to both public research funding agencies. This could include, for instance, authority to ensure that institutions seeking access to their funds establish appropriate procedures to ensure responsible research conduct, including sufficient and sustained training of researchers, adequate resources and research facilities and appropriate auditing and reporting of research conduct. Agency authority could also include an entitlement to establish not only whether researchers who seek or have access to research funding have research records free of irresponsibility, but also that eligible institutions did not have current employees with such records.

Access to research funding has been a potent motivator in the institutional establishment of human research ethics committees, both in the United Kingdom, as Adam Hedgecoe (2009) has shown, and in Australia where the NHMRC’s 1985 decision required institutions to establish institutional ethics committees if they wanted access to research funds with which to conduct human research. In both cases, the decisions were followed by a notable increase in the number of institutional research ethics committees.

An approach that actively promotes responsible research practice may be more likely to achieve wider conformity with good practice standards than a focus on identifying, investigating and punishing failures to meet those standards. If so, the first better practice guide would be how to promote responsible conduct of research; it would not be how to identify investigate and respond to poor research conduct. Indeed, responsible institutions could pre-empt any such requirements by unilaterally setting up programs to instruct researchers in responsible conduct, train and embed research practice advisers in strategic research disciplines, reward examples of responsible research that enhance both researcher and institutional reputations and establish a reliable and comprehensive record keeping system of research. This is an argument that Allen and Israel (in press) make in relation to research ethics.

Australia has an opportunity to adopt a constructive and a nationally consistent approach to the active promotion of good research practice. It would be more likely to achieve this with a code that was not constrained by institutional self-interest nor confined by a punitive focus.

References

Allen, G and Israel, M (in press, 2017) Moving beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In Iphofen, R and Tolich, M (eds) The SAGE Handbook of Qualitative Research Ethics. London: Sage.

Hedgecoe, A (2009) A Form of Practical Machinery, The Origins of Research Ethics Committees in the UK, 1967–1972, Medical History, 53: 331–350

Contributor
Prof Colin Thomson is one of the Senior Consultants at AHRECS. You can view his biography here and contact him at colin.thomson@ahrecs.com,

This post may be cited as:
Thomson C. (2017, 22 May) Cracking the Code: Is the Revised Australian Code likely to ensure Responsible Conduct of Research? Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/cracking-code-revised-australian-code-likely-ensure-responsible-conduct-research

Research Ethics in the Philippines: a personal journey0

 

My recall of the earliest encounter I had with research ethics is when, as a newly appointed faculty member of the department of obstetrics and gynecology of the College of Medicine (CM) of the University of the Philippines (UP) and concurrent attending at the Philippine General Hospital (PGH), I rushed to the office of the ethics research committee (known as the Research Implementation and Development Office or RIDO) of CM before the end of office hours one Friday. In my hand was a letter, addressed to the then chairman requesting approval of a study I was about to conduct. Attached to the letter was a one page synopsis of the research protocol. I was fortunate enough to catch him on his way out of the office, and doubly lucky he agreed to quickly browse through the papers I pushed in front of him. He then instructed the office secretary to stamp the letter “APPROVED”, and proceeded to affix his signature. It was in the early 1990’s!

His stamp of approval went a long way towards legitimizing the outcome of my research. I was able to collect and isolate N. gonorrhoea from commercial sex workers in Manila and Cebu, freeze dried all 92, and transport them hand-carried to the laboratory of at the University of Washington. It turned out, almost all the isolates were resistant to the standard first line drug (ciprofloxacin) at that time. Interestingly, a few months before, my collaborator from the US walked into our office looking for someone to work with. Apparently, a US male citizen had been diagnosed to have ciprofloxacin resistant gonorrhea infection. He admitted to having paid sex in Manila and Cebu prior to flying back home. Fate would have it that I was in the office when my collaborator walked in. And since my sub-specialty in obstetrics and gynecology is in infectious disease, the rest was history. I am including this in my narrative because ordinarily, researches with no international collaboration and/or funding would not warrant a mandatory ethics research committee approval. If the process I went through at that time could be construed as a legitimate one today!

Soon after I finished the gonorrhea study, I found myself being appointed by our department chairman to be the representative to the same ethics research committee (RIDO)! By then, in the early years of 1990, all basic science departments of CM and all clinical departments of PGH appointed representatives to RIDO. Meetings were conducted almost monthly to discuss and evaluate research protocols of faculty members who cared to submit their protocols. In those early times, these usually were those with external funding such as clinical trials, or those with international collaborations. I seem to remember the chair of RIDO would present a brief summary of the protocol at hand for the consideration of the members present. If there were no major objections, the research protocol gets approved, and the study will proceed. There didn’t exist written guidelines and standard operating procedures for RIDO. That was in the later years of 1990 and early years of 2000.

When the chair of RIDO retired from the College of Medicine, she recommended me as her replacement. By then, the beginnings of guidelines and standard operating procedures have been put in place. The developments in the interest and commitment to research ethics were being fueled not only within the walls of the academe (CM, PGH and UP), but also in the scientific community. The creation of the National Institutes of Health in UP Manila, whose mandate is to spearhead research at par with the international community, played a big role in upgrading the standards of research, and along with it, compliance to international standards of conducting ethical review of research involving human participants. A Fogarty International grant to UP Manila, whose prime mover was Professor Leonardo D. de Castro, PhD of the College of Social Science and Philosophy of UP Diliman, made it possible to create training programs which empowered the academe in bioethics. In fact in the early years of 2000, a Diploma course in Bioethics was approved and offered through the collaborative efforts of UP Manila and Diliman campuses. Unwittingly, for what I consider to be totally less noble reasons, I took the Diploma course. My main reason was not to help promote research ethics specifically. It was really more for my professional development. At that time, I was already a tenured faculty member. But the trend in the academe was for younger members, even though not yet tenured, to proceed to obtain masteral and even doctoral degrees. My thought at that time was I didn’t want to be upended by younger colleagues. So I enrolled and finished the Diploma course in Bioethics. A year thereafter, the full Masteral course was approved and offered. I proceeded to re-enroll for the same main reason and motivation. It took me several years and 3 extensions of the maximum residency rules of the University before I was able to finish and defend my thesis, and get my Masteral degree in Bioethics!

The prime movers of the bioethics program UP Manila were from the College of Medicine headed jointly by Dra Marita Reyes and Dra Cecilia Tomas. Equal collaborators of the program were Professor Leonardo D. de Castro of the Department of Philosophy, College of Social Science and Philosophy in UP Diliman, among others. The multi-disciplinary collaboration made it possible for many others to establish the Social Medicine Unit (SMU) of the College of Medicine to administer to the MS Bioethics program. It also paved the way for the establishment of a coordinated and integrated system of research ethics review in UP Manila, called the UP Manila Research Ethics Board (UPMREB).

The UPMREB created several panels, each one practically a research ethics committee, with jurisdiction over various sectors of UP Manila: faculty of the College of Medicine (who conduct most of the basic and clinical trials); resident and fellow doctors of Philippine General Hospital; and faculty and students of the various other colleges. Using the same guidelines and standard operating procedures, all the panels of the UPMREB are able to review, approve and monitor all researches in UP Manila. It was also around this time, after my few years as chair of RIDO, that intense preparations were made for the accreditation of RIDO by the Forum for Ethics Research Committees in the Asia Pacific (FERCAP). With the efforts of Dra Evangeline Santos, professor of Ophthalmology and co-graduate of mine from the Diploma in Bioethics program, assisted by other staff of the College of Medicine, FERCAP accreditation was achieved. Subsequently, UPMREB and all its panels achieved the same accreditation.

In the meantime, a law (Republic Act No. 10532), called the Philippine National Health Research System (PNHRS) was enacted in May 2013 to coordinate and integrate all stakeholders in health research in the Philippines. It is through the force of this law that the scientific community outside the University through the Department of Science and Technology (DOST) of the Philippine government, in collaboration with the Department of Education and Culture through the Commission on Higher Education (CHED) and the Department of Health, asked the NIH of UP Manila to implement a Memorandum Order which mandates that all research involving human participants shall undergo review by accredited ethics research committees (by December 2015). The DOST, through the Philippine Council for Health Research and Development (PCHRD), designated the Philippine Health Research Ethics Board (PHREB) as the policy-making body with regards to the establishment, registration, accreditation and regulation of research ethics committees in the country. Henceforth, all academic institutions, all hospitals and health care facilities, and all entities doing health and health-related research involving human participants should submit their studies to PHREB-accredited research ethics committees for review, approval and monitoring. The main objectives are to assure that research participants are not harmed (but benefitted), and that research outcomes are credible.

The PHREB, under the chairmanship of Professor Leonardo D. De Castro, created two important committees: 1). Committee on Information Dissemination, Training and Advocacy (CIDTA); and 2). Committee on Standards and Accreditation (CSA). CIDTA was initially chaired by Dra Rosario Tan-Alora, professor of internal medicine, bioethics and former dean of the college of medicine in the University of Santo Tomas. I had the privilege of being a member of her committee, which conducted trainings for nearly all hospitals and academic institutions in the country. Trainings programs were on Basic Research Ethics, on Good Research Practice, and on Standard Operating Procedures. The objective was to enable participants to create and work in research ethics committees of their respective institutions, be they hospitals or academes. Very recently, Dra Alora decided to turn over the chairmanship of CIDTA to me, although she continues to be an invaluable member/mentor. And more recently, CIDTA is preparing to embark on including a Good Clinical Practice module among its training programs.

The other committee (CSA), initially chaired by Dra Cecilia Tomas, has been in charge of setting standards for research ethics committees all over the country, registering them, and assessing them for accreditation. Three levels of accreditation have been established by CSA: Level 1 are research ethics committees capable of reviewing all types of protocols, except clinical trials; Level 2 are research ethics committees capable of reviewing even clinical trials but not those for products intended for registration with the Philippine Food and Drug Administration (FDA). Both committees had been busy the past 2 years. From a few accredited research ethics committees a couple of years ago, there are now 72 all over the country, many of them Level 3! (See http://ethics.healthresearch.ph for a complete listing)

The Philippine Council for Health Research and Development (PCHRD), recognizing the existence of research projects whose proponents may not be affiliated with institutions with accredited research ethics committees, and in fact providing funds for some such projects, reactivated the National Ethics Committee (NEC). Chaired by Dra Marita Reyes, the NEC is essentially a research ethics committee composed of multi-sectoral recruited volunteers, myself recently included representing the medical field, which reviews research proposals referred to it by the Department of Health and PCHRD. In 2011, the PHREB published the National Ethical Guidelines for Health Research, providing written, country-specific guidelines on the ethical conduct of researches on various fields. (See nec.pchrd.dost.gov.ph). Currently, a technical working group headed by Dra Marita V.T. Reyes, with me as one of the members, is in the final stages of updating the guidelines for 2017!

My personal journey in the world of research ethics continues in my newly-assigned tasks of handling classes in the MS Bioethics graduate program, specifically handling Research Ethics and Research Ethics Review classes. From the one-man, practically ambush approval of my very first international research collaboration, to the current legislated and well-established research ethics system, I have been a privileged witness, albeit by twists of fate more than intent design on my part in many instances, to the evolving developmental history of research ethics in the Philippines. This narration is by no means the complete accurate picture. It is a humble and modest attempt to share a part of my career in the academe as a professional doctor taking care of patients, teaching younger colleagues, doing research on the side, and performing administrative functions.

I am grateful to Dr Gary Allen for the opportunity.

Submitted 16 April 2017.
Revised 24 April 2017 after obtaining permission (and more accurate inputs) from the persons whose names were included in the article.

Contributor
Ricardo Manalastas, Jr., MD, MSc (Bioethics) is a professor of Obstetrics & Gynecology, Infectious Diseases and Bioethics at the College of Medicine, University of the Philippines, Manila, and Attending obstetrician gynecologist at the Philippine General Hospital.
He can be reached by email at rmmanalastasmd@me.com  | rmmanalastasmd@yahoo.com

This post may be cited as:
Manalastas R. (2017, 24 April) Research Ethics in the Philippines: a personal journey. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/research-ethics-philippines-personal-journey

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