ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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Research Ethics MonthlyISSN 2206-2483

Training

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Hints for Using Worked Examples in Training Sessions0

 

First of all a frank acknowledgement by the AHRECS team – In the past we’ve merrily used invented applications/vignettes, sometimes with deliberately inserted defects, and de-identified real proposals (with permission) in the professional development activities we’ve facilitated. We did so as a way to help research ethics reviewers and researchers (but reviewers made up the overwhelming majority of these workshops) to spot mistakes and in doing so demonstrating they understood an ethical principle or a specific provision of a statement/code/policy. At the time we might even have congratulated ourselves on providing a real world practical activity rather than merely telling attendees what they should do.
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A couple of years ago each of us drew the same conclusion and were horrified – The use of ‘can you find the hidden flaw’ exercises was part of the reason for the adversarial climate between researcher and research ethics reviewers. They reinforce the message that the job of a research ethics review body is to find what’s wrong with a project, that members are being effective if they find something other members may have missed and that they should expect to find ethical defects: that is, an (unwarranted) assumption that participants need to be protected from researchers.
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As Jim notes, examples can be used positively in professional development activities for research ethics reviewers and researchers. Such activities can be used as a way to focus on congratulating researchers for novel or elegant solutions to ethics challenges, on facilitating rather than policing research, and how to achieve best practice in review feedback.
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Such examples should be used in all our professional development strategies.
The use of defective examples is dead. Long like the use of positive examples. 

Training sessions for new ethics committee members and new researchers frequently use a completed application as a fully-worked example of how to practically implement legislation, codes, and administrative processes.  There is now a solid body of scientific findings that can guide the effective use of worked examples in promoting learning and its generalisation to new situations.1  Based on these findings, here are three evidence-based hints:

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(1) Walk trainees through at least two completed ethics applications for related projects.  According to the available research, a single example will most likely cause new committee members to see it as an ideal exemplar that all applications must conform to.  Similarly, new researchers will tend to see a single example as an ideal template.  They may try to squeeze all their information into that template even if it metaphorically means pounding square pegs into round holes.  Enabling trainees to study, compare, and contrast two or worked examples dramatically increases understanding of the underlying principles and, more importantly, the ability to see analogies between the examples and new applications.2
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(2) The initial worked examples should be correct, particularly for new members and researchers who are not yet familiar with the legislation, codes, and administrative processes.  As familiarity increases, test cases with deficiencies can then be introduced for study and facilitated discussion.
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(3) The projects described in initial examples should be relatively simple while still being authentic.  Then, as understanding and skill increases, more complex worked examples and test cases can be introduced.4
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Given that the time allocated to a training session may be limited to a few hours, readers may wonder how they are going to find the time for extensively using examples while still covering the principles in the legislation, codes, and administrative procedures.  One way to free up time and promote a better linkage of the principles to ethics applications is to convert a lecture-based “just-in-case” approach to learning to an experiential, trainee-centred, “just-in-time” mode.  This conversion can be accomplished by providing a short (5-10 min) introduction that orients the audience to the main points to be covered.  Then, the principles can be brought out in facilitated discussions at relevant points during walk-throughs of the examples and test cases.
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  1. Renkl A: Toward an instructionally oriented theory of example-based learning. Cognitive Science 2014;38(1):1-37.
  2. Gentner D, Holyoak KJ: Reasoning and learning by analogy: Introduction. American Psychologist 1997;52:32-4.
  3. Stark R, Kopp V, Fischer MR: Case-based learning with worked examples in complex domains: Two experimental studies in undergraduate medical education. Learning and Instruction 2011;21(1):22-33.
  4. Paas F, Van Merrienboer J, Van Gog T. Designing instruction for the contemporary learning landscape. In: Harris IKR, Graham S, Urdan T, editors. APA Educational Psychology Handbook: Vol 3 Application to Learning and Teaching Washington: American Psychological Association; 2011. p. pp. 335-57.
    http://ro.uow.edu.au/cgi/viewcontent.cgi?article=1688&context=edupapers

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Disclosure of interests

I have no conflict of interest

Contributor
James Kehoe, PhD FRSN
Jim is a Professor of Psychology, UNSW, where his 49-year research career has spanned many areas of learning, memory, and training.  He has served as chair of the Animal Care and Ethics Committee and convener of the Human Research Ethics Advisory Panel (Behavioural Sciences)
Jim’s UNSW staff profileejameskehoe@gmail.com

This post may be cited as:
Kehoe J. (26 March 2018) Hints for Using Worked Examples in Training Sessions. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/hints-for-using-worked-examples-in-training-sessions

How can we get mentors and trainees talking about ethical challenges?0

 

When it comes to research integrity, the international community often tends to focus on the incidence of research misconduct and the presumption that the remedy is to have more training in responsible conduct of research. Unfortunately, published evidence largely argues that these perceptions are demonstrably wrong. Specifically, formal training in courses and workshops is much less likely to be a factor in researcher behavior than what is observed and learned in the context of the research environment (Whitbeck, 2001; Faden et al., 2002; Kalichman, 2014).

These research findings should not be surprising. Most of an academic or research career is defined by actually conducting research and working with research colleagues. The idea that a single course or workshop will somehow insulate a researcher from unethical or questionable behavior, or arm them with the skills to deal with such behavior, would seem to be a hard case to make. That isn’t to say that there is no value in such training, but the possible impact is likely far less than what is conveyed by the research experience itself. With that in mind, the question is how, if at all, can research mentors be encouraged to integrate ethical discussions and reflections into the context of the day-to-day research experience?

With this as a challenge, we have been testing several approaches at UC San Diego in California to move conversations about RCR out of the classroom and into the research environment. With support from the US National Science Foundation, this project began with a 3-day conference comprised of ~20 leaders in the field of research integrity (Plemmons and Kalichman, 2017). Our goal was to develop a curriculum for a workshop in which participating faculty would acquire tools and resources to incorporate RCR conversations into the fabric of the research environment. Based on consensus from the conference participants, a curriculum was drafted, refined with input from experts and potential users, and finalized for pilot testing. Following two successful workshops for faculty at UC San Diego, the curriculum was rolled out for further testing nationally with interested faculty.

The focus of the workshop curriculum was five strategies participating faculty might use with members of their research groups. These included discussions revolving around (1) a relevant professional code of conduct, (2) creation of a checklist of things to be covered at specified times with all trainees, (3) real or fictional research cases defined by ethical challenges, (4) creation of individual development plans defining roles and responsibilities of the mentor and trainees, and (5) developing a group policy regarding definitions, roles, and responsibilities with respect to some dimension of practice particularly relevant to the research group. In all cases, the goal is to create opportunities that will make conversations about the responsible conduct of research an intentional part of the normal research environment.

The results of this project were encouraging, but still leave much to be done (Kalichman and Plemmons, 2017). Workshops were provided for over 90 faculty, who were strongly complimentary of the program and the approach. In surveys of the faculty and their trainees after the workshops, there were high levels of agreement that the five proposed strategies were feasible, relevant, and effective. However, while use of all five strategies was high post-workshop, we surprisingly found that trainees reported high levels of use pre-workshop as well. In retrospect, this should have been expected. Since workshops were voluntary, it is likely that faculty who attended were largely those already positively disposed to discussing responsible conduct with their trainees. One question worth asking is whether repeating workshops for interested faculty only will have a cascading effect over time, drawing in increasing numbers of faculty and serving to shift the culture. Also, it remains to be tested whether these workshops would be useful if faculty were required to attend.

For those interested in implementing these workshops in their own institutions, the curriculum, template examples and an instructor’s guide are all available on the Resources for Research Ethics Education website at: http://research-ethics.org/educational-settings/research-context.

References

Faden RR, Klag MJ, Kass NE, Krag SS (2002): On the Importance of Research Ethics and Mentoring. American Journal of Bioethics 4(2): 50-51.

Kalichman M (2014): A Modest Proposal to Move RCR Education Out of the Classroom and into Research. J Microbiol Biol Educ. 15(2):93–95.

Kalichman MW, Plemmons DK (2017): Intervention to Promote Responsible Conduct of Research Mentoring. Science and Engineering Ethics. doi: 10.1007/s11948-017-9929-8. [Epub ahead of print]

Plemmons DK, Kalichman MW (2017): Mentoring for Responsible Research: The Creation of a Curriculum for Faculty to Teach RCR in the Research Environment. doi: 10.1007/s11948-017-9897-z. [Epub ahead of print]

Whitbeck C (2001): Group mentoring to foster the responsible conduct of research. Science and Engineering Ethics 7(4):541-58.

Contributors
Michael Kalichman – Director, Research Ethics Program, UC San Diego | University biomkalichman@ucsd.edu

Dena Plemmons | University of California, Riverside | University page

This post may be cited as:
Kalichman M. and Plemmons D. (2017, 21 December 2017) How can we get mentors and trainees talking about ethical challenges? Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/can-get-mentors-trainees-talking-ethical-challenges

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)

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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