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

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Terms and conditions apply0

 

Kids tell us that making decisions can sometimes be hard (anyone who has taken a child to an ice cream shop can attest to this). Adults don’t often give children choices and kids tell us that when they do it can be confusing: ‘what am I being asked?’, ‘can I really say no?’, ‘do they seriously care?’ and ‘what will happen if I make a decision the adult doesn’t like?’ are questions that might spring to mind. After all, they tell us that it’s not usual for adults to seek out children’s views, to let them make big decisions or to give up some of their ‘adult power’ and act on children’s wishes.

And yet children are required to ‘assent’ to research, often with little information about what research actually is and what they will be required to do. In most cases, they know that their parents have already given permission for them to be involved – which may be reassuring but also a bit daunting (how often is it that kids can say ‘no’ when their parents have already said ‘yes’?) – but in most cases a complete stranger comes into their home or schoolroom and pulls out a note pad and asks them whether their happy to answer a few questions. “Um OK?”

Since the Helsinki Declaration there has been an expectation that children provide assent to their participation in research. Often this entails providing them with a long-winded, legalistic and ‘pretty boring’ information letter, telling them that if they agree they might get a movie voucher or at least a packet of chips and a can of soft drink before asking them to tick a box to show that they agree. As a child in one of my studies reported, the process is ‘kinda like’ the terms and conditions process they go through when downloading a new app from i-Tunes. Like 73% of Terms and Conditions non-readers, kids in research often have no idea what they are signing up for and what their rights are when things go wrong.

In a recent study my colleagues and I conducted for the Australian Royal Commission into Institutional Responses to Child Sexual Abuse we got advice from children and young people about how to best help kids understand and consent to participating in research on a fairly sensitive topic. Based on this advice we conceptualized consent as an ongoing process that included six steps: (1) present information in a child-friendly and accessible way; (2) make sure they understand what research is and what they are expected to do; (3) give them the choice to participate (or not) and ask them to formally agree; (4) give them lots of opportunities (and the skills or tools) to bow out of the research (particularly after they’ve got a ‘feel’ for what they are being asked to do) or to change the way that they are participating; (5) be aware of the ways that kids resist or ‘dissent’ (yawning or sneaking out of the room might give it away) and constantly ‘check in’ with them in child-friendly ways (6) Get an agreement with them at the end of the research activity that they are still happy for their input to be included in the study and negotiate what, if anything, they’re happy for the researcher to share with their parent, teacher or older sibling who is standing behind the door.

In the paper “More a marathon than a hurdle: towards children’s consent in a safety study” my colleagues and I outline how we went through these steps with kids, we describe how we used felt toys, ‘stop signs’ and ‘rights posters’ to help children and young people consent and, most importantly, quote advice and feedback from children and young people on how adult researchers might best help kids to make decisions within the research context.

One tool we feature in the article is our “Charter of Rights” poster which we provide kids in our studies. The poster informs them of what they should expect from us, as researchers, and what to do if they are unhappy. The poster is given to the children prior to them meeting with our staff and is further explained before assent is sought. On the advice of children and young people who have advised our projects, the rights charter has also been used as the basis of a series of games and activities that can be used to help children understand their rights in research (and in welfare practice). More detail about these can be found here. My team at the Institute of Child Protection Studies are working with peers from the Centre from Children and Young People (Southern Cross University), UNSW and the University of Melbourne to progress ethical research with children and young people. We’re currently hosting a survey on ethical decision-making – take a minute to fill it in! We’re keen to chat with others who are grappling with how to meaningfully engage kids in research (and support them to make good decisions) and would love to hear from you. *Terms and Conditions Apply.

Contributor
Dr Tim Moore
Senior Research Fellow | Institute of Child Protection Studies, ACU
Bio page at ACUTim.Moore@acu.edu.au

This post may be cited as:
Moore T. (2017, 21 July) Terms and conditions apply; Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/terms-conditions-apply

Professional Development across the Term of an HREC Committee Member0

 

AHRECS has considerable experience working with universities, hospitals, research institutions, government and non-government organisations to care for and build the capacity of its HREC Committee members across the entire term of their appointment. We start with the needs of our clients and offer support from recruitment all the way through to running an exit interview.

Many HRECs have quite simple manual-based inductions; we help HRECs to create something more welcoming and interactive that takes members from first contact to the point where they can contribute effectively to a committee. There is a significant difference between delivering a single ‘training session’ and creating a suite of professional development activities over two to three years, that covers committee members’ terms, and that might include dedicated annual PD and Strategy sessions and incorporate ongoing PD into each HREC meeting.

We can:

  • help recruit expert external members to meet the needs of specific HRECs
  • create interactive and multi-media induction and orientation materials
  • introduce members to the broader literature on research ethics
  • create material and run professional development sessions tailored to the specialist roles of particular HRECs
  • evaluate the performance of the HREC and provide feedback to the HREC and its host institution
  • offer exit interviews to HREC members stepping down from their role, and then….
  • help recruit replacement members to HRECs

We have provided elements of such services in Australia, Canada, Mauritius, New Zealand, Taiwan, United Kingdom, United States and Vietnam for new and established, small and large institutions and consortia of research organisations.

Contributor
Prof. Mark Israel, AHRECS senior consultant
AHRECS profile page
mark.israel@ahrecs.com

This post may be cited as:
Israel M. (2017, 22 June) Professional Development across the Term of an HREC Committee Member. Research Ethics Monthly. Retrieved from: https://ahrecs.com/services/professional-development-across-term-hrec-committee-member

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

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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