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Constructive Voices Online Panels – Australian Code session 08/11/2018 – Information for registrants0

 

To register for this event complete the short form at https://zoom.us/webinar/register/WN_nsbPkzfbT6S4YWzeEekKxA

Date Panel members Questions
Australian Code

 

8th November at 14:30 AEDT MODERATOR
Mark Israel
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Jillian Barr 
(NHMRC)
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Kandy White (Expert Working Committee and Director, Research Ethics and Integrity, Macquarie University)
.
Gary Allen (AHRECS)
What are the responsibilities of institutions for implementation of the new Code?
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What steps should institutions take to meet these responsibilities?
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What would you like to see happen over the next two years in relation to the Code and Guides?

 

New South Wales Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia Thursday, 8 November at 11:30:00 am AWST UTC+8 hours
Australian Capital Territory Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Queensland Thursday, 8 November at 1:30:00 pm AEST UTC+10 hours
South Australia Thursday, 8 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory Thursday, 8 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria/Tasmania Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand Thursday, 8 November at 4:30:00 pm NZDT UTC+13 hours

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The panels run for 30 minutes. Each panellist has been asked to speak for five minutes on a particular question.

The panels will include a discussion of how institutions and researchers might best respond to the new Australian Code. The discussion will be partly based on

1. Questions submitted in advance to ACburningquestion@ahrecs.com – please consider doing so now, as it may allow panellists to provide you with better prepared answers

2. questions raised through the Q&A feature on Zoom

You’ll need to make sure that you have Zoom as an app on your device or access to Zoom on the internet. Login details will be sent to registrants.

You’ll have access to a website page after the seminar where panellists may leave further materials. We’ll also be distributing a questionnaire asking you about what worked, what didn’t work and what you’d like future sessions to cover.

I look forward to you joining the audience online.

Prof. Mark Israel
Moderator

Constructive Voices Online Panels0

 

The NHMRC, ARC and Universities Australia have had a busy 2018. Among other things, there is a new Australian Code for the Responsible Conduct of Research and the National Statement on Ethical Conduct in Human Research has been revised.

AHRECS will be running two free Constructive Voices online panel discussions in November. The first will consider the new Australian Code (8th November) and the second the recent changes to the National Statement (22nd November).

Our observations of Australian institutions indicate it is easy either to do too much in response and end up with excessive bureaucratic requirements that make research harder, or do too little and risk institutional exposure to regulatory censure. The panels will last for 30 minutes and will include briefings from representatives of the NHMRC, and discussion of how institutions and researchers might best respond to the changes.

If you are interested in joining the online audience, you can register here where you will also find out more about the panellists. Details about joining the Zoom meeting will be circulated near the time.

If you would like to ask a question of the panel members, you can use the Q&A feature within Zoom during the meeting. However, you are more likely to gain a more considered answer if you email your question in advance to ACburningquestion@ahrecs.com (for the Australian Code) or  NSburningquestion@ahrecs.com (for the National Statement).

Feel free to circulate this message to interested colleagues. We look forward to the possibility of seeing you there.

Topic Date Panel members Questions
Australian Code

 

8th November at 14:30 AEDT Jillian Barr (NHMRC)

Kandy White (Expert Working Committee and Director, Research Ethics and Integrity, Macquarie University)
Colin Thomson (AHRECS)

What are the responsibilities of institutions for implementation of the new Code?

What steps should institutions take to meet these responsibilities?

What would you like to see happen over the next two years in relation to the Code and Guides?

National Statement 

 

22nd November at 14:30 AEDT Jeremy Kenner (NHMRC)

Wendy Rogers (Chair National Statement Review Working Group, Macquarie University)

Pamela Henry (Chair of ECU, Human Research Ethics Committee)
Gary Allen (AHRECS)

What’s new?

How could researchers use and benefit from the changes?

How could HRECs use and benefit from the changes?

 

Are you attending the ‘Constructive voices’ panel discussions in November about the 2018 changes to the Australian Code and National Statement on Ethical Conduct in Human Research?0

 

Just a reminder these online discussions are free, but you will need to RSVP. Details below. Recordings of the sessions will be available from our subscribers area (https://www.patreon.com/ahrecs).


Australian Code (2018) – 8 November 2018
https://www.nhmrc.gov.au/guidelines-publications/r41

New South Wales Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia  Thursday, 8 November at 11:30:00 am AWST UTC+8 hours
Australian Capital Territory Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Queensland Thursday, 8 November at 1:30:00 pm AEST UTC+10 hours
South Australia Thursday, 8 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory Thursday, 8 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria  Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand  Thursday, 8 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Mark Israel
Guests: Jillian Barr (NHMRC) and Kandy White (Expert Working Committee and Director, Research Ethics and Integrity, Macquarie University)
Voices: Prof. Colin Thomson AM
Rapporteur: Dr Gary Allen

To RSVP:
Yes.AC_081118@ahrecs.com



National Statement (Updated 2018) – 22 November 2018

https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

New South Wales Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia  Thursday, 22 November at 11:30:00 am AWST UTC+8 hours
Australian Capital Territory Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
Queensland Thursday, 22 November at 1:30:00 pm AEST UTC+10 hours
South Australia Thursday, 22 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory  Thursday, 22 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria  Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand  Thursday, 22 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Colin Thomson AM
Guests: Jeremy Kenner (NHMRC), Professor Wendy Rogers (Chair National Statement Review Working Group, Macquarie University) and Associate Professor Pamela Henry (Newly appointed Chair of the ECU, Human Research Ethics Committee)
Voices: Dr Gary Allen

To RSVP:
Yes.NS_221118@ahrecs.com



PROFILES:

Dr Gary Allen (AHRECS)

Gary is a member of the National Statement Review Working Group and chaired the committee that drafted the revision to NS Chapter 3.1. He is the Managing Director of, and a Senior Consultant with, AHRECS. Gary has worked in the human research ethics and research integrity spheres since 1997. He was formerly a member of the NHMRC’s Australian Health Ethics Committee. Gary holds a social science doctorate and a bachelor of education.
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Jillian Barr (NHMRC)

Jillian Barr is the Director of Ethics and Integrity NHMRC. Jillian’s work involves developing a range of ethics guidelines and research standards including the recently released 2018 Australian Code for the Responsible Conduct of Research, the National Statement on Ethical conduct in Human Research and animal ethics guidelines. Jillian’s team is responsible for providing policy and guidance for Human Research Ethics Committees in Australia and for supporting the Australian Health Ethics Committee. Jillian is also responsible for research integrity matters that relate to research involving NHMRC funding.
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Associate Professor Pamela Henry

Associate Professor Pamela Henry is the Director of the Sellenger Centre for Research in Law, Justice and Social Change at ECU. She is also a newly appointed Chair of the ECU, Human Research Ethics Committee. Her role as the Director of the Sellenger Centre has seen her develop an extensive body of research in policing focused on integrity, use of information management systems, human source recruitment and management, use of force, policing those experiencing mental illness, and other programs of research examining the effectiveness of police operational deployment models. She also holds a PhD in Psychology.
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Professor Mark Israel (AHRECS)

Mark provides advice to higher education institutions, research agencies, government and non-government organisations in Australia, Hong Kong, New Zealand, Taiwan, the United Kingdom and acts as an ethics reviewer and rapporteur for the European Research Council

As an Executive Director of and Senior Consultant with Australasian Human Research Ethics Consultancy Services, he works on institutional policy and practice in relation to research ethics and research integrity. Mark was a member of the Australian National Health and Medical Research Council’s Working Party responsible for revision of Section 3 of the National Statement. He was professor of law and criminology at Flinders University and University of Western Australia

He has a degree in law and postgraduate qualifications in sociology, criminology and education from Oxford (DPhil), Cambridge (MA, MPhil) and Flinders Universities (MEdStudies) respectively. He has over 90 publications in the areas of criminology and socio-legal studies, higher education policy and practice, and research ethics and integrity. His recent books include Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance (Sage, 2015).
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Jeremy Kenner (NHMRC)

Jeremy is Expert Advisor for Ethics at NHMRC. At NHMRC, he contributes to the development of guidelines and advice on matters related to health and research ethics, research integrity and governance and clinical trials. Jeremy’s experience includes ethics administration at Peter Maccallum Cancer Centre, multiple roles in education and law practice. His various loyalties extend to Melbourne, Tasmania, Canada and the U.S
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Professor Wendy Rogers (Professor of Clinical Ethics, Macquarie University)

Wendy Rogers is Professor of Clinical Ethics at Macquarie University and Deputy Director of the Macquarie University Research Centre on Agency, Values and Ethics, with strong interests in healthcare policy and practice. During her first term on the Australian Health Ethics Committee she served on the working party responsible for the 2007 revision of the National Statement. Since 2010, she has been Chair of the working party on the current rolling revision of the National Statement. Her research interests include over diagnosis, ethics of surgical practice and research, transplant abuse and vulnerability.
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Professor Colin Thomson AM (AHRECS)

Colin Thomson AM is a senior consultant with Australasian Human Research Ethics Consultancy Services Pty. Ltd. (AHRECS) and a former Professor in Health Law and Ethics in Graduate Medicine, University of Wollongong and positions in law faculties at the Australian National University and the University of Wollongong.

He was a member of the Medical Research Ethics Committee of the National Health and Medical Research Council (NHMRC), a member and chair of the Australian Health Ethics Committee and Consultant in Health Ethics to the NHMRC.

As a consultant, he conducted training for human research ethics committees (HRECs) in State Health departments in Queensland, NSW, Victoria and Tasmania and in universities in all States and territories; certification assessments for the NHMRC National Certification Scheme and advised government departments in the Commonwealth, NSW and Victoria.

He has been a member and chair of multiple HRECs in universities, local health districts, government departments and public sector agencies.

In 2018, he was made a Member of the Order of Australia for services to medical research and research ethics.
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Dr Karolyn (Kandy) White

Kandy is the Director, Research Ethics and Integrity at Macquarie University. Kandy has taught research ethics to undergraduate and postgraduate student both in Australia and overseas as well as to ethics committee members. She Chairs a Social Science and Humanities Human Research Ethics Committee. Kandy has been the Chair of the AEN Advisory Group, co-convenor of ARMS Research Ethics and Integrity SIG, a member of the national Code Review Committee established to revise the Australian Code and Chair of the Better Practice Guides (BPG) working group responsible for developing the Investigation Guide.
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Undue Influence in Research Between High-Income and Lower-Income Countries3

 

Red Thaddeus D. Miguel

According to the Belmont Report (1979), respect for persons incorporates two ethical convictions: individuals are to be treated as autonomous agents, and those with diminished autonomy are entitled to protection.

It is because of these guiding principles that we, researchers and health practitioners, are extremely careful in planning and designing our research on populations who are more likely to have diminished autonomy. We endeavour to protect vulnerable groups in our studies because their circumstances make them more susceptible to being taken advantage of. To do otherwise, according to Gillet (2008), would simply be selfish and would be acting in bad faith. In fulfilment of their mandate, ethics review boards likewise have clear guidelines in the protection of vulnerable populations. Unlike protocols for the protection of minors, pregnant women, prisoners, terminally ill, intellectually challenged, and militarized to name some of the most common guidelines for vulnerable populations, guidelines for impoverished population may be more difficult to construct. As laid out by the Guidelines for Good Clinical Practice (1996, p.8), impoverished persons may have the propensity to be unduly influenced by the expectations of benefits associated with participation. But how does one judge whether a token for participation is enough to influence the decision of a person? For children, for example, being below a certain age is understandably a reason to protect the child’s interest and warrants the use of assent forms. However, for the economically disadvantaged drawing the line is more difficult to assess.

Some studies have questioned whether incentives impair the ability of participants to make decisions about risk. These claims have cited the studies of Halpern et al. (2004) and Bentley and Thacker (2004), which find participants are not likely to forego the risks of participation when offered greater compensation.However, these findings were based on hypothetical enrolment and were done with small sample sizes. More important for this discourse, however, is that these studies were done in developed countries. In a study by Kass et al.(2005), participants of studies implemented in developing countries (LMICs) were noted not only to be facing challenges in understanding the study protocol thus affecting their autonomous decision making, but were also noted to participate primarily because of the incentives presented.As Benatar (2002) notes great disparities exist in health and wealth between developed and developing countries and therefore ethical standards must take into consideration the differences and adapt to the rising level of research in developing countries.

Recognizing the imbalances of power, resources, and knowledge that exist in the setting of research between high-income and lower-income, the Global Code of Conduct for Research in Resource-Poor Settings (2018) outlines guidelines to avert ethics dumping in lower-income setting. Article 6 of the guidelines tackle specifically the topic of compensation and benefits, ‘Researchers from high-income settings need to be aware of the power and resource differentials in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue’.

Coming from an LMIC, I could not agree more with the guidelines set. In gauging the amount for benefits, one has to be careful with the amount being paid to participants for their involvement so as not to cause undue influence to those who wish to participate in the study; including the local parties into the dialogue is therefore vital to upholding ethical standards. What is acceptable in one country may cause undue influence in another, especially to economically disadvantaged persons in LMICs. Moreover, even within the LMIC itself, interactions between researchers from a high-income region and participants from a low-income area likewise pose some problems and therefore knowing the local factors that could cause undue influence is important.

In the Philippines for example, a number of factors are involved when it comes to deciding the amount of compensation. For example, the daily minimum wage in one area of the Philippines is 265.00 Philippine Pesos (~AUD7), while in other areas this could be as high as 512.00 Philippine Pesos (~AUD13). For this reason, I have been involved in a study that handed out supplies worth 40 Philippine Pesos (~AUD1), yet in another study we thought it was appropriate to hand out 1,000 Philippine Pesos (~AUD25). In making our decision as to how much to pay participants, we conduct our research based on the principles set forth by the Philippine Health Research Ethics Board’s National Ethical Guidelines for Health and Health-Related Research (2017, p.20):

35.4 Research participants shall be reimbursed for lost earnings, travel costs, and other expenses incurred when taking part in a study. Where there is no prospect of direct benefit, participants may be given a reasonable and appropriate incentive for inconvenience. The payments shall not be so large as to induce prospective participants to consent to participate in the research against their better judgment (undue inducement).

With this we make sure that our computation includes all the components set forth by this guideline, thus we try to include lost earnings, reimbursement for travel, incentives, and other expenses incurred by the respondent. In valuing exactly how much each of these costs, we don’t have a memorandum on the exact cost to follow instead we rely heavily on the nature, population, and area of the study.

Upon discussing this topic with two of my colleagues I find that we share similar techniques in estimating the value of each of the cost. Other researchers in the country may have different techniques, but the following are a few of the methods I have compiled from discourse with my colleagues on how to approximate the amount to compensate the participants.

  1. First, we get to know the population of interest very well. This includes taking into consideration the cultural, historical, and geographic background of the region, province, city, municipality, and town. Towns inhabited by people of a certain religion for example should not be brought a specific type of food. Another example could be that because of the terrain of a certain town, getting to the interview may mean riding a motorcycle for an hour. Knowing this we will be able to estimate the reimbursement of travel better.
  2. Different areas at different times of the year will have different needs as well. Therefore, we make sure to take this into consideration. For example, if we know that classes are about to start in one area, we might offer school supplies to participants. Similarly, if it is the rainy season, one could probably give out umbrellas to respondents.
  3. Knowing the region, a general rule of thumb one of my colleagues utilizes is to base his computation on the regional minimum wage published and updated by the Department of Labor and Employment. Using the published minimum wage, he then computes the hourly wage and makes this the maximum compensation for every hour of participation.
  4. Another practice done is to discuss the amount with local government units. Talking to the officials in the town, we are able to gauge the average income of their residents as well as the usual occupation in the area.
  5. We also take into consideration the type of study being done and the inconvenience it could cause. For example, a more difficult questionnaire asking very specific points in the timeline of the patient’s disease may warrant higher compensation than a simple demographic survey.
  6. We talk to researchers or local data collectors who have done studies with the same population, or who have undertaken the same method. Knowing how the respondents reacted to a specific amount of bother fee in the past gives us a benchmark for our studies.
  7. During the conduct of pre-testing our tools, we likewise ask our colleagues for an estimate that they believe would be a reasonable compensation for participants who would answer the questionnaire.

After we have the appropriate ‘bother fee’ in mind, we then submit this to the research ethics committees responsible for the study area. We are then given feedback whether the amount is appropriate and reasonable.

This system seems to be working largely because of the safeguards and competency of local research ethics committee and partly because of our familiarity with the system being locals ourselves. However, I cannot help but wonder how the increasing number of research projects in developing countries can affect this process. With more studies being done in LMICs maybe there is now a need to perform research into this area specifically on the exact amount or situations wherein undue influence can unintentionally occur. For example, with the theories of colonial mentality, does research done by non-Filipinos affect the responses or even influence the participation of respondents in studies done in the Philippines? Due to the volatile weather in the Philippines affecting the prices of commodities every month, does the bother fee deemed appropriate in one month still assure that there won’t be undue influence in the other months? Does the status of diplomatic relations between other countries and the Philippines affect the decision of participants when dealing with researchers from another country? Are there undue influences caused by the perception of Filipinos about certain companies funding the studies?  Will the reputations of certain institutions or organizations leading the study cause participants to participate even if normally they would not have agreed to do so? Could certain areas in the Philippines be more susceptible to undue influence than other areas due to the large gaps in income and health services between regions? Knowing these may be helpful to local researchers and those who wish to do studies locally by providing us with evidence-based standards that could guide our data collection process away from undue influence.

The author declares that he has no affiliations with or involvement in any organization or entity with either financial or non-financial interest in the subject matter or materials discussed in this manuscript. The author has no conflict of interest.

Bibliography

Benatar SR (2002) ‘Reflections and recommendations on research ethics in developing countries’, Social Science & Medicine,1131–1141.

Bentley JP and Thacker PG (2004) ‘The influence of risk and monetary payment on the research participation decision making process’, Journal of Medical Ethics,200430293–298.

Gillett G (2008) ‘Autonomy and selfishness’Lancet, 372(9645):1214-5. https://doi.org/10.1016/S0140-6736(08)61507-X

TRUST Project (2018) Global Code of Conduct for Research in Resource-Poor Settings.http://www.globalcodeofconduct.org/ (Accessed September 8, 2018).

Halpern SD, Karlawish JHT, Casarett D, Berlin JA and Asch DA (2004) ‘Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials’, Journal of the American Medical Association Internal Medicine, 164801–803.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use (June 10, 1996)ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1) Current Step 4 version. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (Accessed September 8, 2018).

Kass NE, Maman S and Atkinson J (2005) ‘Motivations, Understanding, and Voluntariness in International Randomized Trials’, IRB: Ethics & Human Research, 27(6):1-8.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, Md.: The Commission. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html (Accessed August 20, 2018).

Philippine Health Research Ethics Board (2017) National Ethical Guidelines for Health and Health-Related Research, Department of Science and Technology – Philippine Council for Health Research and Development, p.20. Available at: http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg?download=98:neghhr-2017 (Accessed September 8, 2018).

Contributor
Red Thaddeus D. Miguel, Health Policy Researcher, Ontario, Canada
LinkedIn profileredasmph@gmail.com

This post may be cited as:
Miguel, Red TD. (27  September 2018) Undue Influence in Research Between High-Income and Lower-Income Countries. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/undue-influence-in-research-between-high-income-and-lower-income-countries

We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.

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