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Undue Influence in Research Between High-Income and Lower-Income Countries

 


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

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