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Undue Influence in Research Between High-Income and Lower-Income Countries0

 

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.

How do we ‘do’ consent?0

 

This blog post expands on ideas from our recent publication: McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.

Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.

Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.

After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?

Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.

Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.

This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.

So, consent doesn’t have to be boring.

But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.

These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).

For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.

These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.

So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.

I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.

We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.

Contributor
Rebekah McWhirter
Centre for Law and Genetics, Faculty of Law, University of Tasmania
http://www.utas.edu.au/profiles/staff/law/rebekah-mcwhirter

This post may be cited as:
McWhirter R. (26  August 2018) How do we ‘do’ consent?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/how-do-we-do-consent

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.

Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) – With interview0

 

The revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018) was released on 9 July 2018.

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Content of the updated National Statement

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement are updated as needed, in accordance with strategic planning, or in response to user feedback or national or international developments in research or ethics.

Since 2007, Section 3 of the National Statement has addressed ethical considerations specific to research methods or fields. The 2018 revision provides a new structure for Section 3, based on the elements of a research project (from conception to post-completion). The revised Section 3 begins with a chapter that addresses ethical issues in all research, followed by specialised guidance for research involving human biospecimens, genomics and xenotransplantation.

This approach emphasises that researchers, Human Research Ethics Committees (HRECs) and other users of the National Statement must take account of the principles and major themes in research ethics addressed in Sections 1 and 2 of the document as the foundation of the guidance in Section 3 and then, in turn, consider the guidance provided in Chapter 3.1 as a base for the guidance provided in the other chapters included in this section.

While significant changes have been made to all aspects of the guidance provided in Section 3, we note, in particular, the additional guidance that has been provided in relation to collection, use and management of data and information and to management of the findings or results arising from genomic research.

As part of this update, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of the revisions to Section 3.

Revisions to the National Statement were informed by working committees and through public consultation in accordance with requirements of the National Health and Medical Research Council Act 1992.

Currency and effective date

All users of the National Statement, including HRECs, research offices and researchers are expected to ensure that the current version of the National Statement is being used in developing research proposals, making submissions for ethics review and undertaking ethics review. However, as a consequence of the scope of the revisions to Section 3, we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019.

This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated, most recently, in 2015. To facilitate this transition, both the current version of the National Statement and the updated version are available on the NHMRC website at http://nhmrc.gov.au/guidelines/publications/e72.

Use of the National Statement is also linked to the Human Research Ethics Application (HREA), released in December 2016 to replace the National Ethics Application Form.

To coincide with the release of the revised National Statement, questions in the HREA will require revision and users of the HREA will be advised when the revised HREA is online.

Institutions and HRECs are encouraged to allow a transition period for researchers while the revisions to the HREA take effect. The provision of a transition period, how it will be managed and its timeframe are at the discretion of individual Institutions/HRECs.

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Context

Australia’s research integrity framework is underpinned by three national standards developed by NHMRC and its co-authors, the Australian Research Council (ARC) and Universities Australia (UA). Together these three standards provide guidance on responsible and ethical research conduct for both humans and animals.

The overarching document is the Australian Code for the Responsible Conduct of Research, 2018. The Code is the leading reference for researchers and institutions across all disciplines about the expectations for responsible research conduct and the handling of investigations into research misconduct. After 10 years in operation, the Code has been reviewed and the 2018 edition was released in June 2018. The other two documents are the National Statement and the Australian code for the care and use of animals for scientific purposes (also endorsed by CSIRO).


INTERVIEW

AHRECS (While we know it predated the recent work on s3) What drove the decision to conduct a rolling review, rather than a review of the entire document?

NHMRC During the revision of the National Statement that was completed in 2007, it was determined that a more flexible, more efficient approach to revising the document would be a good innovation. We wanted to be able to both respond to the needs of users for more limited changes – from a word, to a paragraph, to a single chapter – without having to review the whole document and to be able to integrate or modify the content in response to changes nationally or internationally in research, research ethics or government regulation. Review of the 1999 National Statement took three years from start to finish and we thought we could improve on that timeline! We have found that this approach has, in practice, enabled us to make both minor changes and significant changes to single chapters of the document, as well as to review one of the five sections of the document, as we have just done.

AHRECS Are there downsides to that approach?

NHMRC Yes, there are. The major downside is that the document is ‘of a piece’ and changes to any one part of the document invariably require consideration of changes to the other parts, not just in terms of cross-referencing, but in terms of the content itself. This issue of ‘consequential effect’ manifests itself in the need to ensure consistency in our guidance and to consider the impact on the whole document of more philosophical or conceptual changes that have been introduced by the changes. An example in the most recent revision of Section 3 is that our approach to interventional research in Section 3 had a ‘flow on’ effect to Section 5 in terms of where certain guidance belonged, how that guidance should reflect changes in the clinical research sector since 2007 and how it should reflect other guidance documents (e.g. related to safety reporting) that NHMRC has published in the last 12 months.

AHRECS What were you hoping to accomplish with the changes to section 3 (and Section 5 + the Glossary)? Was it achieved?

NHMRC Principally, we were hoping to facilitate a re-thinking on the part of users (researchers and HRECs, primarily) regarding how they conceptualise and address ethical issues in the design, review and conduct of the research. We began with a decision to abandon the idea of ‘categories’ or ‘types’ of research as the main way to package this guidance and to focus on the reality that most ethics guidance applies to ALL research, thereby requiring ALL researchers to consider it, rather than just going to their specialised chapter of the document and, potentially, ignoring the broader issues. We then settled on the ‘life cycle’ of a research project as the best structure – that is, from conception to post-completion stages of a research project. This also enabled us to see more clearly what was not general guidance and encapsulate that extra guidance in separate, specialised chapters that each required consideration of the general guidance as a prerequisite to fully understanding and implementing the specialised guidance content.

The changes that we made to Section 5 and the Glossary were a direct consequence of the revision of Section 3 and we purposefully did not introduce changes to those parts of the document that were independent of the Section 3 revision, even though it was pretty tempting to do so sometimes.

We do think that we achieved our objectives and we are very satisfied with the results of the review process.

AHRECS If you could say just one thing about the work to date what it be?

NHMRC Review of the National Statement, while challenging, involves very stimulating and satisfying dialogue with lots of researchers, reviewers and other users of the document. We are so committed to it that we are almost immediately taking on the review of Section 4 and Section 5 – so, watch this space!

AHRECS When someone says they would have liked examples to better illustrate the new concepts in the update how do you respond?

NHMRC A weaselly response would be: it depends on which new concepts you are talking about; but, to use one example, a good look at Chapter 3.3: Genomic research and the Decision tree for the management of findings in genomic research and health care that we included (on page 52) to address this complex issue provides just such an attempt to illustrate by example. The main impediment to using examples or case studies to illustrate concepts is the difficulty of deciding which concepts to illustrate and with how many examples, as well as potentially expanding the size of the document exponentially in order to do the examples justice.

AHRECS When will a html version be available online?

At present, the 2007 version of the National Statement (updated May 2015) is available in both PDF and HTML format; whereas the version updated 2018 is only available in PDF. We are not 100% sure when the HTML version of the National Statement (updated 2018) will be available, but we anticipate within the next two to three months. Please also note that the current address (https://beta.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1) is only temporary, which means that you’ll need to update your bookmarks/links again when the final version of the new NHMRC website is released in late August or early September.


 

This post may be cited as:
NHMRC (31 July 2018) Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview

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.

The complex art of benefit-sharing0

 

In community-based participatory action programs (programs which have a research component but which are also focussed on community development and empowerment), it might be possible to identify a link between a research project and a benefit to the participating community. Over and above conducting the study, in research on domestic violence, studies have provided emotional and practical support for victims, offering information about, and organizing access to, formal and informal services, providing feedback to the study community and relevant agencies, and supporting or engaging in advocacy on behalf of abused (Usdin et al. 2000). Work on victims of state violence has also advocated for broader political change (Stanley 2012).

However, in other circumstances it may be far more likely that participants may contribute to research but gain very little direct or even no benefit from it. The lack of reciprocity may be particularly problematic if participants are drawn from vulnerable groups.

For example, members of poorer communities have a right to feel aggrieved if research undertaken in their communities is only likely to be of benefit to wealthier societies. This is most obviously the case where multinational pharmaceutical corporations trial drugs or procedures in the Global South that are in the end likely to be priced out of the reach of participant communities or which were never relevant to their needs. Not surprisingly, therefore, the concept of benefit-sharing has been most widely developed in discussions of health and genetic research.

In response, international agreements and statements related to biomedical research such as the Declaration of Helsinki (from 2000 onwards) and non-human genetic and bioprospecting research such as the legally-binding Convention on Biological Diversity (1992), formalised in the Nagoya Protocol (Convention on Biological Diversity, 2010), instituted obligations relating to benefit-sharing for projects that fell within their jurisdiction. These agreements recognised that:

Those who contribute to developments in science and technology ought to share in the benefits, so if those benefits are not shared with the contributors to scientific advancement, that advancement is exploitative. (Arnason and Schroeder, 2013, p. 21)

As a result, the Nagoya Protocol pointed to the principle that research projects should offer benefits to participants. Non-financial benefits might include: sharing research results; collaboration, cooperation and contribution in research and development programmes, education and training; institutional capacity-building; contributions to the local economy; research directed towards priority needs of the participating community; institutional and professional relationships that can arise from an access and benefit-sharing agreement and subsequent collaborative activities; livelihood security benefits; and, social recognition. It is easy to imagine how such benefits, in the context of biomedical research, can be applied to social research; or, at least, it would be if social researchers were funded at the same level as biomedical researchers.

Unfortunately, the art of benefit-sharing has proved to be complex.

First, it might not be straightforward to identify what constitutes a benefit, particularly at the beginning of a researcher’s engagement with a new community. In her recent critique of transnational Feminist researchers, Rajan (2018) portrayed some external attempts at intervening in support of women’s rights in the Global South as ‘unfairly patronizing, or alternatively… ill-advised and characterized by a lack of sufficient knowledge of local context and concerns’ (p.271).

Second, it may not always be easy to work out what a particular community might regard as a fair way of sharing benefits. Even those projects that have sought to implement formal benefit-sharing arrangements have struggled to achieve a just and equitable distribution of benefits. For example, there is evidence that women have been marginalized in the negotiation and implementation of benefit-sharing arrangements, despite (and indeed because of) their additional susceptibility to exploitation within vulnerable communities. In addition, it is possible that some benefits aimed at individual participants might undermine commitments to respond to injustice at a macro-level and might even cause intra-community conflict. For instance, providing a participant family with additional food in a village where food is scarce may cause resentment among neighbours.

Third, some disciplines are less likely than others to generate tangible benefits and, even if they can, researchers may not be able to assure that the intended benefits of a research project will flow to participants. They may be particularly powerless in the face of powerful institutions whose job it is to restrict the freedom of participants. Zion et al. (2010), for example, argued that researchers seeking to work on projects on self-harm by asylum seekers funded by the Australian Commonwealth government were likely to be compromised. As asylum seekers are subjected to indefinite mandatory detention in Australia, Zion and her colleagues concluded that even projects aimed at improving the mental wellbeing of detainees risk legitimizing a detention regime that inevitably breached human rights.

Finally, acceptance of the importance of benefit-sharing arrangements is not universal. In 2008, the United States effectively opted out of the provisions of the Declaration of Helsinki that relate to ensuring that research participants must be allowed access to tested clinical interventions that were found to be successful and that research in low and lower middle-income countries must be designed to benefit local communities. Even before that time, there was little evidence that Institutional Review Boards in the US were taking the requirement seriously (Macklin, 2004).

So, benefit-sharing offers a way of directing both the outcomes and the process of research towards the pursuit of global and social justice. Unfortunately, a broader range of disciplines need to do more to develop and share strategies of benefit-sharing before we can have confidence that it has found a place in across our research programs.

Acknowledgements:

This article further develops an argument that will appear in Israel, M. & Fozdar, F. (in press) The ethics of the study of ‘Social Problems’ . In Treviño, J. & Marvasti, A. (eds) Researching Social Problems. New York: Routledge.

Bibliography

Arnason, G. and Schroeder, D. (2013) Exploring Central Philosophical Concepts in Benefit Sharing: Vulnerability, Exploitation and Undue Inducement. In Schroeder, D. and Lucas, J.C. (eds.) Benefit Sharing: From Biodiversity to Human Genetics. Springer. pp.9-31

Convention on Biological Diversity (2010) Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. http://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf

Macklin, R. (2004) Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press.

Rajan, H. (2018) ‘The Ethics of Transnational Feminist Research and Activism: An Argument for a More Comprehensive View’, Signs: Journal of Women in Culture and Society 43(2): 269-300.

Stanley, E. (2012) ‘Interviewing Victims of State Violence’ in Gadd, D., Karstedt, S. and Messner, S.F. (eds) The Sage Handbook of Criminological Research Methods. Sage: London. DOI: http://dx.doi.org/10.4135/9781446268285.n15

Usdin, S., Christfides, N., Malepe, L. and Aadielah, M. (2000) ‘The value of advocacy in promoting social change: implementing the new Domestic Violence Act in South Africa’, Reproductive Health Matters, 8(16): 55–65.

Zion, D., Briskman L. and Loff, B. (2010) ‘Returning to History: The Ethics of Researching Asylum Seeker Health in Australia’, The American Journal of Bioethics, 10(2): 48-56. DOI: 10.1080/15265160903469310

Contributor
Prof. Mark Israel
Senior consultant AHRECS – AHRECS Profile | mark.israel@ahrecs.com

This post may be cited as:
Israel M. (24 July 2018) The complex art of benefit-sharing. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-complex-art-of-benefit-sharing

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.