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Is ethical review a barrier to research on violence against women and violence against children in low and middle income countries?

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Is ethical review a barrier to research on violence against women and violence against children in low and middle income countries?

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Introduction

Violence against women (VAW) and violence against children (VAC) are sensitive topics. Undertaking research in these areas poses some unique methodological and ethical challenges, including issues of safety; confidentiality; and researcher skill and training. The physical safety and psychological well-being of research participants and the research team alike can be put at risk if adequate precautions are not taken. Furthermore, the quality of data may be impacted if researchers do not take adequate measures to address the range of ethical and safety challenges posed by such research. However, accessing appropriate ethical review processes can be challenging, particularly in low- and middle-income countries (LMICs).

This blog outlines the inequities and barriers that researchers in LMICs face in accessing and benefiting from ethical review processes. We draw on our experiences as researchers and research facilitators in the fields of VAW and VAC in LMIC contexts and make recommendations for improved research supports and infrastructure.

Why obtain research ethics approval?

The requirement that research on VAW and VAC must obtain ethical approval before the commencement of a study is a core part of VAW and VAC researcher training.  Approval by a Research Ethics Committee (REC) or Institutional Review Board (IRB) helps to ensure the quality and safety of research and provides reassurance to participants, researchers, employers, funders, and the wider academic and practice community. It provides a level of assurance that research will do no harm and all efforts have been taken to protect the rights, welfare and dignity of the people who agree to be a part of research projects.

Beyond the primacy of protecting research participants, ethical approval from an appropriate REC or ethical board is increasingly required for researchers to submit a paper for publication in peer review / academic journals, and for the release of funds (e.g., by donors, universities, and research institutions) for research. Journals serve as a crucial avenue for disseminating research outcomes, and in recent times, it has become common for journals to require proof of REC endorsement before considering a paper for publication. This requirement may involve a comprehensive evaluation of the proposed research project or a similar procedure aimed at confirming a research proposal poses minimal risk.

Although essential for the reasons noted above, obtaining research ethics approval from a properly constituted, nationally recognised REC can be a challenge for researchers in LMICs, for a range of reasons. These include:

  • The availability and accessibility of appropriate RECs through university, hospital or other institutions
  • Expertise of REC members to evaluate and advise VAW/VAC researchers in LMIC contexts
  • Conflicts between stringent REC criteria and local mandates in research locations, i.e., conflicts between international RECs and local RECs, and / or local expectations of how research should be conducted.

We examine these challenges below.

Who gets access to ethical review?

Ethical review systems exist in most LMICs. Researchers studying public health related matters such as VAW and VAC, are often obligated by government regulatory systems to apply for ethical review and approval with a relevant local authority. In cases where such systems are absent within a specific country, researchers can pursue ethical endorsement via locally situated universities, government-funded bodies, or officially acknowledged research councils (which might also encompass certain private RECs). Researchers generally require some form of affiliation to obtain approval through such institutions, which can impose constraints on accessibility, particularly for early-career researchers. Access to these in-country review processes can be problematic for researchers and / or practitioners located within an NGO or working as independent consultants. Sometimes access is not possible at all; or comes at considerable cost; or involves opaque, highly bureaucratic processes (Alemayehu, Mitchell, & Nikles, 2018).

Limited access to funding (Shinkafi, 2020), including the fees charged for ethics review (Baluku, et al., 2021) is a substantial barrier to research in LMICs. The cost of ethics review through university or government bodies can vary greatly. For example, the fee for non-affiliated researchers for ethics review from one Kenyan university is USD1000 (MKU, 2021), whilst the Malawian government charges non-Malawian researchers a USD150 upfront fee, plus 10% of the total research budget (NHSRC, 2023).

Furthermore, researchers can face layers of bureaucratic complexity and opaqueness.  A study comparing ethical review committees and processes across four different countries (Burkina Faso, Palestine, Peru, and the Democratic Republic of the Congo) found a lack of standardisation of application requirements and significant variation in processing time, fees and committees’ structure and function (Sambiéni, 2018). While this is not unique to LMICs, the researchers concluded: Most often, their [RECs] cumbersome and sluggish approach to organizing the review of dossiers delays the implementation of studies” (Sambiéni, 2018, p. 58).

Academic and bureaucratic literacy present further barriers to access. For many researchers, especially those engaged in practice-based research (such as clinicians, frontline workers, or programme implementers), and those from historically marginalised backgrounds (such as researchers with disabilities, researchers who work primarily in languages other than English, researchers from indigenous populations, etc.), the procedures to obtain ethics approval can be onerous, potentially creating additional access barriers for non-academics who are unaccustomed to academic/research language (Wolf, Walden, & Lo, 2005). Lack of specialist knowledge on VAW and VAC research on ethic boards can also be a major hurdle for obtaining ethical approval. Some ethics boards can be hesitant to approve research on VAW and VAC because of the potentially greater risk of harm or distress that could be caused by the research (Sikweyiya & Jewkes, 2011). This hesitancy can stem from a fundamental lack of understanding about the safety needs in VAW/VAC research on the part of IRBs (Sikweyiya & Jewkes, 2012). RECs that lack specialist VAW and VAC expertise and knowledge on methods that have been built up over many decades, may be hesitant to grant approval, resulting in ethical, rigorous and important research not being approved (Cook, et al., 2022). Conversely, a REC may approve unsafe research, due to a lack of expertise on VAW/VAC and the methods for conducting safe, ethical VAW/VAC studies (Sikweyiya & Jewkes, 2011).

Finally, even when ethics approval is granted, unrealistic standards can be applied, such as unnecessary procedural delays, or unrealistic methodological adaptations (Falb, Laird, Ratnayake, Rodrigues, & Annan, 2019). Again, these oftentimes are the result of the lack of specialist knowledge of VAW/VAC research (Falb, Laird, Ratnayake, Rodrigues, & Annan, 2019; Hellmuth & Leonard, 2013). These can add lengthy costs and delays to the research and can make REC approval an unappealing process, with many researchers opting to forego the process altogether. This can lead to “IRB shopping”, whereby researchers seek an alternative REC to approve their research should they receive unfavourable outcomes from an ethics board (Spellecy & May, 2012).

What to do when there is no ethics board?

In situations where there is no formal ethical review board available, conducting ethical research can be challenging. In such situations, researchers and practitioners could:

  • Align with Existing Guidelines. Ensure research conforms to existing guidelines for human research (CIOMS, 2016) and existing guidance about VAC and VAW research, and research in LMIC.
  • Seek External Guidance. Consult with ethical experts, and / or seek approval from a local or national government authority (van Teijlingen & Simkhada, 2015).
  • Establish a Local Advisory Group. Create a local advisory board to provide guidance and contextual knowledge on the research setting and to identify ethical principles to guide the research (Mannell, et al., 2023).
  • Engage with Ethical Review Bodies in LMICs. Explore the possibility of involving ethical review bodies in other LMICs to undertake the review.
  • Thoroughly Document Ethical Considerations. This documentation can be instrumental in establishing the ethical rigor of the study.

Whilst these options provide a proxy for ethical review, none of them are ideal. One notable limitation is that they do not resolve the fundamental challenge researchers encounter—being unable to publish their findings in peer-reviewed journals if they lack access to formal ethical review through an established ethical review framework. They are, however, helpful in ensuring that critical ethical guidance and expertise is shared with researchers and provide options other than foregoing ethical review, and more importantly appropriate consideration of ethics and ethical practice, altogether.

Final thoughts

Ethical review should not end at receipt of ethical approval or at having undertaken all or one of the above suggestions. Ethics should be built into the design, completion, and reporting lifecycle of a research project.  This process must be seen as more than a burdensome, bureaucratic tick-box exercise. It should, rather, be viewed as a genuine process of protecting the quality, safety and rigour of the research and a means to mitigate any real, potential or perceived risks to participants, researchers, communities and the public.

Appropriate ethical review should be the gold standard for research conducted in LMICs on VAC and VAW issues. Where this is available and accessible, this should be used for all research, including evaluations and implementation studies. Where research ethics review is not available, there needs to be work by policy makers, academics, not-for-profits, peak bodies, and other key stakeholder groups to strengthen and build the availability of high standard RECs and to address access barriers, especially for practitioners and researchers outside of academic settings.

Authors: Elizabeth Dartnall1, Sarah Homan2, Kevin Lalor3, and Chi-Chi Undie4

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About the Authors

  1. Elizabeth Dartnall is Executive Director of the Sexual Violence Research Initiative. Liz is committed to making sure research and knowledge building is an essential part of development. And to addressing the deep inequalities in research infrastructure so that adequate resources reach LMICs countries to build evidence based on their own contexts, need and realities – evidence that allows us to reduce and ultimately end violence in every country, context, and community. To provide feedback or comments on this blog please email me elizabeth@svri.org.
  2. Dr. Sarah Homan (she/her) is Senior Research Associate at The Equality Institute (EQI), based in Naarm/Melbourne, Australia. As a feminist researcher from the Global North, Sarah’s work focusses on research and evaluation, policy development, advocacy and capacity development for the prevention of violence against women and girls around the world.
  3. Dr. Kevin Lalor is Social Sciences Discipline Lead at Technological University Dublin. He is Chair of the Board of the International Society for the Prevention of Child Abuse and Neglect (ISPCAN) and is a member of the Research Ethics Committee of the National Society for the Protection of Cruelty to Children, UK (NSPCC). He is a former editor of the Irish Journal of Applied Social Studies, and a member of the editorial boards of Child abuse and neglect: the international journal and Children, Youth and Environments.
  4. Chi-Chi Undie is Senior Associate and Technical Director with the International Programs Division of the Population Council, where she serves as Research Director for the Baobab Research Programme Consortium (RPC). Her time for co-authoring this blog was supported by the Foreign, Commonwealth and Development Office through the Baobab RPC.

The authors would like to thank Abby Haslehurst; Nicolas Makharashvili, Director, Safe Futures Hub; Ayesha Mago, SVRI Global Advocacy Director; Priti Prabhughate, SVRI Director of Research and Joan Njagi, SVRI CSV Researcher, and Natasha Stern, SVRI Intern for their review and comments on various drafts of this blog.

References

Alemayehu, C., Mitchell, G., & Nikles, J. (2018). Barriers for conducting clinical trials in developing countries – a systematic review. International Journal for Equity in Health, 17(37). Retrieved from https://doi.org/10.1186/s12939-018-0748-6

Baluku, J., Olum, R., Katagira, W., Namaganda, R., Osaigbovo, I. I., Dhiblawe, A., . . . Bongomin, F. (2021). Ethics approval fees constrain early career researchers in Africa: a call for alternative financing for ethics committees. Therapeutic Advances in Infectious Disease. doi:10.1177/20499361211035205

CIOMS. (2016). International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. . Geneva. Council for International Organizations of Medical Sciences. Retrieved from ‘International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016.’ See https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.

Cook, E., Markham, S., Parker, J., John, A., Barnicot, K., & McManus, S. (2022). Risk, responsibility, and choice in research ethics. The Lancet Psychiatry, 9(1), 5-6. Retrieved from https://doi.org/10.1016/S2215-0366(21)00434-X

DisabilityWales. (2021). DRILL Webinar: Ethics in Research Co-Production – Lessons for research and practice [Video]. Youtube. Retrieved from https://www.youtube.com/watch?v=2oz-0pR_KWk&t=2s&ab_channel=DisabilityWales

Falb, K., Laird, B., Ratnayake, R., Rodrigues, K., & Annan, J. (2019). The ethical contours of research in crisis settings: five practical considerations for academic institutional review boards and researchers. Disasters, 43(4), 711-726. doi:10.1111/disa.12398

Hellmuth, J. C., & Leonard, K. E. (2013). Methods for Assessing and Addressing Participant Protection Concerns in Intimate Partner Violence Research. Partner Abuse, 4(4), 482-493. doi:10.1891/1946-6560.4.4.482

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Mannell, J., Tevaga, P., Heinrich, S., Fruean, S., Chang, S. L., Low, H., . . . Suaalii-Sauni, T. (2023). Love Shouldn’t Hurt – E le Sauā le Alofa: Co-designing a theory of change for preventing violence against women in Samoa. Global Public Health, 18(1). Retrieved from https://doi.org/10.1080/17441692.2023.2201632

MKU. (2021, December 11). IERC Review Charges. Retrieved August 7, 2023, from Mount Kenya University: https://cgsr.mku.ac.ke/ierc-review-charges/

National Health Sciences Research Committee (NHSRC). (2023). Press Release of the National Health Sciences Research Committee NHSRC on the Health Research Review Clearance in Malawi [Press Release]. Malawi. Retrieved August 7, 2023, from https://www.health.gov.mw/download/press-release-of-the-national-health-…

Sambiéni, N. E. (2018). Differences and structural weaknesses of institutional mechanisms for health research ethics: Burkina Faso, Palestine, Peru, and Democratic Republic of the Congo. BMC Med Ethics, 19(Suppl 1). Retrieved from https://doi.org/10.1186/s12910-018-0284-3

Shinkafi, T. S. (2020). Challenges experienced by early career researchers in Africa. Future Sci OA., 6(5). doi:10.2144/fsoa-2020-0012

Sikweyiya, Y., & Jewkes, R. (2011). Perceptions about safety and risks in gender-based violence research: implications for the ethics review process. Culture, Health & Sexuality, 13(9), 1091-1102. Retrieved from https://www.jstor.org/stable/23047513

Sikweyiya, Y., & Jewkes, R. (2012). Perceptions and experiences of research participants on gender-based violence community based survey: implications for ethical guidelines. PLoS One, 7(4), e35495. doi:10.1371/journal.pone.0035495

Spellecy, R., & May, T. (2012). More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. J Law Med Ethics, 40(4), 990-996. doi:10.1111/j.1748-720X.2012.00726.x

van Teijlingen, E., & Simkhada, P. (2015). Failure to Apply for Ethical Approval for Health Studies in Low-Income Countries. Nepal J Epidemiol, 5(3), 511-5. doi:10.3126/nje.v5i3.13609

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