Modules

Social Justice, Vulnerability and Inclusion

Instructions for:TraineeTrainer

Goal

The aim

To encourage learners to consider how and why matters of social justice, vulnerability and inclusion are relevant to research and the impacts of research.

The learning outcomes

At the end of this module, learners will be able to:

Consider the meaning and relevance of social justice in research.
Explain the importance of inclusion in research and the ethics issues associated with exclusion.
Describe the special measures that need to be implemented for the ethical inclusion of vulnerable populations in research.

Duration (hours)

1

For whom is this important?

All stakeholders in research

Part of

iRECS

Steps

1What is Social Justice? Quiz

2Vulnerability in Research Ethics Codes

3Vulnerability in Research Ethics Codes cont.

4Who is Vulnerable in Research?

5Vulnerability and Justice

10Social Justice in Research

11Social Justice in Research cont.

12Social Justice in Research Ethics Codes

13Leaving No One Behind in Research

14Leaving No One Behind in Research cont.

15Inclusion and Exclusion in Research

16Vulnerability in Research

17Maria Maia - Aspects of Vulnerability in Research

1

What is Social Justice? Quiz

There is no unified definition of social justice. For this reason, in this module we take a working and broad definition of the concept. We interpret social justice as a guiding principle for achieving a just society, including full and equal participation of individuals in all social institutions; fair, equitable distribution of material and nonmaterial goods; and recognition and support for the needs and rights of individuals. To do that, historical processes of oppression and domination of certain populations need to be taken into account to understand current inequalities and injustices.

Even if you are not already familiar with the terms ‘social justice’ and ‘social injustice’, you are likely already familiar with the concepts. Take a look at the following eight questions and select the correct answer from the options provided. Be sure to click the small left and right arrows to navigate between questions.

Irecs Social Justice, Vulnerability And Inclusion Audio2_Step1

2

Social Justice in Research

The most prominent case of social injustice in research, is that of the Tuskegee Syphilis Study, conducted by the United States Public Health Service between 1932 to 1972 in Tuskegee, Alabama.

The Tuskegee Syphilis Study aimed to observe the natural progression of untreated syphilis in African American men. During the study, 600 African American men, primarily sharecroppers from rural Alabama, were told they were receiving free medical care for ‘bad blood’, a term commonly used in the area to describe a variety of health problems. They were not informed that they had syphilis or that they were participating in a research study.

The participants were left untreated for several decades while being monitored to observe the progression of syphilis. Even when penicillin became widely available as a treatment for syphilis in the 1940s, the participants were not offered treatment. Many participants experienced severe health consequences as a result of untreated syphilis, including debilitating symptoms, organ damage, and premature death. Some also transmitted the disease to their partners and children.

The Tuskegee Syphilis Study came to public attention in 1972 when a whistleblower exposed the unethical nature of the research. Disturbingly, the study had run for 40 years and was only stopped after a news article drew attention to the study. Participants experienced psychological distress as a result of being misled about their health status and the true nature of the study. The study also eroded trust in the medical profession and government institutions, particularly among African Americans.

It reinforced existing suspicions of exploitation and discrimination within the healthcare system and contributed to longstanding disparities in access to healthcare. While the participants and their families will never achieve the justice they deserved, in 1973, a class action was filed on behalf on the study participants and in May 1997, President Bill Clinton issued a formal presidential apology for the study.

Irecs Social Justice, Vulnerability and Inclusion_Audio_Step2

3

Social Justice in Research cont.

While it may be difficult to imagine that research conducted nowadays could involve the same degree of social injustice as the Tuskegee Syphilis Study, social injustice remains a challenge that researchers must address.

Here are some short examples of how social injustice might be perpetuated through contemporary research. Click on the different images to see examples of situations in which social justice is relevant and the consequences of not taking this into account.

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4

Social Justice in Research Ethics Codes

Most research ethics and integrity codes and guidelines do not mention social justice explicitly. However, some prominent codes give accounts of justice that are in line with our understanding. For instance:

CIOMS: Research must also be sensitive to issues of justice and fairness. This concern is manifest in choosing whose health needs are investigated; how risks, burdens, and anticipated benefits of individual studies are distributed; and who will have access to any resulting knowledge and interventions.

Belmont Report: Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.

Cape Town Statement on Research Integrity: All research stakeholders should be aware of potential power imbalances in their research collaborations and ensure their actions do not exacerbate them, but rather contribute to redressing imbalances.
Irecs Social Justice, Vulnerability and Inclusion_Vid_Step4

5

Leaving No One Behind in Research

‘Leaving no one behind’ is a principle often invoked in the context of social justice. It emphasises the importance of ensuring that progress and development benefits all individuals and groups within society, particularly those who may be marginalised or vulnerable. The concept recognises that systemic inequalities and discrimination can prevent certain groups from fully participating in and benefiting from development initiatives.

Marginalization in research refers to the systematic exclusion, underrepresentation, or neglect of certain individuals or groups within the research process. Marginalized groups can include those who are disadvantaged or oppressed based on factors such as race, ethnicity, gender, sexual orientation, socioeconomic status, disability, or other identity markers. Marginalization can occur at various stages of the research process, including study design, data collection, analysis, interpretation, and dissemination.

Irecs Social Justice, Vulnerability and Inclusion_Vid_Step5

6

Leaving No One Behind in Research cont.

Addressing marginalization in research requires a commitment to diversity, equity, and inclusion throughout the research process. This includes actively involving marginalized communities in research design and decision-making, adopting culturally responsive methodologies, acknowledging and addressing power imbalances, and prioritizing the voices and perspectives of those who have been historically marginalized.

However, the equitable inclusion of all is not always easy and can raise specific ethical concerns. Including historically marginalized populations in research requires sensitivity and may, on some occasions, require adaption of research processes, methodologies and assumptions.

Irecs Social Justice, Vulnerability and Inclusion_Audio_Step6

7

Inclusion and Exclusion in Research

We now consider a short example case in which social justice is relevant. In this case, both the exclusion and inclusion of a specific population provoke ethical and methodological questions. We encourage you to reflect on the intersection of social justice and research ethics in this case to consider the pros and cons of inclusion and exclusion.

This study concerns the sexual and reproductive health of young people. It aims to evaluate the use of sexual health services as well as understanding regarding these matters amongst young people in a large city. During the study, the research team face difficulties recruiting participants from some cultural backgrounds. In particular, they find that migrants and refugees are less likely to participate in the study due to social stigma and different cultural norms. However, not including them might have detrimental implications for these populations.

Lack of trust in researchers and cultural insensitivity are potential consequences for both inclusion and exclusion. If the researchers do not adapt their methods and approaches, this demonstrates insensitivity whether young people are included or excluded. If the researchers do adapt their approach and methods in a manner that shows respect to cultural norms and preferences, this could enable sensitive inclusion and promote trust. Can you think of any ways that the research team might address structural & cultural barriers to facilitate participation in the study?

8

Vulnerability in Research

The word vulnerability can be broadly used to describe a state or condition of being susceptible to harm, exploitation, or other adverse outcomes due to various factors or circumstances. It is difficult to define precisely because multiple and diverse factors can contribute to vulnerability such as systemic inequalities, health status, social dynamics, environmental conditions, or individual characteristics. Additionally, it can affect individuals, groups, or communities and manifest in various ways. Furthermore, the word vulnerability does not have a precise equivalent in many languages. Still, it is important for researchers to have an understanding of the concept of vulnerability because it has significant implications for research ethics.

Historically, revelations about the exploitation of vulnerable people in the name of science have motivated the development of ethics codes and governance mechanisms in research. For instance, revelations about dishonesty and withholding of treatment in the notorious Tuskegee Syphilis Study prompted the development of the highly influential Belmont Report in the US in 1978.

Exercise Feedback

Participants in the Tuskegee Syphilis Study were from a predominantly poor, rural community, and particularly vulnerable due to their race and socioeconomic status. Most did not have access to adequate healthcare due to economic constraints and systemic barriers such as racial segregation and discrimination in healthcare services.

They also had limited education and access to information, which made them more vulnerable to deception and manipulation. Additionally, they were not fully informed about the purpose of the study, the risks involved, their right to refuse participation, or alternative treatment options when they became available. These multiple intersecting factors rendered the participants vulnerable to exploitation in research.

9

Maria Maia - Aspects of Vulnerability in Research

Well actually, vulnerability emerges when you have life challenges, and you have limited resources. And vulnerability can be intrinsic to the person, or it can be something that emerges at some point of your life. So, if you think about for instance, persons with visibility impairments, so they are not able at some point to understand exactly what the research is about or to have a full understanding of the informed consent. So, this is a group of vulnerable people.

The same happens, for instance, with children. So, they are not in full legal capacity to make their own decisions and to understand that they are an object of research. You have also for instance, older adults

who can have also difficulties in understanding the research itself and specific groups, for instance, employees of a company or prisoners. So, this type of individuals, they are within a hierarchy, an institutional hierarchy, and therefore they may not be so free to say what's on their minds due to possibility of side effects from when they open up in research.

So, there are actually a couple of groups where we have to be careful when doing research. And it's very important that in advance we identify who really has the possibility not to understand our research fully, and to whom we need to be very careful in explaining and make sure that they understand the informed consent that we are providing to do our research.

Well special considerations, I would say that should be the risk of exploitation. So, researchers need to be aware, and they need to identify vulnerable groups or people and they need to treat them with respect, with dignity, and not to exploit them. And this is something that sometimes, unfortunately, happens and they are not treated in a very ethical way. So, this is a consideration that researchers need to consider before doing their research.

And another one deals with exclusion. The documents and the guidelines that we have - ethical guidelines, they try to protect especially these groups and persons. However, sometimes they unintentionally leave them behind and they exclude them. And so, the researcher needs to be aware about these guidelines, and where these gaps or these voids are.

And I would even add as a challenge, that they should be aware about and understand what vulnerability is, what groups' or persons' vulnerabilities are, so to identify them. Because when they do this, then they can easily or in a more easy way address these persons with dignity, to include them in the research, instead of sometimes unintentionally leaving them behind.

The major challenge is really to identify, first to understand what vulnerability means and then to identify the groups and persons vulnerable in research. And then it's about adapting the methods, the materials that usually we have, for instance, for informed consent and understand that we cannot have a model and apply it to everyone. Because people have different needs, they have different expectations, they have different understandings and different intellectual capabilities. And therefore, the researcher needs to be aware of this and needs to adapt their informed consent, for instance, to each group or each individual.

Another issue or topic that the researcher should reflect is on the power dynamics. And the relationship that the individual or groups of individuals have within society, and within their personal relationships in order to understand if they need to be aware in addressing specific topics.

And it's also important to understand that vulnerability is culturally dependent. So, if one person is vulnerable at a certain period or a certain time in life, it does not mean that it applies in another moment for the same individual, but also that specific groups or persons can experience different vulnerabilities throughout their life.

So, this is why it's important again to identify, to understand what is vulnerability. And in that specific moment of research or during the period of research, to understand if this vulnerability remains, or emerges could be the case. So, it's a really dynamic process, and it's very important that the researcher understands vulnerability and it is crucial to identify those who can be vulnerable in research.

Of course, we need to protect people from exploitation in research but ethics codes and processes that aim to protect vulnerable populations might inadvertently lead to the exclusion of certain individuals if they are wrongly labelled as vulnerable, or the researchers do not understand how to mitigate their vulnerability in research.

10

Vulnerability in Research Ethics Codes

While many research ethics codes and guidelines have something to say about the inclusion of vulnerable people in research, in general they promote the same two messages: first, that most vulnerabilities are associated with voluntariness, and second, that certain groups should be awarded more protection than others.

When vulnerability is mentioned in research ethics codes, it is primarily in relation to the ability to provide informed consent. This can be associated with innate characteristics (for instance, young children or adults with severe cognitive dysfunctions). It can also be associated with circumstances that might impact upon the voluntariness of their consent (for instance, with prisoners or employees).

Some codes also mention risk-based vulnerabilities whereby vulnerability stems from being at an increased risk of mental or physical harm (for instance, pregnant women).

Exercise Feedback

The Australian National Statement (2023, p12) provides an extensive list of the sorts of harm to which research participants might be vulnerable including:

physical harm: including injury, illness, pain or death;
psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease;
devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly;
cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices;
social harm: including damage to social networks or relationships with others, discrimination in access to benefits, services, employment or insurance, social stigmatization, and unauthorized disclosure of personal information;
economic harm: including the imposition of direct or indirect costs on participants;
legal harm: including discovery and prosecution of criminal conduct.

11

Vulnerability in Research Ethics Codes cont.

It is generally agreed across ethics codes that the involvement of people with these types of vulnerabilities requires special justification and special protections. Indeed, the Declaration of Helsinki states that medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group (Article 20).

12

Who is Vulnerable in Research?

Do you think you could identify who is vulnerable in research? Take a moment to consider this issue and then click on the feedback tab below.

The most striking commonality across research ethics codes is the suggestion that vulnerability can stem from belonging to a certain group. When vulnerability is mentioned, it is commonly accompanied by examples of the sorts of groups to whom this applies. A problem with the naming of particular groups, even as examples, is the implication that people are to be considered vulnerable simply by virtue of belonging to a certain group. This can render the term unhelpful and patronizing.

Nowadays, there is acknowledgement across many codes and guidelines that determining who is vulnerable requires a nuanced approach because vulnerability can stem from a range of factors, for instance, power differentials between researchers and participants, capacity to understand, unrealistic expectations and so on. We need to be careful not to jump to conclusions about who is vulnerable.

13

Vulnerability and Justice

There are undoubtedly times when a blanket approach to protection is warranted for certain entire groups, like babies and young children, or for adults with severe cognitive impairment.

However, this protectionist stance is often applied to entire groups of people who do have the capacity to provide consent (like impoverished persons, for example). So why does this happen? To answer this question, it is helpful to remember that research ethics codes originated in the biomedical domain, and were intended to prevent the kinds of abuses that occurred in the Tuskegee Syphilis Study, whereby people might be subjected to a high risk of harm in research, without their knowledge or consent.

The resolve to protect people from exploitation in research runs deep, but we need to be careful not to patronize participants by well-meaning exclusions that serve to perpetuate systemic inequalities and disadvantages.

14

End of Module Quiz

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15

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16

Glossary of Terms

Equality

Equality implies that people are treated equally in terms of rights, or access to services etc. without discrimination or unfair advantage. In the context of social justice and human rights, equality involves equal access to resources and opportunities, as well as ensuring that individuals are not disadvantaged or marginalised. This can include efforts to address systemic inequalities, discrimination, and barriers to full participation in society.

Equity

Equity refers to fairness in the distribution of resources, opportunities, and rights. It involves ensuring that everyone has access to what they need to thrive and reach their full potential, regardless of their background, identity, or circumstances. Unlike equality, which aims to treat everyone the same, equity recognizes that different individuals or groups may require different levels of support or resources to achieve equal outcomes.

Human Dignity

Human dignity can be thought of as the inherent value and worth that every individual possesses. It encompasses the idea that each person is deserving of respect, honour, and ethical treatment, regardless of their background, identity, or circumstances. Respect for human dignity requires fostering environments that value diversity, protect human rights, and ensure the wellbeing and dignity of every individual within society.

Inclusion

Inclusion in research requires the active and meaningful involvement of individuals and groups from diverse backgrounds, identities, and experiences. It requires the creation of research designs, environments, systems, and policies that value and respect the contributions and perspectives of every individual, regardless of differences such as gender, ethnicity, religion, sexual orientation, disability, or socioeconomic status and so on.

Solidarity

Solidarity refers to cooperation and mutual support amongst individuals or groups, especially in pursuit of common values or goals. Solidarity recognizes the interdependence and interconnectedness of all members of society and emphasizes the importance of working together to create positive change and promote the wellbeing and dignity of all individuals.

Structural Violence

Unlike the more obvious physical violence, structural violence refers to a hidden violence that is embedded within the structures of social, economic, political, and cultural systems. It is rooted in unjust systems and power imbalances and operates through unequal power dynamics, systemic injustices, and institutionalized inequalities that provoke and perpetuate harm and suffering. Addressing structural violence requires challenging and transforming the underlying structures, systems, and ideologies that perpetuate inequality and oppression.

17

Bibliography

Further reading and references

Abbott, K. (2014). Social Justice. In: Michalos, A.C. (eds) Encyclopedia of Quality of Life and Well-Being Research. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-0753-5_2772

Bell, L. A. (2007). Theoretical foundation for social justice education. In M. Adams, L. A. Bell, & P. Griffin (Eds.), Teaching for diversity and social justice (2nd ed.). New York: Routledge.

Brady, E., Nielsen, M.W., Andersen, J.P. et al. Lack of consideration of sex and gender in COVID-19 clinical studies. Nat Commun 12, 4015 (2021). https://doi.org/10.1038/s41467-021-24265-8

CIHR, NSERC, SSHRC (2022) Tri-council policy statement: ethical conduct for research involving humans, December 2022. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. https://ethics.gc.ca/eng/documents/tcps2-2022-en.pdf. Accessed 21 Jan 2024

Coleman, C. H. (2009). Vulnerability as a regulatory category in human subject research. Journal of Law, Medicine & Ethics, 37(1), 12-18.

Council for International Organizations of Medical Sciences (CIOMS) (2016) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at: https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/

Gordon BG. Vulnerability in Research: Basic Ethical Concepts and General Approach to Review. Ochsner J. 2020 Spring;20(1):34-38. doi: 10.31486/toj.19.0079. PMID: 32284680; PMCID: PMC7122263.

Luna, F. (2019). Elucidating the Concept of Vulnerability: Layers Not Labels. International Journal of Feminist Approaches to Bioethics, 2(1), 121–139. http://www.jstor.org/stable/40339200

WMA (2013) WMA Declaration of Helsinki: ethical principles for medical research involving human subjects. World Medical Association. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

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