Values and Concepts of Ethics for Research Involving Humans

Site: EUPATI Open Classroom
Course: Ethics
Book: Values and Concepts of Ethics for Research Involving Humans
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Date: Monday, 17 June 2024, 6:46 AM

1. Introduction

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

Ethics in research, like ethics in general, is based on values. Values are abstract concepts, like truth, dignity and fairness, which are widely considered to be of the greatest importance for human well-being. One of the most important statements of values is the 1948 United Nations (UN) Universal Declaration of Human Rights. The role of Research Ethics Committees (RECs) is to ensure that the human rights of participants in research are respected.

Values are often expressed as principles. For the purpose of this training material, the following is a list of principles of ethics that help to protect human rights and dignity and are discussed further in the document below and next lesson:
  • Justify the inclusion of humans in research by ensuring social value and scientific validity.

  • Bring about more good than harm.

  • Promote the interests of humans who participate in research before the interests of science and society.

  • Ensure voluntary participation - participants must be able to choose to take on the risks of research.

  • Distribute the risks and potential benefits of research fairly.

  • Show ongoing respect for persons.

  • Uphold transparency during the research process.
Because principles of ethics are, by their nature, fairly general, they need to be interpreted and applied to specific situations. One role of ethics is to show how general principles apply in specific situations. When the principles appear to conflict, it is the role of ethics and ethics review committees to identify and manage such conflicts.

There is a rich literature on ethics and its application to research. The analysis and discussion of principles of ethics in these philosophical texts can be useful to RECs faced with new or complex challenges when reviewing research protocols or applying regulations.

1.1. Social Value

In light of the ethical principle of respect for persons, the justification for including individuals in a research project depends on the social value of the proposed research. Research will be considered as having value when the hypotheses or questions being researched have potential benefits.

These benefits may relate to:
  • Individuals or a particular population or sub-group,
  • To society generally, in relation to an important topic or issue, or
  • To some combination of the above.
To have social value, a research project should be designed to solve a problem that is relevant to society concerns.

Case study: Malaria Trial

An anti-malarial medicine called atovaquone-proguanil was tested in a developing country. However, it was intended for use by travellers going to areas where malaria is common. Although the research burden was taken by the developing countries, the medicine turned out to be too expensive to be administered in those same countries. Conducting a research study to test new medicines that will not be affordable to the community that bears the burden of the research is an example of research that does not have social value in that community.

1.2. Scientific Validity or Rigour

A project is scientifically valid if it has the potential to result in facts, reproducible observations or information in relation to the question under study. The phrase ‘scientific validity’ is used here to refer to the need for sound methodology and protocol design that is likely to lead to reliable conclusions. In qualitative research (i.e. research that looks at observations and descriptions rather than measurements and numbers), instead of scientific validity, research must have scientific rigour. In other words, it must use the appropriate research tools to meet the objectives of the study.

Research involving human participants that lacks scientific validity or rigour is inherently unethical. This is because it exposes participants to risks of harm or inconvenience without foreseeable benefit. This goes against the overarching principle of respect for persons and it is a waste of resources.

2. Bringing About More Good Than Harm

In an ideal world, research might always ‘do well’ (i.e. beneficence) and ‘not do harm’ (i.e. non-maleficence). However, in today’s world, a more realistic goal for research is to try to bring about more good than harm while avoiding unnecessary or disproportionate harm. Any harm caused by the research should be outweighed by the good that researchers hope to achieve. Thus, researchers should optimise the potential benefits of their research (e.g. health, safety, knowledge, satisfaction), and try to minimise the risks of unwanted effects associated with the research (e.g. reduced health, pain, exploitation, inconvenience, emotional burden).

Researchers have to take these principles into account when designing their projects in order to ensure that all risks have been minimised to the greatest extent possible and that remaining risks are justified in the context of the question being studied.

In conducting their review, RECs should pay particular attention to the well-being of research participants. However, they should also consider the potential benefits and risks for others, including those who may benefit from the results of the research.

3. The Interests Of Humans Who Participate In Research Must Come Before the Interests of Science and Society

The interests of persons who take part in trials as research participants should be of highest importance. It is central to ensuring respect for human dignity. This means that patients should not be entered into studies, no matter how important, if they are likely to suffer an unacceptable or unreasonable level of harm.

4. Voluntary Participation: Choosing to Take on The Risks of Research

Individuals are self-governing. This means that:
  • Within limits set by society, people generally control or shape their own lives in significant and meaningful ways.

  • They have personal goals, values and preferences.

  • They can make and act on plans for themselves and their lives. This will take into account goals, values, preferences, the options before them and other matters.
This self-overning ability is called ‘autonomy’. It is often thought to be what sets humans apart from other beings. It is considered valuable and worth protecting. Autonomy is held in such high regard that it is considered part of the integrity of a person, that is, part of what makes a person complete or whole.

Historically, this principle is connected to the idea that all persons have intrinsic worth or value. This is independent of any special circumstances that might grant that person value. In other words, it doesn’t matter who that person is or what they do, they still have value. Actively showing respect for the autonomy of others involves due appreciation of their abilities and opinions.

This includes their rights to:
  • Hold certain views,
  • Make certain choices, and
  • Take certain actions based on personal values and beliefs.
In research involving human participants, researchers must conduct studies in a way that demonstrates respect for autonomy. This is particularly important when gaining a prospective participant’s consent to take part - they must make sure that a participant is able to make their own choice about whether or not to participate in research. Consent is a process that may be achieved in different ways. However, for the consent to be valid or genuine, respect for autonomy is key (among other factors).

In some communities, the values of individuals are dependent on the values of the wider group (e.g. the family and/or community). Before a person can decide whether or not to give their individual consent to participate in research, they may need to consult, inform, or agree with members of their family (e.g. parents, head of household or spouse).

5. Fair Distribution Of The Burden and Potential Benefits of Research

In research ethics, justice refers specifically to the fair distribution of the burden and potential benefits of taking part in research. The meaning of a ‘fair distribution’ is often debated. Yet typically, researchers respect justice by ensuring that those who share in the burdens of research participation (e.g. by taking experimental medicine) also share in its potential benefits.

A more challenging aspect of justice is ensuring that research results will be accessible to both in general those who will benefit from them and more specifically those who took the research burden.

Planning to exclude groups of individuals from research (systematic exclusion) can also result in unfair distribution of benefits. A group might be excluded or suffer adverse drug reactions due to the lack of specific research on their shared characteristics, such as age, environment or nutrition. Exclusion of an affected group from a single research study might not be problematic on its own, but the exclusion of an affected group from an entire field or programme of research is certainly problematic. It is important to take a global view on systematic exclusion of certain groups and give serious thought to the ‘90/10 gap’, as described below:

Quote from World Health Organisation (WHO): ‘The majority of biomedical research has been predominantly motivated by concern for the benefit of already privileged communities. This is reflected by the fact that the WHO estimates that 90% of the resources devoted to research and development on medical problems are applied to diseases causing less than 10% of the present global suffering. The establishment of international guidelines that assist in strengthening the capacity for the ethical review of biomedical research in all countries contributes to redressing this imbalance.’

[WHO Operational Guidelines for Ethics Committees, 2000]

6. Showing Ongoing Respect For Persons

In research ethics, respect for humans should be present before a trial starts. This happens when projects are evaluated by RECs to ensure they meet the highest ethical standards and are worthy of participant consent. Continued respect for persons must also be shown during a trial and after it is completed. Some examples of this are:

  • Any new information that may be relevant to a participant’s continued participation should be communicated to that person. They should be given the opportunity to reassess their consent.

  • Personal information about research participants must be kept confidential. It should not be shared with outside persons, i.e. people not involved in the trial.

  • The way in which research results are reported and published must be considered carefully to avoid stigmatising groups and communities that participated in the research.

  • After the trial is completed, consideration should be given to whether participants in any placebo control group will receive the experimental medicine if it is proven to be effective and whether participants in the trial continue to receive the tested medicine once the trial is complete.

  • In developing countries, consideration should also be given to whether the wider community will be provided with access to the benefits arising from research. This is a contentious issue with no easy answer.
It is generally agreed that all of these concerns should be addressed before the research starts.

7. Upholding Transparency During the Research Process

‘Transparency’ here means that an individual or group does not conceal information from others who have a legitimate interest in knowing that information.
Transparency is important in the research context because there are many interests (scientific, corporate, financial, personal, etc.) involved. Some of these interests may compete with each other. Without sufficient transparency, public trust in researchers and research generally may be hindered.
Striving to ensure a transparent research process is an ongoing task, as many factors may need to be addressed. For example, conflicts of interests are common among sponsors, governments, organisations hosting research, researchers and RECs. There are many types of conflicts of interests, some of which are more apparent than others, some manageable and others simply not. In dealing with such conflicts, researchers and RECs should adhere to the principle discussed above, that the interests of research participants should take priority over other types of interests.
One means of ensuring transparency in health research is to keep a registry of clinical trials. In the past, negative results from clinical trials may not have been reported. Starting in 2015, the EU Clinical Trials Register contains summaries of clinical trial results, both positive and negative.
Further reading: US, Advisory Committee on Human Radiation Experiments, Report Chapter 3