Ethics are a set of principles that help us figure out what’s right and wrong. In medical research, they help to keep the people taking part safe, make sure the research does more good than harm, and ensure the results can be trusted.
Bottom line up front – Medical research is strictly regulated, and ethical principles or rules play a key role in keeping people safe and the scientific process rigorous. These “moral values” are among many checks and balances in place to make sure this happens. That said, like the rest of science, this is an ongoing and interactive process, and there is always room for improvement.
But what does it MEAN?
In essence, ethics refers to the principles of right and wrong that guide behavior, and it includes the study of moral obligations and values.
And how is this important in human medical research?
In human medical research, ethics plays an important role to ensure that studies are carried out in a way that people taking part are protected and that some important principles are upheld. These principles make sure that researchers maintain scientific integrity through clearly-defined standards, like obtaining informed consent, minimizing risks, and treating those taking part in the research with respect and fairness.
Research projects have to go through a thorough review to get “ethics approval” from a Research Ethics Committee before they can even begin. This is a detailed process for scientists, and there are many checks and balances in place before a university’s Research Ethics Committee or an Institutional Review Board (called “IRB”) accepts and then reviews a study proposal. The members of the study team themselves also have to complete ethics training. So all in all, there is a rigorous process in place, and only when all ethical and regulatory “conditions” are satisfied will the study get the ok to go ahead.
But what are some of these principles? Let’s dive in a little deeper:
⚖️ Respecting people’s choices and giving extra protection to those who can’t fully decide for themselves – AUTONOMY
In practice, this is to make sure that all people taking part in research:
- Are treated with respect.
- Have been fully told about the details of the study (so they can give “informed consent”).
- Have given informed consent (said yes or no to the individual parts of the study).
- Know what is required of them and any potential risks, benefits, or inconveniences they might encounter (even if they are small or might not happen).
- Know they can stop taking part at any time without having to fear any consequences.
⚖️ Doing good for others and making sure it benefits people – BENEFICENCE
In practice, this means researchers have to make sure that they:
- Solve a real health problem (like finding a new vaccine for a deadly disease).
- Design studies in a way that minimizes risk to those taking part.
- Stop studies that are found to be causing harm.
⚖️ Avoiding harm to people taking part in research, the principle of “do no harm” – NON-MALEFICENCE
In practice, this means that researchers:
- Can’t withhold an already existing proven treatment from participants who are in a control group (the group against which the people who receive the new treatment are compared).
- Constantly watch for potential harms.
- Take action to prevent any harm to participants, even if this means stopping a trial.
⚖️ Researchers honestly do not know if one treatment is better than another – EQUIPOISE
In practice, this means that researchers:
- Carry out studies because they truly don’t know if one treatment is better than another, not because they already know it is better and want to prove it.
⚖️ Ensuring that the benefits and burdens of the research are distributed fairly – JUSTICE
In practice, this means that:
- People from all walks of life should be included in research, including older people and people of different genders, ethnicities, and socio-economic backgrounds.
- A plan has been made for access to the vaccine/ treatment/ medication for people who need it, including in underserved communities.
- Compensation is carefully considered to avoid coercion amongst vulnerable people (for example, offering only a small or a token amount of money).
- It ensures that the burden of the research is fairly distributed (and is not unevenly placed on vulnerable or marginalized people).
What does this mean for clinical trials studying vaccines, new medications or treatments?
One example of ethics in action in medical research would be the development of the COVID-19 vaccine back in 2020 – this was a new infectious disease, and at that point, there was no existing vaccine that could be used to prevent it. As a result, when the first vaccines against COVID were made, they went through thorough testing in randomized placebo-controlled clinical trials (you can read more about how new vaccines are developed here). Participants in these trials were randomly assigned to either a group that received the new vaccine or a group that received a placebo (substances that look identical to the treatment being tested but have no therapeutic effect – in this case, saline). You can read more about the four main COVID-19 vaccine trials here, here, here, and here. Despite the urgency, all trials required ethics approval, and all key ethical principles were upheld. This is a good example of the principle of Equipoise (researchers genuinely didn’t know if the new vaccine would work).
A second, maybe more intuitive example of why ethics are so important in medical research is the following:
Imagine researchers want to test a new cancer drug. There is an already-proven treatment for this particular cancer, and this is recognized as the first-line treatment and considered “standard of care.” If the research team designed a placebo-controlled trial, patients in the control group (people with cancer NOT receiving the new drug) would receive no actual treatment, but a placebo instead. This clearly violates the principle of non-maleficence (“do no harm”) by withholding proven treatment from people with cancer and would be considered unethical by a Research Ethics Committee or IRB. Instead, in most clinical trials for cancer treatments, the new treatment is compared to an existing and already proven treatment, which makes sure that all participants in the study receive active care. This ethical approach protects patients while still advancing medical knowledge.
Are there important historical failures in research where these ethical principles were ignored?
Yes, unfortunately, there are way too many examples in medical history where ethical principles were disregarded. This partially led to the rigorous principles and regulations we have today. This list by no means covers all the horrors committed, but serves as a snapshot to highlight why ethics in medical research is so important:
Bottom line – Medical research is strictly regulated, and ethical principles play a key role in keeping people safe and the scientific process rigorous. That said, like the rest of science, this is an ongoing and interactive process, and there is always room for improvement.
Stay well. Stay safe. Stay curious.
Love,
Those Nerdy Girls
Key documents:
World Medical Association – Declaration of Helsinki
Council for International Organizations of Medical Sciences (CIOMS) with the WHO
HHS regulation 45 CFR 46 [archived link]
Belmont Report (1979) [archived link]
