The Four Scientific Ethical Principles

Science ethics is based on a number of ethical principles, each of which forms the basis for a series of practical requirements for scientific projects. These principles are reflected in international and national guidelines, legislation, and regulations of scientific experiments, especially in the health science area.

On this page, you can read more about the four most prominent ethical principles in science. They are not presented in any prioritized order, as none of them are immediately superior to the others. Instead, they each point to their relevant ethical considerations, which must be weighed against each other when competing interests are at play. However, to be able to handle such ethical dilemmas in connection with scientific experiments, it is necessary to know what is at stake.

Autonomy

Research must respect individuals' right to autonomy. This means that research must respect people's right to make their own decisions – in accordance with their own values and beliefs. Generally, the consideration for autonomy requires that capable adults to a large extent should have the opportunity to decide over their own lives. The principle of autonomy thus demands that one does not manipulate others, for example, by providing them with incorrect information, or by withholding information that can be expected to influence their decisions. This principle also requires that one does not pressure people, for example, by imposing costs on their choices, and that one does not encourage others to act against their best interests or values, for example, by paying them to take very large risks.

Participants in clinical trials must, therefore (at least initially), give their consent before they can participate in scientific experiments. Among other things, this means that participants must be sufficiently informed about any risks, inconveniences, and burdens associated with participating in the trial. It also means that participants must not be manipulated, pressured, or unduly encouraged to give consent.

However, consideration for autonomy requires more than just participants signing a consent form. It is a continuous consideration throughout the experiment. This means, among other things, that participants should be informed if new relevant information arises, and that trial participants should have the opportunity to leave a trial without providing a reason and without any negative consequences for their further treatment.

Consideration for autonomy also implies that there are limits to how persistent one may be about recruiting potential participants and how insistent one may be about following up on trial participants through phone calls or letters. Finally, consideration for autonomy requires that trial participants both must have the opportunity to opt out of information about any incidental findings and secondary findings that may arise during a trial, and the opportunity to receive information about the trial's results after its conclusion, if they wish.

Beneficence

Research should promote the good. This means, in a broad sense, that research should create sufficient value to outweigh any risks, inconveniences, or burdens associated with conducting the trial. This applies to the purpose of conducting the trial, the likelihood of the project's success, the usefulness of the trial's results, and so on. Poor research is, at best, a waste of time and scarce resources. At worst, it risks exposing trial participants to unnecessary risks.

However, it's worth noting that not all forms of benefits count in this context. For example, it is presumably a good thing for the research staff to be paid for conducting the trial, but such benefits do not count in the scientific-ethical assessment. In a scientific-ethical context, it is about the potential to benefit the individual participant's health (individual value) or more broadly about better understanding or treating health problems for the benefit of the broader society (social value).

In the context of scientific projects, it must be demonstrated that new questions are being addressed, that the design of an experiment is well-chosen in relation to the question being answered, that the project is practically feasible, that the researcher in charge is competent, and so on. All this must ensure that the project has the potential to contribute relevant value for either the participants themselves or the broader society.

In some types of trials, however, there is a heightened requirement for the utility assessment of a trial in the sense that there must be a scientifically justified presumption that participants will have a direct clinical benefit from participating in the trial. This may be the case, for example, in certain types of trials with vulnerable populations. In such trials, it must be demonstrated that participants are expected to gain a health benefit that flows directly from the intervention in the trial. In these kinds of trials, it is not enough that the trial potentially benefits others, nor is it enough that it only indirectly benefits the participants (for example, by including examinations that may have a health benefit in themselves).

Non-maleficence

Research must not cause harm. This means, broadly, that there are limits to the risks, inconveniences, and burdens that participants may be subjected to. This applies even if a project has the potential to create significant value, and even if the project respects participants' autonomy in all respects.

The principle of non-maleficence is in some ways the opposite of the principle of beneficence. But while the latter requires that there are certain things one must actively do, the principle of non-maleficence dictates that there are some things one must not do. In a research context, this includes not involving unnecessarily many participants, not subjecting participants to indefensible risks, not carrying out unnecessary experimental procedures, not wasting participants' time, and so on.

Thus, the principle of non-maleficence sets limits on how much harm one may inflict on research participants in the name of science, regardless of the potential benefits of a trial. This principle, therefore, prioritizes the interests of the individual over the interests of the wider society when it comes to actively exposing participants to risks. This applies not only to physical harm but also to psychological harm (such as trauma), economic harm (such as loss of employment capability), or social harm (such as stigmatization).

It is worth noting in this context that some types of trials have stricter requirements for risk assessment in connection with the trial. This may be, for example, in trials where there is no direct benefit to the participants, in acute research, or in placebo-controlled trials where an active treatment already exists. In such trials, there are further limits on how much (and what kinds of) harm one may inflict on participants to advance scientific and general interests.

Justice

Research must be fair. This broadly means that a reasonable distribution of the benefits and burdens arising from a scientific trial must be ensured, unnecessary inclusion of vulnerable populations should be avoided, and equal opportunities to participate in scientific trials should be secured.

Regarding the distribution of benefits and burdens, it should be ensured (all else being equal) that the trial population is the same as the treatment population. In other words, it should generally be ensured that the group bearing the health-related risks, inconveniences, and burdens of participating in the trial is also the group that could potentially benefit from the trial's implementation. Thus, it is not only for scientific reasons but also for reasons of fairness that the trial population (all else being equal) coincides with the treatment group.

Following the above, it is crucial that members of so-called vulnerable populations are not unnecessarily included in trials. It is also an important principle of fairness that the strongest shoulders bear the heaviest burdens and that special consideration is given to the least advantaged. If it is somehow possible to conduct the trial on other populations first, one should start there before beginning to include members of a vulnerable population.

Furthermore, the consideration of justice implies that participants should be compensated for their expenses to participate in a trial, such as additional transport costs or lost earnings. This is not only for the sake of a fair distribution of benefits and burdens but also in terms of equality regarding the opportunity to participate in scientific trials. Finally, the principle of justice demands active efforts to enroll members of underrepresented groups in research projects so that all members of society can receive their fair share of the benefits of scientific trials.

Last updated 01-02-2024
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