Which Is True of Inducements in Research ?

Ethical Concerns About Inducements in Research

In research, inducements are offers that attract participants to take part in a study in a way they wouldn’t have otherwise. They can be offered in cash or in kind and include prizes, gift cards, trinkets, course credit or the chance to win a drawing prize.

Although many researchers offer payment to research subjects, some ethics guidelines caution against undue inducement through offers of payment. A recent survey suggests that members of Institutional Review Boards (IRBs) endorse interpretations of coercion and undue influence that, if strictly applied, would stringently limit the amount of payment offered to research subjects. In this blog section, we will discuss about Which Is True of Inducements in Research ?

Reimbursement

Despite the ethical concerns with reimbursing research participants, it is widely accepted that offering payment can enhance and increase research recruitment. It can make a study more attractive to potential subjects, especially those who would otherwise not participate, due to financial constraints or because of their social status (Abadie 2010; Czarny et al., 2010; Stunkel and Grady 2011; Fisher et al., 2018; Manton et al., 2019).

It is also common for researchers to offer compensation in kind rather than cash when the latter is not realistically compensated by a procedure type or level of risk (for example, gift cards, food, class marks). These kinds of incentives may encourage people to take part in research that would otherwise be a no-go because of the cost and inconvenience of participation.

But it is important to note that in determining appropriate amounts and kinds of compensation, REBs need to respect the autonomy of participants, avoid paternalism and ensure protection for vulnerable groups (homeless youth, intravenous drug users, gambling addicts). They should not set compensation levels that exceed those they normally would do so for non-vulnerable populations.

According to some empirical studies, monetary offers to participants are often the most influential factor in influencing their decision to enroll into a research project (Center for Information and Study on Clinical Research Participation 2019, Grady et al. 2017; Fisher et al., 2018; MacKay and Walker 2021).

However, this does not mean that it is ethical to offer remuneration to all prospective participants or that it should be offered at any level. It is only reasonable to offer it if the principle of social beneficence requires this, and if there are no other ethical reasons for doing so.

The use of payment to attract prospective subjects is a logically necessary part of the research process, as the aim of any scientific activity is to advance science and society. Nevertheless, the payment should not be offered in such a way that it becomes a significant incentive to participate and should not be used to overshadow or mask some ethical deficiencies of the study (especially those regarding its risk-benefit profile or the criteria of subjects selection) as these are essentially normative issues that RECs/IRBs need to examine with their own minds.

Compensation

The offer of payment for participation in research can be a powerful recruiting tool, but it can also raise concerns about ethical issues, including coercion and undue influence. For the most part, these concerns are based on concerns about whether offering compensation will influence a participant’s decision to participate in the study or stay in it once enrolled.

According to federal guidance, coercion involves a threat of severe negative consequences while undue influence occurs through an excessive offer of something valuable or desirable that influences decision-making in inappropriate ways. For these reasons, researchers must ensure that the payments they offer for participation in their studies do not induce subjects to act in ways that would otherwise be unintentional.

One of the most common forms of financial incentives in research is to pay a small amount of money for each session of participation in the study. In this way, research participants are compensated for the time and effort they contribute to the study, which is usually an important factor in their decision to participate.

Another form of compensation is to reimburse participants for any expenses they may incur as a result of their participation in the study (e.g., travel costs). The reimbursement method can be used when research participants do not wish to accept the offer of cash but still want a token of appreciation for their participation in the study.

In other cases, research investigators may offer prizes or draws in lieu of payment for participating in the study. These draws are sometimes used when research is under- or unfunded and there is not enough funding to cover the cost of compensation for all participants.

A draw-in-lieu of payment is a form of incentive that does not involve cash, but rather offers the potential for a prize to be awarded to a randomly selected individual. Although these approaches are not always effective, they can be useful for studies that do not have sufficient funding to pay the full costs of a prize-winning lottery.

The approach that researchers take to establishing appropriate compensation depends on the type of research and the socioeconomic status of the subject population. Some researchers, for example, offer a sliding scale of compensation, which can be considered unethical because it encourages unequal payment for equal work. However, if compensation can actually increase participation rates for reluctant members of low-income groups, this may be a more effective recruitment strategy than a fixed-rate payment plan.

Incentives

Incentives can be used to increase recruitment in studies. They may take many forms, including gift cards, money, and other non-monetary benefits. However, they should not be offered at levels that might unduly influence the decision to participate in a study or impede informed consent.

Researchers who offer incentives for participation should be careful not to violate ethics principles such as justice, the principle of integrity, and fairness. They should also be sure to consider whether the level of compensation is appropriate for the study’s procedures and risks.

One of the most important aspects of research is the ability to recruit participants who are willing to participate in a risky and time-consuming process. Although some people may decide to participate for altruistic reasons, many would not do so without financial compensation.

Some IRBs require investigators to reduce incentive payments in research based on the fear that they can lead to coercion. This is an unfortunate misconception, and IRBs should stop using the concept of coercion as a basis for reducing incentive payments.

Another argument against inducements is that they can lead to demographically biased enrollment. This is especially true in studies involving healthy subjects, because these participants are more likely to be members of different socioeconomic classes and might be motivated to participate by the possibility of receiving medical benefits from the study.

In addition to causing recruitment problems, financial incentives can exploit poor research subjects by offering them larger payments than rich participants for similar work. This practice may encourage participants to lie about their income, salaries, or other details to increase their compensation.

Wilkinson and Moore explain that these concerns are unpersuasive, because the only case in which they could be valid is when researchers have an exclusion criterion that excludes a particular group of subjects from participating in a study. These exclusion criteria must be based on a method that is independent of the subject’s self-report.

IRBs should use a unified approach to minimize the potential for undue influence, regardless of the method of payment or benefit. This would include not enrolling individuals who present a high risk of harm in research or ensuring that all benefits are carefully evaluated and presented to prospective participants in a manner that is clear, reasonable, and understandable.

Coercion

Generally speaking, coercion in research refers to the act of using money or other incentives to force people to participate in studies that may have significant risks. This is rare, but a number of cases have occurred over the past few decades in clinical research.

This type of conduct violates the ethical principle of respect for persons, and it should never be allowed. It is an example of what Dickert and Grady13 describe as “undue influence.” According to the Belmont Report, undue influence is defined as the offering of an excessive, unwarranted, inappropriate or improper reward or other overture to obtain compliance with a request for participation in a study.

The concept of coercion has been studied and debated by philosophers in the past, most notably Hobbes, Kant and Locke. All three hold that the function of the state is tied to its use of coercion, and Hobbes in particular holds that coercion is an essential tool for maintaining the legitimacy and sovereignty of the state.

Many researchers find that the concept of coercion is difficult to understand, especially when they encounter it in their own research. They often feel it is an unfair way to get people to participate, and that it can lead to harm.

Nonetheless, coercion is an important factor in research and must be accounted for in every ethical assessment of the study’s conduct. In some cases, it is even a necessary part of the research process.

For example, in the case of research that involves children or developing nations, payment for their care can be an incentive to enlist subjects into a study. This could also include financial compensation in the form of gifts, trips or food.

However, many IRBs struggle to understand and resolve the complexities of deciding how much to compensate participants in a research study. They often rely on ‘gut feelings’ and are unsure how to define ‘coercion’ or ‘undue influence’, resulting in wide variation between and within IRBs.

The ambiguity of how to understand these concepts is rooted in the fact that there are no universally agreed upon definitions of them. This creates a lot of uncertainty for IRBs when they are faced with these issues, and the results of this study suggest that guidelines are needed to help these groups make decisions about these topics.