01 · The Question
When Is Participant Selection Actually Fair?
Suppose you need 300 participants. You recruit from the university nearest your office because access is easy, communication is simple, and recruitment will be fast. Everyone who qualifies receives the same information and goes through the same consent process.
Have you selected participants fairly?
Not necessarily. Justice in research ethics asks a broader question than whether individual participants are treated consistently. It asks whether the people and groups who are asked to bear the burdens of research, and those given access to its potential benefits, have been selected fairly in the first place.
This matters because participant selection is never merely logistical. Decisions about where you recruit, whom you include, whom you exclude, and which barriers you are willing to remove can determine which populations repeatedly supply research participants and which populations repeatedly remain outside the evidence base.
03 · What You Need to Know
How Justice Changes the Way You Think About a Sample
Justice is concerned with the distribution of research burdens and benefits
The Belmont Report frames justice in terms of fairness in distribution and asks a deceptively simple question: who should receive the benefits of research, and who should bear its burdens? In participant selection, this principle becomes a requirement for fair procedures and outcomes in choosing research participants.
A research burden can include more than physical risk. Participation may require time, travel, uncomfortable procedures, disclosure of sensitive information, inconvenience, loss of privacy, psychological distress, or exposure to social and economic consequences. Potential benefits may include direct benefits to participants in some studies, access to an experimental intervention, or the longer-term value of knowledge that may improve practice or policy for a population.
The underlying ethical concern is therefore not simply whether the study is worthwhile. Researchers should also consider who is being asked to carry its burdens and who is positioned to receive its benefits.
Belmont distinguishes individual justice from social justice
The Belmont Report makes a useful distinction between justice at the level of individual participants and justice at the level of social groups. Individual justice requires fairness in selecting particular people. Researchers should not reserve potentially beneficial research for favored individuals while disproportionately directing risky research toward people regarded as less desirable or less powerful.
Social justice looks beyond individual treatment. It asks whether certain classes or populations are being asked to participate because there is a defensible reason for involving them, and whether groups that are already burdened are being asked to carry additional research burdens unnecessarily. Belmont specifically warns against systematically selecting groups merely because they are readily available, occupy a compromised position, or are easier to manipulate.
Individual justice
Are particular people being selected fairly rather than favored for benefits or targeted for burdens?
Social justice
Are the burdens and opportunities of research being distributed fairly across populations and social groups?
A protocol can therefore appear fair at the individual level while still raising concerns at the social level. Imagine that every eligible person at one low-income clinic has exactly the same probability of recruitment. Selection within the clinic may be procedurally fair, yet a justice question remains if researchers repeatedly use that clinic primarily because its patients are accessible while the knowledge generated is intended chiefly for populations elsewhere.
Equitable does not mean identical or statistically representative
Justice is sometimes misunderstood as requiring every demographic group to appear in every study or requiring the sample to reproduce population proportions. That is not what equitable selection means.
The relevant population depends on the scientific question. A study of an intervention for adolescents will legitimately recruit adolescents. Research on workplace experiences may require employed participants. A study examining a condition affecting a particular population may appropriately concentrate recruitment there.
CIOMS states that individuals, communities, and groups invited into health-related research should be selected for scientific reasons rather than because a compromised social or economic position makes them easy to recruit or manipulate. When benefits or burdens are distributed unequally, there should be scientific and ethical justification for that difference.
The practical test is therefore not simply, “Is everyone represented?” A better question is, “Can I explain why each important inclusion and exclusion decision follows from the scientific aims and ethical requirements of this particular study?”
Justice constrains both inclusion and exclusion
Historically, research ethics has had good reason to worry about exposing vulnerable or disadvantaged populations to research risks. Protection remains essential. Yet protection through automatic exclusion can create a different problem.
CIOMS cautions that categorical exclusion may contribute to or worsen health disparities and therefore calls for justification when groups needing special protection are excluded. The 2024 Declaration of Helsinki similarly states that groups underrepresented in medical research should have appropriate access to participation and recognizes that excluding people in situations of vulnerability may itself perpetuate or exacerbate disparities.
This creates an important ethical tension. Inclusion can expose people to burdens, but exclusion can prevent evidence from being generated about them.
Watch Out
Do not assume that excluding a population is automatically the more protective choice. Protection may sometimes require exclusion, additional safeguards, or a modified protocol. In other circumstances, unjustified exclusion may leave the very population affected by a problem without evidence that adequately applies to them.
This is why decisions involving groups such as pregnant people, older adults, disabled people, or people facing language barriers should be examined rather than treated as administrative defaults. The ethical question is whether an exclusion is genuinely justified rather than merely convenient.
Scientific relevance is central to fair selection
Justice does not operate independently of good methodology. If a population is necessary to answer the research question, that scientific relevance may provide an important reason for including it. Conversely, deliberately recruiting a group that has little relationship to the question simply because access is easy can create both scientific and ethical concerns.
Under the U.S. Common Rule, an institutional review board must determine that participant selection is equitable, taking into account the purpose of the research and the setting in which it will occur. The regulation also directs attention to categories of participants who may be vulnerable to coercion or undue influence.
The connection between science and justice is especially visible when a sample systematically omits people most affected by the research question. A study can follow its recruitment protocol perfectly and still deserve scrutiny if the protocol itself produces an ethically difficult pattern of inclusion or exclusion.
Convenience is not automatically unjust, but it needs scrutiny
Almost every real research project faces constraints. Researchers recruit through institutions they can access, within geographic boundaries they can reach, using languages the research team can support, and within available budgets and timelines. Practical feasibility is not ethically irrelevant.
The problem arises when convenience becomes the decisive reason that one population repeatedly bears research burdens, particularly when its members occupy a disadvantaged or dependent position. Belmont explicitly identifies selection based on easy availability, compromised position, or manipulability as a justice concern. CIOMS likewise rejects selecting groups because their social or economic circumstances make recruitment easier.
Researchers should therefore distinguish between using an accessible population for a defensible research reason and allowing accessibility itself to substitute for ethical justification.
Sampling methodology and ethical justice overlap, but they are not the same question
A sampling strategy may be methodologically appropriate yet still warrant ethical scrutiny. Conversely, a justice concern does not automatically prove that a statistical sampling technique is invalid.
Consider convenience sampling. Methodologically, the concern may involve selection bias, limited representativeness, or restricted generalizability. Ethically, the concern is different: why are these particular people repeatedly being asked to contribute their time, information, or accept risk? Could other appropriate populations share those burdens? Are some groups excluded from the opportunity to participate simply because including them would require additional effort?
That is why convenience sampling can raise an ethical problem as well as a methodological one. The two analyses intersect, but one should not be used as a substitute for the other.
Fair selection must be examined in context
There is no universal demographic formula for a just sample. Researchers and ethics committees have to consider the purpose of the study, the setting, relevant risks, possible benefits, inclusion and exclusion criteria, recruitment procedures, and characteristics that may make some prospective participants particularly susceptible to coercion or undue influence.
Justice is therefore contextual without being arbitrary. “It depends” is not the end of the analysis. It means the researcher should be able to identify what it depends on and defend those choices.
04 · A Practical Example
When a Convenient Sample Creates a Justice Question
Hypothetical Example
A digital health study recruits only from one public clinic
A research team wants to evaluate a digital system intended eventually for use across both public and private outpatient clinics. The team recruits 400 participants exclusively from a public clinic serving a relatively disadvantaged population. The researchers explain that recruitment there is faster because they already have institutional access, staff can identify eligible patients, and participants are concentrated in one location.
Scientific question
The intervention is intended for a broad outpatient population, and nothing about the research question requires recruitment exclusively from patients at the public clinic.
Selection decision
The team chooses the clinic primarily because its patients are readily accessible and recruitment is administratively efficient.
Justice concern
One population is being asked to supply all of the participants and bear the associated inconvenience, data collection, and research risks without a clear scientific reason for concentrating those burdens there.
Possible response
The researchers reconsider recruitment sites, justify any remaining differences scientifically, and determine whether recruitment can be broadened without undermining the study design.
The ethical issue is not that recruiting from a public clinic is inherently wrong. Nor does justice require an arbitrary 50:50 split between public and private patients. The problem is that the proposed concentration of research burdens is being driven primarily by ease of access rather than by the research question.
Now change one fact. Suppose the intervention was specifically designed to address a documented service problem unique to resource-constrained public clinics, and the study results were intended to improve care in those same settings. Recruiting primarily from those clinics could then have a strong scientific and ethical justification.
The participants have not changed. The ethical interpretation changes because the reason for selecting them has changed.
06 · What This Means for You
How to Evaluate Whether Your Participant Selection Is Just
When designing a study, do not begin the ethical analysis only after you have finalized your sample. Justice should influence the decisions that produce the sample: the target population, eligibility criteria, recruitment sites, recruitment channels, accommodations, and enrollment procedures.
A useful starting point is to ask whether every major selection decision can be connected to the research rather than merely to what is easiest for the research team.
A simple decision framework
If a group is included because the research question specifically concerns that population
Explain the scientific relevance and assess whether risks, safeguards, and anticipated benefits make inclusion ethically appropriate.
If a group is included mainly because recruitment is unusually easy
Ask whether accessibility is causing that group to bear a disproportionate share of research burdens without adequate justification.
If a group is excluded because participation may create additional risk
Determine whether the risk can reasonably be addressed through study design, safeguards, monitoring, or other protections before defaulting to exclusion.
If a group is excluded because inclusion would require translation, accommodation, additional sites, or greater recruitment effort
Separate genuine scientific or safety requirements from administrative convenience and justify the restriction accordingly.
If the people carrying the research burden are unlikely to benefit from the resulting knowledge or intervention
Examine the distribution more closely and determine whether there is a compelling scientific and ethical reason for that arrangement.
You should also examine selection at more than one level. A seemingly neutral eligibility criterion can produce systematic exclusion once applied in practice. A fair recruitment procedure within one institution can coexist with an unfair decision about which institution or community supplies the participants.
This is particularly important when research is conducted in disadvantaged communities but its anticipated applications primarily benefit people elsewhere. That situation raises a broader question about whether the population carrying the research burden is meaningfully connected to its anticipated benefits.
Finally, document the reasoning. An inclusion criterion such as “ages 18 to 65” or “English-speaking participants only” may look routine in a protocol, but routine wording is not itself an ethical justification. If a criterion materially shapes who can participate, you should be able to explain why it is necessary or appropriate for this study.
07 · A Quick Checklist
Check the Justice of Your Recruitment and Selection Plan
Before finalizing participant selection, check:
Can I explain why this population is scientifically relevant to the research question?
Are any groups being selected primarily because they are easy to access, dependent on the institution, economically disadvantaged, or easier to influence?
Do my inclusion and exclusion criteria have scientific or ethical justifications rather than merely administrative ones?
Could apparently neutral eligibility requirements systematically exclude populations affected by the research question?
Am I excluding a population automatically in the name of protection when additional safeguards could make responsible inclusion possible?
Are the burdens of participation concentrated on one population, and if so, can I justify why?
Is there a reasonable relationship between the populations participating in the study and those expected to benefit from the resulting knowledge?
Have I considered how the recruitment setting itself affects who has the opportunity to participate?
Would I be comfortable explaining each major selection decision to an ethics committee and to the community being recruited?