Should Participants Be Paid More for Riskier Research?

If Participants Take More Risk, Should They Receive More Money?

The intuition seems straightforward: if one study exposes participants to greater risk than another, perhaps those participants deserve more compensation.

That logic resembles familiar practices outside research, such as hazard pay. It also creates a difficult ethical problem. If money increases with risk, could payment begin to function as a price for accepting danger? More importantly, could researchers or ethics committees start treating higher payment as something that makes greater research risk acceptable?

Research ethics draws a crucial boundary here. Whether a study's risks are acceptable must be decided independently of how much participants are paid. What happens after that determination is more contested.

Greater Risk Does Not Automatically Require Greater Payment

Risk and Payment Must Be Analyzed in the Right Order

First Ask Whether the Risk Is Acceptable Without Considering Payment

The first question is not how much a risky procedure should pay. It is whether exposing participants to that risk is ethically acceptable in the first place.

FDA states that payment to research participants is not considered a benefit when weighing research risks and benefits. OHRP likewise maintains that an IRB should not treat remuneration as a way of offsetting research risks when deciding whether research should be approved.

This ordering prevents payment from becoming a mechanism through which increasingly problematic research can supposedly be justified by increasingly large offers.

Risk Is Not the Same as Burden or Discomfort

A procedure can be burdensome without being particularly risky. It can also involve meaningful risk without taking much time.

Consider an uncomfortable two-hour procedure compared with a comfortable two-hour procedure. Paying more for the former might reflect additional inconvenience or discomfort rather than risk itself. OHRP identifies time, inconvenience, and discomfort among the considerations that IRBs may examine when reviewing remuneration.

This distinction matters because researchers can accidentally describe payment as "compensation for risk" when what actually changed was the participant's time, effort, discomfort, or inconvenience.

Before introducing risk into the payment rationale, separate it from the other factors considered in participant compensation for time, inconvenience, and risk.

CIOMS Does Not Treat Risk as a Basis for Compensation

For health-related research, the 2016 CIOMS International Ethical Guidelines take a relatively clear position. Guideline 13 states that participants should be reasonably reimbursed for direct costs and reasonably compensated for inconvenience and time spent. It specifies that compensation is not intended to compensate participants for the risk they agree to undertake.

Under this approach, greater research risk would not itself generate a larger compensation amount. If the riskier procedure also requires more time, inconvenience, effort, or other compensable burden, those differences could still affect payment for reasons other than risk.

OHRP Permits a More Nuanced Role for Risk-Related Remuneration

OHRP's position is different.

In 2013, OHRP revised its guidance concerning remuneration and risk. It reaffirmed that IRBs should not count remuneration as a benefit that offsets research risk when deciding whether a study is approvable. At the same time, OHRP clarified that remuneration may include compensation associated with risks and that such compensation may be an acceptable reason for an individual to agree to participate.

SACHRP's later discussion similarly recognizes this OHRP position while emphasizing the distinction between an IRB's risk-benefit assessment and a participant's own reasons for enrolling.

The difference is substantive. Researchers should therefore avoid claiming that international research ethics has settled on one universal answer.

A Participant May Consider Payment When Deciding Whether Risk Is Worthwhile

There is another distinction between institutional approval and individual choice.

An ethics committee might determine that a study presents an acceptable risk profile. A prospective participant can still decide that those risks are not personally worthwhile. Payment may enter that person's decision.

OHRP explicitly recognizes that compensation associated with research risk may be an acceptable motive for participation. SACHRP also notes that participants are likely to include payment in their personal weighing of potential benefits and harms even though the IRB should not use payment to justify approving the risk.

Those are two different judgments:

Payment may matter to the second judgment without repairing a failure of the first.

More Risk Can Make a Large Incentive More Ethically Sensitive

There is an apparent paradox. Increasing payment because a study is riskier might seem fair, yet a very attractive incentive in risky research can also intensify concerns about decision-making.

SACHRP argues that incentive payments deserve attention when they may inhibit adequate consideration of study risks, burdens, or discomforts. It also notes that when research is especially risky, limiting the size of a completion bonus relative to total payment may sometimes be appropriate because withdrawal remains an important safeguard.

The problem is therefore not solved by a simple equation in which payment rises proportionately with risk.

Hazard Pay Is an Analogy, Not a Research-Ethics Rule

Researchers sometimes reason by analogy with dangerous occupations: workers may receive hazard pay, so research participants should receive more for accepting greater risk.

The analogy can illuminate why people might reasonably value risk-related remuneration. It does not establish an ethical rule for research.

Research participation involves informed-consent requirements, independent ethics review, risk minimization, scientific and social-value considerations, and the right to withdraw. These requirements prevent the payment relationship from being treated simply as a market transaction in which any risk can be accepted for the right price.

Higher-Risk Procedures May Still Justify Different Payments for Other Reasons

A riskier procedure may also take longer, require additional visits, involve uncomfortable monitoring, impose dietary restrictions, require recovery time, or create other burdens.

Those differences can support different compensation even under a framework that does not compensate risk itself.

This is why payment rationales should identify precisely what participant compensation is intended to recognize rather than using "risk" as shorthand for every unpleasant feature of participation.

When the Riskier Procedure Also Creates More Burden

This prevents researchers from attributing the entire payment difference to risk when several other participant burdens have changed at the same time.

Common Mistakes About Paying for Research Risk

Separate Risk Approval From Payment Design

This sequence keeps two legitimate questions from becoming one misleading calculation: whether the risk is acceptable and whether the payment is appropriate.

Before Paying More for a Riskier Study or Procedure

Frequently Asked Questions About Payment for Research Risk

Higher Risk Does Not Automatically Mean Higher Payment

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