03 · What You Need to Know
Participant Choice Works Only When the Options Actually Mean Something
Why should participants have a choice?
Incidental findings can change what a person knows about their present health, future disease risk, reproductive options, or family. Such information can be beneficial, but it can also produce anxiety, uncertainty, unwanted medical investigations, or knowledge that cannot be acted upon.
Respect for autonomy therefore supports allowing participants some control over whether they receive information generated about them. Canada’s TCPS 2, for example, requires disclosure of material incidental findings within the limits of consent provided by the participant and explicitly links this approach to respect for persons and participant welfare.
The broader principle is not unique to that framework: return of individual findings is not merely a technical transfer of data. It can affect important personal decisions, so participant preferences matter.
Choice does not mean participants must receive every result they request
Suppose a participant selects “I want all findings.” Does that require researchers to return every unusual measurement, exploratory association, raw sequence variant, or uninterpretable anomaly?
No. Participant preference cannot make information scientifically valid or clinically interpretable. Researchers still need a defensible policy determining what counts as a finding suitable for return.
Return threshold
Determines which findings are sufficiently valid, significant, and appropriate for the study to offer at all.
Participant preference
Determines whether the participant wishes to receive findings that meet the study’s return threshold, subject to applicable ethical and legal limits.
This is why the decision about what makes a finding important enough to return should come before asking participants to choose among findings the research team cannot responsibly interpret.
A single yes-or-no choice may be too crude
“Do you want incidental findings? Yes or no” appears simple, but participants may feel very differently about different kinds of information.
Someone might want findings for which treatment or prevention exists but decline information about untreatable future disease. Another participant may want reproductive information. A third may value information with substantial personal utility even when it does not alter clinical care.
Where a study can operationally support such distinctions, researchers may consider preference categories rather than an all-or-nothing choice.
| Possible category |
Example preference question |
Why the distinction may matter |
| Serious and clinically actionable findings |
Do you want findings that could allow treatment, prevention, or meaningful surveillance? |
These often present the strongest potential health benefit |
| Serious but non-actionable findings |
Do you want reliable information about serious conditions even when no effective medical action is currently available? |
Participants may differ substantially in whether they value such knowledge |
| Reproductive findings |
Do you want qualifying findings that could affect reproductive decisions? |
Utility may exist even when the participant is healthy |
| Other findings with established personal utility |
Does the study offer a defined category of non-clinical but potentially meaningful information? |
Personal value can extend beyond medical intervention, although return thresholds should remain defensible |
This table illustrates possible distinctions rather than a universal consent template. Too many categories can produce another problem: participants may be asked to make technically complex choices they do not understand. Granularity should improve autonomy, not turn consent into a small taxonomy exam.
Participants need to understand what “receive findings” actually means
A meaningful choice requires enough information to understand its implications. Where incidental findings are reasonably foreseeable, participants should know what kinds of findings may arise, which categories the study plans to return, whether confirmation may be required, how communication will occur, and what follow-up the research team will and will not provide.
TCPS guidance specifically states that where material incidental findings are foreseeable, participants should be informed during the initial consent process about the likelihood of their discovery and, where applicable, the strategy for disclosure. It also encourages research teams to plan how participant preferences will be handled.
Researchers should avoid creating expectations that the study will identify every possible health problem. A policy for returning qualifying incidental findings is not equivalent to clinical screening.
Choice can be part of ongoing consent
Preferences are not necessarily permanent. A participant may select one option when enrolling and reconsider years later. Their health, family circumstances, tolerance for uncertainty, or available treatments may change.
TCPS guidance recognizes both initial and ongoing consent regarding material incidental findings. It notes that participant circumstances can change over time and influence decisions to continue agreeing or refusing to receive findings.
Where the research relationship is long-term and the study infrastructure permits it, researchers should consider whether and how participants can update their preferences.
Do not reveal the finding while asking whether the participant wants it
An unexpected finding may arise even though incidental findings were never discussed during initial consent. Researchers may then need to seek the participant’s consent to receive the information.
This creates a surprisingly delicate communication problem. Saying, “We found something that suggests you may have cancer. Would you like to know what it is?” has effectively disclosed much of the information before consent has been obtained.
TCPS guidance specifically cautions researchers not to reveal unnecessary details about a material incidental finding while contacting a participant to seek consent to receive it.
The contact procedure should therefore be designed to offer a meaningful choice without making the choice fictitious through premature disclosure.
The participant’s choice should be distinguished from the right to raw data
Choosing to receive incidental findings does not necessarily mean choosing to receive every raw data point generated by the study. Raw data, individual research results, interpreted findings, and clinically confirmed results are different things.
A return policy should state what researchers are actually offering. Otherwise, “all findings” can become an undefined promise that neither participants nor researchers understand consistently.
What if the participant chooses not to know?
A preference not to receive information can be ethically significant. Knowledge of a serious future condition may itself impose psychological and personal burdens, particularly when little can be done medically.
The harder question is whether a participant’s refusal should always control when researchers later discover information indicating a serious and preventable threat. That issue deserves separate treatment because it brings autonomy into direct tension with concern for welfare.
The scope and possible limits of the right not to know potentially important research information should therefore be distinguished from the more general proposition that participants should be offered meaningful choices.
Exceptionally important findings require advance planning
A research team should decide prospectively what it will do if a participant declines findings and the study later uncovers an unexpected, highly credible, immediately actionable threat.
TCPS 2 illustrates one possible approach. When researchers have undertaken not to disclose material incidental findings but later discover an unforeseeable material finding that could be addressed through a potentially significantly beneficial intervention, it advises consultation with the research ethics board to determine whether sufficient ethical grounds exist for disclosure and how it should occur.
This is not a general permission to override refusals. It is an example of why exceptional cases should be addressed through an ethics framework rather than one researcher deciding that the participant “really ought to know.”
Children and participants lacking decision-making capacity require additional safeguards
When a participant cannot provide legally valid consent independently, an authorized third party may make decisions about receiving findings. That authority is generally constrained by duties to act in the participant’s interests.
TCPS 2, for example, states that an authorized third party must receive findings for a child that are actionable immediately or during childhood, while findings actionable only in adulthood are treated differently.
Rules for pediatric and incapacity contexts vary among jurisdictions and research frameworks. Researchers should therefore follow the applicable ethics and legal requirements rather than simply applying the adult opt-in or opt-out model.
Participant choice cannot override legal reporting obligations
Some discoveries trigger obligations that are not simply return-of-results decisions. Applicable laws or professional requirements may require reporting certain information despite a participant’s preference for confidentiality or nondisclosure.
Participants should be informed of relevant limits to confidentiality during consent when those limits are reasonably foreseeable. Researchers should not promise absolute control over disclosure when the law or applicable professional obligations do not permit it.
The circumstances in which confidentiality may give way to a duty to act or report depend heavily on jurisdiction and the nature of the information.
Watch Out
Do not offer participants choices your study cannot actually honor. If the research lacks resources to validate, interpret, recontact, counsel, or return a particular category of findings, promising participants that they can choose to receive that category creates an ethical and operational commitment the study may be unable to fulfill.
