Incidental findings are traditionally defined as results that are outside of the original purpose for which a test or procedure was performed. These are distinct from primary findings, which are results that are actively sought as the primary goal of a test or procedure. Incidental findings can be "anticipated" or "unforeseen." An anticipated incidental finding is one that is known to be associated with a test or procedure. Predictable incidental findings do not have to be common or even likely to occur; its defining characteristic is that the possibility of finding them is known.
What are incidental findings?
Incidental findings (IF) are observations, results, or other findings that may occur during the analysis but are not related to the objectives of the analysis. FIs are generally encountered during the course of investigation or case work, but are considered beyond the scope of the project and often beyond the analyst's expertise. FIs are intrinsic to human subject research and the problem of FIs is ever-present and growing.
Incidental and Secondary Findings
The unexpected incidental findings include findings that could not have been anticipated given the current state of scientific knowledge. Researchers cannot plan for these kinds of findings specifically. However, they can consider in advance what they might do if a particular type of unexpected finding arises, for example one that might be actionable. A secondary finding, on the other hand, is not the primary goal of the test or procedure; rather, it is an additional actively sought outcome. Secondary findings can be deliberately sought when doing so is recommended by a body of experts or by consensus of practitioners.
Why should researchers inform participants thepossibility of incidental and secondary findings?
Investigators must communicate the fundamental aspects of their research, including the possibility of discovering incidental or secondary findings. In the same way, they must establish the plan for its disclosure or management. This is so that participants can make fully informed decisions about whether to enroll. Researchers can also determine early on what participants prefer to know, rather than know, about incidental or secondary findings. For example, a participant may prefer to know only those findings that are meaningful and actionable.
Action should be taken in accordance with the preferences expressed by the participants on whether to receive incidental and secondary findings. To the extent possible, they help researchers to respect the autonomy of the participants. If practical or logistical limitations prevent an investigator from seeking, interpreting, or disclosing incidental and secondary findings, the investigator may propose a plan. Disclosing a plan for handling incidental findings, and allowing non-participation if a potential participant chooses, appropriately respects an individual's ability to make informed and autonomous decisions about whether to participate in research.
What are some of the arguments in favor of incidental and / or secondary findings?
Investigators should consider both the potential benefits and risks of disclosure of incidental and secondary findings. However, disclosure could also lead to testing, additional incidental findings, costs, and anxiety and distress, potentially without corresponding benefit. Similarly, they must assess whether the potential benefits of an action outweigh the risks. In this regard, researchers must also carefully consider whether to allocate time and resources to search for secondary findings.
Thus, it should be established how to interpret, evaluate and disclose incidental findings. Especially when these decisions could benefit the people in the research study but stall the broader social benefits of the research activity. Researchers do not have an ethical duty to look for secondary findings. However, researchers must determine how their incidental findings management policy will affect participants as individuals and how it will affect their ability to contribute to generalizable knowledge.
What constitutes an ethically appropriate plan for managing incidental and secondary findings?
Investigators have an ethical duty to plan for incidental findings, whether common or rare, to the extent possible. However, researchers do not have an ethical duty to seek secondary findings. Investigators must develop an evidence-based plan on the analytical validity of potential findings and their significance.
They must also make careful consideration of the benefits, risks, and costs of disclosure. Including the risk that the search or analysis of incidental and secondary findings could distract from the central objective of the investigation. For certain types of research, disclosure of incidental findings is difficult, if not impossible.
For example, data stored in biobanks is often not identified. Researchers cannot easily link the data to particular individuals, making the return of incidental findings impractical or impractical. In such cases, researchers can develop a nondisclosure plan. It must be carefully deliberated and evaluated by an institutional review board (IRB). Researchers should consider the following elements when developing secondary and secondary findings policies.
There are at least three potential sources for such obligations, which we consider in turn.
First, if the researcher (or another member of his research team) is a professional.
Second, they can stem from duties rooted in general charity. Regardless of any professional or other relationship between the parties.
Finally, and most persuasively, they could derive from the nature of professional responsibility in general or from professional responsibility in the researcher-subject relationship.
In considering these possibilities, it turns out that it sheds light not only on the duties of investigators with respect to incidental findings, but more fundamentally on the nature of the investigator-subject relationship itself.
Investigators should develop a plan to handle the types of findings that may arise and clearly communicate the plan to participants during the informed consent process, even if the plan should not reveal any incidental or secondary findings. This allows individuals who choose not to participate in research if they feel uncomfortable with an investigator's management plan. Consent materials must include information on the following items:
- Secondary findings that will be actively sought and returned to participants must be communicated in the informed consent process, and there must be a specific plan for their disclosure.
- A plan for anticipated incidental findings (for example, that investigators will or will not return some or all potential findings) should also be included in the informed consent process and, to the extent that findings are returned, a plan should be outlined.
- For findings that are unpredictable, researchers should plan for the types of findings that might emerge and plan for return if appropriate (for example, that researchers will return unexpected findings that will be more useful but will not return unexpected findings of unknown significance).
Understanding the importance of some incidental findings may be outside the experience of researchers. Investigators must be sufficiently familiar with the anticipated incidental findings associated with the tests or procedures used in their investigation to formulate and communicate a plan for how these findings will be handled. If investigators need additional expertise to manage incidental and secondary findings, they could gain this expertise, for example:
- Add members to the investigation team who have sufficient experience to handle the range of anticipated incidental findings;
- Relying on IRB or research ethics consultants if there are concerns about the advisability of disclosing a particular finding to a participant;
- Seek qualified experts for consultation when investigators are unsure whether a finding is of clinical or reproductive significance.
Researchers must develop and communicate the plan to disseminate and manage findings that are outside their area of expertise. For example, researchers may wish to reveal incidental genetic findings in the presence of a genetic counselor to help participants understand the significance of the finding.
Researchers and IRBs commonly struggle with the question of how to address incidental findings. That is, a finding about an individual research participant that has potential significance and is discovered in the course of the research, but is beyond the objectives of the study. However, little ethical guidance is available to guide such efforts, and practices appear to vary widely. Although various articles have cataloged the ethical dilemmas surrounding incidental findings, the more general theme is that of providing auxiliary care to research subjects. But an ethical analysis of the problem of incidental findings is lacking.
One conceivable position on this question is that researchers have no default obligations, only promise-keeping duties that arise when they make particular representations to subjects. This view is based on the notion that the researcher-subject relationship is essentially contractual in nature, as opposed to fiduciary or professional. As such, the rights and obligations inherent in the relationship are defined by the “contracts” that the parties execute - the informed consent form and the surrounding interaction - and the implicit guarantee of good faith and fair treatment that accompanies them. This is a legalistic and minimalist view in the sense that few implicit duties are presumed. From this point of view, unless the incidental findings are within the terms of this contract, the investigators have no obligation to respond to them.
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