Guidelines

Incidental findings

During the course of research involving humans, findings relating to a subject's health may be discovered that is unrelated to the purpose or objectives of the study. These findings are termed "Incidental Findings" (IFs), which may be of clinical significance that could have potential serious implications for the subject's well-being. In general, a research subject should be allowed to consent if he/she wishes to be re-identified in the case of an IF, if the proposed biomedical research expressly provides for such re-identification, especially if the IFs are both clinically significant and actionable. Ethical management of IFs is thus necessary and researchers have and obligation to anticipate these findings and make a plan in advance of starting the research, that addresses what, when and how findings will be communicated to the research subjects.

In line with NTU's policy on IFs, PIs are to determine from the outset on the potential for IFs occurring, and if these will be released to the subjects. The threshold for reporting IFs, which are the potential medical beneficence of the findings versus the need for respect for persons, should be determined. Based on this, a management plan should be developed by the PI, and these are to be submitted to NTU IRB for review and approval.

[A detailed guideline on this can be found here]


Examples of Incidental Findings

Research Domain IFs – Key Examples
Genetic Studies

 Misattributed paternity
 Other misattributed lineage (e.g. undisclosed adoption)
 Unanticipated genetic or chromosomal variant beyond genes or chromosomes being studied
 Pleiotropy – new unexpected clinical implication of genetic pattern

MRI of Brain

 Unexpected mass
 Aneurysm
 Bleed/ Stroke
 Evidence of current or past trauma to brain
 Malformation
 Anatomic evidence of dementia

CT Scans

 Findings anywhere in torso (e.g. aortic aneurysm, renal neoplasm) not part of original study site
 Colonic findings unrelated to neoplasia (e.g. inflammatory bowel disease) 


Recommended classification of Incidental Findings (adopted from NIH)

IF Disclosure Category Relevant IFs Recommended Action

Strong Net Benefit

(IFs whose disclosure is likely to offer markedly more benefit than burden to the research participant)

 Information revealing a condition (or significant risk)  likely to be life-threatening
 Information revealing a condition likely to be grave and can be avoided or ameliorated
 Genetic information that can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be life-threatening or grave or (2) to ameliorate a condition likely to be life-threatening or grave

Examples:
 In genetic studies, an IF revealing alleles associated with hereditary nonpolyposis colorectal cancer. This is likely to be life-threatening or to impose grave harm that may be avoided.
 In CT colonography research, discovery of an extracolonic neoplasm or abdominal aortic aneurysm is likely to be life-threatening or grave and amenable to treatment.

Disclose to research participant as an incident finding, unless he/ she elected not to know.

Possible Net Benefit

(IFs that may offer more benefit than burden to the

research participant)

 Information revealing a nonfatal condition likely to be grave or serious but that cannot be avoided or ameliorated, when a research participant is likely to deem that information important
 Genetic information that is likely to be deemed important by a research participant and can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be serious or (2) to ameliorate a condition likely to be serious

Examples:
 In genetic studies, an IF of APOE4 indicating susceptibility to Alzheimer disease at some point in the far future. The risk of Alzheimer disease is serious but cannot now be avoided or ameliorated.
 Discovery of multilevel degenerative disk disease in the lumbar spine because the condition is likely to be serious but cannot be corrected and the research participant is likely to find this information of importance.

May disclose to research participant as an incidental finding, unless he/ she elected not to know.

Unlikely Net Benefit

(IFs that probably offer more burden than benefit)

 Information revealing a condition that is not likely to be of serious health or reproductive importance, or importance cannot be ascertained.  

Examples:
 An IF of misattributed paternity would usually be in the "unlikely net benefit" category, particularly because communicating misattributed paternity may carry serious burdens for research participants.
 Discovery of a lung nodule less than 4mm in a nonsmoker because this information is not likely to be of serious health or reproductive importance.

Do not disclose to research participant as an incidental finding.




References:

Schaefer GO, Savulescu J. The Right to Know: A Revised Standard for Reporting Incidental Findings. Hastings Cent Rep. 2018 Mar;48(2):22-32.

Susan M. Wolf, et. al.., Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. J Law Med Ethics. 2008; 36(2): 219–211.