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Last updated: Apr 27, 2018

Incidental findings

The decision to return incidental or secondary findings and the process by which to do this is dependent on a number of factors and needs to be accounted for in the consent process. 

The study design will have an impact on the incidence of incidental or secondary findings and the relationship between the researcher and the participants, the nature of the informed consent and the duty to do no harm will guide this decision [1]. 

Why might you consider returning incidental or secondary findings [2]?
  • Clinical benefit for the individual (and their family)
  • Accounted and addressed in the consent process
  • Maximises the benefits of the research process (may not have another chance)
  • Participants rights and desire to know

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Why might you consider limiting return of incidental or secondary findings [2]?
  • Beyond research goal i.e.  “therapeutic misconception”
  • Variants of uncertain significance and absence of clinical meaning of information
  • Accuracy is not clear
  • Potential for harm
  • Benefits overstated
  • Resource intensive [3]

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Considerations to be addressed in an ethically defensible plan may include:
  • Whether to report results at all
  • Whether to deliberately look for, and report, secondary findings
  • What to do when incidental findings arises
  • Whether and when to obtain further specific consent before reporting findings back to participants

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[1] Souzeau E , Burdon K P, Mackey D A, Hewitt A W, Savarirayan R, Otlowski M, and Craig J E. (2016) Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research.  Translational vision science and technology. 5:1,1-11.

[2] Newson, A (2016) ‘Ethical aspects of genetic and genomic research’ [Slide Deck]. Sydney Health Ethics: University of Sydney.

[3] Vassy J L, Christensen K D, Schonman E F, Blout C L, Robinson J O, Krier J B and Medseq Project. (2017) The Impact of Whole-Genome Sequencing on the Primary Care and Outcomes of Healthy Adult Patients: A Pilot Randomized Trial. Ann Intern Med.167 (3):I-20