Incidental research findings

From The Embassy of Good Science

Incidental research findings

What is this about?

Sometimes findings occur that fall outside of the scope of the research questions. These are known as incidental findings [1]. These findings may be highly valuable to the participants of a study. They also raise ethical and legal issues, so researchers need to handle them with care.

  1. European Commission. Ethics in Social Sciences and Humanities. October 2018. [cited 2020 Sept 11]. Available from: https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf.

Why is this important?

Prominent examples of incidental research findings include the discovery of penicillin, X-rays, radioactivity and microwaves. These findings have provided significant benefits for society. Swift technological developments, large amounts of data and the constant drive to innovate increase the chances of uncovering new and important incidental findings in the future [1].

In some disciplines, these findings raise ethical and legal questions and can lead to serious dilemmas for human research. For example, in the social sciences and the humanities, confidentiality obligations to human participants can clash with obligations to disclose information to relevant authorities [2]. These findings could relate to criminal activities, human trafficking, abuse, domestic violence and bullying. The European Commission’s “Ethics in Social Science and Humanities” from 2018 states that if such findings are revealed during the research, then researchers must report them to the relevant authorities, regardless of their prior commitments to confidentiality and the preservation of the anonymity of the participants[2] .

Incidental findings in biomedicine can include medical abnormalities that could have serious clinical significance [3]. For example, research can reveal a brain tumor [4], and identifying it on time can save a life [3]. Some recent studies in neurology have revealed a great number of incidental findings. For example, one study revealed incidental findings in 47 % of the MRI and fMRI scans of adult volunteers (n=151), 6.6 % of which required a follow-up. Furthermore, 9.8 % of the total findings required a routine referral and 4 % an urgent referral [3].

  1. Government of Canada. How to Address Material Incidental Findings. [cited 2020 Sept 22]. Available from: https://ethics.gc.ca/eng/incidental_findings.html?wbdisable=true#a3.
  2. 2.0 2.1 European Commission. Ethics in Social Sciences and Humanities. October 2018. [cited 2020 Sept 11]. Available from: https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf.
  3. 3.0 3.1 3.2 Milstein A C. Research Malpractice and the Issue of Incidental Findings. J Law Med Ethics. 2008;36(2):356-360. Available from: https://journals.sagepub.com/doi/abs/10.1111/j.1748-720X.2008.00280.x.
  4. Illes J, Kirschen M P. Unexpected findings. APA. 2014;45(3):54. Available from: https://www.apa.org/monitor/2014/03/unexpected-findings.

For whom is this important?

What are the best practices?

There are some guidelines and recommendations available on how to handle incidental findings in the social sciences and the humanities. The APA Committee on Human Research, for example, suggests including potential incidental findings in a researcher’s study plan or project proposal, with details about the threshold for reporting them [1]. The European Commission’s “Ethics in Social Sciences and Humanities” also suggests that researchers should consider potential incidental findings in their research [2]. They should draft a policy for coping with these findings and discuss them with their consortium, taking into account the legal context in which they are conducting their research, and, if appropriate, liaising with the legal department of their host institution. Furthermore, researchers should also inform the participants about the limits of confidentiality [2]. The European Commission also released their “Guidance note — Research on refugees, asylum seekers & migrants”, intended to help researchers in the social sciences and the humanities deal with incidental research findings when they relate to specific vulnerable populations [3]. When human research subjects are refugees, asylum seekers and migrants, the European Commission recommends that researchers contact the relevant NGOs rather than the authorities [2]. In order to mitigate the potential power differences between researchers and participants, the European Commission advises that projects involving these specific vulnerable populations should look to include researchers with a refugee or migrant background or, at least, researchers from the same culture. When the participants are unaccompanied minors, researchers should also contact National Refugee Councils for legal advice, psychological and interpretive support, and legally assigned supervision [3].

Researchers in the biomedical and health sciences also require guidance regarding the management and communication of incidental findings [4]. The Presidential Commission for the Study of Bioethical Issues in 2013 issued a report, stating that researchers should communicate potential incidental findings as part of the informed consent process [5]. In addition, researchers should make a plan to evaluate and manage anticipatable and un-anticipatable incidental findings and seek the approval of the relevant institutional review board [5]. It is important that researchers inform the participants about the potential un-anticipatable incidental findings. If such findings occur, researchers should assess their importance and consult with experts on the matter [5].

  1. American Psychological Association. Incidental findings in research with human participants: Ethical challenges for psychologists. [cited 2020 Sept 30]. Available from: https://www.apa.org/science/about/psa/2011/04/human-research.
  2. 2.0 2.1 2.2 European Commission. Ethics in Social Sciences and Humanities. October 2018. [cited 2020 Sept 11]. Available from: https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf.
  3. 3.0 3.1 European Commission. Guidance note – Research on refugees, asylum seekers & migrants. [cited 2020 Sept 11]. Available from: https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-refugees-migrants_en.pdf.
  4. Milstein A C. Research Malpractice and the Issue of Incidental Findings. J Law Med Ethics. 2008;36(2):356-360. Available from: https://journals.sagepub.com/doi/abs/10.1111/j.1748-720X.2008.00280.x.
  5. 5.0 5.1 5.2 Presidential Commission for the Study of Bioethical Issues. Anticipate and Communicate. Ethical Managements of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Washington, D.C. 2013. [cited 2020 Sept 11]. Available from: https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf.