Bad News about Bad News: The Disclosure of Risks to Insurability in Research Consent Processes

Abstract

One of the phenomena associated with research is “incidental findings,” that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.

Keywords:

• consent
• incidental findings
• insurability risks
• neuroethics
• research ethics

ACKNOWLEDGMENTS

The authors are grateful to the Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) for their generous financial support through the Neuroethics New Emerging Team (NET) grant. The authors would like to thank Lorraine Lafferty for her comments on an earlier version of this article.

Notes

1. Different jurisdictions use different labels for entities tasked with the ethical oversight of research (for example, Institutional Review Board [IRB], Research Ethics Board [REB], and REC). For the purposes of this article, we use the most generic label, REC, so as to not limit the apparent relevance of the topic or targets of the recommendations.

2. In order to aid the reader in other jurisdictions to transfer our analysis and recommendations, references for relevant legislation and common law in the United Kingdom, United States, and Australia are provided throughout this article. Also, where differences arise, as between jurisdictions, these differences are highlighted.

3. The scope of this article is further limited insofar as we only look at the law as it is now. Hence we do not address the ethical question of whether the law is as it should be (e.g., is it ethically defensible that even innocent misrepresentation enables the policy to be voidable by the insurer?). Nor do we address the pragmatic question of how the law may need to be changed if, at some point in the future, the development and use of technology is such that IFs become extremely common. While interesting, these must remain questions for other articles.

4. The principle of uberrimae fidei is widely applicable to life insurance law across many jurisdictions. For instance, in Australia, this duty of the utmost good faith is codified in the Insurance Contracts Act 1984, s. 13. In the United States, there is also a positive duty on the insured to disclose all material facts (Dobbyn, 1996). However, many states have legislation on this issue that modifies the general common law principle. In the United Kingdom, the principle of uberrimae fidei also applies to insurance contracts. At the application stage, it requires both parties to not misrepresent material facts and confers the obligation to disclose material facts even if the question is not asked (http://www.lawcom.gov.uk/insurance_contract.htm). The duty of good faith is also codified in the U.K.'s Marine Insurance Act 1906, s. 17.

5. Voidable means the contract continues to be in force unless and until it is avoided by the party entitled to rescind it, which retroactively nulls the contract (Norwood and Weir, 2002).

6. Insurance Act, s. 183(2): “Subject to section 184, a failure to disclose, or a misrepresentation of, such a fact renders the contract voidable by the insurer.”Section 184(2) states: “… where a contract has been in effect for two years during the lifetime of the person whose life is insured, a failure to disclose or a misrepresentation of a fact required to be disclosed by section 183 does not, in the absence of fraud, render the contract voidable.”Insurance is within provincial jurisdiction. Similar statutory provisions exist in other provinces. There is a large body of case law on the issue of what constitutes fraud. See, for example, Kruska (1985).

7. The law in the United States with respect to innocent misrepresentation in life insurance requires bad faith by the insured in withholding material information to void the policy (Dobbyn, 1996).

8. The reasoning behind this is that, if the material fact was disclosed at the time of the application, the insurer would not have entered into the contract and, therefore, would not bear the risk, regardless of the good intentions of the applicant. See, for example, Thompson (2004).

9. The common law regarding insurance law was superseded in many respects by the introduction of a uniform statute law in the common law jurisdictions in Canada in 1925 (http://www.fin.gc.ca/toc/1999/health-eng.asp).

10. Insurance Act, s. 183 (emphasis ours). This wording is the same across all common law provinces per the Uniform Life Insurance Act. The Civil Code of Quebec provides similarly (Art. 2408 C.C.Q.): “The client, and the insured if the insurer requires it, is bound to represent all the facts known to him which are likely to materially influence an insurer in the setting of the premium, the appraisal of the risk or the decision to cover it…”Note that this same duty also applies upon reinstatement of a lapsed policy: Ontario's Insurance Act, s. 189(4): “Sections 183 and 184 apply with necessary modifications to reinstatement of a contract.”

11. In Australia, for instance, the insured's duty of disclosure upon application for insurance is to disclose “every matter that is known to the insured” that either the insured or a reasonable person in the circumstances “knows to be a matter relevant to the decision of the insured to accept the risk” (Insurance Contracts Act, 1984, s. 21).

12. This principle applies equally in the United States (Dobbyn, 1996).

13. In the United Kingdom, the materiality test is as follows: “A representation is material which would influence the judgment of a prudent insurer in fixing the premium, or determining whether he will take the risk” (Marine Insurance Act, 1906, s. 20(2)).

14. A similar analysis could be run with the specifics of IFs in the context of other kinds of research.

15. This is, of course, a point of controversy in the literature. We do not enter into that debate here but rather proceed on the assumption that the arguments in support of disclosing IFs to participants will win out (as, for reasons we cannot go into here, we think they should).

16. Life insurance is a common financial planning tool used by many. The Canadian Life and Health Insurance Association (CLHIA), a voluntary trade association whose membership accounts for 99% of the life and health insurance in force in Canada, estimates that by the end of 2008, approximately 7.7 million people in Ontario owned $1.4 trillion of life insurance. (www.clhia.ca/prov/facts2008_ON.pdf). Total ownership of life insurance in Canada is estimated to be $3.3 trillion with an estimated 20 million plus Canadians owning life insurance (www.clhia.ca/download/KeyStats2009_EN.pdf). The issue of life insurance is, therefore, clearly of great importance to manypeople.

17. The TCPS is the document which establishes the standards for research ethics for research conducted in institutions receiving funding from one or more of the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council. The goal is “to promote the ethical conduct of research involving human subjects” (TCPS, Introduction).

18. In the United States, the “Common Rule” sets out the legal standards for the protection of human research subjects. The standards prescribed apply to all government funded research involving human subjects (Title 45 Code of Federal Regulations, Part 46, (45 CFR 46) Subpart A). It also applies to research conducted in an institution that receives federal funds for research, even if specific research is not funded by federal agencies (Hadskis, 2007).

19. Hopp (1980), Reibl (1980). The modified objective standard espoused in Hopp and Reibl, arguably a higher standard than the objective test set out in Halushka, would more likely be applicable today. See Hadskis (2007, pp. 287—288) for a full discussion of this issue.

20. Hadskis (2007, p. 289), quoting from Picard and Robertson (1996, p. 150).

21. For example, MRI research consent forms found at the following sites were reviewed: http://www.brainnrg.ca/index.php?section=507; http://research.bmap.ucla.edu/sample_consent.html; http://www.queensu.ca/neurosci/MRI/Templates/subject_information_template.doc; http://www.welcomebackcentre.com/files/documents/MRI-consent.pdf; http://www.mni.mcgill.ca/files/staff/MRResearch.engconsentrevisedmay08.pdf

22. With respect to IFs, some of the sample wording stated: “Although this is not a diagnostic scan and any images obtained are for research purposes only, it is possible that the MR scan may disclose an unknown abnormality. In this event, a medical imaging specialist will be asked to review the images and we would send a report to your physician. The researchers directly involved with this procedure do not have the credentials to diagnose medical conditions.” “… in the unlikely event that we note an atypical finding on your MRI scan, we will contact you to help you arrange medical follow-up to interpret the significance of the findings, if any. We may ask a radiologist, or other health professional, to look at your scan, and by signing this consent form you agree to releasing the scan for review. It is possible that you could be unnecessarily worried if a problem were suspected, but not actually found.”