Australian researcher's perspectives on the Australian industry-led moratorium on genetic tests in life insurance
Abstract
Fear of insurance discrimination can inhibit genetic research participation. In 2019, an industry-led partial moratorium on using genetic results in Australian life insurance underwriting was introduced. This mixed-methods study used online surveys (n = 59 participants) and semi-structured interviews (n = 22 participants) to capture researchers’ perceptions about the moratorium. 66% (n = 39/59) were aware of the moratorium before the survey. Of researchers returning genetic results, 56% (n = 22/39) reported that insurance implications were mentioned in consent forms, but a minority reported updating consent forms post-moratorium (n = 13/39, 33%). Most researchers reported that concerns regarding life insurers utilizing research results inhibited recruitment (35/59, 59%), and few perceived that the moratorium positively influenced participation (n = 9/39, 23%). These findings were supported by qualitative findings which revealed that genetic discrimination concerns were a major issue for some individuals, though these concerns could be eclipsed by the promise of a diagnosis through research participation. The majority thought a regulatory solution should be permanent (n = 34/51, 67%), have financial limits of at least ≥1,000,000 AUD (37/51, 73%), and involve government oversight/legislation (n = 44/51, 86%). In an era where an increasing number of research studies involve genomics as a primary or secondary objective, it is crucial that we have regulatory solutions to address participants’ hesitation.
1 INTRODUCTION
Previous studies have shown that fear of genetic discrimination (GD), particularly as it pertains to insurance underwriting, deters participation in genomics research (Joly & Dalpe, 2022). Given the ever advancing, expanding field of genomic research and testing, there is potential for GD concerns to increase among patients and research participants. Consequently, genetic nondiscrimination protections have been introduced in many countries worldwide, including the United Kingdom, Canada, the United States, and many European and Asian nations (Joly et al., 2020).
In Australia, underwriting decisions in risk-rated insurance can legally include genetic test results. This includes for policies pertaining to life insurance, income protection, total and permanent disability, and travel insurance. Health insurance in Australia is community-rated (Australian Government, 2007), meaning risk information (including genetic results) cannot be used to deny cover or increase the cost of premiums. In 2018, a Parliamentary Joint Committee (PJC) inquiry into Australia's life insurance industry concluded that fear of GD was negatively affecting the uptake of genetic testing and participation in research, and recommended that life insurers be urgently prohibited from using genetic test results in underwriting (Parliament of Australia, 2018). The PJC recommended a moratorium, with government oversight, mirroring the UK's approach, where genetic test results cannot be used in any insurance underwriting, with the exception of Huntington's disease results for life cover >£500,000 (~925,000 AUD) (Joly & Dalpe, 2022). In 2019, the Financial Services Council (FSC) introduced an industry-led, partial moratorium restricting the use of genetic test results by life insurers (Financial Services Council, 2019a). However, the Australian moratorium terms and structure are considerably different to the UK model, and ultimately fall short of the Inquiry recommendations (Tiller, Lacaze, & Otlowski, 2022). The Australian moratorium only prohibits insurance companies from requesting applicant's genetic test results for policies under certain limits, including 500K AUD for death cover and 4000 AUD/month for income protection. For policies exceeding these values, applicants must disclose genetic test results if requested. The moratorium's definition of genetic test is broad and covers all tests which “examine a person's chromosomes or DNA”, which includes clinical test results as well as research results. Insurance companies are not permitted to request genetic test results from other family members, regardless of the policy value, unless the test confirms a clinical diagnosis. Risk mitigation, preventative measures and negative (favorable) predictive test results, should be considered in underwriting.
It is necessary to evaluate the impacts and limitations of the moratorium as experienced by researchers, to understand its effectiveness, whether it has improved the ability to conduct genetic/genomic research (“genomic research”), and whether any changes are required, or whether a different regulatory solution altogether is required in Australia. In this study, we used a mixed methods approach to capture Australian researchers' awareness of and attitudes towards the moratorium and their perceptions regarding the impact of moratorium on genomic research.
2 MATERIALS AND METHODS
2.1 Editorial policies and ethical considerations
This study was approved by The University of Queensland Human Research Ethics Committee (2021/HE001554). The participant information text was provided at the start of the survey and concluded with text which stated that completion of the survey implied consent. Individuals who were receptive to the qualitative study were sent a Participant Information and Consent Form which they signed and returned. Data collection, including surveys and interviews occurred between October 2021 and March 2022.
2.2 Study design and recruitment
This study forms part of the Australian Genetics and Life Insurance Moratorium (A-GLIMMER) project (Tiller, McInerney-Leo, et al., 2021). A-GLIMMER was funded by the Australian Government Medical Research Future Fund, Genomics Health Futures Mission, and aims to evaluate and monitor the impact of the FSC moratorium on the use of genomic test results in life insurance underwriting in Australia between 2020 and 2023 (Tiller, Winship, et al., 2021). A sequential mixed-method study was conducted to evaluate genomic researchers' awareness and understanding of the life insurance moratorium as a key stakeholder group, and their perceptions regarding the impact of the moratorium on genomic research recruitment. Data was collected via an anonymous, online cross-sectional survey and from virtual interviews. Researchers were eligible to participate if they were conducting human genomic research in Australia that returned, had the potential to return, and/or decided not to return genomic results to study participants. Invitations to complete the survey were distributed via mailing lists from medical research institutes in Australia, professional organizations (e.g., the Human Genetics Society of Australasia), and social media. After completing the survey, individuals could choose to self-select participation in an interview to explore issues further. Purposive sampling was also used to supplement the survey sample. Key genomic researchers identified via professional networks were invited to participate by email. The participant information sheet was provided at the start of the survey, and consent was implied by completion of the anonymous survey. Separate consent was sought for researchers who participated in the follow-up interview.
2.3 Survey development and analysis
Survey design and questions were based on prior questionnaires administered to health professionals (Tiller et al., 2018; Tiller, Keogh, et al., 2022) and consumers (Tiller et al., 2020) in Australia by our group, to ensure consistency. The researcher's survey specifically evaluated the following outcomes: knowledge of the use of genomic information in insurance underwriting in Australia; attitudes towards GD; awareness of the Australian life insurance moratorium; impact of the moratorium on genomics research; satisfaction with the moratorium as a regulatory solution, and demographic characteristics (see Supplementary Material Data S1: Survey). Surveys were distributed via the Qualtrics platform (Qualtrics, Provo, UT). Descriptive statistics, including frequencies and measures of central tendency, were used to describe the sample and results. A chi-square goodness-of-fit test was performed to determine whether the frequency of awareness and perceived knowledge differed between certain demographic groups.
2.4 Interviews
To gain a richer description of the impact of the Australian moratorium in genomic research, a sequential qualitative study was also conducted. Researchers participated in semi-structured interviews lasting around 30 min (Supplementary Material Data S1: Interview Schedule), conducted by authors (TY, AH, AML, and MB). Participants were asked to elaborate on how they became aware of the moratorium, whether they altered their consenting process following the introduction of the moratorium, their impressions regarding the impact of the moratorium on research participation, and their thoughts about the strengths and weaknesses of the moratorium. All interviews were recorded, de-identified, and transcribed verbatim. Transcripts were entered into NVivo software and coded approximately three times to capture the main themes. Thematic analysis was conducted using the methodology described by Braun and Clarke (2006). Authors MB and TY independently coded all interviews and developed an initial coding framework. The framework was revised and finalized with author AML.
3 RESULTS
3.1 Survey results
3.1.1 Researcher characteristics
Of the 90 researchers who accessed the survey (October–November 2021), 29 did not complete any survey responses and one researcher was excluded as ineligible. Of the 60 eligible researchers, 9 partially and 51 fully completed the survey. Given the broad methods used for survey distribution and recruitment, including the use of social media, it was not possible to calculate a participation rate. Table 1 provides a summary of researchers' demographics and their study characteristics. As demographic questions were placed at the end of the survey, this data is available for the 53 researchers who completed all items. Over a third were the principal/chief investigator for their study (n = 20/51, 39%) and/or had a concurrent clinical position (i.e., clinician-researcher) (n = 19/51, 37%). Many participants worked across more than one genomics study (n = 40/51, 78%) and most consented participants themselves (n = 26/56, 46%) or supervised those performing consenting (n = 19/56, 34%). Most researchers confirmed that their current studies included an option for participants to receive their research genomic testing results (n = 39/51, 77%). Among researchers whose current studies are returning results, over half reported that their consent form included a statement about potential insurance implications (n = 22/39, 56%), while five were unsure (n = 5/39, 13%). Of the 12 studies not actively returning results, only one indicated that this was due to concerns about insurance discrimination (see Table S1).
| N (%) | |
|---|---|
| Profession (n = 51) | |
| Principal/chief investigator | 20 (39) |
| Associate investigator | 14 (28) |
| Research assistant/project officer | 5 (10) |
| Trial manager/study co-ordinator | 9 (18) |
| Higher degree student | 1 (2) |
| Other | 2 (4) |
| Age (n = 51) | |
| <40 years | 18 (35) |
| 41–60 years | 28 (55) |
| >61 years | 5 (10) |
| Identified gender (n = 51) | |
| Male | 14 (28) |
| Female | 36 (71) |
| Other | 1 (2) |
| Employment setting (n = 51) | |
| University/research institute only | 31 (61) |
| Hospital only | 9 (18) |
| Both at university and hospital | 10 (20) |
| Nongovernmental organization | 1 (2) |
| Years of employment as a researcher (n = 51) | |
| 0–5 | 10 (20) |
| 6–10 | 15 (29) |
| 11–15 | 13 (26) |
| >16 | 13 (26) |
| Has a clinical position (n = 51) | |
| Yes | 19 (37) |
| No | 32 (63) |
| Works in more than one genetic study (n = 51) | |
| Yes | 40 (78) |
| No | 11 (22)) |
| Personally involved in consenting participants to genetics research (n = 56) | |
| Yes | 26 (46) |
| No | 11 (20) |
| Not personally, but supervise team members who do | 19 (34) |
| Current study includes options to return genetic test results (n = 51) | |
| Yes | 39 (77) |
| No | 12 (24) |
| Consent form includes statement about potential insurance implications (n = 56) | |
| Yes | 32 (57) |
| No | 17 (30) |
| Don't know | 7 (13) |
3.1.2 Perspectives on life insurance discrimination and knowledge of the moratorium
The majority of researchers believed that the potential use of genomic results in life insurance underwriting was a barrier to recruitment of participants into genomic studies (n = 35/59, 59%) (Table 2). Two thirds were aware of the introduction of the Australian moratorium (n = 39/59, 66%). When asked about the ways in which they became aware of the moratorium, the most commonly selected answer was through their workplace (e.g., specific education provided or conversations with colleagues) (n = 25/59, 42%), followed by professional organizations (n = 16/59, 27%), media coverage/social media (n = 9/59, 15%) and the Financial Services Council of Australia (n = 2/59, 3%). Five researchers who were not previously aware of the moratorium indicated that they became aware through completion of the study questionnaire. Of the 20/59 (34%) researchers who were not previously aware of the moratorium, seven were directly involved in consenting participants to their study, and eight were responsible for supervising team members who conducted this work (data not shown). Clinicians were not significantly more likely to be aware of the moratorium than nonclinician researchers, χ2(1, 51) = [0.6941], p = [0.405]. Of the 45 researchers who were either directly involved in the consent process or supervised team members, 60% (n = 27/45) felt they had sufficient knowledge about potential insurance implications to properly carry out their research role. Researchers responsible for obtaining informed consent from study participants were not significantly more likely to report having sufficient knowledge about potential insurance implications than other researchers, χ2(1, 56) = [1.85], p = [0.17].
| Item | N (%) |
|---|---|
| Do you believe that the potential use of genetic results in life insurance is a barrier to study recruitment (n = 59) | |
| Yes | 35 (59) |
| No | 24 (41) |
| Aware of introduction of the moratorium in 2019 (n = 59) | |
| Yes | 39 (66) |
| No | 20 (34) |
| Satisfaction with the moratorium as a solution to genetic discrimination in life insurance underwriting (n = 51) | |
| Very satisfied—this is the ideal solution | 2 (4) |
| Somewhat satisfied—this is a pretty good solution | 24 (47) |
| Somewhat dissatisfied—the solution could be better | 20 (39) |
| Extremely dissatisfied—the solution could be much better | 5 (10) |
| What is your opinion about the amount of insurance coverage people can apply for before having to disclose genetic test results (n = 51) | |
| Too low | 40 (78) |
| Just right | 9 (18) |
| Too high | 2 (4) |
| Amount of insurance coverage that should be allowed before having to disclose genetic test results (n = 51) | |
| $500,000 | 4 (8) |
| $1,000,000 | 17 (33) |
| Unlimited | 20 (39) |
| Unsure | 10 (20) |
| Thoughts on the temporary nature of the moratorium (n = 51) | |
| The moratorium should be temporary | 8 (16) |
| I don't have any feelings about it | 9 (18) |
| The moratorium should be permanent | 34 (67) |
| Should the Australian Government introduce legislation/law to regulate the use of genetic test results in life insurance? (n = 51) | |
| Yes | 44 (86) |
| No | 2 (4) |
| Don't know | 5 (10) |
When researchers were asked about which types of insurance genomic results could be used in Australia, 64% (n = 26/59) correctly identified that this information only applies to risk-rated insurance such as life insurance. Fewer were aware of the potential use in income protection (n = 26/59, 44%), disability (n = 22/59, 37%) and travel insurance (n = 15/59, 25%). The majority correctly realized that it could not be used in health insurance (n = 46/59, 78%) but only six researchers (10%) correctly identified all five of the above responses (i.e., genomic test results can be used in underwriting for life, income protection, disability, and travel insurance, but not health insurance) (Table S2).
3.1.3 Researchers' perceptions regarding the life insurance moratorium
After being provided with information on the moratorium, only % (n = 2/51) of respondents felt that the moratorium is an ideal regulatory solution to GD. Approximately half of the researchers indicated they were dissatisfied with the moratorium in its current format (n = 25/51, 49%) (Table 2). Concerns included the temporary nature of the moratorium, with most researchers indicating there should be a more permanent solution (n = 34/51, 67%). The majority felt the financial limits were too low (n = 40/51, 78%), with most (n = 37/51, 73%) favoring a minimum cover limit of 1 AUD million, and many of those (n = 20/37, 54%) believing there should be no limit at all. An overwhelming majority of researchers favored government legislation as a permanent regulatory solution (n = 44/51, 86%).
The majority of researchers felt that the moratorium was easy to understand (n = 41/51, 80%), and easy to explain to research participants (n = 34/51, 67%) (Table S3). However, they were divided on whether participants were less confused and concerned about the insurance implications of genomic testing since the introduction of the moratorium (Table S3).
3.1.4 Impact on research
Thirteen researchers involved in studies that are returning results confirmed that their consent forms were updated following the introduction of the moratorium (n = 13/39, 33%). Sixteen researchers indicated that their approach to consent discussions had been revised to include updated information about the moratorium (n = 16/39, 41%) (Table 3). Changes to the approach of participant discussions regarding consent included informing potential participants about the moratorium, describing the limitations, and providing links to fact sheets and related resources.
| Item | N (%) |
|---|---|
| Study recruitment started before or post introduction of the moratorium | |
| Before moratorium | 23 (59) |
| Post moratorium | 16 (41) |
| Consent form updated since introduction of the moratorium in July 2019 | |
| Yes | 13 (33) |
| No | 20 (51) |
| Don't know | 6 (15) |
| Consent discussion with participants has changed since introduction of the moratorium | |
| Yes | 16 (41) |
| No | 16 (41) |
| Don't know | 7 (18) |
| Have insurance concerns been raised by potential participants since introduction of the moratorium | |
| Yes | 21 (54) |
| No | 14 (36) |
| Don't know | 4 (10) |
| Beliefs about the impact of the moratorium on willingness to participate in genetic research | |
| More likely to participate following moratorium | 9 (23) |
| Equally likely to participate following the moratorium | 16 (41) |
| Less likely to participate following the moratorium | 2 (5) |
| Not sure/did not return results prior to moratorium | 12 (31) |
Approximately half of the researchers indicated that prospective study participants raised concerns about insurance implications since the introduction of the moratorium (n = 21/39, 54%). However, when asked about researchers’ perceived impact of the moratorium on participant's willingness to participate in genomics research, responses were divided, with nine (n = 9/39, 23%) reporting a greater likelihood of participation and 16 (n = 16/39, 41%) reporting an equal willingness to consent pre and post moratorium, while 12 were unsure (n = 12/39, 31%) (Table 3). However, qualitative comments in open-text fields consistently reflected that some individuals were so strongly motivated to participate due to the desire to obtain a clinical diagnosis, that although the potential insurance implications were concerning, they were eclipsed by the need for a diagnosis. Other responses to open-ended questions indicated that researchers felt the temporary and restricted protections offered by the current moratorium were the primary reason for the limited impact of the moratorium on willingness to participate in genomics research (e.g., uncertainty regarding the duration and low financial limits of the moratorium). Two participants noted that insurance companies used family history as grounds for coverage restrictions in the absence of genomic test results, which limited the effectiveness of the moratorium.
3.1.5 Qualitative study
Of the 59 researchers who partially or fully completed the survey, 14 participated in a follow up interview. An additional eight researchers were recruited for interviews either through snowballing (i.e., recommended by their colleagues) or approached directly by the research team. Of the 22 researchers interviewed between February and June 2022, 11 were principal/chief investigator, 10 trial manager/study co-ordinator and one was a PhD candidate. Ten participants also had a clinical role (seven genetic counselors and three doctors). All researchers interviewed were involved in genomic research that offered participants the option to receive their research genomic testing results. Table 4 provides a summary of qualitative findings and illustrative quotes.
| Theme | Subtheme | Quote |
|---|---|---|
| Genetic discrimination: barrier to recruitment | Major issue for a minority | “I would say 90% of the time, it doesn't affect their decision [to participate] because they've either got insurance in place or they can't get it.” |
| “I think we had at least one case that did not end up participating in the studies; I think cited insurance as a key concern.” | ||
| “For reasons for declining participants five participants (out of 90) declined because they were worried that their genetic risk will be used by insurance companies.” | ||
| Consent discussions | “And to be perfectly honest, we don't want to dwell on it because we know that it's not it's probably not a big issue. You don't want to put people off unnecessarily, but it's difficult to talk in absolutes when you don't have guarantees.” | |
| “What it required was a more nuanced conversation because there are a lot of myths that people had around life insurance and genetic testing, and so they jumped to conclusions.” | ||
| “So, a lot of them [participants] will get confused between health insurance and travel insurance and life insurance and what is covered and what isn't covered” | ||
| Potential discrimination | “We used to get calls from patients saying, you know, the insurance company said this…” and it was just completely out of left field what they were saying, the person had prophylactic survey, and they were still saying they had to pay a higher premium.” | |
| “They don't take into account the fact that even if someone's at high risk, it doesn't mean they're going to develop melanoma, and there's lots of things that you can do to reduce that risk.” | ||
| “Very dependent on the insurer. Some of them have good medical experts advising them and some have not so good medical experts advising them. And yeah, and so I think it's- I think it's a bit actually it's a bit random, to be honest.” | ||
| Impact of moratorium | Minimal impact on research participation | “It [moratorium] doesn't really persuade them. Not so much that they've made up their minds. It's just not yet enough to reassure them.” |
| “I think the people that don't want to do it [participate] because they're concerned about genetic discrimination, that [moratorium] doesn't reassure them enough.” | ||
| Changes to consent? | “We generally do talk about it. A lot of the people we see are probands, so they are directly affected themselves.” | |
| “…it hasn't changed what we do, but it has changed how we speak about it, I guess, in the relations.” | ||
| “You know, we have it in writing that there is a moratorium for the use of this sort of genetic genomic information in assessing your any sort of life insurance or income protection insurance, or disability insurance that you might go for.” | ||
| Further education and resources needed | Roles and responsibilities: Call for research genetic counselors | “For nongenetic researchers, I think it would be really tricky because its not their area of expertise…. you have to be across a whole range of issues, there's all the ELSI issues (Ethical, Legal and Social implications), there's the science, there's everything. You can't expect researchers to be across it all. That's where you need research genetic counselors.” |
| “I don't necessarily think the discussion has to be done by a genetic counselor, but the (researchers) who were running the study weren't comfortable having the discussion….so that's why me and my team helped with it—Genetic counselor” | ||
| Motivated but need support/resources | “I would prefer that we in the research community had good resources to be able to inform our participants well, rather than flipping it on the GC's because I know that all the people that I work with are completely buried in work.” | |
| Moratorium provides inadequate protection | Temporary | “I understand there's a moratorium … but that moratorium can be lifted and then it will be used to discriminate against me, that's the absolutely the first thing that insurance companies will do, they're profit-based. |
| “Look, I guess it's probably not very satisfactory. I mean, the fact that the timing is limited, the fact that it's capped at a certain value, those kind of things are concerning to me, it's a lot of uncertainty still. You know, there's already so much uncertainty for people in undergoing genetic testing and research settings that you know I think that added layer of complex information and uncertainty doesn't help.” | ||
| Inadequate limits | “I don't actually know many people who would want their life insurance to be $400,000 or less because our mortgages are like ten times that [laugh].” | |
| Lack of legislation/oversight | “What we have is an industry self-regulated moratorium, whereas (in) other countries it's legislated in law.” | |
| “Insurance companies are still asking, which is a big thing because, if they (patients/participants) don't know about the moratorium can disclose information and then it can be used for underwriting.” | ||
| Overestimating the predictive value of genetic results | “Yeah, well, I think limitations they [insurance companies] don't take into account the fact that even if someone's at high risk, it doesn't mean they're going to develop a melanoma in particular is what I work with and there's lots of things that you can do to reduce that risk.” |
3.1.6 Genetic discrimination: A barrier to recruitment
Nearly all the researchers interviewed could recall at least one instance where a participant's concern about GD and insurance had been a barrier to recruitment. Like many forms of discrimination, most researchers viewed GD as a major issue that affected a minority of individuals. Although not affecting every participant, researchers still advocated for measures to address GD. When discussing informed consent with participants, interviewed researchers felt that conversations around life insurance required a nuanced approach. Researchers felt the uncertainties regarding the moratorium made it difficult to structure these consent conversations, while others described not dwelling on insurance issues to avoid worrying participants unnecessarily. Some researchers also described the negative impact of misunderstandings on research recruitment, such as the potential for genomic test results to impact health insurance. Such misunderstandings were often addressed and corrected by researchers during the consent process. Lastly, some researchers, most commonly research genetic counselors, described an advocacy role where they had to correct insurance providers’ misunderstandings regarding the predictive value of genomic test results.
3.1.7 Impact of the moratorium
Nearly all researchers interviewed reported that the uncertainties and limitations of the current moratorium failed to address participants’ concerns. For this reason, most felt the moratorium has had a minimal impact on recruitment or research participation. Most commonly, researchers reported adding a statement about the moratorium to their participant information sheet, including this information in the consent discussion, and/or providing participants with a fact sheet for example, Centre for Genetics Education (2017) or the Financial Services Council (2019b).
3.1.8 Further education and resources are needed
Overall, interviewed researchers without a clinical qualification expressed a lack of confidence in addressing and supporting participant research consent. In some instances, researcher teams had employed genetic counselors, to whom they delegated responsibilities for facilitating informed consent, supporting recruitment, and providing expertise around the ethical, legal, and social implications of genomic testing. Nevertheless, some researchers were aware of the shortage of genetic counselors in the workforce and identified a need for centralized resources, such as additional fact sheets, visual aids, and videos, as well as more widespread information dissemination.
3.1.9 Moratorium provides inadequate protection
All participants interviewed felt the current moratorium was ultimately an inadequate solution to the problem of GD in life insurance. Many cited common issues with the moratorium's terms and limitations (e.g., the temporary nature, capped financial limits, and lack of legal enforcement). Of note, interviewed researchers also reported instances when some insurance companies have asked applicants about genomic testing (after the moratorium's introduction) on policies which should have been exempt. In these cases, applicants had insufficient knowledge of the moratorium to know that they did not have to disclose this information, and the insurers used it inconsistently with the moratorium's terms. Researchers expressed concern that insurers could be prone to genetic determinism or genetic essentialism that is, the belief that the genetic contribution to a disease outweighs all other factors (Harden, 2023). They emphasized the ongoing need to engage with and educate insurance underwriters about genomics, to mitigate the risk of overestimating the importance of genomic results.
4 DISCUSSION
This mixed-methods study of Australian researchers found that there is variability among researchers regarding awareness of the current moratorium on the use of genomic test results in underwriting, and some researchers were uncertain about which types of insurance to which it pertained. Researchers involved in obtaining informed consent from prospective study participants reported that insurance implications are mentioned in most study consent forms, however, fewer have updated their consent forms post-moratorium. The majority of researchers reported that fear of GD remained a barrier to research participation and few perceived that the moratorium has positively influenced research participation since its introduction in 2019. Researchers did not view the current moratorium as an adequate regulatory solution, and suggested improvements to existing terms and conditions. An overwhelming majority favored legislation as a regulatory solution.
Regarding awareness of the moratorium among Australian researchers, only around two thirds were aware of the moratorium prior to completing the survey. This was despite a national campaign to disseminate the moratorium information and terms in 2019–2020, including through the HGSA. This level of awareness is lower than that among Australian health professionals (86%) (Tiller, Keogh, et al., 2022) but higher than among other studied groups, including Australian financial advisors, (Haining et al., 2023) genetic consumers (16%) (Tiller et al., 2023) and dermatologists (26%) (Primiero et al., 2022). By way of comparison, following the introduction of the United States 2008 Genetic Information NonDiscrimination Act (GINA) which protected against GD in risk-rated health insurance, reported levels of awareness were lower, including among family physicians (50%) (Laedtke et al., 2012), nurse practitioners (34%) (Steck et al., 2016), and the general public (Lenartz et al., 2021; Prince et al., 2021). Although a majority Australian researchers were aware that genomic test results could be used in life insurance underwriting, relatively fewer were aware of the potential use in other types of risk-rated insurance, including income protection, disability, and travel insurance. This was consistent with findings from Australian health professionals (Tiller, Lacaze, & Otlowski, 2022) Interestingly, although health insurance is community rated in Australia (Australian Government Department of Health and Aged Care, 2023), a fifth of researchers thought that genomic test results could still be used in health insurance underwriting. This is an important misconception which persists in Australia and was also observed among Australian health professionals (15%–17%) (Tiller et al., 2018; Tiller, Lacaze, & Otlowski, 2022).
Most researchers felt that fear of insurance discrimination was a deterrent to genomic research project participation. This is consistent with international studies regarding researchers' perceptions and study participation (Joly & Dalpe, 2022). Half of the researchers surveyed in this study reported that participants had raised concerns about insurance implications, and that the frequency of these concerns being raised was comparable pre- and post-moratorium. This failure of the moratorium to address known concerns about insurance discrimination was also reported by health professionals (Tiller, Lacaze, & Otlowski, 2022). Qualitative interviews revealed that the moratorium had minimal impact on recruitment due to the temporary nature and limited protections, thereby failing to achieve one of its major publicly-stated goals (Tiller, Lacaze, & Otlowski, 2022). Interestingly, researchers’ qualitative comments revealed that consumers concerns did not typically deter participation for individuals/families seeking a clinical diagnosis through research (where the benefit of obtaining a diagnosis may outweigh insurance concerns). This suggests there is a threshold effect, where concerns regarding potential discrimination exist but may be eclipsed by the significance of the study benefits to individuals/families.
While most researchers felt that the moratorium terms were easily understood to them, in practice most did not answer all knowledge questions correctly. Most researchers reported they did not make changes to their consent forms or approaches to consent discussions with participants after the moratorium. This may be reflective of a lack of knowledge and understanding, or their lack of certainty regarding the permanence of the moratorium. Most researchers reported referring to and/or sharing fact sheets about the moratorium, and recommended that these resources be centralized to facilitate access and utilization. In qualitative interviews, nonclinical researchers reported a lack of confidence in addressing participant questions regarding the moratorium and GD. Some researchers reported recruitment of research genetic counselors to whom all responsibilities pertaining to discussion of this topic were delegated. Therefore, awareness of the moratorium by our respondents did not necessarily equate to confidence in explaining and discussing it.
Almost all researchers felt the current moratorium had fundamental limitations, and that it is ultimately not an adequate long-term regulatory solution. Firstly, researchers felt that any regulatory solution should be permanent to minimize the uncertainty regarding the potential for future discrimination. At the time the survey was conducted the moratorium was temporary. It has since been extended indefinitely (Financial Services Council, 2022). However, as a self-regulated industry standard, which is not legally enforceable and lacks government oversight, it is open to the industry to withdraw the moratorium at any time. Thus, the uncertainty expressed by our respondents has arguably not been addressed by this extension. Secondly, most felt that the limit of 500K AUD of life insurance cover was insufficient. Over two thirds of researchers suggesting that coverage should be higher, at least 1M AUD, and more than half of those believed there should be no financial limit. Qualitative comments supported this sentiment, stating that existing coverage limits do not align with current Australian mortgage commitments. The Australian Bureau of Statistics showed that the average mortgage size in Australia in November 2022 was $601,797 (Australian Bureau of Statistics, 2022), well above the moratorium cap. Finally, most respondents felt that the industry-regulated model was an inadequate long-term solution, and that Government legislation, regulation, or oversight is required. Researchers' reported experiences regarding the lack of adherence to the moratorium highlight that in the absence of legislation, “insurers must respond to this challenge by increasing transparency and clarifying the rationale behind their underwriting practices” (Joly et al., 2010). A recent review, which examined the Australian approach to genetic nondiscrimination protections along with those of other countries, echoed the call for government oversight to ensure the needs of both consumer and industry are balanced and regulated (Joly et al., 2020). Of particular importance, the literature highlights the political philosophy and purpose of insurance, “to spread risk across many that most vulnerable are not overly burdened”, is negated when using genomic test results to underwrite policies (Chapman et al., 2021), rather than attempt to use genomic test results to eliminate individuals from the risk pool.
Researchers also perceived that insurance companies were potentially vulnerable to genetic determinism or essentialism, and that they tended to overweight the effect of genomic test results on overall risk (Harden, 2023). Respondents’ reported experience of having an “advocacy role” where they had to correct insurance providers’ misunderstandings regarding the predictive value of genomic test results, adds to concerns that life insurance companies are not properly using the genomic data to which they regulate their own access. This challenge is only likely to increase in the future as genomic testing expands to include polygenic risk scores (Yanes et al., 2023). Both open-ended and qualitative data emphasized the need to educate insurance underwriters to mitigate the risk of GD arising from misunderstanding.
4.1 Strengths and limitations of our study
Strengths of our study include the timing of the survey, administered after the introduction of a new industry standard, the diversity of both quantitative survey and qualitative interview responses, the breadth of researchers responding, and the complementarity of the study findings with other surveys of key stakeholder groups including genetic health professionals, consumers/genetic testers and financial advisors in Australia. Limitations include the inability to calculate response rate. Similarly, some qualitative interviewees were self-selected, and others were purposively recruited due to the leadership of particular investigators in the field. Both recruitment strategies may introduce biases.
4.2 Conclusions
Our study found that Australian researchers did not regard the current industry-led partial moratorium in Australia to be an adequate long-term regulatory solution to genetic discrimination. They felt that the current moratorium still results in the deterrence of research participation, meaning it has failed to achieve one of its major publicly stated goals. There was an overwhelming call from Australia researchers for a long-term regulatory solution, with government oversight or legislation.
AUTHOR CONTRIBUTIONS
Tatiane Yanes: conception of the project, data collection and analysis, writing—original draft, and writing—review and editing. Marisa Blencoe: Data collection and analysis, writing—original draft, and writing—review and editing. Antonia Howard: Data collection and analysis and writing—review and editing. Jane Tiller: conception of the project, writing—review and editing. Courtney Wallingford: conception of the project and writing—review and editing. Margaret Otlowski: conception of the project and writing—review and editing. Louise Keogh: conception of the project and writing—review and editing. Paul Lacaze: conception of the project and writing—review and editing. Aideen McInerney-Leo: conception of project, project supervision, data collection and analysis, writing—original draft, and writing—review and editing.
ACKNOWLEDGMENTS
We would like to thank all the researchers who completed the surveys and/or were interviewed for this study. The project is supported by a grant from the Australian Government's Medical Research Future Fund Genomics Health Futures Mission (MRFF), ref 76721. Tatiane Yanes is funded by a National Health and Medical Research Council (NHMRC) EL1 Grant (APP2009136). CW is supported by an Australian Government Research Training Program Scholarship. During this project, A.M.L. held an NHMRC Early Career Fellowship (APP1158111) and is currently supported by a University of Queensland Faculty of Medicine Fellowship. PL is supported by a National Heart Foundation Future Leader Fellowship (ID 102604).
CONFLICT OF INTEREST STATEMENT
The authors declare that there are no conflicts of interest.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
