Conflicts of interest in genetic counseling: acknowledging and accepting.
Conflicts of interest in genetic counseling: acknowledging and accepting.
复制标题
遗传咨询中的利益冲突：承认和接受。
DOI：
10.1038/gim.2016.216
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Michie,Marsha
中科院分区：
文献类型：
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作者：
Stoll,KatieA;Mackison,Amanda;Allyse,MeganA;Michie,Marsha
与医学专业指南保持一致。尽管实践指南旨在权衡扩大产前筛查和测试数量的风险与收益-例如，基于人群的脆性X筛查仍然不推荐10-商业测试公司对扩大订购的测试数量表示感兴趣。作为公司的雇员，遗传咨询师因此有两个利益：遵循实践指南和使雇主受益。这两种利益并不总是冲突的，但潜在的冲突是存在的。虽然商业实验室可能会强调实验室提供的遗传咨询师的遗传咨询是一项有益于患者的增值服务，但患者可能并不总是很明显地知道他们正在接受基因检测公司员工的遗传咨询。虽然测试前的遗传咨询引起了人们的关注，但行业雇用的遗传咨询师的测试后咨询也可能存在问题。一些基因检测实验室积极宣传遗传咨询的可用性，以鼓励使用他们的品牌检测。然而，接受这些服务的人质疑，商业实验室雇用的遗传咨询师是否像独立雇用他们那样开放地讨论测试的潜在弱点和失败。此外，促进遗传咨询的便利性，以市场新的基因检测可能会促进不适当的测试使用;供应商可能会被鼓励订购超出他们的理解和专业知识的测试，因为他们觉得他们可以依靠实验室为基础的遗传咨询师来解决可能出现的任何问题。3我们认识到，实验室雇用的遗传咨询师可能并不比其他遗传咨询师更专注于提供最好的、专业的护理，但现实是，COI存在，不管它们是否会导致临床医生违背患者的利益。此外，事后发现COI可能会严重破坏患者的信任，不仅是对单个遗传咨询师，而是对围绕基因检测的整个生物医学基础设施。关键的第一步是透明度。在全行业层面上，通过年度状况调查记录遗传咨询师的就业状况，不应像现在这样只包括“工作环境”（http：//www. nsgc。org/page/whoaregeneticcounsellers），而且也是就业的来源--为了反映越来越多的实验室雇用的遗传咨询师，他们在实验室之外提供直接的患者咨询。这种区别已经被一些保险公司所认识，这些保险公司只要求（和报销）由非实验室雇用的遗传咨询师进行某些涵盖的遗传测试。[11]随着遗传信息越来越多地被纳入临床护理，遗传咨询的保险范围可能在认证遗传咨询师的就业选择中发挥越来越大的作用。在个人层面上，对临床实践中的董事会认证遗传咨询师来说，披露财务COI应该是强制性的，就像医生一样。虽然《阳光法案》没有为这种披露提供法律的授权，但它确实提供了一个明确的例子和模式，可以由NSGC和/或遗传咨询师的认证机构美国遗传咨询委员会（ABGC）实施。不幸的是，如果没有法律的授权，这种模式将需要遗传咨询师对他们的COI进行准确的自我报告。该行业还需要决定如何...
COMMENTARY alignment with medical professional guidelines. Although practice guidelines are designed to weigh the risks versus benefits of expanding the number of screens and tests offered in the prenatal period—for instance, population-based screening for Fragile X is still not recommended10—commercial testing companies have a stated interest in expanding the number of tests that are ordered. As an employee of the company, a genetic counselor thus has two interests: following practice guidelines and benefiting their employer. These two interests are not always in conflict, but the potential exists. And while commercial laboratories may highlight genetic counseling by a laboratory-provided genetic counselor as a value-added service benefiting patients, it may not always be obvious to patients that they are receiving genetic counseling from an employee of a genetic testing company. Although pretest genetic counseling raises concerns, posttest counseling by industry-employed genetic counselors can also be problematic. Several genetic testing laboratories actively advertise the availability of genetic counseling as an incentive to use their brand of testing. Recipients of these services, however, have called into question whether genetic counselors employed by commercial laboratories are as open to discussing the potential weaknesses and failures of the test as they would be if they were independently employed. Furthermore, promoting ease of genetic counseling to market new genetic tests may promote inappropriate test utilization; providers may be encouraged to order testing beyond their understanding and expertise because they feel they can rely on the laboratory-based genetic counselors to address any issues that may arise. 3 We recognize that genetic counselors employed by laboratories are likely no less focused on providing the best, professionally responsive care than any other genetic counselor, but the reality is that COI exist, regardless of whether they cause clinicians to act against patients’ interests. Furthermore, the discovery of COI after the fact can seriously undermine patients’ trust, not just in an individual genetic counselor but in the entire biomedical infrastructure surrounding genetic testing. A crucial first step is transparency. At the profession-wide level, documentation of the employment status of genetic counselors through the annual status survey should include not only “work setting,” as it now does (http://www. nsgc. org/page/whoaregeneticcounselors), but also the source of employment—in order to reflect the increasing numbers of laboratory-employed genetic counselors who provide direct patient counseling outside of laboratories. This distinction has already been recognized by some insurers, which mandate (and reimburse) genetic counseling only by a non-laboratory employed genetic counselor for certain covered genetic tests. 11 Insurance coverage for genetic counseling may play an increasing role in the employment options of certified genetic counselors as genetic information is increasingly integrated into clinical care.At the individual level, disclosure of financial COI should be mandatory for board-certified genetic counselors in clinical practice, as it is for physicians. Although the Sunshine Act does not provide a legal mandate for such disclosures, it does offer a clear example and a model that could be implemented by the NSGC and/or the certifying body for genetic counselors, the American Board of Genetic Counseling (ABGC). Unfortunately, without the legal mandate this model would require accurate self-reporting by genetic counselors about their COI. The profession would also need to decide how to …