Skip to main content
SpringerLink
Log in

Risk for Patient Harm in Canadian Genetic Counseling Practice: It’s Time to Consider Regulation

  • Original Research
  • Published:
Journal of Genetic Counseling

Abstract

With the increasing awareness of genetic contributions to disease in Canada, the availability of and demand for genetic testing has soared. Genetic counseling is becoming a recognized and rapidly growing (yet unregulated) health profession in Canada. We hypothesized that the potential risk for harm to the public posed by genetic counseling practice in the province of Ontario is sufficient to consider regulation. The Ontario Ministry of Health and Long-Term Care (MOHTLC) sets criteria (both primary and secondary) to identify health professional bodies that meet the threshold for regulation in the province. We developed a survey based on the MOHTLC criteria to determine if genetic counselors meet the primary criteria to be considered for health professions regulation in Ontario. We surveyed 120 Ontario genetic counselors about their clinical practice and perceptions of risk for harm to the public. Results indicate that Ontario genetic counselors are highly independent in their clinical practice and are involved in patient care activities, clinical judgement and decision-making that have the potential to harm patients. In particular, cancer genetic counselors were identified as a cohort that practices with relatively high autonomy and low supervision. In summary, our study indicates that genetic counseling practice in Ontario meets the primary criteria to be considered for regulation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • Andermann, A., & Blancquaert, I. (2010). Genetic screening: a primer for primary care. Canadian Family Physician, 56(4), 333–339.

    PubMed  PubMed Central  Google Scholar 

  • Andermann, A., & Narod, S. A. (2002). Genetic counselling for familial breast and ovarian cancer in Ontario. Journal of Medical Genetics, 39(9), 695–696.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Austin, J., Semaka, A., & Hadjipavlou, G. (2014). Conceptualizing genetic counseling as psychotherapy in the era of genomic medicine. Journal of Genetic Counseling, 23(6), 903–909.

    Article  PubMed  PubMed Central  Google Scholar 

  • Bensend, T. A., Veach, P. M., & Niendorf, K. B. (2014). What’s the harm? Genetic counselor perceptions of adverse effects of genetics service provision by non-genetics professionals. Journal of Genetic Counseling, 23(1), 48–63.

    Article  PubMed  Google Scholar 

  • Botkin, J. R., Belmont, J. W., Berg, J. S., Berkman, B. E., Bombard, Y., Holm, I. A., et al. (2015). Points to consider: ethical, legal, and psychosocial implications of genetic testing in children and adolescents. American Journal of Human Genetics, 97(1), 6–21.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • CAGC, C. A. O. G. C. (2012a). 2011 CAGC Professional Status Survey, from https://www.cagc-accg.ca/doc/2011%20PSS%20report%20-%20English%20(1).pdf.

  • CAGC, C. A. O. G. C. (2012b). Knowledge-Based Competencies for Canadian Genetic Counsellors, from https://www.cagc-accg.ca/doc/knowledge_based_competencies_final_french_translation%20-%20june%2026%2C%202012.pdf.

  • CAGC, C. A. O. G. C. (2012c). Practice-Based Competencies for Canadian Genetic Counsellors, from https://www.cagc-accg.ca/doc/cagc%20practice%20based%20competencies.pdf.

  • Cameron, L. D., & Muller, C. (2009). Psychosocial aspects of genetic testing. Current Opinion in Psychiatry, 22(2), 218–223.

    Article  PubMed  Google Scholar 

  • Canada, S. (2015). Estimates of population, Canada, provinces and territories, quarterly (persons), from http://www5.statcan.gc.ca/cansim/a26?lang=eng&retrLang=eng&id=0510005&&pattern=&stByVal=1&p1=1&p2=31&tabMode=dataTable&csid=.

  • Carroll, J. C., Rideout, A. L., Wilson, B. J., Allanson, J. M., Blaine, S. M., Esplen, M. J., et al. (2009). Genetic education for primary care providers: improving attitudes, knowledge, and confidence. Canadian Family Physician, 55(12), e92–e99.

    PubMed  PubMed Central  Google Scholar 

  • Christian, S., Lilley, M., Hume, S., Scott, P., & Somerville, M. (2012). Defining the role of laboratory genetic counselor. Journal of Genetic Counseling, 21(4), 605–611.

    Article  PubMed  Google Scholar 

  • Clarke, A., & Thirlaway, K. (2011a). Genetic counselling for personalised medicine. Human Genetics, 130(1), 27–31.

    Article  PubMed  Google Scholar 

  • Clarke, A., & Thirlaway, K. (2011b). ‘Genomic counseling’? Genetic counseling in the genomic era. Genome Medicine, 3(1), 7.

    Article  PubMed  PubMed Central  Google Scholar 

  • Dillman, D. A. (2007). Mail and internet surveys: The tailored design method (2nd ed.). Hoboken: Wiley.

    Google Scholar 

  • Egalite, N., Groisman, I. J., & Godard, B. (2014). Genetic counseling practice in next generation sequencing research: implications for the ethical oversight of the informed consent process. Journal of Genetic Counseling, 23(4), 661–670.

    Article  PubMed  Google Scholar 

  • Eisenstein, M. (2015). Genetics: fluent in DNA. Nature, 526(7571), 151–152.

    Article  PubMed  Google Scholar 

  • Featherstone, C., Colley, A., Tucker, K., Kirk, J., & Barton, M. B. (2007). Estimating the referral rate for cancer genetic assessment from a systematic review of the evidence. British Journal of Cancer, 96(2), 391–398.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Frelick, K., & McFadden, J. (2009). Significant changes to Ontario’s regulated health professions act, 1991 in effect. Health Law in Canada, 30(1), 24–27.

    PubMed  Google Scholar 

  • Gordon, E. S., Griffin, G., Wawak, L., Pang, H., Gollust, S. E., & Bernhardt, B. A. (2012). “It’s not like judgment day”: public understanding of and reactions to personalized genomic risk information. Journal of Genetic Counseling, 21(3), 423–432.

    Article  PubMed  Google Scholar 

  • Green, E. D., Guyer, M. S., & Institute, N. H. G. R. (2011). Charting a course for genomic medicine from base pairs to bedside. Nature, 470(7333), 204–213.

    Article  CAS  PubMed  Google Scholar 

  • Guttmacher, A. E., McGuire, A. L., Ponder, B., & Stefánsson, K. (2010). Personalized genomic information: preparing for the future of genetic medicine. Nature Reviews. Genetics, 11(2), 161–165.

    Article  CAS  PubMed  Google Scholar 

  • Hawkins, A. K., & Hayden, M. R. (2011). A grand challenge: providing benefits of clinical genetics to those in need. Genetics in Medicine, 13(3), 197–200.

    Article  PubMed  Google Scholar 

  • Hooker, G. W., Ormond, K. E., Sweet, K., & Biesecker, B. B. (2014). Teaching genomic counseling: preparing the genetic counseling workforce for the genomic era. Journal of Genetic Counseling, 23(4), 445–451.

    Article  PubMed  PubMed Central  Google Scholar 

  • Horowitz, M., Sundin, E., Zanko, A., & Lauer, R. (2001). Coping with grim news from genetic tests. Psychosomatics, 42(2), 100–105.

    Article  CAS  PubMed  Google Scholar 

  • Houwink, E. J., Henneman, L., Westerneng, M., van Luijk, S. J., Cornel, M. C., Dinant, J. G., et al. (2012). Prioritization of future genetics education for general practitioners: a Delphi study. Genetics in Medicine, 14(3), 323–329.

    Article  PubMed  PubMed Central  Google Scholar 

  • HPRAC, H. P. R. A. C. (2011). Regulation of a New Health Profession Under the Regulated Health Professions Act, from http://www.hprac.org/en/reports/resources/RegulatingaNewProfession_CriteriaProcess_Nov2011.pdf.

  • Ingles, J., Yeates, L., & Semsarian, C. (2011). The emerging role of the cardiac genetic counselor. Heart Rhythm, 8(12), 1958–1962.

    Article  PubMed  Google Scholar 

  • Korf, B. R., Berry, A. B., Limson, M., Marian, A. J., Murray, M. F., O’Rourke, P. P., et al. (2014). Framework for development of physician competencies in genomic medicine: report of the competencies working Group of the Inter-Society Coordinating Committee for physician education in genomics. Genetics in Medicine, 16(11), 804–809.

    Article  PubMed  Google Scholar 

  • Machini, K., Douglas, J., Braxton, A., Tsipis, J., & Kramer, K. (2014). Genetic counselors’ views and experiences with the clinical integration of genome sequencing. Journal of Genetic Counseling, 23(4), 496–505.

    Article  PubMed  Google Scholar 

  • Martin, D. K., Greenwood, H. L., & Nisker, J. (2010). Public perceptions of ethical issues regarding adult predictive genetic testing. Health Care Analysis, 18(2), 103–112.

    Article  PubMed  Google Scholar 

  • Matloff, E. T., & Barnett, R. E. (2011). The growing role for genetic counseling in endocrinology. Current Opinion in Oncology, 23(1), 28–33.

    Article  PubMed  Google Scholar 

  • McCabe, E., Guttmacher, A., Hegele, R., Holtzman, N., & McKenzie, A. (2001). Genetic Services in Ontario: Mapping the Future. A Report of the Provincial Advisory Committee on New Predictive Genetic Technologies. In O. M. O. H. A. L. T. Care (Ed.)).

  • McGowan, M. L., Glinka, A., Highland, J., Asaad, G., & Sharp, R. R. (2013). Genetics patients’ perspectives on clinical genomic testing. Personalized Medicine, 10(4), 339–347.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Mendes, A. F., Santos, T. A., & Sousa, L. (2011). Experiencing genetic counselling for hereditary cancers: the client’s perspective. European Journal of Cancer Care (Engl), 20(2), 204–211.

    Article  CAS  Google Scholar 

  • Mills, R., & Haga, S. B. (2014). Genomic counseling: next generation counseling. Journal of Genetic Counseling, 23(4), 689–692.

    Article  PubMed  Google Scholar 

  • MOHLTC, O. (2016). Health Workforce Planning and Regulatory Affairs Division: Regulated Professions, from http://www.health.gov.on.ca/en/pro/programs/hhrsd/about/regulated_professions.aspx.

  • MOHLTC, O. M. O. H. A. L. T. C. (2002). Genetics, Testing and Gene Patenting:Charting New territory in Healthcare, from http://www.ontla.on.ca/library/repository/mon/3000/10301166.pdf.

  • O’Daniel, J. M. (2010). The prospect of genome-guided preventive medicine: a need and opportunity for genetic counselors. Journal of Genetic Counseling, 19(4), 315–327.

    Article  PubMed  Google Scholar 

  • Ontario, G. O. (1991, 2015). Regulated Health Professions Act, 1991, from https://www.ontario.ca/laws/statute/91r18.

  • Ontario, C. C. (2008). Ensuring access to high quality molecular oncology laboratory testing and clinical cancer genetic services in Ontario: Report of the Molecular Oncology Task Force, from https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=31935.

  • Ontario, C. o. P. a. S. o. (1999, 2012). Delegation of Controlled Acts, from http://www.cpso.on.ca/policies-publications/policy/delegation-of-controlled-acts.

  • Ormond, K. E. (2013). From genetic counseling to “genomic counseling”. Molecular Genetics & Genomic Medicine, 1(4), 189–193.

    Article  Google Scholar 

  • Powell, K. P., Hasegawa, L., & McWalter, K. (2010). Expanding roles: a survey of public health genetic counselors. Journal of Genetic Counseling, 19(6), 593–605.

    Article  PubMed  Google Scholar 

  • Radford, C., Prince, A., Lewis, K., & Pal, T. (2014). Factors which impact the delivery of genetic risk assessment services focused on inherited cancer genomics: expanding the role and reach of certified genetics professionals. Journal of Genetic Counseling, 23(4), 522–530.

    Article  PubMed  Google Scholar 

  • Resta, R. G. (2006). Defining and redefining the scope and goals of genetic counseling. American Journal of Medical Genetics. Part C, Seminars in Medical Genetics, 142C(4), 269–275.

    Article  PubMed  Google Scholar 

  • Resta, R., Biesecker, B. B., Bennett, R. L., Blum, S., Hahn, S. E., Strecker, M. N., et al. (2006). A new definition of genetic counseling: National Society of genetic counselors’ task force report. Journal of Genetic Counseling, 15(2), 77–83.

    Article  PubMed  Google Scholar 

  • Rosen, L. J., & Sunshine, E. (2010). Amendments to the regulated health professions act, 1991: major implications for health care professionals. Health Law in Canada, 30(4), 227–228.

    PubMed  Google Scholar 

  • Shields, A. E., Burke, W., & Levy, D. E. (2008). Differential use of available genetic tests among primary care physicians in the United States: results of a national survey. Genetics in Medicine, 10(6), 404–414.

    Article  PubMed  PubMed Central  Google Scholar 

  • Somers, A. E., Ware, S. M., Collins, K., Jefferies, J. L., He, H., & Miller, E. M. (2014). Provision of cardiovascular genetic counseling services: current practice and future directions. Journal of Genetic Counseling, 23(6), 976–983.

    Article  PubMed  Google Scholar 

  • Somerville, M. J., & Allingham-Hawkins, D. (2010). Regulation of genetic testing/service in Canada. In U. Kristoffersson, J. Schmidtke, & J. J. Cassiman (Eds.), Quality issues in clinical genetic services (pp. 83–90). Dordrecht, Heidelberg, London, New York: Springer.

  • State of Colorado, D. (2013). 2013 Sunrise Review: Genetic Counselors, from http://hermes.cde.state.co.us/drupal/islandora/object/co%3A12704/datastream/OBJ/download/2013_sunrise_review__genetic_counselors.pdf.

  • Swanson, A., Ramos, E., & Snyder, H. (2014). Next generation sequencing is the impetus for the next generation of laboratory-based genetic counselors. Journal of Genetic Counseling, 23(4), 647–654.

    Article  PubMed  Google Scholar 

  • Vanstone, M., Chow, W., Lester, L., Ainsworth, P., Nisker, J., & Brackstone, M. (2012). Recognizing BRCA gene mutation risk subsequent to breast cancer diagnosis in southwestern Ontario. Canadian Family Physician, 58(5), e258–e266.

    PubMed  PubMed Central  Google Scholar 

  • Vig, H. S., & Wang, C. (2012). The evolution of personalized cancer genetic counseling in the era of personalized medicine. Familial Cancer, 11(3), 539–544.

    Article  PubMed  PubMed Central  Google Scholar 

  • Weil, J. (2002). Genetic counselling in the era of genomic medicine. As we move towards personalized medicine, it becomes more important to help patients understand genetic tests and make complex decisions about their health. EMBO Reports, 3(7), 590–593.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Zetzsche, L. H., Kotzer, K. E., & Wain, K. E. (2014). Looking back and moving forward: an historical perspective from laboratory genetic counselors. Journal of Genetic Counseling, 23(3), 363–370.

    Article  PubMed  Google Scholar 

  • Zhou, Y. Z., Wilde, A., Meiser, B., Mitchell, P. B., Barlow-Stewart, K., & Schofield, P. R. (2014). Attitudes of medical genetics practitioners and psychiatrists toward communicating with patients about genetic risk for psychiatric disorders. Psychiatric Genetics, 24(3), 94–101.

    Article  PubMed  Google Scholar 

  • Zierhut, H., & Austin, J. (2011). How inclusion of genetic counselors on the research team can benefit translational science. Science Translational Medicine, 3(74), 74cm77.

    Article  Google Scholar 

Download references

Acknowledgments

The authors wish to acknowledge and thank the Canadian Association of Genetic Counselling for funding via a special project grant, Ms. Cheryl Shuman for her thoughtful and thorough scientific review of our research proposal and manuscript, and Ms. Gabrielle Herman for her assistance in preparing this manuscript.

Author information

Authors and Affiliations

  1. Department of Genetic Counseling, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada

    Andrea L. Shugar & Nada Quercia

  2. Department of Molecular Genetics, University of Toronto, Toronto, ON, Canada

    Andrea L. Shugar & Nada Quercia

  3. LifeLabs, Toronto, ON, Canada

    Christopher Trevors

  4. Genetics and Genomics, Invitae Inc, San Francisco, CA, USA

    Marina M. Rabideau

  5. Genetic Counseling, GeneDx, Gaithersburg, MD, USA

    Sohnee Ahmed

Authors
  1. Andrea L. Shugar
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nada Quercia
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christopher Trevors
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Marina M. Rabideau
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sohnee Ahmed
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Andrea L. Shugar.

Ethics declarations

Funding

This research project received funding via a Canadian Association of Genetic Counsellors special project grant awarded to the authors, who were co-investigators.

Conflict of Interest

Authors Andrea Shugar, Nada Quercia and Christopher Trevors declare that they have received a special project grant from the Canadian Association of Genetic Counsellors to conduct this research as part of a larger project.

Author Marina M. Rabideau declares that she has no conflict of interest.

Author Sohnee Ahmed declares that she has no conflict of interest.

Human Studies and Informed Consent

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study.

Ethical Approval

Ethics approval was sought and granted for this research project through the Hospital for Sick Children Research Ethics Board and in accordance with the Canadian government’s Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans.

Electronic supplementary material

ESM 1

(DOCX 20 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Shugar, A.L., Quercia, N., Trevors, C. et al. Risk for Patient Harm in Canadian Genetic Counseling Practice: It’s Time to Consider Regulation. J Genet Counsel 26, 93–104 (2017). https://doi.org/10.1007/s10897-016-9983-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10897-016-9983-4

Keywords

Search

Navigation