Genetic Discrimination Observatory

Info and Consent Form

Study description:

Advancements in genetic research have allowed for the development of tests capable of predicting individual risks of developing various diseases or drug response on an individualized level. As such, genetic knowledge increasingly contributes to better decision-making in health care. However, genetic information may be used outside the health care and research contexts for discriminatory purposes. Genetic discrimination (hereafter GD) refers to differential treatment based on genetic information. Victims of GD may see their professional and social opportunities reduced and may face psychological distress. There are no empirical studies evaluating the magnitude of GD in Quebec. In Canada, the only studies available focus on the particular subject of access to insurance for persons (affected by or) at risk of developing Huntington’s disease. Outside of this particular context, there is no substantial data confirming the existence of systemic discriminatory practices. Nevertheless, the fear of GD among Canadians has been well documented.

We designed a website, the Genetic Discrimination Observatory (GDO), which functions as a communication platform with the public in order to offer tools and GD-related information, scientific publications, and conference announcements. The GDO can also serve as a research platform to better characterize the GD phenomenon. To this end, we recently used the GDO to conduct an online forum to help assess the apprehensions, concerns, needs, and opinions of participants from Quebec about GD (the Quebec online forum on genetic discrimination).

Given the research mission of the GDO, we are also motivated to better understand GD events and to compile data with the objective of advancing the policy debate on this issue. In the Genetic Discrimination Case Report Project, the GDO platform will be used to offer online visitors the opportunity to confidentially contribute case reports of GD-related events that they may have experienced. Any information provided through the secure submission page of the project will be kept confidential and only be made public as anonymized generalized research results.

Submission of a genetic discrimination case report
As a visitor of the GDO, you may have experienced GD and wish to confidentially disclose the events that took place to our team of researchers. We have designed a case report submission process that minimizes risks to privacy and confidentiality associated with your sensitive information. The data you submit will be de-identified, coded, and kept on a restricted access server to be used by researchers of the Centre of Genomics and Policy to review your information. Your information will contribute to better understanding and characterizing genetic discrimination, and to compile data with the objective of advancing the policy debate on this issue.

Confidentiality:
Your information will remain confidential. No identifying information will ever be published. The case report you submit will be de-identified¹ and coded (i.e. personal identifiers are stripped and replaced by codes). A master code index containing personal information and your re-contact address will be kept separate from the coded case reports, and will only be available to the project manager. Researchers reviewing and analyzing your information will only be able to see the code attributed to your case report and will therefore not be able to re-identify you. All data will be stored on a restricted access secure server hosted by McGill University.

¹ Also in accordance with the standards set by HIPAA Privacy Rule (USA), Section 164.514(a)(b)(c)

Benefits of research:
There are no direct benefits to you as a participant in this project. However, your participation may contribute to statistical data about GD and/or advance the policy debate on genetic discrimination. The general results of this study will be published in open-access journals. They may also be made available to research participants online at http://www.genomicsandpolicy.org.

Risks of research:
Since there is a risk that third party disclosure of data may cause you harm, we designed a data submission and collection process that minimizes your privacy and confidentiality risks.. Consequently, we confidently expect that you will be able to share your GD experience with us without running the risk of physical, psychological, or social harm as a result.

Freedom of participation:
Your participation in this research is completely voluntary. You are free to withdraw your submitted information at any moment using the contact information provided in this consent form. Moreover, your withdrawal from the study will not have any prejudicial consequence. If you withdraw from the project, the information that has been collected before your withdrawal will be destroyed upon your request. In the case you withdraw from the project after your data has been analyzed, the information you submitted will be destroyed but general results from the analysis of your data by researchers will be kept.

If you decide to withdraw from the study, you can communicate with our study coordinator using the contact information below.

Contact person:
If you would like any further information regarding this study, or if you have any questions about your rights as a research participant, please communicate with the project coordinator.

Indemnity:
Participants will not receive any financial compensation.

Disclaimer:
The team of the Genetic Discrimination Observatory does not provide legal nor professional advice. For any legal or health problems resulting from the aforementioned experience, we recommend that you consult the appropriate professional.

Consent

I have read the information above, I have received answers to my questions about my participation, and I understand the aims, the nature, the advantages, the risks and inconveniences of this research.

I consent to participate in this study, knowing that I can withdraw at any moment, without any prejudice. yes no

First Name *

Last Name *

I consent to be re-contacted to be informed of specific development or initiatives associated with the project knowledge base. yes no

Email for re-contact

This project has been approved on ethical grounds by the McGill University, Faculty of Medicine Research Ethics Board (equivalent to an Institutional Review Board in the USA). Any questions regarding your rights as a participant may be addressed to the Board through the McGill University, Faculty of Medicine Ethics Office (514-398-3124). Out of town participants may call collect.

The Genetic Discrimination Observatory aims to better understand discriminatory events and compile information on the incidence and consequences of genetic discrimination in different countries to enable policymakers, genetic service providers, patient groups, and industry to address this issue in a manner that is both ethical and informed by evidence.

If you have been treated differently, negatively, or unfairly profiled based on your actual (e.g. genetic tests) or presumed genetic characteristics (e.g. family history), you are invited to share your story with the Observatory.

Your identity will be kept confidential.

Disclaimer

This project has received ethics approval by the Institutional Review Board of the Faculty of Medicine at McGill University, Canada. At this moment, we can only accept cases from Canada and the United States. However, we are in the process of obtaining ethics approval for other countries.