Ma'n H. Zawati

• LL.B. LL.M. Ph.D. (D.C.L.)
• Managing Director at McGill University

Recent advances in human genomics have transformed the field, leading to increased integration of genomics into mainstream clinical care, broadening the potential of personalized medicine, and expanding data generation and sharing. From the outset, genetics and genomics have given rise to a broad array of ethical concerns, including issues related...

Properly obtaining informed consent is a core obligation for research conducted using human subjects. The traditional informed consent process involves written forms and obtaining signatures. This process remains the standard, but in various research settings, such as COVID-19 and rare disease research, verbal consent has increasingly become the no...

Background This study explores the ethical and moral challenges faced by paediatric oncologists when they are informed of patient genomic results, particularly during molecular tumour boards (MTBs), highlighting the interplay between their clinic, research and expert roles. Methods This was an explanatory sequential mixed-methods study using a sur...

Many neurological disorders currently lack effective treatments, thereby setting the stage where gene therapies can represent an attractive option. Given the early onset of many genetic conditions, including neurodevelopmental disorders, proponents of gene therapy advocate for earlier therapeutic interventions, meaning pediatric or even fetal gene...

Background Advances in technology and knowledge have facilitated both an increase in the number of patient variants reported and variants reclassified. While there is currently no duty to recontact for reclassified genetic variants, there may be a responsibility. The purpose of this clinical practice advisory document is to provide healthcare pract...

Importance Governments worldwide have become increasingly cognizant of the spread of genetic discrimination (negative treatment or harm on the basis of actual or presumed genetic characteristics). Despite efforts by a number of governments to establish regulations addressing this phenomenon, public concern about genetic discrimination persists. Ob...

In Canada, the field of genetic counseling is rapidly evolving alongside the increasing integration of and demand for genetics in healthcare practice. In tandem, there is a growing body of literature advocating for the regulation of genetic counseling, as legal recognition can protect patients from potential risk of harm and provide counselors with...

UNSTRUCTURED Technology is increasingly being used in our decision-making in all fields, but especially in healthcare. Automated decision-making (ADM) promises to change medical practice and potentially improve and streamline the provision of healthcare. Although the integration of AI into medicine is encouraging, it also is met with fears concerni...

Many countries consider long-term implications for society

Advances in medical genetics have led to a significant increase in demand for genetic services and expertise across almost all medical specialties. Genetic counselors (GCs) in Canada play key roles in genetic services both within and outside of the Genetics Clinic, while not being regulated or legally recognized as healthcare professionals (HCPs) i...

More than 5 billion people in the world own a smartphone. More than half of these have been used to collect and process health-related data. As such, the existing volume of potentially exploitable health data is unprecedentedly large and growing rapidly. Mobile health applications (apps) on smartphones are some of the worst offenders and are increa...

Background Acute myeloid leukemia (AML), a rapidly progressing cancer of the blood and bone marrow, is the most common and fatal type of adult leukemia. Therapeutic web portals have great potential to facilitate AML research advances and improve health outcomes by increasing the availability of data, the speed and reach of new knowledge, and the co...

Background Artificial intelligence (AI)–based chatbots could help address some of the challenges patients face in acquiring information essential to their self-health management, including unreliable sources and overburdened health care professionals. Research to ensure the proper design, implementation, and uptake of chatbots is imperative. Inclus...

The role of genetic counselors is evolving in response to health-related direct-to-consumer genetic tests (DTC-GT). While there is consensus in the literature that pre- and post-DTC-GT genetic counseling would benefit consumers, genetic counselors have reservations about DTC-GTs, and there is a paucity of research on providing DTC-GT counseling. Th...

BACKGROUND Self-management interventions are emphasized as a way to optimize health outcomes and care, but they necessitate supporting patients to access timely and reliable health information, which remains a challenge. In the realm of digital health, artificial intelligence-based chatbots capable of conversing with users in natural language have...

The use of smartphones has greatly increased in the last decade and has revolutionized the way that health data are being collected and shared. Mobile applications leverage the ubiquity and technological sophistication of modern smartphones to record and process a variety of metrics relevant to human health, including behavioral measures, clinical...

Genetic counseling is a fast-growing profession worldwide, with genetic counselors taking on increasingly comprehensive and autonomous roles in the healthcare sector. However, the absence of appropriate legal frameworks could potentially create risks of harm to the public. Legal recognition serves to protect the public from risk of harm by regulati...

Online resources offer a uniquely efficient way of sharing health research with scientists and the public. Using web portals to make results and study information available to diverse audiences could work to accelerate research translation and empower patients to play a more active role in their care. But using online tools to broadly share health...

UNSTRUCTURED The growing prominence of Artificial Intelligence (AI) in mobile health has given rise to a distinct subset of applications that provide users with diagnostic information using their inputted health status and symptom information: AI-Powered Symptom Checker Apps (AISympCheck). While these applications may potentially increase access to...

The growing prominence of artificial intelligence (AI) in mobile health (mHealth) has given rise to a distinct subset of apps that provide users with diagnostic information using their inputted health status and symptom information—AI-powered symptom checker apps (AISympCheck). While these apps may potentially increase access to health care, they r...

Risk prediction models hold great promise to reduce the impact of cancer in society through advanced warning of risk and improved preventative modalities. These models are evolving and becoming more complex, increasingly integrating genetic screening data and polygenic risk scores as well as calculating risk for multiple types of a disease. However...

Background Scientific research is becoming an increasingly collaborative and global venture. The Healthy Life Trajectories Initiative (HeLTI), for instance, is an international Developmental Origins of Health and Disease research collaboration developed to address the increasing burden of noncommunicable diseases around the world. It comprises four...

HostSeq was launched in April 2020 as a national initiative to integrate whole genome sequencing data from 10,000 Canadians infected with SARS-CoV-2 with clinical information related to their disease experience. The mandate of HostSeq is to support the Canadian and international research communities in their efforts to understand the risk factors f...

Objective: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to...

Risk prediction models hold great promise to reduce the impact of cancer in society through advanced warning of risk and improved preventative modalities. These models are evolving and becoming more complex, increasingly integrating genetic screening data and polygenic risk scores as well as calculating risk for multiple types of a disease. However...

Objectives COVID-19 research has significantly contributed to pandemic response and the enhancement of public health capacity. COVID-19 data collected by provincial/territorial health authorities in Canada are valuable for research advancement yet not readily available to the public, including researchers. To inform developments in public health da...

Fully understanding autism spectrum disorder (ASD) genetics requires whole-genome sequencing (WGS). We present the latest release of the Autism Speaks MSSNG resource, which includes WGS data from 5,100 individuals with ASD and 6,212 non-ASD parents and siblings (total n = 11,312). Examining a wide variety of genetic variants in MSSNG and the Simons...

HostSeq was launched in April 2020 as a national initiative to integrate whole genome sequencing data from 10,000 Canadians infected with SARS-CoV-2 with clinical information related to their disease experience. The mandate of HostSeq is to support the Canadian and international research communities in their efforts to understand the risk factors f...

Fully understanding the genetic factors involved in Autism Spectrum Disorder (ASD) requires whole-genome sequencing (WGS), which theoretically allows the detection of all types of genetic variants. With the aim of generating an unprecedented resource for resolving the genomic architecture underlying ASD, we analyzed genome sequences and phenotypic...

This paper summarizes the results of a 31-country qualitative study of expert perspectives on the regulation of international “direct-to-participant” (DTP) genomic research. We outline how the practice of directly recruiting participants for genomic studies online complicates ethics and regulatory considerations for the return of individual researc...

International biomedical research, in which projects span borders and engage participants from multiple countries, has increased substantially during the last several decades. Despite the proven value of large, geographically, and ethnically diverse studies, further advancements are being impeded by the burden of submitting separate, and often nume...

COVID-19 was declared to be a pandemic in March 2020 by the World Health Organization. Timely sharing of viral genomic sequencing data accompanied by a minimal set of contextual data is essential for informing regional, national, and international public health responses. Such contextual data is also necessary for developing, and improving clinical...

Single-site review means protection and efficiency.

Bioethics is an integral part of various medical disciplines and ought to be assimilated into day-to-day practice. Traditional sources of medical ethics, such as the Hippocratic corpus or the 'Four Principles' approaches can provide guidance but are not always clear regarding the most ethical path. Emergencies and crises can sometimes challenge thi...

Genetic services have historically been housed in tertiary care, requiring referral, which can present access barriers. While integrating genetics into primary care could facilitate access, many primary care physicians lack genomics expertise. Integrating genetic counsellors (GCs) into primary care could theoretically address these issues, but litt...

Over the next two Chapters, I aim to demonstrate that the concept of reciprocity provides a plausible grounding for relational autonomy, a conception of autonomy that will need to be respected by researchers when disclosing information to participants during the consent process. More importantly, I argue that such reciprocity-based relational auton...

In Chapter 1, I demonstrated that an individualistic conception of autonomy is at the core of the jurisprudential interpretation of the duty to inform in Canada. One consequence of this is that the duty to inform in research is more exacting than in the clinic setting. Participants, accordingly, have a right to receive “full and frank disclosure of...

I argue that these shortcomings of individual autonomy transcend the clinical setting and have important implications for population biobanks. More concretely, I focus on two specific problems with individual autonomy in the population biobank setting. The first turns on how individual autonomy fails to recognize the complexities of benefit conside...

In this chapter, I will argue that the jurisprudential interpretation of the duty to inform of researchers in Canada is foundationally based on an individualistic conception of autonomy. In presenting this view, I will first give an overview of the evolution of the medical duty to inform and its underlying principles. In this context, I use the wor...

Despite having adopted requirements that apply in all nontherapeutic research, the case law presented in the previous Chapter was explicitly based on a single category of research projects: the clinical trial. Population biobanks are, as we will see, a distinct category and raise distinct concerns. Whether in their structure, ultimate objectives, o...

In this chapter, I demonstrate that, despite certain limitations, reciprocity is the most suitable conceptual grounding for relational autonomy in population biobanks. The result of which, as I will show, is a more appropriate conception of autonomy that is capable of theoretically framing the disclosure of information during the consent process. T...

Background In the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the manage...

Importance The number of adolescents who are diagnosed with a genetic disorder is increasing as genome sequencing becomes the standard of clinical diagnostic testing. However, the experience of receiving a diagnosis of a genetic condition has not been extensively studied in adolescents. Objective To identify how adolescents with a genetic conditio...

Genetic discrimination (GD) is the differential or unfair profiling of an individual based on genetic data. This article summarizes the actions of the Genetic Discrimination Observatory (GDO) in addressing GD, and recent developments in GD since late 2020. It shows GD can take many forms in today’s rapidly evolving society.

Genetic discrimination (GD) is the differential or unfair profiling of an individual on the basis of genetic data. This article summarizes the actions of the Genetic Discrimination Observatory (GDO) in addressing GD and recent developments in GD since late 2020. It shows how GD can take many forms in today’s rapidly evolving society.

The implementation of precision medicine and next-generation sequencing technologies in the field of oncology is a novel approach being more widely studied and used in cases of high-risk primary and recurrent malignancies. Leukemias are the second most common cause of cancer-related mortality in children and the sixth most in adults. Relapsed leuke...

Genetic counseling is a fast-growing profession in Canada. Yet, despite its growth, genetic counseling lacks legal recognition in the majority of Canadian provinces. Legal recognition serves to regulate professions, including genetic counseling, that if not properly regulated, expose the public to the risk of harm. Under Canadian law, there are thr...

[This corrects the article DOI: 10.3389/fgene.2021.535340.].

SARS-CoV-2 infection causing the novel coronavirus disease 2019 (COVID–19) has been responsible for more than 2.8 million deaths and nearly 125 million infections worldwide as of March 2021. In March 2020, the World Health Organization determined that the COVID–19 outbreak is a global pandemic. The urgency and magnitude of this pandemic demanded im...

Biomedical research based on the sharing and use of ever larger volumes of samples and data is increasingly becoming an essential component of scientific discovery. The success of biobanking and genomic research is dependent on the broad sharing of resources for use by investigators. However, important ethical challenges need to be addressed for th...

Introduction Childhood overweight and obesity (OWO) is a primary global health challenge. Childhood OWO prevention is now a public health priority in China. The Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI), one of four trials being undertaken by the international HeLTI consortium, aims to evaluate the effectiveness of a multifaceted...

Children with rare and common diseases now undergo whole genome sequencing (WGS) in clinical and research contexts. Parents sometimes request access to their child's raw genomic data, to pursue their own analyses or for onward sharing with health professionals and researchers. These requests raise legal, ethical, and practical issues for profession...

The last fifteen years have seen the emergence of Public Health Genomics (PHG), a multidisciplinary field related to the effective and responsible translation of genome-based knowledge and technologies to improve population health. While at the beginning the main concern of PHG was that genetic/genomic applications should be evaluated rigorously be...

Genetics and genomics are playing increasingly important roles in the Canadian health care system. With their specialized training in medical genetics and counselling, genetic counsellors have come to occupy more comprehensive roles in the provision of health care services. Despite these important advances, the majority of Canadian provinces have y...

BACKGROUND Medical care and health research are jointly undergoing significant changes brought about by the Internet [1,2,3]. New online tools, apps, and programs are helping to facilitate unprecedented levels of data sharing and collaboration, potentially enabling more precisely targeted treatment and rapid research translation [4,5,6]. Patient po...

Background This study aims to identify a novel potential use for web portals in health care and health research: their adoption for the purposes of rapidly sharing health research findings with clinicians, scientists, and patients. In the era of precision medicine and learning health systems, the translation of research findings into targeted thera...

As genetics becomes increasingly integrated into all areas of health care and the use of complex genetic tests continues to grow, the clinical genetics workforce will likely face greatly increased demand for its services. To inform strategic planning by health-care systems to prepare to meet this future demand, we performed a scoping review of the...

Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three...

Introduction: Biospecimens and associated data are invaluable tools in Genomics and Personalized Health (GAPH) research and can aid in the discovery of disease etiology and the development of therapeutics. Objective: To examine the experiences of patients invited to a particular GAPH study, Spectrometry in TIA Rapid Assessment (SpecTRA), and to ex...

Background Research in the field of genomics and genetics has evolved in recent years and so has the demand of consumers who are increasingly interested in genomic prediction of diseases and various traits. The aim of this study is to identify genetic service delivery models, policies governing the use of genomics medicine, and measures to evaluate...

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is n...

This chapter surveys law and policy approaches to the return of individual genomic findings in health research and the oversight role of Institutional Review Boards (IRBs). We review legal principles influencing return, including fiduciary duties, the duty to rescue, and the right to know (or not). We also identify core elements of applicable laws...

Medical practitioners are increasingly adopting a personalized medicine (PM) approach involving individually tailored patient care. The Personalized Prevention of Chronic Diseases (PRECeDI) consortium project, funded within the Marie Skłodowska Curie Action (MSCA) Research and Innovation Staff Exchange (RISE) scheme, had fostered collaboration on P...

Over the past decade, smartphone technology has become increasingly sophisticated and ubiquitous. Modern smartphones, now owned by more than three quarters of Canadians and 94% of millennials, perform an array of functions that are potentially useful in the health care context, such as tracking fitness data, enabling health record sharing, and prov...

Our understanding of the clinical significance of genomic data is rapidly evolving. The meaning of a patient’s test results can therefore change over time. Reanalysis of genomic data over time and patient recontact offer an opportunity to improve patient health. But are physicians legally responsible to do so? Professional associations worldwide ar...

UNSTRUCTURED Over the past decade, smartphone technology has become increasingly sophisticated and ubiquitous. Modern smartphones, now owned by more than three quarters of Canadians and 94% of millennials, perform an array of functions that are potentially useful in the health care context, such as tracking fitness data, enabling health record shar...