Report on CILE Seminar: “Management of Incidental Findings: Biomedical, Clinical, and Islamic Ethical Perspectives”
On February 25, 2025, the Research Center for Islamic Ethics and Legislation (CILE) hosted a CPD-accredited seminar titled “Management of Incidental Findings: Biomedical, Clinical, and Islamic Ethical Perspectives.” Convened by Dr. Mohammed Ghaly, the seminar brought together experts from biomedical science, clinical genetics, and Islamic ethics to address one of the most pressing ethical challenges in modern genomics: the management of incidental findings. These are unexpected discoveries made during genetic testing or research that are unrelated to the primary purpose of the study. The seminar explored these issues from multiple angles, emphasizing the need for interdisciplinary collaboration and ethical frameworks that respect both scientific/clinical progress and moral values.
Dr. Mohammed Ghaly, CILE’s Head and Professor of Islam and Biomedical Ethics at the College of Islamic Studies, Hamad Bin Khalifa University, opened the event by highlighting CILE’s mission to address complex ethical questions at the intersection of Islamic moral thought and contemporary biomedical sciences. He noted that CILE’s initiatives, including its conferences, seminars, and publications like the Journal of Islamic Ethics, aim to foster dialogue between tradition and modernity, particularly in fields like genomics where rapid advancements raise new ethical dilemmas.
First Topic: Returning Incidental Findings at the Age of Big Data
Presented by Dr. Said Ismail, Acting President and Chief Scientific Officer, Qatar Precision Health InstituteDr. Said Ismail opened the seminar by addressing the challenges of managing incidental findings in large-scale genomic projects like Qatar Genome. He explained how the dramatic drop in the cost of sequencing technology has made whole genome sequencing more accessible, but it has also created a flood of data that raises complex ethical questions.
Dr. Ismail shared insights from Qatar Genome’s experience, where over 45,000 whole genomes have been sequenced. He emphasized the importance of returning actionable findings to participants, especially when they are life-saving or clinically significant. For example, he described a pilot program focused on BRCA1 and BRCA2 genes, which are linked to hereditary breast and ovarian cancer. The program successfully identified carriers of these mutations and connected them to preventive care pathways, demonstrating the potential benefits of returning incidental findings.
However, Dr. Ismail also highlighted the challenges of managing such findings at scale. Not all genetic variants have clear clinical significance, and the science is constantly evolving. This raises questions about whether researchers and clinicians have an obligation to recontact participants with updated information—a logistical and ethical challenge that requires careful consideration.
He further elaborated on Qatar Genome’s seven-pillar national strategy, which includes policies, regulations, and ethics as a core component. Dr. Ismail stressed the importance of preparing the ethical, policy, and regulatory framework early on, as genomic research is a new and complex territory. He discussed the difficulty of distinguishing between actionable and non-actionable findings, noting that while some variants, like those linked to hereditary cancers, have clear preventive measures, others, such as those predisposing individuals to Alzheimer’s, lack effective interventions. Another challenge explained is the complexity of classifying genetic variants, which range from benign to variants of unknown significance, and pathogenic. This raises ethical dilemmas about whether to disclose such information to participants, especially when no clinical solutions exist.
Additionally, he raised questions about the rights and obligations of researchers and participants: Should researchers disclose findings even if participants may not want to know? Whose right takes precedence—the participant’s or the researcher’s? He referenced the global debate encapsulated in the "Your DNA, Your Say" initiative, emphasizing that these questions lack universal answers and must be addressed within the cultural and societal context of each region.
Second Topic: The Gray Area of Genomics: Clinical Perspectives on Secondary "Incidental" Findings
Presented by Dr. Tawfeg Ben Omran, Division Chief of Genetics and Genomics, Sidra Medicine
Dr. Tawfeg Ben Omran brought the discussion into the clinical realm by presenting real-life cases where incidental findings were discovered during genetic testing. One case involved a newborn with abnormal screening results, which led to the discovery of a life-threatening genetic condition in the mother. Another case involved a child with developmental delays, where whole exome sequencing revealed a pathogenic variant unrelated to the primary condition but significant for the family’s future health.
Dr. Ben Omran also mentioned that, according to the latest guidelines from the American College of Medical Genetics, there is now a list of about 73 actionable genes that can be identified through whole exome or whole genome sequencing. With pre-test genetic counseling and patient consent, families can opt in or out of receiving information about these genes, highlighting the importance of informed choice in the process. He also highlighted the cultural and social challenges of disclosing such findings, particularly in societies where consanguineous marriages are common. In some cases, families may refuse to share findings with at-risk relatives, creating ethical dilemmas for clinicians.
Third Topic: IRB Considerations and Ethical Perspectives on Incidental Findings
Presented by Dr. Amal Robay, Assistant Dean of the Office of Research Compliance, Weill Cornell Medicine in Qatar
Dr. Amal Robay shifted the focus to the ethical and regulatory challenges of managing incidental findings in research. She outlined key ethical principles, such as beneficence, respect for persons, and justice, that guide decisions about returning incidental findings. She also discussed the role of Institutional Review Boards (IRBs) in reviewing research protocols and ensuring that researchers have a plan for managing incidental findings.
Dr. Robay emphasized the importance of informed consent, ensuring that participants are aware of the possibility of incidental findings and have the option to opt out of receiving such information. For participants who provide consent, she stressed that researchers must evaluate whether the potential benefits of returning findings outweigh the risks. Findings that are validated (e.g., through CLIA-certified labs or FDA-approved tests) and actionable (clinically or personally) are more justified for return, while those that are unvalidated and non-actionable carry less justification.
She also highlighted the complexities of returning incidental findings in a research context, be it the method of disclosure—whether face-to-face (often necessary in the case of significant clinical relevance), via email, or by phone—, the participant’s status (for adults lacking capacity or minors, findings should be communicated to legal authorized representatives (LARs) or guardians, respectively), and even the importance of involving qualified professionals, such as treating physicians, investigators, genetic counselors, and ethics committees, in the process of returning findings.
Fourth Topic: Islamic Perspectives on GenEthics
Presented by Dr. Mohammed Ghaly, Professor of Islam and Biomedical Ethics
Dr. Mohammed Ghaly provided a unique perspective by framing the ethical management of incidental findings within the Islamic ethical framework. He presented the key findings of his recently published book Islamic Ethics and Incidental Findings Genomic Morality Beyond the Secular Paradigm.
He explained that, from an Islamic viewpoint, the issue goes beyond the traditional benefit-risk or benefit-harm assessment commonly viewed and evaluated exclusively through medical and health-related parameters. It extends beyond clinical utility and actionability, emphasizing the individual's relationship with God and the belief that they will be held accountable before God for their actions, even in clinical or research settings.
He explained that human actions in Islam are, morally speaking, categorized into five levels: obligatory, recommended, permissible, reprehensible, and prohibited. Applying this framework, Dr. Ghaly argued that providing research participants with sufficient information to enable them to make truly informed decisions about consenting to receive incidental findings—given that these findings are almost inevitable—is considered an obligatory act in Islam. He also mentioned that life-saving information must be disclosed as an obligatory act, as preservation of life (hifz al-nafs) is one of the higher objectives of Sharia. For example, if a clinician discovers a life-threatening condition during genetic testing, they are ethically and religiously obligated to inform the patient, even if it was not the primary objective of the test.
However, Dr. Ghaly also highlighted findings that should not be disclosed, such as the so-called “misattributed” paternity. He argued that disclosing such information would normally fall into the category of prohibited acts, as it could lead to various harms, including stigmatization, and injustice, particularly for women who may be unfairly blamed for extramarital relationships. In Islamic jurisprudence, Muslim scholars throughout history stressed that paternity is not solely determined by biological relationship but is also tied to the institution of marriage. Therefore, challenging paternity based on genetic findings could undermine the stability of families and violate Islamic ethical principles.
By bringing together experts from diverse fields, the event highlighted the importance of developing ethical frameworks that are both scientifically sound and culturally sensitive, ensuring that genomic research benefits individuals and communities while respecting their values and beliefs.
