Home 
Contact 
Profile 
Videos 
Presentation at the 1st Genomics Medicine and Research Symposium: New Horizon in Genomics Applications held at King Fahad Medical City, Riyadh on 10-12 February 2019. By: Prof. Dr. Omar Hasan Kasule, Sr. MB ChB, MPH, DrPH (Harvard). Professor of Epidemiology and Chairman of the Human and Medical Ethics Committee, Chairman of the Behavior Standards Committee, and Chairman of the Institutional Review Board / Research Ethics Committee
Genomic
Research
} Genomic research
involving sequencing and analysis of the genome.
} Rapidly growing
field rapidly integrated into the health care system.
} Ethical dilemmas
some old and some very new.
Ethical
Issues
} Human identity and
human dignity.
} Informed consent.
} Privacy and
confidentiality.
} Return or disclosure
of results.
} Approval and
regulation.
Human
Dignity
} Genomic research
and fundamental questions about the human: who are we? What is our past and
what is our destiny?
} Issues about
personhood: neuro and psychiatric genomics.
} Demystifies the
human: collections of genes, amino acid sequences, and mutations.
} Creation of new
and artificial categories of discrimination and stigmatization.
Informed
Consent
} Getting informed
consent for genomic research is complex because stakeholders include the family
and the tribe as well as future generations.
} Disclosure of
benefits vs risks ?vague
} Consent for a
research program vs consent study-by-study?
} Local research vs
multi-center research?
} Parental
privileges to consent for children: traditional vs genomic research / future
risks and benefits not yet clear.
Elements
Of Informed Consent
} Sequencing
details.
} Return of results:
Anticipated vs. incidental.
} Return of results:
Treatable vs. non-treatable conditions?
} Future use of the
material and the results: Science vs commerce.
Privacy
And Confidentiality
} Privacy and
confidentiality nightmare because of increasing sequencing.
} Sequencing data of
a person reveals secrets about the whole family, clan, or tribe.
} Building family
trees is part of the research but it puts familial data at risk.
} Disclosure of
results about disease risk: research participant vs family members?
} Refusal to
disclose results that overwhelm the participant with too much information?
Incidental
Findings
} Incidental
findings can be disclosed to the research participant, the extended family, or
a committee that will decide what to do.
} Incidental
findings are more problematic when the research is done on hospital pathology
or biobanks anonymized tissues without prior specific consent.
Research
vs Treatment
} The rapid
development of genomics is obliterating the boundary between research and
treatment.
} Research results
enter into in treatment almost immediately.
} Risk of dangerous
therapies that will be discovered much later.
Institutional
Review Board (IRB)
} IRB handling of
genomic research projects has been evolving.
} Genomic research
was at first treated like gene-based research as high risk because of
confidentiality.
} As more sequencing
was done, both locally and overseas, and the confidentiality issues became
clearer, the risk categorization is being reconsidered.