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150430P - ETHICS IN GENETIC RESEARCH

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Presented at the First Annual Saudi Society of Medical Genetics Conference held at King Abdulaziz City for Science and Technology on 30 April 2015. By Dr. Omar Hasan Kasule, Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) College of Medicine, King Fahad Medical City, Riyadh


Introduction: Genetic Diseases are Diseases
  • Genetic diseases are ‘diseases’ like other types of disease: disorder in the patient or inherited from parents
  • Genetic diseases have negative but sometimes positive aspects
  • Treatment of genetic diseases is mandatory: for every disease there is a cure
  • Heredity, biological or environmental, is found in other diseases
Introduction: Research on Genetic Diseases
  • Genetic research is mandatory within the rubric of searching for cures
  • Genetic research is ijtihad involving reading Allah’s signs in humans, ayat al Allah fi al anfus.
  • Its ethically adverse side effects can be avoided if we follow ethic0-legal guidelines
Introduction: Research on Genetic Diseases, con’t…
  • Ethico-legal guidelines are derived from have a joint reading, al jam’u baina al qira’atain, of the book of empirical knowledge, kitaab al kawn and the book of revealed knowledge, kitaab al wahy.
  • This paper is based on the theory of purposes of the law, maqasid al shari’at,[1] and principles of fiqh, qawa’id al fiqh.[2]
Ethico-legal Issues Covered By This Paper
  • Human dignity
  • Underlying intentions
  • Consent
  • Disclosure
  • Genetic therapeutic intervention
Human Dignity: Basis
  • Human dignity is a concern in genetic research.[3]
  • A human is a deliberate and best of creation being a duality between body and ruh. Allah dignified the human being giving him superior intelligence (‘aql), a conscience to tell right from wrong, hidayat, limited will-power, iraadat, and control over the environment, tashkiir.
  • Preserving human dignity is one of the fruits of the purpose of hifdh al ddiin. Genetic research if mis-conceived could lead to loss of human dignity by looking at the human as a collection of genes with their random mutations that determine both biology and behavior.  
Human Dignity: Violation vs Respect
  • Genetic research could lead to violation of human dignity if it results in discrimination based on genetic make-up,[4] commodification of the human corps especially if commercialized.[5]
  • On the other hand by showing the common origin of the human genome, genetic research can restore human dignity by de-emphasis of external variations of race, color, ethnicity, tribe, and family lineage.  
Intentions:  Positive
  • According to the fiqh principle of intention, qa’idat al qasd, all matters are judged by the underlying intentions, al umuur bi maqasidiha, and not the outwardly expressed intentions.
  • Genetic research can have good underlying intentions in the diagnosis, prevention, and treatment of disease to fulfill the purposes of the Law in (a) protecting life, hifdh al nafs, (b) protecting lineage, hifdh al nasl, (c) protecting intellect hifdh al ‘aql, and (d) protecting resources, hifdh al maal.
Intentions:  Negative
  • Genetic research may have intentions of financial gain from patenting new diagnostic or treatment processes.
  • Genetic research may have bad underlying intentions if it is used to (a) provide scientific support for forbidden sexual orientations[6], [7] and addictions (b) creating a potential for stereotyping such as genetic research on intellectual disability,[8] community genetic survey for anti-social personality[9] or genetic research on intelligence.[10]
Consent
  • Like all other forms of research, genetic research requires consent of the research subject.
  • The process is more rigorous than other forms of research because more information must be provided to and must be understood by the research subject mainly related to the disclosure of both main and incidental findings.
  • Genetic findings in a research subject disclose genetic details of all members of the family or community and require additional privacy and confidentiality measures.
Consent, con’t…
  • Some forms of findings may upset the research subject or the family and they need advance counseling and consent.
  • Study of community genetic variation requires consent at the level of the community. Study of individual disease risk requires consent by the individual. Genetic therapy requires consent.[11]
Privacy, Confidentiality, & Disclosure of Anticipated Findings
  • Strict privacy and confidentiality must be maintained in genetic research to prevent harm to patients and relatives. Non-disclosure whatever its benefits may lead to loss of patients of trust in the researchers.[12]
  • We may need to weigh the harm and benefits of the disclosure according to detailed rules of the principle of injury, qa’idat al dharar. Public interest, al maslahat al ‘aamat, of either disclosure or non-disclosure takes precedence over individual interest, almaslahat al khaasat.
Privacy, Confidentiality, & Disclosure of   Anticipated   Findings, con’t…
  • Strict The principle of maslahat can be applied in the following cases to allow disclosure to relatives:  a gene of a preventable or treatable condition is found in a patient who refuses disclosure to relatives who could benefit, a gene of treatable disease is found from the patient after death?[13] genetic data collected from critically ill patients who die soon after?[14]
Disclosure of Incidental Findings - 1
  • Issues of disclosure of anticipated findings in research can be resolved in advance by the consent process. Problems arise regarding disclosure of incidental findings if such consent was not obtained in advance.
  • Among questions that arise are: Is it ethical to look for incidental findings? Should we disclose incidental findings to the patient or the family? Should we break the anonymity of genetic research on biobanked material to disclose an incidental finding that will require medical intervention?[15] Should we disclose wrongly attributed parentage? Should we disclose an incidental finding of an unsuspected but treatable genetic disease?
Disclosure of Incidental Findings - 2
  • The genetic researcher must avoid the complications of incidental findings by not looking for them or even noticing them because he is bound by the principle of intention to carry out only what he set out to do. It is therefore not obligatory to look for incidental findings.[16]
  • According to the principle of certainty, yaqiin, the findings must have a high degree of certainty (validity: analytical and clinical) before we even consider disclosure.
Disclosure of Incidental Findings - 2
  • According to the principle of injury the disclosure must have benefit (value, clinical utility, clinical relevance, and actionability) and the patient must consent to be told (volition) because he/she is the best protector of self-interest.[17], [18], [19]
Case Scenario - 1:
In the course of genetic research you reach the conclusion that the purported father is not the biological father. Do you disclose this or not? How do you handle the information?

Case Scenario - 2:
A genetic researcher receives blood for doing research on a specific project. When he finds that he has a surplus of the blood he decides to run additional tests to test a newly acquired kit. He discovers a genetic disease. How will he handle this information?

References:

[1]  Abu Ishaq Ibrahim Bin Musa al Shatibi (d. 790H). Al Muwafaqaat fi Usuul al Shari’at. Dar al Marifat, Beirut 2008G.
[2]  Majallat al Ahkam Aladliyyat. Dar Ibn Hazm. Beirut. 2004
[3]  Bioethics. 2014 Jun 9.
[4]  Rev Derecho Genoma Hum. 2013 Jul-Dec;(39):173-203.
[5]  Med Anthropol. 2005 Jan-Mar;24(1):45-70.
[6]  Hastings Cent Rep. 1997 Jul-Aug;27(4):6-13.
[7]  Camb Q Healthc Ethics. 1995 Summer;4(3):340-50.
[8]  J Intellect Disabil Res. 2003 Oct;47(Pt 7):548-54.
[9]  J Nerv Ment Dis. 2012 Mar;200(3):260-4.
[10]  Bioethics. 2000 Jan;14(1):1-15
[11]  J Assoc Physicians India. 2002 Nov;50:1395-7.
[12]  Hastings Cent Rep. 2015 Feb 11
[13]  Am J Bioeth. 2013;13(10):61.
[14]  Pharmacogenomics J. 2010 Apr;10(2):77-85.
[15]  IRB. 2010 Mar-Apr;32(2):7-18.
[16]  Am J Bioeth. 2013;13(2):32-42.
[17]  J Law Med Ethics. 2014 Summer;42(2):190-207.
[18]  Pharmacogenomics J. 2015 Feb;15(1):1-5.
[19]  Annu Rev Genomics Hum Genet. 2013;14:557-77.