Prof. Bartha KnoppersKatie SaulnierLingqiao Song

The University of Hong Kong, April 7th, 2017

Beyond the Individual:Familial and Solidarity Claims?

Knoppers, Bartha MariaChadwick, Ruth, NatureReviews/Genetics, Volume 6,January, 2005

Knoppers, Bartha MariaChadwick, Ruth, Science 30 Sep1994: Vol. 265, Issue 5181, pp.2035-2036

Knoppers, Bartha MariaChadwick, Ruth, BMC Medical Ethics(2015) 16:58

● Governance● Security● Empowerment● Transparency● Right Not to Know● Globalization

● Reciprocity● Mutuality● Solidarity● Citizenry● Universality

● Autonomy● Privacy● Justice● Equity● Quality

Human Dignity

Conflicts among Different Values❏Different roles of the individual: patient,

participant, family member, and citizen.❏Individual Rights vs. Familial Rights vs.

Public Interest: Are they necessarily inopposition?

❏A question of context? A question of trust ingovernance?

❏“Autonomy is not exercised in isolation but isinfluenced by a person’s various connectionsto family, to community, and to cultural,social, linguistic, religious and other groups.”(TCPS2, Art. 1.1)

Source:https://www.pinterest.com/explore/rights-and-responsibilities/

OUTLINE

❏Organ Donation

❏ Individual Rights

❏Familial Rights

❏Public Health

Organ Donation

❏Donor’s Consent and Family Override❏ Forms of consent➢Opt-in approach: Canada➢Opt-out approach: France

Organ DonationCanada

❏ Safety of Human Cells, Tissues and Organ forTransplantation Regulations (SOR/2007-118)

- Regulate the handling of organ for transplantation.❏ National Organ Donor Week Act, SC 1997, c 4

- Prescribes the last full week of April as “National Organ Donor”- In the past 10 years, the number of deceased organ donors has gone up by

44%. However, the number of people needing a transplant has gone up as well.

- Public campaigns to raise awareness for organ donation each year in April.- British Columbia, “2017 National Organ and Tissue Donation Awareness

Week”

http://www.transplant.bc.ca/our-services/awareness-programs/national-organ-and-tissue-donation-awareness-week

Organ Donation

QuebecCivil Code of Quebec. art. 43-44 (1991, c. 64, a. 43; I.N. 2014-05-01)

- Individuals over 14 years old (included): a. 43 “A person of full age ora minor 14 years of age or over may, for medical or scientific purposes, givehis body or authorize the removal of organs or tissues therefrom.”

- Minor under 14 years old: a. 43 “A minor under 14 years of age mayalso do so with the consent of the person having parental authority or of histutor.”

- Format and revocation of consent: a. 43 “These wishes are expressedverbally before two witnesses, or in writing, and may be revoked in thesame manner. The wishes expressed shall be followed, unless there is acompelling reason not to do so.”

Source:https://en.wikipedia.org/wiki/Flag_of_Quebec

Organ DonationQuebecCivil Code of Quebec. a. 43-44 (1991, c. 64, a. 43; I.N. 2014-05-01

- Substitute consent: C.C.Q. a. 44 “A part of the body of a deceased personmay be removed, if the wishes of the deceased are not known or cannot bepresumed, with the consent of the person who was or would have been qualifiedto give consent to care.”

- Person qualified to give consent to care: C.C.Q. a. 15 “Where it isascertained that a person of full age is incapable of giving consent to carerequired by his or her state of health and in the absence of advance medicaldirectives, consent is given by his or her mandatary, tutor or curator. If theperson of full age is not so represented, consent is given by his or her married,civil union or de facto spouse or, if the person has no spouse or his or herspouse is prevented from giving consent, it is given by a close relative or aperson who shows a special interest in the person of full age.”

Source:https://en.wikipedia.org/wiki/Flag_of_Quebec

Organ DonationTransplant Quebec: Standardized Organ Donation Procedure

Source: http://www.transplantquebec.ca/en

Step 4: Offer/Team Approach

Organ DonationQuebec

Three Ways to Donate

1. Online registry of l’assurancemaladie du Quebec

2. Sign the sticker and place it on theback of the health insurance card

3. Record it in the will with theRegistre des consentements au dond’organes et de tissus of theChambre des notaires du Québec.

Source: http://www.transplantquebec.ca/en

Source: http://www.transplantquebec.ca/en

Source:https://en.wikipedia.org/wiki/Flag_of_Quebec

Organ DonationFrance

❏ Loi Caillavet du 22 décembre 1976❏Established system of presumed consent to organ donation

❏ Loi n° 94-654 du 29 juillet 1994 relative au don et à l'utilisation deséléments et produits du corps humain, Loi bioéthique no 2004-800du 6 août 2004❏Reinforced organ donation as a national priority

❏ Amendment to the Code de la santé publique, via LOI n° 2016-41 du26 janvier 2016 de modernisation de notre système de santé, inforce as of January 2017❏Banned familial intervention in organ donation

Source:http://franceflag.facts.co/frenchflagof/franceflag.php

Organ DonationFamily Override of Individual Autonomy❏Family override of consent to organ donation

extremely common❏In France, such override is expressly prohibited by

law as of January 2017❏Prior to this, 32% of cases where patient had not

expressly opted out of presumed organ donationnevertheless ended in family override.

Source:http://www.geripal.org/2012/03/when-surrogates-override-dnr-terrific.html

Individual Rights

Human Dignity❏ “Whereas recognition of the inherent dignity and of the equal and inalienable

rights of all members of the human family is the foundation of freedom, justiceand peace in the world [...] “(Universal Declaration of Human Rights, 1948,Preamble)

❏ “Parties to this Convention shall protect the dignity and identity of all humanbeings and guarantee everyone, without discrimination, respect for theirintegrity and other rights and fundamental freedoms with regard to theapplication of biology and medicine.” (Oviedo, 4.IV.1997,Article 1)

Individual Rights

Ethical and Legal Values Implicated inIndividual Rights

❏Human Dignity❏Respect for Persons❏Respect for Autonomy❏Control of the Samples and Data (Ownership?)❏Privacy and Confidentiality

Individual RightsInformed Consent“Researchers have a duty to provide potential researchparticipants with the information and the opportunity togivetheir free and informed consent to participate in research,or todecline to do so, unless a research ethics committee hasapproved a waiver or modification of informed consent.”(International Ethical Guidelines for Health-relatedResearchInvolving Humans, 2016, CIOMS in collaboration withWorldHealth Organization (WHO))

Individual RightsTypes of consent in the context ofbiobanking❏ Specific consent: individuals consent to the use

of samples for the specific study only❏ Broad consent: a wide range of unspecified

future research with ethics approval❏ Presumed consent (opt-out): individuals are

presumed to consent to use the residual samplesunless they opt-out (Noor A. A. et al. 2012)

❏ REB waiver: research without obtaining consentafter ethics approval (Knoppers B.M. 2005)

Source:http://futurehealthbiobank.com/terms-and-conditions/

Individual RightsInformed Consent to Collection and Use of Human BiologicalMaterial❏ “Research involving collection and use of human biological material requires REB

review and: (a) consent of the participant who will donate biological material; or (b)consent of an authorized third party on behalf of a participant who lacks capacity,taking into account any research directive that applies to the participant; or (c) consentof a deceased participant through a donation decision made prior to death, or by anauthorized third party.” (TCPS2, Article 12.1)

❏ Human Tissue Gift Law may apply to provide a legal framework for the donation oftissue upon death (TCPS2, Article 12.1)

Individual Rights❏ Secondary Use of Identifiable Human Biological Material for Research

Purposes Without Consent (TCPS, Chapter 12)Researchers who have not obtained consent from participants for secondary use may only usethe material if the REB is satisfied that they meet the following requirements:❏ the materials are essential to the research;❏ unlikely to adversely affect the welfare of individuals;❏ appropriate measures have been taken to protect the privacy of individuals and the

materials;❏ any known preferences by individuals about any use have been respected;❏ impossible or impracticable to seek consent;❏ the researchers have obtained any other necessary permission for use.

❏ This Policy does not require that researchers seek consent from individuals forthe secondary use of non-identifiable human biological materials.

Individual RightsBroad Consent for Secondary Research Use

Allows the use of broad consent (i.e., seeking prospective consent tounspecified future research) from a subject for storage, maintenance, andsecondary research use of identifiable private information and identifiablebiospecimens. Broad consent will be an optional alternative that aninvestigator may choose instead of, for example, conducting the research onnonidentified information and nonidentified biospecimens, having aninstitutional review board (IRB) waive the requirement for informedconsent, or obtaining consent for a specific study. (United States Final Rule ofFederal Policy for the Protection of Human Subjects, Effective Date: January 19,2018)

Individual RightsResearch Directive

Some types of research initiatives (e.g., the creation of large databasessometimes known as research platforms) involve long-term retention and useof information or human biological materials for research purposes (e.g.longitudinal studies that involve biobanking). When data for these platformsare initially collected, it is not typically possible to specify every research thatcould be carried out using the participant’s information or human biologicalmaterials. Research directives may be used in these contexts to giveparticipants the opportunity to express their preferences about future researchshould they lose capacity (TCPS2, Art. 3.11, Application)

Individual Rights

Return of Results❏ The right to results obtained through

medical research❏ Challenges in the context of Biobanking➢ Research Results = Clinical Diagnostic Results (Joanna

et al. 2009)➢ Misinterpretation can create potential psychological,

social and economic anxiety. (Knoppers B.M. 2005)➢ Anonymous or anonymized human biological material

has made it impossible to offer the beneficial findings tothe participants and the family members. (TCPS 2,Chapter 12 A)

➢ Results of WGS are often not clinically actionable as wellas raising incidental (Secondary) findings (KnoppersB.M. et al. 2005)

Source: http://secondscount.org/heart-condition-centers/info-detail-2/myths-about-women-heart-disease-2

Individual RightsOwnership of the Sample ?Washington University V. Catalona (2007), United States Court of Appeals, EighthCircuit❏ The federal regulation does not address the matter of a RP’s ‘right’ to physically

possess their sample upon termination of their participation in a research study,or a ‘right’ to direct their sample[s] transfer to another institution or PrincipalInvestigator.

❏ Washington University is the owner of the biological samples.❏ Research participants donated their biological materials to the university as inter

vivos gifts.❏ The right to withdraw does not include the right to retrieve prior samples.

(437F. Supp.2d 985)

Individual RightsProperty Rights in Biological Tissue Samples:

Greenberg v. Miami Children’s Hosp. Research Inst., Inc. (United States District Courtfor the Southern District of Florida, 2003)❏ Issue: Are property rights retained in body tissue and genetic matter if they were

donated voluntarily to research?❏ Decision: property rights are not retained in body tissue and genetic matter if they

were donated voluntarily to research. Using results from medical research is notconversion because the tissue donors lose their property interest in the tissue afterthe donation, regardless if the receiving party uses information gathered from thattissue and sells it as a commodity on the open marketplace.

❏ The court upheld the plaintiffs' claim of unjust enrichment at the expense of thedonors of tissue, saying “the facts paint a picture of a continuing researchcollaboration that involved plaintiffs also investing time and significant resources.”(264 F. Supp. 2d 1064 (S.D. Fla. 2003))

Individual RightsCommon Law:➔ Lam v University of British Columbia (2010 BCCA 325 (CanLII))❏ Whether samples could be considered property for the purposes of the

province’s Warehouse Receipt Act?❏ British Columbia Court of Appeal: Medical science had advanced to the

point where sperm could be considered to be property.➔ Piljak Estate v Abraham (2014 ONSC 2893 (CanLII))❏ Whether excised human tissue was personal property within the meaning of

Rules of Civil Procedure of Ontario?❏ Ontario Superior Court: diagnostic tissue once excised becomes pursuant

to applicable laws a “component of the medical record”.Civil Law: Quebec Droit de la famille - 061409 (2006 QCCS 7871 (CanLII))❏ Whether women could take possession of their placentas and determine

their fate?❏ Yes, but it was based on considerations of dignity, autonomy and privacy,

as opposed to consideration of ownership or property.

Familial RightsEthical and Legal Values Implicated inFamilial Rights

❏ Mutuality;❏ The family as a social unit;❏ Right to request/receive/be notified of pertinent health

information;❏ Risk of Genetic Discrimination;❏ Legal approaches surrounding disclosure to family vary across

jurisdictions.

Source:https://www.pinterest.com/fullfamilytree/family-tree-template/

Familial RightsThe Family as a Social Unit:❏ Approach that views the family as a social unit, implying that genetic

information “belongs” to the family rather than the individual:

“The family is the natural and fundamental group unit of society and isentitled to protection by society and the State.”

(Universal Declaration of Human Rights, 1948, Art. 16 paragraph 3).

“Everyone has the right to respect for his private and family life, his home andhis correspondence.”

(European Convention on Human Rights, 1953, Art. 8 paragraph 1).

Familial RightsHenrietta Lacks Cell Line❏ Shared genetic information: Individual privacy and family

privacy❏ In March 2013, researchers published the DNA sequence of

the genome of a strain of helA cells.❏ Objections from the Lacks family about the genetic

information that was available for public access.❏ In August 2013, an agreement between the family and the

National Institutes of Health gave the family some controlover access to the cells DNA sequence.

❏ Members of the family not included in the 2013 agreementhave recently announced plans to file a lawsuit using theargument of a “continuous tort”, alleging that the violationsof Lacks’ “personal rights, privacy and body parts” havecontinued over time (“Henrietta Lacks’s family wantscompensation for her cells”, Washington Post, 14 February2017).

Source:https://heymikeyatl.com

Familial RightsRights of Access in Research

❏ Article 13.2 Researchers conducting genetic research shall: (a) intheir research proposal, develop a plan for managing informationthat may be revealed through their genetic research; (b) submittheir plan to the REB; and (c) advise prospective participants ofthe plan for managing information revealed through the research(TCPS2, Art. 13.2)

❏ Participants’ preferences may be overridden for disclosure torelatives in exceptional circumstances (e.g., if genetic researchreveals information about a serious or life-threatening conditionthat can be prevented or treated through intervention) (TCPS2, Art.13.3).

Familial RightsRights of Access in Clinical Care❏Disclosure is considered appropriate in exceptional

circumstances “where attempts to encourage disclosure onthe part of the patient have failed; where the harm is highlylikely to occur and is serious and foreseeable; where the at-risk relative(s) is identifiable; and where either the disease ispreventable/ treatable or medically accepted standardsindicate that early monitoring will reduce the genetic risk.

(American Society of Human Genetics Social IssuesSubcommittee on Familial Disclosure, 1998)

Familial Rights

Duty to warnEthical duty to warn

❏Ethical (not legal) duty to warn family members under thevalue of mutuality (US President’s Commission 1982)Legal duty to warn

❏Not well-articulated in caselaw❏Some jurisdictions (e.g. France, Taiwan, Spain) have

procedures established by law requiring the return of certaingenetic testing results to family members (Knoppers B.M. etal, 2015)

Familial Rights

Posthumous rights❏ Strength of familial claim on information may be strengthened after the death of

the patient❏ Ex. In the United States, HIPAA protects individually identifiable health

information for 50 years after death❏ During this time, personal representative can authorize certain disclosures❏ Privacy rule permits disclosure to family members unless it violates the

expressed preferences of the deceased❏ In some cases, this information can be released to biological family members

even in the face of express refusal, if they are accessing medical informationof a deceased patient in order to verify the existence of a specific genetic orinherited illness (Quebec, Loi sur les services de santé et les servicessociaux, art. 23 para. 4)

Familial RightsFamily Override of Individual Autonomy

❏In the context of advance directives“A doctor is not free to disregard a patient’s advance

instructions any more than he would be free to disregardinstructions given at the time of the emergency” (Malettev. Shulman, 1990 at 424)

However:❏Terms of advance directives may be unclear❏Impacted by fluctuating capacity

Public Health

Ethical and Legal ValuesImplicated in Public Health

❏Solidarity❏Public goods❏Shared goals and mutual benefit to the

health system❏Challenges from commercial

biobanking (DTC)

Public Health

Solidarity:❏ “[M]anifestations of a collective commitment to carry costs

to assist others (who are all linked by means of a sharedsituation or cause)” (Nuffield Bioethics, 2011);

❏ Willingness to share in a certain degree of risk (e.g. privacyrisks in biobank participation) to bring value to thecommunity as a whole;

❏ Raises questions about who are the relevant “others” forwhom we are willing to take these risks: family only, orbroader community and future generations?

Public Health

❏ Individual rights and public health“The justification for a database is more likely to be grounded in

communal value, and less on individual again… it leads to thequestion whether the individual can remain of paramount importancein this context.” (WHO’s Report on Genetic Databases, 2004)

❏ Human genomic databases are global public goods.“a. Knowledge useful to human health belongs to humanity.b. Human genomic databases are a public resource.c. All humans should share in and have access to the benefits of

databases.”(Human Genome Organization Ethics Committee’s Statement onHuman Genomic Databases, 2002)

Source:http://www.economist.com/node/18681796

Public HealthEthical Issues in Direct-to-Consumer Testing❏ Use of consumer data for research that does not comply

with guidelines on confidentiality, privacy, and secondaryuses of data (Laestadius, 2016);

❏ Lack of availability of genetic counselling to help patientsprocess their results (Burton, 2015);

❏ Lack of guidance for patients communicating results withtheir family members (Acharya, 2015).

GA4GH Framework for Responsible Sharing ofGenomic and Health-Related Data

❏ Current frameworks are founded on the principle ofprotection from harm. In contrast,

❏ GA4GH Framework aims to activate the right to scienceand the right to recognition for scientific production bypromoting responsible data sharing.

genomicsandhealth.org/framework

Human Rights Foundation

Universal Declaration of Human Rights (1948)

“The Right to Science” “The Right to Recognition”

“Everyone has the right freely toparticipate in the cultural life ofthe community, to enjoy the artsand to share in scientificadvancement and its benefits.”

27(1)“Everyone has the right to theprotection of the moral andmaterial interests resulting fromany scientific, literary or artisticproduction of which he is theauthor.”

27(2)

Framework for Responsible Sharing ofGenomic and Health-Related Data

•Consent Policy•Consent Clauses andInternational Data SharingTemplate•Data Sharing Lexicon

•Privacy & Security Policy

•Data Safe Havens

•Accountability Policy•Ethics ReviewRecognition Policy