The Ethics and Governance of Human Genetic Databases European Perspectives Part 2 pptx

There are certain decisions which are, so to speak, only ours to make.

Some of them concern our bodies, others the attainment and disclosure

of information about ourselves. These define the domain of our decisional

privacy. Respect for this can imply, for instance, that we have a ‘right to

choose what happens in and to our bodies’, as some people have claimed

in the abortion debate. Decisions concerning personal data are intrinsi￾cally related to the informational aspect of our privacy.

Consent

Permission to seek, store and disseminate genetic information about

individuals can be obtained in many ways. The standard approaches in

the biomedical context are based on the notions of ‘actual’, ‘implied’,

‘hypothetical’ and ‘proxy’ consent.

Actual consent is the real, genuine permission of the individuals them￾selves to collect, store and disseminate their tissue samples or genetic

data. In medical contexts, consent is, as a rule, considered valid only if

three conditions are met. The individual consenting must be competent,

not permanently or temporarily unable to make reasonably clear-headed

decisions for herself. The consent must be given freely, not as a result of

coercion, intimidation or pressure. And the individual must be informed

as to what exactly she consents to, and what the implications of the

decision for her will, or can, be.

Implied consent (also known as ‘presumed consent’) is the notion evoked

in cases where individuals have not actually consented or dissented to the

procedure in question, but others claim that their permission can, never￾theless, be assumed. The claim can be backed up by various strategies.

One is to point out that a genuine opportunity to register dissent has been

given to individuals, but they have chosen not to use it. Another is to

appeal to related evidence which gives indirect support to the assump￾tion, perhaps by showing that the same people have not in the past

dissented to similar practices in other fields.6

Hypothetical consent (or ‘rational consent’) can be used even in cases

where we know nothing about the actual or probable attitudes of the

individuals involved. We can then hypothesize that they are rational or

moral in a sense defined by us, and assert that these qualities necessarily

elicit, or should elicit, certain responses from them. We may think that no

6 On how dangerous it is to read more into what people say than they actually do say, see,

e.g., Søren Holm, ‘ ‘‘Parity of Reasoning Arguments in Bioethics’’ – Some Methodological

Considerations’, in Matti Ha¨yry and Tuija Takala (eds.), Scratching the Surface of Bioethics

(Amsterdam: Rodopi, 2003), pp. 47–56.

18 Matti Ha¨yry and Tuija Takala

rational person would object to having her genetic data stored. Or we may

argue that since individuals have benefited, or will benefit, from other

people’s willingness to participate, they cannot therefore claim a moral

right to opt out.

Proxy consent is introduced in situations where the individuals them￾selves are temporarily incapacitated, persistently incompetent or dead.

The permission in these cases is not sought from them, but from some

other people, usually their relatives or friends. This form of consent is

resorted to in medical emergencies, in cases where the individuals them￾selves cannot make reasonably sound decisions, and in dealings with

small children.

Confidentiality

In medical and certain other settings, we can consent to share some

private information with other people or institutions, on the condition that

they do not pass it on to anybody else, or at least not to any unauthor￾ized third parties. In theory, confidentiality can be regarded as an absolute

or a qualified requirement.

Respect for absolute confidentiality would require that the information

acquired will under no circumstances be made public, disseminated or

passed on to any other, or any unauthorized, parties. Ethicists have

sometimes tried to impose this kind of duty on those who receive, in

their professional capacity, sensitive and personal knowledge about their

patients or clients. In practice, however, strict obligations like this are

often difficult to honour.7

Respect for qualified confidentiality requires a presumption of secrecy,

but recognizes the need, in exceptional cases, to breach the confidential￾ity of individuals, either to uphold other moral principles, or for their own

good, or for the good of others. This is linked with, among other things,

public interest. It has been argued, for instance, that family doctors

should, or should be allowed to, disclose information about potentially

lethal socially transmissible conditions to the family members of their

patients. In the context of genetics, the claim has been made that blood

relatives should be entitled to have access to each other’s genetic records.8

7

See, e.g., Raanan Gillon, Philosophical Medical Ethics (Chichester: John Wiley & Sons,

1985), pp. 108–109.

8

See, e.g., Rosamond Rhodes, ‘Genetic Links, Family Ties and Social Bonds: Rights and

Responsibilities in the Face of Genetic Knowledge’, Journal of Medicine and Philosophy

23 (1998), pp. 10–30. Cf., however, Tuija Takala and Matti Ha¨yry, ‘Genetic Ignorance,

Moral Obligations and Social Duties’, Journal of Medicine and Philosophy 25 (2000),

pp. 107–113.

The mezzanine rules of ethical genetic databanking 19

Security

Genetic databanks need systems and procedures to secure the privacy

and confidentiality of the people whose samples and records they collect,

store and disseminate; and to ensure the ethical use of the information

with which they are trusted. Security issues can be approached from at

least two angles, which may be complementary.

The promotion of objective security is a matter of safety mechanisms,

data protection, scientific risk assessment and good professional practice

in handling sensitive information. It can be argued that as long as experts

in this field are satisfied with the security of the system, this is, in and by

itself, sufficient.

Another aspect of the matter is, however, the sense of security felt sub￾jectively by individuals, intersubjectively by groups and communities, or

politically by nations and international alliances. Several methods can be

employed to create and enhance this feeling of trust, which may or may

not be a function of the objective measures taken.

In liberal democracies, it is usually held that trust can be rightfully

achieved by the openness and transparency of the system, and by the

honesty and clear accountability of the individuals working within it.9

In

social democracies, it can also be maintained that the political system,

and other systems authorized by it, should be regarded as trustworthy,

unless a significant portion of the citizenship questions this through

democratic processes.

In political environments which do not emphasize democracy, the best

way to lull people into a false sense of security is to inform them only

selectively – perhaps even by concealing facts which could alarm the

public. Since the study of non-democratic responses to genetic databanks

falls outside the scope of the ELSAGEN project, and of this chapter, we

shall not explore it any further. It is worth mentioning, however, that the

widely acclaimed practice of ‘promoting public awareness’ can assume

radically different forms in different political systems. In liberal demo￾cracies, the public can be thought to have a duty to know about the facts and

conjectures behind political decisions. In social democracies, the right to

know can be stressed. And in non-democratic societies, people presum￾ably have an obligation to comply with the inevitable. The ‘awareness’ to be

promoted will not be the same in all these cases.

9 On the significance of these, see, e.g., Onora O’Neill, ‘Informed Consent and Genetic

Information’, Studies in History and Philosophy of Biological and Biomedical Sciences

32 (2001), pp. 689–704.

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