XX Conference Seattle 2005

Consent and other legalitiesMedLawconsult

Sketching the discussion

What are biobanks … Residual tissue …

What legal issues …• Are ethical issues as well

Consent ‘Ownership’ privacy Feed-back of results Import- export, exchange

Against a background

Background, balance of values

‘self determination’ / autonomy

Protection from ‘harm’ Privacy protection

Expectations of patients

Better prospects for future patients

Solidarity

‘freedom’ of research

Protection of harm Divide research

realm and economical world

XX Conference Seattle 2005

Background2, other issues

Tissue (data) = economic value Patents, IPR

Commercial interest of researchers Economic interest for governments

Protecting research infrastructure > barriers exchange of tissue

Erosion of public trust Public / commercial culture, the culture of ‘feelings’ instead of ratio Those who feel wronged

Uneasy reaction by political elite Policy making on incidents Promises of a risk-free society Research easy target (even though nothing went wrong) Double bind because of economic value

Background 3, ‘emperics’

Host of international documents UNESCO

• Human genetic data Council of Europe OECD WMA, ‘Helsinki’

• Race to the top

What do patients want Some kind of involvement Expect something in return, feed-back …

What are biobanks

a collection of tissue which can be used for research

so with data connected …

Types of

Population Prospective Tissue taken out for

research

gwa, large and see whether you find any correlations

Disease driven Retrospective Using residual tissue

Hypothesis driven

For consent, what type of tissue

Coded anonymous tissue Double coding Sufficiently secure, researcher will not

retrieve identity

Types of consent

Specific for each protocol Standard of clinical trials France, our CCMO

Multi choice consent Especially whether or not feed-back Commercial use etc. Council of Europe, Germany

Broad consent UK

Opt out Denmark, Netherlands , Belgium

A cry for harmonisation ?

European Directive ?

Very naïve

Usually does not really harmonise Data protection Directive

Makes things more complicated Clinical trials Directive

Clinical trials directive discussion

Not directly relevant However, now commonly recognised that it has

adverse effects for academic clinical research Me: q.e.d. for ‘harmonisation’ Various solutions suggested

More explanation More support for academic Researchers Trimming down the Directive A whole new Directive or even Regulation

encompassing all biomedical research, also epidemiological etc., so also biobanking

No harmonisation at all ?

Yes, bottom up: Quality PET’s Basic ethics Governance

Not about consent The rule of recognition suffices for that

Rule of recognition (Tubafrost)

If tissue may used for research at the country where it comes from according to the consent regulations of that country, it can also be used for that research in another country even if that other counry has different consent rules.

Home country control principle

Feed back, Yes ?

Growing tendency in literature Participants seem to expect this Because of gwa and non hypothesis driven

research distinction between incidental findings and research results have become blurred

However, no obligation in recommendations etc. yet

UNESCO, right to know ‘your’ genetic data

Unless: individual case, acute, life threatening

Good reasons for no individual feed-back

Statistical methods, too crude for personal prediction;

Coding makes it practically impossible Sheer number makes it practically unfeasible Time factor, comes too late Clinical meaning often still very unclear; Applies to all with this risk factor, if useful in

clinical practice should be applied to all … Biobanking is not screening Researchers are usually not the treating doctors Etc.

However

Something must be done about:

Patient expectations Ideas of ownership, Benefit sharing Worries about privacy as DNA is seen

more and more as inherently identifiable

Must avoid to be seen like this….

Good Research Governance

- achieving a fair and transparent balance between the interests at stake

PUBLIC BENEFIT - bottom up Not only researchers, also with

interested patients Management of expectations…

Against often paternalistic tendencies of ethicists and regulators

Harm from observational research, like biobanking ?

Data public good, if managed properly,

strict privacy protection no individual harm feasible

Now, some of those good research governance principles

Transparency about projects and who is who Patient orientated website

Involvement patient groups Involvement other stakeholders All policies written out :

Policy of how are projects approved, how is scarce tissue used for projects etc.

Privacy protection IPR issues, balance researcher, inventor, contributors

to tissue bank, etc. Data-sharing Dissemination results of research Whether or not individual feed-back

In short: how project will benefit the public good