What happens when the research is over? Researcher and funder perspectives

J WhitworthHead of International ActivitiesWellcome Trust

Global Forum on Bioethics in Research BlantyreMarch 2005

Basic premise:

To leave a study population

better off after a research

study than it was before

Widespread agreement with

this in principle, the difficulty

is in the implementation

Two aspects:

•Collateral benefits (standard of care)

•Access to established or successful trial interventions

Collateral benefits

•By–products of conducting research

•May or may not be necessary for study design

•Examples:Provision of health care benefits to communityStrengthening local research capacityProvision of technical or clinical equipment

Collateral benefits

Basic premise:

Aim to ratchet up general standard of care with each

and every trial

Needs to be sustainable once research is overBest done in collaboration with local health servicesMinimise gulf between service provision for study participants and community

Collateral benefits

Wellcome Trust will consider funding collateral benefits

if:

They are sustainable once research is overThey do not adversely affect local research environmenteg by raising unrealistic expectations for future trials They do not amount to coercive or undue pressure to participate

Provision of proven interventions

May be successful research interventions,

or previously established interventions

Widespread agreement with this in principle,

ensures local applicability, avoids exploitation

Funders often require application to include plan

for after trial access to care

Provision of proven interventionsTo whom?

Study participants,

study community,

national citizens

For how long? Some

interventions are life long

Whose responsibility?

Researchers, funders, sponsors, national governments

Whose responsibility?

•ResearchersUsually assumed to be responsible. But team may leave

after research. May not have power.

•Funders Usually consider health care outside remit eg NIAID,

Wellcome Trust, MRC.

Whose responsibility?

•SponsorsMay be appropriate to assist researchers engage

with government ministries or pharmaceutical

companies. Do they have the expertise?

•GovernmentsUltimately responsible for provision of health care.

Proper authority to determine ‘best practice’.

Policy makers unlikely to agree to provision of intervention

before results of trial known.

Examples

•DARTMulticentre trial of ART regimen and monitoring (Uganda and

Zimbabwe)

Funders made clear would not pay for ART even during trial

Drug companies made clear would not pay for ART after trial

Local ethics committees felt trial was on balance beneficial

to participants with 4 yrs ART

Researchers obtained letter from relevant Ministers of Health accepting

responsibility for appropriate continuing care of trial participants

including ART

No sense of a ‘team’ of researchers, funders and sponsors

•Observational study of non-communicable

diseaseCross-sectional prevalence study of obesity, diabetes, hypertension

East African country

Who is responsible for health care for those individuals found with

treatable conditions?

Diabetes, hypertension require skilled treatment for life.

Researchers/sponsors? Able to commit for decades?

National government? Struggle to provide single dose vaccines.

Is such a trial ethical?

Case study 2

Practicalities of post-trial access

•Intervention may be long-term, eg insulin

•Intervention may not be needed for several years,

eg ART in HIV seroconverters

•Untested mechanisms, eg ‘escrow accounts’

•Mechanisms for systems where the patient pays

Should payments be waived for study participants?

For what? How to organise?

Wellcome Trust position statement on research

involving people in developing countries

•Launched today <www.wellcome.ac.uk>

•Ethical framework underlying funding decisions

•Guidance and practical advice

•Covers relevance of research, selecting participants,

consent, ethical review, collateral benefits,

standards of care for control groups,

post-research access.

Wellcome Trust position statement on research

involving people in developing countries

Will consider supporting processes to address

post-research access ideally before starting research.

Assistance – letter of support

Funding – meetings and discussions with health

authorities, governments, pharmaceutical companies,

NGOs.

These are not controversial principles.

But they are difficult to apply in practice.

As usual, the devil is in the detail.