The ethics of aHUS patient involvement.

Over the past 10 years the movement of involvement of patients in the development of medicines, their regulation and use has grown enormously. aHUS alliance Global Action watched its growth and added its own opinions about including patients. If , individually, all aHUS patients cannot be involved around the world then patients organisations can at least listen to what they say and amplify their voice for them.

The emphasis has been on “how to do it?” particularly with little resource that aHUS advocacy possess.

But before that, even though there are good practical reasons for involving patients , perhaps it should be asked “ is it ethical to do it” .

Clinical research has been bound by increasing regulation since the unethical practices of the past demanded that something needed to be done to make such research ethical.

But what are the key ethical principles that underpin all clinical research including medicine development and is there ethical case for patient involvement too.

Late last year an international group based in Geneva, Switzerland, The Council for International Organisations of Medical Sciences , produced a report about patient involvement in medicines development , regulation and use. At the beginning of that report there was a chapter in which the organisation makes the argument that patient involvement is ethical.

This is the gist of their assertion.

All clinical research ethical practices have developed over the past 60 years rooted in both the Helsinki Declaration and the Belmont Principles. They deal with questions about how best to deal ethically with people who use medicines.

A fundamental principle underpinning bioethics – the ethics of medical and biological research- is that the people who use medicines are expert partners who can help improve development of what medicines they are expected to use.

This reflects:

Respect of the person– they are not just subjects , or unthinking individuals without opinion

Beneficence and nonmaleficence – maximising benefits and minimising harm from treatments

Justice – that all groups in the global society have equal chances of involvement

Not involving patients can be seen as not respecting them as persons and could reduce potential benefits and increase harms from medicines and cause an injustice to those with unmet needs. Patient involvement therefore can be regarded as an ethical imperative.

But even if it is the right thing to do it just how do you do it?

How best can patient involvement complement the efforts of business and science to meet aHUS patients needs and preferences.

How able is the Global aHUS Community to do it ?

Article No. 575


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