B2.1. Case Study - Professor Helsinki

Professor Helsinki, a world famous psychiatrist specialising in the treatment of children, wants to comparatively evaluate four different treatments for a rare behavioural disorder called RBDC. RBDC, which involves occasional bouts of abusive and violent behaviour and episodes of severe paranoia, is most prevalent in children aged between 11 and 15, but 14 % of cases occur in young adults, and a further 6 % of cases are in people aged over 25.

All of the treatments that Professor Helsinki wants to test are ‘standard’ insofar as each has been used in clinical practice in the recent past. However, the evidential basis for each one is minimal (at least specifically in relation to RBDC) and none is proven to work.

In general terms, the options for trial are:

1. (a)  a widely used pharmaceutical product;

2. (b)  a programme of anger management and relaxation exercises;

3. (c)  group therapy;

4. (d)  cognitive behavioural therapy.

Professor Helsinki wants to enter almost all of his patients with RBDC (all of whom are younger than 16) into the study and to randomly allocate them into one of the above options. He proposes to do this without telling them or their parents/guardians and, hence, without prior consent for participation in the research (although the parents/guardians will be informed after the trial). Consent for the particular therapies offered will be obtained as normal, but the patients and their parents will not be told about the existence of the study or about the randomisation process.

Professor Helsinki’s grounds for the non-disclosure policy include:

(i) that disclosure to patients or parents would undermine the scientific validity of the study by affecting the behaviour and mental states of the research subjects;

(ii) that disclosure would harm the research subjects by upsetting them and/or exacerbating their paranoia (e.g. the idea of being ‘experimented on’ and ‘watched’ would be highly disturbing to many of these young people);

(iii) that disclosure would make it impossible to recruit research subjects;

(iv) that most people with RBDC lack the capacity to validly consent owing to the nature of
the illness;

(v) that this important research will benefit sufferers from RBDC and may even benefit the research subjects themselves;

(vi) that his patients could have (‘randomly’) received any of the treatment options in ordinary clinical practice depending on, for example, where they happen to live and that Helsinki’s research is just a more systematic and scientifically valuable version of what would have happened anyway.

Questions:

1. What are the possible benefits that this research proposal raises?

2. What are the ethical problems with this research proposal? In particular, is it ethical
   to conduct the research without obtaining the consent of either the children participating in the trial or that of their parents/guardians?

3. Do Professor Helsinki’s grounds for non-disclosure justify him carrying out the trial without consent?

4. Are there any additional safeguards that should be put in place to protect the welfare of the research subjects if they are unable to give valid consent to participate?