My Bioethical Opinion Is... (4) Getting Approval for Medical Experiments on Human Subjects

Here is the question:

What would have to happen for a research/surgical team to be given approval by a university/hospital ethics committee to fit a willing human subject with an iPlant (see http://knol.google.com/k/christopher-harris/iplant/3t1ux01d2xqyk/2 or http://www.iplant.eu)? Do you think such approval would be granted in the US or EU?

For the sake of argument, let's assume that the application for approval is submitted regarding either

1) An attempt to use rewarding deep brain stimulation to motivate physical exercise in a morbidly obese patient. Note that rewarding brain stimulation has long been an effective method for motivating behaviors such as physical exercise in experimental animals (Burgess et al, 1991; Garner et al, 1991), and that deep brain stimulation has already been used, unsuccessfully, in an attempt to reduce hunger in a morbidly obese patient (Hamani et al, 2008).

or

2) The case of one member of the research/surgical team wishing to serve as experimental subject. Note that researchers such as Kevin Warwick have already been granted permission to 'self-implant' on several occasions (Warwick et al, 2005).  Christopher Harris


References

Burgess et al (1991) Intracranial self-stimulation motivates treadmill running in rats. Journal of Applied Physiology 71(4), p1593-1597

Garner et al (1991) Intracranial self-stimulation motivates weight-lifting exercise in rats. Journal of Applied Physiology 71(4), p1627-1631

Hamani et al (2008) Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Annals of Neurology 63(1), p119-23

Warwick K et al (2003) The application of implant technology for cybernetic systems. Archives of Neurology 60(10), p1369-1373

Here is my answer:

An Institutional Review Board (IRB) in the United States is legally responsible to review, approve and monitor the biomedical and psychologic research investigations which involve human subjects to protect the subjects rights and welfare.  In the case of a research project as suggested in the above commentary,  there would be a great deal of investigation of the project, the protocol, the project researchers themselves, the risks for the human subjects and then consideration of the balance between the risks and the potential benefits which might come out of the experiment.  The issue of iPlant and whether it itself is a realistic and rational project and not some commercial concoction along with the question of the ethics of its implementation or use if found effective in humans is not at all clear from the descriptions given.  All of this first has to evaluated in detail by the appropriate IRB.  Therefore in response to the first question “What would have to happen for a research/surgical team to be given approval by a university/hospital ethics committee to fit a willing human subject with an iPlant”, my answer would be a detailed investigation by an IRB in the areas noted above.  Without that one cannot begin to answer the hypothetical situations noted in the above commentary. I have no answer to the second question “Do you think such approval would be granted in the US or EU?”  As I already suggested, ..it all depends.  

I do want to thank Christopher Harris for bringing up this subject since I think that most of the public don’t know what goes on with regard to medical research in the United States or about the presence or activities of IRBs.  IRBs, having been established by law in the 1970s are  yet  not uniformly ideal in their membership and their  function.  However, they still are an important safeguard to human subjects of medical experiments and an important barrier against subject abuse carried out in Nazi Germany and elsewhere in the 20^th Century.   ..Maurice.