You are viewing the site in preview mode

Skip to main content

Advertisement

Table 3 Case study: the Joint Committee process

From: Development, implementation and evaluation of an evidence-based program for introduction of new health technologies and clinical practices in a local healthcare setting

One particularly significant innovation was the introduction of joint committee meetings for complex applications. Applicants submitting to the TCPC, Human Research Ethics, Clinical Ethics or Therapeutics Committees were often asked to submit to a second and sometimes third committee, depending on the nature, complexity and implications of their application. To reduce the duplication of paperwork, delays in decision-making and wasted time attending multiple meetings a collaborative process involving joint meetings and streamlined documentation was established. Details are outlined in the Toolkit [Additional file 1].
The four committees held their first joint meeting to discuss Baby Z, a neonate with molybdenum cofactor deficiency, a rare metabolic disorder with no effective treatment that leads to death in early infancy. With the permission of Baby Z’s parents, the treating doctors sought authorisation to use a therapy that was effective in mice but had not been tested in humans.
Members of each committee researched in their respective areas (eg scientific literature, legislation and regulations, preparation of therapeutic agents, etc.), provided documentation and contributed relevant expertise in the discussion. A report of the process and compilation of the documentation was undertaken by the Monash Health legal team. This information was used by the Victorian Office of the Public Advocate and the Family Court in their decision to allow the treatment. Baby Z survived [18].
Clearly the scientists and clinicians deserve the credit for identifying and refining this ground-breaking treatment and diagnosing and treating Baby Z. However the decision to use an experimental treatment is a burden that should not be left to the treating clinicians and the family. The rigour of this transparent, accountable and evidence-based decision-making process utilising the specialist knowledge of relevant experts gave those involved confidence that this was the right thing to do. This information was subsequently accepted by other decision-making bodies around the world to expedite rapid treatment of the next few infants diagnosed with the same rare condition. Babies are now routinely treated at birth [19].