Table 1.

Needs assessment

Needs	Evidence of need
Identified at initial consultation
Appropriate and representative views in decision-making	Limited availability of committee members to attend meetings at short notice
Sufficient preparation time for committee members to review applications	Applications provided to committee members 24–48 h before meeting
Increased awareness of requirement for authorisation of new TCPs	New TCPs introduced in the organisation without application or authorisation
More easily accessible application materials	Applicants expressed difficulty accessing application materials
Explicit criteria for decision-making	Lack of documentation for how and why decisions were made
Increased transparency in decision-making process	Lack of documentation of actual decisions
Mechanism to appeal decisions	Applicants are unaware of recourse when they are unhappy with decision
Resources to monitor newly introduced TCPs	Technology/Clinical Practice Committee (TCPC) run by Ethics Committee Secretariat without any additional resources
Reporting of outcomes following introduction of new TCPs	No reporting structure or requirements
Resources to develop, maintain, evaluate and improve rigorous systems and processes	TCPC run by Ethics Committee Secretariat without any additional resources
Electronic communications to reduce inefficiency and inconsistency	All correspondence in hard copy
Identified during program development
Appropriate categories of information about new TCP provided to decision-makers	Existing application form did not address all principles in Victorian Department of Health guidance
Appropriate detail in information about new TCP provided to decision-makers	Existing application form allowed applicants to determine level of detail provided
Issues of access and equity are considered	Not in previous Monash Health application form or Department of Health guidance
Opportunities for disinvestment of current practice following introduction of new TCP are identified	Not in previous Monash Health application form or Department of Health guidance
Standardised recommendations and conditions to capture and implement decisions	Not in previous Monash Health application form or Department of Health guidance
Increased understanding, skills and resources in evidence based practice	Applications contained inappropriate information to establish evidence of effectiveness
Availability of expertise in assessing costs and health service resource utilisation	Applications contained limited information about costs and resource use
Process to assess when new TCP can be considered ‘standard’ practice, monitoring can be ceased and special patient information is no longer required.	New TCPs are introduced in a ‘probationary’ model. Outcomes are collected and reported and patients are informed that the TCP is new to the organisation and is being monitored.
Process to assess ‘change in use’ of current TCP to identify any potential risks for the patient, clinician and organisation as a result of the change	Current use of TCPs may change to address a new indication or different patient population, if there has been modification to the equipment or technique, or if there are new operators or practitioners.
Process to assess organisational issues (eg capacity, credentialing, funding) for research applications	HREC application process did not address these issues adequately
Process for approval in urgent or emergency situations is in place	Not in previous Monash Health application form or Department of Health guidance
Communication, collaboration and streamlining of processes between the Therapeutics, Technology/Clinical Practice, Human Research Ethics and Clinical Ethics Committees	Applicants submitting to one committee are often asked to submit to a second and sometimes third committee. This results in considerable delays in decision-making and requires additional documentation of the same information on different forms
Patient information sheets are of high quality and consistent with Monash Health patient information format	Brochures submitted by applicants do not meet recognised standards of patient information, do not cover and are not consistent with Monash Health format
Data collection is accurate and produced in a format that can be collated with others for monitoring and reporting	Many clinicians have no knowledge, skills or experience in data collection