Table 1 Needs assessment
Needs | Evidence of need |
|---|---|
Identified at initial consultation | Â |
 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 | Â |
 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 |