ALFREDHOSPITAL ETHICS COMMITTEE

Module Six – Alfred-specific details

This form must be completed for all projects to be conducted atAlfred Health sites and/or involving Alfred Health patients, staff or resources (including data).

Project Title:

Principal Researcher:

1. BEFORE YOU BEGIN - ‘PRE-ETHICS’ ASSESSMENT/AUTHORISATION PROCESSES

A number of Alfred Health departments/services need to assess proposed research before it is submitted for ethical review. If your project involves one or more of the following, please ensure that you have the relevant sign-off and provide evidence of this with your ethics submission.

1.1Nursing Research

Will the research involve Alfred Health nurses as research participants and/or investigate nursing practices? Yes No If No, go to [1.2]

If Yes, the project must be assessed by the Nursing Research Advisory Committee (NRAC)BEFORE it is submitted for ethical review.

Please submit the signed ‘Application for Nursing Research Advisory Committee (NRAC) Review’form with your ethics application as evidence of NRAC approval.

1.2Caulfield Hospital involvement

Will the research involve Caulfield Hospital resources, staff or patients?

Yes No If No, go to [1.3]

If Yes, Caulfield Hospital must authorise the research (via a Notice of Intention)BEFORE it is submitted for ethical review.

Please submit one of the following as evidence of Caulfield Hospital authorisation:

  • Notice of Intention with the ‘Authority to proceed’ section signed
  • Email from Caulfield Research Support Coordinator confirming authorisation

1.3Clinical Registries and Health Informatics involvement

Does the research involve the establishment of, or contribution to, a Clinical Registry?

Yes No If No, go to [2]

If Yes, the project must be assessed by the Organisational Data Steward for compliance with theAlfred Health Support for Clinical Registries PolicyBEFORE it is submitted for ethical review.

Please submit a signed Health Informatics Resource Centre Declaration with this ethics application as evidence of HI approval.

2.HOSPITAL RESOURCES

2.1Multiday hospital stay

Will multiday hospitalisation be required or prolonged for the purposes of the study? Yes No

If Yes, providedetails below

How many additional days in hospital are expected for each patient?

How many admission days (on average) per month?

Under which unit will admission take place?

2.2Day admission

Will additional day patient admission be required for the purposes of the study?Yes No

If Yes, providedetails below

How many such admissions will be required for each patient?

How many admissions (on average) per month?

Under which unit will admission take place?

2.3Outpatient visits

Will additional outpatient visits be required for the purposes of the study?Yes No

If Yes, providedetails below

How many such visits will be required for each patient?

How many visits (on average) per month?

Under which unit will visit take place?

2.4Staffinvolvement

(a)Will staff be involvedin targeting, recruitment, enrolment and/or management of research participants? Yes No

If Yes, please list all departments and staff involved

Department
/
Name
/
Position
/ Average hours/week to be devoted to study (hospital paid hours only) / Funding Source
HSA or other

(b)Will a startup meeting or information session be arranged to appraise staff involved of all relevant aspects of the study?

Yes No

If Yes, please providedetails below, including the anticipated date

3.OTHER ALFRED HEALTH RESOURCES/SERVICES

Are other Alfred Health resources/services required? Yes No If No, go to [4]

If Yes, please indicate below:

The following resources/services have Resource Centre Declarations. Please include the relevant signedResource Centre Declaration/s with this application.
Pathology
Radiation
Nuclear Medicine / Pharmacy
Heart Centre
Lung Function / Medical Records
Health Informatics
Nursing
Resources/Services that do not have Resource Centre Declarations. Please list belowand include sign-off by the relevant Manager/Head of Department/Unitin Module One, 1.40

4.Standard of Care

Does the project involve any treatments or procedures?Yes No If No, go to [5]

If Yes, pleaseprovide the following details relating to standard of care at Alfred Health:

Treatments/procedures / Is the treatment or procedure standard of care at Alfred Health?
Yes/No/N/A / If No, please provide details of what is standard of care / If No, please justify why it is acceptable to conduct the study at this institution
(e.g. safety, costs covered, etc)
Treatment (drug/device)
Drug/procedure being studied
Standard/comparator drug/procedure in a controlled trial
Procedures
Number, frequency and volume of blood samples
Number, frequency and volume of other tissue samples (e.g. bone marrow, sputum, urine etc)
Number, frequency of radiation/imaging procedures
Other procedures (Please specify, e.g. ECGs, spirometry)

5.ACCESS TO ALFRED HEALTH PATIENT INFORMATION - NON-ALFRED HEALTH STAFF

(a)Will the project involve access to Alfred Health medical records by external research personnel (i.e. who arenot Alfred Health staff members)? Yes No If No, go to [5b]

If Yes, please provide details below(duplicate table as required):

Researcher’s name
Access type / Honorary Alfred Health appointment (provide letter of appointment)
Undertaking a clinical placement at Alfred Health
Applying to ITS for Cerner access via Research Study Coordinator*
*Name & Department of Research Study Coordinator

(b)List ALL ‘external others’ who, for the purposes of this research, will have authority to use or have access to Alfred Health medical records and describe the nature of the use or access. Examples of ‘others’ are: student supervisors, research monitors, pharmaceutical company monitors. Any access by these people must be via the above-named Research Study Coordinator.

Name and/or Role/Position / Nature of this person’s use or access

6.Monash University involvement

(a)Are any of the research team in the employment of Monash University (including joint/dual appointments with Alfred Health) or Monash students? Yes No

If Yes, please provide details

(b)Will the research involve Monash University resources or be administered by Monash University? Yes No

If Yes, please provide details

7.Legal Documents

Please indicate legal documents for this application

CTN (Clinical Trial Notification) formYes N/A

Contract or research agreement (e.g. MoU, MoA)Yes N/A

IndemnityYes N/A

Alfred Health CTRA and Indemnity ChecklistYes N/A

Insurance certificateYes N/A

All legal documents MUST be provided at the time of the full Ethics submission

ALFRED HOSPITAL ETHICS COMMITTEESeptember 2014

MODULE SIXPage 1 of 4