HUMAN RESEARCH AND ETHICS COMMITTEE

RESEARCHER’S DECLARATION (Researchers/Trial Coordinators)

THIS FORM MUST BE COMPLETED FOR EACH RESEARCHER ON EACH SPECIFIC PROJECT

New HREC applications1 signed original, attached to the completedoriginal application form.

Existing HREC applications1 signed original of the Researcher’s Declaration is required.

RESEARCHER’S DETAILS

Title / Given Name / Surname / Address / Email
Primary Employer (please circle/delete as appropriate) / The Royal Victorian Eye and Ear Hospital (Eye and Ear)
CERA
University of Melbourne Dept of Otolaryngology
Bionics Institute
Other (please state)

PROJECT DETAILS

Project Title:
Project No: (if known)
Principal Investigator:
Are Eye and Ear patients involved? / Yes No
If YES, are the patients <18 years of age?Yes No
If YES, a current Working With Children Check is required.
Describe your role in the context of this project
Do you require access to the Eye and Ear digital health record? / Yes No

EYE AND EAR APPOINTMENT

Do you have an Eye and Ear appointment/honorary appointment? / Yes No Position: ______
Employee No: ______Expiry Date: ______
Current Scope of Practice: ______
If you have an Eye and Ear appointment, is the role you will perform for this project within your current Scope of Practice? / Yes No
If YES, please sign and submit page 1 only of this form.
If NO, please complete details on pages 2 and 3.
If you don’t have a current Eye and Ear appointment, please complete details on pages 2 and 3.

Privacy Declaration

I agree to keep confidential all information that relates to individuals involved in this research/audit. I shall not make any direct copy of participant’s records and all data collected will be de-identified and relevant consents obtained.

I also agree to keep confidential any information concerning persons or events that comes to my attention at The Royal Victorian Eye and Ear Hospital. Such information includes anything relating to the project/audit above, and any other information which I hear, see or read during my time at the hospital.

Researcher’s Signature: Date:

Principal Investigator’s Signature: Date:

Please complete if you do not have a current Eye and Ear appointment, or your role for the project is outside your current scope of practice.

QUALIFICATIONS

Year / Qualification / University/College
Graduation:
Postgraduate:
Profession/Course:
Registration: / AHPRA:YesNoAHPRA Reg No:
Other:
If you are not registered with Aust. Health Practitioner Regulation Agency (AHPRA), please complete the online Health Records Act course and provide certificate of completion as part of this application.

ROLE IN PROJECT

Please tick at least one of the following questions that relate to the rolesyou will perform forthis project:

  1. Perform clinical tests/procedures on Eye and Earpatients(please give brief details below)
  1. Assess Eye and Ear patients relating to inclusion/exclusion risk criteria (including consenting of patients)
  2. Access to Eye and Ear health record only (Eye and Ear honorary appointment
    required for access to the digital health record)
  3. Oversight of research project as Principal Investigator/Supervisor
  4. No Eye and Ear patient contact or access to Eye and Ear health records
  5. Other – please list below

If you have selected 1 and/or 2 above, please refer to the Mandatory Training Section below for further requirements.

What training have you received for the above listed roles? (please provide evidence/certificates of training)

Do you require extra training to perform the roles listed above?Yes No

If Yes, describe the training that is required and who will provide the training.

OFFICE USE ONLY

Personnel Approval Granted: YES NO 

Access to Eye and Ear Digital Health Record Granted:YES NO N/A 

HREC Chair: ______Date: ______

NOTIFICATION: / Principal Investigator / Health Information Services

For Researchers who have direct Eye and Ear patient contact but do not have a current Eye and Ear appointment, the following mandatory training is required prior to receiving an Eye and Ear honorary appointment.

MANDATORY TRAINING

Mandatory training is required in the areas listed below, where there is direct Eye and Ear patient contact involved.

  • Patient Identification
  • Hand hygiene
  • Fire Training
  • Aseptic Technique (if invasive treatment given, ie venepuncture)

Please refer to the Honorary Researcher Information Handbook for details required for the mandatory training components and compliance sign off.

Documentation Checklist (for new Eye and Ear honorary appointments)

Copy of curriculum vitae YES NO 

Police Records Check YES NO N/A 

Working with Children Check (if patients <18 years of age) YES NO N/A 

Certificate of Completion Health Records Act online course YES NO N/A 

(if not AHPRA approved) (

Certificate of Completion Hand Hygiene Australia online course YES NO N/A 

(

Honorary Researcher Information Handbook Compliance Sign Off YES NO N/A 

(page 10)

Good Clinical Practice TransCelerate Training (recommended)YES NO N/A 

N:\Medical\Administration\Clinical Research\HREC\FORMS\HREC Researchers Declaration Version 11.doc

May 2016