Austin Health Human Research Ethics Committee

Austin Health Human Research Ethics Committee

CHANGE OF RESEARCH PERSONNEL

Checklist

Have you submitted the following?:

□HREC Amendment Form

□Updated PICF/s (if PI or contact person has changed)

□Updated participant materials (diaries, wallet cards, flyers etc if they refer to the PI by name)

□Revised Clinical Trial Research Agreement (CTA) (if PI has changed)

□Revised Form of Indemnity (if PI has changed)

□Revised Clinical Trial Notification form (CTN) (if PI has changed)

□Curriculum vitae for all new personnel (Austin Health Investigator CV 1 page Document sufficient)

□CurrentTransCelerate accredited good clinical practice (GCP)certification.

Project details

HREC Reference number
Austin Health project number
Project title
Principal investigator
Contact person / Name
Email address
Phone
Department/Institution
Approval Period

Personnel details

Personnel who have left the study(please add additional rows as required)

Title and name / Finish date / Reason for leaving

Personnel who have changed role(please add additional rows as required)

Title and name / Former role / New role

New personnel

Copy this table and complete for each new research team member

Title and name
Position
Institution
Department
Mailing address
Work phone
Mobile
Email
Role / □ Principal investigator
Please provide amended PICF/s and ensure this form is countersigned by previous PI
□ Associate investigator
□ Student researcher
Degree/course:
Supervisor(s):
□ Student supervisor
Degree/course:
Stduent:
□Contact person/Trial coordinator
Please provide amended PICF/s
Brief description of responsibilities in this project
Brief summary of relevant qualifications and experience
Declare any general competing interests
Commencement date

Training

Will any of the researchers require extra training to enable their participation in this project?

□ Yes [Please provide details below]

□ No

Researcher / Training required / Who will provide the training?

Declaration by Research Personnel

I/WE, the researcher(s), agree:

• To only start and conduct this research project after obtaining final approval from the Institution’s Human Research Ethics Committee (HREC)in accordance with the approved protocols and procedures;
• To only carry out this research project where adequate funding is available to enable the project to be carried out according to good research practice and in an ethical manner;
• To provide additional information as requested by the HREC;
• To maintain the confidentiality of all data collected from or about project participants;
• To provide progress reports to the HREC as requested, including a final report and a copy of any published material at the end of the research project;
• To notify the HREC in writing immediately if any change to the project is proposed and await approval before proceeding with the proposed change;
• To notify the HREC in writing immediately if any adverse event occurs after the approval of the HREC has been obtained and to act promptly to ensure the safety and wellbeing of participants;
• To agree to an audit or other monitoring requirements if requested by the HREC;
• To only collect or use data and any tissue samples collected for the study for which approval has been given;
• To only grant access to data to authorised persons; and
• To maintain security procedures for the protection of privacy, including (but not restricted to): removal of identifying information from data collection forms and computer files, storage of linkage codes in a locked cabinet and password control for access to identified data on computer files.

I have read the NH&MRC National Statement on Ethical Conduct in Human Research (2007) and will observe the principles set out in that document and in the Declaration of Helsinki and ICH Good Clinical Practice.

New research personnel: (add additional rows as required)

______/ ______/ ____/____/______
Name / Signature / Date
______/ ______/ ____/____/______
Name / Signature / Date

Principal investigator:

I authorise the addition of these personnel to the approved project. I certify that all researchers and other personnel involved in this project are appropriately qualified and experienced or will undergo appropriate training to fulfil their role in this project in accordance with this declaration. As the Principal Investigator, I additionally declare that I will take responsibility for the confidential maintenance of records for 15 years after study completion (or 7 years in the case of non-drug studies).

______/ ______/ ____/____/______
Name / Signature / Date

Certification by student supervisor

Only complete this section if a new student has been added to the research team.

I/we certify that:

• I/we will provide appropriate supervision to the student to ensure that the project is undertaken in accordancewith the undertakings above;
• I/we will ensure that training is provided necessary to enable the project to be undertaken skilfully and ethically.

______/ ______/ ____/____/______
Name / Signature / Date

Certification by Head of Department

Only complete this section if there has been a change of principal investigator.

I/we certify that:

• I/we are familiar with this project and endorse its undertaking;
• the resources required to undertake this project are available;
• the researchers have the skill and expertise to undertake this project appropriately or will undergo appropriatetraining as specified in this application.

______/ ______/ ____/____/______
Name / Signature / Date

Change of Research Personnel form Version 327 February 2017 Page 1