BALLARAT HEALTH SERVICES and ST JOHN OF GOD HEALTH CARE

HUMAN RESEARCH ETHICS COMMITTEE

REPORT ON RESEARCH PROGRESS


Project Title:

Principal Investigator:

Date of Original Approval:

Anticipated date of commencement at time of approval:Actual date commenced, if different:

Anticipated date of completion at time of approval: Revised completion date, if applicable:

A.STATUS OF THE PROJECT

Please check the box that applies to your project

In progressAbandoned(terminated before recruitment/data collection)

Not commenced (but it is anticipated the projectTerminated(after recruitment/data collection commenced)

will commence in the near future)

Suspended(notification will be sent to this HREC Completed

before the project is recommenced)

Reason why not commenced, suspended, abandoned, terminated:
Have any participants already recruited been advised of suspension, termination Y N If not, why?

B.CONDUCT OF THE PROJECT

1. Has the project been conducted:

(a) in accordance with the approved protocol?Y N

(b) in accordance with any conditions of approval?Y N N/A

If no, please explain why:

2.Have there been any changes to the approved protocol?Y N

If yes, have these been submitted to, and approved by this HREC? Y N
If not, please attach details and dates, including reason for changes, and summary of ethical implications if any. Please also provide copy of revised protocol/patient information and consent forms, as applicable

3.Have there been any changes to:

(a) the identity or contact details for the Principal Investigator? Y N

(b) the research team? Y N

If yes, please indicate who and explain why

Left::
*Joined:
* Please attach DHS Module One, Question 1.8 (Researchers) and 1.38 (Declaration by Researchers) for each new researcher

4. Have any problems been encountered in the following areas:

  • Study DesignY N
  • FinanceY N
  • Facilities, equipmentY N

If yes, please provide details and result of any efforts to overcome these:

5.Where are study records held?

Are they maintained securely according to the NHMRC National Statement on Ethical Conduct inResearch Involving Humans (1999)? Y N

If no, please explain why:

C.PARTICIPANTS

  1. Recruitment (this site):

Have any problems been encountered in the recruitment of participants: Y N

If yes, please provide details:
  • Target for recruitment:
  • Number recruited to date:
  • Number who have completed project:
  • Number who have withdrawn*:
  • Number currently enrolled in project:
  • Is the project still open to recruitment?Y N

*Please list reasons:
  1. Consent Forms:

Are signed consent forms available for inspection? Y N

  1. Confidentiality:

Have the approved measures for ensuring the confidentiality of participants’ information been:

(a) followed?Y N

(b) effective?Y N

If no, please provide details:
  1. Complaints:

Have there been any complaints during the course of the project: Y N

If yes, please provide details:

D.MANAGEMENT OF RISK

ALL PROJECTS:

  1. Have there been any unforeseen ethical issues, incidents or adverse effects to participants during the course of the project: Y N

If yes, please provide details:
  1. Have the proposed measures for managing risks been:

(a) followed?Y N

(b) effective?Y N

If no, please provide details:

CLINICAL TRIALS:

  1. Have there been any Serious Adverse Events (as defined in “the National Statement”) reported during thecourse of the project (all sites)? Y N

If yes, have these all been reported to the HREC?Y N

4. If the study has commercial sponsorship, is the insurance certificate current and what is the amount of the coverage: Y N N/A , Amount: $ Expiry Date:

5.Is the trial registered on the Australian Clinical Trials Register? Y Registration No: N

If no, please explain why: (e.g. state if registered with an international register that fulfils the ICMJE criteria)

6. If there is a data safety and monitoring committee established for this trial, have there been any changes to its structure or operation, since the last progress report/approval date Y N N/A

If yes, please provide details:

E.BENEFITS

Do you believe the stated objectives of the project have been/will be achieved:
Please describe any benefits to individual participants to date:

F.PROGRESS

  1. Data analysis:

None Proceeding Complete

  1. Presentations/Publications:

Yes No Expected

If yes, please check as applicable:

Publication/s Abstract/s Presentations

(Please attach full details, including reference or means of access to published material)

  1. Progress Report:

Please attach a brief summary (in lay terms) including:

  • Results to date, or outcome in the case of completed research
  • Expected progress for the next twelve months (in the case of continuing research)
  • Details (copy) of any results provided to participants

G.DECLARATION BY PRINCIPAL INVESTIGATOR / SUPERVISOR (for student research)

I confirm that this project is being conducted as originally approved by the Ballarat Health Services and St John of God HREC (and subject to any changes subsequently approved) and that all adverse events are reported to the Committee according to the Committee’s guidelines for reporting adverse events and the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999).

Name:…………………………………………..

Signature:……………………………………..Date:………………………………

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