[Insert UNSW and other organisational letterhead for page 1]

Approval No (when available)   

THE UNIVERSITY OF NEW SOUTH WALES (AND OTHER PARTICIPATING ORGANISATION[S] )

PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM

(Title of project) 

[Participant selection and purpose of study]
You (i.e. the research participant) are invited to participate in a study of (state what is being studied).  We (i.e. the investigators) hope to learn (state what the study is designed to discover or establish).   You were selected as a possible participant in this study because (state why the participant was selected).

[Description of study and risks]
If you decide to participate, we (or other designated research person[s]) will (describe in simple language the procedures to be followed, including the use of placebos, their purpose(s), how long the procedures will take, and their frequency).

(Describe the discomforts and inconveniences reasonably to be expected.   An estimate of the total time required should be included.)   

(Describe the possible risks reasonably to be expected.  Describe any benefits to the participant reasonably to be expected.  

If benefits are mentioned, add:   We cannot and do not guarantee or promise that you will receive any benefits from this study.

(Describe appropriate alternative procedures that might be advantageous to the participant, if any.  Any standard treatment that is being withheld must be disclosed.)

[Confidentiality and disclosure of information]
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission, except as required by law.  If you give us your permission by signing this document, we plan to discuss/publish the results (state the persons or agencies to whom the information will be furnished, the nature of the information to be furnished, and the purpose of the disclosure). In any publication, information will be provided in such a way that you cannot be identified.

[Recompense to participants]
(If the participant will receive remuneration, describe the amount or nature.   If there is a possibility of additional costs to the participant because of participation, describe it.)

Complaints may be directed to the Ethics Secretariat, The University of New South Wales, SYDNEY 2052 AUSTRALIA (phone 9385 4234, fax 9385 6648, email ethics.sec@unsw.edu.au). Any complaint you make will be investigated promptly and you will be informed out the outcome.

[Feedback to participants]
(Describe the mechanism(s) by which a summary of research findings will be offered to research participants at the completion of the study. If there are potential negative effects of providing this feedback to participants these need to be described and the participants need to consent to receiving feedback, eg: by a tick-a-box mechanism.)

[Your consent]
Your decision whether or not to participate will not prejudice your future relations with the University of New South Wales (and the participating organisation[s]).   If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without prejudice.

If you have any questions, please feel free to ask us.  If you have any additional questions later, (Title, name  phone number) will be happy to answer them.

You will be given a copy of this form to keep.					

THE UNIVERSITY OF NEW SOUTH WALES (AND THE OTHER PARTICIPATING ORGANISATION[S] )

PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM (continued)
(Title of project)

You are making a decision whether or not to participate.  Your signature indicates that, having read the information provided above, you have decided to participate.

……………………………………………………                                              .…………………………………………………….
Signature of Research Participant                                                                        Signature of Witness

……………………………………………………                                              .…………………………………………………….
 (Please PRINT name)					(Please PRINT name)

……………………………………………………                                              .…………………………………………………….
Date							Nature of Witness

(INSERT name and address of Chief Investigator).

REVOCATION OF CONSENT
(Title of project)

I hereby wish to WITHDRAW my consent to participate in the research proposal described above and understand that such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New South Wales, (other participating organisation[s] or other professional[s]).

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

……………………………………………………                                              
Please PRINT Name

The section for Revocation of Consent should be forwarded to (INSERT name and address of Chief Investigator).