Participants

All participants in research studies are required to give their informed consent. The Participant Information Sheet (PIS) is a vital part of the process of giving potential participants sufficient information to enable them to make a decision on whether or not to take part in the research.

When compiling a Participant Information Sheet, please bear in mind the following:

• Avoid technical terms where possible or explain them in lay terms.
• A good rule of thumb is that the information should be readily understood by a 13 year old or Grade 8 student.
• Australian spelling and terminology should be used throughout.
• In line with the National Statement please refer to research “participants” rather than “subjects”.
• Write in a conversational style as if you were verbally explaining the study to someone.
• Use reader-friendly formatting.
• Use short words and short sentences.
• Use flow charts or diagrams where possible 
• Avoid repeating information.
• Use at least a size 12 font. 
• If you are submitting a multi-site application, you should make your Participant Information Sheet a Master Version. All participating sites can then use this to produce local versions.
• Number each page (i.e. 1 of 3, 2 of 3 etc) and include a version number and date (i.e. Version 1 dated 15/07/XXXX) 
• Local versions should use the institution’s headed notepaper.

A template for a Participant Information Sheet and Consent Form is available here

 
PARTICIPANTS WHO ARE UNABLE TO PROVIDE CONSENT

A person who is over the age of 16 and who is unable to provide informed consent cannot participate in a clinical trial in NSW unless the trial has been approved by the NSW Civil and Administrative Tribunal (NCAT): Guardianship Division. In reviewing such a trial, NCAT will decide whether consent can be granted by the person responsible or should be granted by NCAT itself. This approval is additional to the review of the clinical trial by the HREC. 

The definition of a clinical trial under the Guardianship Act 1987 (NSW) is “a trial of drugs or techniques that necessarily involves the carrying out of medical or dental treatment on the participants in the trial”.

More information is available here.

CHILDREN

The Sydney Local Health District HREC – CRGH will review single-site (CRGH-only) research which involves children. However, the HREC is not certified by the NHMRC to undertake review of multi-centre research involving children. Multi-centre research submissions should be referred to a lead HREC which is certified to review research involving children, such as the Sydney Children's Hospitals Network Human Research Ethics Committee or the Sydney Local Health District Ethics Review Committee – Royal Prince Alfred Hospital.

Specific consent to the participation of a person under the age of 18 in a research study should be obtained (i) from the child whenever he or she has the capacity to make this decision and (ii) from at least one parent or guardian. Note that consent from the parent or guardian must be obtained for use of tissue for research either before or (if using tissue collected for clinical purposes) after the removal.’

 
CONSENTING NON-ENGLISH SPEAKING PARTICIPANTS TO CLINICAL TRIALS

When obtaining consent for the participation of Culturally and Linguistically Diverse (CALD) or non-English speaking patients (NESP) participants in a clinical trial, the following points must be considered:

• Best practice is to provide the participant with a Participant Information and Sheet & Consent Form (PISCF) that has been translated by an accredited translator into the participant’s native language. All consent discussions should take place with the participation of an accredited interpreter who will countersign the consent document to confirm their involvement in the discussion.
• Where a translated PISCF is not available (due to practical, financial, time or literacy concerns), the participant will be provided with the PISCF in English and a detailed discussion around the study will be held with the participant, carer/family member and an accredited interpreter.
• It is not appropriate to conduct an informed consent discussion with a CALD/NESP participant about a clinical trial without the participation of an accredited interpreter. A family member cannot act as an interpreter or translator for a potential clinical trial participant.
• As per the National Statement on Ethical Conduct in Human Research (Section 3.3.13), researchers are advised that: “Written information should not be unduly long or complex.”
  

WITNESS SIGNATURE

In some research studies, there are regulatory requirements for a witness to be involved in the informed consent process. Researchers may need to factor certain requirements into the consent process, depending on the types of participants recruited. The consent section may also need to be adapted to capture the witness’ role. Note that interpreters are not considered impartial witnesses and they would be signing the Consent Form in their role as the interpreter. 
The ICH Guideline for Good Clinical Practice requires an impartial witness if the consent giver (i.e. the participant or their legal representative) can't read.

Where the consent giver cannot read, a witness must:
•    be present for the whole informed consent discussion; and 
•    sign and date the consent form after the consent giver has done so.

When signing the consent form, the witness is confirming that:
•    all written information was accurately explained to, and apparently understood by, the consent giver, and
•    informed consent was freely given by the consent giver.

The witness should be independent of the study team to provide the impartiality required by the ICH GCP guideline.