Participant Information Sheet (PIS)
Click here to access the sample Participant Information Sheet.
Bellberry is a proud sponsor of the National PICF Project – the national framework designed to help you every step of the way with your PICF.
The following information outlines the requirements and inclusions related to the participant information sheet as per Section 5.2.16 of the National Statement.
1. An Information Sheet is to be given to potential study participants to assist them in deciding whether or not they will become involved in the research study. A Participant Information Sheet must accompany each Consent Form.
2. The Participant Information Sheet is one method of providing information to potential research volunteers so they may reach an informed decision regarding their involvement in the research. It must not replace personal communication between the investigator and the participant. Relevant related contact details and website addresses should be provided.
3. The investigator must ensure that the potential participant is given sufficient time to consider the verbal and written information provided and given the opportunity to discuss it with other people before being asked to consent to involvement. Participants must be informed they may bring someone with them during the consent process.
4. The Participant Information Sheet is to remain the property of the participant and a copy of the signed Consent Form must also be provided to them.
5. Use simple plain English language (Australian not USA). Unit measurements must be reported in metric. Use the term ‘participant’ and not ‘subject’ throughout. See National Statement on Ethical Conduct in Human Research (2007 incorporating all updates) Section 2.2.3 and 5.2.6.
6. The Participant Information Sheet must be translated by a registered translation service if non-English speaking participants are to be recruited and in accordance with the TGA Note for Guidance on Good Clinical Practice July 2009. Plans must be in place for conducting the consent discussion in the language understandable to the participant, and for ongoing communication with the participant throughout the research and in case of emergency.
7. If the study participant is unable to read or if their legal representative is unable to read an impartial witness should be present during the entire informed consent discussion. Refer to clause 4.8.9 of the TGA Note for Guidance on Good Clinical Practice July 2009.
8. The research study title must be included on each page along with the date, page and version number.
9. Highlight in bold the section that advises participants to ask as many questions as possible.
10. Tissue Samples – All tissue samples (blood, tumor samples, urine, saliva etc.) are to be treated as falling in to one of two named categories:
- OBLIGATORY: this relates to analyses on samples necessary for the conduct of the research; refusal to provide them is a sufficient condition for exclusion from the trial. These need to be explained in the PIS but no separate consent of any kind is required for them. In the PIS explanation it is important to specify the ultimate destruction date for samples.
- OPTIONAL: this category covers everything else irrespective of the origin of the tissue (be it residue from the obligatory tests or fresh tissue that is sought via blood draws or biopsies). Since none of these are obligatory they are all therefore voluntary and of the nature of donations for either (i) specified testing regimes, or (ii) unspecified future uses. Both 2(i) and 2(ii) require brief separate PIS/CF documents. It is important to specify ultimate destruction dates for samples in 2(i).
PIS Requirements for Children and Adolescents
- A separate PICF for children and adolescents is required.
- Please be aware that certain disclosures by children about abuse or neglect, or any suspicion formed by the PI or their staff about abuse or neglect, may invoke mandatory reporting obligations under children’s protection legislation. A statement to this effect must be included in the PICF and participants and/or guardians must be informed as part of the consent discussion.
- Where appropriate, the following clause is recommended:
- For children: The study drug could cause bad birth defects in babies. If you are a girl and have started your periods, pregnancy testing will be done. You must not become pregnant during the study. If you think you may be pregnant you must tell your study doctor straight away. You must not take part in this study if you become pregnant.
- For adolescents: The effects of the study drug are unknown. Therefore there are unknown risks to the unborn child if you become pregnant during this study. You must not participate if you are pregnant, plan to become pregnant or are breastfeeding a child during the study. The study doctor must discuss with you effective methods of avoiding pregnancy during the study. Regular pregnancy testing will be done during the study.
Items to be included in the participant information sheet where relevant:
- Research study title
- Principal investigator
- Purpose of the study
- Study procedures
- Risks and discomforts
- Ionising radiation
- Possible Benefits
- Alternatives to Participation
- Tissue Samples
- Voluntary participation/withdrawal
- Illness or Injury
- Compensation for Injury
- Termination of the study
- Investigators benefits
- New information arising during the project
- Results of project
- Researcher contact
Please refer to our Consent pages for information and guidance on the consent form.