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Participant Information Sheet

The following information outlines the requirements and inclusions related to the participant information sheet as per Sec. 5.2.16 of the National Statement.

Click here to access the sample Participant Information Sheet

General Informationexpand

  • 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.
  • 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.
  • 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.
  • 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.
  • 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) Section 2.2.3 and 5.2.6.
  • 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. 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.
  • The research study title should be included on each page along with the date, page and version number.
  • Highlight in bold the section that advises participants to ask as many questions as possible.

PIS Requirements for Children and Adolescentsexpand

  • 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.

  1. Research study title
  2. Principal investigator
  3. Introductionexpand
    This section orientates the reader to the information sheet and invites the reader to become a participant of the study. If this is a follow on study, state this.
  4. Purpose of the studyexpand
    This gives the participant a brief description of the study.  It may be appropriate to provide some key exclusion criteria. The purpose of the study should accurately describe the primary and secondary aims/endpoints of the study as set out in the study protocol.
  5. Study proceduresexpand
    • A brief explanation of all procedures the participant will be involved in and the frequency of each. If possible, tabulate required patient visits.
    • Any discomfort that may be experienced is to be made known. This includes the use of drugs and radioisotopes.
    • The terms randomisation, placebo and any others should be defined in this section.
    • Where diabetic participants are required to fast before attending a clinic visit, refreshments must be provided before they depart the clinic. A statement to this effect must be included.
    • Amounts of blood drawn – if relevant specify the amount of blood to be drawn in layman’s terms. Use metric measurements.
    • The trial treatment(s) and the probability for random assignment to each treatment.
    • Approximate number of participants in the trial.
    • It should be stipulated if the investigational product will be available to participants at the conclusion of the trial, and who will meet the cost.

  6. Risks and discomfortsexpand
    • Foreseeable risks, side effects, discomforts, inconveniences and restrictions, both immediate and later that will or may be involved, including travel and absence from work. It is useful to provide side effect in percentage (%) terms. For early phase studies with minimal participants, it may be more useful to provide actual numbers.
    • If participants are put on an approved drug for an approved indication, AEs should not be listed in the PICF.  The PICF should contain the following wording “Some drugs you will be taking for this study are already approved by the Australian Therapeutic Goods Administration for your condition.  They have side effects and these are described in the Consumer Medicines Information (CMI) for each drug. You should read the CMI for the drug, or each drug if there are more than one, before reaching a decision about your participation in the study and before signing the consent form.”
    • If participants are put on an approved drug for an unapproved indication, AEs should be listed in the PICF and the CMI not used.
    • Provide a clear statement about the effect on both male and female reproductive systems inclusive of necessary contraceptive safeguards, the unborn foetus and breastfeeding. If there is no effect arising from the study state this.If in the event a participant becomes pregnant during the course of the study and the intention is to obtain consent to follow the pregnancy and its outcome a statement to this effect must be included.

  7. Ionising radiationexpand
    Investigators must provide the participant with sufficient information about the purpose, methods, radiation dose, associated risks and any discomforts of the research to enable the subject to give informed consent. Policy No.7 Ionising Radiation (PI007).
  8. Possible Benefitsexpand
     When there is no intended clinical benefit to the participant, the participant should be made aware of this.  Statements to this effect should be included in the first page of the Participant Information Sheet.
  9. Alternatives to Participationexpand
    If you do not wish to participate in this research project there may be treatment options available to you and these should be discussed with the Investigator or your treating doctor.
  10. Tissue Samplesexpand
    If it is intended to seek permission for use of optional tissue samples (either residue from obligatory tests or fresh tissue sought) a separate Participant Information Sheet and Consent Form must be included for this secondary purpose. Refer Sample Participant Information Sheet for further details.
  11. Voluntary participation/withdrawalexpand
    It needs to be clearly communicated that participation is voluntary and that consent to participation may be withdrawn at any time. A decision not to participate or to withdraw from the study will not prejudice the participant’s current or future treatment.
  12. Confidentiality/Privacyexpand
    State to what level and to whom a participant’s identity will be disclosed.  If data will be sent overseas this should be stated (refer sample wording in Policy PI025).
  13. Payment/costsexpand
    Clearly state who will be responsible for payment of any treatments arising out of participation in the study, this must include treatment of any adverse event. Define what out of pocket expenses participants may have and who will pay these. If payments are to be made provide a copy of how the payment is arrived at. The anticipated prorated payment, if any, to the participant for participating in the trial. This section must be clearly expressed and sufficiently detailed to ensure there is no financial embarrassment to the participant. Click here to access Policy No. 2 Participant Payment and Reimbursement (PI002).
  14. Illness or Injuryexpand
    It must be made clear to participants what they should do in the event they are injured as a result of their participation in the study. The measures that will be taken should such an event occur are to be clearly communicated to the participants including compensation and who will pay for medical services in such an event.  Where relevant, this should also include what to do in an emergency situation, such as call 000. The following statement is a useful example. ‘If, as a result of being in this study, you become ill or are injured, please immediately contact your study doctor. She or he will then arrange all necessary information and treatment and will inform the trial sponsor.’  
  15. Compensation for Injuryexpand
    Investigators must provide the participant with sufficient information about compensation. The Bellberry standard clause is to be included in the Participant Information Sheet. Click here to access Policy No. 14 Compensation Policy (PI0014).
  16. Termination of the studyexpand
    Include information outlining why the study may be stopped.
  17. Investigators benefitsexpand
    It is strongly recommended that investigators are encouraged to disclose to potential study participants during the informed consent process that the investigator and/or the institution is receiving payment for the conduct of the study. See National Statement on Ethical Conduct in Human Research (2007). Section 2.2.6 (h).
  18. New information arising during the projectexpand
    Include information about what will happen if new information arises during the research project and what this means for the participant.
  19. Results of projectexpand
     State how participants will be informed of the results when the research project is completed 
  20. Researcher contactexpand
    The name and telephone number (including after hours numbers) of the principal researcher and research coordinator are to be included so that they may be contacted if any problems occur and if the participant has any questions.
  21. Complaintsexpand
    Participants must be informed that complaints can be made in a confidential manner to the Bellberry HREC by contacting the Operations Manager, Bellberry Limited, 129 Glen Osmond Road, Eastwood 5063. Telephone 08 8361 3222. bellberry@bellberry.com.au. Click here to access Policy No. 5 Complaints related to the conduct of the research project. (PI005).