Participant Information and Consent

The requirement for participants to consent to take part in research is the cornerstone of ethical research practice. The Participant Information and Consent Form (PICF) provides a written description of the research and allows participants to provide informed consent to participate in research.

Consent Mechanisms

Participant Information and Consent Form

The National Statement on Ethical Conduct in Human Research outlines the general requirements for consent to participate in research. The choice to participate in research must be voluntary and based on sufficient information and adequate understanding of both the proposed research and the implications of participating in it.

• National Statement
• The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice Section 4.8 Informed Consent of Trial Subjects outlines the conditions for obtaining and documenting informed consent of clinical trial participants.

Types of PICF

Master PICF

The Master PICF is submitted to the HREC for review and approval.  

Any changes to the Master PICF must be approved by the reviewing HREC. For research projects approved by a Metro North HREC, changed to the Master PICF must be approved as a HREC Amendment.  

Tips to completing in a Master PICF

The below guidelines provide information on PICF layout and formatting, and specific guidance for content relevant within the Metro North context. These guidelines are not exhaustive and must be read in conjunction with the National Statement and the ICH Guideline for Good Clinical Practice.

Layout and formatting

• Language used should be readily understandable by the participant Grade 8 or 12 years of age reading level or below) and include Australian spelling of words.
• Text should be at least font size 11 in an easily readable font style.
• Institutional logo
  • If institutional letterhead/logo is to be used, leave space for the letterhead/logo in accordance with the institution’s requirements.
  • For Metro North Health studies, the Queensland Government Coat of Arms should be used.
• Footer to include document identifier, page number, version number and date.
  E.g Master PICF Version 1 dated dd mm yyyy Page 1 of 4
• Ensure that all references to version date or pagination in the text are correct and consistent with the information in the footer.

Reviewing HREC

• Include a statement of the reviewing HREC, informing the participant the research has been ethically reviewed and approved by the relevant HREC.

Provide contact details for the reviewing HREC. For Metro North:

Study details

• Chief or Coordinating Principal Investigator (CPI) / Principal Investigator (PI)
• Associate Investigators are not required by Metro North Health
• Site location
• Statement of how the study is funded
• Sponsor name

Third-party locator agency use

Sponsors wishing to use a third-party locator agency must gain the explicit consent of the participant in the PICF. Example consent statement:

I consent to the disclosure of my personal information to the third-party locator agency for the purpose of locating me for follow-up purposes. I understand that I can withdraw my consent at any time.

☐ Yes
☐ No

Witness to the consent process

In research involving adults who are competent and can consent for themselves, in Queensland a witness signature is not required on the PICF. Although, the person who conducted the informed consent discussion (e.g. Researcher, Principal Investigator) should sign and date the form.

Site Specific PICF

The Site Specific PICF is generated from the Master PICF and is required for research governance approval.

• For single-site studies approved by a Metro North HREC, the Master PICF is the same as the Site Specific PICF.
• For multi-site research approved by a Metro North HREC, the Master PICF must be approved by the Metro North HREC and a Site-Specific PICF (for each site) must be submitted for research governance review.

For research approved by an external HREC, a Site Specific PICF must be submitted for research governance approval.

Tips for completing a Site Specific PICF

Site Specific PICF should contain

• the site version and date
• page numbers Page 1 of 12
• the version and date of the Master PICF which it is based on (multi-site only)
  e.g. MNH Site PICF Version 2 dated dd mm yyyy; based on Master PICF Version 1 dated dd mm yyyy

Metro North Health Research Governance Office/Local details

Impaired capacity to consent

For participants who cannot consent for themselves, but are eligible to participate in clinical trials, a separate participant information and consent form is required.  It is also a requirement to seek Queensland Civil and Administrative Tribunal (QCAT) approval for the study before it commences.  Ethics approval is first required, however your protocol would clearly articulate the requirement for QCAT approval.  Evidence of QCTA approval is required at the time of research governance/SSA submission.

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