Participant Information and Consent Form
The requirement for participants to consent to take part in research is the cornerstone of ethical research practice. 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.
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.
PICF Templates
A range of PICF templates, instructions and advice are available on external websites:
Master and Site-Specific PICF
These templates should be read alongside the National Statement on Ethical Conduct in Human Research Chapter 2.2 which outlines the general requirements for consent to participate in research, and the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice Section 4.8 Informed Consent of Trial Subjects which outlines the conditions for obtaining and documenting informed consent of clinical trial participants.
Master PICF
The Master PICF is submitted to the HREC for review and approval
Site Specific PICF
The Site Specific PICF is generated from the Master PICF and submitted to research governance for review and approval.
For single-site research approved by a Metro North HREC, the Master PICF is the same as the Site Specific PICF. The Master PICF must be listed as a HREC approved document on the Metro North research governance cover letter.
Research projects that involve only Metro North sites are considered single-site research and will only require a Master PICF, regardless of how many Metro North sites are involved. In some circumstances, a Site Specific PICF may be required for individual Metro North sites if there are differences in the research protocol across the sites.
For multi-site research, the Master PICF is submitted for HREC review and a Site Specific PICF must be submitted for Metro North research governance review. For research approved by an external HREC, the Master PICF must be listed as a HREC approved document on the Metro North research governance cover letter and the Site Specific PICF must be submitted for research governance review.
HREC review – Master PICF
The Master PICF must include a statement of the reviewing HREC, including contact details, informing the participant the research has been ethically reviewed and approved by the relevant HREC.
For research approved by a Metro North HREC, the following contact details must be used:
Site Specific PICF details
The Site Specific PICF must also include the statement of reviewing HREC from the approved Master PICF.
The Site Specific PICF should include the following Metro North research governance contact details:
Master PICF changes
Any changes to the Master PICF must be approved by the reviewing HREC.
Any changes to a Master PICF for research approved by a Metro North HREC must be submitted as a HREC amendment via ERM.
Site Specific PICF changes
Any changes to the Master PICF must also be reflected in the Site Specific PICF. Changes to the Master PICF must be approved by the reviewing HREC before changes to a Site Specific PICF can be submitted.
Any changes to the Site Specific PICF must be submitted to Metro North research governance as a Post Authorisation Notification (PAN) via ERM.
Metro North PICF guidelines
The Metro North HREC and research governance office provide the following guidance for Master and/or Site Specific PICF layout and formatting requirements. These guidelines are not exhaustive and must be read in conjunction with the National Statement and the ICH Guideline for Good Clinical Practice
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.
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.
Document footers
All references to version date or page numbers across the text, footers or document lists for Master and Site Specific PICF’s must be correct and consistent.
Master and Site Specific PICF footer’s to include document identifier, page number, version number and date.
Master PICF example: Study Title – Master PICF Version 1 dated dd mm yyyy Page 1 of 4
Site Specific PICF example: Study Title – Metro North Health Site PICF Version 2 dated dd mm yyyy; based on Master PICF Version 2 dated dd mm yyyy
Study details
At a minimum, the following study details should be included in the PICF main text:
- Chief or Coordinating Principal Investigator (CPI) / Principal Investigator (PI)
- Site location
- Statement of how the study is funded
- Sponsor name
Metro North Health does not require Associate Investigators to be listed on the PICF.
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 Queensland, a witness signature on the PICF is not required for research involving adults who are competent and can consent for themselves. Although, the person who conducted the informed consent discussion (e.g. Researcher, Principal Investigator) should sign and date the form
Waiver of consent
The National Statement on Ethical Conduct in Human Research Chapter 2.3 Qualifying or waiving conditions for consent outlines the principles and guidelines for limited disclosure, opt-out approach to research, and waiver of consent.
Where research involves the use of participant information without their consent, the Human Research Ethics Application (HREA) must include a request to the HREC for a waiver of consent.
Impaired capacity to consent
Where a potential participant has impaired capacity to consent, their legally authorised representative must consent on their behalf.
The NHMRC provide PICF templates for the legally authorised representative to consent on the participants behalf.
For potential participants who are eligible to participate in clinical trials and who cannot consent for themselves, it is also a requirement to seek Queensland Civil and Administrative Tribunal (QCAT) approval.
Ethical approval is required before QCAT approval can be granted. The HREC and protocol must clearly articulate the requirement for QCAT approval.
Evidence of QCAT approval is required at the time of research governance/SSA submission.