Participant recruitment and consent
Participant recruitment
The Alfred Hospital Ethics Committee expects to see and approve:
- All ‘participant facing’ recruitment materials for/describing a specific research project, whether provided directly by the sponsor/researchers or via a study site or an external recruitment agency
- The process for identifying and recruiting participants (typically included in the HREA and Protocol or amendment)
Where it is proposed to use an external recruitment agency, it is the responsibility of sponsors/researchers to undertake a ‘due diligence’ assessment of the agency that they contract with to ensure that the agency’s code of practice protects the confidentiality of information provided by individuals visiting their site, and respects and facilitates individuals’ decision-making autonomy. The Alfred Hospital Ethics Committee does not assess, approve or endorse any specific agency.
Participant consent
The requirements for participants to consent to take part in research is the cornerstone of ethical research practice. Researchers should read all of the relevant policies and guidelines on this subject.
Participant information and consent form (PICF)
As part of the consent process, potential participants are generally given written descriptions of the research and a consent form to sign.
There are a series of templates for different scenarios that researchers should use as required.
Standard PICF templates are available on the Department of Health website. They contain wording that is acceptable to all Victorian accredited HRECs. See Participant Information and Consent Forms in the menu on the Ethics Application page.
PICFs for clinical trials
The documents below are the recommended PICF templates for interventional clinical trial research projects and for genetic clinical trial research.
PICF templates
- PICF interventional for self
- PICF interventional for parent & guardian
- PICF interventional for person responsible/medical treatment decision maker
- PICF participant partner pregnancy
- PICF genetic for self
- PICF genetic for parent & guardian
- PICF genetic for person responsible/medical treatment decision maker
PICFs for non-interventional studies
The documents below are the recommended PICF templates for health and medical research projects and genetic research.
PICF templates
- PICF non-interventional for self
- PICF non-interventional for parent and guardian
- PICF non-interventional for person responsible
- PICF health and social science for self
- PICF health and social science for parent and guardian
- PICF health and social science for person responsible
- PICF genetic for self
- PICF genetic for parent and guardian
- PICF genetic for person responsible/medical treatment decision maker
Preferred wording for specific procedures and situations
The Alfred Hospital Ethics Committee has developed standard wording for various risky procedures. It is recommended researchers use this wording in the relevant PICFs (for healthy volunteers only). Researchers must consider whether the wording is appropriate for the particular study, and be mindful of any new information when writing the risks section of the PICF.
For projects that collect or record information that may lead to legal risks for participants, additional wording is required in the PICF as per the guideline on research involving legal risks.
Checklist to establish and assist the Medical Treatment Decision Maker
When establishing who is the Medical Treatment Decision Maker under the Medical Treatment Planning and Decisions Act, the Alfred Hospital Ethics Committee requires that researchers complete a Checklist - this Checklist is to be stored with all Medical Treatment Decision Maker information, such as information & consent forms. The Checklist also explains what Victorian law requires the MTDM to take into account.