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.
Research: Ethics Committee - Research that potentially involves legal risks for participants and researchers guideline
Research: Requirements for a witness to research participant consent guideline
Research: Ethics Committee: Research with participants requiring language services guideline
Consent: Medical research procedures guideline
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.
The PICF template can be downloaded from the Clinical Trials and Research Ethics Application page on the Victorian Department of Health website.
The Alfred Hospital Ethics Committee is also willing to accept PICFs developed from the previous NHMRC templates, available on request by email to research@alfred.org.au.
PICFs should be created for the various scenarios encountered in the research:
- Self (participant)
- Person Responsible/Medical Treatment Decision Maker
- Parent/Guardian
- Carer/Caregiver
- Pregnancy/Pregnant Partner
- Optional sub-study (e.g. biopsy, genetic)
- Retreatment or rechallenge
Contact details for the PICF
If you have any comments or complaints about this project, please contact:
Ethics contact where the Alfred Hospital Ethics Committee is the Reviewing HREC
- Reviewing HREC name: Alfred Hospital Ethics Committee
- Telephone: (03) 9076 3619
- Email: research@alfred.org.au
Include the following details in the site PICF for local site complaints
- Name: Complaints Officer, Office of Ethics and Research Governance, Bayside Health Alfred
- Telephone: (03) 9076 3619
- Email: research@alfred.org.au
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.