Completing relevant documents
Providing all the relevant supporting documentation is important part of your application. The more information you provide, the easier it is for the HREC to assess your application.
Documents you may need to upload in the "Documents" tab:
- Participant Information Statements (see below)
- Participant Consent Forms (see below)
- Interview or focus group questions
- questionnaires, surveys or other instruments and tools
- telephone scripts
- letters and emails seeking participants
- letters of approval from organisations assisting in the research in any way
- a safety protocol for the researcher if he/she is travelling overseas or conducting research off-campus. Please note that the safety protocol must be signed by both the researcher and the Chief Investigator.
See our guidelines and procedures for more information.
Please include version numbers and dates in the footer of all documents associated with your Ethics application forms (Participant Information Statement, Participant Consent Form, letters/emails of invitation, surveys, interview questions, questionnaires etc). Version numbers and dates help the Human Research Ethics Committees and Research Integrity to identify original and updated documents and to note approved versions.
When uploading documents into IRMA you will need to name your documents and select the type of document from a drop down list. Please note, the name you provide and the type you select will be included in your ethics approval letter.
Participant information and consent
The process of providing information to and obtaining informed consent from prospective research participants is a crucial factor in assessing the ethical acceptability of a research proposal.
The HREC must be satisfied that you have provided participants with information that would enable an average lay person to make a voluntary decision to participate, as per chapter 2.2 of the National Statement.
Written consent is the most common form of consent used by researchers. In a written consent process, participants are given a Participant Information Statement (PIS) to read. A Participant Consent Form (PCF) should then be given to participants to sign once they have read the PIS and any questions they had about the research have been answered satisfactorily.
However, consent may also be obtained in other forms, including orally or by some other means (e.g. return of a survey).
As per section 2.2.5 of the National Statement, decisions about the form of the consent process (written, oral or other) should be based on a careful consideration of:
a) The nature, complexity and level of risk of the research; and
b) The participants’ personal and cultural circumstances.
Where consent is to be obtained orally, a written consent script should be read to participants and their consent recorded systematically (e.g. in field notes or using a tape recorder). Where consent is to be obtained by return of a survey, no consent form is necessary – only an information statement.
See Exceptions to written consent for further information on this issue.
The HREC carefully assesses whether or not those who are asked to participate are properly informed regarding what they are being asked to do and what the potential consequences of participating may be.
The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it (NS 2.2.1). Participants should understand the purpose, methods, demands, risks and potential benefits of the research (NS 2.2.2). This information must be presented in ways suitable to each participant (NS 2.2.3). The process of communicating information to participants and seeking their consent should not be merely a matter of satisfying a formal requirement (NS 2.2.4). The aim is mutual understanding between researchers and participants. In some research, consent may need to be renegotiated or confirmed from time to time, especially where projects are complex or long-running, or participants are vulnerable (NS 2.2.8).
Modelling your Participant Information Statement and Consent Form
Participant Information Statements and Consent Forms should be written in clear, non-technical lay language and presented on the Chief Investigator’s University of Sydney letterhead including their name and contact details. Please note that students cannot be Chief Investigators, hence for student projects it is the supervisor who is the Chief Investigator.
The human ethics team has developed Participant Information Statement and Consent form templates to guide you in providing all the necessary information. There are a range of templates for different types of research (e.g. oral history, ethnography) and participant groups (e.g. parents and carers) so you can choose the one that suits you best. Once you have selected a template, you’ll need to adapt it to suit your study and participants. All of the templates contain an introductory page describing the purpose of the template and how to use it, as well as instructions and prompts throughout the template. These are designed to guide you through the process. When you’ve finished creating your forms, please make sure you remove these instructions and prompts from your final documents. If you are not sure about which template suits your project or how to use the templates, contact the .
Who requires a Participant Information Statement and Consent Form?
An appropriate Participant Information Statement and Consent Form modelled on the provided templates should be prepared for:
- Each participant involved
- Participants’ carer/parent/person responsible (guardian), where applicable
- Each ‘category’ of participant involved in the project – e.g., if research is being conducted in a school, it may be appropriate to prepare separate statements for teachers, students, parents, etc.
Where consent will be obtained orally, you should use the Participant Information Statement and Consent Form templates to create an oral consent script and include this in your ethics application.
More information about consent:
Translation of documents
If documents need to be translated this may be done after the HREC has approved final versions of the documents in English. Once the documents have been approved by the HREC, certified translations in the necessary language/s will need to be provided to the Ethics Office via IRMA. The translations must be certified by a person who is not associated with the research project (either an applicant or other persons identified in the application) and who has no conflict of interest. They need to indicate that the translated documents are a true and accurate representation of the English language versions submitted to the HREC. A statutory declaration to this effect would be appropriate if they are not an official translator or a staff member with the relevant expertise. A statutory declaration form can be found at the Attorney-General Department
Guidelines and procedures
More information about specific topics is available in the guidelines and procedures.