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 include with your application:
- Participant Information Statements (see below)
- Participant Consent Forms (see below)
- Interview or focus group questions
- questionnaires/surveys or other instruments/tools
- telephone scripts
- letters/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.
guidelines and procedures
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.
Participant Information Statement and Consent form templates are provided to guide you in providing all necessary information. It is recommended you use these templates as a basis for your application, adapted to suit the particular needs of your research.
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 potential consequences for participating may be.
Participants must also be told that there are no disadvantages/penalties/adverse consequences for not participating or for withdrawing from the research.
This is particularly important where the would-be participant is dependent upon the researcher or close colleagues for continued treatment or is a student of the researcher.
Modelling your Participant Information Statement
Participant Information Statements should be written in clear, non-technical lay language.
Statements must be on the Chief Investigator’s University of Sydney letterhead including the Chief Investigator’s name and contact details.
Who requires a Participant Information Statement?
An appropriate Participant Information Statement modelled on the provided templates should be prepared for:
- Each participant involved (and/or his/her guardian)
- The institution the participant is in (where applicable)
- Other involved professional workers (where applicable)
- Each ‘category’ of participant involved – eg., if research is being conducted in a school, it may be appropriate to prepare separate Statements for teachers, students, parents, etc.
- Include the title of the research project on each page. The title should be in words that the participant can understand. This could be the same as the “Short Title” indicated on the application form.
- Include the names and faculty/department of the researchers and appropriate contact telephone numbers. Home phone numbers and addresses should not be provided. Office phone numbers and mobile phone numbers are acceptable. Please use University of Sydney email addresses.
- Include details of the student researcher’s degree if the project is being conducted as part of a degree requirement. For example:
“The study is being conducted by [INSERT name and position] and [if appropriate] will form the basis for the degree of [insert degree undertaken] at the University of Sydney under the supervision of [name of supervisor and position].”
- Explain the aim/purpose of the research in lay terms appropriate for the participant’s necessary understanding.
- Clearly explain what will be involved/expected of each participant. This should include
- a description of the procedures/tasks, their frequency and the information to be obtained;
- an indication of the time commitment for each component of involvement;
- an indication of where each component of research will occur;
- other requirements such as who is eligible/ineligible for participation, abstaining from meals, wearing special clothing/equipment, etc.
- Inform participants if they will be recorded using audio-tapes, video-tapes, or photography.
- Detail any payment or incentive provided to participants. The conditions of receiving remuneration must be clearly stated. For example, do participants have to complete the entire study to receive remuneration? What if they withdraw half way through? Will students receive course credit if they withdraw from the study? In the case of offering course credit for student participants, researchers must always make it clear that although course credit is involved in participating, should students not wish to participate, there will be alternative educational activities available for them to undertake in order to receive necessary course credit.
- Inform participants how confidentiality of data will be maintained. It is not sufficient to state that “confidentiality is guaranteed”. Participants must be informed who will have access to the data, and if others not directly involved in the study (such as a sponsoring company) will be granted access to data. No information that will identify participants should be released without explicit consent of the participants concerned.
- Provide a statement regarding what the research will be used for and the possibility of publication. There should be assurance that publications will not include any information identifying individual participants unless specific consent has been obtained to do so.
- Advise participants if they will be given the opportunity to preview results or interview transcripts before they are used. Interview participants must be advised if they will have the opportunity to withdraw or amend information any time during or after the interview. Focus group participants must be informed that, should they withdraw from the focus group, it will not be possible to destroy information they have provided due to the interdependent nature of focus groups.
- State how the data will be securely stored, how long the data will be retained, and how it will ultimately be destroyed. If materials may be archived, this should be stated and details provided.
- Inform participants of their right to withdraw at any time without having to provide a reason and without incurring consequences. The Statement should indicate that participants will have the option of having any data already collected destroyed should they withdraw. (In the case of focus groups however it will not be possible to destroy information they have provided due to the interdependent nature of focus groups.)
- Where research data is collected completely anonymously (e.g., anonymous questionnaire) participants cannot be guaranteed the right to withdraw at any time because their data, once submitted, cannot be linked to them. Participants cannot withdraw material from a focus group once it has commenced, nor can audiotapes be erased.
- If a participant is in a dependent relationship with the investigator (e.g., a patient, student, dependent) or with an institution directly or indirectly involved in the research, then it is important to emphasise that refusal to participate or withdrawal will not prejudice the participant’s future care, employment, or academic career in any way.
- Include the University of Sydney HREC complaints clause in footnote form: Any person with concerns or complaints about the conduct of a research study can contact The Manager, Human Ethics Administration, University of Sydney on +61 2 8627 8176 (Telephone); +61 2 8627 8177 (Facsimile) or email@example.com (Email).
- When conducting research outside of Australia, where appropriate, a local, readily accessible contact should be available to participants to receive concerns and complaints about the research in accordance with section 4.8.16 of the National Statement. This person/process for dealing with complaints should be independent of the researcher. Responses and questions can still be handled by the researcher. Please list this contact and provide the University of Sydney complaints clause as an alternative.
Please note that in some instances it will not be appropriate to supply the names and contact details of the researchers and the University of Sydney Research Integrity. An example of where this may apply is research that is intended to study or expose illegal activity.
More information about consent:
Translation of documents
If documents need to be translated this may be done after the documents have been approved in English. Once documents have been approved, certified translations in the necessary language/s will need to be provided to the Ethics Office. 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 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. A statutory declaration form can be found at http://www.ag.gov.au/STATDEC
Guidelines and procedures
More information about specific topics is available in the guidelines and procedures.