- Preparing participant information and consent documents - guidelines and examples
- Consenting children
- Working with Aboriginal and Torres Strait Islander Peoples
- Mandatory Reporting
- Research which may disclose participants’ involvement in criminal activity
- Research involving UOW students
- Research involving NSW Health
- Acceptance of external ethics approval
- National and International Guidelines
The style and content of the information provided in the consent process needs to be suitable for the target group in terms of comprehension and literacy levels and cultural norms. Whatever process is chosen, the core information needs to be presented in a way that can be understood by the person being recruited.
The means of recording consent should also be appropriate to the participant group and the nature of the information being collected. Generally, you avoid collecting identifiable information if it is not necessary. This means consent may be:
- Tacit e.g. for anonymous surveys. In this case you would state clearly in the information provided that return of the survey is taken as indicating consent; or
- Verbal, if written consent is not meaningful (e.g. due to literacy) or inappropriate – just make sure you have a record of obtaining this consent (e.g. audio recording or diary note); or
- Written; or
- A combination of the above. A project may have multiple consent processes reflecting different stages of the project and/or different participant groups.
Examples of appropriate Participant Information Sheet and Consent Form documents are available below, along with checklist guides for what to include in these documents, however no ‘template’ exists – they are different for every study. To access any UOW Human Research Ethics templates (e.g. Application Form templates) please see our Forms, guidelines and policies page.
UOW resources for preparing Participant Information Sheets and Consent Forms
- Checklists for Participant Information Sheets and Consent Forms
- Consent Form Guidelines
- Examples of Alternative Methods of Consent
Please note that whilst these documents download in pdf form, you can "Save As" a Word document with Adobe and use as a template.
UOW examples of Participant Information Sheets
- Participant Information Sheet – Email format
- Participant Information Sheet – Letter format
- Participant Information Sheet – Question and answer format
- Participant Information Sheet – Standard format
UOW examples of Consent Forms
Other sources of examples of consent documentation include:
- NSW Health - standardised documents for clinical trials: trials involving genetic testing and collection of human tissue, and for tissue banking or storage of tissue samples.
- NSW Department of Education: the SERAP guidelines include examples of contact letters, participant information sheets and consent forms for research involving schools.
- NHMRC - has released templates for genetic studies, clinical interventional studies, non-interventional medical studies and health/social science research.
- Murdoch Children’s Research Institute – has developed pamphlets for parents to explain the informed consent process. These are to be provided in addition to the participant information sheet.
Chapter 4.2 of the National Statement on Ethical Conduct in Human Research deals with research involving children and young people in detail. The HREC is looking for the ethics application to demonstrate understanding of this, in particular that consent processes ensure that participants who are children understand what is being asked of them, and that they can choose not to participate, to the extent that their stage of development allows. If there are expected to be barriers to comprehension (e.g. due to language) the process must also be designed to address this.
Consent processes usually involve a combination of written and verbal elements, depending on the project.
For very young children best practice is to provide a simple explanation of the activity, and obtain verbal assent. Formal written consent is obtained from the parent/carer.
For upper primary aged children, age appropriate information documents should be provided and the consent process designed to encourage adults (usually the parent/carer) to discuss the research with the child before consent is obtained. Parent/carer and child sign off are commonly included on the same form. For useful guidance, see the handbook on Understanding Consent in Research Involving Children.
Adolescents, particularly where over 14, should complete an autonomous consent process. Parents/carers should be informed of the research and in most cases parent/guardian consent should also be sought. There are some circumstances where a case can be made for relying solely on the consent of the young person (see National Statement 4.2.8 – 4.2.9).
For a detailed discussion of the legal considerations see Laws relating to the giving of consent for persons with impaired capacity to provide informed consent to participate in research in each Australian State and Territory, 2017.
Most research involving Aboriginal and Torres Strait Islander peoples requires obtaining support from appropriate community representatives, and the process for engaging with the community and developing and managing the research project must respect cultural protocols. There are three key guidelines for Indigenous research in Australia.
- Ethical guidelines for research with Aboriginal and Torres Strait Islander Peoples (NHMRC)
- Keeping research on track II (NHMRC)
- AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research
Ethics applications for health and medical research involving NSW Health must be submitted to the Aboriginal Health and Medical Research Council of NSW HREC and the UOW & ISLHD HREC.
For research not involving NSW Health, consideration should always be given to whether there is a local HREC that would have more relevant knowledge of the cultural protocols of the community involved in the research than the UOW & ISLHD HREC. Where this is the case the application should be submitted to that HREC, and the approved documentation submitted to the RSO via IRMA with a request for acceptance of that approval.
Participants can be harmed by breaches of their privacy. Human Research Ethics Committees must consider the potential for this, and whether research proposals comply with national and state legislation regarding the handling of personal information. Any data which allows identification of an individual is 'personal information'.
The underlying principle in all of the legislation is that personal information should not be used for a purpose other than the one for which the data was collected without consent. The exceptions to this relating to research are:
- When information is already in the public domain.
- In some cases identifiers may be removed by the data custodian and the data provided to a researcher. This generally requires approval by an HREC.
- When an HREC has approved a request for a waiver of the privacy legislation. Strict criteria apply to granting a waiver. All four criteria must be met.
Criteria 1: The use or disclosure is reasonably necessary for research, or the compilation or analysis of statistics, in the public interest.
Criteria 2: You have taken reasonable steps to de-identify the information, or the purpose of the research cannot be served by using or disclosing de-identified information and it is impracticable to seek the consent of the person to the use or disclosure.
Criteria 3: If the information could reasonably be expected to identify individuals, the information is not published in a generally available publication.
Criteria 4: The use or disclosure of the health information is in accordance with the statutory guidelines on research.
- Office of the Australian Information Commissioner
- Privacy Act 1988 (Federal)
- Australian Privacy Principles
- Medical Research - Guidelinesunder Section 95 of the Privacy Act 1988: These Guidelines apply to medical research involving personal information obtained by Commonwealth agencies.
- Medical Research - Guidelines approved under Section 95A of the Privacy Act 1988: These guidelines apply to health information that is collected, used or disclosed in the conduct of research and the compilation or analysis of statistics, relevant to public health or public safety, and in the conduct of health service management activities.
NSW State Government Legislation and Guidelines
There are two key pieces of privacy legislation specific to the use of personal information in NSW. Details can be found on the NSW Information and Privacy Commission website. The key legislation is:
- Privacy and Personal Information Protection Act 1998(NSW): The PPIP Act deals with how NSW public sector agencies manage personal information. Personal information refers to any information that relates to an identifiable person. For an overview of who is bound by PPIP and what it involves.
- Health Records and Information Privacy Act 2002(NSW): The HRIP Act governs the collection, storage, use and disclosure of health information in both the public and private sectors in NSW.
- This includes hospitals whether public or private, doctors and other health care organisations. It also includes other organisations that have any type of health information. This can be as varied as a university that undertakes research or a gymnasium that records information about a person's health and injuries.For an overview of who is bound by HRIP and what it involves.
Researchers wishing to access health and medical records should consult the Statutory Guidelines on the use or disclosure of Health Information for Research Purposes
Although researchers in NSW are not considered to be “mandatory reporters” of child abuse and neglect, Section 24 of the Children and Young Persons (Care and Protection) Act 1998 provides for any person to make a report if they suspect on reasonable grounds that a child is at significant risk of harm, such as:
- Information from your own observations of the child’s physical condition or behaviour, something that the child might tell you, or information gained from any other person
- You must be able to recognise and understand the abuse and neglect.
The extent of harm to a child’s safety, welfare and wellbeing that may prompt a report include:
- The child’s basic physical or psychological needs are not being met or are at risk of not being met (neglect)
- The parents/caregivers have not arranged and are unable or unwilling to arrange for necessary medical care for the child
- The child has been or is at risk of being, physically or sexually abused or ill-treated
- The child is living in a household where there have been incidents of domestic violence and, as a consequence, the child is at risk of serious physical or psychological harm
- A parent/caregiver has behaved in such a way towards the child that the child has suffered or is at risk of suffering serious psychological harm.
Any report made under the Act can be made anonymously and the maker of the report is protected from actions such as breach of professional etiquette or ethics, professional conduct or defamation.
If there is a possibility that disclosures about child abuse or neglect could be made in the conduct of your research, you should include a brief statement explaining your reporting obligations on the Participant Information Sheet.
Chapter 4.6 of the National Statement on Ethical Conduct in Human Research addresses research which may potentially reveal illegal activities. It identifies the following research where information gathered could lead to legal consequences:
- Research intended to study, and perhaps to expose, illegal activity
- Research not specifically intended to discover illegal activity, but likely to do so
- Research where illegal activity is discovered inadvertently and unexpectedly.
If, during the conduct of your research, a participant gives you information about a serious indictable offence (a crime punishable by five years or more imprisonment) you are required to report the information to police or the appropriate authority. This is only where the offender has not previously been investigated/prosecuted and/or convicted for the offence.
Researchers may also be required to provide information about illegal activity that is disclosed to them during the conduct of their research if it is ordered by a court (eg. subpoena or search warrant).
If your research has the potential to collect information about illegal activity by participants or others, you should:
- Clearly outline on the Participant Information Sheet and during the consent process any limits on confidentiality that are associated with your reporting obligations under the law
- Consider the use of pseudonyms, or the removal of links between names and data, for participants whose illegal activity may be revealed or discovered in research.
Researchers must be clear to their participants from the start as to the circumstances in which they will breach the confidentiality of the data that the participant provides and what the researcher will do to avoid having to disclose confidential information.
Chapter 2.2 of National Statement on Ethical Conduct in Human Research details the general requirements for consent. The basic principle is that consent should be informed and voluntary. Academics wishing to conduct research on university student groups, whether to evaluate their own teaching or for other purposes, need to ensure that the research is designed so that the students do not perceive any obligation to agree to participate.
Key considerations to be mindful of are:
- There is an inherent power imbalance between university students and academic staff. This is greater when the academic is, or is likely to be, teaching the students in question, either now or in the future. It is always preferable to conduct research on students you do not teach.
- If the research activity will take place in class time, the activity must be directly aligned with the learning objectives of the subject and this should be clearly communicated to all students invited to participate. The decision not to participate must not have any negative impact on student’s learning outcomes from that class.
- Students must receive adequate notice of the activity, to allow time to consider whether or not they wish to be involved.
- Active consent is always required where you are using student generated content e.g. journals, blog posts, assessment results.
- Where the research is using student grades or student evaluations of a class, consideration should be given to how the identity of participants can be concealed from the teaching staff conducting the research. This may include having a third party de-identify the data, not analysing data until after subject results have been released, or both. Consideration should also be given to whether students are likely to encounter the relevant teaching staff in future subjects during their studies.
- Where the research involves classroom observations but not recording information about individual students, opt out consent may be an option. Adequate information must be given to students to give them time to opt out. Consideration must be given to what these students do while the observations are happening, and how they can be excluded from the observations without making it obvious to others that they are being excluded or ostracising them from the rest of the class. Applications seeking opt out consent should explain how the proposed research meets each of the criteria for opt out consent as detailed in paragraph 2.3.6 of the National Statement. For useful guidance see the Scholarship of Teaching and Learning Human Research Ethics Resource Manual.
The NSW Ministry of Health website provides guidance on policies and links to forms to be used for applications involving NSW Health researchers, data or sites.
For NSW Health research the local HREC is not always the right HREC, this will depend on the location of the sites and the population involved in the study.
- If your research is single site, or within a single Local Health District, you would normally use the local HREC.
- If your research involves multiple Local Health Districts, you must use a Lead HREC The UOW & ISLHD Health and Medical HREC is a Lead HREC.
- If your research involves more than one jurisdiction participating in the National Mutual Acceptance Scheme the application can be lodged with a Certified Reviewing HREC. The UOW & ISLHD Health and Medical HREC is a Certified HREC.
- Research involving Aboriginal and Torres Strait Islanders must be reviewed by the NSW Aboriginal Health and Medical Research Council HREC. Find more information here.
- Research using state wide data collections owned or managed by NSW Health must be reviewed by the NSW Population and Health Services HREC.
- All human research projects undertaken with people in the correctional environment in NSW must be reviewed by the Justice Health HREC and the NSW Aboriginal Health & Medical Research Council HREC. See here for more information.
The UOW & ISLHD Health and Medical HREC is both a Lead HREC in the NSW Health system and a Certified Reviewing HREC in the National Mutual Acceptance Scheme.
Current Governance Processes
Applications involving NSW Health sites or researchers must be approved by the administration of the relevant Local Health District, which reviews governance issues (e.g. resource availability) related to the applications. The governance application form is the Site Specific Assessment Form (SSA); it is generated automatically when you fill in a HREA form in REGIS.
Governance approval is additional to the HREC review, which looks at applications for their compliance with relevant ethical and privacy guidelines and laws. For information about ISLHD governance processes please see ISLHD Information for Researchers.
Queries about the ISLHD governance review should be directed to Leigh Lees on 4253 4800.
You are eligible to apply for acceptance of an externally approved research project if you are a UOW staff or student investigator on a research project and:
- The project has been reviewed and approved by an NHMRC registered HREC other than UOW
- Where the research is low or negligible risk, the project has been reviewed and approved by a non-HREC level of review, where the requirements of the National Statement section 5.1.10-5.1.17 have been met (Appendix A)
- The project has been reviewed and approved by an overseas ethics review body, where the requirements of the National Statement section 4.8.1 to 4.8.10 have been met (Appendix B)
What is an acceptance of external ethics approval?
The UOW HREC recognises that a project has received ethics approval from an external review body in accordance with the requirements of the National Statement.
The UOW HREC does not:
- Re-review the project documents
- Approve the project
- Monitor the ongoing conduct of the research
The following documents must be submitted with your application for acceptance of external approval:
- Initial Application documents including information sheets, consent forms, study tools etc
- All correspondence with the reviewing HREC
- Letter of Approval
- Any amendments
- Evidence that all UOW researchers listed on the project have completed required ethics training
The documents must demonstrate:
- The approving body is an accredited ethics review body
- The approving body accepts responsibility for the project at all sites including ongoing project monitoring
- The UOW researchers are listed as investigators
- UOW is listed as a site where appropriate
Note: all future progress reports, amendments etc. must be approved by the external review body. The UOW HREC must only be notified of any adverse event associated with the project, such as data or privacy breaches, physical or psychological harm.
When is acceptance of external approval not appropriate?
- There is no equivalent overseas ethics review body
- A transfer-in of your project should occur where you are the chief investigator relocating the project to UOW and the approving HREC discontinues ongoing monitoring of the project.
- The Australian Code for the Responsible Conduct of Research
- National Statement on Ethical Conduct in Research Involving Humans
- Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders
- Keeping research on track II
- AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research