Useful information, legislation and links
Much of the information on this page is based on the National Statement on Ethical Conduct in Human Research.
For more resources, visit the Forms and resources page.
3.1 Qualitative Methods removed & re-written
3.2 Databanks removed & incorporated into 3.1
3.3 Interventions & Therapies removed
3.4 Human biospecimens remains (see below)
3.4 Human genetics removed & replaced with Genomic Research
New Animal-to-Human xenotransplantation.
Chapter 3.2: Human biospecimens in laboratory based research (formerly Chapter 3.4) was not revised but minor amendments were approved to align it with the new structure in Section 3. Further information on these changes is available on the NHMRC consultations portal.
- Human Ethics Research policy
- Safety in Research and Teaching Policy
- School of Education Research Ethics Exemption Guideline
- HREC Standard Conditions Of Approval
- Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities- Guidelines for researchers and stakeholders
- Keeping research on track II
- Desert Knowledge CRC Aboriginal Knowledge and Intellectual Property Protocol
- Intellectual Property and Protocol - Community Guide
- Western Australian Aboriginal Health And Ethics Committee (WAAHEC)
The National Statement informs these notes to offer Murdoch researchers guidance.
The benefits of research are usually easy to outline. Even if there are few benefits to the participants, there will be wider benefits.
Risks are often not simple to identify. Think carefully about risks. Some risks are fairly common e.g. asking probing questions can upset people; showing confronting images can create strong emotional reactions; taking blood samples risks needle stick injuries. Other risks are far less common and more difficult to identify. HREC frequently comments to researchers that risks need to be considered in more detail.
Researchers commonly underestimate the risks of a project. Remember that participants are not usually familiar with the specific areas of research and may experience risks in diverse ways:
- Think about what could occur and how a participant might feel
- Use the ‘news media’ test. What could possibly go wrong, and what would happen if the research received media attention because something went wrong?
- Apply the ‘reasonable person’ test. What might a reasonable person expect and what response would be appropriate?
The HREC can approve research, even risky research, if the risks are justified, if strategies are in place to protect participants, and if plans are in place to mitigate risks.
HREC is required to review the proposed research method carefully (NS 3.1-3.6) before approving an application. A good application:
- provides sufficient information to describe clearly what the project involves
- outlines the project's objectives and methods in an understandable way
- ensures that the method/approach is sufficient to meet the aims and objectives of the research
- considers the people from or about whom data is being collected as participants in the research process, who have right to be protected and informed
- justifies the sample size. How was the estimation arrived at? Is sample size too few, too many?
- presents sufficient detail on the approach to data analysis, and
- ensures that the benefits and risks of the project have been carefully considered
Where the methodology has already been through a formal peer review (e.g. ARC or NHMRC), HREC will generally not re-review the methodology.
The primary reason for the ethics application process is to ensure the impacts on participants have been carefully thought about and risks planned for. The core objective of the National Statement on Ethical Conduct in Human Research is the protection of participants. Research must have merit and integrity, be methodologically sound, be just, have beneficence, and above all demonstrate respect of people.
People who choose to enrol in a research project are voluntary active participants. Participants do not need to understand every detail of the project, but must be fully informed about what is being asked of them and any risks they are being asked to take - a useful guide is NS 2.2. Imagine the questions a participant might ask about the research:
- What is the research about?
- Why are you doing this?
- How will people benefit from the research?
- What are you intending to do to me?
- What effect/impact could this research have on me?
- Could it hurt me or embarrass me in any way?
- Will you use or retain my name / identity?
- Will my details remain anonymous and confidential?
- Will I gain anything or benefit personally in any way?
- Who is responsible if I get hurt / harmed? What will you do if something occurs?
While it may seem a remote possibility that anything could go awry, planning for predictable risks helps to make the less predictable manageable.
Participants come from all walks of life. The design and conduct of research, especially when people may be vulnerable is outlined in the National Statement on Ethical Conduct in Human Research, specifically:
- Women who are pregnant and the human foetus (4.1)
- Children and young people (4.2)
- People in dependent or unequal relationships (4.3)
- People highly dependent on medical are who may be unable to give consent (4.4)
- People with a cognitive impairment, an intellectual disability, or a mental illness (4.5)
- People who may be involved in illegal activities (4.6)
- Aboriginal and Torres Strait Islander peoples (4.7)
- People in other countries (4.8)
Consider whether people will be recruited because of their membership in any of these categories, or whether the recruitment strategy makes it highly likely that people from these categories will be recruited.
Some additional considerations:
- For vulnerable participants consider establishing informed consent with both the participant (where possible) and witnessed by an appropriate person (e.g. parent, carer, guardian).
- Some people can experience personal issues, the impact of which may change significantly over a relatively short time. Ensure that consent is re-confirmed with such participants - e.g. through an oral affirmation of consent at appropriate points.
- Some participants are in dependent or unequal relationships (e.g. students, clients or patients of the researcher). Take additional care to fully inform them of their rights to choose not to participate or to withdraw from the project.
- Non-participation or withdrawal must not affect the treatment/care/service a person ordinarily receives.
- People must not be pressured to participate, including subtle and coercive pressure (e.g. offering a significant ‘prize’ or overstating the potential benefits of the research).
- Participants have a right to confidentiality and privacy.
- Consider, where possible, collecting data anonymously.
- What people consider sensitive, personal or private can vary enormously between individuals and cultures. Participants will generally view questions about their personal circumstances, family status, age, income, cultural origin, religious beliefs etc. as sensitive or personal even if the data will only be used for demographic purposes. A simple strategy (e.g. for surveys or interviews) is a reminder that participants do not need to respond to questions they feel uncomfortable about.
- Provide sufficient information on how possible harm, embarrassment or discomfort to participants will be handled. Potential harms must be justified by the benefits anticipated from the research.
- Simple observation of people is not always harmless as sometimes assumed. Do participants know they are being observed? People being observed in a public place may feel they are being followed or stalked. Observation can raise diverse reactions which need to be planned for.
For research involving school children, see Permissions from other institutions section.
- Active consent is considered the norm i.e. where a parent/guardian signs and returns a Consent Form. Passive consent (e.g. where a note is sent home stating that consent will be assumed if there is no contrary notice from a parent/guardian) is not usually permitted.
- Consent should be obtained from a parent/guardian.
- Children/adolescents should also consent for themselves. They have the choice to decline to participate even if their parent/guardian has provided consent.
- Information Letters and Consent Forms need to be written in age appropriate language.
- Where a whole class or group is invited to participate, alternative supervision and activities for non-participating students need to be arranged.
- Where and how will participants be recruited?
- Will there be advertising (e.g. media, posters, email or web)? If yes, provide a copy. The advertisement should clearly state the purpose and procedures of the study, and must not pressure people to participate.
- Is there access to individuals' names/addresses? How will these be obtained? Is any authorization or permission required, or are details publicly available?
- Will recruitment be through a third party (e.g. will a company or organisation forward the invitation on your behalf)? To contact people through an organisation or work place, written approval from the organisation / employer is required (provide a copy).
- How will people who wish to participate contact the researcher?
- How will confidentiality be ensured?
Prizes and reimbursements
Door-knocking
- sample size calculations
- optimum sizes for focus groups
- accepted norms of a field
- recruitment of an entire cohort
- what is achievable in the time allocated
- the number of interviews likely to lead to saturation
Consider these issues in the ethics application:
- Detail where, when, and how the questionnaire or interview will be administered.
- Provide a copy of the questionnaire, survey or interview questions (even if only in draft form).
- Is the researcher qualified to use the questionnaire/instrument? This applies especially to areas such as psychological testing or to sensitive interviews / questionnaires.
- Detail what action will be taken if a participant becomes distressed or upset, (e.g. referral to a qualified counsellor).
- If data may reveal a participant's illegal behaviour, ensure that participants are fully informed and forewarned of the limits to confidentially concerning the data they provide.
- It is usual to provide participants with a copy of interview transcripts or excerpts (e.g. the quotes you wish to use) for them to check.
- For standard or widely used questionnaires or tests, provide evidence that this is a standard measure and is accepted in established practice.
- Ask only for information essential to the research, particularly in relation to personal or private information, including demographic information.
- For demographic details (e.g. age or income), consider utilising publicly available standards (e.g. from the Australian Bureau of Statistics or the Australian Taxation Office) to simplify potential comparisons with other research.
- Sometimes participants are inadvertently identifiable e.g. an anonymous survey in a small university which reports a participant as ‘female, mid 40s, professor’ may be sufficient to identify or nearly identify the specific individual. This needs to be carefully considered in the design of a questionnaire.
- In some instances a police / security clearance will be required.
- Unless a participant's name / details are required, consider collecting data anonymously or assigning a code to participants.
- If an anonymous questionnaire needs to ask for name and contact details e.g. for a possible follow-up interview, consider a format which detaches data from identity.
- Ensure that codes for re-identification are stored securely, separate from participant data.
- To interview people with whom there is a prior relationship (e.g. fellow employees, members of your extended family, friends, students, clients or patients) focus on dependent or unequal relationships in the ethics application.
- Surveys conducted through organisations and work places require careful consideration of privacy, confidentiality and anonymity.
Privacy, confidentiality and anonymity are complex issues. Legal requirements (e.g. privacy legislation) in various jurisdictions need to be adhered to. Consider:
- Anonymity is usually where the researcher is unable to identify participants in any way (i.e. data have no identifying information).
- Where a participant can be identified (directly or indirectly) the data are not anonymous, but may be de-identified or coded and are confidential.
- How will participant confidentiality be maintained and how will this be reflected in the handling and storage of data?
- Ensure that participant anonymity will be maintained if it is promised.
- While participants may be identifiable or re-identifiable to the researcher, confidentially assures individuals that their name and personal details will NOT be published except by prior (written) agreement.
- Use codes or aliases where appropriate.
- Store personal details securely and appropriately. No personal or identifying material should be published or given to a third party unless required by law.
- Naming or identifying participants in a publication requires their deliberate consent.
- Some participants will be identifiable due to their role or circumstances (e.g. CEO of a company, spokesperson for a group, captain of a ship, a tribal leader). Ensure either that consent is obtained or that the information is presented such that these participants are not identifiable.
- Professional requirements (e.g. where a researcher is also a lawyer, psychologist, clergy, journalist or medical practitioner) place their own limitations on research. Address this in the ethics application.
- To utilise data previously collected by another researcher, ensure there is appropriate authorisation and / or evidence of participant consent (see Approvals for databanks). Obtain only de-identified data where possible.
- Surveying people through their workplace or through an organisation or association requires steps to ensure confidentiality from employers or managers. Ensure the organisation is given at most aggregate data only.
The National Statement on Ethical Conduct in Human Research (1.5) requires feedback to participants on research results. Feedback gives participants insight into the results and their value or contribution to knowledge. Some institutions will use feedback e.g. for policy formation or other developments.
Feedback should be in a language and format appropriate to the participants. Do not assume that participants will read a thesis or academic journal papers. Feedback usually completes the interactions between the researcher and participants.
In some instances feedback is an ongoing process.
Feedback needs to take into account any confidentially or anonymity agreements made with participants.
Common feedback mechanisms include:
- a generic or ‘executive’ summary of the project (usually 2-4 pages) sent to participants or published on a pre-arranged website (specify the URL in the Information Letter).
- a transcript of the interview with opportunity to correct or add statements, or approve quotes intended to be used.
- a copy of personal test results, and insight into how to understand them and what to do with them.
- a detailed report or analysis including breakdowns according to relevant categories with advice or recommendations on implementation.
- oral feedback e.g. if participants have low literacy or in some cultures/countries.
The Western Australian University Sector Disposal Authority provides a useful guide on the retention of research data and materials.
Each ethics application should make a case for the data retention standards pertaining to the specific project, including what data will be stored, in what format/s, and for what duration.
| Research data, analysis and results relating to short-term research projects undertaken by students for assessment purposes. | Retain a minimum of 12 months after the completion of the project, then destroy. |
| Research data, analysis and results with outcomes that are classed as major. | Retain a minimum of 5 years after date of publication, or 5 years after completion of the project, whichever is later, then transfer to Archives. |
| Research data, analysis and results where the projects involve children (-18 years) who may be reidentifiable. | Retain a minimum of 7 years after publication or project completion, or the subject/s have reached 25 years of age, whichever is later, then destroy. |
| Minor research data, analysis and results involving clinical trials. | Retain minimum of 25 years after date of publication, or 25 years after conclusion of the project, whichever is later, then destroy. |
| Research data, analysis and results involving humans or animals that utilise high risk material such as teratogens and carcinogens, ionising radiation or dangerous drugs. | Retain minimum of 50 years after date of publication, or 50 years after conclusion of the project, whichever is later, then destroy. |
- How will data be stored during the research? Will it be sufficiently secure? Is there a back-up, and how and where will this be stored? How will any sensitive data be handled?
- How will data be stored following the completion of the research? Where will it be stored? For what length of time (Murdoch University policy specifies 5 years minimum). In what format will it be stored?
- It is common to erase interview tapes after transcription and to retain only a transcript. Where will transcripts be stored? In what format?
- Sometimes tapes have ongoing research significance and should be retained (e.g. interviews of famous people, recordings of dying languages, commentary of historical significance). Specify whether or not tapes will be erased. If not, specify where and how they will be stored and for what length of time.
- Obtain written permission for access from the owner / controller of the database (provide a copy with the ethics application).
- Obtain specific permission to access personal or identifiable information. This usually requires either participant consent or evidence that this use of the data is consistent with consent already given.
- Usually a data custodian is responsible for undertaking any 'data cleaning' required and providing data to the researcher. The custodian may be the Chief Investigator of the research project, the agency who collected the information, or an intermediary who collected the data from multiple sources (NS, p. 28).
- Consider obtaining only de-identified data - where all identifying details have been removed before being given to the researcher.
Research collaboration across institutions (multi-centre research) includes:
- research conducted at more than one institution by the same research team
- research conducted jointly by researchers affiliated with different institutions
- research approved at one institution and transferred to another
- research where more than one institution has responsibility for ethics review
Researchers must ensure that all necessary approvals are obtained, all conditions are met and required documentation submitted to each institution.
Minimising duplication of ethics review
If ethics approval has been given by the HREC of another institution, review by Murdoch University's HREC can usually be expedited:
- Submit a Reciprocal Application through IRMA.
- Nominate, as chief investigator, the responsible Murdoch University researcher.
- Attach a copy of the application as approved by the other institution, their letter of approval, and details of any conditions.
If an application is being submitted simultaneously to two or more HRECs, obtain advice from Research Ethics and Integrity.
Once approval has been granted the nominated Murdoch University researcher is responsible for ensuring that all Murdoch University requirements are completed, and that any adverse events (regardless where they occur) are promptly reported, in writing, to the Murdoch University HREC.
WAAHEC
Health-related research projects involving Aboriginal people or communities in Western Australia need to be submitted to the (WAAHEC) even if approval has been or will be obtained from other institutions.
Submit projects to WAAHEC for approval if one or more of the following apply:
- Aboriginality is a key determinant
- Data collection is explicitly directed at Aboriginal peoples
- Aboriginal peoples, as a group, will be examined in the results
- The information has an impact on one or more Aboriginal communities
- Aboriginal health funds are a source of funding
Further information is available from WAAHEC or contact Research Ethics and Integrity.
Permission is normally required to recruit participants from other institutions e.g. government departments, educational institutions, businesses, clubs, associations etc. Obtain written permission from the appropriate person and attach to the ethics application, or provide as soon as possible following ethics submission.
Research in government schools
Researchers must be familiar with the requirements of the WA Department of Education Department of Education Policy library, in addition to the National Statement on Ethical Conduct in Human Research.
Department applications are normally submitted after ethics approval is obtained. The Department can process applications in parallel with Murdoch University's ethics application.
Site managers (e.g. principals) may be consulted for advice on the design and implementation of research. However, no commitment regarding participation may be made until formal Department approval is obtained.
The Department ordinarily responds to applications within 2 weeks.
Department approval only becomes final when Murdoch University ethics approval has been obtained. Likewise, Murdoch University's ethics approval becomes final when a copy of the Department approval is provided.
For education in other states, contact the relevant state education department.
Research in non-government schools
- For research at a WA Catholic schools, contact Catholic Education (CEWA)
- For research at any other church or independent school, the local policy must be followed.
Security clearances protect both researchers and participants. Applications, made through a Post Office, include:
- a National Police Certificate if working with participants in private locations, e.g. at private homes.
- a Working With Children check if participants are minors (under 18) unless they are university students.
Other security clearances, e.g. international clearances, may be acceptable or required in certain situations.