The Barwon Health Consent Manual provides education and resources about consent in research. Click here for quick links to key templates, contact details and instructions for how to complete consent requirements in your research project application.
How and when to seek consent for participation in research
One of the most important ethical rules governing research with humans is that participants must give their informed consent before taking part in a study, or an ethics committee must approve a request to waive the requirement for consent. The requirement to seek consent is both a legal duty to provide information about research risks and a moral duty to respect people by ensuring that they are making free and informed decisions.
A form of participant consent is required for all research, except for research involving the use of;
- existing data collected for clinical purposes, AND
- when the data is being analysed and stored in a de-identified format, AND
- when the data being collected is being used for research related to the clinical purpose, AND
- by researchers who have access to the data as part of routine clinical care.
What is informed consent?
The National Statement on Ethical Conduct in Human Research states that:
Respect for human beings involves giving due scope to people’s capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by participants – commonly known as ‘the requirement for consent’.
This requirement has the following conditions:
- consent should be a voluntary choice, and
- should be based on sufficient information and
- adequate understanding of both the proposed research and the implications of participation in it.
The key elements of consent are therefore voluntariness, information and understanding, each of which will be described below:
The National Statement advises that
No person should be subject to coercion or pressure in deciding whether to participate. Even where there is no overt coercion or pressure, consent might reflect deference to the researcher’s perceived position of power, or to someone else’s wishes. Here as always, a person should be included as a participant only if his or her consent is voluntary.
Adequate time should be allowed for prospective participants to understand and consider what is proposed and for their questions and expression of concerns to be addressed by those obtaining their consent. Situations involving relationships between researchers and participants, e.g., lecturers or teachers recruiting students, students recruiting family or friends, or recruitment through employers require care to ensure that the effect of unequal relationships on the decision to participate, including any perception of coercion, need to be addressed and minimised.
Among the factors that could undermine voluntariness are concerns that payments to research participants may act as inducements. As a general principal, research guidelines advise that researchers should avoid offering financial inducements large enough to encourage participation to act against better judgment, or that might lead participants to ignore or undervalue risks or burdens. However, the reimbursement of expenses incurred by participants, such as for travel and for time and inconvenience, are appropriate. The NHMRC guidance on payment of participants in research can be found here.
Some research protocols involve dozens of pages of information about interventions, side effects, results of pilot studies or details about methodology. It can be difficult to summarise information about research in a way that is easy to understand for people that are not involved in health, social sciences or research. As a rule of thumb, researchers should provide sufficient information to enable participants to understand the purpose, methods, risks, side effects (even if rare), and all information that would be expected to materially influence a person’s decision. It is likely that individuals will have different views about what risks or burdens they consider acceptable and when research involvement constitutes a benefit. It is therefore important to to consider individuals’ needs and interests and to provide information relevant or important to each individual, by discussing the research with potential participants (in addition to providing written, or other forms of information) wherever possible.
The National Statement provides the following guidance on information that should be provided to potential research participants
Information on the following matters should also be communicated to participants. Except where the information in specific sub-paragraphs below is also deemed necessary for a person’s voluntary decision to participate, it should be kept distinct from the information described in paragraphs 2.2.1 and 2.2.2:
(a) any alternatives to participation;
(b) how the research will be monitored;
(c) provision of services to participants adversely affected by the research;
(d) contact details of a person to receive complaints;
(e) contact details of the researchers;
(f) how privacy and confidentiality will be protected;
(g) the participant’s right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data;
(h) the amounts and sources of funding for the research;
(i) financial or other relevant declarations of interests of researchers, sponsors or institutions;
(j) any payments to participants;
(k) the likelihood and form of dissemination of the research results, including publication;
(l) any expected benefits to the wider community;
(m) any other relevant information, including research-specific information required under other chapters of this National Statement.
The National Statement (5.2.6) advises that
Researchers should present information about the research to participants in ways that help them make informed choices about their participation and support them in those decisions and in their participation. Researchers should consider:
(a) whether the information about the research is best communicated to participants through speech, writing, visually or in some other way, or a combination of these; (b) the need for accurate and reliable translation (written and/or oral) of the information into a participant’s first language or dialect;
(c) the participant’s cultural background and its potential effects on the communication process;
(d) the participant’s educational background and level of literacy, numeracy and understanding of scientific and academic concepts, if known;
(e) the participant’s age and level of maturity; and
(f) any visual, hearing or communication impairment with which the participant is living.
Researchers are advised to provide information in Plain Language avoiding the use of scientific jargon or medical terms that might undermine potential participants’ ability to understand the proposed research.
At times the capacity to give consent can be compromised, due to internal or external factors such as ill health, pain or substance use. Some people lack the capacity to consent due to cognitive impairment, mental illness or intellectual disability or if highly dependent on medical care. In these instances, a person or appropriate statutory body can be called on to exercise the lawful authority to decide whether a person who lacks the capacity to consent should participate in research or whether this would be contrary to the person’s best interests. The Guardianship & Administration Act 1986 prescribes a process of obtaining consent for medical research procedures to be conducted with people who are unable to provide consent for themselves, see below.
The National Statement on Ethical Conduct in Human Research, chapter 2.2 General requirements for consent, provides guidelines on the requirement for consent and provides guidelines on conditions under which the requirement may be qualified or waived.
Methods to Seek Consent
There are a number of different types of consent (active, passive, opt-in, opt-out, waived) and ways in which consent can be sought from potential research participants (written, verbal, implied). Many factors must be considered by researchers to ensure the most appropriate approach is used for their research project. This page provides some introductory guidelines on the various considerations in seeking consent. Researchers are reminded that consent is a process and that there may be instances where the information provided to participants in seeking their consent needs to be updated, or revised or when consent should be renegotiated.
An opt-out approach, also referred to as passive consent, is a method used in the recruitment of participants into research where information is provided to the potential participant and where their participation is presumed unless they take action to decline to participate.
An opt-out approach may be appropriate for research projects where it is not feasible to get express consent from each person and a whole population data set is required, for example when establishing a registry. Researchers must provide participants with written information about the study using a reliable method with an option for opting out. In this case “no response” is taken to imply consent
While an opt-out approach makes it possible for people to make an informed choice about their participation, this choice can only be made if participants receive and read the information provided, and there are clear and easy processes that allow them to decline to participate.
Researchers must provide justification for the use of opt-out consent and why it is necessary to achieve the study outcomes.
Section 2.3.5 of the National Statement provides guidance for the use of the opt-out approach.
In general, the HREC discourages ‘cold contact’ phone consent. However, the HREC may approve phone consent on a case-by-case basis. The application for phone consent should provide a phone script – including how the person is greeted and informed about the reason for the phone call, and how participation will be invited and consent sought and recorded.
For this type of research, researchers must provide participants with written information regarding the study and how the participant’s information and responses will be used. The return of a completed survey by a participant can be considered to imply consent. However, best practice for obtaining consent from participants for questionnaire and survey project activities is for the researcher to request that the participants acknowledge they have read and understood the information provided to them. This can be achieved using a tick box on the front page of a questionnaire or survey. If verbal consent is given by participants, it must be documented by the researcher (written or audio documentation).
Participant details should not be collected for anonymous survey (online or hard copy). Participants should be informed that the completion and return of an anonymous survey will be taken to imply consent to participate. REGI recommends the use of a short plain language statement for anonymous surveys see here Plain Language Statement (PLS) Template for Surveys
Do I need consent or a waiver of consent to access existing data or biosamples for research?
Currently, the collection of patient data and samples for research purposes can be provided under certain conditions. In general:
- patients must give informed consent for the prospective collection, storage and use of identifiable data for research purposes
- patients must give informed consent for the prospective collection, storage and use of bio samples for research purposes
The collection and use of data and biosamples for research purposes must comply with several international national and state laws and guidelines including legislation relevant to human research involving information privacy (Information Privacy Act 2000), health information (Health Records Act 2001 removal of human tissues (Human Tissue Act 1982 etc. and guidelines produced by the National Health and Medical Research Council (NHMRC).
Access to existing data
The National Statement identifies three mutually exclusive forms of data identifiability, as follows [NS 3.2]:
- Individually identifiable data where the identity of a specific individual can reasonably be ascertained
- Re-identifiable data, from which identifiers have been removed and replaced by a code
- Non-identifiable data, non-identifiable data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed
Current laws and guidelines permit access to data without consent in some instances:
- In Victoria, the Health Records Act 2001 and the Information Privacy Act 2000 provide that an organisation’s quality assurance or clinical audit activities may constitute secondary activities that are directly related to the purpose for which consent was given, and therefore that consent may not be required for these types of activities.
More specifically, the access or use of data (both de-identified and identified) for the purpose of research does not require consent or a waiver when:
- The data to be accessed or used has already been collected as a routine part of practice; or
- The data will be collected as a matter of routine business (e.g. clinical care, training, planning, or management of the health service); or
- The data that will be used for the purpose of research, audit or quality improvement or other research activities are directly related to the primary purpose for which the data was/will be collected
However, a waiver is required when:
- Access to data is sought by a person that would not normally have access to the data as part of their employment with Barwon Health for that purpose; or
- The purpose of use and access to the data is not related to the original purpose of collection.
If you are unsure whether consent or a waiver is required for your research, please complete the Waiver of Consent Checklist.
Access to Biosamples
If the research involves only the use of stored biospecimens and involves no more than low risk, then then the project may be exempt from the requirement for full HREC review. Research that carries only negligible risk may be exempted from ethical review.
Where human biospecimens were obtained for clinical purposes and have been retained by an accredited clinical pathology service, the biospecimens may be used for research purposes if:
(a) the identity of the donor is not necessary for the activity; or
(b) where the identity of the donor is required for the purposes of the research, a waiver of consent has been obtained.
If you are unsure whether consent or a waiver is required for your research, please complete the Waiver of Consent Checklist.
Researchers are reminded that consent is a process and that there may be instances where the information provided to participants in seeking their consent needs to be updated or revised or when consent should be renegotiated.
The National Statement also provides guidance on seeking consent for future use of data or tissue for research. Extended consent involves participants providing consent for the future use of their data/ samples and includes participants providing consent to being contacted again in the future. The terms and ramifications of extended consent must be clearly explained to potential participants and its terms clearly recorded.
Researchers should consider and make clear to participants their intentions for possible future uses of research data and tissue as follows.
Specific, Unspecified and Extended Consent
Researchers are encouraged to think of the obtaining informed consent as an ongoing process: Consent forms should be revised when new information about reasonably foreseeable risks, potential benefits, or other information becomes available. Amendments to consent documents must be reviewed and approved by an HREC.
Consent may be:
(a) ‘specific’: limited to the specific project under consideration;
(b) ‘extended’: given for the use of data or tissue in future research projects that are:
(i) an extension of, or closely related to, the original project; or
(ii) in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research);
(c) ‘unspecified’: given for the use of data or tissue in any future research. The necessarily limited information and understanding about research for which extended or unspecified consent is given can still be sufficient and adequate for the purpose of consent
2.2.15 Extended or unspecified consent may sometimes need to include permission to enter the original data or tissue into a databank or tissuebank
2.2.16 When unspecified consent is sought, its terms and wide-ranging implications should be clearly explained to potential participants. When such consent is given, its terms should be clearly recorded.
2.2.17 Subsequent reliance, in a research proposal, on existing unspecified consent should describe the terms of that unspecified consent.
2.2.18 Data or tissue additional to those covered by the original extended or unspecified consent will sometimes be needed for research. Consent for access to such
additional data or tissue must be sought from potential participants unless the need for this consent is waived by an ethical review body.
An Interventional Study is one involving the administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial. In general, written informed consent is required for all research that is greater than low risk and is mandatory for research involving invasive procedures and clinical interventions. Examples include research involving drugs, surgery, research involving questions about sensitive matters, sample collections, genetic testing. A plain language information statement (PLS), also known as a Participant Information and Consent Form (PICF) or an Explanatory Statement, should be provided to inform potential participants about all aspects of the research. Verbal consent is not acceptable for invasive procedures and drug trials.
Data linkage process involves the use of personal information and although de-identified to varying degrees, should be considered as re-identifiable, and accordingly this needs to be considered as part of the HREC approval.
Where research involves linkage of data sets with the consent of participants, researchers should advise participants that use of data or information that could be used to identify them may be required to ensure that the linkage is accurate. They should also be given information about the security measures that will be adopted, for example the removal of identifiers once linkage is completed
Projects where clear, informed consent has not been given by the individuals who are the subject of the data, are to be specifically considered by the HREC, and provide an endorsed ‘waiver of consent’ when applicable.
Participant Information and Consent Form (PICF) Templates
Researchers are strongly encouraged to use existing templates for participant information and consent available on the Department of Health’s website. The templates have helpful hints and questions to assist researchers in writing a plain language statement (PLS) and prompt researchers to think about type of consent, future use of data etc.
PICF non-interventional for self
Adult providing own consent. A Non-Interventional research project involves clinical research where no interventional treatment is given to participants other than their routine care. It does not involve the administration of an investigational product, treatment or procedure. Examples include observational research and monitoring of participants
PICF non-interventional for parent and guardian
A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level. See Research involving children.
PICF non-interventional for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible/medical treatment decision-makers when the potential participant does not have decision-making capacity or not competent to provide consent for themselves.
A Participant Information sheet should be aimed at persons responsible/medical treatment decision-makers when the potential participant does not have decision-making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians.
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
PICF genetic for parent & guardian
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
PICF genetic for person responsible/medical treatment decision maker
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
PICF health and social science for self
Use for Adult providing own consent. Health/Social Science Research involves quantitative and/or qualitative research of issues in health and society.
PICF health and social science for parent and guardian
A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level.
PICF health and social science for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible/medical treatment decision-makers when the potential participant does not have decision-making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians.
Use this for adult providing own consent. An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial.
PICF interventional for parent & guardian
Use this for an Interventional Study where Parent/Guardian consenting on behalf of participant. An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial.
PICF interventional for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible when the potential participant does not have decision-making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians.
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
PICF genetic for parent & guardian
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
PICF genetic for person responsible/medical treatment decision maker
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
Participant partner pregnancy PICF
In the event that a participant in an approved interventional clinical trial (or the participant’s partner) becomes pregnant during the course of the research, this Participant Information Sheet/Consent Form should be provided to the pregnant participant/partner.
Variations and Exceptions to the standard consent process
There are certain circumstances where individuals may not be able to consent to a medical research procedure. The following Acts provide guidance on best practice when this occurs. The two Acts work in tandem, whereby:
Guardian and Administration Act, 2019
Victorian laws about guardianship and administration were updated in March 2020. They aim to ensure that people with disabilities are best supported when making life decisions. A guardian and/or administrator may be appointed for a person with a disability that reduces their capacity to make their own decisions. The appointment is made by the Victorian Civil and Administrative Tribunal (VCAT).
If a patient under the age of 18 years does not have capacity to consent to research, in general the parent or guardian may give consent on their behalf.
For adults unable to consent to a medical research procedure, there is a four-step process for obtaining consent.
- Step 1: Determine whether an ethics committee has approved the project (s. 42Q Guardianship and Administration Act).
AND - Step 2: Determine whether the patient is likely to recover capacity within a reasonable time to give consent to the procedure. If the patient is likely to recover capacity within a reasonable time, the researchers must wait and seek the patient’s own consent (s. 42R Guardianship and Administration Act).
OR - Step 3: If the patient is not likely to recover capacity within a reasonable time, seek the consent of the ‘person responsible’ (s. 42S Guardianship and Administration Act).
OR - Step 4: If the ‘person responsible’ cannot be identified or contacted, consider procedural authorisation
More information on the Guardian and Administration Act, 2019 can be found here.
Medical Treatment Planning and Decisions Act, 2016
On 12 March 2018 the Medical Treatment Planning and Decisions Act 2016 commenced. This act provides a framework for making decisions about medical treatment when people do not have capacity to make their own decisions.
If a person does not have decision-making capacity in relation to the decision to be made (including consent to research), their medical treatment decision-maker must make the decision.
When a medical treatment decision-maker makes this decision, they must make it in accordance with their instructional directive. If there is no directive, they should align with what they believe the person would want in the circumstances.
If there is not an instructional directive or a medical treatment decision-maker, a health practitioner must obtain consent from the Public Advocate if the proposed medical treatment is significant
More information on the Medical Treatment Planning and Decisions Act can be found here.
If medical or psychiatric research involves a child or young person under 18 years, a decision must be made about who will provide consent.
The National Statement Chapter 4.2 provides guidance for this issue.
See also guidance from the Royal Children’s Hospital Consent in Research. Involving Children: The ethical Issues. A Handbook for Human Research. Ethics Committees and. Researchers
Young people with capacity to give informed consent
A young person may give informed consent to research, depending on their level of maturity and capacity to understand the nature and expected outcomes of the research.
If a young person can give valid consent to research, the consent of the parents or guardian is not strictly necessary. However, parents and guardians should be involved in the decision wherever possible.
If a patient under the age of 18 years has capacity to make a decision about research and refuses consent, the research cannot be performed.
Young people without capacity to give informed consent
If a patient under the age of 18 years does not have capacity to consent to research, in general the parent or guardian may give consent on their behalf.
The authorised psychiatrist should seek advice from the Office of the Public Advocate if there is any doubt about whether a parent or guardian has the power to give consent to research on behalf of a child or there is disagreement between the parents and the child.
If a young person is incapable of consenting to research and there is no parent or guardian who is reasonably available, willing and able to make a decision, the research cannot be performed.
If the research is considered necessary, the authorised psychiatrist might consider making an application for a guardian to be appointed under the Children, Youth and Families Act 2005. Seek advice from the Office of the Public Advocate.
The authorised psychiatrist cannot consent to research, even when the research may be considered to be a psychiatric treatment, for example, a drug trial intended to treat the young person’s mental illness.
A medical research procedure (which is part of a research project that has been approved by a human research ethics committee) may be carried out without consent if a registered medical practitioner believes, on reasonable grounds, that the procedure is necessary, as a matter of urgency, to:
- save a patient’s life
- prevent serious damage to a patient’s health
- prevent a patient from suffering or continuing to suffer significant pain or distress.
However, this source of authority would be rarely exercised in the context of research.
The practitioner would need to have reasonable grounds for believing that the medical research procedure is necessary on the basis that available conventional treatment would not meet the patient’s urgent clinical needs. (Victorian Dept of Health https://www.health.vic.gov.au/rights-and-advocacy/research-participation)
Where the project involves participants whose ability to provide consent is anticipated to deteriorate through the course of the project, researchers are expected to make provisions for this eventuality, for example, by ensuring that a person responsible is involved.
Waiver of Consent
The National Statement recognises that there may be circumstances where the use of identifiable information in research may be justified without complying with the requirement of individual consent from all participants NS, Chapter 2.3: Qualifying or waiving conditions for consent. This can occur in epidemiological research but is also possible for human tissue research and genetic research.
The National Statement requires that ‘only an HREC may grant a waiver of consent for research using personal information in medical research, or personal health information’. HRECs may ‘sometimes’ waive consent “where neither consent nor an opt-out approach are appropriate” (Section 2.3), after taking into account a number of factors. The matters that may be taken into account are:
- Involvement in the research carries no more than a low risk
- the nature of any existing consent relating to the collection and storage of the sample;
- the justification presented for seeking waiver of consent including the extent to which it is impossible or difficult or intrusive to obtain specific consent;
- the likelihood that participants would have consented had there been provision for this;
- the proposed arrangements to protect privacy including the extent to which it is possible to de-identify the sample;
- the extent to which the proposed research poses a risk to the privacy or well-being of the individual;
- whether the research proposal is an extension of, or closely related to, a previously approved research project;
- the possibility of commercial exploitation of derivatives of the sample; and
- the relevant statutory provisions.
The Guidelines under Section 95 of the Privacy Act 1988 (s95 Guidelines) provide a framework for the conduct of medical research using information held or collected by agencies where personal information needs to be used and where it is not practicable to obtain the individual’s consent.
In these situations, an agency may collect, use, or disclose records containing personal information for medical research purposes without breaching the Privacy Act if the proposed medical research has been approved by a properly constituted Human Research Ethics Committee (HREC) in accordance with the s95 Guidelines.
As a general rule of thumb, consent or a waiver of consent is not required where a study gives rise to only negligible risk and involves the use of data derived from routine clinical practices for the purposes of quality assurance.
The Office of the Federal Privacy Commissioner’s Guidelines on Privacy in the Private Health Sector states that an organisation’s quality assurance or clinical audit activities may constitute secondary activities that are directly related to the purpose for which consent was given, and therefore that consent may not be required for these types of activities.
More specifically, the access or use of data (both de-identified and identified) for the purpose of research does not require consent or a waiver when:
- The data to be accessed or used has already been collected as a routine part of practice; or
- The data will be collected as a matter of routine business (e.g. clinical care, training, planning, or management of the health service); or
- The data that will be used for the purpose of research, audit or quality improvement or other research activities are directly related to the primary purpose for which the data was/will be collected
However, a waiver is required when:
- Access to data is sought by a person that would not normally have access to the data as part of their employment with Barwon Health for that purpose; or
- The purpose of use and access to the data is not related to the original purpose of collection.
If you are unsure whether a waiver of consent is required for your research, please complete the Waiver of Consent Checklist .
Researchers who wish to apply to waive the requirement to seek consent should complete the Waiver of Consent Application. This document briefly outlines the relevant Statutory Guidelines and summarises the key privacy principles, and provides information regarding the project, the nature of access to information and consent (section 1-7) and for the HREC review. This should be submitted to the REGI team for review.
HREC review and approval of applications for a waiver of consent
The Barwon Health Human Research Ethics Committee (BH HREC) reviews all applications for waiver of consent. These are reviewed out of session and ratified by the full HREC, Approval of the waiver is required in order for full project approval to be granted.
HREC reporting of waiver of consent
For the purposes of transparency and accountability supporting the desire to instil public faith in research, research institutions are required to make publicly available a summary of all the research projects for which consent has been waived according the conditions set out in National Statement, section 2.3.10 and 2.3.11 (with the exception of research which seeks to expose illegal activity, which should be made publicly available only after the completion of the research). REGI is required to report annually to the Health Services Commissioner all projects for which consent has been waived according the conditions set out in National Statement, section 2.3.10 and 2.3.11
Barwon Health makes this information available via its Annual Reports and the Research website.
The National Statement provides guidance on a number of special research activities, including human-animal research and genomic research. Several chapters are also dedicated to the ethical consideration specific to groups of participants.
For further advice on providing participant information and seeking consent for these types of research activities contact RDU@Barwonhealth.org.au.
- Chapter 3.2: Human biospecimens in laboratory-based research
- Chapter 3.3: Genomic research
- Chapter 3.4: Animal-to-human Xenotransplantation
- Section 4: Ethical considerations specific to participants
- Chapter 4.1: Women who are pregnant and the human fetus
- Chapter 4.2: Children and young people
- Chapter 4.3: People in dependent or unequal relationships
- Chapter 4.4: People highly dependent on medical care who may be unable to give consent
- Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness
- Chapter 4.6: People who may be involved in illegal activities
- Chapter 4.7: Aboriginal and Torres Strait Islander peoples
- Chapter 4.8: People in other countries
Page last updated: November 21, 2024