Publication Ethics for Mental Health Treatment Reports

1. Introduction

Following the Declaration of Helsinki in 1964 to protect people from intrusive clinical research, Governments have taken action to ensure that health services are developed and published in ways that follow ethical procedures [1]. Governments have introduced Institutional Review Boards (IRBs), also called Human Research Ethics Committees (HRECs), to protect the rights of research participants with aims of ensuring that health interventions are developed and published in ways that respect the rights of participants and meet ethical and scientific principles.

The article distinguishes between mechanisms / procedures that have been introduced regarding research that informs and develops innovative clinical practices, and procedures regarding publication of clinical practices that are innovative. The article notes that different mechanisms are used to monitor the ethicality of research that generates new knowledge and clinical practices that apply new knowledge. Research is regulated as prior approval is required before research can be implemented, while therapy is monitored as recipients can lodge complaints about interventions received with ethics bodies. The article addresses a proposal to extended regulatory procedures to govern all innovative therapies. The article proposes that tensions arise about whether similar ethical principles will be monitored if innovative therapy were to be regulated by bodies that regulate research and experimentation, and that skilled clinicians will be further deterred from developing and providing therapy for vulnerable groups in society if all innovative therapy is regulated, including for vulnerable children who live in court-involved families. The article proposes that parent-child therapy for children who live in court-involved families that is individualised and non-invasive and innovative be exempt from regulation using procedures that were designed for different purposes.

Recent research has identified children who live in court-involved families as both being at heightened risk of developing a mental disorder, and as receiving low levels of evidence-based therapy. There is a disparity between the needs of these children and their receipt of evidence-informed therapy. One explanation of the disparity is that clinicians perceive delivery of required innovative therapies for these vulnerable children to be professionally risky as ethical standards for providing services to these children are under-developed. A second explanation for the sparse provision of evidence-informed therapy to these vulnerable children is that clinicians consider they are discouraged from following the usual practice of publishing relevant single case studies when they develop innovative therapies to the vulnerable children.

The article addresses six topics: (1) delivery of evidence-based therapy for children whose mental health is vulnerable due to their family circumstances; (2) COPE guidelines regarding publication of scientific research; (3) functioning of HRECs / IRBs; (4) differentiating research from evidence-informed therapy; (5) risks of creating a sole approval mechanism regarding publication of innovative therapy; and (6) a proposed solution.

2. Delivery of Evidence-Based Therapy for Vulnerable Children

The Australian Government in 2021 introduced a National Children’s Mental Health and Wellbeing Strategy [2] that identifies children who live in court-involved families as being at increased risk of developing a mental disorder due to parenting that is inadequate or abusive. The National Strategy follows research indicating that children who live in families where they are exposed to ongoing risk factors experience cumulative harm that is associated with higher rates of mental disorder [3,4]. The National Strategy recognizes three types of intervention for vulnerable children; (a) treatment of a parent with a diagnosed disorder; (b) treatment of a child with a diagnosed disorder; and (c) joint parent-child early intervention therapy for families who present with risk factors but where neither person yet displays sufficient symptoms to be diagnosed with a disorder. The National Strategy recommends early intervention therapy for children who are at heightened risk due to exposure to parental or personal risk factors.

Macvean et al. [5,6] reviewed evidence about parenting programs for vulnerable children and identified 81 evidence-based parenting interventions for children who are vulnerable to being maltreated and developing a mental health disorder. They reported the most effective interventions include parent education programs that are delivered by clinicians, including in family homes, and therapies that are targeted to address identified risk factors.

However, Wade et al. [7] found that established evidence-based intervention programs were used only sparingly with vulnerable children in Australia. One explanation they identified for the low use of evidence-based early intervention therapy with vulnerable children is that therapists consider interventions need to be individualized to meet each family's assessed needs, rather than by delivering standardized interventions that treat all vulnerable families as the same.

Carr [8,9] reviewed research about early intervention parent-child therapies with vulnerable children and found that joint parent-child therapy was as effective as traditional treatment of disorders. Joint parent-child therapy aims to improve inadequate parenting practices and replace dysfunctional interaction patterns with interactions that benefit both parents and children. Tustin [10] reviewed research on the efficacy of therapies with court-involved families and found that effective therapies draw on a range of theoretical models, indicating that therapists who provide parent-child therapies for vulnerable children need to be able to apply principles from several theoretical models.

Amos et al. [11] noted that families where children are at increased risk of developing a mental disorder due to exposure to parental risk factors are not always responsive to standardized treatments and opined that these families require individualized interventions based on assessment using standardized instruments. Amos et al. [11] emphasised a need to introduce innovative therapies for families where children are vulnerable that address risk factors and interactions between parents and children.

Parents whose child-rearing practices have been criticized in a family-oriented court can approach clinicians to request therapy to address criticisms made in court about their child-rearing practices, and then request a treatment report that summarises their progress in therapy which is submitted to court [12]. Treatment reports can be provided both to Family Law Courts that manage disputes between separated parents about children’s matters, and to Child Protection Courts when an allegation is made that a child is at risk of significant harm due to maltreatment by a parent. Progress has been made clarifying how treatment reports need to be written to meet court standards for providing expert evidence, so that reports assist decision-making by family-oriented courts [12].

Treatment reports address circumstances in each individual family. Tustin [13] reviewed research about parents who attend family-oriented courts and found these parents commonly present with up to five treatable parental risk factors that increase chances a child might develop a mental disorder. The five parental risk factors are: (a) difficulty in managing their child’s behaviour; (b) a parental mental health condition; (c) some parental substance misuse; (d) co-parenting with a separated partner; and (e) some exposure to domestic violence. The review found that mild and moderate levels of each risk factor are treatable [13]. However, if a parent exhibits several risk factors, then the parent is viewed as having multiple complex problems that may be beyond the capacity of any one government department to treat, as government departments are commonly funded to treat only single risk factors. Some government departments provide treatment only for people who display sufficient symptoms to be diagnosed with a disorder, rather than early intervention therapy.

Tustin [13] reported that parents who are involved in family-oriented courts in Australia increasingly approach mental health clinicians in community private practices who are skilled in treating several risk factors in a coordinated manner, and who both provide individualised therapy and provide treatment reports that can be submitted to court. A clinician who provides a treatment report to court is likely to be cross-examined about their report by lawyers representing all parties, including a lawyer representing the interests of the children involved.

The low level of delivery of effective therapies for vulnerable children results in high numbers of children who live in vulnerable families developing mental disorders. Obstacles that impede delivery of effective therapies need to be explored and addressed.

As discussed below, separate mechanisms have been developed to ensure ethicality of the development and publication of innovative clinical interventions. Care is needed to ensure there are neither gaps nor overlaps between the two sets of mechanism. The remainder of the article describes mechanisms, identifies possible obstacles to publication of innovative interventions, and proposes a solution.

3. COPE Guidelines

The organisation Committee on Publication Ethics (COPE) in 1999 developed guidelines for publishers of scientific research entitled ‘Guidelines on good publication practice’ to identify best practices when research studies are published [14]. The COPE guidelines use ten headings to summarise topics, but they do not include a definition of research and experimentation that distinguishes between research and therapy.

Item 3 of the COPE Actions [14] states, “Protocols must be carefully agreed by all contributors and collaborators, including, if appropriate, the participants.” Item 7 of the COPE Actions [14] states, “Formal and documented ethical approval from an appropriately constituted research ethics committee is required for all studies involving people, medical records, and anonymised human tissues.” Item 9 of the COPE Actions [14] states, “Fully informed consent should always be sought.” Clinicians who provide therapy services that apply existing knowledge are expected to meet these three standards.

The COPE guidelines were developed to monitor the ethicality of publication of experimentation and research [14]. However, it appears that some advocates consider the scope of the COPE guidelines should be extended to cover publication of treatment reports involving clinical therapy, including reportable therapy that has been provided to court-involved families so that this therapy can be regulated.

The article notes that ethicality of treatment reports submitted to a family-oriented court is currently monitored by the recipient court. The article cautions against publishers adopting a single mechanism such as the COPE guidelines to regulate the ethicality of publication of all clinical interventions, including individualized treatment reports, as this is likely to restrict publication of individualized therapy for families with complex conditions. Extending the scope of the COPE guidelines also unnecessarily gives bodies outside publishers a monopoly role in deciding which reports to publish about effective clinical therapies for vulnerable children. The article proposes that publishers accept a role of gatekeeping innovative clinical interventions to ensure appropriate ethical standards are being followed rather than delegate this role to external bodies.

The article proposes that extending the regulatory scope of the COPE guidelines to cover publication of interventions used in individual treatment reports is a significant barrier to the development, dissemination and publication of therapies that are effective for vulnerable children.

The article proposes that the COPE guidelines were designed to monitor publication of set protocols that will be implemented without variation, rather than to control publication of interventions that are individualised to meet the distinctive circumstances of individual clients, and where significant clinical judgment is required when individualised therapy is provided. The article proposes that regulation of the development of individualised therapies for vulnerable children who live in court-involved families using the COPE guidelines and associated procedures is inappropriate.

4. Functioning of HRECs / IRBs

Literature of the functioning of IRBs / HRECs has been published from several sources. Literature from the World Health Organisation (WHO), independent researchers, and Australian reviews is summarised.

4.1. WHO Literature About Mechanisms to Govern Ethicality of Scientific Research

The World Health Organisation (WHO) published standards and operational guidelines for the ethical review of experimentation and research involving humans that identify ten standards, and recommended established of Human Research Ethics Committees (HRECs) to oversight and approve proposals for research [1]. The primary task of a HREC is to assess the ethicality of research proposals and their supporting documents. Approval or disapproval of a proposal is based on the ethical acceptability of the proposal, including its social value and scientific validity, an acceptable ratio of potential benefits to risks of harm to participants, minimization of risks, adequate informed consent procedures, measures to ensure protection of vulnerable populations, and attention to the impact of research on communities from which participants will be drawn. In effect, HRECs regulated research and experimentation involving humans.

The WHO standards address topics about composition of HRECs, independence of HRECs, transparency of HRECs, decision-making procedures for HRECs, a need for written policies and procedures to communicate decisions, and safety precautions [1]. WHO standards that are of interest to mental health clinicians are summarised below.

WHO Standard 5 [1] requires researchers to take precautions to safeguard the privacy and confidentiality of participants, and to minimise feelings of loss of control and embarrassment, social stigma, rejection by family or a community, and lost opportunities to receive services.

WHO Standard 6 [1] addresses the importance of researchers gaining the informed consent of participants, to ensure that competent individuals are entitled to choose freely whether to participate in research based on an adequate understanding of what the research entails. Decisions for children and adults who lack the mental capacity to provide informed consent should be made by an authorised surrogate decision maker.

WHO Standard 7 [1] requires the HREC to make clear the specific ethical guidelines it relied on when making decisions and to make the guidelines readily available to researchers and to the public.

WHO Standard 10 [1] indicates that researchers have a responsibility to ensure there is no deviation or change made to a protocol that has been approved by the HREC without prior approval of the HREC.

WHO issued a further guideline about emergency use of clinical interventions that distinguishes between research interventions and clinical interventions and defines terms [15]. A clinical intervention is an intervention used by a health worker that is intended to provide a clinical benefit to a client as it promotes the well-being or best interests of recipients of the intervention. A research intervention is designed primarily to generate knowledge for the public good. The term ‘unproven intervention’ is used to describe an intervention for which there is insufficient evidence about efficacy and/or safety for an intervention to be regularly used in a health system. ‘Duty of care’ refers to the ethical and professional obligation of healthcare workers to provide care to individuals who are ill and who seek assistance, and requires a professional to apply their knowledge and skills for the benefit and best interests of their patient and also to explicitly acknowledge uncertainties about the risks and potential benefits of unproven interventions.

The WHO standards cited above that apply to researchers are applicable to clinicians who provide therapy.

4.2. Independent Reports About IRBs

The USA Government introduced Institutional Review Boards (IRBs) to review the ethicality of proposed research with an aim of protecting the rights and wellbeing of participants. A number of independent reports about the efficacy of IRBs in protecting participants have been published as summarised below.

Babb [16] reported that introduction of IRBs resulted a rapid professionalisation of workers who are employed by IRBs to conduct regulatory roles.

Abbott and Grady [17] provided a systematic review of 43 empirical studies of IRBs that conduct ethics reviews in USA. They found IRBs differed in how they applied federal regulations, and in the decisions they made.

Lynch et al. [18] reviewed instruments used to evaluate performance of IRBs and concluded that the quality of performance by IRBs is rarely subject to the same scrutiny the boards apply to research projects. They found that 8 out of 10 instruments examined had no mechanism to assess IRB impact on outcomes for participants, and two instruments focused only on adverse events.

Nesom et al. [19] surveyed managers of IRBs in USA with an aim of developing an instrument that assists in evaluating the performance of IRBs. They found that organisations that hosted IRBs included universities, children’s hospitals and some healthcare organisations. They found that some IRBs had established a number of ethics review committees to address specific types of issue.

Dicken [20] from the USA Government Accountability Office (GAO) reported that most IRBs in USA are based at universities with some IRBs being independent as they are not part of institutions that conduct or sponsor research. Dicken found that relevant governmental agencies conduct relatively few inspections of functioning of IRBs, as the relevant agencies have not determined the best approaches for performing this task. As a consequence, agencies that review IRBs have not assessed the extent to which IRB reviews are effective in protecting human subjects.

Nicholls et al. [21] proposed that reviews of IRBs placed too much emphasis on process issues such as composition of committees and the number of proposals reviewed, and too little emphasis on the quality of reviews. Nicholls et al. [21] recommended more analyses of topics including types of people who were subjects of research, outcomes for participants, experiences of research participants, and evaluation of assessment instruments.

Serpico [22] noted that regulations and standards in USA do not prescribe clearly how research proposals are to be submitted to IRBs, and they do not state components of an IRB application that identify what a good quality application looks like. As a result, applicants can be unsure about what risks and issues a particular IRB might focus on, beyond the standard topics of obtaining consent and protecting privacy.

Green and Rosenfeld [23] noted that, due to the composition of IRBs, it is possible for conflicts of interest to emerge between members of an IRB, and this has potential to threaten approval of research that meets ethical standards.

Capili et al. [24] reported that, as IRBs consider their primary responsibility is to protect the rights of society’s most vulnerable people, they may be especially cautious about approving research involving children and individuals with a mental disorder or disability.

Eissenberg et al. [25] writing on behalf of the American Psychological Society noted that while IRBs are mandated at a federal level, they are administered at a local level, allowing different interpretations about ethical topics to occur when risks and benefits are evaluated. They opined that as the role of IRBs is to protect the rights and welfare of research participants, there is potential for conflicts of interest to be high when behavioural research is considered including when therapy is involved. They reported that researchers are often required to describe in unprecedented detail how they will manage even the most unlikely risks to participants. They argued for a more collaborative approach between IRB administrators and researchers.

Stryjewski et al. [26] proposed several measures to improve IRB review processes including the promotion of guidelines that distinguish between research and innovative therapy.

The website for the USA Code of Federal Regulations [27] in section 46.104 provides information about educational practices that are exempt from requiring HREC approval.

In summary, published articles have raised a number of topics of concern regarding the functioning of IRBs.

4.3. Australian Applications of HRECs

The Australian Commission on Safety and Quality in Health Care (ACSQHC) conducted an investigation and a literature review following reports of differential functioning by HRECs in different jurisdictions in Australia involving research that was proposed to be conducted on multiple sites that were located in different jurisdictions and were covered by different HRECs [28]. The ACSQHC review found there were differences in operations of HREC committees between jurisdictions, together with variable access to relevant experts. The review found that multiple HREC reviews could be conducted into a single research proposal. In recognition of issues that were identified, jurisdictions agreed to expand a scheme administered through the Australian Commission on Safety and Quality in Health Care Commission with aims of enhancing consistency and efficiency and building reciprocal confidence in HREC reviews across Australia.

The Australian Government in 2025 adopted Accreditation for Human Research Ethics Committees (AHRECs) to monitor clinical trials [29]. AHRECs require all health and medical research conducted in Australia which poses more than a low risk of harm to participants to be reviewed by a Human Research Ethics Committee (HREC) that functions in accordance with the National Statement on Ethical Conduct in Human Research (National Statement) [30]. The roles of HRECs in Australia are to advise on protection of participants in research participants and to protect the scientific validity of proposed research.

The National Statement [30] recognises that the emphasis on ethical reviews of research involving humans in Australia commenced in the 1960s and was related to federal funding of medical research. In 1985 the Medical Research Council recommended that any institution that conducts research on humans conform with a requirement to obtain a prior review and approval by an independent ethics body in order to be eligible to receive funds for research from the Medical Research Council. The National Statement [30] recognises that research can produce ethical dilemmas where it may be difficult or impossible to find consensual agreement about what is right and wrong. Peer review is recommended when experimentation involves human subjects. Clinical trial research in Australia must also undergo an ethics review.

4.4. Scope of Australian HRECs

Standard 1.4 of the National Statement [30] indicates the standards introduced are intended to provide oversight of use of drugs, biologics, and medical devices, as well as national and/or international clinical trial registries.

4.5. Composition of HRECs

Standard 2 of the National Statement [30] requires HRECs to have a composition that is multi-disciplinary, that reflects the social and cultural diversity of the community, and includes individuals with backgrounds relevant to the areas of research the committee reviews.

The National Statement [30] in section 5.1.30 requires HRECs in Australia to have a minimum of 8 members who include: a chairperson; one person with knowledge of and current experience in the professional care or counselling or treatment of people involved in the research; two people with current research experience that is relevant to research proposals being considered at the meetings they attend; two independent community representatives; one lawyer; and one person with a pastoral role. Members do not represent organisations.

HRECs in Australia are not required to include representatives of groups that represent users / consumers of research.

4.6. Decision Making by HRECs

The National Statement [30] indicates that research has merit if it is committed to a search for knowledge and understanding, is conducted using recognised principles of research, and findings are disseminated. Research is beneficial if the likely benefit to participants justifies any risks of harm or discomfort to participants. The National Statement [30] recognises that ethical guidelines are not a set of rules to be followed as their application always requires deliberation about the values and principles involved, exercise of judgement, and an appreciation of context.

Standard 6 of the National Statement [30] requires HRECs to make decisions that are unbiased, of high quality, and are published to show transparency.

Standard 7 of the National Statement [30] requires decisions by HRECs to be based on the ethical acceptability of research proposals including their social value and scientific validity, an acceptable ratio of potential benefits to risks of harm, minimization of risks, adequate informed consent procedures (including cultural appropriateness and mechanisms to ensure voluntariness), and measures to ensure protection of vulnerable populations; while also considering internationally accepted ethical principles and national laws and policies. Standard 7.2 [30] recognises that risks can involve social or psychological harm at an individual, family or population level. Standard 7.5 [30] requires researchers to safeguard participants’ privacy and confidentiality. Standard 7.6 [30] requires researchers to gain informed consent to participate. Standard 7.7 [30] requires HRECs to ensure that research produces benefits for communities.

Standard 8 of the National Statement [30] discusses decision-making processes to be followed by HRECs.

Standard 9 of the National Statement [30] requires HRECs to have written policies on many topics, with policies being available to the public.

Standard 10 of the National Statement [30] establishes that research is conducted by personnel with relevant qualifications, who conduct the research in compliance with the protocol approved by the HREC without deviation. Standard 10.3 [30] requires any serious, unexpected adverse event to be reported promptly to the HREC and/or other relevant authorities.

4.7. Informed Consent by Participants

The National Statement [30] discusses requirements for informed consent by participants in sections 2.2 and 2.3.

Section 3.1.37 of the National Statement [30] discusses innovative health interventions and treatments and states that researchers must inform potential participants if an intervention is novel as it has not yet been approved for a health condition, or the intervention is not used in the usual care of the relevant health condition, or an intervention is being investigated for use with a new health condition.

4.8. Level of Risk to Clients

Section 3.1.6 of the National Statement [30] states, ‘In health research involving an intervention, the risks of an intervention should be evaluated by researchers and reviewers in the context of the risks of the health condition and the treatment or treatment options that would otherwise be provided as part of usual care.’

The National Statement [30] in section 2.1 divides risk of harm into four categories: minimal / low / greater than low / high. Risk is low when the only foreseeable risk involves discomfort to a participant which includes mild anxiety associated with an interview. Research where risk of harm is greater than low requires review by a HREC. The purpose of an ethics review is to establish that expected benefits of a research proposal outweigh any associated risks.

AHREC [29] requires that all health and medical research that poses more than a low risk to participants must be reviewed by a HREC that functions in accordance with the National Statement on Ethical Conduct in Human Research [30].

Section 5.1.13 of the National Statement [30] indicates that organisations may establish a non-HREC pathway for ethics review of lower risk research, if they have the resources and capacity to carry out a review competently and professionally. Section 5.1.14 [30] lists requirements for non-HREC approval of low-risk practices, including secondary use of information. Section 5.1.17 [30] requires any publication of low-risk practices to be de-identified.

4.9. Australian Review of Research into HRECs

An Australian Commission on Safety and Quality in Health Care (ACSQHC) was established as the national agency with a role to develop national accreditation schemes that relate to safety and quality in health care [28]. ACSQHC [28] stated that the purpose of an accreditation scheme for researchers is to enhance consistency of practice and to build reciprocal confidence in the ethical review of human research across the public and private sectors in Australia.

HRECs that receive funding from National Health and Medical Research Council (NHMRC) are required to register with the NHMRC’s Australian Health Ethics Committee, must be certified under the NHMRC National Certification Scheme, and must provide annual reports [28].

A review of governance arrangements by six countries was reported by ACSQHC in 2018 [28]. One reason for the review was that the operational and administrative burdens associated with the jurisdictional approach in Australia were perceived as detrimentally affecting the cost, quality and efficient conduct of clinical trials. The literature review favoured a national approach to quality control of clinical trials and led to ACSQHC being established as a national coordinating agency.

The ACSQHC review [28] proposed the development of a national Clinical Trials Governance Framework with an aim of reducing duplication and increasing efficiency, cohesion and productivity across the clinical trials sector. ACSQHC described clinical trial research as the link between science and clinical practice [28, p 14]. However, ACSQHC found that both duplication and inconsistency in ethics and governance approval processes occurred between jurisdictions in Australia [28, p 16], resulting in inefficiencies and missed opportunities to enhance consumer outcomes [28, p 17].

The ACSQHC reviewed peer-reviewed publications and found that published studies universally described the governance of clinical trials as being overly bureaucratic, inefficient, fragmented, lengthy [28, p 23], and overly complex, inefficient, time-consuming and producing delays, and costly [28 p 24]. In Australia the costs, complexity and time delays associated with clinical trials were compounded by inter-jurisdictional and regulatory differences between private and public sites, resulting in a need for repeated institutional governance reviews and separate regulatory approvals [28 p 24].

ACSQHC found system-level barriers identified in the peer-reviewed literature that affected the conduct of clinical trials including: (a) a lack of a universally agreed set of good governance principles; (b) the regulation of clinical innovation was not proportionate to risks to clients; and (c) a lack of research on the balance of risk to benefit, and lack of guidance about what constitutes a low-risk clinical practice [28 p 26].

ACSQHC reviewed international literature published by governments and private bodies and found that the way services are funded influences practices about innovative practices [28]. Funding for health services varied between countries with both user-pays and government subsidised health systems being used.

Initiatives that were proposed in the ACSQHC literature review included: (a) integrate research into routine healthcare to foster a research culture in the delivery of health [28 p 18]; and (b) clearly articulate performance metrics for domains within an accreditation standard [28 p 18].

ACSQHC [28] identified two administrative procedures that might be used by clinicians; quasi-experimental designs, and descriptive studies of intervention programs. In standard mental health clinical practice, a clinician assesses a client, provides an intervention, and monitors the outcome. In a quasi-experimental design, a clinician might withhold an intervention for a period while making observations as part of a control condition. Many therapists report intervention programs without having sought ethics approval in advance.

It is likely that most registered mental health clinicians implement the conditions required by ACSQHC of researchers.

4.10. Review by Australian Law Reform Commission

The Australian Law Reform Commission (ALRC) was invited to comment on proposals about the role of HRECs after receiving submissions [31].

In section 65.100 the ALRC [31] recognised that the National Statement [30] provides that ethical reviews can be undertaken at various levels depending on the degree of risk involved in the research. Research involving ‘negligible risk’ and the use of existing collections of data or records that contain only non-identifiable information may be exempt from review.

In section 65.106 the ALRC [31] stated support for the continuing role of HRECs in reviewing and approving research proposals that seek to rely on exceptions to the Privacy Act.

In section 65.115 the ALRC [31] stated its expectation that HRECs will focus on factors such as the value and public importance of the research; the risk of harm to individuals; standards of conduct that are to be observed in the research; and the extent of any possible breach of privacy.

In sections 65.135 and 65.143 ALRC [31] noted that members of HRECs are generally volunteers who are appointed in a personal capacity, are drawn from a range of community sectors, and are not representatives of any organisation, group or opinion. Members are asked to make decisions on the basis of their own personal judgement. This may contribute to HRECs adopting differing positions on ethical topics. In section 65.145 the ALRC [31] noted it had received statements of concern about inconsistencies in the way HRECs balanced the public interests in research and privacy.

In section 65.112 the ALRC [31] noted that NHMRC had itself noted the complexity of the regulatory regime and that its own obligation to provide detailed reporting had resulted in an excessive administrative burden.

5. Differentiating Research and Evidence-Informed Therapy

This article supports suggestions noted above [25,26] that research can be differentiated from therapy, and that it is wise to use different mechanisms to oversight ethicality of research and therapy, including the publication of innovative therapy that is provided in single case studies by registered clinicians.

One requirement of HRECs is that approval be granted before a researcher is permitted to implement a project that involved experimentation or research, leading to regulation of practices. The requirement for prior HREC approval for an innovative protocol appears to have been introduced to monitor medical assessments and treatments that are associated with a potential risk of significant harm to clients/patients, such as surgery and the use of intrusive investigations and medications.

Commonly, research that is approved in advance by a HREC involves a proposal to test a standardised protocol that will be administered by appropriately qualified practitioners to an identified group of clients who have a diagnosed disorder. The standardised protocol is implemented routinely, with few adjustments made on the basis of clinical judgment.

In contrast, therapy for complex mental health conditions often requires a clinician to make a number of clinical assessments and judgments before selecting a set of interventions that are suitable. This is especially the case when a client has a complex condition, as often occurs in court-involved families.

It is proposed that extending the COPE proposal so that innovative therapies may be published only if they were granted prior approval by a HREC would restrict the delivery of individualised therapies for families with complex needs.

5.1. Distinguishing Research From Evidence-Informed Therapy

It is proposed that a distinction can be made between research that generates new knowledge using scientific procedures that are controlling and therapy that provides care to individuals by applying existing knowledge in evidence-informed ways.

It is noted that some of the most important innovations in clinical psychology originated from application of established theoretical principles in single case studies to resolving problems experienced by people who were diagnosed with a mental disorder, including in the development of cognitive behaviour therapy [32].

It is recognised that similar ethical principles are applied when conducting research and when providing therapy. Nonetheless, it is proposed that it is wise to use different mechanisms to monitor the ethicality of research that develops research protocols and when providing evidence-informed therapy in individual cases.

Three established mechanisms to monitor ethicality of innovative therapies are summarised involving: (a) clinicians use a combined scientist-practitioner model and levels of evidence approach; (b) registration of mental health practitioners; and (c) monitoring of assessment and treatment reports that are submitted to family-oriented courts.

5.2. The Scientist-Practitioner and Levels of Evidence Approach

The discipline of psychology distinguishes two aspects of science, basic science that identifies core principles, and applied science where established basic principles are applied to solving practical problems. Application of an established basic principle to solving a practical problem is described as ‘evidence-informed intervention.’ An intervention is described as ‘evidence-based’ if a standardised intervention has been shown in adequate trials to be effective in reducing a problem. Evidence-informed interventions are more likely to be used by clinicians when interventions for complex conditions are individualised, and when a problem has received limited attention from researchers.

Psychologists who are trained in the application of scientific methods are described as following a scientist-practitioner approach [33]. Barlow and Herson [33] described the scientist-practitioner approach as being associated with three stages in the development of interventions that are: (a) report a single case study; (b) replicate the single case study in a group trial to produce a standardised intervention; and (c) replicate the now standardised intervention in a randomised controlled trial. In a single case study, measures are made of a problem behaviour in a pre-test before an intervention is applied, and in a post-test or follow-up after the intervention is applied in what is called an A-B design as measurement occurs in two phases. The intervention applies principles that have been established in basic science, and the intervention is described clearly so that it can be replicated by people trained in the basic science. A single case study may be published to facilitate replication. In a group trial the innovative intervention is applied in a standardised way to a group of clients who display the same issue and data are analysed using statistical methods. If reliable changes are found in a group trial, then the intervention is described as evidence-based. The efficacy of an intervention can be further evaluated in randomized controlled trials that are implemented at different sites and by different clinicians.

It is conventional for HREC approval to be sought when a new intervention transitions from being a single case study to a group trial that will be implemented in a standardised way using a protocol to a group of clients who share a common problem.

Applied psychologists who are trained in the principles of science and in the application of basic principles to the resolution of practical problems commonly form a case formulation based on an individualised assessment of the client’s issues that need to be addressed, then design an intervention package to provide individualised therapy that addressed the identified key issues [32,33,34,35,36,37,38]. Scientist-practitioners are trained to evaluate the outcome of their therapy by using standardised outcome measures in individual cases, where the outcome measure may be described in a published single case study. The topic of how single case studies are conducted in different disciplines is discussed by Greenhalgh [37]. Many journals publish single case studies and some journals such as Clinical Case Studies are devoted to publication of single case studies.

Tustin [39] discussed the value of publishing single case studies that describe innovative assessment and therapy interventions for vulnerable children who live in court-involved families, and recommended use of individualised therapies before a child is removed from parental care and placed into state care. Tustin [39] recommended: (a) adoption of agreed universal screening instruments to identify modifiable risk factors in court-involved families; (b) a focus on therapies that address interactions between a parent and child that are both beneficial and harmful for children; (c) a move towards naming effective evidence-informed interventions; (d) use of standardised outcome measures; and (e) replication of interventions that are reported to be effective in single case studies in further single case studies and in group trials.

Bodies that oversight clinical research such as the Australian National Health and Medical Research Council recognise the levels of evidence approach and recognise that the levels of evidence approach commence with single case studies that are well conducted and are reported [40].

5.3. Registration of Health Practitioners

Governments commonly register members of health professions including mental health clinicians and authorise clients to make a notification to a registration board if a client considers that a health professional has acted in an unprofessional manner. Unprofessional conduct includes both poor clinical practice and inadequate ethical practice.

Registered health professionals are required to accept responsibility for following both ethical/legal guidelines and clinical best practice standards that are established by their professional bodies when they provide interventions. Registration bodies operate by responding to complaints made after interventions have been provided, rather than by authorizing proposed interventions in advance. In this sense, registration bodies monitor professional practices rather than regulate professional practices.

The Australian Commission on Safety and Quality in Health Care (ACSQHC) [41] issued a fact sheet for clinicians about their ethical duty of care that emphasises the importance of obtaining valid informed consent before a health care intervention is provided. Consent to a healthcare intervention may be obtained either verbally or in writing or implied. Written consent is recommended when a clinician administers an intervention that is newly developed, is complex to understand, is intrusive, is experimental, or is known to be associated with a high risk of complication.

ACSQHC [41] recommended that a client be assessed by a health professional as having legal capacity to make a decision about a proposed treatment when they are able to display all of the following: Understand the facts involved; Understand the treatment alternatives; Understand how the consequences of treatment will affect them; Retain the information and recall the details; Weigh up the consequences of their choice including a choice to refuse treatment; and Communicate their decision and their understanding of its implications.

Granting authority to a client who receives a health care intervention to give informed consent to a recommendation that they participate in an innovative intervention or combination of interventions recognises that the client is in the best position to assess the adequacy and ethicality of an evidence-informed or evidence-based intervention in their specific circumstances.

5.4. Monitoring by Family-Oriented Courts

It has become a common practice in some jurisdictions for parents whose parenting practices have been criticised in a family-oriented court to approach a community based private practicing mental health clinician to seek therapy to address their inadequate parenting practices, and then to request a treatment report that can be submitted to court documenting the progress they have made in therapy [12].

The American Association of Family and Conciliation Courts (AFCC) in 2010 produced Guidelines for Court-Involved Therapy (GCIT) and noted that courts at times issue orders for litigants to participate in therapy that is court-ordered and reportable [42]. The AFCC GCIT guidelines use ten headings to summarise legal and ethical principles a therapist is expected to follow when they provide therapy for court-involved families [42]. AFCC states that the guidelines do not define mandatory practices for therapists as each case involves unique factors and dynamics. Neither do AFCC GCIT guidelines provide practice guidelines that describe best ethical practices as therapists are required to exercise clinical judgment about how to manage issues that arise when applying ethical principles that are relevant in their jurisdiction. The legal and ethical principles cited in the AFCC GCIT guidelines that therapists are required to consider and follow include; obtain informed consent; respect confidentiality and privilege; inform clients about limits to confidentiality; avoid conflicts of interest; maintain objectivity; manage relationships including multiple relationships; respect boundaries; operate within areas of competence; select appropriate assessment and treatment methods; avoid role conflicts; obtain authority to communicate with third parties; understand roles of different professionals in courts; understand legal principles and procedures and precedents; and keep adequate records [42]. Therapists are expected to use their professional judgment about how to apply each principle, and registered clinicians are accountable to their registration boards for their interpretations.

The AFCC GCIT Guidelines in section 2.6 recognizes that other professionals in the legal system have a role of monitoring therapeutic processes, and that therapists are accountable to these professionals for their professional practices [42].

Section 8.5.b of the AFCC GCIT recommends that therapists use methods and interventions that are generally accepted within their professional communities and literature, and that therapists apply methods or interventions that are appropriate to the situations and characteristics of court-involved families [42].

Private practicing clinicians who provide reportable therapy for court-involved families are encouraged to follow a distinct process [12]. A clinician uses available instruments to assess each family to identify specific risk factors in a family, develops an individualised case formulation that identifies risk factors relevant to a family that need to be addressed, and obtains consent from participants to deliver relevant assessments and therapies to address identified risk factors. This leads to individualised therapy. Clinicians are expected to use established assessment instruments regardless of the scientific standing of the instrument, and they are permitted to exercise clinical judgment when selecting evidence-informed therapy interventions to meet the individual needs of each family. A clinician who is appointed by a family-oriented court might be asked to submit a written case formulation to the court in advance of commencing therapy. The court might appoint personnel to monitor progress made by clients in therapy and request treatment reports.

As family-oriented courts receive evidence and make rulings about individual cases, the court can manage distinctive issues that arise in individual cases, can make rulings that are relevant to the circumstances in individual cases, and can set precedents.

Judicial officers in Family Law Courts in Australia make decisions both about whether to admit testimony from a therapist as being expert evidence, and about weight to give to evidence from expert witnesses. Family Law Courts in Australia demonstrate transparency about their processes by publishing significant findings in a website AustLii [43]. Rulings by Family Law Courts include comments about the adequacy of the professional and ethical practices displayed in a clinician’s written report and during cross-examination. Judges publish findings about behavioural science research they have accepted in Judge’s Bench Books [44,45].

6. A Sole Approval Mechanism for Innovative Therapy

A question can be raised about whether the scope of the COPE guidelines should be extended to govern publication of innovative mental health interventions that are individualised and are delivered by a registered clinician to families involved in family-oriented courts. Extending the scope of the COPE guidelines would recognise HRECs as the sole pathway and the sole authority to monitor and approve ethicality of evidence-informed mental health therapies that are designed to improve parenting practices, including when clinical interventions are reviewed by a family-oriented court and have been the subject of court orders for reportable therapy.

This article submits that involving a HREC in providing advance approval before a mental health clinician is authorised to proceed with a parenting intervention that might later be published is very restrictive and would greatly impede the already limited delivery of early intervention therapy for children who live in families where parenting is considered to be inadequate.

Requiring prior approval from a HREC before delivery of individualised parent-child therapy that might include innovative clinical practices before the intervention can be published introduces six practical problems. First, families, including court-involved families, would need to wait for an HREC to deliberate and grant approval before they can access assessment or therapy, when delays in accessing therapy have very adverse effects on children. Second, confidential information would likely need to be provided to the HREC to justify use of individualised therapy for a family. Third, every proposal for individualised therapy with court-involved families would need to be submitted to a HREC as therapy addresses individual needs and is not standardised. Fourth, some countries do not have HRECs established to approve innovations provided by private practicing clinicians. Fifth, established NRECs might lack expertise in the specific issues that arise in court-involved families. Sixth, clinicians cannot tell in advance which interventions a HREC will consider to be well accepted, and which interventions will be considered as possibly experimental and research.

It is submitted that identifying HRECs as the sole authority for ruling on the ethicality of publishing individualised therapy for court-involved families introduces a significant barrier to the dissemination of effective evidence-informed therapies for vulnerable children in these families, and impedes implementation of the scientist-practitioner and levels of evidence models of practice.

6.1. Transparency of Agencies

Further, granting authority and showing trust only in HRECs to make judgments about ethicality of individualised clinical interventions highlights issues associated with transparency of committees.

It appears that some HRECs display limited transparency about their operations. Concern about transparency is raised if: a HREC does not publish the composition of its membership; a HREC does not publish the criteria used when making judgments; a HREC communicates only with researchers who submit proposals; and a HREC does not publish rulings it makes about submissions.

6.2. Potential for Biases

A further ground for unease about HRECs that are internal to large organisations becoming the sole authority for making judgments about ethicality of interventions is that a committee might display a range of biases.

An example is given. First, reviews of international research are briefly summarised.

Jacobs et al. [46] examined 41 reviews of instruments used to assess the mental health of children including children who have child welfare involvement, childhood trauma and developmental disabilities. They found that a range of instruments were used to assess children’s mental health, with low consensus between reviewers about suitability of instruments for children in different circumstances. Jacobs et al. identified one instrument, the Strengths and Difficulties Questionnaire, as a suitable instrument to assess children’s general mental health as the instrument is easy to administer, identifies criteria for families to be referred for additional assistance, identifies core mental health concerns, and can function as a screen and an outcome measure. The Strengths and Difficulties Questionnaire was reportedly used in 9772 published research studies in the period 1997-2024 [47].

A meta-analysis of assessment instruments by Ride et al. [48] found that teacher-reports using the Strengths and Difficulties Questionnaire was the instrument most commonly used to assess children’s mental health, and found there was statistical evidence of its ability to detect change following targeted interventions that address children's mental health issues.

Hudson et al. [49] conducted a review of 152 meta-analytic and systematic reviews of intervention literature regarding efficacy of targeted mental health intervention programs for children aged 4–9 years. They found substantial evidence for the efficacy of focused interventions that address children’s general mental health concerns including externalizing and internalizing problems, as well as emerging evidence for interventions that address children’s trauma. Their review found that children whose initial symptoms were more severe had benefitted more from interventions that were targeted following individualised assessments.

However, established assessment instruments such as the Strengths and Difficulties Questionnaire are not always recommended by agencies. An example from Australia is cited. The Government of South Australia allocated the role of supporting families where children are vulnerable to its Department of Human Services (DHS). DHS established a Child and Family Support System (CFSS) to receive referrals for families who require additional support including Intensive Family Support as the family experienced issues including developmental delay in children, parental mental health issues, substance misuse, and domestic violence [50]. The aim of providing additional services is to keep families together and to minimise removal of children from parental care for child protection reasons. Services provided by CFSS are reportedly based on research, evidence and quality practice.

CFSS reviewed 42 instruments used to assess outcomes of services, generated a list of seven domains it considered to represent important outcomes, evaluated instruments against the list of domains, and assigned ratings to each instrument according to how well the instrument aligned with the department’s hierarchy of outcomes [50]. The CFSS review included three instruments that have been used extensively in scientific and clinical work to evaluate efficacy of interventions with children. The CFSS review gave the following ratings to well-established instruments: Ages and Stages that assesses children’s developmental level was given a rating of 1 out of 7; Strengths and Difficulties Questionnaire that assesses children’s mental health was given a rating of 2 out of 7; and Children’s Behavior Checklist that assesses children’s mental health was given a rating of 3 out of 7 [50]. The criteria used in the CFSS review appear to have resulted in ratings being allocated to the Strengths and Difficulties Questionnaire and other instruments that are markedly lower than would be expected from meta-analyses of data.

It appears that results of scientific research that are highly respected by one discipline can be disrespected and ignored by another discipline. It appears possible that, when committees composed primarily of members of one discipline evaluate assessment instruments and therapy procedures used by another discipline, then various types of bias can emerge and predominate. A bias could emerge that favours interventions provided by the majority discipline in an agency, or interventions that favour maintenance of the status quo while resisting interventions that promote change.

A retainer bias can develop when an assessor provides a report that is designed to meet the vested interests of a funding body [51]. Retainer biases can continue for long periods of time without being detected by a funding body. One mechanism to minimise risk of retainer bias is to allow individual clients to select their own assessor who is accountable to an independent authority, rather than be reliant of evaluative reports that are provided by assessors who are funded by the agency that makes decisions.

7. A Proposed Solution

The article proposes that publishers be cautious about extending the COPE guidelines to cover publication of mental health treatment reports that are monitored through other accepted mechanisms. The article draws attention to the existence of other well-established mechanisms to monitor the ethicality of mental health treatment reports, including treatment reports that are submitted to family-oriented courts.

Health professionals are expected to inform clients about impacts of participating in a project and obtaining informed consent regarding both likely and possible impacts. One right of clients that is emphasised in legislation and by ethicists involves a right to confidentiality of private information. When a treatment report is written that may be submitted to a family-oriented court, it is possible for a clinician or one party will be required to disclose the report to third parties. A clinician has an obligation to inform a client who requests a written treatment report of the possibility the report could be disclosed by recipients to a number of parties, and to obtain consent from the client for taking this risk. This article proposes introduction of a distinct mechanism to show that a client has both been informed of the risk of disclosure and consented to the risk of disclosure, by using a standardised consent form that summarises ways that confidential information might be disclosed.

A consent form for use by clinicians who provide individualised therapy for court-involved families is attached in Appendix 1. The consent form summarises the agreement made between a clinician and client.

The article proposes that publishers accept a standard consent form used by a clinician and designed for use with court-involved families as sufficient evidence that the ethicality of interventions has been approved by the mechanism of receiving informed consent from recipients for interventions that may be considered innovative.

The article proposes that publishers avoid adopting unnecessarily restrictive practices that constrain publication of innovative applications of existing knowledge to clinical practices in areas where there are significant gaps in research. The article proposes that publishers accept responsibility for gatekeeping and judging the ethicality of clinical work that has met ethical standards using established mechanisms, rather than outsourcing the role of making judgments about ethicality to an external agency.

It is proposed that adoption of a standard consent form for use with court-involved families who participate in parent-child therapy will clarify topics that have been addressed by the clinician when informing clients about interventions that appear innovative, and will clarify the nature of consent that has been granted.

8. Conclusion

This article discusses mechanisms that have been introduced by scientists, legislators and other bodies to ensure that mental health interventions are developed, implemented and published using ethical approaches.

The article notes there is a need to continue to develop assessment and therapy interventions for some vulnerable sections of the population, including children who live in court-involved families. The ethicality of delivery of innovative assessment and therapy interventions is currently monitored using three main mechanisms; following scientific procedures involving levels of evidence; registration of mental health professionals; and review of treatment reports by family-oriented courts. The development of innovative therapies commonly occurs as a progression from published single case studies to group trials and then to multi-site randomised controlled trials. It is conventional for HREC oversight to be sought following publication of single case studies when a group trial is proposed.

The article proposes that the introduction of agreed standardised assessment and consent frameworks for use with court-involved families will facilitate collaboration between clinicians, researchers, ethicists, and publishers. It is further proposed that the introduction of standardised assessment and consent forms will enhance recognition of the important role of individualised therapies and will improve the confidence of clinicians who provide therapy for vulnerable clients when there is limited agreement about how ethical principles will be interpreted in different jurisdictions and by different professionals.

The article proposes that ethicists and publishers recognise the current roles of government established agencies for monitoring the ethicality of mental health interventions that are delivered by registered professionals, and not duplicate this process. The article proposes that publishers resist a movement to have the COPE guidelines recognised as the sole mechanism for approving publication of innovative mental health interventions for court-involved families, when interventions involve a low risk of harm to clients. This proposal will require work on identifying mental health interventions that involve low risk when provided by registered practitioners.

Risks to children who live in vulnerable families are highlighted if publishers were to recognise only a single pathway and mechanism to approve mental health interventions that are innovative and non-intrusive. One risk in countries that do not have an established HREC that is authorised to approve innovations developed by private practicing mental health clinicians is that public servants will become the sole source of innovation for vulnerable groups who are currently not well served by existing structures, where public servants operate under known constraints.

The article recommends that publishers encourage mental health clinicians who are qualified and accountable to publish single case studies describing preventive innovative practices that reduce risk that children who live in court-involved families may experience mental health difficulties. The article proposes that evidence a clinician who provided an innovative intervention has received informed consent for the intervention from an authorised adult be recognised as sufficient evidence that ethical practices were followed in the case.