Fake Qualifications

'Are You for Real? Lessons for the Academy About Professors with Fake or Fraudulent Degrees' by Sarah Elaine Eaton and Jamie J Carmichael in Sarah Elaine Eaton, Jamie J Carmichael and Helen Pethrick (eds), Fake Degrees and Fraudulent Credentials in Higher Education (Springer, 2023) 251–267 comments 

In this chapter we demonstrate what can happen when professor and educational leaders have fake or fraudulent degrees or other qualifications. We present four key issues: (a) the threat to institutional reputation; (b) the threat to the credentials awarded by the institutions; (c) the impact on students; and (d) material costs to the organization. Then, we propose seven recommendations to prevent or address academic qualification fraud: (a) verify applicant credentials; (b) develop or update internal risk assessment plans; (c) conduct an internal qualifications audit; (d) develop or update institutional codes of conduct; (e) develop an internal process to investigate allegations of credential fraud; (f) develop and follow internal quality assurance processes for courses, programs, and curricula; and (g) Develop or update crisis communications plans to include credential fakery or fraud. We conclude by emphasizing that moral outrage will not solve the problem of academic credential fraud. Clear policies and procedures must be in place to prevent, investigate, and address qualifications fraud in educational contexts.

Pretendians

'Academia, Twitter wars, and suffocating social justice in Canada: the case of unrecognised Indigenous peoples by Michel Bouchard, Sébastien Malette and Jo-Anne Muise Lawless in (2022) Dialectical Anthropology comments 

The “woke movement” is now under fire globally. Seeking to right social injustice and battle racism, the woke movement has laudable intentions, but its implementation can exacerbate social inequalities. In the case of Canada, a social movement seeks to ferret out “Pretendians” or those White individuals deemed to be falsely assuming, and thus appropriating, Indigenous identity. Though this movement may seem righteous, the problem arises that individuals targeted are those who are Non-Status Indians and have yet to be recognised by the state, as well as Métis (or mixed-heritage people) whose historical communities have yet to be sanctioned by governments or courts, and who are also portrayed as being “Fétis” or fake Métis. Our challenge as researchers is to do the deep ethnographic, historical, and legal research to provide a nuanced understanding of indigeneity that does not constrain it solely to colonial models as the case studies provided will demonstrate.

The authors argue 

Social media has become the go-to tool for social justice activism. Through tweets and other digital media, individuals can successfully reach thousands, if not millions, globally. There are increasing concerns that the polarization of positions and the search for quick validation on social media may contribute to stifling academic exchanges, suffocating nuanced analysis, and discouraging discussions potentially leading to greater equity. As Beckerman (2022) highlights, online success necessarily requires resort to the use of algorithms which cater to a narrow spectrum of emotions, notably outrage, anger, and shame (Jones 2022). Though Twitter certainly fuelled large and important protests such as the Black Lives Matter movement, it arguably provides few pathways to lasting change, as this requires “[c]arefully crafted manifestos and patient debate” (Jones 2022). Rather, social media risks amplifying expressions of moral outrage, which is what is rewarded (Hathaway 2021). Those expressions in turn feed into moral panic, generating further social problems (Walsh 2020). Sociologically, a moral panic occurs when a mass movement propagates a false or exaggerated perception that some behaviour or group of people is deviant and poses a threat to society’s values and interests (Cohen 2011). Moral panic is generally fuelled by saturated media coverage of a perceived deviant behaviour. 

Recently, Canada has witnessed an uproar surrounding the legitimacy of those who are outside state-sanctioned spaces claiming Indigenous identity (Basken 2022; Martens 2021) As media attention on this topic grows, circles of activists and academics are trying to seize on these concerns with notions of pan-indigeneity, turning them into a crisis that can boost their own social influencer and righteous gatekeeper status. A consequence is disregard of concerns for diversity of Indigenous experiences within Canada’s colonial context—especially regarding Non-Status and “Other Métis” communities. Traditional media and online activists do not seek out those claiming a Métis identity outside of the state-sanctioned Métis Nation and Non-Status individuals who are not members of recognised bands. Instead, they publish anonymous accusations based on superficial analysis which, in turn, has led to individuals losing their jobs or having their work repudiated. Filmmaker Michelle Latimer is one example (Dowling 2021; Bresge 2018). Another is the Ardoch Algonquin First Nation community. Our paper examines those two cases within the larger colonial structure which has sought, and still seeks, to slowly limit and decrease the number of Indigenous identities in Canada. We also argue that, as online aggression builds, calls to censor academic research will increase as communities deemed to not exist a priori are deemed unworthy of research and the very act of studying these communities is described as promoting what Leroux (2019) termed “race-shifting”.

Homeopathy

Last month's Homeopathic Drug Products Guidance for FDA Staff and Industry document is described as representing the current thinking of the US Food and Drug Administration (FDA or Agency), does not establish any rights for any person and is not binding on FDA or the public. 

The Guidance states 

I. INTRODUCTION 

This guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health. 

The Agency anticipates that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enforcement and regulatory action as described in Section III below. 

For the purposes of this guidance, we define a “homeopathic drug product” as a drug product that is labeled as “homeopathic,” and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS). 

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 

II. BACKGROUND 

Homeopathy is an alternative medical practice that has a historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”); and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”). Proponents claim that a significantly diluted aqueous solution, consisting mainly of water molecules, retains therapeutic properties due to a “memory” of the substance diluted in it. 

Historically, homeopathic drugs have been identified through “provings,” in which substances are administered to healthy volunteers in concentrations that provoke overt symptoms. Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the substances. In other words, if a substance elicits a particular symptom, individuals experiencing that symptom would be treated with a diluted solution made from that substance. 

In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to the law recognizing the HPUS alongside its counterparts, the U.S. Pharmacopeia (USP) and the National Formulary (NF). Recent years have seen an increase in the sale of homeopathic drug products. In the past, these products were mostly prepared by homeopathic physicians for individual patients. Today they are frequently mass manufactured and widely marketed as over- the-counter (OTC) products. 

The definition of “drug” in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)) includes, among other articles, articles recognized in the HPUS or any of its supplements. As such, homeopathic drugs are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements. Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended, or suggested in the labeling. 

Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), before any “new drug” is marketed, it must be the subject of an approved application filed pursuant to section 505(b) or section 505(j) of the FD&C Act. The requirements in section 505 of the FD&C Act apply to biological products regulated under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262); however, as stated in section 351(j) of the PHS Act (42 U.S.C. § 262(j)), a biological product with an approved license under section 351(a) of the PHS Act (42 U.S.C. § 262(a)) is not required to have an approved application under section 505 of the FD&C Act. Accordingly, absent a determination that a homeopathic drug product is not a “new drug” under section 201(p), such a homeopathic drug product is subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are currently no homeopathic drug products that are approved by FDA. 

Under section 505G of the FD&C Act (as added by the CARES Act6)—which reforms and modernizes the OTC drug review process established in 1972—FDA now issues administrative orders to make GRAS/E determinations for certain nonprescription drugs marketed without an approved application. Prior to enactment of CARES, FDA had not reviewed any homeopathic drug products under the OTC Drug Review, because the Agency had placed homeopathic drug products in a separate category and deferred consideration of them. 

Subsequent to enactment of CARES, no GRAS/E determinations will be made for homeopathic drug products under section 505G, because section 505G does not apply to homeopathic drug products. 

Because at this time no homeopathic drug products have been determined by FDA to be GRAS/E, all homeopathic drug products remain subject to the premarket approval requirements. 

A. Compliance Policy Guide 400.400 In May 1988, the Center for Drug Evaluation and Research (CDER) issued Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” CPG 400.400 described the Agency’s enforcement priorities for homeopathic drugs. 

B. FDA’s Reexamination of its Enforcement Policies 

In light of the growth of the industry and passage of more than two decades since the issuance of CPG 400.400, FDA announced on March 27, 2015, that it was evaluating its regulatory framework for homeopathic drug products.  In April 2015, FDA held a public hearing to obtain information and comments from stakeholders about the current use of homeopathic drug products, as well as the Agency’s regulatory framework for such products.  FDA sought broad public input on its enforcement policies related to homeopathic drug products in an effort to better promote and protect the public health. 

Since the issuance of CPG 400.400, the Agency has encountered multiple situations in which homeopathic drug products posed a significant risk to patients. Such products either caused or could have caused significant harm, even though the product labeling and ingredient formulation appeared to meet the conditions of CPG 400.400. 

FDA has also documented many serious violations of Current Good Manufacturing Practice (CGMP) requirements by some manufacturers of homeopathic drug products, raising significant concerns about the safety of products made with inadequate process controls. 

As a result of the Agency’s evaluation of its regulatory framework, including consideration of the information obtained as a result of the public hearing and the recent growth of safety concerns associated with some homeopathic drug products, FDA believes that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to homeopathic drug products marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally. 

C. FDA’s Risk-based Approach 

Regardless of the product area, FDA generally applies a risk-based enforcement strategy. For example, FDA has generally employed a risk-based enforcement approach with respect to marketed unapproved new drugs. The Agency historically has prioritized compliance actions involving unapproved new drug products that have potential safety risks, lack evidence of effectiveness, are health fraud products, present challenges to the new drug approval process or the OTC Drug Review, are violative of the FD&C Act in other ways, or are reformulated to evade an FDA enforcement action. The Agency generally intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products, as described below. 

III. FDA’s ENFORCEMENT POLICY 

FDA is not required, and generally does not expect, to give special notice that a drug product may be subject to enforcement action. In the listing that follows, we clarify our general approach to prioritizing our enforcement and regulatory actions with regard to homeopathic drug products marketed in the United States without the required FDA approval. However, this guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time. 

Enforcement and Regulatory Priorities 

In developing a risk-based approach, FDA has identified certain categories of homeopathic drug products marketed without the required FDA approval as potentially posing higher risks to public health. FDA generally intends to prioritize enforcement and regulatory actions with respect to premarket approval requirements involving homeopathic drug products that are marketed without the required FDA approval that fall within the following categories:

• Products with reports of injury that, after evaluation, raise potential safety concerns. For example, MedWatch reports or other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues. 

• Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:

o An infectious agent with the potential to be pathogenic; 

o A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 802; 

o Multiple ingredients that, when used in combination, could result in possible interactions, synergistic effects, or additive effects of the various ingredients; or, 

o Ingredients that pose a risk of toxic, or other adverse effects, particularly when the ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process. 

• Products for routes of administration other than oral and topical. For example, injectable drug products and ophthalmic drug products in general pose a greater risk of harm to users because the routes of administration for these products bypass some of the body’s natural defenses. In particular, contaminated injectable and ophthalmic products can pose serious risks to the patient. 

• Products intended to be used for the prevention or treatment of serious and/or life- threatening diseases or conditions. Unapproved products for serious and/or life- threatening diseases or conditions raise public health concerns, in part, because they may cause users to delay or discontinue medical treatments that have been found safe and effective through the new drug application (NDA) or biologics license application (BLA) approval processes. 

• Products for vulnerable populations. For example, patient populations such as immunocompromised individuals, infants and children, the elderly, and pregnant women may be at greater risk for adverse reactions associated with a drug product, even if it contains only small amounts of an ingredient, due to the varying ability of individuals in these populations to absorb, metabolize, distribute, or excrete the product or its metabolites. These populations may also be at greater risk of harm as a result of foregoing the use of medical treatments that have been found safe and effective through the NDA or BLA approval processes or under the OTC Drug Review. 

• Products with significant quality issues. For example, products that are contaminated with foreign materials or objectionable micro-organisms, and/or are made in facilities with significant deviations from CGMP, pose a significant safety risk to patients.

The FDA notes that in 2016 its search of the FDA Adverse Event Reporting System (FAERS) database 

identified 99 cases of adverse events consistent with belladonna toxicity, including reports of infant deaths and seizures, possibly related to teething products. Multiple homeopathic drug products were identified as associated with this safety concern. Further investigation revealed that the poisonous belladonna alkaloids in some of the homeopathic teething tablet products far exceeded the labeled amounts, raising a serious safety concern. As another example, by 2009, FDA had received more than 130 reports of anosmia (loss of the sense of smell) associated with the use of Zicam homeopathic intranasal zinc products. FDA determined that if the products were used as labeled, a user would receive significant daily exposure to intranasal zinc, raising a serious safety concern. These are only two examples among many.

In 2019, as an example of enforcement, the FDA issued Warning Letters 

 to four companies that jointly manufacture and package Puriton Eye Relief Drops. The warning letters describe failures to conform to CGMP requirements due to improper methods, facilities or controls for manufacturing, processing and packing drugs. For example, multi-dose, preservative-free, homeopathic ophthalmic drug products were manufactured without any attempt to render them sterile. FDA tested multiple samples of these homeopathic ophthalmic drug products and found that they (1) were non-sterile (samples were found to be contaminated with Bacillus spp., high levels of particulate matter, or both), which could lead to eye infection; and (2) had a dangerously high pH level, which could lead to eye injury such as glaucoma, corneal scarring, and loss of vision. .

Judicial Commission

The national Attorney-General has released a discussion paper on Scoping the establishment of a federal judicial commission .

The paper states

The Australian Government is considering the potential scope and design of a federal judicial commission that can independently examine complaints made to it about federal judges and refer its findings for appropriate action. This was announced by the Attorney-General, the Hon Mark Dreyfus KC MP, on 25 October 2022 in the context of the 2022-23 Budget, and reflects the Attorney-General’s longstanding support for a federal judicial commission. 

On 29 September 2022, the Government published its response to the Australian Law Reform Commission’s (ALRC) 2021 report, Without Fear or Favour: Judicial Impartiality and the Law on Bias (ALRC Report), agreeing in-principle with the ALRC’s recommendation that the ‘Australian Government should establish a federal judicial commission’.  The ALRC acknowledged that establishing a federal judicial commission would be a significant reform, requiring its own policy development process, including further broad consultation. 

The establishment of a federal judicial commission would follow the creation of similar bodies in five of Australia’s states and territories, and would build on the Australian Government’s strong commitment to integrity, fairness and accountability across all areas of government, including by complementing the National Anti-Corruption Commission which will commence operation in 2023. 

This paper seeks views from stakeholders and interested members of the public on the model and key features of a federal judicial commission. This paper does not consider reforms to complaints-handling mechanisms for non-judicial officers or state and territory judges, nor does it canvass the implementation of other recommendations from the ALRC Report. 

The Australian Government has not yet made any decisions on the merits and policy design of a federal judicial commission. 

Responses to this discussion paper will be considered by the Attorney-General’s Department to inform advice to Government in relation to the merits and design of a model for a federal judicial commission. Any proposed model for a federal judicial commission must respect the independence of the courts and judiciary in accordance with the Constitution, which is fundamental to the rule of law and democracy in Australia. The decision to establish a federal judicial commission will be a matter for the Australian Government.

The questions for consideration are - 

Composition and decision-making 

1. Should the membership of a federal judicial commission include some or all of the heads of jurisdiction of the High Court of Australia, the Federal Court of Australia and the Federal Circuit and Family Court of Australia? 

2. Should a federal judicial commission have any other ex officio or appointed members? If so, how many members should constitute the commission, and what criteria and appointment processes should apply? 

3. How should decisions of a federal judicial commission be made where the members are not able to unanimously agree? 

Scope: judicial officers 

4. Should a federal judicial commission be empowered to examine complaints about a justice of the High Court in addition to other federal judges? 

5. Should a federal judicial commission be empowered to examine complaints about a former judicial officer and, if so, in what circumstances? 

Grounds for considering complaints 

6. Should a federal judicial commission be empowered to examine a complaint related to any matter that, if substantiated, the commission is satisfied: a. may justify removal by the Governor-General in Council on an address from both Houses of the Parliament on the ground of proved misbehaviour or incapacity, or b. warrants further consideration on the ground that it may affect or may have affected: i. the performance of judicial or official duties by the officer, or ii. the reputation of the court of which the judge is or was a member? 

7. Are there any circumstances in which a federal judicial commission should not be empowered to examine a complaint that meets one of the above criteria? 

8. Are there any circumstances in which a federal judicial commission should be empowered to examine a complaint that does not meet the above criteria? 

9. Would it be appropriate to have any additional limitations on a federal judicial commission’s jurisdiction to handle complaints about a matter arising after the resignation of a judicial officer, or concerning conduct alleged to have occurred before the appointment of a judicial officer to judicial office or before the commencement of any enabling legislation? 

Avenues for receiving complaints 

10. Should a person be able to make a complaint to a federal judicial commission anonymously, and in what circumstances would this be appropriate? 

11. Should it be open to professional bodies to make complaints to a federal judicial commission? If so, should any limitations apply? 

12. Should any person be able to make a complaint to a federal judicial commission with a request for confidentiality regarding the particulars of the complaint, or the identity of the complainant? 

13. Should a federal judicial commission have the discretion to: a. consider multiple complaints together, and b. take into account repeat conduct of the same or similar nature in relation to the same judicial officer, and if so, should any limitations apply? 

14. Should a federal judicial commission have discretion to initiate an investigation on its own motion if it considers a matter would otherwise meet its thresholds for consideration if it were the subject of a complaint? 

15. Should consideration be given to providing a federal judicial commission with express powers to declare a person to be a vexatious complainant? 

Actions a commission may take 

16. Should the grounds on which a federal judicial commission may appoint an ad hoc investigatory panel to investigate and report on a complaint be expressly limited to matters that a commission considers could, if substantiated, justify removal from office? Alternatively, would it be appropriate for a federal judicial commission to have a discretion to establish an ad hoc investigatory panel to investigate and report on a complaint if the commission considers such an investigation to be appropriate in the circumstances? 

17. Should the identity of judicial officers, the subject matter of complaints, and/or the findings or recommendations made by a federal judicial commission or ad hoc investigatory panel be made publicly available? If so, at what stage in the complaints process and on what, if any, conditions? 

Composition of an investigatory panel 

18. How should an ad hoc investigatory panel established by a federal judicial commission be constituted? What criteria and appointment processes should apply? 

Powers of the commission and an investigatory panel 

19. Would it be appropriate for a federal judicial commission to have the same powers as an ad hoc investigatory panel established by the commission, including the ability to issue summonses and examine witnesses? If not, how and why should the powers of the commission differ from the powers of an investigatory panel? 

Intersection with other bodies and processes 

20. How could a federal judicial commission best complement or support the role of existing judicial education bodies, such as the National Judicial College of Australia and the Australasian Institute of Judicial Administration? 

21. Should complainants be able to rely on evidence resulting from a complaints process, or the findings or recommendations made by a federal judicial commission, in other proceedings?

NZ Clinical Trials Regime

The Enhancing Aotearoa New Zealand Clinical Trials report released last month states 

 Clinical trials are a central element of a modern, high-functioning health system. Clinical trials can provide access to novel treatments for patients and deliver cutting-edge healthcare. Further, investment in clinical trials allows for efficient healthcare and provides health sector returns in excess of the dollars invested. The evidence generated by clinical trials is used to improve our health services, ranging from public health and prevention interventions through to specialised medicines and novel devices. Clinical trial research increases the efficacy and efficiency of care, thereby bettering the health of New Zealanders. 

While there are examples of high-quality research, Aotearoa New Zealand does not invest as effectively as it could, and should, in clinical trial research. We do not realise the significant potential benefits of clinical trial research for the people of Aotearoa New Zealand and those benefits that are realised are distributed inequitably because of the current health system’s fragmentation and rigidity, and because clinical research is not embedded within it as part of a learning healthcare system. To respect Te Tiriti o Waitangi and meet obligations as a treaty partner, it is critical that we have clinical evidence of the efficacy and safety of healthcare interventions for Aotearoa New Zealand’s population, especially Māori. This project proposes a future direction for developing infrastructure that will support equitable clinical trial activity, ensure that trials (including commercial ones) benefiting from publicly funded infrastructure are responsive to the needs of New Zealanders and ultimately enable the equitable delivery of the best healthcare we can achieve to all New Zealanders. 

This report is the outcome of independent research funded by the Health Research Council of New Zealand and Manatū Hauora | Ministry of Health. 

This project was conducted by a diverse group of clinical researchers from a range of backgrounds and disciplines and involved a specific Māori Rōpū, a Pacific advisory group and a consumer group. It also consulted a group of international researchers. The project reported to an expert steering group appointed by the Ministry of Health (MOH) and the Health Research Council (HRC). 

The project proceeded with a characterisation of the current state of clinical trial activity, both in Aotearoa New Zealand and in terms of international practice. We collected information from the Australian New Zealand Clinical Trials Registry (ANZCTR), conducted a survey of researchers, carried out 58 individual and group interviews, and met with the Māori Rōpū, Pacific advisory group and consumer group. This information was reviewed by iNZight Analytics through the Te Ao Māori lens. 

Current-state findings were reviewed by many stakeholders in a workshop at which approaches for improving the clinical trial infrastructure in Aotearoa New Zealand were canvassed. These approaches formed the basis for a modified sector-wide Delphi process to find consensus on a variety of clinical trial infrastructure options. Options that were supported in the Delphi process formed the basis for the research team to propose a preferred model for the infrastructure needed to support clinical trials and achieve benefit from them for the people of Aotearoa New Zealand. Clinical trial research is a barometer for health research activity in general. High-quality clinical trial research gains will only be realised with a functioning and supported health research infrastructure. Thus, while this project is focused on clinical trial research, a number of the recommendations (for example, those targeting improving research leadership, knowledge translation or data governance) apply to health research activity more broadly. Therefore, actioning the recommendations contained within this report will achieve gains within a wider context of health system research, innovation, and improvement. 

Current-state findings 

The main findings of our current-state analysis were: 

• The New Zealand health system does not generally have a strong research culture, notwithstanding individual examples of excellence. Health system decision-making often does not facilitate research activity and, in many cases, can be a barrier to the conduct of research. 

• Prioritisation of clinical trials, in the sense of funders systematically considering what research will reduce inequities and bring benefits for New Zealanders, is rarely practised outside of the HRC. 

• There is great diversity in existing clinical trial activity across different kinds of health intervention, different phases of intervention development, and different settings. 

• Institutional settings for clinical trials vary significantly across philanthropic organisations, universities, district health boards and community health organisations. Within the window of our stakeholder and current-state analysis, few trials have been conducted in Māori health provider settings and none in Pacific provider settings. 

• There is a gap in partnership with Māori, both in the design and conduct of individual trials, and in the wider infrastructure of trial activity, including in the management of data and tissue samples with appropriate tikanga. 

• There is a need for clinical trial methodologies and conduct to be more responsive to Māori needs, and more sensitive to cultural requirements. 

• Consumers have a rapidly growing role in clinical trials and in making sure research is relevant and meaningful. Through the consultation process we have heard there is a need to create more opportunities for consumers to be research partners. 

• Clinical research workforces are fragile. 

• The Māori clinical research workforce is particularly thinly stretched, with barriers to development and support for those wishing to pursue a research career. 

• There are examples of good access to key infrastructure, such as statistical advice, or experienced research nurse support, but that access is very patchy, making this an important barrier to undertaking research and to development of a sustainable research workforce. 

• Existing clinical trial networks provide critical support for researchers, enabling high-quality success, but they are fragile and not resourced sustainably. 

• Information needs are changing, data governance processes are diverse and often not systematic, and there is little guidance on data sovereignty. 

• There is relatively little focus on translation of research results into practice. Translation is a particular issue for Māori given the extractive nature of research, the need to tailor results for Māori providers, and a need to show Māori reasons to become involved in trials. 

• Accurately costing and adequately funding clinical trials and clinical trial development is difficult, and the ability to conduct a long-term clinical trial (>3 years) within existing funding caps is problematic. ...

There is a strong case for significant investment in a national clinical trials infrastructure in Aotearoa New Zealand. These general recommendations form the foundations for a proposed infrastructure to harness the potential of clinical trials within Aotearoa New Zealand’s healthcare system.

• The national clinical trials infrastructure must be underpinned by principles of Te Tiriti and developed in co-governance with Māori. 

• The responsibility for ensuring high-quality research activity must be woven into the job descriptions of all senior clinical leaders in Health NZ and the Māori Health Authority. There must also be targeted measures of accountability for these senior clinical leaders. 

• There must be an adequately resourced National Research Office for Health NZ, co-governed with the Māori Health Authority, with research leadership at the executive level of the organisations. While this function exists within the context of health research policy leadership from the Ministry of Health, in order to envisage possible gains it is essential for Health New Zealand to have research leadership at the operational level. 

• There should be a National Clinical Trial Infrastructure Centre with expertise from across the country, which will provide leadership, governance, expertise, and overall, high-level national support and coordination of trial activity, including the support of clinical trial networks in Aotearoa New Zealand ... 

• There should be Regional Clinical Trial Coordinating Centres around the country that between them provide the necessary expertise to support clinical trials as outlined in section 5.3 of this report. Each of these centres will support trial development and conduct across regional nodes to ensure equity of access for both researchers and participants and will collaborate with other centres to support local, regional, national, and international trials. 

• There should besustainableandsystematicnetworks for Māori researchers and for Pacific researchers to support Māori and Pacific research communities in a regular and coordinated way in accordance with recommendations and priorities identified above. 

• Active development and support for the Māori health research workforce to meet commitments to Te Tiriti and to reducing inequities in health. 

• Partnership with Māori and local Māori communities at every level, including trial implementation and national infrastructure. 

• Supporting Te Ao Māori methods/priorities and engagement with researchers and communities. 

• Embedding Māori data sovereignty and tikanga about data in the clinical trials system. 

• Ensure knowledge translation has a positive impact for Māori and reduces inequities in health outcomes. 

• When funding mechanisms are developed, ensure they are responsive to Māori community needs and researcher obligations. 

• Support and train tauiwi workforce to engage with Te Ao Māori. 

• Active development and support for the Pacific health research workforce. 

• All publicly funded clinical trials should include consumer research partners. 

• There should be a national federated health data system with Māori data governance at the core, that allows embedding of research in routine clinical care and provides culturally appropriate long-term curation of research data. 

• A clear responsibility for research knowledge translation and implementation must be established within Aotearoa New Zealand’s new healthcare system that is well integrated with change management, clinical governance functions, and the health system’s role and responsibilities as an effective Te Tiriti partner for Māori.

These recommendations were developed from consistent needs and themes across the project and from all those consulted. In addition, specific recommendations from the Māori Rōpū and Pacific and consumer groups (see section 6.2) further identify priorities to ensure their needs are meet by the preferred infrastructure model. 

Preferred model 

Our preferred infrastructure model will address the recommendations made by our extensive groups of stakeholders. Our proposal consists of two main components:

• A National Clinical Trial Infrastructure Centre that manages some of the functions and activities that have been agreed to be critical through the Delphi survey process. 

• Multiple Regional Clinical Trial Coordinating Centres, procured by the National Clinical Trial Infrastructure Centre, that manage operational functions and activities at local level or across specific communities on behalf of the centre. Supporting organisations may be consortia or could contract other organisations as suppliers for necessary resources.

We have identified a detailed set of functions and activities to be provided across the National Clinical Trial Infrastructure Centre and the Regional Clinical Trial Coordinating Centres. We envisage that the National Clinical Trial Infrastructure Centre will be an integral part of the newly developing Health New Zealand and Māori Health Authority, with the capability and resources to influence their culture to develop a genuinely learning health system for the benefit of all people in Aotearoa New Zealand. The research leadership must be closely integrated with leadership in clinical governance and quality, innovation and change management, and the professions in order to achieve the promise of improved healthcare based upon high-quality evidence that is relevant for New Zealanders.