Governance of research involving people with psychosocial disabilities

Health-related research with human participants is governed by research ethics regulations in most jurisdictions. Globally, the 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), are especially influential and widely held as an international standard. The CIOMS guidelines support the inclusion of people with psychosocial disabilities in research and offer clear guidance to promote their recruitment, including by outlining provisions for substitute decision-making. The CIOMS guidelines sit alongside the United Nations’ Convention on the Rights of Persons with Disabilities (CRPD). Adopted in 2006 and ratified in 2008, the CRPD offers a robust framework for recognizing the rights of persons with disabilities, including individuals with psychosocial disabilities. Though the CRPD does not explicitly reference research inclusion, its core principles—especially pertaining to the right to universal legal capacity—have clear implications for research ethics governance, specifically with respect to the use of substitute decision-making for research participation. In this paper, we review the extent to which existing research ethics regulations across selected jurisdictions concord with each of these two frameworks, offering first a broad analysis of regulations across 26 African countries, and then exploring two country-specific case studies from Malaysia and Peru. We find that, while many countries’ research ethics regulations align with key aspects of the CIOMS guidelines, core principles of the CRPD are absent. Given the shortcomings of existing regulations, we analyse a key point of tension between CIOMS and the CRPD—the right to participate in research—and offer a proposal for revised regulations that aims to bridge this tension and meet the standards of both frameworks.


Introduction
The 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), address the ethics of including people with psychosocial disabilities in research.Broadly, the CIOMS guidelines support highly inclusive target populations across studies to ensure fair distribution of research benefits.As such, the guidelines set out clear recommendations for the inclusion of people with psychosocial disabilities in research, with special attention to key issues related to capacity to consent to research and substitute decision-making.The CIOMS guidelines make clear that diagnoses of 'mental and behavioural disorders' do not necessarily imply incapacity to consent, marking progress on prior (and mistaken) views that having a psychosocial disability renders an individual incapable of giving informed consent as a matter of course (CIOMS, 2016).Though the CIOMS guidelines move away from classifying groups of populations as inherently vulnerable, recognizing the harm that this designation has caused (in both sanctioning unfair research exclusion and perpetuating stigma toward specific sub-populations), the CIOMS guidelines do suggest that 'some psychiatric conditions' can cause incapacity, in which case surrogate decision-making is permitted (CIOMS, 2016).
Conversely, a key aspect of the Convention on the Rights of Persons with Disabilities (CRPD)-and, indeed, one of its most celebrated and paradigm-shifting provisions-is its guarantee of the right to universal legal capacity for all individuals living with disabilities, including psychosocial disabilities (UN, 2008).Though this right to universal legal capacity has been much debated in the literature (e.g., Appelbaum, 2019;Freeman et al., 2015;Scholten & Gather, 2018) the Committee on the Rights of Persons with Disabilities reaffirmed in their General Comment No. 1 that legal capacity is, in fact, an absolute right that must be afforded to every individual, and that substitute decisionmaking of any kind contravenes the CRPD (UN, 2014).Additional protections afforded in the CRPD include the right to equality, non-discrimination on the basis of disability, the right to full participation in society, and the right to the highest attainable standard of health.Though research participation is not explicitly mentioned in the CRPD, each of these provisions bear critical implications for the research enterprise.
While the CRPD can be understood as empowering individuals living with psychosocial disabilities, the CIOMS guidelines, while progressive, retain a key function of safeguarding individuals living with psychosocial disabilities.Two key tensions arise: firstly, while the CRPD prohibits substitute decision-making of any kind, the CIOMS guidelines permit substitute decision-making where the potential participant is deemed incapable of giving informed consent.Secondly, while the CRPD does not explicitly guarantee a right to participate in research, several of its core principles, especially in light of the CRPD's guarantee to the right to health and the right to full participation in society, warrant further consideration and scrutiny in their application to the design and conduct of health research.
In this paper, we sought to first characterise the nature of a sample of existing research ethics regulations, across diverse jurisdictions, and the extent to which their mandates align with the CIOMS guidelines and the principles of the CRPD.First, we characterise existing regulations regionally, focusing on African countries.Then we offer in-depth reviews of two country-specific case studies: Malaysia's Mental Health Act 2001 and Peru's Regulation on Clinical Trials.Based on our analysis, we offer an orienting framework for revision of existing national research ethics regulations, aimed to align with both the CIOMS guidelines and the CRPD, delineated according to the purpose of the given research study.This paper was developed from presentations delivered during the 'Governance of research involving people with mental health conditions' session of the 2021 Global Forum on Bioethics in Research on ethical issues arising in research with people with mental health conditions.

Review of selected regulations
Regional study: Africa Of 54 African countries, only 26 countries were reported to have guidelines regulating research (clinical and non-clinical) per the Office of Human Research Protections (OHRP, 2019).Guidelines from 14 of these 26 countries (Botswana, Ethiopia, Ghana, Kenya, Liberia, Malawi, Nigeria, Rwanda, Sierra Leone, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe) were included in the analysis.Exclusion criteria included guidelines not written in English and guidelines that did not include reference to ethical considerations related to involving persons with mental, cognitive, legal disability or dementia or Alzheimer's disease in research.Ethics guidelines were analysed to explore degree of alignment with the CIOMS guidelines and principles of the CRPD.Guidelines that permitted the inclusion of participants with psychosocial disabilities in research were characterised by whether they approached inclusion from a starting point of safeguarding (in alignment with the CIOMS guidelines) or empowerment (in alignment with the CRPD).For example, where the sole requirement for inclusion of participants with psychosocial disabilities was the appointment of a surrogate decision-maker, the regulation was considered to adopt a safeguarding, rather than empowering, approach.Conversely, empowerment measures were those that sought to provide participants with some measure of control over their participation by providing for, among other things, advanced directives for consent to research or shared or supported decision-making models.
Ten of 14 guidelines reviewed offered conditions under which participation of persons with cognitive impairment is permissible.Similarly, 10 of 14 regulations also permitted proxy consent only from a legally authorised representative (LAR) or guardian.However, only four of these regulations provided guidance on who qualifies as LAR: Kenya (other appropriate representatives), Malawi (parents or legal guardians), Sierra Leone (responsible family member or LAR), South Africa (legally appropriate person: spouse or partner; parent; grandparent; adult child; brother or sister, according to the National Health Act 2002).
Only two countries-Liberia and South Africa-set out provisions recognizing advance consent or advance directives.In addition, only Sierra Leone and South Africa had provisions recognizing and upholding the participant's refusal to participate as being superior to any proxy consent.Of the 14 countries whose documents were reviewed, those from Ethiopia, Ghana, Malawi, Rwanda, Uganda and Zimbabwe did not include any consideration of consent or assent by the participant.

National case study 1: Malaysian Mental Health Act 2001
Although the CIOMS guidelines are regarded as one of the main references for research ethics governance in Malaysia, no formal guidance has been developed in the Malaysian context to adopt the recommendations by CIOMS to support the inclusion of people with psychosocial disabilities in research.There is some anecdotal evidence that the absence of specific guidance has in fact resulted in the exclusion of such individuals from participating in research (Kaur, 2011), suggesting that this lack of formal guidance may adversely impact the inclusion of participants with psychosocial disabilities in research.
The sole regulatory instrument that addresses the recruitment of participants with psychosocial disabilities, even if only in brief, is the Malaysian Mental Health Act 2001 (MHA).One section of the MHA, Section 77, provides guidance for people living with psychosocial disabilities to participate in clinical trials.The MHA states that if a potential participant is found to have capacity, the participant can provide consent by himself or herself.However, consent needs to be given by a relative if the potential participant is incapable of giving his or her own consent; in the event that there are no available relatives, two psychiatrists can provide consent on behalf of the potential participant.This piece of legislation aligns more closely with a safeguarding approach, permitting surrogate decision-making after determination of incapacity.Significantly, paragraphs (1)(a) and (b) of Section 77 permit proxy decision-making with what appears to be unfettered decision-making powers; indeed, Section 77 makes no mention of the interests or will of the person at all.The MHA does not require the relatives or physicians of the person declared incompetent to even inquire about the person's interests, much less consider the person's interests in their decision.The MHA affords some degree of protection of the individual's interests in the context of clinical care (Section 86), but with no mention of research.
Malaysia's MHA is insufficient to empower people with psychosocial disabilities to make their own decisions to participate in research.

National case study 2: Peru's Regulation on Clinical Trials
In 2018, Peru changed its legal framework on legal capacity and amended its Civil Code in accordance with the Article 12 of the CRPD.This new framework aims to recognize the legal capacity of people with disabilities on an equal basis by eliminating the figure of interdiction 1 and providing them support to exercise their legal capacity and make choices by themselves.Even though this is an important achievement towards equality in the country, it requires several modifications of other laws and regulations, including those related to health-including the Peruvian regulation on the conduct of clinical trials.
Peru's clinical trials regulation was issued in 2017; the regulation has not yet been adapted to the Civil Code.In adherence with CIOMS guidelines, this regulation establishes that, to include participants with psychosocial disabilities who cannot decide by themselves, informed consent must be obtained by their legal representative.Given the evident legal conflict, two scenarios may be occurring in practice: 1) people with psychosocial disabilities are being systematically excluded from research, or 2) people living with psychosocial disabilities are being enrolled in research according to previous practice (i.e., with proxy consent).The latter scenario violates the CRPD, Peru's Civil Code, and more generally, Peru's constitutional order.In any case, both scenarios are ethically fraught: the first unfairly excludes people with psychosocial disabilities from research while the second does not treat them on an equal basis with others in accordance with the CRPD.
How to translate the Civil Code's provisions on legal capacity into the clinical trials governance framework is a pending task in Peru.In 2021, the Ministry of Health, through the National Institute of Health, designated a Working Group to draft an update of Peru's Regulation on Clinical Trials.Revising this regulation stands to offer the opportunity to discuss this specific topic in detail, engage relevant stakeholders, and refine principles and strategies to adapt the CRPD into the clinical trials regulations in order to ensure that clinical trials involving people with psychosocial disabilities are conducted ethically in Peru.

Analysis
As made evident in our regional review of regulations to govern research in Africa, and through the in-depth case studies of regulations in Malaysia and Peru, the global 1 "Interdiction" is a process in which a court appoints a LAR to a person with mental impairments after a capacity assessment that determines if they can decide by themself, and to what extent (Art.564, Peruvian Civil Code, 1984).regulatory landscape of research with people with psychosocial disabilities is varied.Most importantly, no regulations reviewed in this study appear to offer a clear harmonisation between the mandates of the CRPD and the recommendations of CIOMS with respect to research participation.
Our analysis of this review of regulations globally highlights a divide between 'empowering' versus 'controlling' or 'safeguarding' frameworks.In some country contexts, e.g.Liberia and South Africa, people living with psychosocial disabilities are able to create advance directives to govern decisions about their participation in research.Conversely, in some country contexts, e.g., Malaysia, people with psychosocial disabilities can be enrolled in a research study on the basis of proxy consent.In some cases, as in Peru, disagreement between existing regulations creates a third 'conflicting' framework.Here, regulations must be streamlined to better accommodate the rights of persons living with psychosocial disabilities.
In each case, regulations may align more with the CRPD or with CIOMS.That said, no country analysed offered a fully CRPD-compliant approach to enabling research participation for people living with psychosocial disabilities.A core assertion of the CRPD, as further explicated in General Comment No. 1, is that legal capacity should not be determined by mental capacity (UN, 2014)-an assertion that poses a clear challenge to standard research ethics regulations as prescribed by CIOMS.Indeed, while CIOMS concerns itself with capacity evaluations of potential participants as a strategy for ethical recruitment, the CRPD challenges the notion that 'capacity' can be objectively or meaningfully interpreted at all (UN, 2008).
Moreover, the CRPD demands that people living with psychosocial disabilities are treated on an equal basis with others.This imperative challenges the common practice in research ethics of excluding potential participants on the basis of certain characteristics (e.g., disability).
In the next sections, we offer an analysis of how the CRPD and CIOMS could align.We then set forth a proposal for countries' regulatory bodies to consider in revising their guidelines on the inclusion of people living with psychosocial disabilities in research.

Fair research participation: CIOMS and the CRPD
We suggest that resolving tensions between the CRPD and CIOMS requires a closer analysis of rights with respect to research participation.CIOMS does not guarantee the 'right to participate' in research, though CIOMS arguably offers an implicit 'right' not to be unjustly excluded on the basis of a social category (CIOMS, 2016).The CRPD also does not guarantee an explicit 'right to participate' in research (UN, 2008), though some commentators have argued that the text of the Convention implies the right to participate in research (Nilsson & Broström, 2020).
We argue that a more consistent alignment of the principles of the CRPD within the ethically stringent (and necessarily so) bounds of clinical research dictates that the CRPD implies a right to benefit from research as opposed to a right to participate in research, recognising that benefitting from research does not necessarily require participating in research.That is, while an overriding right to research participation should not be understood as a component of the 'right to full participation in society' as guaranteed in the CRPD, the right to benefit from research should be.We also suggest that the CRPD's principles should apply to the research agenda as a whole, but not necessarily to research studies individually, drawing on Little et al.'s work on the inclusion of pregnant people in clinical research (2022).
Proposal: aligning national research ethics regulations with CIOMS and the CRPD Therefore, our proposal for aligning national research ethics regulations with both CIOMS and the CRPD turns on the view that the CRPD affords the right to benefit from research without affording an overriding right to participate in research.
Based on this understanding of fair research participation in the context of the CRPD, we suggest that the ethical application of core principles of the CRPD will depend on the purpose of the research.However, all research should subscribe to the CRPD-compliant view that the presence of psychosocial disability does not imply incapacity.
We put forth the following suggested revisions to national research ethics regulations: • For research intended to be generalizable populationwide, individuals with psychosocial disabilities should be included as part of the general population.
In these instances, researchers should respect the principle of non-discrimination by not excluding on the basis of psychosocial disability.However, this provision does not inherently afford a rights-based claim to participation in any 'general population' study (e.g. a Phase II non-lifesaving vaccine efficacy trial); rather, this provision is intended to ensure accurate representation of the true population to maximize the validity of study findings (e.g. an implementation study for a flu vaccine rollout).
• For research intended to benefit a specific group of individuals living with psychosocial disabilities, and therefore recruiting only people living with psychosocial disabilities, researchers should ensure that assessments of capacity to consent to research are not based on disability, but rather on general principles for informed consent in research.If the person does not consent to research participation, researchers should not, under any circumstance, accept proxy consent to participate.
• All research should accept that the presence of psychosocial disability does not imply incapacity.
This proposal, we contend, attends to both ethical imperatives of equal treatment and universal legal capacity, as set forth by the CRPD, while ensuring that standard research ethics regulations, as set out in CIOMS, are met.Given the complexity of the topic, I concur with earlier reviews that it would be useful to strengthen the background and rationale for the analysis.I add to this a suggestion to include the reasons or benefits for the selection of the three jurisdictions examined.What can each jurisdiction learn from each other?
The paper highlights the question as to whether a clear harmonization between the UNCRPD and CIOMS is currently possible?Or are revisions of the CIOMS to better align with the UNCRPD called for?Within this, should the emphasis be on the right to choose whether to participate in research on an equal basis with others (as opposed to substituted decision-making), rather than trying to delineate between the right to participate in research versus the right to benefit from research?In agreeance with the outlined provisions within the protocols of Sierra Leone and South Africa to uphold a potential participant's refusal to participate in research as being superior to any proxy consent, I concur with your suggestion that CIOMS and other ethical guidelines should move away from substituted decision-making, towards clearer guidance on supported decision-making (where required and with the clear assent of potential research participants) incorporated within strengthened capacity to provide informed consent processed with all potential research participants, regardless of the presence or absence of a diagnosed or undiagnosed condition.Could your first recommendation in relation to generalizable population-based research also reiterate the above point?Simultaneously, are there opportunities within the context of the UNCRPD to strengthen its guidance on the ethical inclusion of people with disabilities within research, beyond the right to benefit from research?
Is the rationale for the Open Letter provided in sufficient detail?

Does the article adequately reference differing views and opinions? Partly
Are all factual statements correct, and are statements and arguments made adequately supported by citations?Partly

Is the Open Letter written in accessible language? Yes
Where applicable, are recommendations and next steps explained clearly for others to follow?Partly Competing Interests: No competing interests were disclosed.
Reviewer Expertise: I am predominantly a qualitative researcher focusing on inclusion of people with disabilities within society and systems.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
Reviewer

Cristian R Montenegro
Wellcome Centre for Cultures and Environments of Health, University of Exeter, Exeter, England, UK Thanks for the opportunity to comment on this insightful and important letter.While the CRPD has significantly influenced advocacy and normative fields, its actual and potential impact on research ethics remains underexplored.This paper usefully addresses this gap by contrasting the CRPD with the CIOMS guidelines.
My only concern relates to the connection between the first and second parts of the letter-specifically, the transition from reviewing selected regulations to contrasting the CIOMS guidelines and the CRPD.While you argue that the review reveals tensions between the two frameworks, it's not clear how this empirical examination of country cases directly informs the proposal you develop at the end.Your proposal to reconcile the tensions between the CRPD and CIOMS based on the notion of a "right to benefit from research" is well-justified.However, the paper could be strengthened by elaborating on how this proposal might address the regulatory complexities in the countries you've reviewed, even if this is in speculative terms.

Does the article adequately reference differing views and opinions? Yes
Comment: Within the scope of the paper which the authors have set for their enquiry.
Are all factual statements correct, and are statements and arguments made adequately supported by citations?Partly Comment regarding the statement "Ten of 14 guidelines reviewed offered conditions under which participation of persons with cognitive impairment is permissible": The article focuses on persons with psychosocial disabilities.I recommend that the term 'psychosocial disability' be used throughout, rather than using this term interchangeably with 'cognitive impairment'.People with psychosocial disabilities are those who have disabling impacts of experiencing a mental disorder or illness, which in some instances or at points of acute illness, or due to medication and other treatment effects may include cognitive impairment (attentional, concentration problems) but psychosocial disabilities are not synonymous with cognitive impairment, nor is the latter experienced for the most part by all people with psychosocial disability all of the time, as may be the case with person with significant cognitive impairment, for example, a person diagnosed with intellectual disability, or dementia.Persons with cognitive impairment may have a concurrent/cooccurring psychosocial disability, for example a person with an intellectual disability also having depression or schizophrenia.It may also be useful for the authors to define what they mean by "psychosocial disability" See panel 4 of the Lancet Commission on Global Mental Health 1 .
The authors note that "We also suggest that the CRPD's principles should apply to the research agenda as a whole, but not necessarily to research studies individually, drawing on Little et al.'s work on the inclusion of pregnant people in clinical research (2022)".The authors are encouraged to note what specific elements of this work is relevant to their paper, given that their argument in the next section of the paper seems in part to rest on these findings and conclusions.The article is a book chapter, which will not readily be accessible to all readers of the paper.

Is the Open Letter written in accessible language? Yes
Where applicable, are recommendations and next steps explained clearly for others to follow?Partly Additional discussion of the recommendations/suggestions would assist to locate the recommendations in the context of the complex social milieus within which research ta with people with psychosocial disabilities takes place.The authors note, for example, that recruitment of people living with psychosocial disabilities should ensure that assessments of capacity to consent to research are not based on disability, but rather on general principles for informed consent in research.While capacity to consent should not be based on disability, researchers, in seeking informed consent, should include consideration of other intersecting issues people with psychosocial disability encounter which might arise during research which are not a consideration for people without this disability, for example, stigma, discrimination, social exclusion and potential for harm when identified as mentally ill in some settings during research, the povertymental health link and possible pressure to participate for financial gain, and the intersection of other vulnerabilities identified in guideline 15-17 of the CIOMS 2 .
The authors note that their "proposal for aligning national research ethics regulations with both CIOMS and the CRPD turns on the view that the CRPD affords the right to benefit from research without affording an overriding right to participate in research.The CRPD does not demand "an overriding right to participate in research", but as the authors note, some writers note that participation in research may be implied.Certainly the CRPD does demands that people living with psychosocial disabilities are treated on an equal basis with others, that is, that as others without disabilities are included, so should people with psychosocial disabilities be included.Given that people with psychosocial disability have historically been excluded from research, and that their participation is still overlooked in many instances, care still needs to be taken to note the need for attention to and enablement of their participation in research which impacts on their lives, when making any statement about their right -or the nature of that right -to participate in research, so as to avoid any inadvertent misreading that it is implied that they may continue to be left out of relevant research.
psychosocial disability in MH policy and service development.self-advocacy by people with intellectual disability I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.It is essential that the authors further clarify the difference between appointment of a 'surrogate decision maker' and 'advanced directives or supported decision-making models'.The authors have classified the former as a safeguarding measure (associated with CIOM) and the latter as empowering and allowing some measure of control (associated with CRPD).The difference between viewpoints is not sufficiently explored and it is pertinent to highlight that 'some measure of control' may not align with the absolute stance of the CRPD on legal capacity.

1.
Although the authors describe their eligibility criteria for the included African countries, it is not evident if these countries have signed or ratified the CRPD.A few sentences or table on this will provide important legal context regarding the compliance of their national laws to the CRPD.

2.
The case studies about Peru and Malaysia are interesting; however, the rationale for choosing both counties are missing.The Malaysia Mental Health Act 2001 (MHA) described by the authors predates the CRPD and expectedly, it does not align with the CRPD.If the case studies are there to further illustrate relevance of the CIOMs or CRPD mandate, would it not be better to use countries with legislations enacted after these instruments?Again, this may be the possible explanation for Liberia having a national policy/regulation that aligns with the CRPD or the 'empowering framework'.

3.
In conclusion, I consider the recommendations in the letter very interesting and useful.

Lana Van Niekerk
Department of Occupational Therapy, Stellenbosch University, Stellenbosch, Western Cape, South Africa The letter foregrounds an important consideration for researchers in general and those who seek to explore issues specifically pertaining people with psychosocial disabilities.The current tendency to exclude persons with psychosocial disability based on assumptions of incapacity is indeed problematic, exclusionary, and counterproductive.The authors' use of the CRDP and CIOMS as a foundation for analysis ensures the relevance and application value of recommendations made in the letter.
I was left wondering about the connection between the two parts of the letter.It would improve the letter if the linkages between the first part, in which guidelines from African countries were 'characterised', are clarified.While the focus on African countries is appreciated as a welcome change from the usual omission of these countries, the rationale for focussing exclusively on African countries was not provided.A sentence of two to improve the link between the two parts of the letter will improve the coherence.
The authors set out to "characterise the nature of a sample of existing ethics guidelines".In my mind, this would entail a full exploration of the nature of the guidelines included in the sample.However, the letter comments on two very specific aspects.I suggest the authors' stated intention should be clarified to focus the reader more accurately on the elements extracted from the ethics guidelines.

Kiran Manku
Department of Clinical Medicine, University of Oxford, Oxford, England, UK The letter makes an interesting contribution to the literature, as it lays out the critical issue of a lack of consistent guidance on the inclusion of persons with psychosocial disabilities in research.
I feel that the letter could be strengthened with clarifications regarding the rationale, interpretation of existing guidance, and the proposal they make, as outlined below.
Specifically, in the introduction it would be useful to have more detail about the origins and intentions of the CIOMS and CRPD.I think it might be helpful to highlight that the CRPD was made with persons with disabilities.In addition, clarification on the CIOMS as a means to ensure a fair distribution of research benefits and the interpretations of safeguarding and "controlling" approaches could be explained in the introduction.
For example, it might be useful to preface the introduction about CIOMS and the CRPD, with an overview of inclusion of people with psychosocial disabilities in research.This would help lay out how they were developed and the concepts of inclusion for scientific validity, "safeguarding", "controlling", and "empowerment".I think these concepts should be clarified for the audience to understand the different perspectives of inclusion in research.
I found the review and analysis very interesting.Across the countries included, I know of local advocacy groups for persons with psychosocial disabilities who advocate for the right to decide, including in research participation.Although their work isn't within the remit of this analysis and review, I wonder if their work could be drawn upon within country settings, should a country want to engage in adopting or creating governance for research including persons with psychosocial disabilities.
The proposed suggestion is helpful but could include some good examples.It would be useful to have templates of assent or measures of capacity where research is only recruiting people with psychosocial disabilities.I also wonder if the paper should state that it would be good practice to include persons with psychosocial disabilities in co-creating these consent tools (and the wider research itself).
Overall, I think the letter highlights an issue that needs more attention and could be clarified to make the case clearer.Reviewer Expertise: Disability, inclusion, mental health, bioethics, research ethics.

Is the rationale for the
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Report 13 October 2023 https://doi.org/10.21956/wellcomeopenres.21362.r66867© 2023 Montenegro C.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reviewer Report 05
October 2023 https://doi.org/10.21956/wellcomeopenres.21362.r66873© 2023 Ebuenyi I.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Ikenna EbuenyiDepartment of Rehabilitation Science and Technology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA Thank you for inviting me to review this very important letter.The subject is relevant and examines critical issues related to informed consent, inclusion, and equal participation of persons with psychosocial disabilities in research.I have a few comments and suggestions that should strengthen the discourse.
Open Letter provided in sufficient detail?Partly Does the article adequately reference differing views and opinions?Partly Are all factual statements correct, and are statements and arguments made adequately supported by citations?Yes Is the Open Letter written in accessible language?Yes Where applicable, are recommendations and next steps explained clearly for others to follow?Partly Competing Interests: No competing interests were disclosed.

consequences of Article 12 of the UN Convention on the Rights of Persons with Disabilities for persons with mental disabilities and an alternative way forward
Office for Human Research Protections (OHRP): International Compilation of Human Research Standards.HHS.gov.US Department of Health and Human Services, 2019.Reference Source Scholten M, Gather J: Adverse .J Med Ethics.2018; 44(4): 226-33.PubMed Abstract | Publisher Full Text | Free Full Text United Nations (UN):

Open Letter provided in sufficient detail? Partly Does the article adequately reference differing views and opinions? Yes Are all factual statements correct, and are statements and arguments made adequately supported by citations? Yes Is the Open Letter written in accessible language? Yes Where applicable, are recommendations and next steps explained clearly for others to follow
? Partly Competing Interests: No competing interests were disclosed.Reviewer Expertise: South America; Mental Health Policy; Global Mental Health; Human Rights and Mental Health; Qualitative Research; Social Theory and Medicine I confirm that I

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Reviewer Report 12 October 2023 https://doi.org/10.21956/wellcomeopenres.21362.r66864

Is the rationale for the Open Letter provided in sufficient detail? Partly Does the article adequately reference differing views and opinions? Partly Are all factual statements correct, and are statements and arguments made adequately supported by citations? Yes Is the Open Letter written in accessible language? Yes Where applicable, are recommendations and next steps explained clearly for others to follow? Partly Competing Interests:
They would elicit further conversations and questions.For instance, the authors 4. recommendation that 'If the person does not consent to research participation, researchers should not, under any circumstance, accept proxy consent to participate' poses the question: does it include or preclude advance directives?No competing interests were disclosed.

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Reviewer Report 27 September 2023 https://doi.org/10.21956/wellcomeopenres.21362.r66871© 2023 Van Niekerk L. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Open Letter provided in sufficient detail? Yes Does the article adequately reference differing views and opinions? Yes Are all factual statements correct, and are statements and arguments made adequately supported by citations? Partly Is the Open Letter written in accessible language? Yes Where applicable, are recommendations and next steps explained clearly for others to follow? Yes Competing Interests:
No competing interests were disclosed.

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.