GFBR 2021 – call for applications now open!

The Global Forum on Bioethics in Research (GFBR) will hold a two-day meeting in Toronto, Canada on 8-9 June 2021 (tentative) on the theme “Ethical issues arising in research with people with mental health conditions.

Meaningful research is required to advance the health of people with mental health conditions, but this has been stymied by a lack of mental health resources in low- and middle- income countries (LMICs) and the ethical and legal challenges faced by researchers globally. There is a need for a more nuanced understanding of how mental health is understood and experienced in diverse contexts, decisional capacity and how to assess it, how stigma and discrimination can be mitigated, and how to address the complex vulnerabilities that people living with mental health conditions may experience. These issues apply not only to mental health research but to research more broadly where exclusionary criteria may prevent the participation of people with mental health conditions resulting in an evidence base for their care that is poorer than for other populations. This is a significant issue given the comorbidity between mental health conditions and physical illness. By addressing these ethical and legal challenges GFBR aims to advance the health of people with mental health conditions by promoting their appropriate and ethical inclusion in research.

As part of the upcoming meeting, the GFBR is seeking case studies that bring attention to key ethical issues that have emerged regarding the involvement of people with mental health conditions in research in LMIC settings. Case studies on the ethics of mental health research are also invited. We will also have a session on governance issues. We are seeking proposals that provide an overview and critique of existing laws, guidance or policy from a LMIC perspective and/or that also identify gaps and propose solutions. The GFBR is also seeking participants and journalists to attend the meeting, with places awarded on a competitive basis.

Successful applicants from LMICs will receive an award to cover the cost of their travel, accommodation and single-entry visa.

Please note: In light of the COVID-19 pandemic, the meeting date will be kept under review and may be postponed until later if necessary.

This notice contains details on the following:

  1. CALL FOR CASE STUDIES
  2. CALL FOR PROPOSALS ON GOVERNANCE ISSUES 
  3. CALL FOR PARTICIPANTS
  4. CALL FOR JOURNALISTS
  5. DEADLINE
  6. AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING
  7. NOTIFICATION
  8. PRIVACY STATEMENT
  9. CHECKLIST FOR APPLICANTS

All applicants are encouraged to read the GFBR background paper for further details on the meeting theme. You’ll find the meeting theme visually summarised in the below infographic and described by members of the Forum Planning Committee in the below video.

If you have any questions about this call, please email gfbr@wellcome.org.

(A video overview of the 2021 GFBR topic)

(GFBR Infographic – click to enlarge, or click here for downloadable PDF infographic)

  1. CALL FOR CASE STUDIES

The GFBR organisers are looking for interesting and important cases that are relevant to the theme. These case studies could: demonstrate the development of good practice; highlight challenges; demonstrate situations in which ethical practice failed; or present unresolved questions for the global community. We welcome case studies from any stakeholder perspective, including policy-makers, researchers, clinicians, ethicists and healthcare workers. Case studies should focus on issues around conducting research in LMICs. (However, we do not want to exclude case studies from HICs if there could be valuable lessons to learn, and some parallel or relevant ethical considerations. If your case study relates to a HIC please use the commentary section to draw-out the relevance for research in LMICs.)

Support will be provided to successful applicants for developing the case studies into a format suitable for them to present at the meeting.  It is anticipated that case studies will be presented by their authors in themed sessions, and then participants at the meeting will discuss the challenges and questions raised by the case studies in both plenary and small group discussion. For guidance on how to write a case study, please see the case studies in this previous GFBR meeting programme.

Case studies should be 2 pages maximum, font Arial, size 10.5 (in Microsoft Word or pdf format), clearly articulated in English and contain the following sections:

  1. Title
  2. Your name and institutional details
  3. Brief description of the research project
  4. Background – relevant facts about the host country/community and disease studied (if disease specific)
  5. Ethical issues with commentary on each issue
  6. Conclusions and two recommendations for how to improve the ethics of, and ethical approaches to, mental health research and/or involving people with mental health conditions in research more broadly (i.e. involvement in non-mental health research). The recommendations can relate to the field broadly or be specific to the case study.

In general, case studies should focus on no more than three ethical issues. We indicate below some examples of issues considered important by the GFBR organisers, but these are not exhaustive and are intended only as examples. The GFBR organisers will decide the exact meeting theme based on the case studies received. Case studies should focus on research in LMICs and could address (but are not limited to) one or more of the following questions:

Conceptualisation of mental health problems

  • Do current approaches to mental health research resonate with how mental health problems are conceptualised by varying stakeholders in LMICs?
  • What are the ethics of choosing different conceptual frameworks? Is it best to go with current clinical frameworks or to go with local conceptualisations and what if either of these have important scientific flaws?
  • How can the methods applied to measure mental health symptomology best reflect local conceptualisations of mental ill-health/wellness?
  • To what extent do conceptualisation of mental health problems lead to the systematic exclusion of those experiencing such problems from research?

Maximising impactful, locally-relevant research

  • How can meaningful, impactful and ethical mental health research be maximised (e.g. through research prioritisation – how should this be undertaken and who should be involved; by adopting context-appropriate and feasible methodologies, and ensuring the feasibility of implementing research outcomes within the resources available to mental health systems in LMICs)?
  • What values and world views should guide the development and prioritisation of mental health research (e.g. solidarity, respect, autonomy or inclusiveness and epistemic values of tractability, explanatory potential etc.)?
  • How can relevant values and belief systems in specific settings be identified and incorporated to ensure research is most relevant to LMICs?

 Engagement and co-creation

  • What methods can be used to engage people with lived experience of mental health conditions to promote inclusion and co-creation of mental health research methods and practice?
  • Who else should be engaged during research design and implementation (e.g. carers, local communities etc.), how and for what purpose (e.g. for setting priority topics to explore, to inform the design and conduct of the research, as part of an anti-stigma campaign etc.)?

 Inclusion/exclusion

  • What ethical values are balanced in determining the inclusion / exclusion of people with mental health problems in research (e.g. equity, protection from harm, etc.)?
  • How do research eligibility criteria impact on the participation of people with mental health problems in research?
  • How can over exclusion be addressed and the ethical inclusion of people with mental health problems be promoted?

 Stigma leading to discrimination and abuse

  • What is the ethical duty of researchers to assess and address mental health stigma as part of their research?
  • What approaches can be used to aid cultural understandings of stigma towards those with mental health problems (e.g. research methods, co-design approaches etc.)?
  • What strategies can researchers adopt throughout the research process to mitigate or address mental health related stigma (including how research is conducted and specific interventions to reduce stigma)?

 Capacity

  • How can researchers provide for people where capacity is lacking, absent, in question or fluctuates, and what is the moral duty of researchers in this process (e.g. to assist them in being able to consent and to protect those who can’t)?
  • Is there a way to have a more meaningful understanding of capacity in relation to mental health status?
  • How do researchers in different countries define and assess capacity to consent to research and what ethical, governance or legal issues have they encountered in making these assessments?

In addition, please provide the following information, compiled into a single Microsoft Word or pdf document using font Arial size, 10.5. Please do not share sensitive personal health information either in the case study or in the information requested below.

  • Short letter of intent not exceeding one page, outlining:
    • Why you would like to participate in the GFBR meeting;
    • Your interest in or experience of research involving people with mental health conditions;
    • The ways in which you would disseminate the meeting outcomes in your local and regional context.
  • Name, institution and contact information.
  • Short CV (2 pages maximum) clearly stating:
    • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, policy-making, regulatory, public health etc.)
    • Your career stage (early, mid, senior)
  • Contact information and email addresses of two references
  • Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
  • Completed consent form (See ‘8. Privacy Statement’ for further details).

If you are unsure about the suitability of a possible case study or would like to discuss your proposed case study further, please email gfbr@wellcome.org.

Please note that the Forum is held in English and the expectation is that presenters present in English. If this causes you difficulty and you need language assistance, please state this in your letter of intent.

 

  1. CALL FOR PROPOSALS ON GOVERNANCE ISSUES

We are seeking proposals that provide an overview and critique of governance issues e.g. existing law, guidance or policy etc. and/or that also identify gaps in current guidance and propose solutions. The proposal could relate to governance issues at the national, regional or international level, including addressing regulatory challenges. Support will be provided to successful applicants for developing their proposal into a format suitable for them to present at the meeting.

Proposals should be no more than 2 pages maximum, font Arial, size 10.5 (in Microsoft Word or pdf format), clearly articulated in English and contain the following sections:

  1. Title
  2. Your name and institutional details
  3. Brief description of the context e.g. what aspect of governance are you addressing – regulation, guidance and/or policy issue etc., is it national/regional/international?
  4. Commentary, conclusion and recommendation.

Proposals might be framed around – but are not limited to – the following questions. The GFBR organisers will decide the exact meeting theme based in the governance proposals received.

  • Are current ethics governance structures, processes and practices fit for purpose to support the inclusion of people with mental health conditions in research?
  • What regulatory models do different countries use to include people who lack capacity to consent (e.g. who decides on behalf of the individual; is a lasting power of attorney or an advance directive possible or applicable to research consent; are the courts involved in appointing a surrogate decision-maker; is this decision-maker legally recognised or recognised ‘in practice’ (e.g. a family member); does the model promote inclusion or increase the likelihood of exclusion?)
  • Does a country’s governance structure and regulation support or challenge the ability to conduct research with people who have mental health conditions and lack capacity (e.g. in relation to how capacity is defined and the provisions (if any) for surrogate decision-making)?

In addition, please provide the following information, compiled into a single Microsoft Word or pdf document using font Arial, size 10.5. Please do not share sensitive personal health information either in the governance proposal or in the information requested below.

  • Short letter of intent not exceeding one page, outlining:
    • Why you would like to participate in the GFBR meeting;
    • Your interest in or experience of research involving people with mental health conditions;
    • The ways in which you would disseminate the meeting outcomes in your local and regional context.
  • Name, institution and contact information.
  • Short CV (2 pages maximum) clearly stating:
    • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, policy-making, regulatory, public health etc.)
    • Your career stage (early, mid, senior)
  • Contact information and email addresses of two references
  • Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
  • Completed consent form (See ‘8. Privacy Statement’ for further details)

If you are unsure about the suitability of your proposal and would like to discuss it, please email gfbr@wellcome.org.

Please note that the Forum is held in English and the expectation is that presenters present in English. If this causes you difficulty and you need language assistance, please state this in your letter of intent.

 

  1. CALL FOR PARTICIPANTS

 Who can attend the GFBR meeting?

The majority of participants are selected through a competitive process. Up to 80 participants will be selected from those eligible who apply by the deadline. We are seeking broad geographical representation, a mix of disciplinary expertise including researchers, clinicians, healthcare workers, bioethicists, policy-makers, mental health advocates, health system functionaries, journalists and lawyers, and a combination of people who are early in their careers and leaders in their fields.

To apply to attend, please provide the following information, compiled into as a single Microsoft Word or pdf document, in English using font Arial, size 10.5. Please do not share sensitive personal health information.

  • Short letter of intent not exceeding one page, outlining:
    • Why you would like to participate in the GFBR meeting;
    • Your interest in or experience of research involving people with mental health conditions;
    • What you can contribute as a meeting participant and the ways in which you would disseminate the meeting outcomes in your local and regional context.
  • Name, institution and contact information
  • Short CV (2 pages maximum)
    • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, policy-making, regulatory, public health etc.)
    • Your career stage (early, mid, senior)
  • Contact information and email addresses of two references
  • Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
  • Completed consent form (See ‘8. Privacy Statement’ for further details)

 

  1. CALL FOR JOURNALISTS

Accurate journalistic reporting is essential to ensure that the public are engaged and well informed about the potential benefits and risks of research. GFBR will support the participation of up to four journalists from LMICs. The meeting will provide a unique opportunity for talented journalists to network with international experts and forge stronger connections between scientists, ethicists, policy-makers and journalists.

To apply to attend, please provide the following information, compiled into a single Microsoft Word or pdf document, using font Arial, size 10.5, in English. Please do not share sensitive personal health information.

  • Short letter of intent not exceeding one page, outlining:
    • Why you would like to participate in the GFBR meeting;
    • Your interest in or experience of research involving people with mental health conditions;
    • Your journalistic experience;
    • The ways in which you would disseminate the meeting outcomes in your local and regional context, including which media outlets you propose to use and the format of reporting.
  • Name, institution and contact information
  • Short CV (2 pages maximum), clearly stating career stage (early, mid, senior)
  • Contact information and email addresses of two references
  • Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that support will be provided to LMIC based journalists only
  • Completed consent form (See ‘8. Privacy Statement’ for further details)

 

  1. DEADLINE

All applications should be sent to gfbr@wellcome.org by 17.00 GMT on Wednesday 4 November 2020, in English. Please specify in the subject line whether you are applying to participate, present a case study, present on a governance issue or as a journalist. Please ensure you include all the requested information, including the completed consent form, as incomplete applications can not be considered (see the Checklist below). Applications received after the deadline will not be considered.

 

  1. AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING

Successful applicants from LMICs who require full funding will receive an award to cover:

  • return travel to the meeting (economy airfare and standard ground transportation costs);
  • accommodation (2 or 3 nights maximum, including meals);
  • a single entry visa (if required).

Participants will be expected to meet all other costs.

The GFBR Planning Committee will select successful candidates (both self-funded and those applying for funded places). The selection committee will consider the following factors when considering the applications:

  • Country of origin. We would like to ensure a representative distribution of participants from different regions;
  • Background/current area of expertise. We would like to seek representation from many different disciplines relating to the theme of the meeting;
  • Experience of ethical issues related to research involving people with mental health conditions;
  • Reasons for attending the meeting. We hope to attract participants who will be able to actively contribute to the meeting and who expect to achieve impact from the meeting;
  • Case study applications and governance proposals only: Relevance of the case/proposal to the meeting theme and research in LMICs.
  • Journalists only: Demonstrated journalistic training and experience and concrete proposals for how the meeting findings will be disseminated, including which media outlets and the format of reporting.

If your case study or governance proposal is not selected your name will automatically go forward to be considered in the applications to attend. Applicants are encouraged to submit a case study or a proposal on governance issues.

 

7.     NOTIFICATION

All applicants will be informed of the Planning Committee’s decision by the 20 January 2021. The decision of the committee will be final.

 

8.     PRIVACY

The Global Forum on Bioethics in Research (GFBR) is comprised of a ‘Steering Committee’ and a ‘Planning Committee’ the composition of which is set out here.

When making an application the contents – including your personal information that is set out below – will be stored and processed by Wellcome and those acting on behalf of Wellcome, including the GFBR Secretariat. For this, The Wellcome Trust Limited will be the data controller and details in relation to contact details for the data protection officer, and your rights in relation to your personal data (including the right of access to or erasure of your personal data), are set out in Wellcome’s Privacy Statement.

The lawful basis for Wellcome’s processing of your personal data is that Wellcome has a legitimate interest as a co-funder of GFBR and performing the role of GFBR Secretariat so that the GFBR Planning Committee and Steering Committee can perform their functions to support the annual GFBR meeting and to determine the suitability and eligibility of your application. GFBR seeks a broad geographical representation of attendees, a mix of disciplinary expertise including researchers, clinicians, healthcare workers, bioethicists, policy-makers, mental health advocates, health system functionaries, journalists and lawyers, and a combination of people who are early in their careers and leaders in their fields. As set out below, the Planning Committee and the Steering Committee are comprised of people from organisations outside of Wellcome and the processing by Wellcome will include sending on your personal data to them in accordance with this privacy statement.

Your personal data will be stored securely on Wellcome’s servers and will not be shared with any third parties except as set out below.

Your personal data will be retained in accordance with Wellcome’s retention policies are set out in Wellcome’s Privacy Statement.

Recipients of your personal data – including recipients that are based outside of the EEA

For the purposes noted above, Wellcome will transfer your personal data to the parties noted below. In each case, those parties have been appointed on behalf of Wellcome to perform the processing on Wellcome’s behalf, as set out in this privacy statement.

The parties will only be able to access your personal data via Wellcome’s secure servers and will access these servers remotely.

Where members of the Planning Committee or the Steering Committee are based outside of the European Economic Area (EEA) and there are not appropriate safeguards in place, Wellcome will only transfer your personal data where you have consented. This consent can be provided by you separately to this privacy statement. Please note that this consent is entirely optional. If you do not wish to provide your consent in relation to Wellcome sending your personal data to jurisdictions outside of the EEA, please note that this will not adversely affect your application.

Please record your preferences on this consent form and submit it with your application.

GFBR Planning Committee

Katherine Littler, World Health Organisation, Switzerland; Anna Chiumento, Liverpool University, UK; Rosemary Musesengwa, Oxford University, UK; Ana Palmero, Ministry of Health, Argentina; Dan Stein, University of Cape Town, South Africa; Caesar Atuire, University of Ghana, Ghana; Dixon Chibanda, African Mental Health Research Initiative; Charlotte Hanlon, Kings College London and Addis Ababa University, based in Ethiopia; Ross Upshur, University of Toronto, Canada; Eleni Misganaw, Mental Health Service Users’ Association and Global Mental Health Peer Network, Ethiopia; David Wendler, Department of Bioethics, NIH Clinical Centre, USA; Kaustubh Joag, Indian Law Society, India, Sharon Kaur, University of Malaya, Malaysia and Karen Athie, Health Secretariat of the Rio de Janeiro State Government and Global Mental Health Peer Network, Brazil.

 GFBR Steering Committee

Katherine Littler, World Health Organisation, Switzerland; Michael Parker, Oxford University, UK; Rachel Knowles, UK Medical Research Council, UK; Carla Saenz, Pan American Health Organisation, USA; Barbara Sina, Fogarty International Center, National Institutes of Health, USA; Douglas Wassenaar, University of KwaZulu-Natal, South Africa; Ross Upshur, University of Toronto, Canada; Paul Ndebele, George Washington University, USA; Teck Chuan Voo, National University of Singapore, Singapore, Jantina de Vries, University of Cape Town, South Africa; Ana Palmero, Ministry of Health, Argentina; Phaik Yeong Cheah, Mahidol Oxford Tropical Medicine Research Unit, Thailand; Anant Bhan, Yenepoya University, India and Dan O’Connor, Wellcome, UK.

Personal Data provided by you

All applicants:

  • Short letter of intent (1 page)
  • Your name
  • Your institution
  • Your contact information
  • Short CV (2 pages maximum) stating clearly:
    • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, policy-making, regulatory, public health, journalism etc.)
    • Your career stage (early, mid, senior)
  • Contact information and email addresses of two references
  • Whether you require funding to cover travel and accommodation costs, or you are self-funding

In addition, for case study proposal:

  • Title of case
  • Your name and institutional details
  • Brief description of the research project
  • Background – relevant facts about the host country/community and disease studied (if disease specific)
  • Ethical issues and commentary on each issue
  • Conclusions and two recommendations for how to improve the ethics of, and ethical approaches to, mental health research and/or involving people with mental health conditions in research. The recommendations can relate to the field broadly or be specific to the case study.

In addition, for governance proposal:

  • Title
  • Your name and institutional details
  • Brief description of the context e.g. what aspect of governance are you addressing – regulation, guidance and/or policy issue, is national/regional/international?
  • Commentary, conclusion and recommendation

General

All information collected will be handled in accordance with the Data Protection Act 2018 and General Data Protection Regulation 2016/679 and, in addition to the information noted in Wellcome’s Privacy Statement, you have the option to request that we do not process your personal data by contacting gfbr@wellcome.org. Also, if you have provided any consent for Wellcome to process your personal data (please see above) then you can withdraw your consent at any time by contacting gfbr@wellcome.org.  We will retain your personal information in accordance with Wellcome’s retention policy. For further information about how Wellcome handles personal data, go to Wellcome’s Privacy Statement.

 

9.     CHECKLIST FOR APPLICANTS

Please use the following checklist to make sure you have provided all the requested information in your application, in English.

All applicants:

 

NB Please do not share sensitive personal health information

Short letter of intent (1 page)
Your name
Your institution
Your contact information
Short CV (2 pages maximum)
Contact information and email addresses of two references
Whether you require funding to cover travel and accommodation costs, or you are self-funding
Completed consent form
 
In addition, for a case study proposal: Title of case, your name and institutional details
Brief description of the research project
Background – relevant facts about the host country/community and disease studied (if disease specific)
Ethical issues and commentary on each issue
Conclusions and two recommendations for how to improve the ethics of, and ethical approaches to, involving people with mental health conditions in research. The recommendations can relate to the field broadly or be specific to the case study.
In addition, for a governance proposal: Title
Brief description of the context e.g. what aspect of governance are you addressing – regulation, guidance and/or policy issue etc., is it national/regional/international?
Commentary, conclusion and recommendation

Support for GFBR 2021: Wellcome, the UK Medical Research Council and the US National Institutes of Health are providing funding for this meeting.

21 September 2020