Call now open for GFBR 2019

The Global Forum on Bioethics in Research (GFBR) will hold a two-day meeting in Singapore on 12-13 November 2019 on the theme of: “Genome editing for human benefit: ethics, engagement and governance.

The ability to manipulate the genome has been available for many years; however, the pace of innovation recently has brought a series of ethical, social and legal questions forward. In particular, CRISPR-Cas9 has made precise, simple and cheap editing of a genome a realistic possibility. Genome editing could be used to alter an individual’s genome to address a specific health issue or used as a public health intervention through genetic changes to disease vectors like mosquitoes. Historically, research using emerging genomic technologies has largely taken place in high income countries (HIC) with the ethical debates focused in these settings. The 2019 GFBR meeting will engage low- and middle- income country (LMIC) perspectives so their voices are heard in the research phase and early development of genome editing technologies.

The meeting will focus on emerging applications of genome editing that are designed to benefit human health. Somatic and germline human genome editing research are within scope, along with gene drive research that is intended to prevent the transmission of disease by vectors to humans. Common challenges presented by these applications include the need to negotiate a high degree of uncertainty and demonstrate technical feasibility and safety through complex risk assessments, social acceptability and the need for appropriate governance systems. Please note that gene drive applications in conservation, food security or biosecurity are not within the scope of this meeting.

As part of the upcoming meeting, the GFBR is seeking case studies that bring attention to key ethical issues associated with genome editing research in LMIC settings. We will also be having a session on guidance and policy issues. We are seeking proposals that provide an overview and critique of existing guidance on genome editing and/or identify gaps in current guidance and propose solutions. We also welcome proposals that highlight the policy issues from a LMIC perspective. The GFBR is also seeking participants and journalists to attend the meeting, with places awarded on a competitive basis.

This notice contains details on the following:

  1. CALL FOR CASE STUDIES
  2. CALL FOR PROPOSALS ON GUIDANCE AND POLICY 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 background paper for further details on the meeting theme.

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

1. CALL FOR CASE STUDIES

We invite applicants to submit case studies highlighting ethical issues associated with human genome editing and gene drive research for human benefit. 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 last year’s GFBR conference booklet.

Case studies should be 2 pages maximum (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, conducting genome editing 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. These might be framed around – but are not limited to – the following questions, which are grouped into broad themes:

Social acceptability:

  • How might cultural or religious beliefs and norms impact on the social acceptability of genome editing research (e.g. in relation to the status of the embryos and/or beliefs about what it means to be human and making changes that will affect future generations or have an impact on the environment)?

 Engagement:

  • Whose responsibility is it to undertake engagement work when a new genome editing technology is being researched and introduced in a LMIC?
  • What should this engagement look like, who should be engaged and for what purpose? Does it look different to engagement for non-genomic technologies?
  • Does engagement for human genome editing look different to engagement for gene drive research (e.g. in relation to the methods and who or which groups should be engaged)?

Uptake:

  • What does broad societal consensus look like? What level of community acceptance is needed before research using a genome editing technology can be undertaken? Is there a difference between the level of acceptability required for a technology that has a ‘private’ health impact (human genome editing) vs a public health impact (gene drive research)? Or is this a false distinction given that both technologies present broad societal issues?
  • What constitutes fair and legitimate authorisation for field trials of gene drive organisms?

Governance:

  • What are the responsibilities on funders to promote equitable research collaborations/partnerships involving both HIC and LMIC researcher so research design and conduct is co-created and co-owned?
  • How do you ensure that governance processes are appropriate and fit for purpose in LMICs (e.g. regulatory frameworks, funding mechanisms, institutional structures and policies etc.)?
  • Are current governance structures sufficient for dealing with the long-term social risks of research or are other governance mechanisms required (e.g. an international or national advisory and monitoring group)?
  • When introducing research that uses complex genomic technology in LMICs what are the obligations on funders to address gaps in systems e.g. regulatory gaps, Research Ethics Committee procedures etc.? How can this be managed in such a way that takes account of conflicts of interest?
  • What would an anticipatory ethics framework for research on gene drive technologies and human genome editing, particularly in the context of LMICs, look like?  Can it be drawn from past debates on biotechnological research e.g. synthetic biology and genetically modified organisms?

In addition, please provide the following information compiled into a single Microsoft Word or pdf document, in English:

  • 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 genome editing;
    • 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, genomic research, 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.ac.uk.

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.

2. CALL FOR PROPOSALS ON GUIDANCE AND POLICY ISSUES

We are seeking proposals that provide an overview and critique of existing guidance or policy issues on genome editing research and/or identify gaps in current guidance and propose solutions. The proposal could relate to guidance or policy issues at the national, regional or international level, including addressing regulatory challenges.

Proposals might be framed around – but are not limited to – the following questions:

  • What are the governance and regulatory needs and how can these be addressed?
  • Can guidance help to address some of the ethical challenges and if so, what form should these take and what should they include?

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 (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 guidance or policy issue will you address, is it national/regional/international
  4. Commentary, conclusion and recommendation.

In addition, please provide the following information compiled into a single Microsoft Word or pdf document, in English:

  • 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 genome editing;
    • The ways in which you would disseminate the meeting outcomes in your local and regional context.
  • Name, institution and contact information.
  • Short CV (1-2 pages) clearly stating:
    • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, genomic research, 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.ac.uk.

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.

3. 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, health system functionaries 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 a single Microsoft Word or pdf document, in English:

    • 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 genome editing;
      • 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 (1-2 pages)
      • Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, genomic research, 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)

4. 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, in English:

  • 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 genome editing;
    • 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 (1-2 pages), 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)

5. DEADLINE

All applications should be sent to gfbr@wellcome.ac.uk by 17.00 BST on Friday 7 June 2019, in English. Please specify in the subject line whether you are applying to attend, present a case study, present on guidance or a policy 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.

6. 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 genome editing or genomics more broadly;
    • 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 guidance/policy 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 guidance/policy 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 guidance and policy issues.

7. NOTIFICATION

All applicants will be informed of the Planning Committee’s decision by the 2 August 2019. The decision of the committee will be final.

8. PRIVACY STATEMENT

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, Wellcome will be the data controller and details in relation to contact details, data protection officer, and your rights in relation to 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. 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 as 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 are separate data controllers.

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

Fabiana Arzuaga, Ministry of Science, Technology and Productive Innovation, Argentina; Jantina de Vries, University of Cape Town,South Africa; Paulina Tindana, University of Ghana, Ghana; Elinor Wanyama Chemonges, Uganda Virus Research Institute, Uganda; Maneesha Inamdar, Jawaharlal Nehru Centre for Advanced Scientific Research, India; Jim Lavery, Emory University, USA, Claudia Emerson, McMaster University, Canada; Peter Mills, Nuffield Council on Bioethics, UK; Samantha O’Loughlin, Imperial College London, UK; Lucy Carter, The Commonwealth Scientific and Industrial Research Organisation, Australia; Michael Selgelid, Monash Bioethics Centre, Australia; Katherine Littler, World Health Organisation, Switzerland and Teck Chuan Voo, National University of Singapore, Singapore.

 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 and 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, genomic research, 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

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, conducting genome editing research. The recommendations can relate to the field broadly or be specific to the case study.

In addition, for a guidance or policy issue proposal:

  • Title
  • Your name and institutional details
  • Brief description of the context e.g. what guidance or policy issue will you address, is it 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 Regulations 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.ac.uk. 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.ac.uk.  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.

 
7. 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: Short letter of intent (1 page)
Your name
Your institution
Your contact information
Short CV (2 pages maximum), including career stage and primary discipline
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 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, conducting genome editing research. The recommendations can relate to the field broadly or be specific to the case study.
In addition, for guidance or policy issue proposal: Title, your name and institutional details
Brief description of the context e.g. what guidance or policy issue will you address, is it national/regional/international.
Commentary, conclusion and recommendation

Support for the GFBR: Wellcome, the Bill & Melinda Gates Foundation, the UK Medical Research Council and the National Institutes of Health are providing funding for this meeting.