The Global Forum on Bioethics in Research (GFBR) will hold a two-day meeting in Buenos Aires, Argentina, on 3-4 November 2016 on the theme of: “Ethics of Research in Pregnancy”.
There is currently no broadly acceptable ethical framework for guiding research during pregnancy. This has a significant impact on maternal and neonate health. Unresolved ethical questions – including what is meant by ‘minimal risk’ and how regulations governing pregnancy research should be interpreted – mean that pregnant women are often “over-excluded” from research. This results in a lack of knowledge about the efficacy of medicines and health interventions for pregnant women. These challenges are made harder in low- and middle-income country (LMIC) settings, due to high variability in protections for women and social and cultural conventions that increase women’s vulnerability. This is an area in urgent need for global progress if research on treatments for major LMIC infections (e.g. HIV/AIDS, tuberculosis, malaria, helminths, emerging viral epidemics) and non-communicable conditions (e.g. mental ill-health, substance abuse, diabetes, hypertension, anemia) is to advance.
As part of the upcoming meeting, the GFBR is seeking case studies that bring attention to key ethical issues that have emerged when conducting research during pregnancy in LMIC settings. The case studies will help set out the unresolved challenges that stand in the way of the inclusion of pregnant women in research and on how best these challenges can be overcome.
The GFBR is also seeking participants to attend the meeting, with places awarded on a competitive basis.
This notice contains details on the following:
- CALL FOR CASE STUDIES
- CALL FOR PARTICIPANTS
- DEADLINE
- AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING
- NOTIFICATION
- 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 the “Ethics of Research in Pregnancy”. 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 and healthcare workers on the ground. Case studies should focus on issues around conducting research, not just clinical practice.
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, one or two experts will provide commentary on the issues presented, and then participants at the meeting will discuss the challenges and questions raised by the case studies.
Case studies should be 2 pages maximum (in Microsoft Word or pdf format), clearly articulated in English and contain the following sections:
- Brief description of the research project
- Background – relevant facts about the host country/community and disease studied
- Ethical issues
- Commentary on the issues, conclusions and/or recommendations for discussion or future research
Case studies should highlight no more than three ethical issues for discussion. These might include but are not limited to the following:
- Fair inclusion (Justice)
- Over-exclusion
- Vulnerability
- Policies and regulations addressing inclusion of pregnant women
- Consent (Autonomy)
- Role co-parent or intimate partner
- Consent during labour
- Consent by pregnant adolescents
- Cultural considerations (placental sampling, autopsy, etc.)
- Addressing the philosophical question of how much a woman has the autonomy to decide about risks to a foetus versus how much regulators and ethics boards must limit potential risks to the foetus
- Risk/benefits (Non-maleficence, benevolence)
- Definitions of minimal risk and more than minimal risk
- Whose histories and experiences are informing the more conservative risk calculations and have the experiences/judgments of those working in higher disease burden regions (LMICs) been given sufficient voice in informing research ethics policy on this question?
- Adjudication of risks and benefits to mother and foetus (and possibly child or father)
- Public health analysis of risk/benefits
- Ethical study design (for both observational studies and clinical trials)
- Measuring short term verses long term outcomes
- Standards of care & ancillary care in community based studies
- Ways to increase pregnant women in clinical research
- Policies and regulations
- Role of official and unofficial policies at local or national level
- Regulatory structures;
- drug regulatory authorities
- human research protections regulations
- roles/attitudes/practices of ethics committees
- Community perspectives and experiences with research during pregnancy
For guidance on how to write and present a case study, please see this example from last year’s GFBR meeting.
In addition, please provide the following information in Microsoft Word or pdf format:
- Short letter of intent not exceeding one page, outlining why you would like to participate in the GFBR meeting
- Name, institution and contact information
- Short CV (1-2 pages)
- 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 low- and middle-income countries. Applicants from other countries are welcome to apply if they can self-fund their attendance.
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.
2. CALL FOR PARTICIPANTS
Who can attend the GFBR meeting?
There will be a competitive selection process. Up to 80 participants will be selected from those eligible who submit an application to attend 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 submit an application to attend, please provide the following information in Microsoft Word or pdf format:
- Short letter of intent not exceeding one page, outlining:
- Why you would like to participate in the GFBR meeting;
- What you can contribute to the meeting. Please note we are looking for people who have an interest in or experience of working on research during pregnancy.
- Name, institution and contact information
- Short CV (1-2 pages)
- 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 low- and middle-income countries. Applicants from other countries are welcome to apply if they can self-fund their attendance.
3. DEADLINE
Applications for both case studies and to attend should be sent to gfbr@wellcome.ac.uk by 21.00 BST on 22 May 2016, in English. Applications received after the deadline will not be considered.
4. AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING
Successful applicants from low-and middle-income countries 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 case studies and 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 during pregnancy;
- 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 only: Relevance of the case to the meeting theme.
If your case study is not selected your name will automatically go forward to be considered in the applications to attend. Applicants are strongly encouraged to submit a case study.
5. NOTIFICATION
Case study applicants will be informed of the Planning Committee’s decision in the week of the 13 June 2016.
Applicants applying to attend will be informed of the Planning Committee’s decision in the week of the 4 July 2016.
In both cases the decision of the committee will be final.
6. CHECKLIST FOR APPLICANTS
Please use the following checklist to make sure you have provided all the requested information in your application.
| To present a case study | To attend | |
| Short letter of intent (1 page) | ||
| Your name | ||
| Your institution | ||
| Your contact information | ||
| Short CV (1-2 pages) | ||
| Contact information and email addresses of two references | ||
| Whether you require funding to cover travel and accommodation costs, or you are self-funding | ||
| Case study applications only: | ||
| Brief description of the research project | ||
| Background – relevant facts about the host country/community and disease studied | ||
| Ethical issues | ||
| Commentary, conclusions and recommendations |
Support for the GFBR
The GFBR is sponsored by a range of international funders. The Wellcome Trust, the National Institutes of Health, the UK Medical Research Council and the Bill and Melinda Gates Foundation are providing funding for this meeting.
Members of the Planning Committee for this upcoming meeting are: Francoise Baylis, Dalhousie University; Ana Garcés, NICHD Global Health Network Women’s and Children’s Health Research (Guatemala); Melba Gomes, WHO; Shivaprasad Goudar, Jawaharlal Nehru Medical College; Rose McGready, Oxford University/Shoklo Malaria Research Unit; Omrana Pasha, The Aga Khan University; Maureen Kelley, University of Oxford; Mariana Kruger, University of Stellenbosch; Maggie Little, Georgetown University; Katherine Littler, Wellcome Trust; Florencia Luna, FLACSO; Carla Saenz, Pan American Health Organization; Barbara Sina, NIH; Ajoke Sobanjo-ter Meulen, Bill and Melinda Gates Foundation.
Members of the GFBR Steering Committee are: Anant Bhan, India; Katherine Littler, UK; Florencia Luna, Argentina; Michael Parker, UK; Frances Rawle, UK; Barbara Sina, USA; Douglas Wassenaar, South Africa; Ross Upshur, Canada.