A Value-Based Global Code of Conduct to Counter Ethics Dumping
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The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC, please visit: http://www.globalcodeofconduct.org/
KeywordsGlobal ethics Research ethics International co-operation Ethics dumping Low- and middle-income countries
Research partnerships between high-income and lower-income settings can be highly advantageous for both parties. Or they can lead to ethics dumping, the practice of exporting unethical research practices to lower-income settings.
Providing guidance across all research disciplines
presenting clear, short statements in simple language to achieve the highest possible accessibility
focusing on research collaborations that entail considerable imbalances of power, resources and knowledge
using a new framework based on the values of fairness, respect, care and honesty
offering a wide range of learning materials and affiliated information to support the Code, and
complementing the European Code of Conduct for Research Integrity through a particular focus on research in resource-poor settings.
Local relevance of research is essential and should be determined in collaboration with local partners. Research that is not relevant in the location where it is undertaken imposes burdens without benefits.
Local communities and research participants should be included throughout the research process, wherever possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented. This approach represents Good Participatory Practice.
Feedback about the findings of the research must be given to local communities and research participants. It should be provided in a way that is meaningful, appropriate and readily comprehended.
Local researchers should be included, wherever possible, throughout the research process, including in study design, study implementation, data ownership , intellectual property and authorship of publications.
Access by researchers to any biological or agricultural resources, human biological materials, traditional knowledge, cultural artefacts or non-renewable resources such as minerals should be subject to the free and prior informed consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to researchers, on terms that are co-developed with resource custodians or knowledge holders.
Any research that uses biological materials and associated information such as traditional knowledge or genetic sequence data should clarify to participants the potential monetary and non-monetary benefits that might arise. A culturally appropriate plan to share benefits should be agreed to by all relevant stakeholders, and reviewed regularly as the research evolves. Researchers from high-income settings need to be aware of the power and resource differentials in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue.
It is essential to compensate local research support systems, for instance translators, interpreters or local coordinators, fairly for their contribution to research projects.
Potential cultural sensitivities should be explored in advance of research with local communities, research participants and local researchers to avoid violating customary practices. Research is a voluntary exercise for research participants. It is not a mission-driven exercise to impose different ethical values. If researchers from high-income settings cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
Community assent should be obtained through recognized local structures, if required locally. While individual consent must not be compromised, assent from the community may be an ethical prerequisite and a sign of respect for the entire community. It is the responsibility of the researcher to find out local requirements.
Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been obtained in the high-income setting.
Researchers from high-income settings should show respect to host country research ethics committees .
Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded decision-making.
A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and appropriate access to all research participants and local partners to express any concerns they may have with the research process. This procedure must be agreed with local partners at the outset of the research.
Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a lower-income setting. Exceptions might be permissible in the context of specific local conditions (e.g. diseases not prevalent in high-income countries).
If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly and transparently justified and made easily accessible to interested parties.
Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination (e.g. sex work), discrimination or indeterminate personal risk (e.g. research on political beliefs), special measures to ensure the safety and wellbeing of research participants need to be agreed with local partners.
Ahead of the research it should be determined whether local resources will be depleted to provide staff or other resources for the new project (e.g. nurses or laboratory staff). If so, the implications should be discussed in detail with local communities, partners and authorities and monitored during the study.
In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the country of origin of the researcher, animal experimentation should always be undertaken in line with the higher standards of protection for animals.
In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in the local setting compared with the country of origin of the researcher, research should always be undertaken in line with the higher standards of environmental protection.
Where research may involve health, safety or security risks for researchers or expose researchers to conflicts of conscience, tailored risk management plans should be agreed in advance of the research between the research team, local partners and employers.
A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct throughout the research cycle, from study design through to study implementation, review and dissemination. Capacity-building plans for local researchers should be part of these discussions.
Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a non-patronising style in the appropriate local languages should be adopted in communication with research participants who may have difficulties comprehending the research process and requirements.
Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization, discrimination or incrimination through the research participation.
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