The PREPARED Code
PREPARED project meeting in Amsterdam, May 2024
The PREPARED Code - A Global Code of Conduct for Research during Pandemics (articles only)
FAIRNESS
Article 1
Data and scientific insights about new infectious agents should be quality controlled and shared as swiftly as possible with the scientific community and other relevant stakeholders, and without detrimental impact on the sharer.
It is of crucial importance that scientists around the world obtain fast access to data about new infectious agents that could present a challenge to humanity. This can include the genetic sequence, how the agent spreads, which symptoms are associated with it, and whether any available treatments work.
In 2021, South Africans felt punished – instead of applauded – for discovering Omicron, a concerning new variant of Covid-19.
ARTICLE 2
Research coordination and cooperation is essential to avoid unnecessary duplication of studies which can result in wasted resources and place unfair burdens on participants.
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Article 3
A fair plan for access to the benefits of pandemic research should be agreed, early on in any project, in collaboration with relevant stakeholders.
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Article 4
Where possible, community engagement should be continued or even enhanced during a pandemic, to address the most pressing needs of communities and to help maintain trust in science.
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Article 5
People’s vulnerabilities increase during pandemics. Where possible, research approaches should be adapted to ensure the ethical inclusion of vulnerable persons – with adequate protections – rather than adopting patronizing or convenience exclusions.
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Article 6
Research teams should ensure that additional responsibilities associated with a pandemic are shared fairly across the team to avoid exacerbating existing inequalities.
Respect
Article 7
Research ethics committee guidance and approval is essential also during pandemics and should be obtained and respected. RECs should strive to facilitate timely evaluation of research proposals that address urgent societal needs without compromise of rigorous ethical standards.
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Article 8
Community researchers are part of the research team and should be treated and respected as researchers, including during pandemics.
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Article 9
The urgent need to conduct research can never be an excuse for putting pressure on potential research participants or their proxies to make a hasty decision about involvement in a study. Sufficient time is needed to achieve genuine informed consent.
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Article 10
Changes to the process of seeking informed consent must not compromise understanding for potential participants.
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Article 11
Where healthcare staff rather than researchers obtain consent during crises, special attention must be given to ensuring that research participants do not mistake research for treatment (’therapeutic misconception’).
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Article 12
The informed consent process should explain the study risks and benefits fully and clearly in terms of what is known, what is uncertain and what is unknown.
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Article 13
During pandemics, actors across the research cycle should strive for respectful engagement with each other in the spirit of equitable and collaborative problem-solving.
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Article 14
Researchers must use respectful language in the press or the media at all times, including when under pressure.
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Care
Article 15
Public health responses must not be compromised by research. In particular, any involvement of clinical staff in research should not have a detrimental impact upon patient care.
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Article 16
Especially during pandemics, researchers who handle biological materials should be adequately trained and equipped to safeguard public health.
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Article 17
Researchers should consider how pandemic conditions may impact upon all stakeholders in a study (including participants, healthcare staff, support staff etc.) and take appropriate measures to mitigate additional burdens.
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Article 18
When prioritizing research during pandemics, it must be ensured that research participants in other ongoing studies are not left worse off than before they entered their study.
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Article 19
If research participants depend on research studies for access to medication and services, study modifications during pandemics need to be managed responsibly to ensure that lives and health are not endangered.
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Article 20
When novel compounds are first administered to humans or when no rescue therapy is available, studies involving healthy volunteers can only be started during pandemics if space in Intensive Care Units is assured for the needs of healthy volunteers and all patients in routine care.
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Article 21
During pandemics, researchers may experience a heightened risk of hostility and related safety and security concerns. Research ethics committees should check that risk management plans are in place.
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Honesty
Article 22
Even under significant pressure, it is vital that researchers uphold the highest standards of research integrity to ensure the reliability of pandemic research results and to maintain public trust in science.
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Article 23
In the context of uncertainty, researchers should review their study protocols regularly to ensure that new findings are taken into account as they emerge.
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Article 24
Participants and research ethics committees should be promptly and fully informed about changes in the risks or burdens of participation in clinical research if new, relevant information becomes available during the trial.
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Article 25
Regulatory requirements for the secondary use of personal data and biological materials apply equally during pandemics unless an explicit exception has been enacted.
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Article 26
Researchers should offer their time to support rigorous, fast-track scientific review to help combat the erosion of good science during pandemics. They should also support quality control mechanisms for open communication modalities such as pre-print servers or social media.
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Article 27
Publishers’ research ethics questions should be answered in full by researchers, also in rapid review submissions.
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Article 28
In public communications, researchers should ensure the reliability of scientific information. They should be clear about study limitations and avoid exaggerations, sensationalism and deception.
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