View source for Instruction:0106d5c9-3d80-4a3a-9a20-1656baff2ccb

{{Instruction
|Title=THE PREPARED CODE: A Global Code of Conduct for Research during Pandemics
|Has Related Initiative=Initiative:50e236b6-b669-4c30-8c7c-837267f44278
|Instruction Goal=Research ethics and integrity challenges during pandemics are not unique, but they are vastly magnified during crises. The PREPARED Code for researchers, research ethics committees and research integrity offices applies throughout a pandemic. The code was developed by an international consortium and is based on research undertaken in English, Chinese, French, German, Hindi, Japanese, Korean, Russian and Spanish. It was refined through a human rights analysis and extensive consultation with stakeholders. Input from marginalized populations was obtained at every stage.


THE PREPARED CODE:
*Respects the Declaration of Helsinki as the primary  source of research ethics guidance during pandemics.
*Provides support across all research disciplines.
*Presents concise statements in clear language to encourage access.
*Combines guidance on research ethics and integrity.
*Complements the TRUST Code and the European Code  of Conduct for Research Integrity, because the risks of  inequitable research and breaches of research integrity can increase during a crisis.
*Links each guidance article to the values of fairness,  respect, care and honesty.
VISION: Pandemic research should be trustworthy and the results accessible to all
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|Important For=All stakeholders in research
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|Instruction Step Title=Article 1
|Instruction Step Text=Data and scientific insights about new infectious agents should be quality controlled and shared as swiftly as possible with the scientific community and other stakeholders, without prejudice to the sharer.
|Instruction Step Interactive Content=Resource:H5P-339
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|Instruction Step Title=Article 2
|Instruction Step Text=Research coordination and cooperation are essential to avoid the unnecessary duplication of studies, which could place unfair burdens on participants and waste time and resources.
|Instruction Step Interactive Content=Resource:H5P-340
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|Instruction Step Title=Article 3
|Instruction Step Text=A fair plan for access to the benefits of pandemic research should be agreed early on in any project, in collaboration with stakeholders.
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|Instruction Step Title=Article 4
|Instruction Step Text=Where possible, community engagement should be continued or even increased during a pandemic, to address the most pressing needs of communities and to help maintain trust in science.
|Instruction Step Interactive Content=Resource:H5P-341
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|Instruction Step Title=Article 5
|Instruction Step Text=Vulnerabilities increase during pandemics. Where possible, research approaches should be adapted to ensure the ethical inclusion of persons in vulnerable situations – with adequate protections – rather than adopting patronizing or convenience exclusions.
|Instruction Step Interactive Content=Resource:H5P-342
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|Instruction Step Title=Article 6
|Instruction Step Text=Research teams should share the additional responsibilities associated with a pandemic fairly among their members to avoid exacerbating existing inequalities
|Instruction Step Interactive Content=Resource:H5P-342
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|Instruction Step Title=Article 7
|Instruction Step Text=Research ethics committee (REC) guidance and approval should be sought and respected at all times, including during pandemics. RECs should expedite the evaluation of research proposals that address urgent societal needs without compromising rigorous ethical standards.
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|Instruction Step Title=Article 8
|Instruction Step Text=Community researchers are part of the research team and should be treated and respected as researchers, including during pandemic
|Instruction Step Interactive Content=Resource:H5P-344
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|Instruction Step Title=Article 9
|Instruction Step Text=The urgent need to conduct research can never be an excuse for putting pressure on potential research participants or their proxies to make hasty decisions about their involvement in a study. Genuine informed consent needs time
|Instruction Step Interactive Content=Resource:H5P-345
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|Instruction Step Title=Article 10
|Instruction Step Text=Changes to the process of seeking informed consent must not be allowed to compromise potential participants’ understanding of a research project. This includes ensuring that research participants do not mistake research for treatment (‘therapeutic misconception’), especially when healthcare staff rather than researchers seek consent
|Instruction Step Interactive Content=Resource:H5P-346
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|Instruction Step Title=Article 11
|Instruction Step Text=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
|Instruction Step Interactive Content=Resource:H5P-347
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|Instruction Step Title=Article 12
|Instruction Step Text=During pandemics, all those involved in the research cycle should strive for respectful engagement with each other in the spirit of equitable and collaborative problem-solving
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|Instruction Step Title=Article 13
|Instruction Step Text=Researchers must always use respectful language when communicating through the press or the media, even when under pressure
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|Instruction Step Title=Article 14
|Instruction Step Text=Research must not compromise public health responses. In particular, the involvement of clinical staff in research should not affect patient care negatively.
|Instruction Step Interactive Content=Resource:H5P-348
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|Instruction Step Title=Article 15
|Instruction Step Text=Especially during pandemics, researchers who handle potentially infectious biological materials should be adequately trained and equipped to safeguard public health
|Instruction Step Interactive Content=Resource:H5P-349
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|Instruction Step Title=Article 16
|Instruction Step Text=Researchers should keep in mind how pandemic conditions may affect all stakeholders in a study (participants, healthcare staff, support staff etc.) and take appropriate measures to ease any additional burdens.
|Instruction Step Interactive Content=Resource:H5P-350
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|Instruction Step Title=Article 17
|Instruction Step Text=When research is prioritized during a pandemic, research participants in ongoing studies must not be left worse off than before they joined their original study
|Instruction Step Interactive Content=Resource:H5P-351
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|Instruction Step Title=Article 18
|Instruction Step Text=Where research participants depend on research studies for access to medication and services, study modifications during pandemics need to be managed responsibly to ensure that their lives and health are not endangered.
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|Instruction Step Title=Article 19
|Instruction Step Text=During pandemics, studies involving healthy volunteers in which novel compounds are administered to humans or no rescue therapy is available should only be started if space in intensive care units is assured for the needs of healthy volunteers, as well as for all patients in routine care.
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|Instruction Step Title=Article 20
|Instruction Step Text=In the context of uncertainty, researchers should review their study protocols regularly to ensure that new findings are taken into account as they emerge
|Instruction Step Interactive Content=Resource:H5P-352
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|Instruction Step Title=Article 21
|Instruction Step Text=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
|Instruction Step Interactive Content=Resource:H5P-353
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|Instruction Step Title=Article 22
|Instruction Step Text=It is vital that researchers uphold the highest standards of research integrity, even when under significant pressure, to ensure the reliability of pandemic research results and to maintain public trust in science
|Instruction Step Interactive Content=Resource:H5P-354
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|Instruction Step Title=Article 23
|Instruction Step Text=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 a trial.
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|Instruction Step Title=Article 24
|Instruction Step Text=Existing regulatory requirements for the secondary use of personal data and biological materials must prevail during pandemics, unless an explicit exception has been enacted
|Instruction Step Interactive Content=Resource:H5P-355
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|Instruction Step Title=Article 25
|Instruction Step Text=Researchers should actively 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 channels such as pre-print servers or social media.
|Instruction Step Interactive Content=Resource:H5P-356
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|Instruction Step Title=Article 26
|Instruction Step Text=Researchers should answer publishers’ research ethics questions in full, even in rapid review submissions.
|Instruction Step Interactive Content=Resource:H5P-357
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|Instruction Step Title=Article 27
|Instruction Step Text=In public communications, researchers should ensure that the scientific information presented is reliable. They should be clear about study limitations and avoid exaggeration, sensationalism and deception
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