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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 place unfair burdens on participants and waste time and resources.

Emma, Francois, Doris

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.

Doris, Claudia

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.

Joshua, Joyce

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.

Doris, Dafna

Article 6

Research teams should ensure that additional responsibilities associated with a pandemic are shared fairly across the team to avoid exacerbating existing inequalities.

Our research has shown that, during the COVID-19 pandemic, researchers who were already disadvantaged in the academic system were disproportionately burdened with responsibilities such as pastoral care and social and psychological support. In many cases, this led to a decrease in their academic productivity, with an impact on future employability and career progression. In an equitable academic environment additional responsibilities should be shared fairly across the team.

Related PREPARED Publications:

Respect

Article 7

Research ethics committee (REC) 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 compromising rigorous ethical standards.

Vilnius

Article 8

Community researchers are part of the research team and should be treated and respected as researchers, including during pandemics.

Joshua, Joyce

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.

Open

Article 10

Changes to the process of seeking informed consent must not compromise understanding for potential participants. This includes ensuring that research participants do not mistake research for treatment (‘therapeutic misconception’) when healthcare staff rather than researchers collect consent during crises.

Research has shown that the process of obtaining informed consent changed considerably during the COVID-19 pandemic. In particular remote consent and the involvement of legally authorized representatives increased significantly. In addition, healthcare staff often obtained consent rather than researchers. Such changes can have an impact on understanding and when understanding is compromised, the consent process is undermined. It is crucial that measures are taken to ensure that procedural changes do not impact negatively on the consent process.

Relevant research:

Article 11

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.

Vilnius

Article 12

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.

Francois, Doris

Article 13

Researchers must use respectful language in the press or the media at all times, including when under pressure.

Andreas

Care

Article 14

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.

Doris and Dafna

Article 15

Especially during pandemics, researchers who handle potentially infectious biological materials should be adequately trained and equipped to safeguard public health.

Biorisk management is key to maintaining public health during pandemics. In the video, Dr Johannes Rath provides a short overview of the challenges. As the PREPARED Code targets researchers, research ethics committees (REC) and research integrity offices, the most relevant ethics guidance in the context of biorisk is that researchers must be adequately trained and equipped when they handle potentially infectious biological materials. For instance, in many cases, it is part of the ethics protocol, checked by RECs, that staff have adequate training (e.g. certification) to work with specific materials.

Related PREPARED output:

Article 16

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.

Our analysis of peer-reviewed literature from the UK and South Africa paints a bleak picture of healthcare and support staff working during the COVID-19 pandemic; warzone-like conditions with an unprecedented volume of suffering and dying all around them, a situation which was echoed around the world.

As researchers themselves were excluded from intensive care units, healthcare staff were asked to take on additional responsibilities. However, helping their researcher colleagues had the potential to impact on their wellbeing and their ability to function effectively in their roles. The involvement of healthcare staff in research during pandemics needs to be considered carefully.

Related PREPARED Output:

  • Pushed closer to the edge – How the COVID-19 pandemic contributed to the increasing marginalisation of disabled people and their carers in the UK
  • Unprepared – A scoping review of the experiences of health and social care workers in South Africa during COVID-19
  • Battling at the frontline –  The experiences of frontline health care staff in the UK during the coronavirus pandemic

Article 17

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.

Prioritization guidelines

Article 18

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.

Joyce and Joshua

Article 19

When novel compounds are first administered to humans or when no rescue therapy is available, studies involving healthy volunteers should 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.

Charles, Doris, Klaus

Article 20

In the context of uncertainty, researchers should review their study protocols regularly to ensure that new findings are taken into account as they emerge.

Amsterdam team

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.

Nandini and Doris

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.

Amsterdam team

Article 23

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.

Open

Article 24

Regulatory requirements for the secondary use of personal data and biological materials apply equally during pandemics unless an explicit exception has been enacted.

Ock Joo and Young Su

Article 25

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.

Shanghai team

Article 26

Publishers’ research ethics questions should be answered in full by researchers, also in rapid review submissions.

Katerina K?

Article 27

In public communications, researchers should ensure the reliability of scientific information. They should be clear about study limitations and avoid exaggerations, sensationalism and deception.

Kalle