Responsible Conduct of Research Policy

1. Purpose

All researchers and organisations we fund and collaborate with must conduct their research responsibly. We expect organisations to have policies, structures and training in place to enable all researchers to carry out their research responsibly.

Our Grant Conditions and associated Funding Policies outline specific requirements we have of researchers and organisations we fund. They provide the basis for carrying out research responsibly. These policies may form part of any organisational audit by SEA DREAM and if not adhered to may result in sanctions.

2. Guidance on different aspects of research

2.1. Research design

Researchers should employ appropriate research methods, base conclusions on critical analysis of the evidence, and report findings and interpretations fully and objectively by following standard reporting guidelines for specific study types (e.g., CONSORT for randomised trials, PRISMA for systematic reviews, CHEERS for economic evaluations, etc.). Researchers must take care to determine and report appropriate controls and replicates, and specify how bias in data collection and analysis will be managed.

2.2. Safeguarding researchers and research participants

Researchers and organisations must ensure they take all reasonable means to prevent harm, exploitation, abuse and harassment occurring because of their work. This includes all participants conducting the research as well as those who are participants in the research.

• Research Involving Human Participants
• Bullying, Harassment Abuse and Harm

2.3. Research involving animals

2.4. Research records

2.5. Sharing research outputs

2.6. Keeping your research secure

The most benefit can be gained from research when the outputs are made freely available whenever possible and used responsibly.

Data and related materials must be stored for at least 10 years after the study ends. If the research is based on clinical samples or findings that relate to public health, it should be stored for 20 years.

2.7. Biosafety and engineering biology

In addition, as a fund management body designated by Wellcome, SEA DREAM fully adopts a joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Wellcome Trust policy statement for managing risks of research misuse (Annex I) for SEA DREAM-funded research grants. SEA DREAM’s grantees are expected to adhere to these provisions since the application stage. Applicants and grantees are also required to describe whether their intended research outputs may be associated with any potential risks of research misuse and how they plan to mitigate these risks in the Outputs Management Plan (OMP), and reassess them over the course of the research project.

2.8. Promoting a positive research culture

Researchers and organisations should encourage practices that promote responsible research and an environment in which research can flourish. Institutions should recognise and reward researchers for behaviour that supports research integrity and a positive research culture. These could include:

• providing support for collaborations
• undertaking and recognising peer review and advisory board activities
• demonstrating commitment to diversity and inclusion

2.9. Maximising the impact of research

We want the outputs, knowledge and discoveries that research generates to have as much impact as possible. Researchers should explore ways to do this both within and beyond traditional routes.

Organisations should have mechanisms in place to enable and reward these activities. This could be, for example, by translation, public engagement or informing policy.

3. Concordat to Support Research Integrity

4. Annexes

Annex I. Managing Risks of Research Misuse

A joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Wellcome Trust policy statement

As funders, BBSRC, the MRC and the Wellcome Trust strive to support research of the highest scientific and ethical quality that will advance knowledge and its application to deliver benefit to the public. We recognise, however, that there is a risk that the results of some types of research which are funded in line with this objective, could also potentially be misused to cause great harm (for example, to develop biological weapons). In this statement, we set out a shared approach to managing these types of risks, and describe how we think the broader research community should play their part.

Research which poses significant risks of this type has been referred to as ‘dual use research of concern’. In our position statement, we adopt the US government’s definition of this term, which is “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products and technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material or national security”.

Our joint statement covers issues such as:

• Balancing benefit and risk;
• Dissemination of research;
• International collaboration and training;
• Promoting good research practice;
• Ensuring public trust.

While such risks must be considered and managed in an appropriate manner, our view is that responsibly conducted research – including that involving potentially harmful biological agents – must not be unduly restricted. Indeed, such research will be absolutely vital in the fight to combat disease and address other major societal challenges.

We believe that a system based primarily upon self-governance by the scientific community, but drawing on the inputs of other key stakeholders, will ultimately provide the most effective means of managing risks of misuse. We suggest that the community, of which we as funders are part, should take active steps to further develop mechanisms of self-governance, and that through doing so the community can ensure that responsibly conducted research is not unnecessarily obstructed. Crucially, this process must be underpinned by an active ongoing dialogue between researchers and other key stakeholders, including Governments and security services.

BBSRC, the MRC and the Wellcome Trust each have rigorous processes in place for ensuring that the research we support is of the highest scientific quality and conforms to all relevant ethical and regulatory requirements. In light of concerns over research misuse, and in consultation with our research communities, we have implemented five key provisions in our grant application processes and funding requirements to help ensure that risks of misuse associated with research proposals are identified and assessed during the grant funding process, where it is possible to do so.

These five steps are:

• Inclusion of a question on application forms requiring applicants to consider short and medium-term risks of misuse associated with their proposal.
• Explicit mention of risks of misuse in guidance to external experts who peer review grant applications as an issue to consider.
• Development of clear guidance for funding committees on this issue and the process for assessing cases where concerns have been raised.
• Modification of guidelines on good practice in research to include specific reference to risks of misuse.
• A requirement to notify funders, and other relevant authorities, of any change in the status of a dual use risk or any new risks that may emerge during the course of a funded research project that were not anticipated in the original application.

These actions are intended to heighten awareness, and are a means of helping to identify possible risks of misuse at an early stage. Ultimately what matters most is people's motives, and an awareness of the possible motives of research users. The changes we have implemented in our processes will not be sufficient on their own to prevent misuse by somebody with the primary intent to do harm, nor will they identify new risks that arise as the research progresses. Other processes within the research environment are therefore also important. These include effective research governance at the local (institutional) level, appropriate levels of caution in making appointments, provision of appropriate training and education, and compliance with existing biosafety and biosecurity regulations.