Applying the principles
How an organisation can apply the principles will vary according to the nature of its funded research, and the organisation’s own size, partnerships and powers. Starting points for new processes are suggested below.
Principle 1 - Health-related research agendas and priorities should be set with the meaningful involvement of those who will use and be affected by health-related research.
- Involve potential users of research meaningfully in funder’s decision-making process.
- Use a patient need survey or James Lind Alliance Priority Setting Partnership to identify areas of research that are important to patients and clinicians.
- Make the appropriate involvement of potential users of the research a criterion for peer review and funding decisions.
Principle 2 - Research should only be funded if set in the context of one or more existing systematic reviews of what is already known or an otherwise robust demonstration of a research gap.
- Routinely assess whether an adequate review has been done and whether the results of that review support the case for further clinical or preclinical research.
- Expect pilot, feasibility, low-risk, or small-scale studies to clearly address the evidence gap their study intends to address, keeping the level of documentation proportionate to the risk and effort invested in the study.
Principle 3 - Funders should take into account advances in research methodology and fund new research only if adequate steps have been taken to reduce bias.
- Support the development and use of design, conduct or methodological standards and guidelines.
- Require applicants to explicitly state potential sources of bias, along with mechanisms to address them on application forms. Where relevant, approaches and assumptions for sampling bias (random selection), confounding (randomization to control), and observer bias (blinding to control) should be evidenced and critically appraised.
- Manage actual, potential and perceived conflicts of interest in the peer review and decision-making processes.
Principle 4 - Selection and conduct of research should be actively managed in a risk proportionate way, consistent with applicable human subjects research laws, regulations, and ethical guidance.
- Actively manage study conduct against clear objectives and milestones, keeping the study management plan proportionate to risks associated with the study.
- Stage studies where appropriate. For example, pilots with explicit criteria to proceed, or explicit stopping rules for large studies that could become futile.
Principle 5 - Studies should be registered in an appropriate, design-relevant publicly accessible registry at study inception whenever possible.
- Develop and enforce policies on study registration, for example, by monitoring and reporting on registration.
- Present a range of appropriate registries for various types of studies, such as ClinicalTrials.gov for relevant clinical trials and observational studies, the Registry of Patient Registries (RoPR) for patient registries, or the National Library of Medicine Health Services Research Projects in Progress database (HSRProj) for methodological projects.
Principle 6 - Research questions, methods, materials, analysis plans or sequence of analytical choices for all studies should be made available as early as possible and preferably near or before the start of the study or analysis. Any deviation from the original plans should be documented.
- Make reporting templates available, and develop or support policies on the public reporting of study protocols and analysis plans along with any subsequent changes. This could include working with others such as Universities and publishers.
Principle 7 - All studies should report methods and findings in full, following credible and justifiable reporting guidelines. This applies irrespective of the nature of the findings and whether the study completed as planned.
- Make summary results of clinical trials, including negative results, publicly available (for example via clinicaltrials.gov registry or funder website) in a timely manner following primary study completion.
- Application process to require principle investigators (PI) to provide a list of all previous trials on which they were PI within a specified timeframe and their reporting status, with an explanation where trials have remained unreported.
- Have a policy of full publication and adherence to relevant reporting standards (such as EQUATOR network, TOP guidelines).
Principle 8 - When appropriate and when it will add value to evidence users, replication, reanalysis, and reuse of data from studies should be supported and facilitated.
- Consider whether replication, reuse, or reanalysis would benefit evidence users.
- Have and enforce policies on managed access to research data, consistent with applicable privacy, confidentiality and other legal requirements.
- Make funding available for replication and reanalysis.
Principle 9 - New evidence should be placed in the context of existing knowledge to inform appropriate interpretation and use of findings. When appropriate and when it will add value to evidence users, systematic reviews should be updated following primary research.
- Give consideration to whether the next stage following primary research is an updated systematic review.
- Make funding available for the update of systematic reviews.
Principle 10 - Research knowledge that can lead to benefit should be effectively disseminated to end users. Where appropriate, the usage of new knowledge should be supported and facilitated.
- Financially or materially support the dissemination of research findings.
- Require a summary of the study conduct, analysis and findings to be provided in a format accessible to a lay audience.
- Make funding available for implementation research or the implementation of new findings into practice.