Implementation of Guiding Principles
Examples of Implementation of Guiding Principles
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.
- Potential users of research could be involved wherever this can be meaningful in funder’s decision-making process.
- Funders could use a patient need survey or James Lind Alliance Priority Setting Partnership to identify areas of research that are important to patients and clinicians.
- The appropriateness of the involvement of those that benefit from or are affected by the health-related services being researched could be 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.
- Funders could assess whether an adequate review of what is already known has been done and whether the results of that review support the case for further clinical or preclinical research.
- Pilot, feasibility, low-risk, or small-scale studies should clearly address the evidence gap their study intends to address, but the level of effort to document the resource gap should be 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.
- Funders could support the development and use of design, conduct or methodological standards and guidelines.
- Application forms could ensure that potential sources of bias, and mechanisms to address them, are explicitly stated. 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.
- Funders could ensure that actual, potential and perceived conflicts of interest are managed in their 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.
- Study conduct could be actively managed against clear objectives and milestones, and the study management plan should be proportionate to risks associated with the study.
- Studies may be staged. For example, pilots with explicit criteria to proceed, or stopping rules for large studies that become futile and therefore should be stopped.
Principle 5: Studies should be registered in an appropriate, design-relevant publicly accessible registry at study inception whenever possible.
- Funders could have and enforce policies on study registration by, for example, monitoring and reporting on registration.
- Funders could present a range of appropriate registries for various types of studies, e.g., 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.
- Funders could make reporting templates available, and could have and support policies on the public reporting of study protocols and analysis plans along with any subsequent changes. This could include working with others e.g. Universities, publishers etc.
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.
- Summary results of clinical trials, including negative results, could be made publicly available (e.g. clinicaltrials.gov registry or funder website) in a timely manner following primary study completion.
- When a principle investigator (PI) applies for new funding, they may be asked 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.
- Funders could have a policy of full publication and adherence to relevant reporting standards (e.g., 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.
- Funders could give consideration to whether replication, reuse, or reanalysis would benefit evidence users.
- Funders could have and enforce policies on managed access to research data, consistent with applicable privacy, confidentiality and other legal requirements.
- Funding for replication and reanalysis could be available.
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.
- Funders could give consideration to whether the next stage following primary research is an updated systematic review.
- Funding for the update of systematic reviews could be available.
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.
- Funders could financially or materially support the dissemination of research findings.
- Funders could ensure that a summary of the study conduct, analysis and findings are provided in a format accessible to a lay audience.
- Funding for implementation research or the implementation of new findings into practice could be available.