Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.
Legal and good practice requirements
Sponsors are responsible for ensuring appropriate arrangements are made for:
- Making information about the research publicly available before it starts, e.g. registering the research project on a public research register.
- Making the findings of the research publicly available, e.g. posting results online or publishing in a journal.
- Making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after the research has finished.
- Where appropriate, making information about the findings of the research available to participants.
These four responsibilities are reflected in the UK Policy Framework for Health and Social Care Research. Information on each of these responsibilities is set out below.
Research Ethics Committees consider assurances about the plans in each area as part of their decision to approve a study. Through final reports, they also receive information about whether those undertakings were fulfilled.
It is a good practice requirement that all research is registered in a public research register before it starts.
For drug trials (clinical trials of investigational medicinal products) other than adult phase I trials, this is also a legal requirement.
For drug trials and all other types of clinical trial, not registering within six weeks of recruiting the first patient is a breach of approval conditions, unless a deferral has been agreed by or on behalf of the Research Ethics Committee.
For the purpose of registering research projects other than clinical trials, the Research Registry accepts observational studies, interventional studies, systematic reviews and meta-analyses, including prospective and retrospective designs.
Making results public
It is a good practice requirement that all the results are made publicly available within 12 months of study completion (last subject, last visit). This applies no matter whether the results are positive, negative, neutral or inconclusive.
For drug trials other than adult phase I trials, this is also an EU regulatory expectation. It will become a legal requirement when the forthcoming EU Clinical Trials Regulation takes effect.
For paediatric drug trials, the timeframe for reporting is six months after the end of the study, not 12.
Summary results including key outcomes should be posted to the results section of the register(s) where the research project is registered.
If the register used does not have a results section, the results should be posted on a free-to-access, publicly available, searchable institutional website of the sponsor, funder or chief investigator.
Where the main findings are also to be submitted for publication in a journal, this should be done within 12 months of study completion, to be published through an open-access mechanism in a peer-reviewed journal.
Making data and tissue accessible
It is a good practice requirement that the data and any tissue collected for a research project are made accessible with appropriate safeguards.
Individual participant-level data (IPD) should normally be shared, provided it is anonymised in accordance with the Information Commissioner’s Office anonymisation code of practice.
Feedback to participants
It is a good practice requirement that people who have taken part in a research project are thanked for their contribution and told about what it helped the researchers find out, where appropriate.
Top tips for transparency
- Plan ahead – getting your paper accepted by a particular high-impact journal should not be your one and only plan for making your findings known – plan to post summary results on line too, including in the register where you registered your study.
- Make sure your register records can be curated – keeping a note of log-in details and using a generic email address instead of an individual colleague’s will avoid you falling foul of transparency rules down the line if the person who originally entered the information has left your team.
- Keep your register records up to date – results will be expected 12 months (6 months for paediatric drug trials) from whatever completion date is on the register, so if your research is going to end later than originally stated, remember to update your entry.
- Report the agreed outcomes – finding something unexpectedly interesting does not mean the original intended outcomes no longer need reporting.
- Beware of publication bias – money, time and patients’ lives are wasted because of decisions based on selective reporting, so make your negative, neutral and inconclusive findings public too, not just your positive ones.
- Report consistent results – if you have registered your research in more than one place, make sure you post the same results to each register.
- It’s not “your” data and tissue – people gave it freely to help increase knowledge, so make it accessible for other researchers to learn from too – being open with data also means your findings are verifiable, reproducible and trustworthy.
- Remember your participants – when the people you did your research with are not told what they helped you find out – or even thanked for their contribution – that undermines trust and goodwill, reducing the recruitment pool for future studies.
Our transparency agenda
Read more about the Health Research Authority’s work to improve transparency in research.
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