Make it Public workshop summary

• impact of staff turnover
  • for example, staff changes mid-project may mean that registration becomes a lower priority

• understanding of registration needs versus capacity or system knowledge
  • some organisations assign the responsibility to register to the research coordinators and wider research and development teams, rather than the study’s Chief Investigator(s). Unless there are clear lines of communication and information exchange, this can sometimes mean key details needed for the registration process are missing or incorrect.
  • there’s also not always the resource to check people are doing what they have agreed to in terms of registration
  • examples of where registration had been done properly were often studies where information on requirements on registration had been consistently shared between the people doing the research, and the people who work on the systems in research administration doing the registration

Possible solutions

• more communications and reminders about when registration needs to happen within and between research teams and research offices
• having a dedicated – or named – individual in each study who has defined responsibility for completing the registration

• costs of registration can be a barrier to smaller-scale research
  • some attendees noted that certain registration platforms are significantly simpler to use than others. However, financial constraints means that these registration platforms are too costly for some smaller-scale studies.

• defining and including costs early
  • it is difficult to allocate funding for registration if they're not specified in the project outline or kept aside at the beginning of a study. Repurposing designated funds to cover a sudden need to register is very difficult to do.
    

Possible solution

• building the cost of registration into funding applications – both to cover the cost of registering, and to ensure it is accounted for before the study commences

• knowledge or availability of a registry that can include non-interventional studies, including social care research, that might not have a medical element to it
  • there was a lack of understanding about where these studies should be registered
    

Possible solution

• database or list of registry options that defines what registry will accept what type of studies. For example, many people do not know that ISRCTN will accept studies other than clinical trials.

• it can be assumed that registration is a simple action, and that all platforms require the same information and in the same way – but this is not the case
  • using the platform can be a complex task, and people often need support
  • as already noted under point one above, completing study registration with all the proper detail can require a good understanding of the study, which often requires a level of information and knowledge sharing between those leading the study and those registering the study
  • some workshop attendees said that ISRCTN is easier to use compared to other registries, but it has started to become more complex and therefore more resource intensive
  • similarly, some workshop attendees said that Clinicaltrials.gov can be complex in the information it requires and restrictive in the format it requires this information in
  • it is time consuming to add information into different systems, and what registries require is not always clear

• sponsors and researchers are unaware of changes to platforms
  • changes introduced by registries are often technical and potentially complicated, which may elongate the time it takes to complete, or require information in a different way
  • earlier lead-in to any changes to the platform would make it easier for researchers and sponsors to respond

Possible solutions

• guidance on how to navigate the registration platform. For clinical trials of medicines where HRA passes on data to ISRCTN for registration, there could be clearer guidance on what is expected and/or encouraged from sponsors.
• a checklist or guidance to help make everything more user-friendly
• to educate early career researchers, as transparency and requirements are currently not part of the curriculum

Other suggestions to increase registration

• some journals will not take publication if a study is not registered, so this could be highlighted on the IRAS form to help influence registration
• possible joint working between regulators and publishers more broadly, to encourage behaviour change
• NIHR could write their conditions into grant agreements, making the responsibility more defined and more binding

In addition to feedback on registration, attendees shared and spoke of other issues and themes important to transparent research.

• ensuring plain language is used in sharing information about the research project
  • the need for information to be in plain language, to help members of the public to understand the terminology used in registries, was raised as a need that is often not met
  • resources that can support study teams and can guide what language to use, such as that published recently by the Association of Medical Research Charities, were discussed in response to this . The HRA’s guidance was also referenced.

• wider language barriers in excluded people becoming involved in research
  • the wider exclusion and accessibility issues around language were also noted by attendees. For example, non-English speaking patients are often excluded from studies or getting access to wider information about research and participation.

• difficulties in clearly defining the type of research being done
  • an issue in registration is that sometimes people say a study is a particular type of study (for example, clinical trial), when it is not. These errors in defining the study can impact on audits and reviews of performance on registration of specific types of studies.
  • certain study types, such as Clinical trials of investigational medical products (CTIMPs), were discussed as having clear parameters making them easier to correctly categorise them as clinical trials but there can be ambiguity in relation to other types of trials
  • some attendees noted that the HRA and Research Ethics Committees (RECs) will not question or challenge how a study is defined or categorised unless it is very obvious that it is wrong and the need for this to be addressed

• need for clear messaging and leadership
  • the groups recognised the important role of vocal leaders in sending a clear message about the importance of research transparency, including registration.
  • this included being vocal about the importance and benefits to transparency, including reducing research waste or repetition
  • different contexts were acknowledged; for example, it can be a struggle to get across the importance of registration in an academic setting, as shown in the registration data published by the HRA

Possible solutions

• new or updated guidance to support when defining research projects. This could include adding examples of different study types to existing guidance, to allow study teams to compare
• visible, vocal leadership and joined-up prioritisations from regulators to help position research transparency as a non-negotiable