Policy positions addressing some aspects of participation change management can inform process-level documents, ensure consistent approaches are taken across all trials and embed principles in practice.
They can also help find a satisfactory resolution if something arises in practice that is not covered by specific process documents.
CTUs can even choose to make policy documents public (more easily than, say, more detailed and changeable process documents), thereby improving transparency and accountability around approaches they take to managing participation changes.
Recommendations
(1) If your CTU uses all or many of the PeRSEVERE principles to guide local practice, consider referencing them directly in policy documents.
In any case, we recommend that policy documents cover what standard positions apply to management of trial participation changes, including how to achieve a ‘balanced’ approach.
(2) Consider adopting a ‘presumed ongoing consent’ approach to trial data collection and/or other aspects of trial participation. This means that participants can say they do not want data collection to continue, but it will continue unless and until they do express such a wish, even if their participation reduces or changes in other ways.
PeRSEVERE principle O5 suggests that, for participants whose participation is changing or reducing, ongoing consent to continued data collection (see Glossary, below) can be presumed, as long as certain conditions are met.
This means that participants can say they do not want data collection to continue, but it will continue unless and until they do express such a wish, even if their participation reduces or changes in other ways.
CTUs may consider setting this principle out at policy level, if they want to adopt it, with trial processes and documents putting the policy into practice.
Policies could also state that this same ‘presumed ongoing consent’ idea applies to other areas of trial consent that meet the conditions described in PeRSEVERE. This means consent would be presumed to persist unless and until a participant explicitly says they want the activity concerned to stop.
In other words, participants should ‘reasonably expect’ the activity to be continuing, in the circumstances. This is similar to the idea of ‘reasonable expectations’ used in the context of privacy and confidentiality. Other examples of where this might apply:
- Consent for trial data to be linked with routine data sources (and consent for confidential information to be shared with routine data providers for the purpose of such linkage);
- Consent for medical notes to be accessed by trial staff for trial monitoring purposes;
- Consent for further contact from trial staff after participants end their participation where evidence suggests most participants would like to be contacted – in particular regarding receipt of trial results;
- Consent for storage and use of biological samples for research purposes;
- Consent for re-use and/or sharing of trial data for secondary research purposes (where CTUs’ approach is to ask for participants’ consent to this point).
(3) Policies can confirm that data already collected until a participant says they want data collection to stop is retained (as per PeRSEVERE principle O6 and other guidance, for example from the UK Health Research Authority).
This can include data generated prior to that time (see principle O5), i.e. data that exists and that was created prior to the date, but which has not yet been added to trial forms or systems (with possible trial-specific exceptions; see recommendations about standard operating procedure content).
Principle O6 also suggests that the collected data should be included with other data made available at the end of the trial for secondary research or re-analysis purposes, in line with international standards.
Policies can outline related, broader points such as the idea that that trials will only collect data that is absolutely required for analysing or running the trial, or that participants’ rights must always be communicated to them.
(4) Policies could remind CTU staff that each situation nonetheless needs to be assessed on its own features,that the principles set out in the policy (and in PeRSEVERE) are only intended to be a guide and should not be applied in a blanket manner without further thought.
This may mean that the principles are not followed in some cases, where doing something different is a better way to uphold participants’ rights and interests.
Data collection: this means the act of adding relevant data onto study forms or systems, to make the data available for running and analysing each study. It does not refer to any separate tests or procedures used to generate the data in the first place.