Principle D5: Encouraging dialogue

Throughout each study, researchers should make reasonable efforts to check that participants are still willing and able to take part.

Researchers should be prepared to discuss possible changes to participation, where these might allow participants who are still willing to make a contribution to the study to do so.

Participants should be encouraged to contact the researchers at the earliest opportunity if they are experiencing difficulties with any part of the study or if their circumstances may be changing in ways that will make taking part more difficult.

Consent is an ongoing process and study participants can stop their involvement at any time.

Researchers should make reasonable efforts throughout the study to check that participants are still willing and able to take part in the study in the same way as they currently are.

The nature and frequency of this sort of checking should depend on the study and on the relationship between the researchers and the participant.

The checking should not be burdensome, intrusive or off-putting for the participant, but should make them feel supported during their time taking part, and remind them that their participation remains voluntary.

The checking might not need to be in the form of a direct question to participants, if researchers can establish whether or not participants are happy to keep taking part through routine discussion.

The checking should also not be burdensome for researchers, in terms of extra documentation or anything else.

Participants should be encouraged from the outset to talk to the researchers about any challenges completing study activities as they emerge, or any changes in their circumstances that might affect their participation.

This allows for an open discussion of the issues and the potentially acceptable solutions that may allow participants to continue making a contribution to the study, if they want to.

For example, there may be alternative methods of data collection that might be less intrusive and more acceptable for the participant, such as reduced study visits or only using data collected from routine healthcare activities.

Or if participants are planning to move home, it might be possible for them to continue participating in the study at a different study site, if they want to.

Participants can be offered the chance to discuss their participation with someone outside the main researcher team, if they might like more independent advice on their options.

See also:

Relevant PeRSEVERE resources:

Relevant PeRSEVERE principles:

  • When they discuss, both participants and researchers should be as well informed as possible about participants’ rights, but also about why it is important for studies to collect as much of the planned data as possible. See principle O3 for more on this.
  • If a participant is thinking about stopping or reducing their participation, they should be reminded that data collection will continue until they want it to stop, and encouraged to express their wishes about whether data collection can continue or not. See principle O5 for more about this.
  • Any potential alternative methods of collecting data that would allow the participant to stay in the study should be specified in advance in the study protocol. See principle D1 for more on this.
  • Researchers who are in direct contact with participants should be appropriately trained and supported to have these discussions. See principle D6 for more on this.
  • 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.