Principle D1: Protecting study integrity by design

Studies should be designed and resourced to allow data collection to continue wherever possible, particularly for study outcome data.

Participants should be allowed to continue participating while making less commitment to the study, where this is feasible, safe and does not negatively affect the scientific integrity of the study.

We know that in almost all studies, some participants will want to stop planned study activity before it was supposed to stop, so researchers designing studies should prepare for this.

Researchers should make sure there are adequate resources to complete all follow-up activity. This includes making sure research sites have enough funding to collect all the data required for a study.

It is also important, and in line with guidance and laws on both clinical research and data protection, that researchers designing studies should not ask for more data than is really needed. Researchers should aim to ensure that taking part in a study will involve as little burden on participants as possible.

If participants are finding the commitment of study visits too much but are still keen to make a contribution, it might be possible for them to reduce their active commitment but still provide data for the study.

For example, a participant who has stopped study treatment but agreed to keep attending some study-specific hospital visits might be finding those visits difficult to keep attending, alongside the other commitments in their life.

It might be possible for them to have occasional phone calls with their research nurse instead of going in for all the clinic visits.

This could suit participants, because they can reduce their level of commitment but still contribute to the research. It can also suit the needs of the research, because data can still be collected.

It might not be appropriate or feasible in all cases to make adjustments like these. Where it is feasible and appropriate to make adjustments, researchers designing studies should plan for them in advance.

It might not be necessary or helpful to mention the adjustments to participants upfront (before they have agreed to take part in the study), as this might give participants a confusing message about what taking part in the study involves.

In any case, the most suitable way that an individual participant’s participation should change may depend on their specific circumstances (within the limits of what is possible for each study).

Researchers should always make every effort to ensure that the standard level of participation will be as easy as possible for participants.

They can then plan ways to help participants to make continued contributions with reduced commitment, and be ready to offer these to participants who say they are struggling with the standard level of involvement.

There are a different set of considerations if study participants lose capacity to make decisions for themselves during their time on a study (see the Introduction to these principles for more on this).

See also:

Relevant PeRSEVERE resources:

Relevant PeRSEVERE principles:

  • The study protocol should be written with the knowledge that participation can stop, reduce or change, so participants’ wishes to reduce their participation might not need to result in them stopping all aspects of participation. See principle O1 for more on this.
  • The available options for participants who want to stop or reduce their participation should be communicated to participants before and during the study when necessary. See principles D3 and D5 about this topic.
  • Training and support for researchers should ensure they are aware of the options for participants who want to stop or reduce their participation. 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.
  • Outcome data: all research studies involve measuring something in order to reach conclusions. The thing being measured is the ‘outcome’, and data about it is the outcome data. For example, a healthcare study might give two groups of people different treatments, then measure how their health changes over time to see which treatment is better. The data about how the participants’ health changes over time is the outcome data. Outcome data is particularly important, because without it, studies cannot reach clear conclusions.
  • Capacity or capacity to consent means a person’s ability to make decisions for themselves. In the context of research, it means a person’s ability to give informed consent to take part in a study. Some people have a varying or reduced ability to make decisions for themselves, for example people with dementia. By law, children also do not have capacity to consent, so their parents or guardian need to consent (or not) on their behalf.