Research Consent

PKB captures consent for research in a number of ways.

Patient consents to provide data for research

The patient can explicitly click to link their record to the research team through the registration page of the research team.

  1. For example (fictitious) https://sandbox.patientsknowbest.com/go/team

2. Clicking on "Log in" or "Register" links the patient's record with the research team with the research consent model the Organisation had set up with the patient.


3. PKB shows the patient the default consents of the research team and asks the patient to choose how much consent to give.

4. The patient choose how much data to share. At any point the patient can change their choices or switch sharing off completely.

Professional documents patient’s consent to provide data for research

An existing non-research team (eg the hospital team working with a CRO) can capture the consent of the patient to share data with the research team in a number of ways:

  1. Normal paper-based consent models outside of PKB (this can also then be uploaded to the PKB record)

  2. Recorded via a consent care plan in PKB (please see consent plans section below)

  3. Verbally asked and recorded within PKB at the point of adding the patient to the research team

The team can then document in PKB the consent of the patient to open data to a research team by:

  1. Using PKB's web site without the patient having to do anything (as noted above). The patient and carer are notified by e-mail that this happened.

  2. Using the PKB API without the patient having to do anything. The patient and carer are notified by e-mail that this happened.

For as long as the research team has access to a patient's record they can see the data using the PKB web site and they can copy the data using the PKB API.

Care plans to capture consent

Consent can also be captured via PKB consent plans (possibly as the means of capture as mentioned above). The plan can capture the patient’s consent to take part in research, to open up their data for research, or both.

Advanced consent capture

Configuring advanced consent in PKB allows PKB to automatically capture patients’ consent for research. This includes permission to be contacted about research trials, and permission to store samples for research. The PKB Manual has more details on capturing advanced consent.