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Inspection report

Date of Inspection: 1 May 2013
Date of Publication: 25 May 2013
Inspection Report published 25 May 2013 PDF

Before people are given any examination, care, treatment or support, they should be asked if they agree to it (outcome 2)

Meeting this standard

We checked that people who use this service

  • Where they are able, give valid consent to the examination, care, treatment and support they receive.
  • Understand and know how to change any decisions about examination, care, treatment and support that has been previously agreed.
  • Can be confident that their human rights are respected and taken into account.

How this check was done

We looked at the personal care or treatment records of people who use the service, carried out a visit on 1 May 2013, talked with people who use the service and talked with carers and / or family members. We talked with staff and reviewed information given to us by the provider.

Our judgement

Before people received any treatment they were asked for their consent and the provider acted in accordance with their wishes.

Reasons for our judgement

Before people received any treatment they were asked for their consent and the provider acted in accordance with their wishes. We spoke with two people and reviewed their medical records. They had both received very detailed patient information about their clinical trial following consultation with one of the doctors. They had taken this away so that they had the opportunity to discuss and think about whether they wished to participate in a clinical trial. They had had continuing opportunities to ask more questions and seek more information whenever they wished.

The medical records contained the signed patient information sheet and consent forms. Staff told us that if the clinical trial protocols were changed then there would be a new consent process and people confirmed that this was what they had experienced. People also said that the information was presented in a way that they understood.

The information sheet detailed that people could drop out of the trial at any time and people were well aware of this. All the people recruited for the trials had capacity so that they were able to give informed consent.

The provider had undertaken an audit of consent for one of the clinical trials in March 2013. This involved 59 people all of whom had consented using the correct version of the consent form. One finding was that the informed consent process was “very well documented” in patient notes. In addition every clinical trial had strict protocols, agreed by an Ethics Committee, that were reviewed by the trial sponsors and these required informed consent as part of the trial process.