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About this session

Facilitated by Alison McTavish and Val Peddie, this session focussed on the impact of the new provision in the Act which requires clinics to ask patients whether or not they would like to consent to the disclosure of their data from the HFEA Register for research purposes or whether they would like to take part in follow-up studies.

The participants had a number of questions about disclosure of data added to the register both before and after October 2009.

• Questions and answers from this session

The main themes

• This is a positive move for researchers and scientists because we will understand more about the impact of IVF on patients and their children.
• However, collecting consents will have resource implications for clinics, particularly smaller ones. Clinics now have yet another thing to follow up with patients.

 

Data security and safeguarding

• Participants were concerned (for themselves or their patients) that the data is handled securely and only disclosed under strict conditions
• HFEA staff reassured participants that access to data will be controlled and carried out under supervision of the HFEA, subject to forthcoming regulations from Parliament. Researchers will not be taking identifiable information away from the HFEA.
• Regulations will be out next year with further clarification but there will be strict controls over the research taking place before permission is granted.  The National Information Governance Board (NIGB) will be used to aid decision making and applicants will have to prove that their research is sound, that they have sound methodology. The Authority will have to be satisfied and ethics approval will also be needed.

 

What else can HFEA do to help centres and their patients?

• Stringent checks should be in place to ensure that data will be used and stored effectively and in accordance with research data/governance
• HFEA could eventually publish the process on the website so that patients could see how rigorous it is. The current leaflet could be expanded.
• There’s work to be done by HFEA to sell the benefits to centres so that they are better informed and can advise patients. It’s more than just a tick box exercise.
• HFEA should monitor the submission of consents, as this may highlight clinics who never seek consent to disclosure for research.

Future review

• The HFEA is keen to understand the experience of clinics in seeking this consent and informing their patients about the use to which their data might be put. As time goes on, we will publish examples of good practice to help centres.
• Consenting to disclosure for research should be covered on inspection, not just to ensure that patients are asked and provided with information, but also to allow the sharing of best practice.

Page last updated: 30 October 2009

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