CE(09)01

30 October 2009

Dear PR

Follow up to Annual Conference

I said I would write before the end of this month to follow up three action points from our Annual Conference on 1 October. They are -

  • Freedom of information (FOI) legislation;
  • Publishing Incident Reports;
  • Disclosure for research purposes.

These three issues are linked. Each relates to the circumstances in which information might be made known to other parties.

On FoI, I attach a briefing paper that sets our our understanding. Please note that:

  • an FoI request attaches to any information that the public body concerned – in this case, us – holds; it does not matter whether it “belongs” to us or whether it originated with us;
  • personal and patient data are separately protected;
  • we follow a structured process for each and every request; if your centre is referred to we will inform you of the request and listen to your comments; but you do not have a veto since the reply is our responsibility.

The chief implication for centres of this – and of the publication of category A incident reports – is that the environment of public administration is now one that values greater openness. And the advice I would give PRs is not to wish this would just go away – because there are benefits for the sector in greater transparency.

Take the second issue, the publication of incident reports, as an example. Here, what we propose is that when a Licence Committee has considered the report on a category A incident and the investigation has been closed, the minutes of that meeting and the report that led to the Committee considered will be published on the website. This is, after all, what happens with inspections.

The chief reason for doing this is that it is the right thing to do now that we have built up, and continue to develop, a focus on learning from errors and near – misses. Some of the people I heard discussing this at Conference were concerned. Will centres be hung out to dry ? Will this fuel sensationalist, unfair reporting? Will this cause centres to be less open about notification?

These concerns can be answered straight – forwardly. It is a forlorn hope to believe that irresponsible and unscrupulous reporting will go away. It won’t. Nor is there reason to believe that things would somehow be better if we tried to draw a veil over our honest attempts to look into and learn from mistakes. They would not – they would be worse because we would be accused of concealing risks from patients and the public.

As you know, very few category A incidents are reported in any given year and this points to the robustness of the arrangements you have in place. Sustaining the willingness to report is therefore of particular value to quality improvement and we do of course intend to continue with the alert system that was so strongly supported at the Conference.

Our sector is one which attracts enormous interest and sparks highly- charged debates. There will always be stories about the latest miracle breakthrough (“removing” a cancer gene) or the most recent alleged laboratory error. Yet at the same time there will also be serious and considered scrutiny of what is happening in an important area of clinical service. By demonstrating that we have effective processes in place, that we follow them and that we have confidence in applying our standards we will enhance confidence and trust in the services the sector offers.

The new policy on category A incidents applies to any that go to Licence Committee after 1 October. Our general policy on incidents is set out in section 5 of our Compliance and Enforcement Policy.

The principle of openness implies that information has a real potential to be of value. The HFEA Register is probably the oldest and most extensive of its kind in the world. Parliament has decided to change the law so the information embedded in the Register can be used for research purposes. To realise the benefits that such research might offer, the law now allows identifiable information about people who have had IVF or related treatment to be shared with researchers.

It cannot be stressed enough that this will not lead to any lessening of the general safeguards about confidentiality that are extended to patients under the HFE Act. Identifiabl    e data would only go to researchers who are bound by their own very tight obligations on confidentiality, who would need to secure ethics approval in the usual way and who would need to satisfy our own soon-to-be established oversight committee about the proposed use and the need for identities to be shared.

Researchers want to be able to link patient records (usually held in different databases) in order to study a wide variety of topics. They need identifiable information to do this. The proposal we will put to the Authority (in January) is that researchers will access such data only at our premises. We have, as promised, produced some new FAQs on transitional issues in this area to supplement the existing pages we have on patient-identifying data on our website.

Please feel free to discuss any of these topics with your Inspector or contact me via e-mail. 

Alan Doran CB
Interim Chief Executive

Page last updated: 24 August 2012