Consent for research - breakout session questions
Transitional arrangements
Is it possible for people who were registered at a clinic before 1 October 2009 to consent to the disclosure of their identifying information from the HFEA Register for contact research purposes?
Answer: Patients registered at clinics before 1 October 2009 will have been registered using the pre-October 2009 versions of EDI forms. These do not cover consent to disclosure of information from the HFEA Register to contact research and so a clinic cannot simply update the registration form recording the patient’s consent. Instead, a clinic should re-register the patient using the post-October 2009 version of EDI forms which allow for this consent to be recorded and notify the HFEA that they wish to delete the previous registration form.
Does a patient’s consent, given after 1 October 2009 on the new CD form, apply to all data held about them on the HFEA Register, ie, data from any previous cycles, including those carried out at other clinics, pre-October 2009?
Answer: Consent collected after 1 October 2009 on the new CD form will apply to all data held about a patient on the HFEA Register. Equally, if a patient declines to give consent to the disclosure of their data from the Register then this would apply to all of their data held on the Register. They would not also have to complete an opt out form to cover treatment before 1 October 2009.
Communicating with the public
How will patients who registered before 1 October 2009 be notified of the mechanism for opting out of having their information disclosed from the Register?
Answer: It is the HFEA’s understanding that the Department of Health is planning to publicise this once the relevant Regulations have been finalised in April 2010.
Will potential research projects be listed on the HFEA website?
Answer: The process for handling applications to use information on the Register for research purposes will not be finalised until the relevant regulations are in place. However, it is likely that, the HFEA will publish information about these applications on the HFEA website research. This is currently done for applications to carry out research involving human embryos.
Will patients know the results of the research? Can patients contact HFEA for results?
A As part of determining the process for handling applications, the HFEA will consider the feasibility of publishing information about any published outcome of approved research.
Taking consent
At what point in the treatment pathway should the CD form be completed? Could the patient complete section 3 of the consent form (ie, allowing the clinician to contact their GP/ referring doctor) at the first consultation and complete section 4 of the form at a later date?
Answer: Section 4 of the CD form must be completed before a patient is registered so that the HFEA can handle their Register information appropriately. Centres should endeavour to collect all consents on the CD form at one time but where this is not possible the centre may partially complete a CD form and later, when able, fully complete a new version of the CD form.
How should a clinic deal with sections of a consent form that are left blank?
Answer: Sections of a form that are not applicable should have a line drawn through them. Those taking consent should ensure that the patient signs the bottom of the page, even if no consent is given on the page, to indicate that the patient has read and understood its contents.
How should a clinic deal with patients who refuse to complete section 4 or leave it blank?
Answer: The clinic should ensure that the patient signs the bottom of the page to indicate that they have read and understood the consent options and record on EDI forms that no consent has been given to the disclosure of identifying information form the HFEA Register to researchers.
Opting out for pre-October 2009 patients
Do patients need to complete a new CD consent form in order to opt out of having their identifying information disclosed from the HFEA Register to researchers?
Answer: Patients who registered before 1 October 2009 and do not wish to have their identifying information disclosed from the HFEA Register to researchers should opt out via the HFEA website. They do not have to complete a new CD consent form.
Can clinics help patients to opt out if needed?
A Clinics may tell patients who registered before 1 October 2009 that they can opt out. They may also contact former patients if they wish, taking into account any risk of breach of confidentiality.
Contact research
Can people whose data was entered on to the Register before 1 October 2009 consent to contact research? If so, how?
Answer: Patients registered at clinics before 1 October 2009 who wish to consent to their identifying information held on the HFEA Register being disclosed to researchers for contact research should re-register at their clinic.
Patients registered at clinics before 1 October 2009 will have been registered using the pre-October 2009 versions of EDI forms. These do not cover consent to contact research and so a clinic cannot simply update the registration form recording the patient’s later consent to contact research. Instead, a clinic should re-register the patient using the post-October 2009 version of EDI forms which allow for this consent to be recorded and notify the HFEA that they wish to delete the previous registration form.
What is the process for a patient to consent to their identifying information held on the HFEA Register being disclosed to researcher for contact research?
Answer: The patient must complete the CD consent form. For patients who registered before 1 October 2009 please see above answer.
Disclosure
Why is identifying information of any value to a researcher?
Answer: Identifying information is a very valuable resource for researchers and could be used to carry out medical and social research. It could, for example, be used to investigate the safety and efficiency of fertility treatments, develop new treatment and storage techniques and study the effect of national policies, such as the HFEA multiple births policy.
The main use of identifying information is to link fertility treatment data with other healthcare records for example, to see whether IVF affects the health of women or their children. A minimum amount of identifying information (eg, one or two identifiers) would be needed to perform the linkage.
What might the unique identifiers be?
Answer: The identifying information may include data such as the patient’s name or date and place of birth.
If patients agree to disclosure of information then leave the country what action should be taken?
Answer: Their data could be used in research, but if they cannot be reached, contact research would not be possible.
What if a patient opts out after their data has been disclosed?
Answer: The ‘opt out’ will apply from the date that the patient opts out. It cannot apply to data which has already be used in research.
What mechanisms will be in place to ensure that data is held securely by researchers?
Answer: There will be strict guidelines for the application and disclosure procedure. Applications will be peer reviewed, have to go through ethical approval and conditions will be imposed on the handling of the data by successful applications.
What will the HFEA do to remove the ‘opt out’ cases?
Answer: Processes will be in place for recording patients’ consent status on the HFEA Register.
Will centres know if patients opt out online? It’s important because centres could continue to disclose patient data without knowing that patients have opted out.
Answer: The opt-out system available via the HFEA website relates to opting out of the disclosure of information by the HFEA from the HFEA Register to researchers. The opt-out system does not apply to the disclosure of any information by centres as part of any research they may be conducting based on specific patient consent.
Page last updated: 30 October 2009