CH(92)01
28 January 1992
To all Directors of Centres
Dear Director
DIRECTIONS ABOUT THE REMOVAL OF INFORMATION FROM RECORDS WHICH CENTRES HAVE BEEN DIRECTED TO KEEP BY THE HFEA
The HFEA has a duty under the HFE Act to make directions telling centres how long they must keep information which the Authority has directed them to record under treatment, storage or research licences. I therefore attach Directions Ref D. 1992/1. Without these new directions, centres would have to keep information indefinitely
The information referred to in these directions consists of:
- copies of data collection and consent forms;
- the results, conclusions and reports from research projects and
- details about other centres to which gametes or embryos are supplied.
It is important to note that these Directions do not relate to any other treatment, storage or research records which centres keep.
Information kept under a treatment licence
Paragraph 1 of these Directions relates to the following:
a. IVF treatment cycle forms (yellow)
b. DI/Donor gamete treatment cycle forms (pink)
c. Outcome forms (blue)
d. Donor information forms (green)
e. Embryo storage or research forms (orange)
f. Consents to the use and storage of gametes and embryos; and
g. Details about other centres to which gametes are supplied.
I should also draw your attention to Section 24(1) of the HFE Act. This specifies that centres should be required to keep information for 50 years while there is doubt as to whether or not any child was born following treatment.
Information kept under a storage licence
Paragraph 2 of these Directions relate to copies of the following:
a. Donor information forms;
b. Embryo storage or research forms
c. Consents to the use and storage of gametes and embryos; and
d. Details about other centres to which gametes are supplied.
Please note that the requirements for information recorded under a storage licence distinguish between information about gametes or embryos to be used in treatment and information about those to be used in research. Where gametes or embryos are subsequently used in treatment, the same rules apply as for information recorded under a treatment licence ie, paragraph 1 of the Directions. Where gametes are subsequently used in research, the same rules apply as for information recorded under a research licence ie, 3 years.
Where gametes or embryos in storage are not to be used in either treatment or research, centres may remove information which they are directed to record when the gametes or embryos cease to be stored. If a storage centre is in any doubt about the use to which gametes or embryos were put, it must keep information about these gametes or embryos for at least 50 years.
Information kept under a research licence
Paragraph 3 of these Directions relate to copies of the following:
a. Embryo storage or research forms;
b. Consents to the use and storage of gametes and embryos; and
c. The results, conclusions and reports from research projects.
If you have any queries about this letter, or the attached directions, please contact Liz Baldock or Carolyn Heaney on the number below.
COLIN CAMPBELL
DIRECTIONS GIVEN UNDER THE
HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990
Removal of information from records maintained by centres under a treatment licence, storage licence or research licence
Ref. D 1992/1
These Directions are: GENERAL DIRECTIONS
Section of Act providing Section 13(4), 14(2), 15(3)
for these Directions: and 24(1)
These Directions come into
force on: 1 February 1992
These Directions remain
in force: Until revoked
1. This paragraph applies to centres in respect of information which they are directed to record and maintain under a treatment licence.
a. Where the person responsible knows that a live child was not born following the treatment, no information shall be removed from the records of the centre for which that person is responsible before the expiry of a period of 8 years after the conclusion of the treatment.
b. Where the person responsible knows tnat a live child was born following the treatment, no information shall be removed from the records of the centre for which that person is responsible before the expiry of a period of 25 years after the birth of the child concerned.
c. Where the person responsible does not know that any child was born following the treatment, no information shall be removed from the records of the centre for which that person is responsible before the expiry of a period of 50 years after the information was first recorded.
Page last updated: 15 August 2012