For the Assessment of Individualised Risk (FAIR)
Research type
Research Study
Full title
For the assessment of individualised risk (The FAIR Project).The Framing of Assessment of Individual Behaviour as Risk or Safety Checks for Blood Donation.
IRAS ID
270580
Contact name
Eamonn Ferguson
Contact email
Sponsor organisation
The University of Nottingham
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Research Summary
In November 2017, the blood donor selection guidelines for men-who-have-sex-with-men (MSM) were changed in England, Wales and Scotland from a 12 month deferral since last sex with a man to a 3 month deferral. Similar changes were made for other donor selection criteria related to higher risk sexual behaviours. The UK leads the way in shortening the population-based time limited deferral for MSM and donors with sexual partners at higher risk of acquiring blood borne infections. Although the change to the donor selection criteria was welcomed by a range of lobby groups and activists, many viewed this as still discriminatory in terms of UK equality law, as screening is still on grounds of sexuality. Some MSM are at lower risk than non-MSM, on ground of sexual behaviour. As such, the Department of Health and Social Care has asked NHSBT to explore more the feasibility of an individualised sexual risk behaviour assessment for donor selection and how this may be implemented. A similar request has been made by the Scottish parliament to SNBTS.
Ethical approval is sought for a series of focus groups among the following key groups: (i) frontline staff from donor centres in England, Scotland, Wales and Northern Ireland and (ii) current blood donors in England, Scotland, Wales and Northern Ireland. These focus groups will ask staff and donors (separately) to discuss, in general terms, the nature of the sexual behaviour questions that are being proposed, their acceptability, if they think people can accurately recall them if they would have detrimental effects on current donors and deter them from donating blood, how they would define people as a potential risk to the blood supply and what they would feel is the best way to introduce these question as a means to ensure safety or to reduce risk.Summary of Results
When a person attends to give blood they complete a donor health check questionnaire, which helps identify if they are eligible to donate. All blood is then tested for infections to keep the patient safe. Men-who-have-sex-with-men (MSM) were, however, deferred from donating blood unless they had not had sex for 3 months prior to donating. The “For the Assessment of Individualised Risk (FAIR)” project and steering group was set up to take an evidence-based approach to review whether the UK blood services could move away from a population-based to a more individualised blood donor selection policy. That is assessing all donors on their current sexual behaviour regardless of lifestyle choices. The behavioural part of this project was to explore the sexual behaviour in blood donors and non-donors to see if there is a cluster of sexual behaviours that identify higher-risk donors. To examine how acceptable is it to ask about sexual behaviour, perspectives, how accurately people believed sexual behaviour could be recalled and if asking about sexual behaviour would put other people off donating blood. These were asked from both staff and donor perspectives. We also asked how risky to patients the policy change was perceived to be and if it would encourage donations. Four risker sexual behaviours in the last 3 months (a recent sexually acquire infection, having new or multiple partners, using drugs [not cannabis, alcohol, or Viagra] to enhance sexual experience, and anal sex) were likely to occur together. This is a person does or has one of these they are also likely to do the others. People doing these behaviours were able to identify themselves as being at higher risk if s a sexually transmitted infection. Staff and donors felt that asking about most sexual behaviours was acceptable, with anal sex being the least acceptable. It was felt that people could reasonably recall their sexual behaviour. The new policy was seen as low risk and changing to the new policy was a small risk, and the new policy would make people more likely to encourage others to donate. While donors thought that asking about sexual behaviour may put others off donating, other evidence, we gathered showed that this was unlikely. These behavioural data were triangulated with epidemiological evidence and other research on sexual behaviour to produce a final set of clear recommendations that received ministerial approval in December 2020 and entered into practice in June 2021.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0319
Date of REC Opinion
16 Oct 2019
REC opinion
Favourable Opinion