Guidance

Regulator's notification 01-2025: FSA-BIO 100 (accessible)

Published 3 July 2025

Issue

Preparation for FSA-BIO 100 the Forensic medical examination of complainants believed to be relevant to an alleged sexual offence from a complainant in a dedicated facility coming under the FSR Code of Practice in October 2025.

Background

The Regulator with the support of the Office of the Forensic Science Regulator (OFSR) has reviewed the preparedness for the FSA of the forensic medical examination of complainants coming under the statutory Code in October 2025, this has involved:

• Conducting a compliance survey for all organisations who undertake the FSA BIO 100 the forensic medical examination of complainants,

• Visiting Sexual Assault Referral Centres SARCs to listen to practitioners, quality managers and other staff involved in the delivery of SARC services,

• Consulting a variety of stakeholders to understand the challenges and risk in the introduction of statutory regulation of forensic medical examination of complainants

The Regulator has indicated this review could lead to some changes in the regulatory approach to undertaking the forensic medical examination of complainants. The Regulator has carefully considered the information from the compliance survey and discussions with SARC staff and stakeholders and has decided that the FSA for forensic medical examination of complainants should proceed as planned and be subject the statutory Code in October 2025. There are however some additional guidance and clarification of regulatory requirements that is needed.

1. The focus when managing the risk of DNA contamination must to be on the basis that organisations understand and actively manage the risks, rather than a procedural approach and blanket requirements for monitoring and testing. Batch testing and point of use testing are not required.

2. the general and specific requirements in the Code highlight the need for competency to be demonstrated not only in the recovery of forensic material but the interpretation and presentation of expert opinion in the forensic medical examination of complainants. The Regulator will be issuing guidance on the competencies required for interpretation and provision of expert opinion taking account of the work undertaken by the FSR Interpretation Specialist Group and the FFLM guidance. Interpretation and expert opinion in the forensic medical examination of complainants as it relates to sub-activity 40.3.1 is not required by the Code to be within the scope of accreditation but it is important that, in making declarations of compliance with the Code, individuals consider their compliance with this requirement.

3. Based on the survey results the Regulator believes it is likely, in October 2025 the majority of SARCs will not be compliant with the Code and therefore will be required by the Code to make a non-compliant declaration and set out the mitigating steps to address this. In anticipation of v2 of the Code coming into force in October a revised version of the Declaration’s Guidance will be issued by the Regulator. This will include guidance on making declarations of compliance for the forensic medical examination of complainants. Work is well underway on this, with the aim of developing an approach which enables practitioners to understand the non-compliance and then to set out mitigating steps that represent the level of risk associated with the non-compliance.

Process and date of implementation

The Regulator will be issuing further guidance in support of the regulation of the forensic medical examination of complainants covering the three areas described above. The target dates for this are:

• DNA Contamination Guidance: update and publication of Issue 2 of FSR GUI 017 DNA contamination controls – Forensic medical examinations in August 2025.

• Interpretation and Expert Opinion: update and publication of Issue 2 of FSR GUI 020 Forensic medical examination of sexual offence complainants in August 2025.

• Declaration of Compliance: update and publication of Issue 3 of Declarations of compliance and non-compliance with the Code of Practice in August 2025.

Mr Gary Pugh OBE

Forensic Science Regulator

July 2025