Statute Details
- Title: Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019
- Act Code: HBRA2015-RG4
- Legislative Type: Subsidiary legislation (SL)
- Authorising Act: Human Biomedical Research Act 2015
- Primary Subject: Exemptions from specified “appropriate consent” requirements, including the need for a prescribed witness
- Key Provisions (as extracted): Regulations 2–6 (including exemptions relating to witness requirements and transitional exemptions for pre-cut-off biological material)
- Relevant Cut-off Dates (from text): 1 Nov 2017; 1 Nov 2018; 1 Nov 2019
- Current Version Noted: Current version as at 27 Mar 2026 (with a 2025 Revised Edition dated 2 Jun 2025)
- Most Cited Act Provisions (from text): Human Biomedical Research Act 2015, including sections 6, 8, 10, 12, 22(2)(c), 25, 37
What Is This Legislation About?
The Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019 (“the Regulations”) are subsidiary legislation made under the Human Biomedical Research Act 2015 (“the Act”). In practical terms, the Regulations carve out specific situations where certain statutory consent formalities do not apply. The focus is on “appropriate consent” requirements—particularly the requirement that consent be obtained in the presence of a prescribed witness—and on transitional arrangements for biological material and health information obtained before specified dates.
In plain language, the Regulations recognise that biomedical research ethics and legal compliance must be workable in real-world settings. For example, some research activities may be low risk or purely informational, making a witness requirement unnecessary. Similarly, where biological material or health information was obtained before the Act’s consent information requirements took effect (or before later amendments), the Regulations allow research to proceed without re-triggering certain consent steps—provided that documentary evidence shows that relevant consent was already obtained and that the subject (or authorised representative) was informed of key matters.
Overall, the Regulations aim to balance two objectives: (1) maintaining safeguards for research subjects and tissue donors, and (2) avoiding unnecessary legal friction for historical datasets and samples where consent was already obtained under earlier regimes or before particular cut-off dates.
What Are the Key Provisions?
1. Exemption from the need for a witness for research subject consent (Regulation 2)
The Act contains a general requirement that “appropriate consent” must be obtained in the presence of a prescribed witness (referenced in the extract as section 6(d) of the Act). Regulation 2 provides targeted exemptions where the witness requirement does not apply.
Regulation 2(1) removes the witness requirement where the research is simultaneously: (a) not invasive; (b) not interventional; and (c) not “restricted human biomedical research.” This is a significant threshold-based exemption. It effectively treats certain low-impact research as not requiring the additional procedural safeguard of a witness, provided it falls within all three categories.
Regulation 2(2) clarifies that research comprising solely of a survey or collection of information from research subjects is treated as “not invasive” and “not interventional.” This is important for practitioners designing study protocols: if the study is purely survey-based or information-collection, it should generally fall within the exemption (subject to the “not restricted human biomedical research” condition).
Regulation 2(3) provides a further exemption even where the research is interventional, but only if the intervention involves no more than minimal risk, the research subject can read and sign the consent form, and the research is not restricted human biomedical research. This is a nuanced compromise: interventional research can still proceed without a witness if risk is minimal and the subject has capacity to read and sign.
Regulation 2(4) introduces a temporal exemption: the witness requirement does not apply to any consent given by a research subject before 1 November 2017. This is a transitional “grandfathering” provision. It reduces the need to retrospectively satisfy a witness formality for older consents.
Regulation 2(5) defines “interventional” broadly. It includes subjecting an individual to any intervention (including any wilful act or omission) that has a physical, mental or physiological effect (temporary or permanent) on the body. This definition matters because it determines whether a study is “interventional” for the purposes of the exemption analysis.
2. Exemption from the need for a witness for tissue donor consent (Regulation 3)
Regulation 3 mirrors Regulation 2 but for tissue donors. It exempts the witness requirement where the tissue donor’s tissue is: (a) to be removed primarily for a therapeutic or diagnostic purpose; and (b) not to be used for restricted human biomedical research. This reflects a policy that tissue removed for clinical purposes and then used for non-restricted research may not require the same witness safeguard.
Regulation 3(2) adds another pathway: the witness requirement does not apply where tissue removal involves no more than minimal risk, the tissue donor can read and sign the consent form, and the consent is not for restricted human biomedical research. Again, the combination of minimal risk and the donor’s ability to read and sign is central.
Regulation 3(3) is another temporal grandfathering provision: the witness requirement does not apply to any consent for removal, storage, supply or use of tissue given before 1 November 2019.
3. Exemption from need to provide certain information for pre-1 November 2018 biological material/health information (Regulation 4)
Regulation 4 is a transitional exemption addressing not the witness requirement, but the information disclosure obligations. It states that sections 12, 22(2)(c) and 25 of the Act do not apply in relation to the use of individually-identifiable biological material or health information in research where the material/information was obtained before 1 November 2018.
To rely on this exemption, the Regulations require documentary evidence that: (i) relevant consent in writing was given before 1 November 2018; (ii) the research subject (or the person authorised to give consent) was informed of specific matters listed in section 12(1)(a), (b), (c), (d), (h), (k) and (n) of the Act before the relevant consent was obtained; and (iii) the relevant consent was not withdrawn at any time before 1 November 2018.
Regulation 4(2) defines “relevant consent” for certain categories of subjects: where the research is not restricted human biomedical research and the research subject is a minor, lacks mental capacity, or was deceased when the individually-identifiable biological material or health information was obtained. In such cases, “relevant consent” may be given on behalf of the subject by specified persons (e.g., donee/deputy, spouse, adult son/daughter, parent/guardian, adult brother/sister). This is particularly relevant for consent governance in cases involving incapacity or death.
4. Exemption from need for appropriate consent where tissue was collected before 1 November 2019 (Regulation 5)
Regulation 5 provides a broader transitional exemption for tissue. It states that sections 12 and 37 of the Act do not apply to the storage of tissue for research, the supply of tissue for research, and the use of tissue for research where the tissue was removed from a human body (living or dead) before 1 November 2019.
As with Regulation 4, the exemption is conditional on documentary evidence that relevant consent in writing was given before 1 November 2019 for use in research; that the donor (or authorised person) was informed of certain matters in section 12(2)(a), (f) and (i) of the Act before the relevant consent was obtained; and that the relevant consent was not withdrawn before 1 November 2019.
Regulation 5(2) defines “relevant consent” where the donor is a minor, lacks mental capacity, or was deceased at the time of removal. Consent may be given on behalf of the donor by specified persons, including donee/deputy, spouse, adult son/daughter, parent/guardian, or adult brother/sister. This provision is practically important for biobanks and tissue repositories that hold samples collected before the cut-off date.
5. Exemption from need for parent/guardian consent for blood donated by a minor (Regulation 6)
Regulation 6 addresses a specific consent scenario: it exempts the Act’s requirements (sections 8 and 10) that appropriate consent must be obtained from an adult parent or guardian of a minor. The exemption applies where the tissue is the blood of a minor who is of or above 18 years of age; the blood was donated by the minor for a therapeutic purpose under a national blood donation programme administered by the Health Sciences Authority; the minor has sufficient understanding and intelligence to understand what is proposed; and the minor has given consent and was informed of the matters in section 12(2) of the Act before consent was obtained.
Although the wording is technical, the practical effect is clear: where a minor (aged 18 or above) donates blood under a national programme for therapeutic purposes and meets the understanding/intelligence and disclosure requirements, the law does not require an additional parent/guardian consent step.
How Is This Legislation Structured?
The Regulations are structured as a short set of provisions (numbered 1 to 6 in the extract). Regulation 1 provides the citation. Regulations 2 and 3 address witness-related exemptions for consent by research subjects and tissue donors respectively. Regulations 4 and 5 are transitional exemptions tied to cut-off dates for biological material/health information and tissue respectively, focusing on whether certain Act sections apply. Regulation 6 is a targeted exemption relating to blood donation by minors and the elimination of parent/guardian consent in specified circumstances.
Who Does This Legislation Apply To?
The Regulations apply to activities that fall within the scope of the Human Biomedical Research Act 2015, including research involving research subjects and the storage, supply, and use of tissue, as well as the use of individually-identifiable biological material and health information. The exemptions are relevant to researchers, sponsors, institutional review bodies, and tissue repositories/biobanks that must ensure their consent processes comply with the Act.
In particular, the Regulations are most consequential for: (1) studies that are non-invasive/non-interventional and non-restricted; (2) interventional studies involving no more than minimal risk where subjects can read and sign; (3) tissue removed for therapeutic/diagnostic purposes and not for restricted research; and (4) projects using historical samples or information obtained before 1 November 2018 or 1 November 2019, where documentary evidence of prior written consent and disclosures is available.
Why Is This Legislation Important?
These Regulations are important because they directly affect how consent must be documented and operationalised in biomedical research. In practice, consent compliance is often the most time-sensitive and audit-sensitive part of study set-up. By specifying when witness requirements do not apply, and when certain disclosure or consent requirements are exempted for pre-cut-off materials, the Regulations reduce the risk of procedural non-compliance while preserving core ethical safeguards.
From an enforcement and governance perspective, the Regulations also emphasise evidence. Multiple exemptions hinge on documentary evidence that relevant written consent was obtained and that the subject or authorised person was informed of specified matters. For practitioners, this means that consent forms, information sheets, and records of disclosure must be retained and retrievable. Where documentary evidence is missing or incomplete, the exemption may not be available, and the default Act requirements may apply.
Finally, the Regulations provide clarity on key legal concepts—such as what counts as “interventional”—and they establish practical pathways for low-risk research and for historical biobank holdings. This can influence study design, consent workflow, and institutional policies for handling legacy samples and data.
Related Legislation
- Human Biomedical Research Act 2015 (including sections 6, 8, 10, 12, 22(2)(c), 25, 37 as referenced)
- Health Sciences Authority Act 2001 (referenced in Regulation 6 regarding the national blood donation programme administered by the Health Sciences Authority)
Source Documents
This article provides an overview of the Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.