Code E: Relevant material and research

24.    The HT Act does not contain a definition of research, but for the purposes of what falls within the HTA’s remit, we endorse the following definition:

A study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge.

25.    The HTA also endorses the definition provided by the UK Policy Framework for Health and Social Care Research, which is as follows:

Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods.
 

26.    The HT Act defines relevant material as ‘material, other than gametes, which consists of or includes human cells’. Relevant material does not include hair or nails from living people, embryos outside the human body or any material which contains only cells created outside the human body; for example, cell lines.

27.    The fundamental concept of relevant material is that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material.

28.    Further information can be found in the Relevant material under the Human Tissue Act 2004 section of the website.

29.    Tissue from the living means tissue taken while the person was alive, and this definition persists after their death.

30.    Tissue that was taken from the living for diagnosis and subsequently stored in a diagnostic archive can be valuable for use in research in connection with the disorders, or the functioning of, the human body. Diagnostic tissue can only be released for research under the following circumstances:

a)    when the person has given consent for use of their tissue in research (the preferable scenario); or
b)    when the tissue will be released to the researcher in a non-identifiable form and will be used in a project that has approval by a recognised Research Ethics Committee (REC). For more information on recognised RECs, see paragraphs 65-69.

31.    Once tissue is released from a diagnostic archive for research, it must be stored on HTA-licensed premises, unless it is for a specific project approved by a recognised REC, or where any of the exceptions described in paragraph 84 apply. Further information about diagnostic archives releasing tissue for research is available on this website and is covered in paragraphs 94-97 of this Code.

32.    On rare occasions, tissue may be removed from the living for transplantation and not used; for example, it may be surplus to clinical requirements and might otherwise be disposed of. Such tissue can be used for research where consent is in place for that purpose, or where the tissue will not be identifiable to the researcher and it will be used in a specific project approved by a recognised REC.

33.    If a person has made known their objection to the use of tissue for purposes other than medical care, such as research, this must be respected.

34.    Findings of potential medical importance to donors may be made while undertaking human tissue research, including ‘incidental findings’ beyond the aims of the research. There is no single approach for the feedback of such findings. Researchers are therefore encouraged to consider how they would manage such findings and should be able to demonstrate appropriate arrangements where these are relevant, reflecting these clearly in the information used to support the consent process. The Medical Research Council (MRC) and Wellcome Trust have published a framework on the feedback of health-related findings in research.
 

35.    The HT Act requires that removal of tissue from the deceased for research within the scope of the HT Act must always take place under the authority of a HTA licence. In other words, the specific removal premises must be licensed and a Designated Individual (DI) will be responsible for the removal activity.

36.    Human tissue removed from the deceased must only be retained for use in research if appropriate consent has been given. You can find more information about appropriate consent in Code of Practice A and Code of Practice B, which is about post-mortem examinations.

37.    Once tissue from the deceased is stored for research it must be held on HTA- licensed premises, unless it is being used in a specific project approved by a REC (or where approval is pending), or where any of the exceptions described in paragraph 84 apply.
 

38.    Obtaining consent for the removal, storage or use of the tissue of babies from stillbirths or neonatal deaths should be handled in accordance with provisions for seeking consent for use of the tissue of the deceased.