Specialist research contexts

If you are planning a research project involving human participants, ethical issues should be considered early on in the planning process and approval sought in good time before the planned start of the project.

Ethics in archival Research

The use of data already in the public domain does not need to go through ethical approval.

Published biographies, newspaper accounts of an individual’s activities and published minutes of a meeting would not be considered "personal data" or sensitive personal data requiring ethics review, nor would interviews broadcast on radio, television, or online and diaries or letters in the public domain. Information provided in forums or spaces on the Internet that are intentionally public would be valid to consider "in the public domain", but the public nature of any communication or information on the Internet should always be critically examined and the identity of individuals protected unless it is critical to the research - such as in statements by public officials.

Ethics review may also not be required for anonymised records and data sets that exist in the public domain. This includes, for example, datasets available through the Office for National Statistics or the UK Data Archive where appropriate permissions have already been obtained and where it is not possible to identify individuals from the information provided. Specific regulations relate to the use of administrative data and secure data. Other data providers are likely to specify their own restrictions on the access to and use of their data, and these must be complied with.

Ethics in online Research

(This section is under review and will be updated in Winter 2016).

Collection and storage of blood and human tissue

Research involving the collection of human tissue  - primarily small samples of blood - from healthy volunteers not recruited via the NHS may be approved under the University’s ethical review protocols as the University holds a licence from the Human Tissue Authority for research (Licensing Number 12384) which meets the requirements of the Human Tissue Act 2004.

Specific requirements

Such projects must be ethically reviewed via the University’s internal system to the agreed standards outlined in the University’s Code of Practice for Research Ethics Concerning Human Participants (Non-NHS).

Specifically, appropriate consent must be obtained. This is a legal requirement of the Human Tissue Act 2004, and failure to comply with this requirement can result in severe penalties, including substantial fines and imprisonment.

It is the policy of the University of Leicester that informed consent must be obtained and recorded. Projects should normally include arrangements for a donor to withdraw consent and request the destruction of their tissue.

Additionally:

  1. It is good practice to label samples with an ID number and keep a log of these in a separate secure location. Samples must not be labelled with a donor’s name or initials or any other identifying data - such as their date of birth.
  2. Tissue may not be used for a purpose for which consent was not given - such as for another research project. To do so would be an offence under the Human Tissue Act 2004.
  3. Following use in the project for which consent was given, unless it is proposed to seek appropriate ethical approval and donor consent for further use, any remaining or excess tissue must be destroyed according to laboratory standard operating procedures.
    1. If the excess or remaining tissue is to be used in a further research project, the tissue must be transferred to the University’s Licensed Area for tissue holding in the Robert Kilpatrick Clinical Sciences Building. Researchers must contact the University’s Human Tissue Act Committee for details of how to arrange this.
    2. While the tissue is in storage in the Licensed Area, ethical approval for the new project should be sought under the University’s ethical review protocols and steps taken to obtain new informed consent from the original donors of the tissue. If it is not possible to contact the original donor to seek new informed consent, the tissue may only be used for further research after approval has been granted by an NHS Research Ethics Committee.
    3. There is no limit to the length of time tissue may be held in the licensed area. It should be noted that Human Tissue Authority guidance states that "human tissue is an invaluable resource for research, and disposal should be a last resort".
    4. The technician maintaining the University’s Licensed Area for tissue holding must be informed if consent for further use of the tissue is denied, so that the tissue can be destroyed as per standard operating procedures.
  4. Departmental Ethics Officers, Ethics Committee members and researchers can obtain ethical and technical advice on the use of human tissue in research from the University’s Human Tissue Act Committee.
  5. The collection of blood must be undertaken by someone competent in taking blood samples, or supervised by an experienced colleague until competent.
  6. Blood and tissue collection should be undertaken away from public areas.

 

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