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There are a number of web based resources for researchers who are preparing an application to a Research Ethics Committee. These sites provide guidance to researchers on various general and specific ethical issues to consider whilst both preparing a REC application and developing the study protocol.
Declaration of Helsinki
The Declaration of Helsinki is the internationally accepted statement of ethical principles in medical research. It provides overall guidance on ethical principles to physicians and other participants in medical research involving human subjects. The Declaration of Helsinki can be accessed here: Declaration of Helsinki
ICH Good Clinical Practice Guidelines
Good Clinical Practice (GCP) is an
international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects.
The objective of the ICH GCP Guidelines are to provide a unified standard
for the EU, Japan and the United States to facilitate the mutual acceptance
of clinical data by the regulatory authorities in these jurisdictions. The
guidelines can be accessed here: ICH
GCP Guidelines.
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MRC Ethics Series
The MRC have produced a series of guidance notes relating to ethical issues in research. The whole series can be accessed here: MRC Ethics Series
MRC Guidance on Good Research Practice
This booklet outlines the key elements
of good research practice, setting out the principles that should be taken
into account when planning and conducting research, and likewise when recording,
reporting, and applying the results. The guidance notes can be accessed
here: MRC
Guidance on Good Research Practice.
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Data Protection Guidance
LTHT Data Protection & Research Guidance
Please note: It is important to contact the Trust's Information Governance Officer to discuss any data protection issues relating to your proposed research, at the earliest opportunity. Please contact:
Christopher Plumstead
Information Governance Officer
Email: christopher.plumstead@leedsth.nhs.uk
Tel: 0113 39 26936
Data Protection & Research guidance has been produced by the Trust R&D
Department in collaboration with the Trust Data Protection Officer and the
Caldicott Guardian.Data
Protection in Research - Guidance Notes for Researchers
Patient Information Advisory
Group (PIAG)
The Patient Information Advisory Group was established to provide advice on issues of national significance involving the use of patient information and to oversee arrangements created under Section 60 of the Health and Social Care Act 2001. This act enables the Secretary of State to support and regulate the use of confidential patient information in the interest of patients or the wider public good. Guidance on applying for Section 60 support and further information on PIAG can be accessed here: Guidance for Section 60 Applications
MRC's Guidance on Personal Information in Medical Research
This guidance sets out the procedures that need to be followed by those undertaking
or planning research that involves the use of individual patient data where
consent from the individual patients concerned has not or will not be obtained
under Section 60 of the Health and Social Care Act 2001. MRC
Guidance on Personal Information in Medical Research
DH Patient
confidentiality and Access to Health Records Guidance
This website can be accessed here.
Informed Consent Guidance
LTHT Guidance on Informed
Consent
This guidance summarises
the requirements for informed consent of participants in all research studies,
with emphasis on clinical trials of investigational medicinal products (CTIMPs).
LTHT
Guidance on Informed Consent
Patient Information Sheet
The Research Ethics Committee scrutinises patient information sheets very
carefully. A research study frequently does not receive approval in full
because the patient information sheet (PIS) is too complex or does not inform
the patient of everything they need to know in order to make an informed
decision on whether or not they wish to take part in a research study.
The Central Office for Research
Ethics Committees has produced guidance on writing Patient
Information Sheets.
Background Information - DH Good Practice in Consent Initiative
This group has produced guidance documents on obtaining consent:Good
Practice in Obtaining Consent
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GTAC considers and advises on the acceptability of proposals for gene therapy research on human subjects, on ethical grounds, taking account of the scientific merits of the proposals and the potential benefits and risks. It is currently a legal requirement that all UK gene therapy clinical research be submitted to the GTAC. Guidance on making an application to and further information can be accessed here: Guidance on GTAC Applications.
The HFEA is a non-departmental Government body that regulates and inspects all UK clinics providing IVF, donor insemination or the storage of eggs, sperm or embryos. The HFEA also licenses and monitors all human embryo research being conducted in the UK. Their website can be accessed by clicking here. The site contains guidance on applying for a HFEA research licence.
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This guidance has been produced by the Royal College of Psychiatrists and can be accessed here:
Consumers for Ethics in Research
(CERES) have produced a number of leaflets that list the questions people
may want to ask before they make a decision whether to participate in research.
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People in Research helps members of the public make contact with organisations that want to actively involve them in clinical research. For example this could be by helping to decide what gets researched or possibly carrying out part of the research. For further information please click here.
Bulletin of Medical Ethics
The Bulletin of Medical Ethics is an independent publication offering a source of current news and views on a wide range of issues in health care ethics, both in the UK and abroad. The bulletin can be accessed here.
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