Resource index: Specific research projects

All:

Approvals

• ESRC Ethics framework (pdf)

  Framework outlining structure and function for university research ethics committees.

• Gene Therapy Advisory Committee website

  Information on remit and application to GTAC.

• Nuffield Council on Bioethics publication

  The Ethics of Research Related to Healthcare in Developing Countries.

• UK Stem Cell Tool Kit

  A regulatory tool for those conducting human stem cell research in the UK.

Consent (All research)

• MRC Ethics Guide: Medical research involving adults who cannot consent

  This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to participation in research. It also discusses participation in research projects when such capacity is lacking.

• NRES Guidance: Research involving adults unable to consent for themselves (pdf)

  Includes information on Mental Capacity Act 2005 and Adults With Incapacity Act 2000

• NRES Questions & Answers to the Mental Capacity Act 2005 (V3)

  NRES guidance in the form of questions and answers

• NRES web page listing guidance on adults unable to consent for themselves

  NRES web page providing links to guidance produced by NRES and Department of Health; and links to the Mental Capacity Act 2005, Adults with Incapacity (Scotland) Act 2000, and associated Regulations.

Consent (Children)

• MRC Ethics Series: Medical Research Involving Children

  Section 5: Children, ethics and the law.

Embryo research

• HFEA Code of Practice 8th edition

  Sections 17 and 22 are relevant to research.

• Human Fertilisation and Embryology Act 2008

  The Human Fertilisation & Embryology Act 2008 amends the 1990 Act from the 1st October 2009, providing clarification of the scope of embryo research.

• Human Fertilisation and Embryology Authority Inspections

  Information on HFEA inspections

• Human Fertilisation and Embryology Authority Progress Reports

  Guidance on progress reporting to HFEA

• Human Fertilisation and Embryology Authority Renewal of Licence

  Application form and guidance for changes renewal of, or changes to licences

• Human Fertilisation and Embryology Authority contact details

  Contact details for HFEA

• Human Fertilisation and Embryology Authority licensing pages

  HFEA Human Embryo licensing pages

• Human Fertlisation and Embryology Authority Incident Report Form

  HFEA Incident Report Form

• Human Fertlisation and Embryology Authority Incidents Procedure

  Standard Operating Procedure for incidents and near misses

Reporting

• Human Tissue Authority Adverse Event Reporting

  For projects involving human application

Research Governance Framework

• Streamlined NHS Permissions Approach to Research - Cymru (SPARC)

  SPARC provides a streamlined and consistent approach for obtaining NHS permission for primary care research studies in Wales.