Resource index: Specific research projects

All:

Approvals

• ESRC Ethics framework

  Framework outlining structure and function for University Research Ethics Committees.

• 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

  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

  PDF page 20 - Section 5: Children, ethics and the law.

Embryo research

• HFEA After you are licensed

  Guidance on progress reporting to HFEA.

• HFEA Code of Practice 8th edition

  Sections 17 and 22 are relevant to research.

• HFEA Incident Report Form

  HFEA Incident Report Form.

• HFEA Incidents Procedure

  Standard Operating Procedure for incidents and near misses.

• HFEA Inspection reports - research

  Information on HFEA research inspections.

• HFEA Licence renewals

  Guidance on HFEA licence renewals.

• HFEA Research licence

  Human Fertilisation & Embryology Authority Research licence page.

• HFEA Vary your licence

  Guidance on varying your HFEA licence.

• HFEA contact details

  Contact details for HFEA.

• 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.

Gene therapy

• Gene Therapy Advisory Committee website

  Information on remit and application to GTAC.

• Gene therapy medicinal product legal definition

  Legal definition of gene therapy medicinal product - legally these trials must go to GTAC.

Reporting

• HTA Adverse Event Reporting

  For projects involving human application.

Research Governance Framework

• Medicines for Human Use (Clinical Trials) Regulations 2004

  Medicines for Human Use (Clinical Trials) Regulations 2004.