Useful links

Sources of information related to the research ethics review process and conducting research in the NHS.

The National Research Ethics Service accepts no responsibility for the accuracy or suitability of linked content. This listing does not indicate our endorsement of the relevant organisations or the views expressed by their websites and onward links.
 
Please also refer to our Guidance page for links to guidelines, policies and standards.

• Regulations and guidance 

• Associations and organisations 

• Databases of ongoing and completed research 

Regulations and guidance

• Appointing Authority for Phase 1 Ethics Committees (AAPEC)
  Established to take on the appointing authority functions previously performed by the UK Ethics Committees Authority (UKECA) for the independent sector ethics committees under the Medicines for Human Use (Clinical Trials) Regulations 2004.
• Administration of Radioactive Substances Advisory Committee  (ARSAC) 
  Any doctor or dentist wishing to administer radioactive medicinal products to humans must hold a certificate issued by health ministers. This committee advises ministers on applications for certificates.
• Clinical Trials Tool Kit
  Provides practical help for clinical trialists and R&D managers working in the academic sector when trying to meet the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004. 
• Department of Health: Consent home page
  Information about the Good Practice in Consent initiative. 
• Department of Health: Patient Confidentiality and Access to Health Records home page 
  Information about the use and protection of patient data in the NHS. 
• Department of Health: Research Governance home page
  The Research Governance Framework for Health and Social Care defines the broad principles of good research governance and is key to ensuring that health and social care research is conducted to high scientific and ethical standards. 
• Ethics Research Information Catalogue (ERIC)
  A collection of articles related to the ethics of medical research on humans, provided for researchers or members of research ethics committees to help them consider ethical issues during the development or ethical review of a research proposal.
• Gene Therapy Advisory Committee (GTAC)
  Has UK-wide responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies. Also advises Ministers on the development and use of gene and stem cell therapies and works with other Government agencies with an interest in this area.
• Governance Arrangements for NHS Research Ethics Committees (GAfREC)
  Expands on the standards and principles set out for Research Ethics Committees (RECs) in the Research Governance Framework for Health and Social Care, and clarifies the accountability for establishment and support for RECs. 
• Human Fertilisation & Embryology Authority (HFEA)
  The UK's independent regulator overseeing the use of gametes and embryos in fertility treatment and research. Also licenses fertility clinics and centres carrying out in vitro fertilisation (IVF), other assisted conception procedures and human embryo research.
• Human Tissue Authority (HTA)
  Set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004.  The HTA is the Competent Authority under the EU Tissue and Cells Directive for regulating human application establishments and is also responsible for approving donation of solid organs and bone marrow from living donors. 
• Information Commissioner’s Office
  The UK's independent authority set up to promote access to official information and to protect personal information.
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  Brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. Aims to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
• International Standard Randomised Controlled Trial Number (ISRCTN) Register
  Provides a unique identification number for clinical trials worldwide. In addition to randomised controlled trials, the ISRCTN Register accepts registration of other forms of studies designed to assess the efficacy of healthcare interventions.
• Medicines and Healthcare products Regulatory Agency (MHRA)
  Enhances and safeguards the health of the public by ensuring that medicines and medical devices work and are acceptably safe. Underpinning all its work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. 
• Medical Research Council (MRC)
  A publicly-funded organisation dedicated to improving human health through world-class medical research. Support researchs across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. Works closely with the NHS and the UK Health Departments to deliver its mission, and gives a high priority to research that is likely to make a real difference to clinical practice and the health of the population. Publishes material to assist medical researchers.
• National Information Governance Board for Health and Social Care (NIGB)
  Provides leadership and promotes consistent standards for information governance across health and social care. Considers ethical issues; the interpretation and application of the law and policies;  and provides advice on information governance matters at a national level. Reports annually to the Secretary of State for Health and is responsible for the NHS Care Record Guarantee for England. Functions include administration of applications under section 251 of the NHS Act 2006 which allows the common law duty of confidentiality to be set aside in specific circumstances.  (This function was formerly carried out by the Patient Information Advisory Group (PIAG) which was abolished on 31 December 2008.)
• NHS Research and Development Forum
  A network for those involved in managing and supporting R&D in health and social care. Aims to improve the environment for research in health and social care by facilitating and encouraging sharing of best practice, and working with other organisations. Membership of the Forum is free and open to anyone involved in or interested in managing and planning research and development in the NHS or social care. Its website also provides some direction on R&D matters for researchers wishing to undertake research within the NHS. 
• Nuffield Council on Bioethics
  Examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. Has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics.
• Patient Information Advisory Group (PIAG)
  Established to provide advice on issues of national significance involving the use of patient information (data) and to oversee arrangements created under Section 251 of the NHS Act 2006 (originally enacted under Section 60 of the Health and Social Care Act 2001). PIAG was replaced by the National Information Governance Board for Health and Social Care under and was formally wound up on 31 December 2008. Responsibility for administering Section 251 powers transferred to the National Information Governance Board on 1 January 2009, which has established a new committee to administer applications on its behalf. 
• World Medical Association (WMA)
  An international organisation representing physicians. Provides ethical guidance to physicians through its declarations, resolutions and statements, which cover a wide range of subjects, including an International Code of Medical Ethics, the rights of patients, and research on human subjects. 

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Associations and organisations

• Administration of Radioactive Substances Advisory Committee  (ARSAC) 
  Any doctor or dentist wishing to administer radioactive medicinal products to humans must hold a certificate issued by health ministers. This committee advises ministers on applications for certificates.

• Association of Research Ethics Committees (AREC)
   An independent, self-governing body of Research Ethics Committees, local and multi-centre, including their members and administrators. Provides meetings, training and advice for its members.
  

• Colorectal Cancer Coalition (C3)

  C3’s mission is to win the fight against colorectal cancer through research, empowerment and access.  C3 pushes for public policy that supports evidence based screening and treatment; for research that promotes public and patient health; and for access to screening and treatment.  C3 trains policy and research advocates so that it can effectively engage directly with research leaders and policy makers to achieve these goals. In addition, C3 works to increase the efficiency and productivity of the clinical research enterprise through efforts with coalitions such as the Clinical Trials Transformation Initiative and the National Cancer Institute Clinical Trials Working Group efforts.
  

• Department of Health
  A UK Government Department, committed to improving the quality and convenience of care provided by the NHS and social services. Its work includes setting national standards, shaping the direction of health and social care services and promoting healthier living.

• Gene Therapy Advisory Committee (GTAC)
  Has UK-wide responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies. Also advises Ministers on the development and use of gene and stem cell therapies and works with other Government agencies with an interest in this area.

• Human Fertilisation & Embryology Authority (HFEA)
  The UK's independent regulator overseeing the use of gametes and embryos in fertility treatment and research. Also licenses fertility clinics and centres carrying out in vitro fertilisation (IVF), other assisted conception procedures and human embryo research.

• Human Tissue Authority (HTA)
  Set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004.  The HTA is the Competent Authority under the EU Tissue and Cells Directive for regulating human application establishments and is also responsible for approving donation of solid organs and bone marrow from living donors.

• Information Commissioner’s Office
  The UK's independent authority set up to promote access to official information and to protect personal information.

• INVOLVE
  A national advisory group, funded by the National Institute for Health Research  (NIHR).  Supports and promotes active public involvement in NHS, public health and social care research. INVOLVE was established to promote public involvement in research, in order to improve the way that research is prioritised, commissioned, undertaken, communicated and used, and believes that the active involvement of the public in the research process leads to research that is more relevant to people and is more likely to be used. (Formerly known as Consumers in NHS Research).

• James Lind Library
  The James Lind Library has been created to help people understand fair tests of treatments in health care. The principles of fair tests are explained in essays containing many examples. To illustrate the evolution of fair tests of treatments from 1550 BCE to the present, the library contains key passages and images from manuscripts, books and journal articles. The website also contains many commentaries, biographies, portraits, doctoral theses and other relevant material about the history of fair tests.
  
  A  free, downloadable 100-page book ‘Testing Treatments: better research for better health care’ (by Imogen Evans, Hazel Thornton and Iain Chalmers) was published by the British Library in 2006.

• Medicines and Healthcare products Regulatory Agency (MHRA)
  Enhances and safeguards the health of the public by ensuring that medicines and medical devices work and are acceptably safe. Underpinning all its work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. 

• Medical Research Council (MRC)
  A publicly-funded organisation dedicated to improving human health through world-class medical research. Support researchs across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. Works closely with the NHS and the UK Health Departments to deliver its mission, and gives a high priority to research that is likely to make a real difference to clinical practice and the health of the population. Publishes material to assist medical researchers.

• NHS Choices: Find services
  Provides information on NHS services and where to find them, including details on Strategic Health Authorities and hospitals. 

• NHS Research and Development Forum
  A network for those involved in managing and supporting R&D in health and social care. Aims to improve the environment for research in health and social care by facilitating and encouraging sharing of best practice, and working with other organisations. Membership of the Forum is free and open to anyone involved in or interested in managing and planning research and development in the NHS or social care. Its website also provides some direction on R&D matters for researchers wishing to undertake research within the NHS. 

• Nuffield Council on Bioethics
  Examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. Has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics.

• Patient Information Advisory Group (PIAG)
  Established to provide advice on issues of national significance involving the use of patient information (data) and to oversee arrangements created under Section 251 of the NHS Act 2006 (originally enacted under Section 60 of the Health and Social Care Act 2001). PIAG was replaced by the National Information Governance Board for Health and Social Care under and was formally wound up on 31 December 2008. Responsibility for administering Section 251 powers transferred to the National Information Governance Board on 1 January 2009, which has established a new committee to administer applications on its behalf.

• People in Research
  Helps members of the public make contact with organisations that want to actively involve them in clinical research. For example, by helping to decide what gets researched or possibly carrying out part of the research.

• United States Office for Human Research Protections (OHRP)
  Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the US Department of Health and Human Services . Helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.

• World Medical Association (WMA)
  An international organisation representing physicians. Provides ethical guidance to physicians through its declarations, resolutions and statements, which cover a wide range of subjects, including an International Code of Medical Ethics, the rights of patients, and research on human subjects. 

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Databases of ongoing and completed research 

• ClinicalTrials.gov
  A registry of federally and privately supported clinical trials conducted in the United States and around the world. Provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals. 

• European Clinical Trials Database (EudraCT)
  A database of all clinical trials commencing in the European Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. Allows sponsors access to the EudraCT application in order to obtain a EudraCT number, and to complete, save, and print a pdf version of the clinical trial application form. 

• IFPMA Clinical Trials Portal
  This service, provided by the International Federation of Pharmaceutical Manufacturers and Associations, allows you to search for comprehensive information on ongoing clinical trials (registry) and results of completed trials (database) conducted by the innovative pharmaceutical industry.

• National Research Register Archive (NRR)
  The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the UK’s National Health Service (NHS). It has now been archived and a searchable copy of the records that were held in the National Research Register (NRR) Projects Database can be found on this website. It was created using the final issue of the NRR published in October 2007, based on records collected up to September 2007.

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