Endnotes

1. Medical practice (2013)

2. Consent: patients and doctors making decisions together

3. Confidentiality: good practice in handling patient information

4. The World Health Organization defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes phase I to phase IV trials.

5. Service provides definitions of research, clinical audit, service evaluation and surveillance.

6. Research ethics committees (RECs) have a responsibility to safeguard the rights, safety, dignity and wellbeing of people participating in research. They review applications for research and give opinions about the proposed participant involvement and whether the research is ethical. Guidance on whether research requires ethical review under either the law or the policy of the UK health departments can be found on the website.

7.

8. Restricting research participants to subgroups of the population that may be defined, for example, by age, gender, ethnicity or sexual orientation, for legitimate methodological reasons does not constitute discrimination.

9. A sponsor is the person, individual or group that takes responsibility for the initiation, management and financing (or arranging the financing) of the research. All research undertaken in the NHS must have a sponsor. You should refer to the Medicines for Human Use (Clinical Trials) Regulations 2004 for a full definition of a sponsor and its responsibilities in clinical trials of investigational medicinal products.

10. Medicines and Healthcare products Regulatory Agency

11. Further advice is provided in the publication (Administration of Radioactive Substances Advisory Committee, 2006).

12. Further advice on responding to incidents and complaints is set out in paragraphs 44-45 of Management for doctors.

13. (pdf) (Medical Research Council, 2000) provides further advice on how long research records should be kept. (2016); (Scottish Government, 2008); (National Assembly for Wales); and (Department of Health, Social Services and Public Safety, Northern Ireland, 2005) all include schedules of the minimum periods for which research records should be kept.

14. The website provides advice on good practice in reporting health research.

15. Further information on publication and authorship is provided in section 3.15 of the (UK Research Integrity Office, 2009).

16. Research Governance Framework for Health and Social Care (Department of Health, 2005). Research Governance Framework for Health and Community Care (pdf) (Scottish Executive Health Department, 2006). Research Governance Framework for Health and Social Care in Northern Ireland (Department of Health, Social Services and Public Safety, Northern Ireland, 2006). Research Governance Framework for Health and Social Care in Wales (National Assembly for Wales, 2009).

17. International Conference on Harmonisation Topic E 6 Note for Guidance on Good Clinical Practice (2002)

18. Medicines for Human Use (Clinical Trials) Regulations 2004, Amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004: Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006, Medicines for Human Use (Miscellaneous Amendments) Regulations 2009, Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008.

19.

20. A legal representative under the Medicines and Human Use (Clinical Trials) Regulations 2004 means a person who is suitable to act as a legal representative for a minor (under 16) or an adult who lacks capacity for the purpose of the trial and is available and willing to do so. They must not be involved in the conduct of the trial. For trials involving adults who lack capacity in Scotland, a legal representative means any guardian or welfare attorney who has power to consent, or the adult’s nearest relative. In all cases, if there is no such person, a doctor not connected with the conduct of the trial but who is responsible for the medical treatment of the minor or adult, or a person nominated by the relevant healthcare provider, can be approached. You should refer to the clinical trials regulations for a full description.

21. and

22. The and the provide guidance on safety reports for clinical trials of investigational medicinal products.

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