1. Professor David Stanley Northumbria University

2.  “Human participants or subjects are defined as including living human beings, human beings who have recently died, (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids, human data and records (such as but not restricted to medical, genetic, financial, personnel, criminal or administrative records including scholastic achievements)” ESRC (2005) ‘Research Ethics Framework (REF)’ 2

3.  Historical background – Nuremberg Code  Declaration of Helsinki  Identify all the stages and elements of the research  Identify all of the possible uses of research outputs  Assessing all the risks  Ensure all participants, site managers (governance) and researchers are fully informed 3

4.  No adult is permitted in UK law to consent on behalf of another adult, however, the Mental Capacity Act does allow for advice to be sought from a consultee for research purposes so long as the project has been approved by a recognised Research Ethics Committee (REC)  Written consent is preferable but is it always possible / desirable?  Consent can be withdrawn at any time. 4

5.  Different legislation gives different age definitions of children and young people  Helsinki now includes specific reference to children as a research subject in relation to informed consent  Issues to take into account:  Age  Best interests  Possible impact of the research  Capacity to understand  Capacity to decide  Whether parental consent required  ‘Gillick’ competence 5

6.  Lord Scarman’s comments in his judgement of the case in the House of Lords (1985) are often known as the "Gillick competency“ test:  "...it is not enough that she should understand the nature of the advice which is being given: she must also have a sufficient maturity to understand what is involved."  He also said generally on parents’ v children’s rights:  "Parental right yields to the child’s right to make his own decisions when he reaches a sufficient understanding and intelligence to be capable of making up his own mind on the matter requiring decision." 6

7. Since the Gillick case, legal, health and social work professionals continue to debate the issues of a child’s rights to consent or refuse treatment, and how to balance children’s rights with the duty of child protection professionals to act in the best interests of the child. Further court rulings, new legislation and revised guidance continue to amend the legal position. (source NSPCC, 2009) 7

8.  Ensuring that there is no link back to the individual so that they can be identified  Personal data must be collected and stored in line with the Data Protection Act 1998 (see www.mrs.org.uk)www.mrs.org.uk  Confidentiality applies regardless of the status of the individual participant 8

9.  Factors that may influence coercion  Vulnerability  Status  Power relationships  Inducement  Lack of, or inaccurate, information 9

10.  Identify risk of harm  Monitor harm as it arises  Psychological and physical harm  What about risks to researchers  What about environmental harm 10

11.  When are conflicts of interest most likely to arise?  How do you make decisions about funding given pressure to increase research income?  How to make decisions about accepting funding from ethically challenging sources?  How to ensure clarity? 11

12.  What if I only carry out lab based research and never have anything to do with research participant/subjects?  What if I don’t carry out my research in the UK?  What if I know that my research is ethical and I don’t see a need to have my work scrutinised? 12

13.  ESRC (2005) ‘Research Ethics Framework (REF)’  ESRC (2010) ‘Framework for Research Ethics (FRE)’  www.esrcsocietytoday.ac.uk/ESRCInfohttp://Centre/opportuniti es/research_ethics_framework/ www.esrcsocietytoday.ac.uk/ESRCInfohttp://Centre/opportuniti es/research_ethics_framework/  UCL guidance note on research involving children:  http://ethics.grad.ucl.ac.uk/forms/guidance1.pdf http://ethics.grad.ucl.ac.uk/forms/guidance1.pdf 13