Dr Meera Warrier Research Development Coordinator Academic Practice RESEARCH ETHICS Dr Meera Warrier Research Development Coordinator

Introduction Who are you? What is your area of research? Why have you come to this session?

Why are we doing this? New University policy http://www2.le.ac.uk/institution/committees/research-ethics/code-of-practice Thinking about ethics can make you a better scholar and researcher. Because we want you, your research participants and the University to be protected.

Exercise 1 In pairs, identify four principles which you regard as underpinning ethical research? 5 Work in Pairs! 10 min exercise 10 min feedback

Principles Where, what, why and how Confidentiality and anonymity – clear to participants Fair and accurate representation/IPR Understanding of research context/environment Integrity and honesty (plagiarism) Safety of participant Respect for participants and their context

University of Leicester Principles Researchers must respect the rights, interests and dignity of participants and related persons. Research must be undertaken in accordance with any relevant common law or legislation. Informed consent should normally be obtained from participants. Consent itself shall be given freely without force or other coercion. Researchers have an obligation to protect research participants wherever possible from significant harm consequent upon the research. The confidentiality of information supplied by research subjects and any agreement to grant  anonymity to  respondents should be respected

University of Leicester Principles 7. All research involving human subjects whether undertaken by academic staff, other university staff or students is to be subject to ethical approval. Where research projects fall within the scope of the NHS Research Governance Framework such research this should be referred to an appropriate NHS Research Ethics Committee[1]. All other research concerning human subjects should be dealt with through the University research ethics review structure. 8. Both the design of research and its conduct should be with the aim of ensuring integrity and quality. 9. Research is to be undertaken subject to the principle of academic independence. Where any conflicts of interest or partiality arise these must be clearly stated prior to ethical approval being obtained.

Key Issues Consent Vulnerable groups Confidentiality and data protection Use of human material Research projects which are intended to operate in conjunction with researchers outside the university and outside the jurisdiction Dissemination of research Risk of Harm to Research Participants from Third Parties

Key Issues (Contd) Risk to researchers Researchers’ responsibilities Complaints procedures Monitoring

Consent Consent should be both voluntary and informed and should be obtained without duress. Is the participant competent to make their own decision regarding participation? Are the participants free to choose to participate or to not participate? Have the participants sufficient information to make this decision? Do the participants fully understand this information?

Coercion and Incentives Care should be taken when considering incentives to participate, particularly when dealing with vulnerable individuals/groups

Withdrawal Participants have the right to withdraw at any point in the project including after the research has been completed. They should be informed of this right Any attempt to convince a participant not to withdraw should be carefully considered to ensure that no coercion or duress is being used. The possibility of a withdrawal after the data collection should be considered in the planning stage to ensure that such an occurrence would not have a serious detrimental effect on the project.

When consent might not be appropriate Observation in public places Research necessitating deception Covert research Using data in the public domain When tissue has been obtained from living patients who remain anonymous to the researcher.

Participant Awareness and Deception Care should be taken to ensure that all participants fully understand the research process and the reasons for their participation. They should also understand how the results will be used and to whom it will be reported. Deception should be avoided unless it is specifically required in the research design. In cases where deception is unavoidable researchers should attempt to receive consent after the event if at all possible. Those engaged in Action Research should take great care to be aware of how their own participation impinges on others participants.

Rights, interests, dignity and safety of participants and related persons Participants rights need to be considered throughout the research including during the dissemination stage. Participants should be protected from undue risk. Participants should be protected from physical and psychological harm.

Exercise 2: In pairs, discuss what is meant by anonymity and confidentiality? 5

Anonymity and Confidentiality “Anonymity exists when no one, including the researcher, can relate a participants identity to any information pertaining to the project” “Confidentiality exists when only the researchers are aware of the participants’ identities and have promised not to reveal those identities to others” Reference: Dane 1990 p51

Disclosure On occasions a researcher unexpectedly observes illegal behaviour or behaviour that is likely to be harmful to the participants or others. In these cases they should carefully consider disclosing this information to the appropriate authorities. In so far as possible, researchers should inform the participants and /or their guardians of their intention to disclose and the reasons for this.

Vulnerable Groups: Working with Children Ethical aspects: Child consent Parental consent Gatekeeper consent/pressure Legal aspects: Defined as under 18 years of age CRB checks

Working with Vulnerable Adults Who are vulnerable? University guidelines in preparation… Mental Capacity Act 2005 (came into force April 2007) CRB Definitions of vulnerable adults at : http://www.crb.gov.uk/default.aspx?page=400#v

Criminal Records Bureau In existence since 2002 Does background checks on those working with children or vulnerable adults Checks required under the Protection of Children Act 1999 2 types of disclosure Standard Enhanced Turn around time of up to 4 weeks Further details at http://www.crb.gov.uk/

CRB Disclosure Standard Enhanced primarily for working with children or vulnerable adults or for certain professions (accountancy, law etc.) details of cautions, reprimands, convictions, and warnings on police database. If requested-data on suitability to work with children or vulnerable adults. Enhanced For posts with enhanced contact with children or vulnerable adults (e.g. Teacher, Youth leader, Scout Master etc) Information same as standard but with extra information provided by local police force.

Researcher Safety and Well-being Physical Safety Working within dangerous industries Working at night Working with dangerous groups/participants Working with harmful materials Psychological Well-being Exposure to distressing information Harassment Intimidation

Data Protection Act Deals with information about individuals Collecting Data – only collect data that there is a legitimate research reason for doing so. Processing and storing data-only with the individuals consent Disclosure of Data Deleting/archiving of data-should not be kept longer than is necessary. For on-line training course on the Data Protection Act please see the course in Blackboard. For details see http://www.le.ac.uk/staffdev/ns/sid.html

Ethical duties of authors Reporting standards: Data access and retention Originality and plagiarism Multiple, redundant and concurrent publication Acknowledgement of the paper Authorship Hazards and human or animal subjects Disclosure and conflicts of interest Fundamental errors Taken from Elsevier’s Ethical guidelines for Journal Publication http://www.elsevier.com/wps/find/intro.cws_home/ethical_guidelines

University Guidelines for Authoring All authors should have made a significant intellectual contribution All authors should participate in the manuscript preparation and approve the final version The order of the authors should be decided by all

Other Issues Participants: Follow up, awareness of outcomes Environmental Issues Funding Sources Health and Safety

Legal Framework Human Rights Act 1998 Data Protection 1998 Freedom of Information Act 2000 (2005) Human Tissue Act 2004 (2006) EU Tissues and Cells Directive 2004/23/EC Human Fertilisation and Embryology Act 1990 EU Clinical Trials Directive 2001/20/EC Health and Social Care Act 2001 Caldicott Report 1998 Mental Capacity Act 2005 (2007) Access to Health records Act 1990 Criminal Records Bureau (CRB) checks Public Interest Disclosure Act 1998

Research Ethics Committees

NHS Ethical Review is required for research involving: Patients and users of the NHS Including participants recruited by virtue of the patient or users past or present treatment, by or use of the NHS. Includes NHS patients treated under contracts with private providers. Individuals identified as potential participants by virtue of their status as relatives or carers or patients and users of the NHS. Access to data, organs and other bodily materials of past and present NHS patients. Fetal material and IVF involving NHS patients. The recently dead in NHS premises. The use of, or potential access to, NHS premises or facilities. NHS staff recruited as participants by virtue of their professional role. All Clinical Trials of an Investigative Produce including Healthy Volunteer Studies For further information and access to forms see www.corec.org.uk

University Research Ethics Process Research Ethics Form Supervisor Departmental Ethics Officer Minimal Risk More than Minimal Risk Acceptance Department, School or Faculty Ethics Committee Research Reject University Ethics Committee Appeal

More than Minimal Risk Research involving: Vulnerable groups Sensitive topics Permission of a gatekeeper Deception Records of personal or confidential nature Psychological stress, anxiety or humiliation Intrusive interventions

The process at Leicester For all PhD research involving human subjects you must complete the Research Ethics Review Form BEFORE you undertake any research. This must be submitted to your supervisor/ tutor. If your supervisor/ tutor thinks it is fine they will submit it to the Research Ethics Officer for approval. If the Research Ethics Officer is happy with it she will sign it off and you can start your research. If she thinks it involves more complex issues she may send it to the Faculty Research Ethics Committee for consideration. The Faculty Committee will consider your application and approve it or not. If it is rejected at this level you have the right to have your application considered by the University Committee but this will be for exceptional circumstances only. Leave plenty of time for this process to occur. (circa 4 weeks).

Research Ethics Review Form (Tips) If you think you want to do research with people speak to your tutor/ supervisor as soon as possible Make sure you find out deadlines and get the form in on time. Do not try and hide anything on ethics forms. You will be found out. Be specific and clear about what you are going to do. There is no point in putting in a form for a project that you haven’t developed. Make sure you attach the consent forms and information sheets that you will be using.

Consent forms and Information Sheets They should have a number of features: Say who you are, where you are from and what you are doing Say what the information will be used for, how long it will be kept for and how if will be kept securely Tell the person how they were selected to participate Allow the person to agree to participate with a particular level of anonymity Inform the participant that they may pull out of the research at any time A name of someone not involved in the research who the research participant can contact if they have any concerns Should be tailored to the type of person you are working with, e.g. young people, parents, adults Should be concise

References British Educational Research Association (BERA) revised Educational Guidelines for Educational Research (2004) http://www.bera.ac.uk/publications/pdfs/ETHICA1.PDF Dane, F.C. (1990) Research Methods. Brooks/Cole Publishing Company, California, USA. Cohen, L., Manion, L. and Morrison, K.(2005) Research Methods in Education. RoutledgeFalmer, Abingdon, UK. ESRC Research Ethics Framework http://www.esrcsocietytoday.ac.uk/ESRCInfoCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf Criminal Records Bureau http://www.crb.gov.uk/