Bitesize Seminar 17 February 2011 Ethics & Research: Applying for ethics approval

1. Bitesize Seminar17 February 2011Ethics & Research: Applying for ethics approval Duncan Banks, Chair, Open University REC John Oates, Deputy Chair, Open University REC

2. Overview • Brief history of development of research ethics • Ethics principles • Research benefits, risks and constituencies • The OU REC structure and process • Checklist, Proforma and protocol • Discussion

3. A brief and highly selective history of the development of research ethics to identify the elaboration of issues and practices

4. After WW2, in October 1946, the Nuremberg Medical Trial began, lasting until August of 1947. Twenty-three German physicians and scientists were accused of performing cruel and lethal medical experiments on concentration camp inmates and other living humans between 1933 and 1945.Fifteen defendants were found guilty, and eight were acquitted. Of the 15, seven were executed and eight were imprisoned.

5. 1947 The Nuremberg Code The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

6. 1947 The Nuremberg Code • The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. • The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

7. 1964 Declaration of Helsinki (Finland) “In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.”

8. 1966-2008 • 1966 formation of first British REC • 1978 British Psychological Society research ethics code • 1991 Department of Health guidance for RECs • 1999 Association of Research Ethics Committees • 2000 Central Office for Research Ethics Committees • 2001 European Union Directive 2001/20/EC • 2004 UK Clinical Trials Regulations • 2004 RESPECT framework - socio-economic research • 2004 ESRC Research Ethics Framework • 2007 National Research Ethics Service • 2008 Integrated Research Application System (IRAS)

9. Code for European social science:1. Upholding scientific standards 2. Compliance with the law 3. Avoidance of social and personal harm RESPECT

10. Canadian Psychological Association • Respect for the dignity of persons • Responsible caring • Integrity in relationships • Responsibility to society

11. The six key principles: • Research should be designed, reviewed and undertaken to ensure integrity, quality and transparency. • Research staff and participants must normally be informed fully about the purpose, methods and intended possible uses of the research, what their participation in the research entails and what risks, if any, are involved. Some variation is allowed in very specific research contexts. • The confidentiality of information supplied by research participants and the anonymity of respondents must be respected. • Research participants must take part voluntarily, free from any coercion. • Harm to research participants must be avoided in all instances. • The independence of research must be clear, and any conflicts of interest or partiality must be explicit. ESRC FRE

12. BPS Code of Human Research Ethics • Respect for the Autonomy and Dignity of Persons • Scientific Value • Social Responsibility • Maximising Benefit and Minimising Harm

13. BPS Code of Human Research Ethics • Respect for the Autonomy and Dignity of Persons • Adherence to the concept of moral rights is an essential component of respect for the dignity of persons. Rights to privacy, self-determination, personal liberty and natural justice are of particular importance to psychologists, and they have a responsibility to protect and promote these rights in their research activities. As such, psychologists have a responsibility to develop and follow procedures for valid consent, confidentiality, anonymity, fair treatment and due process that are consistent with those rights.

14. BPS Code of Human Research Ethics • Scientific ValueResearch should be designed, reviewed and conducted in a way that ensures its quality, integrity and contribution to the development of knowledge and understanding. Research that is judged within a research community to be poorly designed or conducted wastes resources and devalues the contribution of the participants. At worst it can lead to misleading information being promulgated and can have the potential to cause harm.

15. BPS Code of Human Research Ethics • Social ResponsibilityThe discipline of psychology, both as a science and a profession, exists within the context of human society. Accordingly, a shared collective duty for the welfare of human and non-human beings, both within the societies in which psychology researchers live and work, and beyond them, must be acknowledged by those conducting the research.

16. BPS Code of Human Research Ethics • Maximising Benefit and Minimising Harm… psychologists should consider all research from the standpoint of the research participants, with the aim of avoiding potential risks to psychological well-being, mental health, personal values, or dignity.

17. Research risks and harm, benefits and goods, and constituencies

18. Risks and harm • physical trauma/injury? • distress? • offence? • breach of confidentiality? • inconvenience? • coercion? • waste of time? • waste of resources / funds? • disrepute or litigation? • failure to publish

19. Benefits and goods • research as intrinsic good? • contribution to knowledge? • development of theories? • improvements to lives? • training researchers? • career advancement? • enhancing reputation/image? • increasing commercial success? • entertainment and enjoyment?

20. Constituencies • participants • researchers • institutions • sponsors / funding bodies • society

21. The Open University REC structure and processes

22. Governance structure RESEARCH COMMITTEE Research Degrees Committee (RDC) Human Research Ethics Committee(HREC) Affiliated Research Centres Management Group (ARCMG) Research Degree Examination Results Ratification Sub Committee (RRAT) MRes Award Board (MRes AB) Innovation & Enterprise Advisory Group (IEAG) Research Careers Working Group (RCWG) Life & Biomolecular Sciences Management Group (LBSMG) Theology and Religious Studies Management Group (TRS) MRes Management Group (MRes MG) Research Strategy Advisory Group (RSAG) Indicates governance reporting line Indicates advisory/management reporting line

23. HREC scope and roles • All persons carrying out research with a contract of employment with The Open University – ethics review and approval role • Taught undergraduate and postgraduate students of The Open University and students in ARCs and sponsoring establishments – advisory and review role • The Open University research community –education and policy development role • National HEI research community –research ethics environment scanning and contributions to national developments

24. HREC committee Membership 1. Four external members appointed by the Pro-Vice-Chancellor (Research & Enterprise), to include: • a medical practitioner • a researcher from a research institution other than the Open University • a lay person • a representative from a corporate body 2. The chair of the Research Committee ex officio, or nominee 3. Two members nominated by the Research Committee 4. Up to six members co-opted by the committee so as to cover any aspect, professional, scientific or ethical, of a research proposal which lies beyond the expertise of existing members

25. HREC process • Extensive intranet and WWW support site • Informal advice and support • Workshops, training and induction sessions • Responsive ethics review and approval system: • e-proforma • pre-review scan and advice • scrutiny panel, 3 HREC members, inc external • 10 day maximum turnaround

26. http://www.open.ac.uk/research/ethics/index.shtml Research Ethics website

27. Code of Practice for Research http://www.open.ac.uk/research/research-school/resources/research_information_and_communications.php

28. Project Registration and Risk Checklist

29. Project Registration and Risk Checklist • Section I Project details • Section II Applicant details • Section III For students only • Section IV Risk Checklist

30. Section IV the Risk Checklist

31. The next step Human research ethics approval process and proforma Once the above checklist process has been followed and it is agreed you need to obtain Open University approval for your research you will need to complete a HREC proforma (182KB). The HREC Chair, Duncan Banks, is happy to offer advice and guidance prior to completing the proforma. The final form should be emailed to Research-Rec-Review so it can be assessed as quickly as possible by the Committee. Once the form is accepted for review, the process takes 10 working days. If you have any queries about completing the proforma please look at the Research Ethics website, in particular the FAQs.

32. How to obtain the proforma 6 pages

33. HREC proforma headings, ethics ‘protocol’

34. HREC proforma headings • Title of project: a short, descriptive title. • Abstract: a summary of the main points of the research, written in terms easily understandable by a non-specialist and containing no technical terms (maximum 200 words). • Investigators: Give names and institutional attachments of all persons involved in the collection and handling of individual data. Name one person as Principal Investigator (PI). Research students should ask their primary supervisor to endorse their application quoting the HREC reference number assigned to them. Research students should normally name themselves as Principal Investigator.

35. HREC proforma headings • Literature review: Provide an indicative brief review of the existing literature or previous research. Clarify whether the proposed study replicates prior work AND/OR duplicates work done elsewhere AND/OR has an element of originality. • Methodology: Outline the method(s) that will be employed to collect and analyse data. • Participants: Give details of the population targeted or from which you will be sampling and how this sampling will be done. Give information on the diversity of the sample.

36. HREC proforma headings • Recruitment procedures: Give details of how potential participants will be identified and approached. • Consent: Give details of how valid consent will be sought and attach copies of information sheet(s) and consent form(s) if applicable. Give details and a timeframe of how participants can withdraw consent and what will happen to their data in such a case (see the Research Ethics website for a guidance document). • Location(s) of data collection: Give details of where and when data will be collected. If on private, corporate or institutional premises, indicate what approvals are gained/required. Explain why the research needs to be conducted in the chosen setting or location.

37. HREC proforma headings • Schedule: Time frame for the research and its data collection phase(s). • Published ethics and legal guidelines to be followed: Detail which guidelines will be followed by the researchers. For example: BERA, BPS, BSA, SRA, MRS, SPA, UK Evaluation Society (see the Research Ethics website for more information).

38. HREC proforma headings • Data Protection: Give details of registration of the project under the DP Act and the procedures and schedule (including dates) to be followed re: storage and disposal of data to comply with the Act. Any requirements by the funding body should also be given. Please note the OU guidance on the Research Ethics FAQ page: www.open.ac.uk/research/ethics/FAQs.shtml#p6. Indicate the earliest and latest date for the destruction of original data if that is required – or any archiving arrangements that have been agreed/permitted/required. Ensure this is also indicated in the project schedule.

39. HREC proforma headings • Recompense to participants: normally, recompense is only given for expenses and inconvenience, otherwise it might be seen as coercion/inducement to participate. Give details of any recompense to participants. • Deception: give details of the withholding of any information from participants, or misrepresentation or other deception that is an integral part of the research. Any such deception should be fully justified.

40. HREC proforma headings • Risk of harm to participants: Detail any foreseen risks to participants or researchers (e.g. home visits) and, based on a risk assessment, the steps that will be taken to minimise/counter these. If the proposed study involves contact with children or other vulnerable groups, please confirm that the requirements of the Vetting and Barring scheme provided by the Independent Safeguarding Authority (ISA) for each person involved in these contacts have been complied with (http://www.open.ac.uk/research/ethics/FAQs.shtml#p9).

41. HREC proforma headings • Debriefing: give details of how information will be given to participants after data collection to inform them of the outcomes of their participation and the research more broadly. • Research organisation and Funding: Please provide details of the principal funding body. If your project is externally funded enter your RED Form reference number below. For further guidance contact your Faculty Research Administrator (FRA) or refer to the Research Grants and Contracts website.

42. HREC proforma headings • Other project-related risks: indicate how research risks are to be limited by anticipating potential problems. • Benefits and knowledge transfer: state how the research may be of general benefit to participants and society in general (100 words maximum). • Declaration: declare here that the research will conform to the above protocol and that any significant changes or new ethics issues will be raised with the HREC before they are implemented. • A Final Report form will need to be filled in once the research has ended (you will be contacted by HREC on the date for final report below).

43. Discussion