Ethics of Research. A Guide to Practice at Northumbria

Transcription

1 Ethics of Research A Guide to Practice at Northumbria

2 1. Sources of Ethics Policy 2. Importance 3. Ethical Risk Categories 4. Approval Process 5. Key provisions 6. Judgment Issues 7. What next 8. Governance 9. Resource Ethics Briefing

3 1. Sources of Ethics Policy 1. University Policy 2. Nuremberg Code / Declaration of Helsinki / Singapore Statement 3. Professional / Governance Codes 4. Legislation

4 Sources: University Policy Northumbria University strives to uphold the highest standards of ethical practice in research and academic integrity. Irrespective of the nature and ethical complexity of a research project, staff and students are expected to ensure that their conduct is driven by the ethical imperative of respect, the intent to do no harm and to contribute to society s knowledge and practice through engagement in research that has beneficent intent. - Research Ethics and Governance Handbook 2013/14 (6 th Ed) p2

5 Sources: University Policy Framework is intended to support staff and student research, not to prohibit activity Approval processes designed to be appropriate and proportionate Processes are meant to ensure good practice and a climate of reflective practice Ethics Policy will itself remain flexible and subject to updating as appropriate, and as our experience grows

6 Sources: The Nuremberg Code The Nuremberg trials of Nazi war criminals were held between The Doctors Trial involved 20 doctors and 3 officials accused of being involved in human experimentation in the concentration camps, and in conducting euthanasia programmes in hospitals and nursing homes. In their defence the doctors argued that there was currently no international law dealing with medical experimentation. As a result the Nuremberg Code was created - a 10-point list calling for voluntary consent and the avoidance of unnecessary pain and suffering in the conduct of research

7 Sources: The Helsinki Declaration Adopted in 1964 by the World Medical Association as a set of ethical principles covering human experimentation. Key articles are: Respect for the individual (Article 8). The right to self-determination and the right to make informed decisions (Articles 20-22). The duty of the researcher is towards the patient or the volunteer (Articles 2,3,10,16,18). The welfare of the participant must take precedence over the research (Article 9). Individuals or groups who are deemed to be vulnerable require special vigilance (Article 8). Even if consent is granted by someone else legally permitted to give it, the individual must still give their assent (Article 25).

8 Sources: The Singapore Statement Adopted in 2010 the principles and responsibilities set out in the Singapore Statement on Research Integrity represent the first international effort to encourage the development of unified policies, guidelines and codes of conduct, with the long-range goal of fostering greater integrity in research worldwide. PRINCIPLES Honesty in all aspects of research Accountability in the conduct of research Professional courtesy and fairness in working with others Good stewardship of research on behalf of others

9 Sources: Codes of Ethics Professional and Funding Bodies codes include: UK Research Integrity Office s Code of Practice for Research British Psychological Society uct.pdf Economic and Social Research Council Framework for Ethics Association of Business Schools Code of Ethics cs_guide_agm_version.pdf Royal College of Nursing Research Ethics Code data/assets/pdf_file/0007/388591/ pdf

10 Sources: Adherence to Legislation Data Protection Act (1998): covers the collection, processing and retention of personal data. Human Tissue Act (2004): covers the storage, use and removal of human tissue. All legal requirements must also be met around human rights, privacy, health and safety, and intellectual property.

11 2. Importance of Adherence to University Ethics Policy Protection for participants, researchers, and the University (insurance applies only to research that has received approval) Evidence of poor practice in the sector including increased number of retractions, scandals and increase in proportion of positive result publication over time Compliance a precondition for research funding Faculty approval is a University requirement for all research Avoidance of allegations of Academic Misconduct In summary, The Only Way is Ethics (TOWIE)

12 3. Ethical Risk Categories All research projects are categorised for their ethical risk through the approval process. Principal Investigators and Supervisors should suggest which band projects fall into at the time of submission: Red: Dealing with sensitive issues (e.g. Vulnerable individuals, Commercial Confidentiality); Intervention Studies (e.g. clinical / medical / physiological) Amber: Other research involving human participants Green: Secondary research on issue without ethical sensitivity Guidance on how to determine banding is found at: If in doubt, always presume the higher band

13 4. Approval Process Staff (Faculty and Service Departments) and Doctoral Students 1. Submit University Online Ethics Form 2. Include supporting documentation (e.g. Draft Organisational and Individual Consent Forms) 3. Approval considered as follows: If Green - Supervisor / Research Mentor / Module Tutor as relevant If Amber - One Independent Reviewer (e.g. Departmental Research Ethics representative or other member of Faculty Research Ethics Panel) If Red - Referred to Faculty Research Ethics Committee to be reviewed by two independent reviewers 4. Once approved proceed in line with Approval 5. Submit Project Amendment Form if making changes

14 Approval Process Engineering and Environment UG and PGT Students 1. Submit Research Ethics Registration and Approval form (see Appendix B of Faculty Research Ethics Guidance) to Supervisor with supporting documents: if Green, Supervisor approves if Amber, Supervisor refers to One Independent Reviewer for approval if Red, Supervisor refers to Faculty Research Ethics Committee to be reviewed by two independent reviewers 2. Reviewer(s) approve with or without conditions or seeks amendment 3. Once approved student proceeds in line with conditions of approval 4. Keep Evidence File including approval, consents, record of any adverse events 5. Submit Project Amendment Form to Supervisor if making changes 6. Include discussion of Ethics in Methods section / chapter 7. Include Ethical Approval documentation as an Appendix.

15 5. Key Provisions Informed Consent - Organisational Consent: Researcher must provide reasons for the research, resources / time / level of access required and what form of data / information. Organizational officers to give written consent and options re dissemination. - Individual Consent : Participants must be shown reasons for the research, potetnial outcomes and be given the option of anonymity. Individuals must indicate consent (normally in writing). Consent must be voluntary i.e. achieved without use of influence. Ensure that participants are aware of their right to withdraw at any time without prejudice. Comply with requests by participants who are withdrawing from research participation that their data is withdrawn, and any information that might identify them be destroyed.

16 Key Provisions (continued) Data Collection, Storage and Disposal - Security (Encryption for electronic / Lock and key for manual) - Coding (Each research participants to be coded if identifiers are collected these should be kept separately and securely) - Disposal or Retention (Retain if possible future use, otherwise dispose after appropriate period)

17 Key Provisions (continued) Safety - Of researcher (incl. Risk Assessment where any doubt) - Of participants Sensitivity - Specific Provisions re Vulnerable Individuals / Under 18s - Commercial sensitivity - Issue sensitivity Other bodies - Is external ethical approval required? If in doubt on any of the issues, refer to the University Ethics and Governance Handbook or seek advice.

18 Key Provisions (continued) Good Practice Debrief Research participants may be debriefed (using a debrief sheet) including: A summary of the aims and expected findings of the research. A reminder that the participant can withdraw their data. A reminder that some feedback can be provided. A reminder that the data will be kept confidential. Information on how the data may be disseminated. Information as to how they can register a complaint (contact details of the investigator, and/or Director of Research Ethics) if they feel that ethical guidelines have been broken.

19 6. Judgement Issues 1. Is this research? There are boundary cases (e.g. data may be collected purely for in-class) but in general any collection and analysis of data conducted by staff and students is research and requires ethical approval. 2. Greater Goods The University s rules (e.g. re parental consent, voluntariness) may be set aside if this is necessary for the achievement of a greater good outlined in the University s principles. This is rare and must be highlighted when approval is sought. 3. Compensation / Inducement. Participants may be compensated / entered in a draw etc; But a/ They must be advised that such income should be reported to relevant public authorities and b/ compensation must not suggest / induce particular responses.

20 Judgement Issues (continued) 4. Vulnerability? A range of factors should be taken into account to determine whether a potential participant is vulnerable (e.g. those listed in the handbook re medical history, housing status). If your research could produce such participants you need to take these factors into account to ensure that consent is voluntary and informed. 5. Risk Assessment? Where research environment subject to regulation (e.g. COSHH) or to be undertaken outside University premises then this should be subject to the University s Risk Assessment procedures: iskassess/?view=standard 6. Organizational consent? You should carefully consider whether an organization s conditions for consent are reasonable e.g. control over subsequent publication. If not, you may withdraw your offer to participate.

21 7. What next? 1. Project Amendment If you need to vary your data collection method or radically alter the nature of your research participants then you will need to seek approval for this revision. 2. Module Approval Where students participate in primary research within a module, staff may seek Module level approval through their Faculty Research Ethics Committee using the appropriate form from the Faculty Research Ethics pages. 3. Adverse Events If something goes wrong in the process of the research then you should report this using the Ethical Incident form (in Faculty Research Ethics pages)

22 8. Governance Faculty Research Ethics Committee - Ensures adherence to University Policy / Audits Process / Considers Red Cases - Comprises experienced research staff from each department and professional support - Academic members comprise panel to consider Ethical Approval - Reports to Faculty Research and Innovation Committee - Reports to Research Ethics Committee (University)

23 Governance (continued) Research Ethics Committee (University) - Ensures adherence to University Policy / Audits faculties / receives external audits / receives reports form Working Groups and Human Tissue sub-committee - Comprises representatives from each Faculty and Service, the Student Union and lay members. - Reports to University Research and Innovation Committee and Academic Board

24 8. Resources 1.Faculty Ethics Pages: 2.University Web Pages for Ethics and Governance 3. Ethics and Governance Handbook 4.Ethical Scrutiny and Risk Assessment Tool 5. Online Ethical Approval Form 6. Faculty Research Ethics Director: Paul Greenhalgh 7. Departmental Representatives: ABE: Graham Capper CSDT: Julie Horton GEO: Maureen Fordham MCE: Reaz Hassan (also nominated to sit on University REC) MIS: Sue Childs PEE: Hoa le Minh