Institutional data, headers etc Building an ethical research culture Institutional data, headers etc A presentation by deputy presiding officer of the CSU HREC Dr Asim Qayyum

Why review human research

What does the word ETHICS mean to you? Are people blind to ethical concerns? Have we always been blind to ethical concerns? In the comments, what does ethics mean to you? Thumbs up or down – are people blind to …. Thumbs up or down – do you think we’ve been blind to ….

Why do we review ethics? To consider ethical issues that arise in a specific enquiry scenario To respect and protect those who assist us in our research projects To ensure integrity of data To think ethically about unique issues that emerge through research To consider animals and the environment To consider the vicarious liability of the institution we work for In the comment box, let me know some thoughts about why you think we need to review ethics?

Individual researcher’s responsibilities Good research and good ethics go together Investigators have direct and ultimate responsibility for all matters relating to their research MUST obtain written approval before commencing each project MUST comply with directions of the Ethics Committee

Individual researcher’s responsibilities MUST comply with the appropriate Code of Practice Must consider other requirements, e.g. Working with Children Check Should consider dependency issues: staff using students as participants; practitioner versus researcher

Ethics sharpens your research project Rigor and validity enhanced by the processes Helps you develop analytical skills Learn to map the geography of your research plan – all ducks line up Every person-facing event (who) in your plan appears in your Human Research Ethics Application (HREA) Each stage (where and why) considers the ethical implications You demonstrate that each strategy and idea (how) affecting participants has been addressed in your HREA Ask yourself - Who, where, why and how

The burgeoning world of ethics Ethical imperialism – or increasing complexity in research methodologies and possibilities Vulnerable people, marginalised groups, Online content, social media, anonymous surveys, chat rooms, survey monkey, use of employer time and resources Classrooms, sporting groups, entering homes, home offices and studios

Principles underpinning the NS Tolerate and not resist ambiguity, disagreement, re- direction

The 4 values of the National Statement Beneficence (NS 1.6 – 1.9) Includes Risks: Justified by benefits Minimised Clarified to participants Respect (NS 1.10 – 1.13) includes: Welfare Confidentiality, privacy Consent – waiver, deception, coercion Form/s of consent Information Sheet/s Research Merit and Integrity (NS 1.1 – 1.3) includes: Evaluation of scientific or academic merit Genuine search for truth Dissemination strategies Justice (NS 1.4 – 1.5) Recruitment Benefits of participation Feedback to participants In the comments, what does ethics mean to you? Thumbs up or down – are people blind to …. Thumbs up or down – do you think we’ve been blind to ….

Assessment of risk involves: NS, Chapter 2.1, Risk and Benefit [quoted text is from pp. 12 – 14 of the NS] Risk = likelihood of harm, discomfort and/or inconvenience + severity and consequences of harm, discomfort and/or inconvenience Assessment of risk involves: Identifying, gauging probability and severity, management and minimisation, Must be justified by the potential benefits of the research; Engagement with researchers, institutions and HRECS.

Components of an ethics application: A Project Description [template available] A completed HREA An Information Sheet/s A Consent Form/s Pro formas for Information Sheets and Consent Forms Copies of any advertisements, recruitment posters/emails/letters, etc. Copies of interview questions, or of the survey/questionnaire to be used

Ethical review of research at CSU One HREC, two fully-constituted panels; one Presiding Officer, two Deputy Presiding Officers. All applications for ethical review should be submitted to the CSU Human Research Ethics Committee (HREC). [No minimal risk review pathway.] The HREC meets every two weeks – meeting dates and agenda closing dates

The HREA review process Researchers may have their application approved at the meeting be asked to resubmit have their application approved pending satisfactory responses to questions/ comments, with members designated to check (outside meeting) Have their research rejected Approval is granted for the length of the research, subject to annual review If research is varied the variation needs to be approved by the HREC Researchers submit final reports

Ethical review of research at CSU Data collection must not commence until HREC approval has been received. Research activity may constitute misconduct if not conducted within boundaries approved by CSU HREC. Retrospective approval CANNOT be given by a HREC. Lots of information

Ethical review of research at CSU Hints and Tips: Check that information is consistent across all documents before submission. Where projects involve different groups of participants and they are being asked to do different things, there should be a different Information Sheet and Consent Form for each group. Where projects involve collecting data from someone in their capacity as an employee of X, permission from X must be obtained before seeking consent from the employees (and evidence of that permission submitted with the ethics application).

Ethical research with Indigenous communities https://aiatsis.gov.au/sites/default/files/docs/research-and-guides/ethics/gerais.pdf Principles of ethical research Principle 1: Recognition of the diversity and uniqueness of peoples, as well as of individuals, is essential. Principle 2: The rights of Indigenous peoples to self-determination must be recognised. Principle 3: The rights of Indigenous peoples to their intangible heritage must be recognised. Principle 4: Rights in the traditional knowledge and traditional cultural expressions of Indigenous peoples must be respected, protected and maintained. Principle 5: Indigenous knowledge, practices and innovations must be respected, protected and maintained. Principle 6: Consultation, negotiation and free, prior and informed consent are the foundations for research with or about Indigenous peoples.

Ethical research with Indigenous communities Principle 7: Responsibility for consultation and negotiation is ongoing. Principle 8: Consultation and negotiation should achieve mutual understanding about the proposed research. Principle 9: Negotiation should result in a formal agreement for the conduct of a research project. Principle 10: Indigenous people have the right to full participation appropriate to their skills and experiences in research projects and processes. Principle 11: Indigenous people involved in research, or who may be affected by research, should benefit from, and not be disadvantaged by, the research project. Principle 12: Research outcomes should include specific results that respond to the needs and interests of Indigenous people. Principle 13: Plans should be agreed for managing use

Key Contacts Dr Anna Corbo Crehan acorbocrehan@csu.edu.au (Presiding Officer) Dr Ann Lazarsfeld-Jensen alazarsfeld-jensen@csu.edu.au (Deputy Presiding Officer) Dr Asim Qayyum aqayyum@csu.edu.au (Deputy Presiding Officer) Ms Kate Organ korgan@csu.edu.au (Ethics and Compliance Unit) Ms Ellen Hannigan ethics@csu.edu.au (HREC Governance Officer)