The Social Science Human Research Ethics Committee

1. The Social Science Human Research Ethics Committee Dr Douglas Colbeck CHAIR - SSHREC

2. Session Overview What is Human Ethics in the Research Context? • Some definitions, documents and policies Application Review Process • An overview of the minimal risk application form and key points to consider when linking this form with a research plan Undertaking Research Outside Australia • Trying to conduct research in a rapidly changing environment Ensuring Consent is Truly Informed – a Focus on Social Media Based Research • Trying to conduct research in a rapidly changing environment Research Data Management • Hints, tips and policies Discussion & Questions • Question time - responses to any specific questions you may have

3. What is Human Ethics in the Research Context?

4. What is human ethics in the research context? • (NS) Human research is conducted with or about people, or their data or tissue. Human participation in research thus includes (broadly): • Surveys, interviews, focus groups, etc. • Testing or treatments (e.g. medical, psychological) • Observation • Use of tissues, blood, organs, etc. • Use of personal information • HRECs = ‘protect the rights and welfare of participants by considering the ethical implications of research proposals involving human participants and approve ONLY those that conform to the National Statement’

5. So what is an HREC? • NS mandates the composition and responsibilities of all HRECs (NS 5.1.24 – 5.1.37) • Minimum membership = 8 men & women from 6 categories (NS 5.1.30): • Chair (1) • Lay people (2) (1 male & 1 female) • Knowledge of & current experience in the care of others (1) • Pastoral role in the community (1) • Lawyer (1) • Experienced researchers in relevant areas (2)

6. HRECs have a triple role • Participants: need protection against involvement in inappropriate research • Researchers: need protection against research misconduct claims • Assuming actual research activities ≡ those approved by the HREC • Sponsoring institutions: need protection against research misconduct claims • And assurance their researchers are not in breach of WHS regulations, insurance policies, etc.

7. The National Statement Sets national standards for the design, review & conduct of human research by applying the principles of: • Research merit & integrity • Justice • Beneficence • Respect for human beings These guidelines apply to all university, hospital, government agency ethics committees http://www.nhmrc.gov.au/book/national-statement-ethical-conduct-human-research

8. Standards and Legislation • Other standards and legislation relevant to the conduct of research: • Privacy guidelines • Guidelines under Section 95A of the Privacy Act* • Guidelines under Section 95 of the Privacy Act* • Privacy Act 1988 • Tasmanian Personal Information Protection Act 2004 • Aboriginal and Torres Strait Islander Peoples • Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC 2003) • Guidelines for Ethical Research in Australian Indigenous Studies (Australian Institute of Aboriginal and Torres Strait Islander Studies, revised 2/E 2012) * Amendments as at March 2014

9. Application Review Process

10. Applying to the SSHREC • Step 1: visit the HREC website and determine whether you should complete a Low Risk or High Risk/Full Committee application. • Step 2: download the appropriate forms and work with your supervisor/s to complete the application form and other required documents (e.g. information sheets, consent forms, and data collection instruments – questionnaires, interview schedules, etc.) • Please make sure you use the latest version from the web – we upgrade these forms regularly • Step 3: submit all documents to human.ethics@utas.edu.au • you will be advised of its status by the HREC Ethics Executive Officer • Deadlines: • If you require a Low Risk application, your application can be submitted to the HREC at any point in time • these are reviewed by the Chair out of session on an on-going basis • If you require a Full Committee Application, look at the deadlines for submission to SSHREC Committee Meetings

11. The HREC Website http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu/human-ethics/human-research-ethics-review-process/social-sciences-hrec/forms

12. Low Risk Applications • Title • Dates • Investigators • Purpose • Outline • Aims, justifications • Review of ethical considerations • A tick in any of these boxes means a full application required • Funding • Participants • Data source/identifiability • Literature • Procedures • Monitoring • Data storage • Information sheet • Consent form • Other approvals • Declarations

13. Full Applications • Title • Dates • Investigators • School approval • Other approval/s • Follow up of previous study • Funding • Keywords • Rationale and background • Participants • Selection/Recruitment • Data source/identifiability • Privacy • Procedures • Data • Disclosure/consent • Reimbursement • Intrusiveness • Benefits/risks/harms • Monitoring • Feedback • Data storage • Others • Declarations • Checklist/attachments

14. SSHREC: Lifespan of a full application • Average time to approval: 36 days Week 1 Week 2 Week 3 Week 4 Week 5 Submission date Agenda to members Feedback to researchers SSHREC meeting Approved Revisions to Chair or Executive Officer Revisions to Committee Not approved Outcomes: Approved out of session

15. Ethics Approval • Projects are approved for 4 years, conditional upon: • Submission and approval of an annual report; • Notification and approval of any amendments using the Amendment form; • Submission of a Final Report form if the project is completed or discontinued; and • Submission of an Extension request form to extend ethics approval beyond 4 years • Submit an amendment if you are: • Modifying the research team structure • This includes changes to supervisory panels • Changing research designs • Or revising a survey or interview protocol … • Applying an existing research design to new or extended participant groups • Extending your project’s duration

16. Application review Process • Minimal risk research is the dominant level or research at UTAS

17. Minimal Risk Application (1) • Title of proposed investigation • Pragmatic – and reproduced on all public documents (information sheets, consent forms, email invitations etc. • Expected commencement date: • Dated after expected date of ethics approval – not project start date (because you can’t commence any research before obtaining ethics approval) • Investigators: • D. Conflicts of Interest • even if you only think you might have a conflict, indicate it and then discuss how it might be managed! • Purpose • Simple checkbox response • Brief Outline of Proposal • Aims – what is it you intend to achieve by doing this research • Justification – why should you be allowed to conduct this research

18. Minimal Risk Application (2) • Review of Ethical Considerations • Tick any “yes” box in this section and you may find yourself having to complete a full committee application – BUT – justify why you have ticked yes and you might still be granted approval depending on the information you provide • Funding • Applicants always miss the second part of this question “please indicate how any costs of the research will be met” • Participants • Selection of participants – age groups, gender, number – WHY? • Recruitment of participants – detail the process you have in mind to contact, provide information and hopefully recruit participants • Data Identifiability • Considered at the point of collection – not what you are going to do with it

19. Minimal Risk Application (3) • Relevant Literature References • This section you can cut & paste ok? • Recent and relevant references that hopefully you refer to in the body of the application • Procedures • Detail, detail, detail • Monitoring • Team meetings – how often, reporting to SSHREC – how often, reporting of adverse events - when • Data • Collection – tick yes – then you need to submit a privacy form – not common • Storage • Where – USB’s in purses or bags – NO. Password encrypted files on a UTAS laptop - YES • Under your pillow – NO - Data encrypted files accessible by password, locked filing cabinet on UTAS premises (where?) – YES • Data will be stored for 5 years after the first date of any publication. It will then be shredded (paper) or deleted from all hard-drives and servers (electronic)

20. Minimal Risk Application (4) • Consent • Opt-out approach • Waiver of consent • Information Sheet and Consent Form • Approvals from other Departments / Institutions • Yes/No • Does this project need the approval of any other HREC? • Researching into mainland schools or other institutions • Declarations • Signatures – final documentation must be signed off • Checklist • USEFUL TOOL – use it!

21. Checklist Tool • Telephone preambles • Email invitations • Information sheets (always need to have an appropriate institutional letterhead) • Consent forms (always need to have an appropriate institutional letterhead) • Questionnaires (not draft format) • Interview schedules (and interview questions) • Copies of permissions / letters of support …

22. Undertaking Research Outside Australia

23. Undertaking Research Outside Australia • Offshore research might have legal, social or cultural implications which would not be an issue if the research was carried out in Australia. Researchers are responsible for ensuring that research conducted offshore is culturally appropriate and complies with the legal requirements of the overseas country and complies with Australian ethical standards. • Overseas research might involve Indigenous people. As with research involving Australian Aboriginal and Torres Strait Islander people, you should ensure that your proposed research is culturally appropriate by consulting with representative bodies. • Approval of your research by UTAS SSHREC ensures that you will be appropriately covered by the University's insurance policy for research that you conduct offshore.

24. An exemplar response • “As these interviews will include research participants based in other countries (predominantly the United States and Canada), the project’s investigators have reviewed Chapter 4.8 of the National Statement on Ethical Conduct in Human Research as well as the Policy for Protection of Human Research Subjects in the U.S. and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans in Canada. No additional ethical approvals processes were found for these countries. However, as explained in section 4.8.19 of the National Statement on Ethical Conduct in Human Research, to ensure the student researcher’s commitment to beliefs, customs and cultural heritage of the participant, part of the recruitment process will include asking the research participants to identify any cultural differences that may need to be accounted for (by the researcher and/or participant). These professionals will be in a better position to highlight any significant cultural issues relating to preparation and organisation of the interview process and the research questions outlined in this study.”

25. Some key points when considering offshore research • 4.8.1 Must comply with the Australian National Statement • 4.8.2 Local cultural values must be acknowledged • 4.8.4 Researchers need to know and then inform the SSHREC if there are any ethics processes in their target country, how they function and whether they require reporting of the SSHREC’s approval • 4.8.9 Researchers should inform te SSHREC of any offshore co-researchers or research assistants, how they are involved, their level of expertise relevant to the project and that they will conduct themselves as required by the National Statement • 4.8.21 Processes for recruiting participants are respectful of their cultural context • Researcher safety if conducting research activities in an other country – even if the researcher is an expat.

26. Ensuring Consent is Truly Informed A Focus on Social Media Based Research

27. Respect for human beings • Respect (NS 1.10) for a person to consent • Voluntary • Informed • Considerations • Communication • Mutual understanding • No coercion or pressure (NS 2.2.9) • Payment for participation (value for effort) • Does not always need to be a written document … • Interviews – • consent can be recorded or • verbal consent given so that the interview might proceed • Surveys could have an information sheet at the start, and the survey should end with a statement such as, ‘Submitting this survey implies your consent for the information you have provided to be used in this research’.

28. Consent • One of the most important considerations when researching humans (NS 2.2) • Voluntary participation, based on sufficient information (p.20) • Coercion and unequal relationships • (NS 4.3 – where one party has a position of influence or authority over the other) • A frequent issue for education researchers – must be taken seriously! • Implied consent (e.g. filling in a questionnaire assumes consent) • Declining / withdrawing consent (must not involve adverse consequences) • Renegotiating consent over time (e.g., longitudinal study) • Reimbursement (should be proportional to time/energy involved) • Giving consent for others (e.g. parents, carers) • Limited disclosure consent (e.g. observing behaviours in public)

29. Social Media and Issues of Consent • In recent years the number of people engaging with social media has exploded. Social media platforms are now utilised as key locations for networking, socialising and importantly, for reflecting on all aspects of everyday life. • Such online spaces therefore hold vast quantities of naturally-occurring data on any number of topics, from consumer behaviours, to attitudes towards pro-environmental policies, to political views and preferences. • This provides researchers with a huge opportunity to gather data that would otherwise have taken much time and resource to obtain.

30. Key areas of concern One of the biggest areas of concern with social media data is the extent to whether such data should be considered public or private data. This is governed by: • End user agreements / terms & conditions • Determined by user online settings • The expectation of privacy • Data containing data from people from broader networks (postings)

31. Informed consent • Informed consent is a critical component of the ethics of all types of research. In more traditional research approaches, informed consent is usually built in to the research design, for example in the form of consent forms or boxes to be ticked and signed on questionnaires. • In many cases, a social media user’s data is accessed and analysed without informed consent having first been sought. • it is tempting to conflate a social media user having agreed to the terms of conditions of the platform (many of which include clauses on the accessing and re-use of data by third parties) with informed consent in research – problematic especially given that many social media users report not having read the terms and conditions properly. • Anonymity is a key consideration in research ethics, particularly in qualitative research practices or when data sets are shared outside of the original research team. When working with social media data, however, anonymising data is more complex.

32. Social Media Ethics Framework 3.1 Terms, conditions and legalitiesBefore considering other aspects of the ethics of your social media project, it is important to consult with all other relevant terms, conditions and guidelines. Firstly, you should carefully read through all of the relevant terms and conditions of the platform(s) that you will be using to obtain your data. These terms and conditions will include those aimed at users, and might also include those aimed at third parties wishing to access data from the platform. 3.2 Privacy and RiskThe next task in working through the framework is to determine whether the data you wish to access is really public, and if it is not to decide how - or indeed if - to proceed. The question as to whether to consider social media data as private or public comes down, to some extent, to whether or not the social media user can reasonably expect to be observed by strangers 3.3 Re-use and Re-publication When reporting your findings, do you want to use units of data (such as individual tweets or Facebook postings, or Instagram images with corresponding text) to illustrate the themes that have arisen in the data? If so, you need to refer to Sections 3.1 and 3.2 in deciding whether it is ethically sound to do so. (http://www.gla.ac.uk/media/media_487729_en.pdf)

33. Case Study 1: • Context: The researcher wishes to study support mechanisms between members of a discussion forum which deals with mental health issues such as depression and feelings of suicide. The forum is a closed forum which is password protected and registration must be approved by a gatekeeper (a site admin). • Concerns: The researcher is aware that this data is private – there is a high expectation of privacy on behalf of the users who feel it is a safe space where they will only be conversing with other people in the same situation. This raises questions about the ethics of accessing the data, and how to report the findings of the data if it is accessed. • Solution: The researcher needs to treat this data as private and sensitive. In order to access the data, the researcher should consider seeking consent from the gatekeeper of the community (site admin), who might seek the approval of the group more widely before deciding. Once consent has been granted the researcher might wish to make themselves known to the community, and give participants the right to opt out (so that their data is not republished or analysed). The gatekeeper might grant the researcher access to a certain area of the site, and retain a ‘safe’ space to accommodate community members who are not comfortable with the researcher’s presence. If the researcher wishes to republish certain units of data in order to illustrate their research findings, it is ethical to seek informed consent from each forum user whose data will be republished. Community members should be fully anonymised in any research outputs.

34. Case Study 2 • Context: A researcher wishes to study pro-legalisation narratives on marijuana use. The data will be collected from Twitter, so it is open public data. The researcher will gather data over the last 7 days posted with the hashtags #cannabis, #legalize and #ismokeit. • Concerns: Firstly, the subject matter is sensitive because it refers to an activity that is still illegal in Australia. Secondly, there may be users under the age of 18 contributing to the debate. Therefore, the researcher must work out how to handle the data in terms of protecting anonymity. • Solution: the researcher decides that the data is public, because it is posted on Twitter, a platform on which the default setting for posts is public; most profiles are set to public and can be viewed and followed by anyone. Furthermore the use of hashtags implies that platform users are keen to contribute to a community or debate and therefore expect an even greater number of people to see their data. The subject matter is sensitive though, and there could be children contributing data, so there is considerable risk of harm. The researcher decides it is ok to access the data and present results from aggregate data, but it is not ok to publish a data set (prohibited by Twitter anyhow) or republish direct quotes which will lead interested parties to the user’s profile, hence compromising anonymity. The researcher will therefore present paraphrased quotes (removing ID handles) to reflect the themes that emerge, and provide details on how interested parties might recreate the data search for themselves. Some direct quotes may be used with informed consent from the platform user, but the researcher knows he must take steps to ensure that the user is over the age of 18.

35. Case Study 3: • Context: A researcher wishes to study public interactions on a dating platform such as Tinder. Although the posts under scrutiny are public, rather than through private messaging, she needs to sign up to Tinder to view them. By signing up, she has to fill in a registration form including questions such as “I am a woman looking for a man/woman” etc. It is therefore reasonable to think that users of the platform expect that other people viewing their profile might be doing so for similar (dating) reasons. The researcher is also aware that there may be people under the age of 18 using the platform. The users of the platform are aware that there is a very large number of people using the platform and potentially able to access their profile. • Concerns: Firstly, can the researcher ethically access and re-publish this data, given that the users of the platform have a reasonable expectation that people seeing their data are likeminded (i.e. using the platform for similar reasons)? Secondly, is there a chance that vulnerable people (such as children) could be using the platform? Thirdly, is the data likely to be sensitive? • Solution: the researcher decides that, although the platform users may expect others viewing their profile to be like-minded, they will be expecting strangers to view their profile – so the data is not private. There is however a chance that children could be using the platform, and the data is potentially sensitive (e.g. underage children engaging in sexual talk or activity, people looking to engage in extra-marital relationships etc.). The researcher therefore can access and analyse the data, but needs to be careful with re-publishing. She does not publish the data set, and when writing up her results she only uses quotes that are paraphrased (and she is sure cannot be used to identify the platform user). Consent to use data is problematic here because the platform is popular with those under the age of 18, who may be dishonest about their age or use a misleading photograph.

36. Research Data Management

37. Retain research data and primary materials • When considering how long research data and primary materials are to be retained, the researcher must take account of professional standards, legal requirements and contractual arrangements. • Researchers should retain research data and primary materials for sufficient time to allow reference to them by other researchers and interested parties. For published research data, this may be for as long as interest and discussion persist following publication. • Research data should be made available for use by other researchers unless this is prevented by ethical, privacy or confidentiality matters. • Research data should be retained for at least the minimum period specified in the institutional policy. • If the results from research are challenged, all relevant data and materials must be retained until the matter is resolved. Research records that may be relevant to allegations of research misconduct must not be destroyed. • The institutional policy on the secure and safe disposal of primary materials and research data must be followed.

38. Manage storage of research data and primary materials • Researchers must manage research data and primary materials in accordance with the policy of the institution. To achieve this, researchers must: • Keep clear and accurate records of the research methods and data sources, including any approvals granted, during and after the research process. • Ensure that research data and primary materials are kept in safe and secure storage provided, even when not in current use. • Provide the same level of care and protection to primary research records, such as laboratory notebooks, as to the analysed research data. • Retain research data, including electronic data, in a durable, indexed and retrievable form. • Maintain a catalogue of research data in an accessible form. • Manage research data and primary materials according to ethical protocols and relevant legislation.

39. Maintain confidentiality of research data and primary materials • Researchers given access to confidential information must maintain that confidentiality. • Primary materials and confidential research data must be kept in secure storage. • Confidential information must only be used in ways agreed with those who provided it. • Particular care must be exercised when confidential data are made available for or used in discussion. • http://www.utas.edu.au/__data/assets/pdf_file/0004/411997/Management-of-Research-Data-Policy.pdf

40. Storing your research data - Requirements • Drawn from and consistent with the Australian Code for the Responsible Conduct of Research (section 2.5): • Ensure that where possible your data is stored on the UTAS cloud or physical servers • Research data must be stored for a minimum of 5 years. However, for most clinical trials, retaining research data for 15 years or more may be necessary. For further specific details refer to the Australian Code. • Have an end of life plan for your data – or – a plan for data archiving • Responsibility for storage rests with the school/unit where the data was generated. • Wherever possible original data should be retained by the school/unit. • All researchers may and should hold a copy of the data. • Storage must be secure to ensure that access to data is appropriately restricted. • Understand who might have access and under what conditions you would permit that access • Data must be stored in a durable format.

41. Storing your research data - Guidelines • To assist researchers in the appropriate storage of material: • Magnetic media are not stable and data should therefore not be stored on magnetic computer discs or hard drive. • Personal USB drives should not be used • CDs/DVDs are an acceptable hard format alternative. • Audio or video tapes should be transcribed and the transcript retained as an additional method of safeguarding their contents. • Where audio or video tapes are to be retained as research data (with the consent of research participants) they should be appropriately stored to minimise the risk of corruption.

42. Discussion & Questions

43. Common HRE Problems • Not recognising that ethics approval is required! • Rushing to get ethics approval and handing in an application which has not been thought through • Not leaving enough time to obtain ethics approval before the research needs to start • Not seeking advice / involving your supervisor in the process

44. When in doubt – ask! • I’ve been told by some HDR candidates that they “are not allowed to talk directly to the HREC” about their projects! • This is definitely NOT the case – the HREC staff are very happy to discuss your application queries ahead of time • It’s much, much, much, much faster (for everyone) to: • Write an email / make a phone call (to Executive Officer or the Chair) to ask about some aspect of your ethics application • Than - to submit an application which comes back for changes • PLEASE ASK! Or even look up the FAQ http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu/human-ethics/human-research-ethics-review-process/social-sciences-hrec/faqs-social-science-hrec

45. Questions?

46. Thankyou to those that stayed awake