Human Ethics Committees and related issues for Qualitative Researchers

1. Human Ethics Committees and related issues forQualitative Researchers Susan Quine School of Public Health October 2004

2. Improving the Human Ethics Process Open Forum Chaired by: Professor Tim Hurst Deputy Vice-Chancellor (Research and Innovation) Associate Professor Stewart Kellie Chair, Human Research Ethics Committee

3. Primary Aims • Protect the rights and welfare of research subjects • Protect the rights of researchers to conduct studies • Minimise the potential for claims of negligence against the researchers or the University

4. What needs Ethics Approval? • All research undertaken by Staff, Honours, Masters, Doctorate and other Higher Degree and Diploma students, involving humans which include… • The use of questionnaires/surveys or interviews; • Access to medical or other personal records; • Investigations of human behaviour; • Routine testing of human subjects; • The administration of drugs, ionising radiation, chemical • agents or vaccines; • Any other experimentation on human beings: • Must be submitted for the approval of the Human Research Ethics Committee.

5. What Type of Research needs Ethical Approval? • Questionnaires; • Surveys or interviews; • Telephone interviewing; • Recording by audio- or video-tape; • The collection of body tissues or fluid samples; • The administration of painful stimuli; • The administration of any substance or agent; • The trial of treatments or therapeutic techniques; • CTN or CTX trials of drugs or devices; • Contracted research.

6. Researcher Feedback Suggested Improvements • More timely advice and approval –review and expand on reasons for not approving protocols • Increased transparency of procedures and better dialogue between the Chair/Committee and researchers • Modify form to improve suitability for CHASS (College of Humanities and Social Sciences) researchers • Improve understanding/expertise on the Committee • Increased consistency of outcomes for similar protocols • Improve understanding of external regulations and requirements • Provide additional support to Faculties

7. Improvements Implemented • Additional resources for ethics administration within the Research Office • New database for approved protocols • New website with updated content • New form designed on a modular approach as a result of feedback from social science researchers

8. Proposed Timeline Dec 2003: Discussion with Social Science researchers Jan 2004: Open Forum Feb 2004: Recommendations to Ethics Committee March 2004: Implementation

9. Improvements • New web site with embedded guidelines and links to NHMRC websites. • Sample of documents e.g. Consent forms, Participant Information Sheet. www.usyd.edu.au\ethics\human

10. Application Form • Humanities application form is now 3 pages less than Medical application form, as sections on Research involving blood and tissues, and clinical trials excluded.

11. FROM 2005 TWO HUMAN ETHICS COMMITTEES • MEDICAL • HUMANITIES Both fully constituted

12. Committee Membership • Chairperson • Two lay persons, not medical, scientific, legal and not otherwise affiliated with the institution • At least one with research experience – health, medical, social, psychological or epidemiological • At least one involved in professional care, counseling or treatment – medical, clinical psychologist, social worker, nurse etc • At least one minister of religion or similar • At least one who is a lawyer

13. Medical Anything to do with health – clinical, allied health, qualitative inquiry into health issues. • HumanitiesCovers arts, education, social work and social policy, anthropology, sociology, history, geography etc.

14. Conducting Qualitative Research Position of Ethics Committee on: • Snowball recruitment • Incentives • Limits on telephone interviews • Home interviews • Focus questions

15. Recruitment Methodology:Snowball Recruitment This form of recruitment is acceptable only if it is in the passive form. That is participants may be asked to discuss the research with friends/contacts whom they think may be interested in volunteering to be participants. Those new participants should then contact the research team to volunteer. Active snowballing when participants volunteer their friends/contacts directly to the research team is not acceptable.

16. Incentives:Lottery Tickets Gambling tickets of any description are not allowed as inducements. Rewards/Expenses The Committee accepts that some form of recompense is often appropriate, but does not approve of lavish (or potentially lavish) rewards. Therefore lottery tickets or other gambling rewards are not acceptable. Theatre tickets or small cash gifts are acceptable but must not be advertised in any “flyers” for the research, except to say that expenses will be covered (if that is the case).

17. Data Collection:Telephone Interviews • Because telephone interviewing is an intrusiveresearch tool, the researcher will need to demonstrate to the Committee’s satisfaction: (a) Why it is the preferred survey methods and why other could not obtain the information less intrusive means, e.g. self-administered questionnaires. (b) If questions are of a sensitive nature, how it is intended to minimise the potential for psychological harm and what referral protocol exists for people who experience emotional distress resulting from the interview or the request for an interview.

18. Home Interviews or Research Only rarely will home visits be acceptable. Firstly there will need to be a well justified reason for the home visit which is required either by the nature of the research or by the requirements of the subjects. In most cases where there are such acceptable reasons the subject should have a friend/chaperone present and so should the researcher. This is to protect both the subject and the researcher from any charge of impropriety.

19. Focus Questions Where the research protocol uses focus questions to start off a self-generated response from participants, the focus questions must be submitted with the application. Brief superficial focus questions are not acceptable. The focus questions submitted must enable the Committee to appreciate the style and type of inquisition that the subjects/participants will undergo.

20. Opportunity to raise issues and/or questions Re: Conducting qualitative health research???