Human Research Ethics and Obtaining Ethics Approval Division EASS Autumn School Janet Bryan

Why we need to consider research ethics and obtain ethics approval UniSA Research Services: “It is important that research involving human participants is conducted in a way that protects all people involved in the research: the researcher, the participants of the research, and the University”

Useful resources for preparing your ethics application UniSA policy http://www.unisa.edu.au/policies/policies/resrch/res02.asp University Human Research Ethics webpage http://www.unisa.edu.au/res/ethics/human.asp National Statement on Ethical Conduct in Human Research (NHMRC, 2007) http://www.nhmrc.gov.au/publications/synopses/e35syn.htm Australian Code for the Responsible Conduct of Research http://www.nhmrc.gov.au/publications/synopses/r39syn.htm

Principles and Themes of Ethical Research

Principles of ethical conduct in research Research merit and integrity – research is valuable and is conducted with integrity Justice – provides a fair distribution of benefits and burdens of research Beneficence – minimise risk to participants Respect – regard for the welfare, rights, beliefs, perceptions, customs and cultural heritage of participants

Themes in research: Risk and benefit Potential benefits of research should justify any risks. Identifying risk: Does the research lead to harm (physical, psychological, social, economic or legal), discomfort or inconvenience? Gauging risk: What kind, severity and likelihood of harm, discomfort or inconvenience? Judgements should be made on available evidence.   Minimising risk: design the research aims and methods to minimise risk. Managing risk: include procedures for dealing with risk and for monitoring it during the course of the research.

Themes in research: Consent Informed Consent The provision of information about purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes so that an informed voluntary choice can be made Those not participating should be able to do so without consequence Consideration of the capacity to make a voluntary choice

Obtaining Ethics Approval

What requires ethics approval? Any research involving contact with human participants: Clinical research Research involving data collected by interviews, questionnaires, focus groups, observation Action research projects Use of human tissue Access to medical or other records which are not publicly available, which identify individuals and which contain personal information

How to obtain ethics approval UniSA has 2 levels of ethics committees, the University Human Research Ethics Committee (HREC) and Divisional ethics committees (DEASS HREC)

DEASS HREC DEASS HREC website: http://www.unisa.edu.au/easacademicservices/committees/ethics/ Assesses the majority of Honours and Masters by Coursework student application Submission made any time but check meeting times Note the recess from 7th-25th July. Deadline before recess is Tues 10th June Submission via email to: lianne.quin@unisa.edu.au

University HREC UniSA Ethics committee website: http://www.unisa.edu.au/res/ethics/human.asp Note meeting and submission dates The information and forms required to submit an ethics application are the same for both Div and Uni committees

Preparing an ethics application Use the following: The Guidelines for Preparing Ethics Protocols is very useful as it takes you through the completion of an ethics application step-by-step The Ethics Protocol Proforma which contains the coversheet, checklist and proforma.

Ethics coversheet Records contact details of the researcher (you), the title of your project and supervisors signature Note that supervisors are responsible for signing to say that they have read the application and they think it is completed in accordance with UniSA’s protocol guidelines

Ethics checklist Identifies any issues that need to be approved by the University HREC rather than the Divisional Ethics Committee. Covers things like: The nature of the sample Risks to participants and researchers Variations to the consent procedures the type of methodology used Whether other organisations will be involved Reporting procedures Payment of participants. If you answer “yes” to any of these questions it will most likely need to be approved by to University HREC

Ethics proforma Write in plain English Answer the questions! Remember the ethics committee is assessing your project with regard to the principles and themes for ethical research Number your responses in line with the numbering on the proforma If multiple ethics approvals required, don’t use another organisation’s proforma

Section 1. Research Aims 1.1 Aims of research, what you project is aiming to do 1.2 The need for and value of the research: Research involving humans must be valuable and the value should outweigh risks.

Section 2. Research Methodology 2.1 Research questions and hypotheses 2.2 Outline design and methods. Committee needs to ensure your methods will produce valid results. Include all copies of research tools 2.3 Indicate whether your project is part of a larger one

Section 3. Research participants Participants must be volunteers, free to choose without consequence, must be fully informed, Student participants must not be subjected to academic, personal or financial pressure. UniSA procedures on gaining approval to access research participants: www.unisa.edu.au/res/ethics/human.asp#access

Research participants 3.1 Who will be approached/recruited. How many? The number of participants should be justifed 3.2 Selection and exclusion criteria. These need to be justified to ensure equality of participation 3.3 How will participants be recruited? Provide copies of advertisements, flyers etc.

Research participants 3.4 How you will provide detailed information about your study to participants? The information Sheet provides all information required for participants to make informed consent. Refer to guidelines for Information Sheet 3.5 How you will obtain consent. Usually by requesting a consent form be signed, use Consent Form template. Signing signifies participants know what’s expected, what potential risks are, that they are free to withdraw without prejudice. Return of anonymous questionnaire also signifies consent.

Research participants 3.6 Acknowledge any unequal power relationship with you as a researcher and detail how you will reduce the obligation to take part. 3.7 How will participants’ confidentiality be preserved? Separate identifying information from data as soon as possible 3.8 Identify any potential risks and detail how these will be minimised.

Research participants 3.9 Indicate how any safety implications for the researcher will be addressed. 3.10 Detail and justify any reimbursement for participation. Can be reimbursed for costs of travel, parking and other expenses incurred due to participation.

Section 4. Recording, reporting, storage and access to data and results 4.1 Describe how data will be recorded. Need explicit consent to audio or video record (include on consent form) 4.2 Describe how, where and in what form data will be stored. Data must be securely stored for 7 years 4.3 Specify who will have access to the data. Data must not be used and disseminated in any way not agreed upon by participants.

Section 5. Ownership of research 5.1 Detail who will own the data. Students normally own the data they collect. Authorship may be shared, must reflect the proportion of work undertaken.