1. HREC Ethics in research

2. HREC Why have ethics reviews? The NHMRC Act (1992) requires all research involving humans to be subject to ethical review Curtin must, by law, have a Human Research Ethics Committee This Committee must comply with the guidelines in the National Statement on Ethical Conduct in Research Involving Humans (1999) The key tasks are to –review research proposals, –ensure research is soundly designed and –ensure research is conducted according to high ethical standards so the welfare of participants is protected.

3. HREC Why? Peer review before conducting research makes better research, protects all involved

4. HREC Responsibilities of HRECs HRECS should review activities with human participation or involvement that aim to establish facts, principles or knowledge or obtain or confirm knowledge AND where human involvement has potential for infringing basic ethical principles, at least: respect, beneficence and justice

5. HREC The potential for infringing basic ethical principles arises where human involvement could cause harm to physical, psychological, spiritual or emotional well being, exploit cultural knowledge, infringe privacy or confidentiality, or impose burdens with little benefit. Responsibilities of HRECs Colin Thomson, ethics consultant, NHMRC

6. HREC Core principles Integrity Respect for persons Beneficence Justice –Minimise risk and harm –Well-being takes precedence over benefits to knowledge

7. HREC Core principles The core principles are derived from the Belmont Report (1979) which was commissioned after the horror of the Tuskegee syphilis experiment was uncovered in 1972. Report author, Tom Beauchamp adds non- maleficence to his list. The Tuskegee study ran from 1932-1972. It recorded the physical changes in black people who had syphilis. When penicillin became available in 1947 as a cure, this was withheld from the study participants.

8. HREC Two-tier system 1.Is it minimal risk? –Form C 2.Does it involve more than minimal risk? –Form A Renewals and variations to protocol –Form B Form C is processed locally (Division, School) by an ethics coordinator. Details are recorded and forwarded to the HREC Form A is processed by the HREC, using a sub-committee review process before being reviewed by the full committee IF YOU DO NOT HAVE AN APPROVAL NUMBER, YOU CANNOT GATHER ANY DATA

9. HREC Applying for ethics clearance

10. HREC Minimal Risk Royal College of Physicians, London: “…the level of risk accepted in everyday life. E.g. measuring height, weight, collecting urine… “…where the level of psychological or physical distress is negligible… or where there is a very remote chance of serious injury or death, comparable to the risk of flying as a passenger on a scheduled aircraft…”

11. HREC Risk Cannot apply purely objective criteria. Different people interpret harm and risk in different ways. Risk of harm: –psychological, –physical, –privacy infringement, –“labelling” [reputation], –economic.

12. HREC Professional decisions on risk Deciding what constitutes minimal risk or unacceptable risk involves professional judgments Seek advice from experienced members in your discipline Put a case, share the thinking, agree, disagree Amend or defend your thinking where necessary This is core business for professionals. It is your responsibility to come to a shared understanding of acceptable risk in your area of research.

13. HREC The review process (non-minimal risk)

14. HREC Adverse events Any variation to the your protocol must be reported and approved before making the change. Any unexpected event with a potential impact on participants must be reported – as soon as it happens. –Stop gathering data, secure and make safe the site (where appropriate), report to Ethics Officer in Office of Research and Development.

15. HREC Adverse events

16. HREC Flowchart

17. HREC Common problems Data has been collected (retrospective approval not possible) Typography, grammar Research method (required to assess this NS.2.8) Recruitment of participants Participants’ rights and welfare Consent forms and information sheets Questionnaires and interviews Research involving minors Research involving indigenous participants Data storage Confidentiality of data Approvals needed from other HRECs

18. HREC Clear information It is vitally important that the people involved or likely to be involved understand clearly what is going to happen to them and their information. Website has samples

19. HREC Clear information

20. HREC Clear information

21. HREC Clear information

22. HREC Forms Form A Form C

23. HREC

24. Integrity and research misconduct Figure 1: Schematic overview for handling research misconduct www.nhmrc.gov.au/publications/_files/anderson2.pdf (Jan 2007)

25. HREC Curtin process This is a draft, not yet ratified. Curtin’s process will reflect the final version of the Australian Code for the Responsible conduct of research

26. HREC The ethical and legal responsibilities of researchers towards participants in research reflect basic ethical values of –respect for human beings, –justice, –research merit and integrity, –and beneficence. These values have a long history in western culture. –Minimise risk and harm –Well-being takes precedence over benefits to knowledge Core principles of ethical conduct From the Draft National Statement

27. HREC From the Draft National Statement Establishing research merit and researcher integrity are necessary for the ethically acceptable involvement of human participants in research. Human research that has no merit or is conducted without integrity uses human participants without ethical justification. Justice in the selection, recruitment and treatment of participants is essential to research that respects participants and benefits humankind. Researchers must find a justifiable balance between the benefits and the risks of participation. Researchers must consider carefully what is needed to respect participants.

28. HREC From the Draft National Statement Conformity with each one is necessary and, conformity with all of them is sufficient for that research to be judged ethically acceptable. No one of the principles or values can be used to negate the need to consider any of the others.

29. HREC Review panels Reviewers should consider themselves co-opted members of the Curtin HREC under Sections 2.8 and 2.9 of the current (2005) National Statement. They fill two roles: –Reviewing the ethics –Acting as scientific sub-committee if their expertise is appropriate

30. HREC Why HREC looks at methodology NS 2.8 “An HREC must ensure that it is sufficiently informed on all aspects of a research protocol, including its scientific and statistical validity, that are relevant to deciding whether the protocol is acceptable on ethical grounds and conforms to this Statement.”

31. HREC NS 2.8 relevant considerations The project Is there a clear hypothesis? Is the research question useful? Will the research yield new information, enhance understanding or clarify uncertainty? Is the research proposal supported by a systematic review of the literature? Have perspectives of participant groups been included in the research proposal? Are the aims clear? Is the value of the project adequate to justify conduct with humans?

32. HREC NS 2.8 relevant considerations The researchers Do the researchers have the necessary qualifications, competence and experience? Are there adequate arrangements to ensure that members of the research team are aware of relevant ethical and legal obligations?

33. HREC NS 2.8 relevant considerations The Funding What is the relationship between the source of funding and the aims of the project? Does that relationship have any implications for the ethical conduct of the project, especially the recruitment of participants, the character of information sought or the freedom to publish results?

34. HREC NS 2.8 relevant considerations Research methodology Are all aspects of the research methodology clearly described? Is the methodology appropriate to the achievement of the aims of the project? Recruitment Is it clear how participants will be recruited? Do recruitment methods respect rights to confidentiality? Are the proposed participants appropriate in number and kind?

35. HREC NS 2.8 relevant considerations The burdens of research Are the burdens and risks of research to participants clearly identified? Have measures been taken to minimise these? Does the balance between the burdens and risks to participants and the aims and benefits of the project warrant approval?

36. HREC NS 2.8 relevant considerations Incentives Are financial or other rewards to be given to participants? Are these of such a size and value that they may unduly influence the freedom of participants to withdraw or otherwise protect themselves from risk?

37. HREC NS 2.8 relevant considerations Consent Are the ways in which participants are approached clearly described? Is the information to be provided to potential participants adequate in content and appropriate in form? Do the methods of securing consent provide: –Adequate time to consider –Evidence that choices are understood –Sufficient opportunities to ask questions and reconsider

38. HREC Consent Participants must be able to make INFORMED consent To get informed consent: –Use plain, clear language –Give all relevant information –Participant must understand fully what will happen –Potential participants must be free to choose to participate or not (watch for power relations between researcher and subject e.g. teacher/student; doctor/patient…)

39. HREC NS 2.8 relevant considerations Discontinuing participation Are the ways in which participants are advised of their freedom to withdraw sufficient in terms of content and frequency?

40. HREC NS 2.8 relevant considerations Information protection Is it clear who will/will not have access to information gathered? Are storage and security measures adequate? Are participants clearly informed that the information they provide will be used ONLY for the project? How is confidentiality of information to be ensured? Are the manner and form in which results will be published clearly described?

41. HREC NS 2.8 relevant considerations Legal issues Does the project involve subject matter or conduct that may give rise to legal vulnerability for participants or researchers? Have adequate precautions been taken?

42. HREC NS 2.8 relevant considerations Legal issues. Does the research involve Children Intellectually or mentally impaired people (temporary or permanent) People highly dependent on medical care People in dependent or unequal relationships Collectivities Aboriginal or Islander people Take extra care for research involving: –Ionising radiation, assisted reproductive technology, clinical trials, epidemiological research, human tissue samples, human genetic research, deception.

43. HREC Care for culture Values and Ethics in Aboriginal and Torres Strait Islander health research: it would be worth adapting these principles for any culture you work with. –Reciprocity –Respect –Equality –Responsibility –Survival and protection –Spirit and integrity (http://www.nhmrc.gov.au/publications/_files/e52.pdf)

44. HREC Indigenous research: ideas for all cultures!

45. HREC Ideas for all cultures Respect Respect for human dignity and worth as a characteristic of relationships between people, and in the way individuals behave, is fundamental to a functioning and moral society. Within Aboriginal and Torres Strait Islander cultures respect is reinforced by and in turn strengthens dignity. A respectful relationship induces trust and co-operation. Strong culture is a personal and collective framework built on respect and trust that promotes dignity and recognition.

46. HREC Ideas for all cultures Reciprocity A mutual obligation exists among members of Aboriginal and Torres Strait Islander families and communities to achieve an equitable distribution of resources, responsibility and capacity and to achieve cohesion and survival of the social order. This mutual obligation extends to the land, animals and other natural elements and features. In contemporary settings In the research context, reciprocity implies inclusion and means recognising partners’ contributions, and ensuring that research outcomes include equitable benefits of value to Aboriginal and Torres Strait Islander communities or individuals. Reciprocity requires the researcher to demonstrate a return (or benefit) to the community that is valued by the community and which contributes to cohesion and survival. … In negotiating the conduct of research, Aboriginal and Torres Strait Islander communities have the right to define the benefits according to their own values and priorities. Benefits may not take only one form or be immediate. They must, however, be valued by the participating community.. The implications of reciprocity extend to all those involved in the potential research enterprise.

47. HREC Ideas for all cultures Equality One of the values expressed by Aboriginal and Torres Strait Islander Peoples and cultures is the equal value of people. One of the ways this is reflected is a commitment to distributive fairness and justice. Equality affirms Aboriginal and Torres Strait Islander Peoples’ right to be different. Equality as a value may sometimes be taken to mean sameness. However, Aboriginal and Torres Strait Islander Peoples hold strong beliefs that sameness is not equality. Aboriginal and Torres Strait Islander Peoples have sought the elimination of ‘difference blindness’ so that Aboriginal and Torres Strait Islander cultures can be appreciated and respected.

48. HREC Ideas for all cultures Responsibility –Central to Aboriginal and Torres Strait Islander societies and cultures is the recognition of core responsibilities. These responsibilities include those to country, kinship bonds, caring for others and the maintenance of harmony and balance within and between the physical and spiritual realms. A key responsibility within this framework is to do no harm, including avoiding having an adverse impact on others’ abilities to comply with their responsibilities. As well, one person’s responsibilities may be shared with others so that they will also be held accountable. –Researchers carry responsibilities in addition to the science of their inquiry. The nexus between their research and community life brings responsibilities for which they or those of the community with whom they work may be held accountable. Ethical research occurs when harmony between the sets of responsibilities is established, participants are protected, trust is maintained and accountability is clear.

49. HREC Ideas for all cultures Survival and Protection –Aboriginal and Torres Strait Islander Peoples continue to act to protect their cultures and identity from erosion by colonisation and marginalisation. A particular feature of Aboriginal and Torres Strait Islander cultures and these efforts has been the importance of a collective identity. –Aboriginal and Torres Strait Islander Peoples do not intend to forego the distinctiveness of their cultures. Barriers between research and Aboriginal and Torres Strait Islander Peoples have been created for example where some researchers or institutions have ignored or sought to undermine this distinctiveness. The repeated marginalisation in research of Aboriginal and Torres Strait Islander values has reinforced these barriers over time creating a ‘collective memory’ that is an obstacle to research today. Researchers…will need to demonstrate through ethical negotiation, conduct and dissemination of research that they are trustworthy and will not repeat the mistakes of the past. –As noted throughout, the distinctive cultures and community life of Aboriginal and Torres Strait Islander Peoples rests at the heart of these guidelines. It is, therefore, essential that researchers engage with Aboriginal and Torres Strait Islander communities collectively, not just with individuals.

50. HREC Ideas for all cultures Spirit and Integrity –This is an overarching value that binds all others into a coherent whole. It has two components. The first is about the continuity between past, current and future generations. The second is about behaviour, which maintains the coherence of Aboriginal and Torres Strait Islander values and cultures. Any behaviour that diminishes any of the previous five values could not be described as having integrity. –Aboriginal and Torres Strait Islander communities have demonstrated a continuity of values and bonds that has sustained and been sustained by the overarching value of spirit and integrity. … –Aboriginal and Torres Strait Islander communities are not homogeneous. However, there are core values and principles that remain common across the cultural spectrum …. –Researchers are perceived as owing an obligation to the spirit and integrity of communities not just to individuals. … –Community decision making based on shared values is an implicit part of spirit and integrity.