1. Ethics in Human Research The notion of informed consent and the HREC review process

2. RMIT University SET- Barbara Polus/Diana DonohueSlide 2 Informed Consent Informed consent is the central ethical principle for conduct of research involving Humans It is founded on the doctrine of respect for the person and the principle of autonomy Autonomy (self determination) –The individual is the rightful determiner of her life and what should / can be done to her

3. RMIT University SET- Barbara Polus/Diana DonohueSlide 3 Informed Consent Two essential requirements that allow a person to give informed consent –Adequate information –Voluntary choice

4. RMIT University SET- Barbara Polus/Diana DonohueSlide 4 Informed Consent and Research – A case Study(1) A chemistry student (RMIT U) was asked to analyse blood samples provided by the RCH using a different method to that used by the RCH The aim of the study – a comparison of the 2 methods The student was given 20 samples – labelled 1 to 20 (non-identifiable data) Blood analysis was completed and study samples and results returned to the RCH

5. RMIT University SET- Barbara Polus/Diana DonohueSlide 5 Informed Consent and Research – A case Study (2) Ethical issues associated with this research project –For the RMIT student The research involves the use of existing collections of data that are non-identifiable The obligation for obtaining consent rests with the RCH where the consent must include consent to use of the tissue in future related research This research is of negligible risk

6. RMIT University SET- Barbara Polus/Diana DonohueSlide 6 Informed Consent and Research – A case Study (3) For the RCH –The blood samples are re-identifiable –The obligation for obtaining consent rests with the RCH where the consent should include consent to use of the tissue in future related research –This obligation includes providing information to participants that allows for adequate understanding of the research including future use of data –The consent may also need to include permission to enter original tissue into a data bank

7. RMIT University SET- Barbara Polus/Diana DonohueSlide 7 Informed Consent and Research – A second case Study The US military conducted a research project in Thailand where local peoples were invited to act as research participants Participants were offered money to allow themselves to be bitten by malaria-carrying mosquitoes While the mosquito was biting, the participant was to catch the mosquito so that the mosquito’s blood could be tested

8. RMIT University SET- Barbara Polus/Diana DonohueSlide 8 The Mosquito Study Mosquito blood was analysed by the US military RMIT staff subsequently received analysed data from the US military They performed geographical studies with the aim of determining the distribution of malaria infected mosquitoes in Thailand What are the ethical issues associated with this research?

9. RMIT University SET- Barbara Polus/Diana DonohueSlide 9 Ethical issues Associated With The Mosquito Study These are 2 studies –Study conducted by the US military –RMIT staff study US military study –Questionable ethical practice Research design is likely to involve harm to participants Payment is likely to encourage participants to take risks The research is ethically unacceptable

10. RMIT University SET- Barbara Polus/Diana DonohueSlide 10 Ethical issues Associated With The Mosquito Study RMIT staff study –Use of secondary data (blood data from mosquitoes) The research therefore involves the use of existing collections of data –The acquisition of these data may be of concern morally (and ethically unacceptable) –The data used by RMIT staff is one step removed from the actual data collection and does not involve the use of Human participants –The benefits of the secondary data analysis outweigh any risk associated with the research

11. RMIT University SET- Barbara Polus/Diana DonohueSlide 11 Take Home Messages All research conducted on Humans must involve careful thought to the possible role that Human participants may play in the research process The ethical review process is important and acts as a monitor / guide to protect the welfare and rights of participants in research involving Humans – but it is only part of the process It is the responsibility of all of us to ensure that all research conducted on Humans is ethically acceptable

12. RMIT University SET- Barbara Polus/Diana DonohueSlide 12 SET Portfolio HRE-SCs Review risk level 1 & 2 research (negligible and low risk research proposals) Sub-committee (a)  Meets 1 st Wed of month Chair – Diana Donohue Sub-committee (b)  Meets 3rd Wed of month Chair – Barbara Polus Secretary  Julie Barnett (X 57096)

13. RMIT University SET- Barbara Polus/Diana DonohueSlide 13 URL: http://www.rmit.edu.au/rd/hrec_apply http://www.rmit.edu.au/rd/hrec_apply