Human Ethics in the Department of Psychiatry
SOME KEY ISSUES
Consent
Guidelines for informed consent for research involving humans, including a sample Consent form, can be found on the following Melbourne Research Office web page: http://www.research.unimelb.edu.au/humanethics/processes/applicprocedure/consent/
Request for consent by email
If sending a request by email:
- the potential participant must be invited to participate;
- it should be made clear on what basis they have been targeted;
- a Plain language statement should be included;
If they respond by email, they must clearly state ‘yes’ they wish to participate.
In other words, researchers need to ensure that they have sent all relevant information to the target group, including the Plain Language Statement and that this information makes it clear to participants exactly how the research will be conducted and what will be required of them.
Secure email
If an email request is sent which contains personal information, the sender must ensure that the email is secure and not accessible beyond the target recipient.
Data retention and disposal
University policy regarding how long data is kept will depend on the type of research and what the researchers want to do with it, generally "5 years from date of the last publication arising from the research" but that can be varied. For example, some data is kept forever = oral histories etc, clinical trial data is kept for between 15 to 25 years and sometimes forever. For most research projects researchers nominate 5 years and then they would normally destroy it. It's really up to the researchers to state how long they intend to keep it for.
The issue is what researchers tell potential participants about:
- what will be done with it
- how it will be stored {i.e. securely}
- who will have access to the raw data - usually just the named researchers
- how long it will be kept for
- when it will be destroyed e.g. data shredded, samples destroyed in accordance with Uni policy for this; electronic files deleted - whatever is appropriate for that particular data set.
- The researchers do not need to nominate a specific date but they would need to indicate approximately when this might happen.
Link to University policy: http://www.research.unimelb.edu.au/admin/res.conduct/code.html - there is a hotlink to the Management of Research Data and Records policy.
Plain Language Statement
The Plain Language Statement should make it clear to potential participants what will happen to their information. An example might be "Your name will be removed from your responses and stored separately. Only the principal investigator will have access to the code linking your name with your data. Your raw data will be kept confidential and only the named members of the research team will have access to it. After 'X' years the raw data will be destroyed by shredding the documents and deleting the electronic files."
Detailed information about Plain Language Statements, including examples, can be found on the following Melbourne Research Office webpage: http://www.research.unimelb.edu.au/humanethics/processes/applicprocedure/plain/
'Handy Hints' on the Melbourne Research Office Human Ethics website
http://www.research.unimelb.edu.au/humanethics/external/hints/
This contains some useful pointers for completing the ethics application.
It also includes a section detailing the most frequently occurring discipline-based issues. This is very useful overview for researchers, highlighting the particular issues which they need to ensure they have adequately addressed.
One of the main complaints which the Research Office receives is from people targeted to participate in research but where they feel the process is not clearly explained to them e.g. they don't realise how much time may be required in participating; it is not explained how and why they have been selected.