Human Ethics

what is human research

it includes all research conducted with or about people, their data, or tissue

humans- survey’s, interview, focus groups, observations

data- access to documents, databases, spreadsheets, social media data

tissue- collection of organs, tissues, or fluids, use of commercially available cell lines or tissue banks

4 principles of the national statement

merit and integrity

justice

beneficence

respect

merit

justifiable by its potential benefit

designed or developed using methods appropriate for achieving the aims

based on a thorough study of the literature

designed to ensure that respect for the participants is not compromised by the aims of the research, by the way it is carried out or its results

conducted or supervised by persons or teams with appropriate experience, qualifications and competence

conducted using facilities and resources appropriate

benefit

who will benefit from your research

why is your research worth doing

will it provide benefits to the community

ethics applications

summerise your project demonstrating scholarly merit and benefits

use lay language

explain if it has been peer reviewed

explain who is funding the project if there is funding

the team- what is ethically relevant, who has worked with these populations

your participants

inclusion and exclusion criteria

how will you show respect

Respect involves "recognising the value of human autonomy" - the rights of people to make up their own minds about whether to participate in research, including the benefits they consider valuable and the risks they are willing to accept

Respect also involves "providing for the protection of those with diminished or no autonomy, as well as empowering them where possible and protecting and helping people wherever it would be wrong not to do so."

details of participation

what will it be like to participate in your project? Are you using pre-existing human data for a new research purpose? (In that case, will participants even know that they are participating?) Will you ask participants to do something? If so, what exactly will you ask them to do?

ethics involves thinking through

are the participants doing something out of the ordinary?

how many questions will you ask in a survey? is it time consuming etc?

how will the participants get places etc?

special considerations for some populations

Woman who are pregnant and the human fetus

Children and young people

People in dependent or unequal relationships

People highly dependent on medical care who may be unable to give consent

People with a cognitive impairment, an intellectual disability, or a mental illness

People who may be involved in illegal activities

Aboriginal and Torres Strait Islander people

Risks- Harm

physical harm

psychological harm

devaluation of personal worth

social harms

cultural harms

economic harms

legal harms

Risks- discomfort

Discomfort is less serious than harm. The National Statement says that discomfort may include anxiety inducted by an interview or the minor side-effects of medication. "When a person's reactions exceed discomfort and become distress, then they should be viewed as harms."

Risks- inconvenience

Inconvenience is the least serious of the three. A person might be inconvenienced, for example, when they give up time to participate in a short innocuous survey or interview or when they have to respond to a number of emails. 

recruitment strategy

is your recruitment strategy respectful of local culture

are your recruitment materials appropriate for the level of education of the people you wish to recruit

is your recruitment accessible for people with (for example) visual or hearing impairments

is your recruitment strategy age appropriate?

is your recruitment strategy appropriate for your inclusion / exclusion criteria?

should you translate your recruitment materials into other languages

indirect recruitment

ie. before recruiting school students, writing a letter to the principal first

cultural considerations

be based on good understanding of the local communities and how best to engage them

acknowledge local values and consider recognising values other than those listed in the National Statement

have due regard for people's beliefs, customs, heritage, and local laws (NS 4.8.19) and be carried-out by people with appropriate experience and expertise to engage participants on those terms

use appropriate language, including translation into participants' first languages in some cases.

informed consent- gold standard

voluntary

sufficient information and understanding

limted disclosure

consent where participants are not fully informed of the research

opt-out recruitment

Opt-out recruitment is a method such that the participation of a cohort is assumed, except in cases where participants explicitly say that they do not wish to participate. 

no consent

Under specific conditions, the requirement to seek consent may be waived. This may be necessary for some research — for example, projects using many thousands of social media posts, or research using existing collections of human data where participants' contact details are simply unknown

risks must be low and benefits must outweigh risks

matters to communicate

1. any alternatives to participation

2. how the research will be monitored

3. provision of services to participants adversely affected by the research

4. contact details of a person to receive complaints

5. contact details of the researchers

6. how privacy and confidentiality will be protected

7. the participant's right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data

8. the sources of funding for the research

9. financial or other relevant declarations of interests of researchers, sponsors or institutions

10. any payments to participants

11. the likelihood and form of dissemination of the research results, including publication

12. any expected benefits to the wider community

13. any other relevant information, including research-specific information required under other chapters of this National Statement.

specific consent

agreement that the data or tissue may be used for a specific research project

extended consent

agreement that the data or tissue may be used in projects that are closely related to the current project, or in a very similar area

unspecified consent

agreement that the data or tissue may be used in any future research

secondary use

research that uses data that was collected for a different purpose

privacy expectations

data collected from the internet:

public social media posts

private social media forums

chat groups

data emitted from devices or apps

blogs or vlogs

human biospecimens considerations

the provenance of the biospecimens, including the manner in which they were originally obtained and the nature of any consent provided by the person whose tissue it is. 

the possibility that the research could derive information from those biospecimens that may have implications for the person or their relatives and community.

the significance of those biospecimens to the person, or their relatives and community

Identifiability and data management

Important: We need to consider matters of identifiability carefully, and in a scholarly way, accounting for the particulars of our own projects. We must identify risks to participants and their privacy, and provide the information clearly to participants so that each person can make up their own mind.

anonymisation

Changes over the life of the project

you may collect identifiable data

remove identifiers when you analyse the data

report the data so it cannot be linked to an individual

manage your data so it can be re-used

revisiting risks and benefits -

Imagine you have a survey, asking low risk questions. You say it will take 15-20 minutes and is completely anonymous. As an incentive, you offer entry to a prize-draw where one participant will win a voucher to an online retailer.

• Have you tested how long the survey really takes? Have you tested with someone who isn't a fellow academic? 

• Is the language age appropriate? Is it culturally appropriate?

• Do you use free-text fields? If so, is it possible or likely that participants may identify themselves in those fields? 

• Do you ask demographic questions? Could these make your data identifiable? Are they inclusive and culturally sensitive (e.g. questions about sex or gender?)?

• To enter your prize-draw participants would have to provide identifiable information. Have you ensured that the prize-draw entry cannot be linked to the research data?

human ethics workflow

prepare application in workflow gen

compliance check

faculty approval

chair confirmation

review —- approval — review outcomes

after approval

act accordingly

seek approval for minor amendments

submit progress reports

if something goes wrong- email detailing the event to bond