Week 1 - Conducting Research with Human and Animal Participants

Question 1

Latrobe: Ethics, Integrity and Biosafety Team?

Answer 1

manages the administrative processes for ethical approval and governance of all human, animal and biological related research and promote research integrity and training.

Question 2

Latrobe: University Biosafety and Ethics Committees?

Answer 2

University Human Research Ethics Committee and the two College subcommittee, La Trobe Institutional Biosafety Committee and University Animal Ethics Committee, review and, where appropriate, approve applications. This approval is a component of Research Governance and must not be construed as final approval to commence a research project. It is the responsibility researchers, in conjunction with the Research Office, to ensure all elements of Research Governance are considered prior to the commencement of a research project.

Question 3

What are researchers expected to do?

Answer 3

support a culture of responsible research conduct. They need to be familiar with the key University policies and conduct and manage their research in a manner consistent with this framework.

Question 4

When staff and students are involved in research they…?

Answer 4

share responsibility and accountability for the University’s research being conducted according to appropriate regulatory, ethical and scientific standards.

Question 5

What is human research?

Answer 5

conducted with/or about people, their tissue, and/or data about them.

Question 6

What is the HREC and what do they do?

Answer 6

Human Research Ethics Committees (HRECs) review proposals for research that involve human participants, to determine whether they meet ethical standards.

Question 7

La Trobe University Committees are made up of:

Answer 7

• lay people who have no affiliation with the institution and do not currently engage in medical, scientific,
  legal or academic work;
• person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, an allied health professional;
• person who performs a pastoral care role in the community;
• lawyer, where possible who is not engaged to advise the institution; and
• people with current human research experience that is relevant to La Trobe.

Question 8

Values of Ethical Conduct per the National Statement:

Answer 8

• Research Merit & Integrity
• Justice
• Beneficence
• Respect

Question 9

What is merit and integrity in research?

Answer 9

proposed research must have merit (be justified) and researchers must have integrity (strong morals/honest)

Question 10

What is justice in research?

Answer 10

A regard for the human sameness that each person shares with every other

Question 11

What is beneficence in research?

Answer 11

Keeping the welfare of participants and benefit to the participant and wider community in mind at all times

Question 12

What is respect in research?

Answer 12

Respecting human beings at all times, and recognising their intrinsic value.

Question 13

What are the themes of ethical conduct from the National Statement?

Answer 13

• Risk and Benefit

- Consent

Question 14

What is risk and benefit in ethical conduct?

Answer 14

Risk - Potential for harm, discomfort or inconvenience (likelihood and severity). Must conduct risk assessment and plan

Benefit - “Do the benefits justify the risks?
Research is ethically acceptable only when its potential benefits justify any risks involved in the research.” (National Statement)

Question 15

Conditions of consent?

Answer 15

• Consent should be voluntary
• Individuals should be given enough information
  about the study in advance, so that they can make an informed choice (Or specific conditions in place if there needs to be ‘limited disclosure’)
• Consent alone may not be enough to justify participation
• There is some variability in the conditions and processes for consent, depending on things like codes, laws, and cultural sensitivities of the participant group

Question 16

What is a PICIF and what does it include?

Answer 16

A Participant Information and Consent Form is required for research projects with humans, to ensure key information about the project is made clear to people prior to their decision making about the study.

• Who is conducting the research
• Who is being asked to participate (inclusion criteria)
• What taking part would involve
• What the benefits (if any) are
• What the risks are
• How data will be used and stored
• How participants will be communicated with about the findings
• When they can withdraw from the study (if possible)
• Who to contact in the research team for more information
• Who to contact if they would like to complain

Question 17

What is needed to apply for for an ethics review at Latrobe?

Answer 17

Application form

Project description form

Question 18

Distinction between human and animal research?

Answer 18

animals cannot give informed consent (Removes the element of choice, As such animals are subjects, not participants)

Thus, the role Animal Ethics Committee is to assess the merit of each project to ensure that the welfare of animal is accounted for.

Question 19

Why are animals used in place of humans?

Answer 19

• A lot of research on animals goes towards helping animals themselves
• Can have constant environmental conditions and genetic
  characteristics
• Can employ procedures that cannot be conducted on humans

Question 20

How can animal research inform human health and behaviour?

Answer 20

• same basic physiological processes are common between human and animals
• anatomically similar
• ability to control conditions without confounding influences

Question 21

Where to find animals and the types of projects involved?

Answer 21

Sources of Animals

• Lab‐bred
• Commercial businesses/Organisations
• Wildlife
• Private owners

Types of Projects

• Disease models
• Behavioural assessment
• Environmental/Ecological assessment/observation
• Human‐animal interactions

Question 22

What is section 1.1 of The Code for animal research?

Answer 22

Respect for all animals MUST underpin all decisions and actions involving care and use of animals for scientific purposes.

• only using animals when justified
• avoiding or minimising harm
• high standards of scientific integrity
• 3Rs

Question 23

What are the 3Rs?

Answer 23

Replacement of animals with other methods (computer modelling, tissue culture, ect)

Reduction in number of animals used

Refinement of techniques to minimise adverse impacts

Question 24

What is section 1.5 of the Code?

Answer 24

• project has scientific/educational merit and has benefits for humans, animals or environment (evidence-based cost/benefit analysis)
• use of animals is essential to achieve stated aims (tried other ways first)
• project involves minimum number of animals required to obtain valid data (priori analysis)
• strict monitoring, reporting and SOPs

Question 25

Who are the members of an animal ethics committees?

Answer 25

• An Independent Vet
• An experienced experimenter from the uni
• An animal house technician
• Independent member of an Animal Welfare Group
• Independent Community Member

Question 26

What is the BAW and what do they do?

Answer 26

Bureau of Animal Welfare

• All researchers, AECs and institutions answer to the BAW.
• Each year researchers must report on animal use and procedures to the
  BAW.
• Random inspections and audits are conducted to ensure all welfare guidelines are adhered to.
• BAW releases annual report to public via website

Question 27

What is the LARTF and what do they do?

Answer 27

La Trobe Animal Research and Teaching Facility

• assists with training for all incoming researchers to help ensure high standards of animal care, best-practice techniques and compliance with LTU and Government requirements
• Agistment, husbandry and colony management for rats, mice and zebrafish
  – Care and housing for avian, reptile and native animals
  – Behavioural neuroscience suites with behaviour testing equipment
  – Surgical facilities
  – PC1 and PC2 certified Specified Pathogen Free and conventional facilities

Question 28

Applying for AEC approval:

Answer 28

• Why must animals be used?
• Do you have the resources to conduct the project to get valid results while maintaining animal welfare?
• Have all protocols been approved by the AEC/Vet?
• Is everyone on the team competent on relevant procedures?
• Are relevant legislative care, monitoring and reporting requirements met?
• How are the 3 R’s addressed?
• Short-term and long-term welfare impacts?
• Analgesia and Anaesthesia?
• Experimental procedures – impact, duration and risk?
• Housing and Care?
• Potential mortality rates and End point?
• Personnel details – evidence of induction, training and assessment of competencies

Question 29

What are SOPs?

Answer 29

Standard Operating Procedures – must be approved by Vet and AEC

• Transport
• Housing
• Welfare checks and monitoring
• Analgesia and Anaesthetics
• Behavioural procedures
• Surgical procedures
• Other methodologies
• End point management

Question 30

What are your rights in research?

Answer 30

Human
– You should never feel obligated to participate in research if you don’t
want to.
– If you start in an experiment, you have to right to withdraw at anytime.
– You have to right to ask what will be done with the data.

Animals
– You have the right to refuse to participate in any project involving animals.
– If you do work with animals, you have the right to refuse to conduct any procedure you don’t feel comfortable with.

If you are unsure about any thing always ask!