ONLINE MODULE 5

define research ethic

a set of moral principles which guide researchers to conduct and report research without deception or intention to harm the participant, or society, whether knowingly or unknowningly

when is ethics approval required

for research with:

• humans

• animals

• collection/use of confidential information

• research with other implications

what studies with human research require approval

with people

without people

use people’s data

use of tissue samples of people

what studies with animal research require ethics approval

any live non human vertebrae

fish, amphibians, reptiles, birds and mammals

what are the 6 points of the Australian Code for the Responsible Conduct of Research

1. honesty and integrity

2. respect for human participants, animals and environment

3. good stewardship of public resources used to conduct researc

4. appropriate acknowledgement of the role of others in research

5. responsible communication of results

6. an environment of responsible research

describe the Tuskegee Syphilis study

from 1932 to 1972 in tuskegee alabama, 600 low income african american males were infected with syphilis

they were monitored for 40 years, and denied effective treatment

describe the Nuremberg trials

from 1946 to 1949 in Nuremberg germany, american military tribunal opened criminial proceedings against 23 german physicians

they were on trial for unethical experimentation of prisoners of war during WWII

resulted in the creation of the nuremberg code

what are the 6 points of the nuremberg code

1. voluntary consent is essential

2. freedom from coercion

3. comprehension of risks and benefits

4. experiment to be conducted by highest qualified professionals

5. risk/benefit analysis essential

6. scientific soundness

describe the issues with thalidomide

thalidomide was approved in europe as a sedative, but was not US FDA approved

it was prescribed to pregnant women to control sleep and nausea, but resulted in severe birth defects to babies

most patients did not know it was not FDA approved, nor gave consent

what is the statement for the declaration of helsinki

the wellbeing of the human subject should take precedence over the interests of science and society

when was the helsinki declaration made and by who

in 1964 by the world medical association

what are the 6 points of the Declaration of Helsinki

1. consent should be in writing

2. respect for persons

3. standard of care must be available, even for control groups

4. limit placebo use

5. use caution if participant is in dependent relationship with researcher

6. participants must benefit from the research

what are the 12 ethical principles of research

1. integrity

2. competence

3. non maleficence

4. beneficence

5. autonomy

6. respect

7. responsibility

8. privacy

9. confidentiality

10. dignity

11. justice

12. honesty

elaborate on honesty as a principle

being honest:

• with beneficiaries and respondents

• about the findings and methodology

• with direct and indirect stakeholders

elaborate on integrity as a principle

ensuring honesty and sincerity

fulfilling agreements and promises

do not create false expectations or promises

elaborate on competence as a prinicple

only undertaking research in areas of your expertise or where you demonstrate competency

ensure bias in all areas is avoided

elaborate on respect as a principle

includes:

• autonomy - those who are capable of deliberation about their personal goals should be treated with respect for their capacity for self determination

• protection of people with impaired or diminished autonomy

elaborate on responsibility as a principle

responsibility for:

• planning

• undertaking and publishing research within area of expertise

• promote and uptake research/knowledge

• no duplicate publication

elaborate on beneficience as a principle

maximise participation of the participants and minimise possible harm

elaborate on non maleficence as a principle

do no harm

minimise harms and risks

ensure privacy, autonomy and dignity

elaborate on autonomy as a principle

respect that individuals should make their own informed decision about participation

elaborate on privacy as a principle

keep the participant anonymous

do not reveal any information which is related to identity

the moral right to be left alone

elaborate on justice as a principle

obligation to distribute benefits and burdens fairly

treat equals equally

give reasons for differential treatment

elaborate on confidentiality as a principle

protecting confidential information

keep identifiable information out of the reach of others

define informed consent

that a persons knowingly, voluntarily and intelligently gives consent to participate in research

what must participants be made aware of to give informed consent

• introduction and objective of research

• purpose of discussion

• procedure

• advantages/risks

• use of research

• their role in research

• right to refuse or withdraw

• methods used to protect anonymity and confidentiality

• freedom to not answer questions

• who to contact for more information

what ethical issues occur before the research

benefit/harm analysis

vulnerability

selection of participants

conflict of interests

what ethical issues happen during research

informed consent

privacy and confidentiality

risk to researchers

risk to participants

what ethical issues may occur after research

sharing results

data integrity and management

integrity and publication ethics

can people under 18 give informed consent

no

the parent/guardian will sign informed consent on their behalf

what are the 5 main roles of the human research and ethics comittee

1. ensure research meets ethical standards

2. ensure research is sufficiently informed

3. ensure protection of participants

4. ensure researchers are competent

5. ensure informed consent documentation is appropriate

what are the 7 member roles on the HREC

1. chairperson

2. lawyer

3. laypersons

4. quantitative researcher

5. qualitative researcher

6. pastoral care profession

7. professional care/counselling/treatment experience

what are the 3 R’s in ethical animal research

replacement

reduction

refinement

what are the 6 governing principles of animal ethics

1. use animals only when justified

2. support the wellbeing of the animals involved

3. avoid and minimise harm (pain and distress)

4. apply high standards of scientific integrity

5. apply 3 R’s

6. know and accept one’s responsibilities

elaborate on use as a principle of animal ethics

the project must have scientific or educational merit, and potential benefits for humans, animals or the environment

elaborate on wellbeing as a principle for animal ethics

at all the times the animals environment and management must be appropriate for the species and the individual animal

procedures must be based on current best practice

elaborate on minimise harm and distress as a principle for animal ethics

death as an endpoint must be avoided unless essential for aim

assume animals feel pain the same way we do

prompt action must be taken to alleviate pain and distress

elaborate on scientific integrity as a principle for animal ethics

all methods must be valid, feasible, well designed and carefully conducted

use methods that accord with current best practice

take into consideration species-specific biology, physiology and behaviour

include strategies to minimise adverse impacts

what are the 5 types of members on an animal ethics committee

chairperson

laypersons

veterinarian

scientist

animal welfarist

what is category A in the AEC

a veterinarian

what is category B in the AEC

an animal researcher

What is category C in the AEC

someone with a demonstrated commitment to animal welfare, and not involved with the institution, animal research or the support of animal research

what is category D in the AEC

an independent person who does not fit the other categories and who is not involved with the association or animal research at any point in time

what does the AEC code state

if an AEC has more than 4 members, categories C and D should present no less than 1/3 of the members