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1

Why are ethics important in research?

  • Awareness of the impact of our actions on people
  • we follow a code of ethics and guidelines to act as a professional compass
  • Not following these guidelines can have significant impacts on all involved

2

Research Ethics

  • A code of what is morally right and wrong
  • not a matter of fact but matter of opnion
  • Ethical Research is heavily influenced by social values
  • Standards of what is ethical change over time

3

Two traditional views of Ethics

  1. Utilitarianism
  2. Deontology

4

Utilitariansim

  • The goodness of an act is judged by their consequences.
  • Summarised by the phrase "the greatest good for the greatest number"
  • Can have many unforeseen consequences - what is good depends on your point of view
  • good things now can have bad long term consequences
  • Extremism can permit any atrocity and justify it with "greater good"

5

Deontology

  • Humans are bound to follow certain universal moral principles
  • These principles manifest in actions
    • some should not be done; ie killing
    • some should be done; telling the truth
  • Consequences are irrelevant to the ethical action
  • Acts are ethical or unethical by their nature
  • Behaving ethically is the end point, it is not a means to an end

6

Is deception a major problem in Psychological Research?

  • Researchers are more sensitive to ethical issues than in the 1960/70s
  • Some psychologists beleive that the problem of deception has been exaggerated
  • Broder argues that extreme examples of deception are rare

7

Tuskegee Syphilis Study (1932-1972)

  • Study of 600 African-American men some with and some without syphilis
  • they were not told they had syphilis 
  • they were not treated for syphilis
  • They received free medical care, meals and burial insurance
  • 1940 penicillin was found to be effective in curing syphilis but this was witheld from subjects
  • A whistle blower led to changes that introduced informed consent

8

The Belmont Report

  • Created in response to the Tuskegee Syphilis Study (1932-1972)
  • Prepared by National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research.
  • Consisted of 3 principles
    • Beneficence
    • Respect for persons
    • Justice

9

Informed Consent

  • Belmont Report's principle of respect for persons
  • Participants are treated as autonomous
  • They are capable of making deliberate decisions about participating in research
  • Potential participants shoud be given all information needed to chose whether to participate

10

Content of Informed Consent forms (7)

  1. Purpose of research
  2. procedures that will be used and time involved
  3. Risks and benefits
  4. any compensation
  5. confidentiality
  6. assurance of voluntary participation and permission to withdraw
  7. contact information for questions

11

Autonomy and Information Issues

  • What happens when participants are unable to make free informed decisions?
  • Autonomy is removed 
  • Vulnerable populations become disadvantaged

12

Information Issues

  • Withholding Information and Deception
  • It is acceptable to withhold information whe it would not affect the individual's decision to participate
  • Also if the information will be disclosed later, such as in a debreifing session 
  • Most people do not expect full disclosure before a study but do expect thorough debreifing, 

13

The Importance of Debreifing

  • Occurs after completion of the study
  • Opportunity to deal with issues of withholding, deception or potential harmful effects,
  • Time to explain any deception and why it was necessary
  • ensures the participant leaves with no ill feelings.

14

Positive aspects of debriefing

  • Opportunity to explain purpose and potential results of the study 
  • Most participants report a positive experience
  • research suggests it is effective.

15

Alternatives to Deception

  • Role Playing
    • asks participants to predict how they would respond in a certain situation
    • Not considered a satisfactory alternative to deception
  • Simulated Studies
    • variation on roleplaying that involves simulation of real world
    • Has a high degree of involvement from participants
  • Honest Experiments
    • Participants are made aware of the purpose of the research

16

Justice and Selection of Participants

  • Issues of fairness in receiving the benefits of research
  • also bears the burden of accepting risks
  • Justice Principle requires researchers to address issues of equity
  • Any decisions to include or exclude certain people from a study must be justified scientifically

17

Justice and Selection of Participants

Researcher Commitments

  • Implied Contract with Participants
    • Punctuality
    • Summary of Details to Participant
    • Course Credit
    • Details that maintain trust between participants and researchers

18

Other Important Codes: Nuremberg (6)

  • Voluntary consent of human subjects is essential
  • Experiment should yeild fruitful results for the good of society; not random or unnecessary in nature
  • should be designed in results of animal testing first
  • based on knowledge of natural history of the disease
  • should be conducted to aviod unnecessary suffering 
  • No experiment should be conducted with may result in death or disability

19

Other Important Codes: Nuremberg continued (5)

 

  • Degree of risk should not exceed humanitarian importance of the problem to be solved
  • Proper preparation and adequate facilities to protect participants from even remote posibility of injury or death
  • should only be conducted by qualified professionals
  • participants should be allowed to end their participation
  • Researcher must be prepared to terminate the experiment at any stage if any harm could result.

20

The Declaration of Helsinki (7)

The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA).

The fundamental principles:

  • respect for the individual
  • right to self determination
  • right to make informed decisions regarding participation in research, both initially and during the course of the research.
  • The investigator's duty is solely to the patient
  • while there is always a need for research the subject's welfare must always take precedence
  • ethical considerations must always take precedence over laws and regulations
  • The recognition of the increased vulnerability of individuals and groups calls for special vigilance

21

What are three codes we base ethics on?

  1. Belmont Report
  2. Nuremberg Code
  3. Helsinki Report

22

What are the three principles of the Belmont Report?

  1. Beneficence
  2. Respect for persons
  3. Justice

23

The Institutional Ethics Review System

  • Each institution that receives federal funding must have a Human Research Ethics Committee
  • Responsible for reviewing research at the institution
    • conditions ie one member must be from outside the institution
    • all research conducted by students and faculty staff must be reviewed.

24

The Institutional Ethics Review System: 

Types of Research

  • Exempt Research (no review needed)
  • Minimal Risk Research
  • Greater than Minimal Risk Research

25

The Institutional Ethics Review System:

Impact on Research

  • Extended time for approval of study
  • Submissions often need to be revised or clarified
  • very cautious around approval

26

NH&MRC STATEMENTS ON ETHICAL RESEARCH

  • National Statement on Ethical Conduct in Human Research 2007 Updated 2014
  • The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia
  • In accordance with National Health and Medical Research Council Act 1992 .
    • any researcher conducting research with human participants;
    • any member of an ethical review body reviewing that research;
    • those involved in research governance; and
    • potential research participants.

27

National Statement of Risk and Benefit: 

What is Risk?

  • A potential for harm or discomfort or inconvenience that involves:
    • the likelihood that harm or discomfort will occur
    • the severity of the harm, including its consequences

28

National Statement of Risk and Benefit: 

Assessment of risks involved

  • identifying any risks
  • guaging their probability and severity
  • assessing the extent to which they can be minimised
  • determining whether they aresjustified by potential benefits
  • determining how they can be managed

29

Assessment of Risks and Benefits:

Physical Harm

Physical Harm

  • Procedures could conceiveably cause some physical harm to participants are rare but possible
  • Often Medical Procedures fall in this category

includes

  • administering drugs like caffeine or alcohol
  • extended sleep deprivation

30

Assessment of Risks and Benefits:

Stress

  • More common than physical stress is psychological stress