PHRM3031 - Research Ethics

Question 1

key principles in bio ethics

4

Answer 1

1. respect for autonomy: respect the rights and dignity of individuals
2. beneficence: help people
3. non maleficence: do no harm
4. justice: treat people fairly

Question 2

key principles in research ethics (5)

Answer 2

1. merit and integrity of the research: conduct good studies well
2. respect for autonomy: respect the rights and dignity of individuals
3. beneficence: help people
4. non maleficence: do no harm
5. justice: treat people fairly

Question 3

human research ethics committees

Answer 3

• min 8 ppl, ideally equal men and women with a third of the committee external to the institution
  at least:
• 2 lay people
• one health care professional
• one person who performs a pastoral role (eg.priest or elder)
• one lawyer
  -two researches

Question 4

merit and integrity

definition

Answer 4

• research has to be good science to be ethical. research with merit
• -aims to fill gaps in our knowledge
• -is will designed to answer its aims
• integrity refers to the way that the research is conducted. there is a genuine search for knowledge and understanding, the research is conducted honestly, and the results are distributed regardless of outcome

Question 5

beneficence/non-maleficence

definition

Answer 5

• the potential benefits of research need to outweigh the risks
• the benefits of the research may accrue to people other than those involved in the study
• the risks involved in some studies is great, what is important is that the risks are considered, minimised and clearly explained

Question 6

respect

definition

Answer 6

• respect people involved in research including: their welfare, beliefs, cultural heritage, perceptions and customs
• respect the capacity people have to make their own decisions about participation
• respect people unable to make their own decisions, empower them to be as involved as possible and protect them by involving people who can advocate on their behalf

Question 7

informed consent

definiton

Answer 7

• participation in research is voluntary. due to respect for participants requires informed consent
• people need to be given enough information about the study to be able to decide whether to participate (the right to know what it involves)
• the effect of unequal power in relationships should be considered
• the need for informed consent may be waived in specific circumstances

Question 8

types of consent

3

Answer 8

• specific: to a particular project
• extended: to future projects that are an extension of the present project or very similar
• unspecified: data and/or tissue (usually de-identified) may be used in any future research

Question 9

justice

definition

Answer 9

• are inclusion and exclusion criteria for the study fair given the objectives of the research?
• are the burdens on participation on particular groups reasonable?
• is there fair access to the benefits of research?

Question 10

should a patient participate in a randomised trial: uncertainty principle

Answer 10

randomisation is acceptable when the clinician-investigator is uncertain which of the randomised treatments is best for the patients

Question 11

should a patient participate in a randomised trial: personal care principle

Answer 11

randomisation is acceptable when the clinician-investigator is indifferent between the randomised treatments for the patients

Question 12

should a patient participate in a randomised trial:

‘clinical equipoise’

Answer 12

randomisation is acceptable when there is no consensus within the clinical community as to which of the randomised treatments is best for the patient