11.1: Research Ethics ✅

Question 1

Describe common ethical issues arising from clinical research

Answer 1

Breach of human rights

Autonomy/ beneficence/ justice

Confidentiality

Patients exposed to risk for no reason

Expenditure of resources

Misleading results

Lack of social value

Question 2

Discuss the importance of consent and confidentiality when patients participate in research and interventions

Answer 2

Valid consent (capacity, voluntary, information, continuous)

Confidentiality (patients entitled to control and access over their information)

Question 3

Why is published research important in academic discipline?

Answer 3

Allow improved scientific understanding

Benefit to society and public health

Question 4

Physicians’ role

Answer 4

Duty of care

Question 5

Researchers’ role

Answer 5

Generating knowledge

Question 6

What are the focuses of medical research?

Answer 6

Disease knowledge

Patterns of disease

Treatment/vaccine/ drug development

Bio-psycho-social aspects

Legal and ethical aspects

Health systems

Question 7

Nuremberg Code summary principles

Answer 7

(1947)

1. The voluntary consent of the human subject is absolutely essential
2. The experiment should be such as to yield fruitful results for the good of society
3. The anticipated results will justify the performance of the experiment
4. The experiment should be conducted so as to avoid all unnecessary physical and mental suffering and injury
5. No experiment should be conducted where there is a priori reason to believe that death/disabling injury will occur
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved
7. Proper preparations should be made and adequate
8. The experiment should be conducted only by scientifically qualified persons
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end.
10. The scientist in charge must be prepared to terminate the experiment at any stage

Question 8

Belmont Report

Answer 8

Ethical principles and guidelines for the protection of human subjects of research

Question 9

Belmont Report summary points

Answer 9

Principles:
1. Respect of persons
2. Beneficence
3. Justice

Application to the conduct of research:
1. Informed consent
-(information, comprehension, voluntariness)
2. Risk/benefit assessment
-(research justified on a favorable risk/benefit assessment)
3. Selection of subjects of research
-(fair procedures and outcomes)

Question 10

VMA Declaration of Helsinki

Answer 10

1946
Ethics review of medical research study

Scientific grounding

Social value and contribution

Assessment of risks and benefits

Informed consent

Confidentiality

Question 11

Scientific integrity and justification

Answer 11

Medical research using human subjects must be justifiable on scientific grounds
- WMA Medical Ethics Manual 2015

Human involvement; lack of respect for human dignity

Subjects exposure to risk for no good reason

Expenditure of resources

Misleading results

Doubting social value

Question 12

Consent

Answer 12

Valid consent
-capacity
-information
-voluntary
-continous

Process of obtaining consent
- signed and oral explanation of the project and what participation will involve
- including that they are free to withdraw their consent to participate at any time, without any consequences or compromise of their healthcare

Researchers must ensure that the information is provided in a way that participants can understand

Question 13

Confidentiality

Answer 13

Research subjects are entitled to confidentiality

Using data from patient records
-some data may be important but could be identifiable
-clinical case histories are unique

Communicating research results
-anonymised data
-consent for research uses etc. should be sought in advance and should be explicit consent

Question 14

Vulnerable groups

Answer 14

Misconceiving research for therapy

Research as the only gateway to some types of medical care

Sense of duty or expression of grateful to the doctor

Fear of withdrawal of care

Question 15

Assessment of Risk vs Benefits

Answer 15

The benefit must outweigh the risk of harm to research participants
-risk: likelihood of the occurrence and severity of the harm
-benefit: direct/indirect, benefits to others

The degree of acceptable risk partly depends on:
-whether the research study is therapeutic or non-therapeutic

Consequences for society

Degree of acceptable risk is debatable

Question 16

Publication ethics

Answer 16

Requirement that results are accurately reported

-scientific advancements
-contribution to society
-potential issues (authorship, conflict of interest, fabrication and plagiarism)