DoH

Question 1

What are the 11 principles of the DoH

Answer 1

1) General Principles (3-15)
2) Risks, Burdens and Benefits (16-18)
3) Vulnerable groups and individuals (19-20)
4) Scientific requirements and Research Protocols (21-22)
5) Research Ethics Committees (23)
6) Privacy and Confidentiality (24)
7) Informed Consent (25-32)
8) Use of placebo (33)
9) Post-trial provisions (34)
10) Research registration & publication & dissemination of results (35-36)
11) Unproven interventions in clinical practise (37)

Question 2

What are the General Principles of DoH

Answer 2

3) Bounds the physician by the words ‘The heath of my patient will be my first consideration’
4) Duty of the physician to safeguard the rights, health and well-being of the patient.
5) *
6) *
7) MR is subject to ethical standards that promote and ensure respect for all human subjects and protect their rights and health
8) New interventions cannot take precedence over rights and interest of individual subjects
9) Responsibility for the protection of research subjects must always rest with the physician.
10) *
11) MR should be conducted in a manner which minimises possible harm to the environment
12) MR involving human subjects must be conducted by individuals with appropriate TRAINING
13) Underrepresented groups in MR should be provided appropriate access to the trial
14) *
15) *

Question 3

What are the risks, burdens and benefits principles in the DoH

Answer 3

16) Importance of objectives outweighs risks and burdens to the research subjects
17) Measures to minimise risk must be implemented. Risks must be continuously monitored
18) Unless risks have been adequately assessed, physicians may not be involved in research. When risks > reward then the research must stop.

Question 4

What are the vulnerable groups and individuals principles in the DoH

Answer 4

19) All vulnerable groups should receive specifically considered protection
20) MR in vulnerable groups only allowed if the research question cannot be answered in non-vulnerable groups. Vulnerable group should stand to benefit from the knowledge, practices or interventions that results from research

Question 5

What are the scientific requirements and research protocols principles in the DoH

Answer 5

21) MR must be based on thoroughly researched scientific principles. Welfare of animals must also be taken into account
22) Trials must have a justified research protocol which is approved by the REC and give information regarding sponsors, affiliations, conflicts of interest, incentives

Question 6

What are the REC principles in the DoH

Answer 6

23) Protocol must be submitted to the REC before study begins
24) Committee must have the right to monitor ongoing studies

Question 7

What are the privacy and confidentiality principles in the DoH

Answer 7

25) Every precaution must be taken to protect the privacy of subjects

Question 8

What are the IC principles in the DoH

Answer 8

25) IC from subject must be completely voluntary
26) In MR where subjects are capable of IC , each individual must be informed of the: Aims, methods, sources of funding, conflicts of interest, institutional affiliations, anticipated benefits vs risks, post study provisions etc. They must also be aware of their right to refuse participation at any time without reprisal. Special attention should be given to specific information needs of the patient and the methods used to deliver this information.
Freely given IC (in writing) can then be obtained. If not in writing, then it can formally be documented and witnessed
All trial participants should be informed about the outcome of the study.
27)