Declaration of Helsinki

Question 1

Helsinki year

Answer 1

1964

Question 2

Helsinki history

Answer 2

• Created by World Medical Association
• Built upon Nuremberg Code
• Further focus on clinical research

**cornerstone document of human research ethics and designed from a clearly formulated protocol

Question 3

Helsinki general principles

Answer 3

1. Medical research subject to ethical standards
2. Medical research should minimize harm to environment
3. Human subjects research must be only conducted by those with appropriate ethical and scientific training
4. Underrepresented groups should have access to participation
5. Combining medical research with medical care should be justified and not cause harm
6. Compensation for treatment resulting from harm should be ensured

Question 4

Helsinki: Physician’s duty

Answer 4

To act in best interest of patient

To promote and safeguard patient’s health and well-being

To protect subject’s dignity, integrity, privacy, confidentiality - this should never rest on subject

Question 5

Helsinki: Purpose of human subjects research

Answer 5

Understand cause, development and effects of diseases and improve interventions

This goal can never take precedence over the rights of human subjects

Question 6

Helsinki: Risks, Burdens and Benefits

Answer 6

1. Benefits must outweigh risks and burdens
2. Medical research must be preceded by assessment of risks
3. Risks must be minimized and continuously monitored
4. If risks outweigh benefits, physicians must whether to continue, modify or stop study

Question 7

Helsinki: Vulnerable Groups and Individuals

Answer 7

1. Research in vulnerable groups is only justified if it is responsive to needs of that group and research can’t be carried out without them
2. This group should benefit from the knowledge resulting from research

Question 8

Helsinki: Scientific Requirements and Research Protocols

Answer 8

1. Human subjects research must be based on scientific principles, literature, lab and animal experiments
2. Research protocol must clearly describe design and performance of study
3. Protocol should include
   - statement of ethical considerations
   - how Helsinki principles addressed
   - information about funding, sponsors, institutions, conflicts of interest, incentives, compensation for injury
   - clinical trials: post-trial provisions (ex: giving Tx to placebo group)

Question 9

Helsinki: Research Ethics Committees

Answer 9

1. Protocol must be approved by committee
2. committee must be transparent, independent, qualified
3. Researchers must provide monitoring information to committee (esp. SAEs)
4. All changes to protocol must be reviewed by committee
5. Must submit final report to committee at end of study - summary of findings and conclusions

Question 10

Helsinki: Privacy and Confidentiality

Answer 10

Every precaution must be taken to protect privacy and confidentiality of PHI

Question 11

Helsinki: Informed Consent

Question 12

Helsinki: Use of Placebo

Question 13

Helsinki: Post-Trial Provisions

Answer 13

Before clinical trial, provisions should be made for post-trial access to interventions found beneficial to subjects still in need of intervention (ex: placebo group)

Question 14

Helsinki: Research Registration and Publication and Dissemination of Results

Question 15

Helsinki: Unproven Interventions and Clinical Practice

Answer 15

Unproven interventions may be used if
- no proven intervention OR all proven interventions have been ineffective
- informed consent obtained
- offers hope of alleviating suffering, saving life

Must be made object of research, new information recorded and made publicly available