This presentations describes the history of human research ethics: from its origins in medical research to a much broader framework

1. History of human research ethics:
‘Human subjects in research must be
protected’:
Joost Groot Kormelink, secretary HREC
March 2018

2. Human research ethics has developed in both
theory and practice from experiences in medical
research

3. Controversial medical research

4. Nuremburg tribunal: medical research
The voluntary consent of the
human subject is absolutely
essential, making it clear that
subjects should give consent
and that the benefits of the
research must outweigh the
risks

5. Helsinki declaration 1964
The subject's welfare must always take
precedence over the interests of
science and society and ethical
considerations must always take
precedence over laws and regulations

6. Principles Helsinki Declaration
• Protect the life, health, privacy, and dignity of the human subject.
• The right of research subjects to safeguard their integrity must always be
respected.
Informed consent by research participants is necessary.
Risks should not exceed benefits.
Vulnerable groups: special procedures.
• Research protocols should be reviewed by an independent committee prior to
the research.
Committees oversee most governmentally-funded medical
research around the world.

7. Milgram Experiments

8. From medical human research to general
adaptation for all experiments
‘Basic ethical principles and guidelines that
should assist in resolving the ethical
problems that surround the conduct of
research with human subjects (also non-
medical)’ .
Always ensure approval by IRB

9. Belmont report: fundamental principles for
human research
• Respect for persons
• Beneficence
• Justice.

10. Menlo report
2012

11. Over the last decades…
Increasing awareness that all
human research needs
institutional review, also
because of regulations from
sponsors and journals.

12. Since 2012 the TU Delft has its own
independent human research ethics
committee.

13. Key references
• WHO/Helsinki declaration and updates: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
• Belmont report 1978 : https://www.hhs.gov/ohrp/regulations-and-policy/belmont-
report/index.html
• Applying Ethical Principles to Information and Communication Technology Research: A Companion
to the Department of Homeland Security Menlo Report (2012):
https://www.dhs.gov/sites/default/files/publications/CSD-MenloPrinciplesCOMPANION-20120103-
r731.pdf
• Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee, 2014 ( David
Koepsell, Willem-Paul Brinkman Sylvia Pont - HREC TU Delft):
https://www.ncbi.nlm.nih.gov/pubmed/24938695
Questions: Hrec@tudelft.nl