CODES AND GUIDELINES

• Developed to observe the rules of research

• Influenced by a series of revelations about inappropriate use of
human participants in research
• Primary focus is protection of research participants
HELSINKI DECLARATION
• The World Medical Association developed the Helsinki declaration
• Originally developed in 1948 for the medical community
• It is considered as a cornerstone document for human research ethics
• It is a set of ethical principles regarding human experimentation
• The declaration has been revised several times, the latest being 2008.
HELSINKI DECLARATION
DUTIES OF PHYSICIANS
• Physicians involved in medical research are required to protect life,
health, dignity, integrity, right to self determination, privacy and
confidentiality of personal information
HELSINKI DECLARATION
Three main principles of the declaration are:
• Respect for individuals
• Right to make informed decisions
• Recognition of vulnerable groups
HELSINKI DECLARATION
• Research should be based on good science
• To be reviewed by an independent committee ( institution review
board/research board)
• Weigh importance in proportion to risk
• Interest of participants must always prevail over those of science and
society
• Informed consent from participant or legal guardian is required
INSTITUTIONAL ETHICS COMMITTEES
• Also called Institutional Review Boards (IRB)
• Boards/committees review research proposals as per guidelines and
procedures before researchers are allowed to collect data.
• They are the watchdogs or gate keepers of society
• They safeguard especially the vulnerable groups in society
• Should be independent panels of professionals from different
backgrounds
• Researcher needs to address the ethical implications of the project in
the proposal
INSTITUTIONAL ETHICS COMMITTEES
• Where the board has questions, they will make suggestions as to how the
project can be modified to conform to set standards
• Boards can refuse permission for a project to be done
• They protect participants from researchers who undertake unethical
projects that do not serve the purpose of science.
• They ensure that the risks to the participants are minimal
• An ethical clearance number is provided by the board as a reference for
future correspondence
• Penalties are imposed on researchers who do not follow laid down
procedures
ERES CONVERGE IRB
• This is the national research ethics board
• Research students submit their proposals to the board for assessment
• The board is located off Addis Ababa drive
• Students pay a fee to the board to have proposals reviewed
NUREMBURG CODE

• Developed in response to NAZI experiments

• Arose from war crimes tribunals
• Experiments were done with prisoners in German concentration
camps
NUREMBURG CODE

• Voluntary consent
• Research to yield fruitful results
• Avoid all unnecessary suffering
• There should be no predictable death/disability
• The risk not to be greater than importance of problem
• Participants to stop anytime
• Investigator must stop if experiment is harmful
CIOMS (COUNCIL FOR INTERNATIONAL
ORGANISATIONS OF MEDICAL SCIENCE GUIDELINES)

• First code to consider less developed communities

• Individual informed consent
• Appropriate inducements are allowed
• Consider special populations
• Observe privacy
• Ensure Independent committee review
 CIOMS
• Research must be responsive to health needs of host country
• Research disease has to be important problem in host country
• Agree in advance that products will be made reasonably available
afterwards
• Develop capacity to carryout similar projects independently, including
ethical review