College of Nursing Silliman University
Ethics in Nursing Research Florenda F. Cabatit RN. MA Facilitator
Hi stori cal Context Past
• German experimentation • Tuskegee Syphilis study
Present
• Cancer research in Brooklyn
Historical Context Ethical
system designed to prevent people from being used as scientific guinea pigs Contemporary emphasis on the ‘rights’ of people to take risks to save themselves
Ethical Codes and Regulations
Nuremberg Code Declaration of Helsinki, Helsinki II The Belmont Report Codes of Federal Regulations for the Protection of Human Subjects (1981, 1991) ANA Human Rights Guidelines for Nurses in Clinical and other research (1985) ANA Position statement on Ethics and Human Rights (1991).
The Nurember g C ode
The B elmo nt R eport
Declaration of Helsinki
Declaration of Helsinki contd.
Ethical Principles The principle of beneficence -
Encompasses the maxim “ Above all do no harm”
Dimensions: Freedom from harm - Freedom from exploitation Benefits from Research The risk/benefit ratio -
The Principle of Res pe ct for Huma n Di gnity
Dimensions: The
right to selfdetermination The Right to Full disclosure
●
Informed consent
•Voluntary participation
Th e Pri nciple of Ju stice Dimensions: 1.The Right to Privacy
•Anonymity •Confidentiality
Th e Pri nciple of Ju stice Dimension 2.The Right to Fair Treatment
•Right to services
Vulnerable Groups • The old and the young • Mentally or physically disabled • Institutionalized persons • Pregnant women
Ele ments o f In for me d Con sent 1. 2. 3. 4. 5. 6. 7.
Purpose of the research project Procedures Risks and discomforts Benefits Alternatives to participation Confidentiality Request for more information
Elements of Informed Consent contd. 1. 2. 3. 4.
Refusal or Withdrawal Injury statement Consent statement Signatures
Institutional Review Boards Mechanism
for reviewing proposed research Mechanism for protecting the institution and researcher Submitting an IRB proposal