WEEK NINE Flashcards
What is ethics in research?
- Protecting rights of subjects
- Balance of benefits and risks
- Informed consent
- Ethics committee review
Principles of Nuremberg Code (1946) ?
- Voluntary consent
- Protection of subjects from harm
- Benefits vs risks
- Qualified researchers
Principles of Declaration Of Helsinki (1964) ?
-Most recent version 2008
- Duty to protect life, health, privacy & dignity
- Proposal submitted to independent ethics committee for approval
- Special provisions for children & other groups unable to give consent
Example of unethical studies?
Tuskagee Syphillis Trial (1932-62)
Cervical Cancer Study NZ 1966
Elements of informed consent?
Title of agency Invitation to participate Basis for participant selection Study purpose/aim Explanation of procedures Description of risks/benefits Access to treatment and compensation if injury occurs Voluntary participation Right to withdraw Assurance of confidentiality/anonymity Conflicts of interests declared Offer to answer any questions Names & contacts of researchers, institution, ethics committee Concluding statement Separate consent form
Elements of informed consent for children?
- Children, parents/guardians/caregivers must all be fully informed in appropriate manner
- Children advised of rights
- Children given opportunity to ask questions
- Person signing must also be advised of rights & given opportunity for questions
Priavcy in research?
concealment of all matters relating to the participants
- Refers to keeping matters concealed- making sure not made public
- Legal AND ethical requirement in Australia
- Australian researchers must adhere to State and Federal laws
- Involves protecting anonymity and confidentiality
Anonymity?
no one should be able to identify study participants
- Not always possible with qualitative research
- Can use pseudonyms (assumed names) or number codes
- Geographical issues may hinder anonymity
- Part of informed consent should alert participants to possibility of lack of anonymity
Confidentiality?
identities of subjects not linked to information provided: use of codes
Data must be securely stored
Can be challenges in qualitative research
What is Justice?
risks and benefit distributed evenly
What is Beneficence?
do good/prevent harm
Human Vulnerability & Personal Integrity
Protection of vulnerable groups: Homeless Refugees Children Prisoners Intellectual disability Ethnic minorities Pregnant women Dying patients
Respect for cultural diverstiy examples?
Ethnicity Sexual orientation Religious affiliation Employment status Disability Age
Researcher Integrity & Honesty
- Critical for conduct, reporting & publication of studies
- Number of cases of previous research misconduct
- Includes: fabrication, falsification, plagiarism
- Does not include honest error or differences of opinion
Legal & Ethical regulatory Mechanisms
- International agreement but ensuring adherence problematic
- NH&MRC
- Agencies for ethical considerations of indigenous populations eg Western Australian Aboriginal Health -Information & Ethics Committee (WAAHIEC)
- Clinical trials in Australia must adhere to legal requirements of Therapeutic Goods Administration (TGA)
