Transcript Ethical Principles and Guidelines for Research Involving Human Subjects Based on guidelines from the University of North Carolina Institutional Review Board.

Ethical Principles and Guidelines for
Research Involving Human Subjects
Based on guidelines from the University of
North Carolina Institutional Review Board
First … a Brief History of Our Current
Human Subjects Protections
The Nuremberg Code
∆ Concern for the protection of people serving as research
subjects was heightened following the Nuremberg war crime
trials.
∆ The Nuremberg Code was drafted as a set of standards for
judging doctors and scientists who conducted experiments on
prisoners in concentration camps.
∆ The code became a prototype for later codes establishing
standards for the ethical treatment of subjects of research.
The Declaration of Helsinki (1964)
∆ Established by the World Medical Association to
guide medical doctors in research involving
human subjects
The National Research Act (1974)
∆ Established the National Commission for the
Protection of Human Subjects of Biomedical
and Behavioral Research in the United States
• The Belmont Report, issued by the commission set
forth the basic ethical principles that should underlie
the conduct of human research
Ethical Principles Underlying Acceptable
Conduct of Research Involving Humans
∆ Respect for persons: recognition of the personal dignity and
autonomy of individuals, with special protections for those
with diminished autonomy
∆ Beneficence: obligation to protect persons from harm by
maximizing anticipated benefits and minimizing potential risks
of harm
∆ Justice: benefits and burdens of research should be
distributed fairly
If the PLACE Assessment Receives
Funding from any U.S. Government
Agency…
∆ All U.S.-funded research involving human subjects is required
by U.S. law to be reviewed according to the rules set out in the
U.S. Code of Federal Regulations, Title 45, Part 46, Protection
of Human Subjects
∆ Each institution conducting research is required to have a
formal mechanism for review, and must comply with all of the
federal regulations
∆ An institutional review board (IRB) provides that formal
mechanism within an institution
∆ Assurances link IRBs with a federal regulatory agency in the
United States
What Do You Need to Consider When
Conducting Research Involving Human
Subjects?
When in Doubt ... Researchers Ask the
Institutional Review Board (IRB)
What is a Human Subject?
A living individual about whom an investigator conducting
research obtains the following:
∆ Data through interaction or intervention with the
individual
∆ Identifiable private information
• Information about behavior that occurs in a context in
which an individual can reasonably expect that no
observation or recording is taking place, or information
provided for a specific purpose
Exemptions
1. Research conducted in established or commonly
accepted educational settings, involving normal
educational practices
2. Anonymous research UNLESS
∆ subjects could be identified, directly or through
identifiers linked to subjects and
∆ disclosure of the subjects’ responses outside the
research could reasonably place the subjects at
risk of criminal or civil liability or be damaging to
the subjects’ financial standing, employability or
reputation
Exemptions
3. Taste and food quality evaluation and consumer acceptance
studies
4. Research involving the collection or study of existing data,
documents, records, or specimens…
Be careful of the risk of deductive disclosure!!
Deductive Disclosure Example
∆ From a sample of 90,000 participants in an adolescent health study,
you could identify one individual by knowing relatively few
characteristics
∆ A 15 year old Asian male in grade 10, born in the U.S. and attending
an urban, secondary school in New York, plays football
15 years old
male
grade 10
Asian
born in U.S.
football
New York
secondary school
urban
14,575
7,423
2,606
1,497
1,386
79
16
13
1
Once It Is Determined that Human
Subjects Are Involved….
∆ The institutional review board (IRB) must be presented with
enough information to evaluate risks and benefits, adequacy
of consent procedures, and protection of confidentiality
PLACE assessments are approved by the
IRB of the University of North Carolina
School of Public Health
and
<LOCAL IRB THAT APPROVED PROTOCOL>
Risks to Participants
Harm may result directly from research procedures or
from breach of confidentiality
Types of risk:
∆ Physical (pain, drug side effects, injury)
∆ Psychological (emotional distress)
∆ Social (stigmatization)
∆ Economic (loss of job for disclosing
information)
Minimal Risk
A risk is considered minimal “where the
probability and magnitude of harm or discomfort
anticipated in the proposed research are not
greater, in and of themselves, than those
ordinarily encountered in daily life or during the
performance of routine physical examinations or
tests.”
U.S. Code of Federal Regulations, Title 45, Part 46
Minimal Risk
Examples of what is considered minimal risk:
∆ Collection of hair and nail clippings, urine,
blood samples <450 ml from non-pregnant
adults
∆ Recording data using non-invasive
procedures (blood pressure, anthropometry,
EEG, EKG)
∆ Interviews, questionnaires, on non-sensitive
subject matter
What Is Sensitive Information?
Depends on the context
∆ Usually or always sensitive: illegal behavior,
immigration status, sexual behavior, health status
(e.g. specific disease status)
∆ Potentially sensitive depending on cultural context:
income (China), abortion data (Philippines but not
Russia)
Benefits
Institutional review boards (IRBs) determine whether the
benefits outweigh the risks to subjects
∆ Will subjects benefit directly?
∆ Will the research result in generalizable
knowledge? Does it present an opportunity to
understand, prevent, or alleviate a serious
problem?
The scientific merit of the research is weighed in the
risk/benefit analysis
Informed and Voluntary Consent
Basic Elements of Informed Consent:
∆ Statement that this is research
∆ Purpose of research, expected duration
∆ Procedures, reasonably foreseeable risks
∆ Benefits, alternative procedures
∆ Compensation
∆ Provisions for confidentiality
∆ Rights to withdraw or refuse specific aspects of protocols
∆ Information on whom to contact for additional information or
problems
Important Aspects of Consent
Comprehension: Information must be presented so that
subjects can understand
∆ Language, reading level, all the terms used
Voluntariness
∆ Freedom from coercion
Documentation of Informed Consent
∆ The PLACE interviews that you conduct will begin
with a formal “verbal consent” step
∆ This insures that respondents who agree to be
interviewed are giving a truly informed consent
Respecting Privacy and Insuring
Confidentiality
Privacy:
∆ You will not be asking for the names or any other
identifying information from respondents during
the PLACE assessment.
∆ Interviews must be conducted where others
cannot overhear the information given (even
friends or family!)
Confidentiality:
∆ Interviewer confidentiality pledge
∆ Separation of data from identifying information
Special Provisions:
Children
Research requires parental consent and assent of a child
Research on children is allowed if:
∆ It poses no more than minimal risk
∆ It poses more than minimal risk but offers direct
benefit to the child
∆ There is no prospect of direct benefit to the child, but
the research is likely to yield generalizable knowledge
AND the risk represents a minor increase over
minimal risk.
Special Provisions:
Prisoners
∆ Incarceration may affect prisoners’ ability to make a truly
voluntary and uncoerced decision about whether to participate
∆ Risks must be commensurate with risk that would be
accepted by non-prisoners
∆ Incentives to participate must not be coercive
∆ To review research involving prisoners, the IRB must include
a prisoner advocate
Ethical Review Questions
Example #1
You interview a community informant who tells you
where sex workers solicit customers.
∆ Is it your duty to report this
illegal activity to the police?
Example #2
During an interview with a respondent who is the
manager of a bar, you notice that illegal drugs are
being bought and sold on the premises. He knows
that this illegal activity occurs at the venue but
chooses not do anything about it.
∆ Is it your duty to report him to the police?
End of Interviewer Ethical Training