2. Outlines
1. Introduction to ethics in research
2. Definition of ethics
3. What is human research?
4. Why is research ethics important
5. Ethical principles guiding research
6. Ethical principles
7. Participants: Who are the?
8. Procedures for protecting study participants
9. Major potential benefits to participants
10. Major potential risks to participants
11. Ethics: areas of focus
12. Treatment of vulnerable groups
4. Ethics
Ethics:
principles for guiding decision making and reconciling
conflicting values
People may disagree on ‘ethics’ because it is based on
people's personal value systems
What one person considers to be good or right may be
considered bad or wrong by another person
6. What is human research?
Human research is:
• research conducted with people
• research conducted about
people
• research dealing in their data or
tissue
7. Why is Research Ethics Important?
• It is a reflection of respect for those who
‘take part’ in research
• It ensures no unreasonable, unsafe or
thoughtless demands are made by
researchers
• It ensures sufficient knowledge is shared by
all concerned
• It imposes a common standard in all the
above respects
8. Why is Research Ethics Important
*It has become the norm as an expectation for
research activity
*…. a professional requirement for practitioners
in some disciplines e.g. psychology
*… a requirement for access to participants in
others e.g. health
9. Ethical Principles Guiding Research
*Respect for human dignity
*Respect for free and informed consent
*Respect for vulnerable persons
*Respect for privacy and confidentiality
*Respect for justice and inclusiveness
*Balancing harms and benefit
*Minimizing harm
*Maximizing benefit
10. 1. Human Dignity
Cardinal Principle
Basis of ethical obligations
Two essential components
• The selection and achievement of morally
acceptable ends
• The morally acceptable means to those ends
Protect the multiple and interdependent interests of
the person (bodily, psychological, cultural integrity)
11. 2. Consent
-Presumption that individuals have capacity
and right to make free and informed decisions
• In research = dialogue, process, rights, duties,
requirements for free and informed consent
by the research subject
• Your research cannot proceed without
consent
• Consent must be maintained throughout
12. 3. Vulnerable Persons
Ethical obligations towards vulnerable persons •
-Diminished competence
-Diminished decision-making capacity
Entitled to special protection, special •
procedures to protect their interests
Entitlement (based on grounds of human •
dignity, caring, solidarity, fairness) to special
protection against abuse, exploitation,
discrimination
13. 4. Privacy & Confidentiality
Fundamental to human dignity •
Standards protect the access, control, •
dissemination of personal information
Helps to protect mental, psychological •
integrity
14. 5. Harms and Benefits
Balance critical to ethics of human research •
Foreseeable harms should not outweigh •
anticipated benefits
Harms-benefits analysis affects welfare and •
rights of subjects
15. 6. Justice and Inclusiveness
i.e., fairness and equity •
Procedural justice •
Application process
Distributive justice •
Harms and benefits
16. 7. Non-malfeasance
Duty to avoid, prevent or minimize harm •
No unnecessary risk of harm •
Participation must be essential to achieving •
scientifically and societally important aims
that cannot be realized without the
participation of human subjects
Minimizing harm requires smallest number of •
human subjects that will ensure valid data
17. 8. Beneficence
-The duty to benefit others
-The duty to maximize net benefits
-Produce benefits for subjects themselves, other
individuals
-Produce benefits for society as a whole and for
the advancement of knowledge (usually the
primary benefit)
18. Participants: Who are they?
Defining participants
• People who are the principal focus of the
research
• Whom the research impacts (concurrently or
retrospectively)
19. Procedures for protecting study
participants
Now that you are familiar with fundamental
ethical principles for conducting research, you
need to understand the procedures researchers
follow to adhere to them .
It is these procedures that should be evaluated in
critiquing the ethical aspects of a study.
20. Risk- Benefits Assessments
• One strategy that researchers use to protect
participants is to conduct a risk-benefits
assessment.
Such an assessment is designed to determine
whether the benefits of participating in a
study are in line with costs be they financial,
physical, emotional, or social (i.e,Whether risk-
to benefits ratio is acceptable).
21. Cont.,
• The general guideline is that the degree of risk
to be taken by participants should never
exceed the potential humanitarian benefits of
knowledge to be gained .
Thus, the selection of a significant topic that
has the potential to improve patient care is
the first step in ensuring that research is
ethical.
22. Major potential benefits to
participants
*Access to a potentially beneficial
intervention that might otherwise be
unavailable to them.
* Comfort in being able to discuss their situation
or problem with a friendly objective person.
*Increased knowledge about themselves or
their condition, either though opportunity for
introspection and self- reflection or through
direct interaction with researchers.
23. Major potential benefits to
participants
*Escape from a normal routine, excitement of
being part of study.
*Satisfaction the information they provide may
help others with similar problems or condition.
*Direct monetary or material gain through
stipends or other incentives.
24. Major Potential Risks to
Participants
*Physical harm, including unanticipated side
effects.
*Physical discomfort, fatigue, or boredom.
*Psychological or emotional distress resulting
from self-disclosure, introspection, fear of the
unknown, discomfort with strangers, fear of
eventual repercussion, anger or embarrassment
at the type of questions being asked.
25. Major Potential Risks to Participants
*Social risks, such as the risk of stigma, adverse
effects on personal relationships, loss of status.
*Loss of privacy.
*Loss of time.
*Monetary costs (e.g, for transportation, child
car, time lost from work).
26. Treatment of Vulnerable groups
Adherence to ethical standards is often straight forward.
The rights of special vulnerable groups, however, ,may
need to be protected through additional procedures and
heightened sensitivity.
Vulnerable subjects may be incapable of living fully
informed consent or may be at high risk of unintended
side effects because of their circumstances.
You should pay particular attention to the ethical
dimensions of study when people who are vulnerable
are involved as being vulnerable are the following:
27. cont.,
1. Children legally and ethically.
2. Mentally or emotionally disabled people.
3. Severely ill or physically disabled people.
4. The terminally ill.
5. Institutionalized people.
28. 1- Children legally and ethically
Children do not have the competence of give •
informed consent and so the consent of children’s
parents or guardians shoud be obtained.
However ,it is appropriate especially if the child is at •
least 7 Years of age-to obtain the child’s assent as well
Assent refers to the child’saffirmative agreement to
participants.
If the child is development mature enough to •
understand the basics of informed consent evidence of
respect for the child’s right to self-determination.
29. 2- Mentally or emotionally disabled
people
Individuals whose disabiity makes it •
impossible for them to weight the risk and
benefits of participation and make informed
decisions .
(peopelaffected by cognitive important, •
mental illness, coma and so on)
Also can not legally provide informed •
consent.In such cases, researchers should
obtain the written consent of lgal guardin.
30. 3-Severely ill or physically disabled
people
For patients who are very ill or undergoing •
certain treatment (e.g.,mechanical ventilation)
it might be necessary to assess their ability to
make reasoned decisions about study
participation.
Another issue that for certain disabilities , •
special procedures for obtaining consent may
be required.
31. CONT
For example :
With people who cannot read and write or
who have a physical impairment preventing
them from writing alternative procedures for
documenting informed consent should be
used.
32. 4-The terminally ill
Terminally ill people can seldom expect to
benefit personally from research, and thus the
risk-to- benefit ratio needs to be carefully
assessed researchers must also take steps to
ensure that if the terminally ill do participate in
a study ,their health care and comfort are not
compromised.
34. References
Beecher, H.K. 1966. “Ethics and Clinical Research.” New England Journal of Medicine 274(24):1354– •
1360.
Faden, R.R., and T.L. Beauchamp. 1986. A History and Theory of Informed Consent. New York: Oxford •
University Press.
Institute of Medicine (IOM). 2001. Preserving Public Trust: Accreditation and Human Research •
Participant Protection Programs.
Washington, D.C.: National Academy Press. •
Jonas, H. 1969. “Philosophical Reflections on Experimenting with Human Subjects.” Daedalus 98:219– •
247.
Jones, J.H. 1981. Bad Blood: The Tuskegee Syphilis Experiment. •
35. •
•
New York: The Free Press. •
Katz, J. 1972. Experimentation with Human Beings. New York: Russell Sage Foundation. •
National Bioethics Advisory Commission (NBAC). 1997. Cloning Human Beings. 2 vols. Rockville, MD: U.S. Government
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National Bioethics Advisory Commission •
———. 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. 2 vols.
Rockville, MD: U.S. Government Printing Office.
•
———. 1999a. Ethical Issues in Human Stem Cell Research. 3 vols. Rockville, MD: U.S. Government Printing Office. •
———. 1999b. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2 vols. Rockville, MD:
U.S. Government Printing Office.
•
———. 2001. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2 vols. Bethesda,
MD: U.S. Government Printing Office.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National •
Commission). 1979.
•
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.:
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Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973. Final Report. Washington, D.C.: U.S. Department of Health, •
Education, and Welfare.
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