1. Research ethics
P r e p a r e d b y, , , , , ,
Hanaa Tharwat
Yassmin Ismail
Somaya Fahmy
Eman Abdel-Moneim
2. Out lines
1- Introduction to ethics in research
•3-What is human research?
4-Why is Research Ethics Important
5-Ethical Principles Guiding Research
6-ETHICAL PRINCIPLES ACORDING TOBelmont Report
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
3. 1. Introduction to ethics in research
•you must accept the responsibility to behave
ethically toward those who will be affected by
your research
•ethics is the study of proper action
•research ethics concerns the responsibility of
researchers to be honest and respectful to all
individuals who may be affected by their
research studies or their reports of the
studies’ results
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:
1-research conducted with people
2-research conducted about people
.1research dealing in their data or tissue
8. 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
9. 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
*… and a requirement to comply with external
REF’s to obtain funding e.g. ESRC
10. 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
11. 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)
12. 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
13. 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
14. 4. Privacy & Confidentiality
•Fundamental to human dignity
•Standards protect the access, control,
dissemination of personal information
•Helps to protect mental, psychological
integrity
15. 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
16. 6. Justice and Inclusiveness
•i.e., fairness and equity
•Procedural justice
–Application process
•Distributive justice
–Harms and benefits
17. 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
18. 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)
19. Members of the Commission
to explained principle of research
ethics•Members of the Commission
•Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.
•Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.
•Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
•Dorothy I. Height, President, National Council of Negro Women, Inc.
•Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San
Francisco.
•Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.
•Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
•*** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
•Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University
of Texas at Dallas.
•***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology,
University of Pennsylvania.
•*** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
•***Deceased.
20. ETHICAL PRINCIPLES ACORDING TOBelmont
Report
The Belmont Report
identified three principles
essential to the
ethical conduct of
research with humans:
1. Respect for persons
2. Beneficence
3. Justice
These three basic principles serve as the foundation of the
current HHS regulations and guidelines for the ethical
conduct of human subjects research supported by HHS.
•
21. Respect for human dignity
•This Principle includes
•1-The right to self-determination
•2-The right to full disclosure
22. The Right to Self-Determination
•The right to self-determination means
that prospective participants have the right to
decide voluntarily whether to participate in a
study, without risking penalty or prejudicial
treatment. It also means that people have
that right to ask question, to refuse to give
information, and to withdraw from the study.
23. The Right to Full Disclosure
•The principle of respect for human dignity
emcompasses people’s right to make
informed, voluntary decision about study
participation. Which requires full disclosure.
Full Disclosure
Means that the research has fully described the
Nature of the study, the person’s right to refuse
Participation, the researcher’s responsibilities,
And likely risks and benefits.
24. The Right to Full Disclosure
Summary
The right to self determination and the right to
full disclosure are the tow major elements on
Which informed consent – discussed.
25. Beneficence
One of most fundamental ethical principles in
research is that of beneficence which imposes a
duty on researchers to minimize harm and to
maximize beneficence. This principle covers
multiple dimensions
-The right to freedom from harm and
discomfort.
- The right to protection from exploitation.
26. The right to freedom from harm and
discomfort
Researchers have an obligation to avoid,
prevent, or minimize harm in studies with
humans. Harm and discomfort can take many forms:-
can be physical (eg.,injury),emotional(eg.,stress) social
(eg.,loss of social port)of financial (eg., loss of wages).
Ethical researchers must use strategies to minimize all
types of harm and discomfort , even ones that are
temporary.
27. The right to protection from
exploitation
Involvement in a study should not place
participants at a disadvantage or expose them
to situations for which they have not been
prepared. Participants need to be assured that
their participation, or information they might
provide, will not be used against them in any
way.
28. The right to protection from
exploitation
•For example
Person describing his or her economic
circumstances to researcher should not be
exposed to the risk of losing public health
benefits; a person reporting drug abuse should
not fear exposure to criminal authorities.
29. cont,
- Qualitative, Quantitative Data
in qualitative research, the risk of exploitation my
become especially acute because the
psychological distance between investigators and
participants typically declines as the study
progresses .On other hand ,qualitative
researchers typically are in better position than
quantitative researchers to do good, rather than
just to avoid doing harm, because of the close
relationships they often develop with
participants
30. JUSTICE
.The third broad principle articulated in the
Belmont Report concerns justice, which
includes participants 'right to fair treatment
and their right to privacy
-the right to fair treatment
-the right to privacy
31. The Right to Fair Treatment
One aspect of the justice principle concerns the
equitable distribution of benefits and burdens
of research .The selection of study participants
should be based on research requirements and
not on the vulnerability or compromised
position of certain people.
32. The Right to Fair Treatment cont
The right to fair treatment encompasses other
obligations. It means that researchers must treat
people who decline to participate in a study or
who withdraw from it in a non prejudicial manner
they must honor all agreements made with
participants, including the payment of any
promised stipends; demonstrate sensitivity to
[and respect for] thebeliefe, habits,and lifestyles
of people from different backgrounds or cultures;
and afford participants courteous and tactful
treatment at all times.
33. the right to privacy
Virtually all research with humans involves
intruding into personal lives; researchers should
ensure that their research is not more intrusive
than it needs to be and that participants’ privacy
is maintained throughout the study. Participants
have the right to expect that any data they
provide will be kept in strictest confidence.
34. •Participants: Who are the?
Defining participants
•People who are the principal focus of the
research
•Whom the research impacts (concurrently or
retrospectively).
35. 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.
36. 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).
37. 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.
38. 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.
39. 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.
40. 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.
41. 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).
42. Research Ethics: Areas of Focus
*Harm
*Informed Consent
*Confidentiality
*Deception
*Reporting Results and Plagiarism
43. Harm
•-As mentioned before, researchers should
take every precaution to ensure that
participants are not subjected to undue harm
or stress
•-Harm and discomfort can take many forms
;can be physical[eg, injury], emotional[ eg
,stress]social[eg,loss of social port]or
financial[eg, loss of wages]. Ethical
•-researchers must use strategies to minimize
all types of harm and discomfort, even ones
that are temporary
44. Informed Consent
-Voluntary Informed Consent is essential for research
involving human subjects
-According to the APA, Informed Consent should include:
*Description of the nature of the research
*Statement that the research is voluntary and
participants can withdraw at any time
*Identification of Risks and Benefits
*Description of how confidentiality will be protected
*Description of compensation
*Description of what info researchers will share with
participants
*Identification of who is responsible for research with
contact information
45. Confidentiality
*All information collected in a research
project should remain confidential
-Participants should be assigned a HIPAA
compliant code
-Data should be locked away in a secure setting
-Electronic Databases should also be protected
What do you do if you bump into a
research participant in Wal-Mart?
46. Plagiarism
*Comes from the Latin word meaning “to
kidnap”
*Examples of plagiarism:
-Copying someone else’s words without proper
citation
-Stealing someone else’s ideas
-Stealing someone else’s intellectual property
Bottom Line: Cite sources properly and
minimize quotations in research reports
47. Treatment of Vulnerable groups
•Adherence to ethical standards is often
straightforward. 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
48. cont.,
1-Children legally and ethically.
•2-Mentally or emotionally disabled people.
•3-Severely ill or physically disabled people.
•4-The terminally ill
•5-Institutionalied people
49. 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.
50. 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.
51. 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.
52. 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.
53. 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.
55. 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.
56. •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
Printing Office.
•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.:
U.S. Government Printing Office.
•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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