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UNIVERSITY OF CEBU
Masters In Criminal Justice Education
With the Specialization of CRIMINOLOGY
Cebu City
Research Methods
DESIGNING ETHICALRESEARCH
Presented to:
MAURO ALLAN P. AMPARADO, MBA, MAN,
Ph.D.
Instructor
Presented by:
Reg. Crmgst. RAE KATHRINE T. GOSOSO
Student
• Defining ethics
• Codes of ethics
• Ethical Principles
• Informed consent
• Vulnerable subject
• Research misconduct
Ethics is….
• general beliefs, attitudes, values, or
standards that guide behavior.
1. Nuremberg Code
a. developed after the Nazi
atrocities were made public in the
Nuremberg trials.
b. One of the first internationally
recognized efforts to establish
ethical standards
2. Declaration of Helnski
a. Adopted in 1964 by the World
Medical Association
b. Revised in 2000
3. American Nurse Association
a. Ethical Guidelines in the Conduct,
Dissemination, and Implementation
of Nursing Research (Silva, 1995)
4. American Sociological Association
a. Published a revised Code of
Ethics (1997)
5. American Psychological
Association
a. Ethical Principles of
Psychologists and Code of Conduct
(1992)
6. National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research
(1978)
a. Belmont Report – served as the
basis for regulations affecting
research sponsored by the federal
government
i. Articulated three primary ethical
principles on which standards of
ethical conduct in research are
based: beneficence, respect for
human dignity, and justice.
PRINCIPLE OF
BENEFICENCE
THE PRINCIPLE OF JUSTICE
THE PRINCIPLE OF RESPECT
FOR HUMAN DIGNITY
PRINCIPLE OF
BENEFICENCE
THE PRINCIPLE OF JUSTICE
THE PRINCIPLE OF
RESPECT FOR HUMAN
DIGNITY
A
1. Freedom from harm
• a. Physical
• b. Psychological
• c. Social
• d. Economic
• e. Minimize all types of harm and discomfort
• f. Achieve balance between potential benefits and risks of
being a participant
• g. Qualified people only to conduct potentially dangerous
technical equipment or specialized procedures
• h. Termination of research: injury, death, disability,
undue distress
2. Freedom from Exploitation
-should not expose them to situations for which they
have not been prepared.
- need to be assured that their participation or
information they might provide, will not be used
against them in any way.
- Study participants enter into a special relationship
with researchers, and it is crucial that this
relationship not be exploited , Exploitation may be
overt and malicious, but it might also be more subtle
3. Benefits from Research
a. Participants may perceive
direct personal benefits
b. Any benefits from the
research accrue to society in
general or to other individuals
c. Researchers should strive
insofar as possible
to maximize benefits and to
communicate potential benefits
to participants’
•
4. The Risk/Benefit Ratio
a. The degree of risk to be taken by
those participating in the research
should never exceed the potential
humanitarian benefits of the
knowledge to be gained
b. The selection of a significant topic
that has the potential to improve
patient-care is the first step in ensuring
that research is ethical
c. Minimal Risk – risks anticipated to
be no greater than those ordinarily
encountered in daily life or during
routine physical or psychological tests
or procedures
c. Quantitative studies vs. Qualitative
studies
PRINCIPLE OF
BENEFICENCE
THE PRINCIPLE OF JUSTICE
THE PRINCIPLE OF
RESPECT FOR HUMAN
DIGNITY
B
1. Right to Self-Determination
a. the right to decide voluntarily whether to
participate in the study, without risking any
penalty or prejudicial treatment
b. the right to ask questions, to refuse to give
information, to ask for clarification, or to
determine their participation
c. Freedom from coercion of any type
- explicit or implicit threats of penalty from
failing to participate in a study or excessive
rewards from agreeing to participate
- position of authority
- generous monetary incentive (or stipend)
2. Right to Full Disclosure
• a. The researcher has fully
described the nature of the study,
the person’s right to refuse
participation, the researcher’s
responsibilities, and likely risks and
benefits.
• b. There is often a need for further
disclosure at a later point of the
study, either in debriefing sessions
or in written communication.
3. Issues Relating to the Principle of Respect
• a. Inability of some individuals
to make well-informed
judgments about the risks and
benefits of study participation
• b. Full disclosure can
sometimes create two types of
bias:
i. subjects provide inaccurate
information
ii. representative sample is not
recruited
EXAMPLE:
Research Study: Relationship
between high school students’
substance abuse and their
absenteeism
Hypothesis: Students with a high
rate of absenteeism are more
likely to be substance abusers
than students with a good
attendance record
c. Techniques that researchers sometimes
use in conflicting situations
• i. Covert data
collection or
concealment
ii. Deception
- Criteria must be met:
• (1) The study must be of such small risk to
the research participant and of such
great significance to the advancement of
the public good that concealment can be
morally justified.
• (2) The acceptability of concealment or
deception is related to the degree of
risks to research participants
• (3) Concealment or deception are used
only as last resorts, when no other
approach can ensure the validity of the
study’s findings
• (4) The investigator has a moral
responsibility to inform research
participants of any concealment or
deception as soon as possible and to
explain the rationale for its use (Silva,
1995)
d. Collection of data from people over
the internet.
EXAMPLE: Some researchers are analyzing the
content of messages posted to chat rooms or list
serves.
ISSUE: Whether such messages can be used as
data without the authors’ permission and their
informed consent.
- Researchers, before collecting electronic data,
negotiate their entry into an electronic community
(e.g., chat room) with the list owner (Schrum, 1995)
- Obtaining consent from list moderators does not
necessarily mean that every member of the
ETHICAL PRINCIPLES
PRINCIPLE OF
BENEFICENCE
THE PRINCIPLE OF JUSTICE
THE PRINCIPLE OF
RESPECT FOR HUMAN
DIGNITY
C
THE PRINCIPLE OF JUSTICE
“Participants’ right to fair treatment and their
right to privacy”
1. The Right to Fair Treatment
• Participants have the right to fair
and equitable treatment before,
during and after their participation
in the study (Polit and Beck, 2004).
Fair treatment includes the
following features:
Who ought to receive
the benefits of research
and bear its burdens?
Respect for cultural and other forms of human diversity
The non prejudicial treatment of those who decline to participate or
who withdraw from the study after agreeing to participate
The honoring of all agreements between researchers and participants,
including adherence to the procedures described to them and payment
of any promised stipends.
Participants’ access to research personnel at any point in the study to
clarify information
Participants’ access to appropriate professional assistance if there is
any physical or psychological damage
Debriefing, if necessary, to divulge information withheld before the
study or to clarify issues that arose during the study
Courteous and tactful treatment at all times.
2. The Right to Privacy
- participants have the right to expect that any data
they provide will be kept in strictest confidence
a. Anonymity – occurs when even the
researcher cannot link participants to their
data
EXAMPLE:
Thomas, Stamler, Lafrenier, and Dumala (2001) used
the Internet to gather data from an international sample of
women about their perceptions of breast health education
and screening. A website with a questionnaire was established.
No identifying information was sought from respondents, and
so their anonymity was guaranteed.
b. Confidentiality Procedures –
implemented when anonymity is impossible.
• - A promise of confidentiality is a pledge that
any information participants provide will not
be publicly reported in a manner that
identifies them and will not be made accessible
to others
• - Research information should not be shared
with strangers nor with people known to the
participants (e.g. family members, physician,
other nurses) unless the researcher has been
given explicit permission to share it.
 Steps to avoid occurrence
of breaches of confidentiality:
• Obtain identifying information (e.g., name, address) from participants only
when essential
• Assign an identification (ID) number to each participant and attach ID
number rather than other identifiers to the actual data.
• Maintain identifying information in a locked file.
• Restrict access to identifying information to a small number of people on a
need-to-know basis.
• Enter no identifying information as quickly as practical.
• Make research personnel sign confidentiality pledges if they have access to
data or identifying information
• Report research information in the aggregate; if information for a specific
participant is reported, take steps to disguise the person’s identity, such as
through the use of a fictitious name.
INFORMED CONSENT
• - participants have adequate
information regarding the research, are
capable of comprehending the
information, and have the power of free
choice, enabling them to consent to or
decline participation voluntarily.
The Content of Informed Consent
• 1. Participant Status
• 2. Study Goals
• 3. Type of data
• 4. Procedures
• 5. Nature of the
Commitment
• 6. Sponsorship
• 7. Participant selection
• 8. Potential risks
• 9. Potential benefits
• 10. Alternatives
• 11. Compensation
• 12. Confidentiality Pledge
• 13. Voluntary consent
• 14. Right to withdraw
and withhold information
• 15. Contact information
> In some Qualitative studies, especially
those requiring repeated contact with the
same participants, it is difficult to obtain a
meaningful informed consent at the outset.
• researcher continually
renegotiates the consent,
allowing participants to play a
collaborative role in the
decision-making process
regarding ingoing participation.
- normally presented to prospective participants while they are
being recruited, either orally or in writing
- a written notice should not, however, take the place of spoken
explanations
- researchers must assume the role of teacher in communicating
consent information
- written statement should be consistent with the participants’
reading levels and educational attainment
- (For participants from a general population (e.g., patients in a
hospital),
- the statement should be written at about seventh or
eighth grade reading level.
• signing a consent form
Guidelines in developing a consent form:
• Organize the form coherently so that prospective participants can follow the logic of
what is being communicated.
• 2. Use a large enough font so that the form can be easily read, and use spacing that
avoids making the document appear too dense.
• 3. In general, simplify. Use clear and consistent terminology, and avoid technical terms
if possible
• 4. If possible, use a readability formula to estimate the form’s reading level, and make
revisions to ensure an appropriate reading level for the group under study.
• 5. Test the form with people similar to those who will be recruited, and ask for
feedback
1. Children
- informed consent of children’s parents or legal or legal guardians should be obtained
- it is appropriate, however to obtain the child’s (at 7 years old) assent as well
Assent: child’s affirmative agreement to participate.
2. Mentally or emotionally disabled people
- Researchers should obtain the written consent of a legal guardian (may not necessarily
have the person’s best interest in mind)
3. Severely ill or physically disabled people
- assess their ability to make reasoned decisions about study participation
EXAMPLE: Assessment of decisional capacity of mechanically ventilated patients
(Higgins and Daly, 1999)
- special procedures for obtaining consent from participants with certain disabilities
EXAMPLE: Deaf participants, People with physical impairment, Participants who
cannot read and write
4.The terminally ill
- careful assessment of risk/benefit ratio
- health care and comfort of participants are not compromised
- special procedures in obtaining consent if mentally/physically incapacitated
RESEARCH MISCONDUCT
Fabrication
– making up data or results and recording or
reporting it.
• punishable when the false data is incorporated into
the official study notebook; submitted to a
funding agency; or publicly disseminated through
the process of publication, patent application, or
at a public forum such as a professional meeting,
seminar, or symposium; regardless of whether the
data is subsequently published or not.
Falsification
• is manipulating research materials,
equipment, or processes, or changing or
omitting data or results such that the
research is not accurately represented in
the research record.
• selective omission/deletion/suppression
Plagiarism
is the appropriation of another person’s ideas,
processes, results, or words without giving
appropriate credit.
• A special case of plagiarism is the
unacceptable practice of "self-plagiarism" in
which an author will use segments of
his/her own published material in a new
publication without reference.
Research methodology

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Research methodology

  • 1. UNIVERSITY OF CEBU Masters In Criminal Justice Education With the Specialization of CRIMINOLOGY Cebu City Research Methods DESIGNING ETHICALRESEARCH Presented to: MAURO ALLAN P. AMPARADO, MBA, MAN, Ph.D. Instructor Presented by: Reg. Crmgst. RAE KATHRINE T. GOSOSO Student
  • 2. • Defining ethics • Codes of ethics • Ethical Principles • Informed consent • Vulnerable subject • Research misconduct
  • 3. Ethics is…. • general beliefs, attitudes, values, or standards that guide behavior.
  • 4. 1. Nuremberg Code a. developed after the Nazi atrocities were made public in the Nuremberg trials. b. One of the first internationally recognized efforts to establish ethical standards 2. Declaration of Helnski a. Adopted in 1964 by the World Medical Association b. Revised in 2000 3. American Nurse Association a. Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) 4. American Sociological Association a. Published a revised Code of Ethics (1997) 5. American Psychological Association a. Ethical Principles of Psychologists and Code of Conduct (1992) 6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) a. Belmont Report – served as the basis for regulations affecting research sponsored by the federal government i. Articulated three primary ethical principles on which standards of ethical conduct in research are based: beneficence, respect for human dignity, and justice.
  • 5. PRINCIPLE OF BENEFICENCE THE PRINCIPLE OF JUSTICE THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY
  • 6. PRINCIPLE OF BENEFICENCE THE PRINCIPLE OF JUSTICE THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY A
  • 7. 1. Freedom from harm • a. Physical • b. Psychological • c. Social • d. Economic • e. Minimize all types of harm and discomfort • f. Achieve balance between potential benefits and risks of being a participant • g. Qualified people only to conduct potentially dangerous technical equipment or specialized procedures • h. Termination of research: injury, death, disability, undue distress
  • 8. 2. Freedom from Exploitation -should not expose them to situations for which they have not been prepared. - need to be assured that their participation or information they might provide, will not be used against them in any way. - Study participants enter into a special relationship with researchers, and it is crucial that this relationship not be exploited , Exploitation may be overt and malicious, but it might also be more subtle
  • 9. 3. Benefits from Research a. Participants may perceive direct personal benefits b. Any benefits from the research accrue to society in general or to other individuals c. Researchers should strive insofar as possible to maximize benefits and to communicate potential benefits to participants’ • 4. The Risk/Benefit Ratio a. The degree of risk to be taken by those participating in the research should never exceed the potential humanitarian benefits of the knowledge to be gained b. The selection of a significant topic that has the potential to improve patient-care is the first step in ensuring that research is ethical c. Minimal Risk – risks anticipated to be no greater than those ordinarily encountered in daily life or during routine physical or psychological tests or procedures c. Quantitative studies vs. Qualitative studies
  • 10. PRINCIPLE OF BENEFICENCE THE PRINCIPLE OF JUSTICE THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY B
  • 11. 1. Right to Self-Determination a. the right to decide voluntarily whether to participate in the study, without risking any penalty or prejudicial treatment b. the right to ask questions, to refuse to give information, to ask for clarification, or to determine their participation c. Freedom from coercion of any type - explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate - position of authority - generous monetary incentive (or stipend)
  • 12. 2. Right to Full Disclosure • a. The researcher has fully described the nature of the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits. • b. There is often a need for further disclosure at a later point of the study, either in debriefing sessions or in written communication.
  • 13. 3. Issues Relating to the Principle of Respect • a. Inability of some individuals to make well-informed judgments about the risks and benefits of study participation • b. Full disclosure can sometimes create two types of bias: i. subjects provide inaccurate information ii. representative sample is not recruited EXAMPLE: Research Study: Relationship between high school students’ substance abuse and their absenteeism Hypothesis: Students with a high rate of absenteeism are more likely to be substance abusers than students with a good attendance record
  • 14. c. Techniques that researchers sometimes use in conflicting situations • i. Covert data collection or concealment ii. Deception - Criteria must be met: • (1) The study must be of such small risk to the research participant and of such great significance to the advancement of the public good that concealment can be morally justified. • (2) The acceptability of concealment or deception is related to the degree of risks to research participants • (3) Concealment or deception are used only as last resorts, when no other approach can ensure the validity of the study’s findings • (4) The investigator has a moral responsibility to inform research participants of any concealment or deception as soon as possible and to explain the rationale for its use (Silva, 1995)
  • 15. d. Collection of data from people over the internet. EXAMPLE: Some researchers are analyzing the content of messages posted to chat rooms or list serves. ISSUE: Whether such messages can be used as data without the authors’ permission and their informed consent. - Researchers, before collecting electronic data, negotiate their entry into an electronic community (e.g., chat room) with the list owner (Schrum, 1995) - Obtaining consent from list moderators does not necessarily mean that every member of the
  • 16. ETHICAL PRINCIPLES PRINCIPLE OF BENEFICENCE THE PRINCIPLE OF JUSTICE THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY C
  • 17. THE PRINCIPLE OF JUSTICE “Participants’ right to fair treatment and their right to privacy” 1. The Right to Fair Treatment • Participants have the right to fair and equitable treatment before, during and after their participation in the study (Polit and Beck, 2004). Fair treatment includes the following features: Who ought to receive the benefits of research and bear its burdens?
  • 18. Respect for cultural and other forms of human diversity The non prejudicial treatment of those who decline to participate or who withdraw from the study after agreeing to participate The honoring of all agreements between researchers and participants, including adherence to the procedures described to them and payment of any promised stipends. Participants’ access to research personnel at any point in the study to clarify information Participants’ access to appropriate professional assistance if there is any physical or psychological damage Debriefing, if necessary, to divulge information withheld before the study or to clarify issues that arose during the study Courteous and tactful treatment at all times.
  • 19. 2. The Right to Privacy - participants have the right to expect that any data they provide will be kept in strictest confidence
  • 20. a. Anonymity – occurs when even the researcher cannot link participants to their data EXAMPLE: Thomas, Stamler, Lafrenier, and Dumala (2001) used the Internet to gather data from an international sample of women about their perceptions of breast health education and screening. A website with a questionnaire was established. No identifying information was sought from respondents, and so their anonymity was guaranteed.
  • 21. b. Confidentiality Procedures – implemented when anonymity is impossible. • - A promise of confidentiality is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be made accessible to others • - Research information should not be shared with strangers nor with people known to the participants (e.g. family members, physician, other nurses) unless the researcher has been given explicit permission to share it.
  • 22.  Steps to avoid occurrence of breaches of confidentiality: • Obtain identifying information (e.g., name, address) from participants only when essential • Assign an identification (ID) number to each participant and attach ID number rather than other identifiers to the actual data. • Maintain identifying information in a locked file. • Restrict access to identifying information to a small number of people on a need-to-know basis. • Enter no identifying information as quickly as practical. • Make research personnel sign confidentiality pledges if they have access to data or identifying information • Report research information in the aggregate; if information for a specific participant is reported, take steps to disguise the person’s identity, such as through the use of a fictitious name.
  • 23.
  • 24. INFORMED CONSENT • - participants have adequate information regarding the research, are capable of comprehending the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily.
  • 25. The Content of Informed Consent • 1. Participant Status • 2. Study Goals • 3. Type of data • 4. Procedures • 5. Nature of the Commitment • 6. Sponsorship • 7. Participant selection • 8. Potential risks • 9. Potential benefits • 10. Alternatives • 11. Compensation • 12. Confidentiality Pledge • 13. Voluntary consent • 14. Right to withdraw and withhold information • 15. Contact information
  • 26. > In some Qualitative studies, especially those requiring repeated contact with the same participants, it is difficult to obtain a meaningful informed consent at the outset.
  • 27. • researcher continually renegotiates the consent, allowing participants to play a collaborative role in the decision-making process regarding ingoing participation.
  • 28. - normally presented to prospective participants while they are being recruited, either orally or in writing - a written notice should not, however, take the place of spoken explanations - researchers must assume the role of teacher in communicating consent information - written statement should be consistent with the participants’ reading levels and educational attainment - (For participants from a general population (e.g., patients in a hospital), - the statement should be written at about seventh or eighth grade reading level.
  • 29. • signing a consent form Guidelines in developing a consent form: • Organize the form coherently so that prospective participants can follow the logic of what is being communicated. • 2. Use a large enough font so that the form can be easily read, and use spacing that avoids making the document appear too dense. • 3. In general, simplify. Use clear and consistent terminology, and avoid technical terms if possible • 4. If possible, use a readability formula to estimate the form’s reading level, and make revisions to ensure an appropriate reading level for the group under study. • 5. Test the form with people similar to those who will be recruited, and ask for feedback
  • 30.
  • 31.
  • 32. 1. Children - informed consent of children’s parents or legal or legal guardians should be obtained - it is appropriate, however to obtain the child’s (at 7 years old) assent as well Assent: child’s affirmative agreement to participate. 2. Mentally or emotionally disabled people - Researchers should obtain the written consent of a legal guardian (may not necessarily have the person’s best interest in mind) 3. Severely ill or physically disabled people - assess their ability to make reasoned decisions about study participation EXAMPLE: Assessment of decisional capacity of mechanically ventilated patients (Higgins and Daly, 1999) - special procedures for obtaining consent from participants with certain disabilities EXAMPLE: Deaf participants, People with physical impairment, Participants who cannot read and write 4.The terminally ill - careful assessment of risk/benefit ratio - health care and comfort of participants are not compromised - special procedures in obtaining consent if mentally/physically incapacitated
  • 33. RESEARCH MISCONDUCT Fabrication – making up data or results and recording or reporting it. • punishable when the false data is incorporated into the official study notebook; submitted to a funding agency; or publicly disseminated through the process of publication, patent application, or at a public forum such as a professional meeting, seminar, or symposium; regardless of whether the data is subsequently published or not.
  • 34. Falsification • is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. • selective omission/deletion/suppression
  • 35. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. • A special case of plagiarism is the unacceptable practice of "self-plagiarism" in which an author will use segments of his/her own published material in a new publication without reference.