Ethics

Lecturer: Violet Naanyu, PhD.

Email: vnaanyu@gmail.com

February, 2013

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 What is ethics?
 Importance of ethics in research
 Fundamental ethics principles in research
 Care and protection of participants
◦ Informed consent
 Ethical & research review committees
 Ethical considerations in publishing
 What is a profession?

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 Ethics:
◦ Norms for conduct that distinguish between acceptable
and unacceptable behavior.
◦ Involves systematizing, defending, & recommending
concepts of right and wrong behavior.
◦ Some ethical principals that various codes address:
-Honesty -Objectivity -Competence
-Integrity -Legality Carefulness -Animal care
-Openness -Human subjects protection
-Respect for intellectual property
-Confidentiality -Responsible publication
-Responsible mentoring -Respect for colleagues
-Social responsibility

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 Relevant players in research
Ethics
Committees and
Review Boards

Ethical Community and

Research Advocates

Researchers
and Sponsors

Interagency Coalition on AIDS & Devpt. V. Naanyu - MSB 102 - Ethics - Feb 2013 4
 Human participants in research may be harmed
 Protection and safeguards needed to prevent harm
 Not all risks can be predicted in advance
 Harms may outweigh benefits

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 Human participants may be wronged
◦ To treat people as a mere “means” or
“objects” to benefit others wrongs them
◦ Individuals possess human rights
 Research produces benefits
◦ Access to research may provide benefits
to the participants that are otherwise unavailable
◦ Health benefits to society result form research

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 Abuses in research have occurred in the e.g.
◦ Tuskegee: poor African-American men
observed , deceived and untreated for syphilis

◦ Contraceptive research with a placebo arm in Puerto

Rico without consent

◦ Nazi era where many experiments were conducted

without their knowledge
 There is widespread agreement on the past abuses

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 RESPECT FOR PERSONS: an expression of ethical
principle that people should not be treated as “mere
means” to the ends of others
◦ Mandates obtaining informed consent from each
individual to be enrolled
◦ Consent must be voluntary – not coerced
◦ Participants must be free to withdraw at will
◦ Privacy should be respected
◦ Confidentiality must be protected

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 BENEFICENCE:
◦ Maximize expected benefits (to participants and others)
minimizing potential harms, including psychological &
social harms
◦ Ensure that research design is adequate to
◦ derive benefits from results
 DISTRIBUTIVE JUSTICE:
◦ Benefits and burdens of research should be distributed
fairly among all social and economic classes, ethnic and
racial groups in society

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 The suitability of the investigator(s)’s qualifications and
experience for the proposed study
 Any plans to withdraw or withhold standard therapies for
the purpose of the research, & justification for such action
 The medical care to be provided to research participants
during and after the course of the research
 The adequacy of medical supervision and psychosocial
support for the research participants
 The criteria for extended access to, the emergency use of,
and/or the compassionate use of study products

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 The arrangements, if appropriate, for informing the
research participant’s general practitioner (family doctor),
including procedures for seeking the participant’s consent
to do so
 A description of any plans to make the study product
available to the research participants following the
research
 A description of any financial costs to research
participants
 The rewards and compensations for research participants
(including money, services, and/or gifts);
 The provisions for compensation/treatment in case of the
injury/disability/death of a research participant
attributable to participation in the research
 The insurance and indemnity agreements

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 A description of the persons who will have access to
personal data of the research participants, including
medical records and biological samples
 The measures taken to ensure the confidentiality and
security of personal information concerning research
participants

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 CIOMS guidelines: ‘research subjects who suffer physical
injury as a result of their participation are entitled to such
financial other assistance as would be compensate them
equitably for any temporary or permanent impairment or
disability. In case of death, their dependants are entitled to
material compensation. The right to compensation may not
be waived’

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 Vulnerable groups
 Prisoners
 Pregnant women or nursing mothers
 Children
 Poor people
 Illiterate
 …
 …

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 WHAT
 WHY
 BY WHOM
 TO WHOM
 HOW
 WHEN
 WHERE

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 Process by which a subject voluntarily confirms his or her
willingness to participate in a particular research study,
after having been informed of all aspects of the study that
are relevant to the subject’s decision to participate
 Informed consent is documented by means of a written,
signed and dated informed consent form
 It is a contract, co-adventure, a promise to deliver
 It must be clear and descriptive enough to stand alone in
describing the essential elements of the study

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 Informing
 Sharing knowledge
 Admitting ignorance if necessary
 Answering questions
 Identifying an answerable questions
 Appreciating doubts
 Respecting fears
 Creating partnership
 Giving rights for self-determination
 Facilitating open and searching dialogue

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1. IRBs
2. The research participants
3. The Investigator or physician
4. The research Institution

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 To ensure independence of ethical review of proposed
research
 To strive for impartiality in judging the merits and
shortcoming of proposed research
 To obtain an assessment of features of proposed
research by laypersons, ethicists, non scientific experts
as well as by scientists

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 To apply ethical principles to research protocols under
review
 To determine that risks are reasonable in light of
anticipated benefits (beneficence)
 To ensure that the process & documentation of informed
consent are ethically acceptable
(respect for persons)
 To ensure that recruitment practices are non-coercive and
respect the privacy and confidentiality of potential
participants (respect for persons)
 To seek to ensure equity in the selection of research
participants (justice)

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 To ensure that research complies with national laws,
and international guidelines governing research
involving human participants : ethical and many times
scientific issues
 To monitor research already in progress
◦ Adverse events reporting
◦ Consent monitoring

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 To develop policies governing specific aspects of
research at institutional, local or national levels
◦ Institutional: ERC/ local ERB e.g in hospitals
◦ Nationally: National Council for Science and
Technology (NCST)
◦ Kenya Medical Research Institute : Assists institutions
without ERBs

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 If you never publish your research results,
the work was never done
 You have an obligation to yourself and co-
investigators to publish your results
◦ career development
◦ satisfaction of completing the work

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Must fulfill ALL of the three following criteria:
1. Contributed to the design, data collection,
analysis, or interpretation of the findings
2. Contributed to the writing or editing of the
final manuscript
3. Agrees with the findings and is willing to
stand up in public and defend the work

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 Authenticity of manuscript content
 Genuine authors only?
 Role of each author
 Acknowledgement of borrowed, adapted,
adopted material
 Giving voice to participants
 Respect for participants views/ lives
 Protection of confidentiality

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A. When the paper is being written
B. When the paper is being published
C. Before data collection starts
D. During the analysis phase

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A. When the paper is being written
B. When the paper is being published
C. Before data collection starts
D. During the analysis phase

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 Characteristics of an occupation that identify it as a
profession are:
◦ Full-time occupation
◦ Training
◦ Associations (local and national)
◦ Codes of professional ethics
◦ Licensing laws
 Some are usually also associated with:
◦ High status
◦ Public prestige

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 What values govern your profession/practice?
 What are the governing association/s in Kenya?
◦ Offices?
◦ Membership?
◦ Codes and associated ethics?
◦ Role & functions?
◦ Activities?
◦ Other associations relevant to your profession?

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