This document outlines several key ethical principles for protecting research participants as described in the Belmont Report. It discusses the principles of beneficence, respect for human dignity, and justice. It also describes procedures used to protect participants, including risk/benefit assessment, informed consent, maintaining confidentiality, providing debriefings and referrals when needed, and ensuring the ethical treatment of vulnerable groups. Research involving human subjects must consider these ethical guidelines.

1. ETHICAL ASPECTS OF
NURSING RESEARCH

2. Ethical Priniciples for Protecting Participants
(Investigator)
 Respects autonomous research participants’ capacity to
consent to participant in research & to determine the
degree & duration of that participation without negative
consequences.
 Prevents, minimizes harm and/or promotes good to all
research participants, including vulnerable groups &
other affected by the research.

3. Ethical Priniciples for Protecting Participants
(Investigator)
 Respects the personhood of research participants, their
families and significant others, valuing their diversity.
 Ensures that the benefits and the burdens of research
are equitably distributed in the selection of research
participants.
 Protects the privacy of research participants to the
maximum degree possible.

4. Ethical Priniciples for Protecting Participants
(Investigator)
 Ensures the ethical integrity of the research process by
use of appropriate checks and balances throughout the
conduct, dissemination, & implementation of research.
 Reports suspected, alleged, or known incidents of
scientific misconduct in research to appropriate
institutional officials for investigation.

5. Ethical Priniciples for Protecting Participants
(Investigator)
 Maintains competency in the subject matter &
methodologies of his/her research, as well as in other
professional or societal issues that affect nursing
research & the public good.
 Involved in animal research maximizes the benefits of
the research with the least possible harm or suffering to
the animals.

6. Ethical Priniciples in the Conduct of
Research
 The Belmont Report articulates three (3)
primary ethical principles on which standards
of ethical conduct in research are based:
 Beneficence
 Respect for Human Dignity
 Justice

7. Beneficence
Imposes a duty on researchers to minimize harm & to
maximize benefits
 RIGHT TO PROTECTION FROM HARM & DISCOMFORT
 Nonmaleficence-encompasses the maxim “above all, do no harm”
(physical, emotional, social or financial)
 RIGHT TO PROTECTION FROM EXPLOITATION
 Involvement in a study should not place the participants at a disadvantage or
expose them to situations for which they have not been prepared.

8. Respect for Human Dignity
Includes the right to self-determination and the
right to full disclosure

9. Respect for Human Dignity
 RIGHT TO SELF-DETERMINATION-humans
should be treated as autonomous agents,
capable of controlling their own activities
 The right to decide voluntarily whether to participate in
a study, without the risk of incurring adverse
consequences

10. Respect for Human Dignity
 Freedom form Coercion, of any type Coercion involves
explicit or implicit threats of penalty for failing to participate
in a study or excessive rewards from agreeing to participate.
 The right of the participant to ask questions,
 The right to refuse to give information, or
 The right to withdraw from the study

11. Respect for Human Dignity
 RIGHT TO FULL DISCLOSURE-refers to the
people’s right to make informed, voluntary
decisions about study participation

12. Respect for Human Dignity
 Full Disclosure – means that the researcher has fully
described the nature of the study, the person’s right to
refuse participation, the researcher’s responsibilities, and
the likely risks & benefits that would be incurred.
 Deception – can involve deliberately withholding or
providing participants false info about the study.

13. Justice
 Refers to the participant’s right to
fair treatment and their right to
privacy

14. Justice
 RIGHT TO FAIR TREATMENT-concerns the
equitable distribution of benefits & burdens of
research. The selection of the study participants
should be based on research requirements &
not on the vulnerability or compromised position
of certain people.

15. Justice
 Groups of People with Low Social Standing
 Poor people
 Prisoners
 Slaves
 Mentally retarded
 And people who cannot protect their own interest
like dying patients to ensure that they are not
exploited for the advancement of knowledge

16. Justice
 RIGHT TO PRIVACY-ensuring that the research
is not more intrusive than it needs to be & that
the participant’s privacy is maintained
throughout the study.

17. Procedures for Protecting Study
Participants
 Risk / Benefit Assessment
 Informed Consent
 Confidentiality Procedures
 Debriefings
 Referrals

18. Risk / Benefit Assessment
 One of the strategies that researchers use to protect
study participants
 Is designed to determine whether the benefits of
participating in a study are in line with the costs, be they
financial, physical, emotional, or social-that is, whether
the risk/benefit ratio is acceptable

19. Risk / Benefit Assessment
 This ratio should also be considered in terms of whether the
risks to participants are commensurate with the benefit to
society & the nursing profession in terms of the quality of
evidence produced
 The general guideline is that 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

20. Risk / Benefit Assessment
 Major Potential Benefits to Participants
 Access to an 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 conditions, either
through opportunity for introspection & self-reflection or through
direct interaction with researchers.

21. Risk / Benefit Assessment
 Major Potential Benefits to Participants
 Escape from normal routine, excitement of being part of a study
 Satisfaction that information they provide may help others with
similar problems or conditions
 Direct monetary or material gains through stipends or other
incentives

22. Risk / Benefit Assessment
 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 repercussions, anger or embarrassment at the type of
questions being asked

23. Risk / Benefit Assessment
 Major Potential Risks to Participants
 Social risks, such as the risk for stigma, adverse effects on personal
relationships, loss of status
 Loss of privacy
 Loss of time
 Monetary costs (e.g. for transportation, child care, time lost from
work)

24. Informed Consent
 One particularly important procedure for safeguarding
participants & protecting their right to self-determination
 It means that participant have adequate information
regarding the research, are capable of comprehending
the information, & have the power of free choice,
enabling them to consent to or decline participation
voluntarily.

25. The Content of Informed Consent
 Participant Status
 Study Goals
 Type of Data
 Procedures
 Nature of the Commitment
 Sponsorship
 Participant Selection
 Potential Risks
 Potential Benefits
 Alternatives
 Compensation
 Confidentiality Pledge
 Voluntary Consent
 Right to Withdraw & Withhold
Information
 Contact Information

26. Confidentiality Procedures
 Study participants have the right to expect
that any data they provide will be kept in the
strictest confidence
 Participants’ right to privacy is protected
through various confidentiality procedures

27. Confidentiality Procedures
 Anonymity
 The most secure means of protecting confidentiality
 Occurs when even the researcher cannot link participants to their
data
 For example: if questionnaires were distributed to a group of nursing
home residents and were returned without any identifying information
on them, responses would be anonymous

28. Confidentiality Procedures
 Confidentiality in the Absence of Anonymity
 When anonymity is impossible, a promise of confidentiality needs
to be implemented
 It is a pledge that any information participants provide will not be
publicly reported in a manner that identifies them & will not be
made accessible to others

29. Confidentiality Procedures
 Confidentiality in the Absence of Anonymity
 This means that research info should not be shared with
strangers, nor with people known to the participants (e.g. family
members, physicians, other nurses), unless the participant gives
the researcher explicit permission to do so

30. Debriefings
 Refers to the communication with study participants after
participation is completed regarding various aspects of the
study
 Sessions after data collection to permit participants to ask
questions or air complaints
 This is especially important when the data collection has
been stressful or when ethical guidelines had to be ‘bent’
(e.g. if any deception was used in explaining the study)

31. Referrals
 Providing contact information for local service providers who
could assist with any issue about participants’ need for help
 Example of Referrals: Neufeld & Harrison (2003) studied
appraisals of support among women caring for a family
member with dementia. The research involved a series of
interviews over an 18-month period with the women
caregivers. Referrals to mental health or other support services
were available to study participants who expressed a need.

32. Treatment of Vulnerable Groups
 The rights of special vulnerable groups may need to be
protected through additional procedures and heightened
sensitivity
 They may be incapable of giving fully informed consent
(e.g. mentally retarded) or may be at high risk for
unintended side effects because of their circumstances
(e.g. pregnant women)

33. Treatment of Vulnerable Groups
 Researchers interested in studying high-risk groups should
be acquainted with guidelines governing informed consent,
risk/benefit assessment, and acceptable research
procedures for such groups

34. Treatment of Vulnerable Groups
 Research with vulnerable subjects should be undertaken
only when the risk/benefit ratio is low or when there is no
alternative (e.g. childhood development studies require child
participants)

35. Consider as Being Vulnerable
 Children
 Assent-refers to the child’s affirmative agreement to participate
 Mentally or emotionally disabled people
 Severely ill or physically disabled people
 The terminally ill
 Institutionalized people
 Pregnant women

36. Reviews and Committees
 Most hospitals, universities, and other institutions where
research is conducted have established formal committees
and protocols for reviewing proposed research plans before
they are implemented.
 These committees are sometimes called human subjects
committees, ethical advisory boards, research ethics
committees.

37. Reference:
Polit, D. F., & Beck, C. T. (2008).
Nursing Research: Generating and Assessing
Evidence for Nursing Practice (8th ed.)