Ethical Aspects of Nursing Research

ETHICAL ASPECTS OF NURSING RESEARCH

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.


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.


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.


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.

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

BeneficenceImposes 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.

Respect for Human DignityIncludes the right to self-determination and the

right to full disclosure

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

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

Respect for Human Dignity RIGHT TO FULL DISCLOSURE-refers to the

people’s right to make informed, voluntary decisions about study participation

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.

Justice Refers to the participant’s right to

fair treatment and their right to privacy

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.

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

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.

Procedures for Protecting Study Participants

Risk / Benefit Assessment Informed Consent Confidentiality Procedures Debriefings Referrals

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

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

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.

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

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

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)

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.

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

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

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

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

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

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)

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.

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)

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

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)

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

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.

Reference:Polit, D. F., & Beck, C. T.

(2008). Nursing Research: Generating and Assessing Evidence for Nursing Practice (8th ed.)

Health & Medicine

Ethical Aspects of Nursing Research