ETHIC

AL PRIN

CIPLE

S FOR

NURSING R

ESEARCH

 DEVELOPMENT OF PROFESSIONAL GUIDELINES

ethical principles related to nursing research were derived from these two:

  Nuremberg Codea. emphasize adequate protection of human subjects from harm or riskb. right to withdraw from experimentation at any time during the course of the

studyc. adequate qualifications of those conducting the research

 

 DEVELOPMENT OF PROFESSIONAL GUIDELINES

ethical principles related to nursing research were derived from these two:

 

Declaration of Helsinkia. emphasized on the subjects need to be informed of the benefits of the study

before consenting to participate in the researchb. allowing legal guardians to grant permission to enroll subjects in research and

recommended written consent

 

BASIC RIGHTS OF HUMAN SUBJECTS IN RESEARCH

right to freedom from injury- Beneficence - Non-maleficence - Freedom from any Physical and Psychological Harm - Freedom from Exploitation

BASIC RIGHTS OF HUMAN SUBJECTS IN RESEARCH

 

right to privacy and dignity- information regarding income, marital

status, personal activities, opinions, beliefs and

attitude s- use of cameras, one-way mirrors, tape

recorders, diaries, patient records

BASIC RIGHTS OF HUMAN SUBJECTS IN RESEARCH

right to anonymity and confidentiality- Anonymityo keeping individuals namelesso limiting access to information that is gathered from the subjecto facilitated by using CODE NUMBERS from subject’s identity----

the master code of which should be locked up; access limited to those who are intimately involved in the research

o in anonymity, the researcher cannot even link the data to the subject

BASIC RIGHTS OF HUMAN SUBJECTS IN RESEARCH

- Confidentiality

o protecting the data by not divulging information gathered  or learned in caring for the a patient without the individual’s permission to do so

o info carrying a stigmaoDx of HIV-AIDSoevidence of domestic violenceoprison record

 

INFORMED CONSENT

- a written consent form to be signed by the subject ensuring that the study participants have adequate information regarding the research, are capable of comprehending the information, and have the power or free choice.

- signed by the subject, signed and dated by the researcher and a witness

KEY ELEMENTS OF AN INFORMED CONSENT

a.freedom from coercion

•no bribery of any type or threat of any form was done to the subject to force him to participate in the research

•right to self- determination- right to withdraw from the research any time he wants without any penalty 

KEY ELEMENTS OF AN INFORMED CONSENT

 

b. adequate disclosure• subjects were provided with enough

information for them to make a voluntary decision

KEY ELEMENTS OF AN INFORMED CONSENT

 

c. comprehension•ensuring the subjects understand the information provided •medical jargon is avoided•language is kept simple•may be written in the local language of the subject•sentences must be short•pages much not be too overcrowded with too much words

CONTENTS OF AN INFORMED CONSENT

1. Title of the study2. Personnel engaged in the study

• principal investigator• co-investigator/s• research assistants

3. Invitation to participate in the study• “You are invited to participate in the research study”• not requested, ‘chosen’, not ‘eligible’

CONTENTS OF AN INFORMED CONSENT

4. Reason the particular subject is being invited to participate5. Clear description of the purpose of the study6. Detailed description of Procedures of the study

• descriptions of what will actually occur• how much time is required of the subject• whether hospitalization will be required• whether it will always , sometimes or never be required

as part of the subject’s standard of care;• how much and how often blood will be drawn

CONTENTS OF AN INFORMED CONSENT

7. Potential risks to subjects, including psychological, social and physical risks

• explanation of steps that will be taken to protect against risks

• estimation of likelihood of occurrence• severity• duration of potential risks

8. Potential Benefits of the study• identification of desired benefit to society• risk-benefit-ratio- estimate of potential risks in relation

to the potential benefits

CONTENTS OF AN INFORMED CONSENT

9. Economic considerations• whether subjects will incur any additional expenses as a

result of participation10. Confidentiality considerations

• explanation of steps that will be taken to ensure the confidentiality of information that is obtained during the course of the study, such as who will have access to the data and when the data and specimens will be destroyed

11. Freedom of subjects to ask questions and withdraw from the study at any time without penalty