this is a by the book copy

1. ETHICAL PRINCIPLES
FOR
NURSING
RESEARCH

2.
DEVELOPMENT OF PROFESSIONAL GUIDELINES
 ethical principles related to nursing research were derived from these
two:
 Nuremberg Code
a. emphasize adequate protection of human subjects from harm or risk
b. right to withdraw from experimentation at any time during the course of the
study
c. adequate qualifications of those conducting the research

4.
DEVELOPMENT OF PROFESSIONAL GUIDELINES
 ethical principles related to nursing research were derived from these
two:
 Declaration of Helsinki
a. emphasized on the subjects need to be informed of the benefits of the study
before consenting to participate in the research
b. allowing legal guardians to grant permission to enroll subjects in research and
recommended written consent

5. 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

6. 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

7. BASIC RIGHTS OF HUMAN SUBJECTS IN RESEARCH
right to anonymity and confidentiality
- Anonymity
o keeping individuals nameless
o limiting access to information that is gathered from the
subject
o 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

8. 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 stigma
oDx of HIV-AIDS
oevidence of domestic violence
oprison record

9. 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

10. 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

11. KEY ELEMENTS OF AN INFORMED CONSENT
b. adequate disclosure
• subjects were provided with enough
information for them to make a
voluntary decision

12. 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

13. CONTENTS OF AN INFORMED CONSENT
1. Title of the study
2. Personnel engaged in the study
•principal investigator
•co-investigator/s
•research assistants
1. Invitation to participate in the study
•“You are invited to participate in the research study”
•not requested, ‘chosen’, not ‘eligible’

14. CONTENTS OF AN INFORMED CONSENT
4. Reason the particular subject is being invited to
participate
5. Clear description of the purpose of the study
6. 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

15. 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

16. CONTENTS OF AN INFORMED CONSENT
9. Economic considerations
•whether subjects will incur any additional expenses as
a result of participation
10. 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