2. A GOOD RESEARCH
PROBLEM CONFIRM TO MORAL,
ETHICAL AND LEGAL
STANDARDS OF ETHICAL
ENQUIRY.A RESARCH SHOULD
HAVE DEEP CONCERN OF
HUMAN WELFARE AND
SENSITIVITY FOR THE RIGHTS
OF RESEARCH SUBJECT.
3. ETHICS
ETHICS IN NURSING RESEARCH CAN BE
DEFINED AS THE ACT OF MORAL PRINCIPLES
THAT THE RESEARCHER HAS TO FOLLOW
WHILE CONDUCTING NURSING RESEARCH TO
ENSURE THE RIGHTS AND WELFARE OF
INDIVIDUALS, GROUPS OR COMMUNITY
UNDER STUDY.
4. A WRITTEN SET OF
GUIDELINES BY AN ORGANIZATION
TO WORKERS AND MANAGEMENT TO
HELP THEM CONDUCT THEIR
ACTION IN ACCORDANCE WITH ITS
PRIMARY VALUES AND ETHICAL
STANDARDS.
5. THE CODE OF ETHICS FOR
REGISTERED NURSE IS A STATEMENT OF
ETHICAL COMMITMENTS OF NURSES TO
THOSE THEY SERVE.NURSES HAVE
DEVELOPED IT FOR NURSES AND SET FORTH
THE ETHICAL STANDARDS BY WHICH NURSES
ARE TO CONDUCT THEIR NURSING PRACTICE.
C N A CODE OF ETHICS,2002
6. PRINCIPLE OF BENEFICENCE
PRINCIPLE OF JUSTICE
PRINCIPLE OF RESPECT FOR HUMAN
DIGINITY
7. NAZI MEDICAL EXPERIMENTS
TUSKEGEE SYPHILIS STUDY
WILLOW BROOK STUDY
JEWISH CHRONIC DISEASE HOSPITAL STUDY
DEPARTMENT OF HEALTH, EDUCATION AND
WELFARE ,REGULATIONS FOR THE
PROTECTION OF HUMAN RESEARCH
SUBJECTS
8. THE NUREMBERG CODE
DECLARATION OF HELSINKI
BELMONT REPORT
9. THE VOLUNTARY CONSENT OF THE HUMAN
SUBJECT IS ABSOLUTELY ESSENTIAL.
THE EXPERIMENT SHOULD BE SUCH AS TO
YIELD FRUITFUL RESULTS FOR GOOD OF
SOCIETY.
THE EXPERIMENTS SHOULD BE SO DESIGNED
AND BASED ON RESULTS OF ANIMALS
EXPERIMENTATION AND A KNOWLEDGE OF THE
NATURAL HISTORY OF DISEASES.
THE EXPERIMENTS SHOULD BE SO CONDUCTED
AS TO AVOID ALL UNNECESSARY PHYSICAL AND
MENTAL SUFFERING AND INJURY
10. NO EXPERIMENTS SHOULD BE CONDUCTED
WHERE THERE IS AN ‘PRIORI’ REASON TO
BE THAT DEATH OR DISABLING INJURY WILL
OCCUR ,EXCEPT, PERHAPS IN THOSE
EXPERIMENTS WHERE THE EXPERIMENTAL
PHYSICIAN ALSO SERVES AS A SUBJECTS.
THE DEGREE OF RISKS TO BE TAKEN
SHOULD NEVER EXCEED THAT DETERMINED
BY THE HUMANITARIAN IMPORTANCE OF
THE PROBLEM TO BE SOLVED BY THE
SUBJECT.
11. PROPER PREPARATIONS SHOULD BE MADE
AND ADEQUATE FACILITIES PROVIDED TO
PROTECT THE EXPERIMENTAL SUBJECT.
THE EXPERIMENT SHOULD BE CONDUCTED
ONLY BY A SCIENTIFICALLY QUALIFIED
PERSONS.
DURING THE COURSE OF THE EXPERIMENT
THE HUMAN SUBJECT SHOULD BE AT
LIBERTY TO BRING THE EXPERIMENT TO AN
END IF HE HAS REACHED THE E IMPOSSIBLE.
12. DURING THE COURSE OF THE PHYSICAL
EXPERIMENTS THE SCIENTIST IN THE
CHARGE MUST BE PREPARED TO
TERMINATE THE EXPERIMENT AT ANY
STAGE.
13. THE INVESTIGATOR SHOULD PROTECT THE
LIFE, HEALTH, PRIVACY AND DIGNITY OF
HUMAN SUBJECTS.
THE INVESTIGATORS SHOULD EXERCISE
GREATER CARE PROTECT SUBJECTS FROM
HARM IN NON THE THERAPEUTIC
RESEARCH.
THE INVESTIGATOR SHOULD CONDUCT
RESEARCH ONLY WHEN THE IMPORTANCE
OF THE OBJECTIVE OUTWEIGHS THE
INHERENT RISKS AND BURDENS THE
SUBJECTS.
14. INFORMED CONSENT
RISKS BENEFIT ASSESSMENT
SELECTION OF SUBJECT RESEARCH
ENSURE THE STUDY IS APPROVED BY AN
IRB
GET INFORMED CONSENT FROM THE
PATIENT.
ENSURE THAT THE PATIENT UNDERSTAND
THE FULL CONTENT OF THE EXPERIMENTS
ENSURE THE PATIENT WASN’T COERCED
INTO DOING THE EXPERIMENTS BY MEANS
OF THREATENING OR BULLING
15. Be careful of other effects of the clinical
trial that were not mentioned and report it
to the proper study coordinator
Support the privacy of patient
Ensure that all patients at least get the
minimal care needed for their condition
16. THE RESEARCHER MUST BE FOCUSED ON;
1.SCIENTIFIC AND SOCIAL VALUE AND
RESPECT FOR RIGHTS OF PARTICIPANTS.
2.RESEARCH SHOULD BE CONDUCTED
IN LOW RESOURCE SETTINGS
3. EQUITABLE DISTRIBUTION OF
BENEFITS AND BURDENS OF THE SELECTION
OF INDIVIDUALS AND GROUPS
4. ASSESSMENT OF POTENTIAL
INDIVIDUAL BENEFITS AND RISKS OF
RESEARCH
17. 5.CHOICE OF CONTROL IN CLINICAL
TRIALS.
6.CARING FOR PARTICIPANT’S HEALTH
NEEDS.
7.COMMUNITY ENGAGEMENT
8.COLLOBORATIVE PARTNERSHIP AND
CAPACITY BUILDING FOR RESEARCH AND
RESEARCH REVIEW.
9.INDIVIDUAL CAPABILITY OF GIVING
INFORMED CONSENT.
10.MODIFICATIONS AND WAIVERS OF
INFORMED CONSENT
18. 11.COLLECTION, STORAGE AND USE
OF DATA IN HEALTH RELATED RESEARCH.
12.COLLECTION,STORAGE AND USE OF
DATA IN HEALTH RELATED RESEARCH.
13.REIMBURSEMENT AND
COMPENSATION FOR RESEARCH
PARTICIPANTS.
14.TREATMENT AND COMPENSATION
FOR RESEARCH RELATED HARMS.
15.RESEARCH INVOLVING
VULNERABLE PERSONS AND GROUPS.
19. 16.RESEARCH IN DISASTERS AND
DISEASE OUTBREAKS.
17. USE OF DATA OBTAINED FROM THE
ON LINE ENVIRONMENT AND DIGITAL TOOLS
IN HEALTH RELATED RESEARCH.
18.PUBLIC ACCOUNTABILITY FOR
HEALTH RELATED RESEARCH.
19.CONFLICTS OF INTEREST
20. ACTIVITIES;
*EXTRAMURAL RESEARCH IS
PROMOTED BY ICMR
*FUNDS TASK FORCE STUDIES WHICH
EMPHASIS A TIME BOUND GOAL ORIENTED
APPROACH WITH CLEARLY DEFINED
TARGETS.
*OPEN BASED RESEARCH IS
CONDUCTED ON THE BASIS OF APPLICATIONS
FOR GRANTS.
*COLLABORATE RESEARCH
ACTIVITIES WITH OTHER INSTITUTES.
21. *THE COUNCIL ALSO AWARDS PRIZES
TO INDIAN SCIENTISTS IN SIGNIFICANT
CONTRIBUTION TO BIO MEDICAL RESEARCH
*THE JOURNAL OF MEDICAL RESEARCH
(IJMR) IS PUBLISHED UNDER THE AUSPICES OF
THE HOSPITAL
22. MISSION
TO ENCOURAGE ALL CLINICAL TRIALS
CONDUCTED IN INDIA TO BE PROSPECTIVELY
REGISTERED.
ACTIVITIES
-ENSURING ALL CLINICAL TRIALS
CONDUCTED IN INDIA TO BE PROSPECTIVELY
REGISTERED WITH FULL DISCLOSURE
-SUBMISSION OF ETHICS APPROVAL AND
DCGI APPROVAL IS ESSENTIAL FOR CTRI
REGISTRATION
23. I. INFORMED CONSENT
II. CONFIDENTIALITY
III. PROTECTION OF SUBJECTS
IV. THE RESEARCH SETTINGS
24. ELEMENTS
1.RESEARCHERS ARE IDENTIFIED.
2.SUBJECT SELECTION PROCESS IS
DESCRIBED
3.THE PURPOSE OF STUDY
DESCRIBED
4.STUDY PROCEDURE ARE DISCUSSED
5.POTENTIAL RISKS ARE DESCRIBED
6.POTENTIAL BENEFITS ARE
DESCRIBED
7.COMPENSATION,IFANY, DISCUSSED
25. INVESTIGATOR MUST PROVIDE ALL
NECESSARY AND DESIRED INFORMATION TO
THE PARTCIPANT
IT MUST BE ENSURED BY THE
INVESTIGATOR THAT NONE OF THE
INVESTIGATOR IS INFLUENCED
A VERBAL INFORMED CONSENT MAY BE
OBTAINED,WHEN PARTICIPANTS REFUSE TO
SIGN OR GIVE THUMBIMPRESSION OR
CANNOT BE DO.
26. A SURROGATE CONSENT ALSO MAY BE
OBTAINED, IF THE PARTICIPANTS LOSES
CONCIOUSESS OR COMPETENCE OF
CONSENT DURING RESEARCH STUDY
INVESTIGATOR MUST ENSURE THAT NON OF
TRHE WAY PATIENT-CLIENT IS AFFECTED
27. THE RESEARCH PROBLEM ITSELF
SETTINGS
PROCEDURES
METHOD OF DATA COLLECTION
PARTICIPANTS
DATA
28. DECEPTION
BREAKING CONFIDENTIALITY
TRANSLATION AND LITERACY
VULNERABLE POPULATION
29. CHILDREN
MENTALLY OR EMOTIONALLY DISABLED PEOPLE
SEVERLY ILL OR PHYSCICALLY DISABLED
PEOPLE
TERMINALLY ILL
INSTITUTIONALIZED PEOPLE
PREGNANT WOMEN
OTHERS
30. PROTECT THE VULNERABLE GROUP AND
OTHERS FROM HARMFUL EFFECTS OF
EXPERIMENTAL INTERVENTIONS.
SAFE GUARD THE PARTICIPANTS FROM
EXPLOITATION BY RESEARCHER.
ESTABLISH THE RISK BENEFIT RATIO FOR
THE STUDY SUBJECTS.
ENSURE FAIR TREATMENT FOR STUDY
SUBJECTS.
BUILT THE CAPABILITY OF SUBJECTS TO
ACCEPT OR REJECT PARTICIPATION IN
RESEARCH STUDY.
31. ENSURE THE RESPECT OF INDIVIDUAL’S
AUTONOMY
PROVIDE AN ADEQUATE PROTECTION OF THE
VULNERABLE GROUP IN
THE NURSE RESEARCHER MUST ENSURE THE
OPTIMUM BALANCE BETWEEN RISK-BENEFIT
RATIO.
THE BENEFITS OF RISK ASSOCIATED WITH
STUDY MUST BE EQUALLY DISTRIBUTED
AMONG SUBJECTS.
32. THE RIGHTS OF SUBJECTS SHOULD BE
PROTED DURING ENTIRE STUDY PERIOD
MAINTAINING COMPETENCE IN IDENTIFIED
RESEARCH AREA TO MAINTAIN PROFICIENCY IN
RESEARCH METHODS
33. IN PLANNIG A RESEARCH PROJECT
INVOLVING HUMAN SUBJECTS, IT IS
IMPORTANT TO CONSIDER THE
ETHICAL GUIDELINES DESIGNED TO
PROTECT THE SUBJECT