PRESENTED BY:

VISHNU.R.NAIR,

4TH YEAR PHARM.D,

NATIONAL COLLEGE OF PHARMACY

GENERAL INTRODUCTION

HELSINKI DECLARATION

OTHER NAMES FOR IEC

RESPONSIBILITIES/ FUNCTIONS OF IEC

COMPOSITION OF IEC

STEPS INVOLVED IN IEC REVIEW

BIBLIOGRAPHY/ REFERENCE

An ETHICS COMMITTEE is defined as :

“A COMMITTEE, formally DESIGNATED, to :

a. REVIEW & APPROVE the initiation of a CLINICAL RESEARCH, involving HUMAN PARTICIPANTS

b. To PROVIDE CONTINUING REVIEW of the RESEARCH STUDY”……………………

The ETHICAL & SCIENTIFIC STANDARDS, for carrying out BIOMEDICALRESEARCH on human subjects are developed and established, according to:

a. HELSINKI DECLARATION

b. INTERNATIONAL ETHICAL GUIDELINES for BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS

c. WHO & ICH GUIDELINES for GCP(GOOD CLINICAL PRACTICE)

The WORLD MEDICAL ASSOCIATION has developed the DECLARATION OF HELSINKI, as a statement of ETHICAL PRINCIPLES, to provide GUIDANCE to PHYSICIANS & other PARTICIPANTS in MEDICAL RESEARCH involving HUMAN SUBJECTS

PRINCIPLES of HELSINKI DECLARATION include:

1. It is the duty of the physician in medical research, to protect the life, health, privacy & dignity of the human subject

2. Medical research involving human subjects MUST CONFORM to GENERALLYACCEPTED SCIENTIFIC PRINCIPLES

3. Appropriate CAUTION must be EXERCISE in the CONDUCT of the RESEARCH, which may affect the environment

4. The DESIGN & PERFORMANCE of each EXPERIMENTAL PROCEDURE, should be clearly FORMULATED in an EXPERIMENTAL PROTOCOL

5. MEDICAL RESEARCH involving human subjects, should be conducted ONLY BY SCIENTIFICALLY QUALIFIED PERSONS, and under the SUPERVISION of a CLINICALLY COMPETENT MEDICAL PERSON

6. PHYSICIANS should CEASE any INVESTIGATION, if the RISK are found to OUTWEIGHT the BENEFITS

7. The SUBJECTS must be VOLUNTEERS and INFORMED PARTICIPANTS in the RESEARCH PROJECT

8. Every precaution should be taken to:

a. RESPECT SUBJECT PRIVACY

b. RESPECT CONFIDENTIALITY of PATIENT’S INFORMATION

c. MINIMIZE impact of the study on the subject’s PHYSICAL & MENTAL INTEGRITY, as well as PERSONALITY……………………….

OTHER NAMES INCLUDE:

1. IRB (INSTITUTIONAL REVIEW BOARD)

2. REB(RESEARCH ETHICS BOARD)

3. REC(RESEARCH AND ETHICS COMMITTEE)

4. ERB(ETHICS REVIEW BOARD)……………………..

1. ETHICAL COMMITTEES should establish STANDARD OPERATING PROCEDURES, that state:

a. FUNCTIONS & DUTIES of EC

b. MEMBERSHIP REQUIREMENTS

c. TERMS & CONDITIONS OF APPOINTMENT

d. INTERNAL PROCEDURES

e. QUORUM REQUIREMENTS

2. To provide COMPETENT REVIEW of all ETHICAL ASPECTS of the PROJECT

3. To UNDERTAKE REVIEW, free from BIAS & INFLUENCE

4. To PROVIDE ADVICE to the RESEARCHERS on all aspects of WELFARE & SAFETY of RESEARCH PARTICIPANTS

5. To PROTECT DIGNITY, RIGHTS & WELL-BEING of the POTENTIALRESEARCH PARTICIPANTS

6. To ENSURE UNIVERSAL ETHICAL VALUES

7. To COMPLY with INTERNATIONAL SCIENTIFIC STANDARDS , in terms of LOCAL COMMUNITY VALUES and CUSTOMS

8. To assist in the DEVELOPMENT & EDUCATION of RESEARCH COMMUNITY responsive to local health care requirements……………………….

1. Involves MULTIDISCIPLINARY & MULTISECTORIAL COMPOSITION, comprising a minimum of 8-12 members

2. MEMBERS include:

a. CHAIR PERSON ( Maintains INDEPENDENCE of the COMMITTEE)

b. MEMBER SECRETARY (Conducts the BUSINESS of the COMMITTEE)

c. 1-2 MEDICAL SCIENTISTS

d. 1-2 CLINICIANS FROM VARIOUS INSTITUTES

e. 1 LEGAL EXPERT/ RETIRED JUDGE

f. 1 SOCIAL SCIENTIST/ REPRESENTATIVE OF NON-GOVERNMENTAL VOLUNTARY AGENCY

g. ONE PHILOSOPHER/ ETHICIST/ THEOLOGIAN

h. 1 COMMON MAN

STEPS INCLUDE:

FIXING OF IEC DATE SUBMISSIONS MADE BY RESEARCHERS REVIEWERS ARE SELECTED PROPOSAL SENT TO THE REVIEWERS FOR REVIEW REVIEW CONDUCTED RESULTS OF REVIEWS ARE DISCUSSED IN AN IEC MEETING BASED ON DISCUSSIONS, DECISION IS MADE DOCUMENTATION OF DECISIONS & DISCUSSIONS DECISIONS ARE SUBMITTED TO THE RESEARCHERS REVISION / RESUBMISSION DONE (BASED ON SITUATION) APPROVAL OF THE RESEARCH…..

SUBMISSION OF APPLICATION OF RESEARCH TO IEC:The following documents should be submitted:

1. TRIAL PROTOCOL(in prescribed format)

2. PATIENT INFORMATION SHEET & INFORMED CONSENT FORM , along with its TRANSLATIONS

3. INVESTIGATOR’S BROCHURE

4. PRINCIPAL INVESTIGATOR’S CURRENT CURRICULUM VITAE

5. INSURANCE POLICY/COMPENSATION FOR PARTICIPATION

6. INVESTIGATOR’S AGREEMENT with the SPONSOR……………

REVIEW OF PROJECT:1. SCIENTIFIC EVALUATION should be completed before ethical evaluation

2. Evaluate POSSIBLE RISKS to the subjects, with PROPER JUSTIFICATION

3. Focus on the EXPECTED BENEFITS of the study

4. Check the ADEQUACY of DOCUMENTATION, to ensure PRIVACY, CONFIDENTIALITY & JUSTICE ISSUES

5. ETHICAL REVIEW should be done through FORMAL MEETINGS

6. DECISIONS are preferably arrived at on a common basis

7. IEC’S MEMBER SECRETARY Screens the PROPOSALS for their COMPLETENESS

8. Depending on risk involved, SECRETARY CATEGORIZES PROPOSALS into:

a. EXPEDITED REVIEW

b. FULL REVIEW

c. EXEMPTED FROM REVIEW

a. EXPEDITED REVIEW:

- Refer to “Those SEARCH PROJECTS, with NO MORE THAN MINIMAL RISK to RESEARCH PARTICIPANTS”

- Examples include:

• Clinical studies of drugs and medical devices

- Research involves already approved drugs, or when an ADVERSE EVENT/ UNEXPECTED ADVERSE REACTION is reported

b. FULL REVIEW:

- Refer to “ALL RESEARCH PROPOSALS, with MORE THAN MINIMAL RISK”

- Example: Projects, involving VULNERABLE POPULATION (children, psychiatric patients)

- FULL REVIEW is carried out in cases, involving:

• COLLECTION of BLOOD SAMPLES

• COLLECTION of BIOLOGICAL SAMPLES (Sputum, skin, amniotic fluid, etc)……..

c. EXEMPTED FROM REVIEW:

- Refer to “Those research proposals, with LESS THAN MINIMAL RISK”

- Examples:

• Research on educational practice

• Instructional technics

• Curricula

• Classroom management methods………………………………

TYPES OF REVIEW:

A. PERIODIC REVIEW:

- Ongoing research reviewed at regular intervals of 6 MONTHS- 1 YEAR

B. CONTINUING REVIEW:

- The IEC has the responsibility to CONTINUE reviewing APPROVED PROJECTS for CONTINUATION, NEW INFORMATION, ADVERSE EVENT MONITORING, FOLLOW-UP, etc

C. INTERIM REVIEW:

- INTERIM REVIEW decides SPECIAL CIRCUMSTANCES for review by SUB-COMMITTEE

- Involves RE-EXAMINATION of PROPOSAL, already EXAMINED by IEC……………

METHODOLOGY INVOLVED IN ETHICAL REVIEW:The methodology for ethical review includes:

1. SCIENTIFIC DESIGN & CONDUCT OF STUDY

2. RECRUITMENT OF RESEARCH PARTICIPANTS

3. CARE & PROTECTION OF RESEARCH PARTICIPANTS

4. PROTECTION OF RESEARCH PARTICIPANT CONFIDENTIALITY

5. INFORMED CONSENT PROCESS

1. SCIENTIFIC DESIGN & CONDUCT OF STUDY :

Include the following:

a. APPROPRIATENESS of study design

b. STATISTICAL METHODOLOGY, including SAMPLE SIZE CALCULATION

c. RISK vs ANTICIPATED BENEFITS for research participants

d. JUSTIFICATION for CONTROLS used

e. WITHDRAWAL CRITERIA of participants

f. CRITERIA for TRIAL TERMINATION

g. ADEQUACY for MONITORING & AUDITING the CONDUCT of RESEARCH

h. SITE FACILITIES for handling EMERGENCIES

i. REPORTING & PUBLICATION ISSUES

2. RECRUITMENT OF RESEARCH PARTICIPANTS:

- Includes the following:

a. STUDY POPULATION – DEMOGRAPHIC CHARACTERISTICS

b. Means by which participants are CONTACTED and RECRUITED

c. Means by which full information is conveyed to research participants or their representatives

- CRITERIA for recruitments include:

a. Inclusion criteria

b. Exclusion criteria

3. CARE & PROTECTION OF RESEARCH PARTICIPANTS:

- Include:

a. MEDICAL CARE to be provided to participants during & after research

b. ADEQUACY of MEDICAL SUPERVISION

c. STEPS TAKEN, if participants VOLUNTARILY WITHDRAW from study

d. INFORMED CONSENT

e. INSURANCE & INDEMNITY ARRANGEMENTS

4. PROTECTION OF RESEARCH PARTICIPANT CONFIDENTIALITY:

Includes:

- DESCRIPTION of persons, who will have access to personal data of research participants, including MEDICAL RECORDS & BIOLOGICAL SAMPLES

- Measures, taken to ensure the CONFIDENTIALITY & SECURITY of PERSONAL INFORMATION concerning research participants

5. INFORMED CONSENT PROCESS:

Includes:

a. ADEQUACY, COMPLETENESS UNDERSTANDABILITY of WRITTEN & ORAL INFORMATION given to participants / their LEGAL REPRESENTATIVES

b. CLEAR JUSTIFICATION, for intention to include RESEARCH INDIVIDUALS , who cannot consent

c. ASSURANCE, that participants will receive any new information, that becomes available

d. CONTACT DETAILS of persons, whom the participants need to contact for any complaints or queries

DECISION:Based on reviews and proposals held in IEC MEETINGS, decisions on research proposals are made, which are classified into:

A. OUTRIGHT APPROVAL:

- Refers to applications, that contain ALL NECESSARY INFORMATION

- Only very minor changes are suggested

B. APPROVAL, WITH MODIFICATIONS:

- Refers to applications, that contain ENOUGH INFORMATION to JUDGE the STUDY, but CLARIFICATION / CHANGES are needed

C. RESUBMIT, WITH MORE INFORMATION:

- Refers to applications, that do NOT contain enough information to judge the application appropriately

D. OUTRIGHT DISAPPROVAL:

- Refers to those applications, in which there is ABSOLUTELY NO WAY OF DOING ETHICAL STUDY…………………………….

1. TIPNIS.H.J; BAJAJ.A; “RESEARCH AND ETHICS COMMITTEE” ; A TEXTBOOK OF HOSPITAL PHARMACY, CAREER PUBLICATIONS, PAGE: 80-82

2. http://www.slideshare.net/Dr.Sirisha/IEC

3. JAMES.A; “RESEARCH AND ETHICAL COMMITTEE OR IRB”

4. YADAV.G; “INSTITUTIONAL ETHICS COMMITTEE & INFORMED CONSENT”

THANK YOU !!!!!