An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs

1. Institutional Review Board (IRB) /
Independent Ethics Committee
(IEC)

2. List of Contents
 Definition
 Roles and Responsibilities
 Composition, Functions and Operations
 Procedures
 Records

3. Institutional Review Board (IRB) / Independent
Ethics Committee (IEC)
IRB/IEC
Review Evaluates
Approves
Decision
Benefits &
Risks
Right,
safety, and
well-being
of the
subject

4. ROLES AND RESPONSIBILITIES OF IRB/IEC
 Safeguard the rights, safety, and well-being of all trail subjects
 Reviews a proposed clinical trial within a reasonable time
 Conduct continuing review of each ongoing trial atleast once per
year
 Provide advice to the researchers on all the aspects of welfare and
safety of research participants

5. WHY IRB/IEC
Balancing Two goals
Advancement
of science
Protection of
subject,
welfare rights

6. Who decide, what is an ethical research?
IRB/IEC
When to apply to IRB/IEC?
 Before any research activity
 Allow at least 1 month for full board review

7. Why do I need an IRB/IEC to review my protocol?
 Make research studies better!!
 Enhance study design
 Enhance protection of subject
 Enhance researcher preparation
 More likely to get published in good journals
 More likely to get funding/grants

8. Frequent Issues With IRB Application
Incomplete or
insufficient description
of purpose,
methods/procedures,
subject selection.
Incomplete or lack
of contact
information
Inappropriate language
on the informed
consent document (too
technical)
Research related
documents are not
included in the
application
ISSUES

9. COMPOSITIONS, FUNCTIONS AND OPERATIONS
 The IRB/IEC should comprise of sufficient number of
members. Who mutually have the qualifications and
experience to review and assess the science, medical aspects
and ethics of the proposed trial.
 It is proposed that the IRB/IEC should incorporate:
The IRB/IEC should consist at least 5 members
In that 5 members 1 of them should be from non
scientific area

10.  The IRB/IEC should perform its functions corresponding to
written operating procedures. Should maintain written records
of its venture and minutes of its meetings, and should abide
by GCP and with the applicable regulatory specifications
In the remaining 1 of them independent of the
institution and trial site
The members who are independent and the
sponsor of the trial should vote their opinion on
at trial related matter
A list of IRB/IEC members and their
qualifications should be maintained.

11.  An IRB/IEC should take its decisions at announced meetings
at which at least a quorum, As stipulated in its written
operating procedure, is present.
 Only members who participate in the IRB/IEC review and
discussion should vote their opinion and advises.
 The investigator may provide information on any aspects of
the trial, but should not participate in he deliberations of the
IRB/IEC (or) in the vote of the IRB/IEC.
 An IRB/IEC may invite non members with expertise in
special areas for assistance.

12. PROCEDURES
Establish, document in writing and follow its procedures:
 Determine composition and source of authority.
 Schedule, notify members and conduct meetings.
 Conduct initial and continuing review.
 Determine frequency of continuing review.
 Provide expedited review mechanism for minor changes.
 Specify that no subject may be enrolled and no deviation prior
to approval.
 Specify that investigator promptly report protocol changes or
deviations, increased risks to subjects, ADRs (serious and
unexpected), new information related to subject safety.
 Promptly notify in writing the investigator/ institution about
its decisions, reasons for its decisions, and procedures for
appeal

13. RECORDS
Maintain all relevant records at least 3 years after completion of
the trial
 SOP’s
 Membership files
 Submitted documents
 of meetings
 Correspondence
 Make them available to regulatory authorities.
 Make available its SOP’s and membership lists to
investigators, sponsors and regulatory authorities.

14. “If you can’t figure out your
purpose, figure out your passion.
For your passion will lead you right
into your purpose”
Thank you….