Institutional Review Board/Independent Ethics Committee (Irb/Iec)

INSTITUTIONAL REVIEW
BOARD/INDEPENDENT ETHICS
COMMITTEE (IRB/IEC)
Research in 20th Century
Ethics
Ethics is not definable, is not implementable, because

it is not conscious; it involves not only our thinking,
but also our feeling.
… Valdemar W.
Setzer
ICH GCP 1.31 Institutional Review Board (IRB)
or Independent Ethics Committee (IEC)
 An independent body constituted of medical,
scientific, and non-scientific members, whose
responsibility is to ensure the protection of the
rights, safety and well-being of human subjects
involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trial
protocol and amendments and of the methods and
material to be used in obtaining and documenting
informed consent of the trial subjects.
ICMR GUIDELINES ON IRB/IEC
AYUSH Guidelines
 “It is mandatory that all proposals on biomedical
research involving human participants should be
cleared by an appropriately constituted Institutional
Ethics Committee (IEC), also referred to as
Institutional Review Board (IRB), Ethics Review
Board (ERB) and Research Ethics Board (REB) in
other countries, to safeguard the welfare and the
rights of the participants….”(ICMR, 2006).
(www.icmr.nic.in)
So What is Ethics Committee?
Any board, committee or other group

formally designated by an institution to
 Review
 Approve the initiation of and
 Conduct periodic review of biomedical

research involving human subjects.
All proposals on
biomedical research involving human
subjects
must be cleared
by an
Ethics Committee
Ethics Committees: Why?
 An objective review of research

activities involving human
subjects by a group of diverse
individuals is most likely to
protect human subjects and
promote ethically sound research
Ethics Committees: Why?
 To protect the study subjects’

well-being, rights & confidentiality
 To meet the mandate of Declaration of
Helsinki
 To make clinical research
- acceptable to regulatory authorities
- journal editors
For What to submit to Ethics Committee?
 Pharmaceuticals
 Medical Devices
 Medical Radiation and Imaging
 Surgical Procedures
All Clinical Research!
 Medical Records
 Biological Samples
 Epidemiological, Social and
Psychological Investigations
PRE-REQUISITES FOR EFFECTIVE IRB
FUNCTIONING
 Scope for making independent decisions
 Functioning independent of the institution (head

of the institution should not be head of IRB)
 Democratic functioning (all members should

have their say)
OVERVIEW- Ethical Review Procedures
 Basic responsibilities
 Review process
 Periodic review
 Composition
 Continuing review
 Terms of reference
 Interim review
 Training
 Monitoring
 Regulation
 Record keeping
 Review procedures  Administration and management
 Submission of application  Special considerations
 Decision making process

BASIC RESPONSIBILITIES
 Safeguard the rights, safety, and well-being of all

trial subjects
 Ensure and verify that universal ethical values and

safety standards are followed with a view on local
community values and customs
 Help in the development and the education of

research community responsible to local health care
requirements
COMPOSITION
 A reasonable number of members

who collectively have the
qualifications and experience to
review and evaluate the science,
medical aspects and ethics of the
proposed trial
COMPOSITION
 Multidisciplinary and multisectorial
 Independence and Competence –two hallmarks
 Number of persons: 8 -12(Maximum of 15 members recommended)
 Quorum –minimum of 5
 Chairperson –outside the Institution
 Member Secretary –same institution
 Others –mix of medical/non-medical, scientific and non-scientific persons, lay

persons from the community
 Adequate representation of age and gender
 Subject experts, if needed

TERMS OF REFERENCE
 To include Terms of Appointment
 Specify these in the SOP
 SOP to be made available to each member
 Written SOPs –to be updated periodically based on the changing

requirements
 Extension of membership for another term
 Preferable to appoint persons trained in bioethics or persons conversant

with ethical guidelines and laws of the country
 Nomination of substitute member in case of continuous missing of

meetings by a member due to illness or other unforeseen circumstances
REGULATION
 Registration of all IECs under a Biomedical

Research Authority, to be set up under the
proposed Bill on Biomedical Research on
Human Participants (Promotion and
Regulation)
REVIEW PROCEDURES
 Before research is initiated, the IEC should review every
research proposal on human participants
 Ensure scientific evaluation has been completed
 Evaluate the possible risks, expected benefits, privacy,

confidentiality and the justice issues
 Screening of proposals by Member-Secretary/Secretariat
 Proposals to be categorized into three types –Exemption from

review, Expedited review, and Full review
SUBMISSION OF APPLICATION
 Application in a prescribed format along with the study protocol as
prescribed in SOP of IEC concerned
 To include, among other details, study title, objectives, rationale for study
etc.
 Plan to withdraw or withhold standard therapies in the course of the

research
 Probable ethical issues
 Funding details
 Agreement to comply with national and international GCP protocols for

clinical trials.
DECISION MAKING PROCESS
 Complete and adequate review
 Periodic meetings at frequent intervals
 Review of new proposals
 Annual progress of ongoing studies
 Review SAE reports
 Assess final reports
 Meetings to be minuted, approved and signed by Chairperson/alternate

Chairperson/designated member of the IEC
Decisions to be based on broad consensus.

REVIEW PROCESS
 SOP to state review process
 SOP to clarify whether review to be done by all

reviewers/primary reviewers
 Review to be done in formal meetings
 No decision through circulation of proposals
 Meetings at regular intervals

PERIODIC REVIEW
Six months to one year
CONTINUING REVIEW
For continuation, new information, adverse event

monitoring, follow-up, after completion of project
INTERIM REVIEW
By a sub-committee
INTERIM REVIEW
 Re-examination of proposal already examined by

the IEC
 Research study of a minor nature such as
examination of case records etc.;
 An urgent proposal of national interest.
MONITORING
 Need for oversight mechanism
 Actual site visits
 Periodic status reports
 SAE reports
 Reports of monitoring by sponsor and recommendations by

DSMB, if needed by IEC
RECORD KEEPING
 Documentation to be dated, filed and preserved per
written procedures
 Strict confidentiality during access and retrieval
 Records for: composition of IEC, CV of IEC

members, records of training, SOP, guidelines,
protocols, correspondence, agenda, meeting minutes
 Records to be maintained for 3 years after

completion/termination of study
ADMINISTRATION AND MANAGEMENT
 Full time secretariat
 Record keeping space
 Members to be compensated reasonably
 Reasonable fees for review and administrative processes
 Allocation of reasonable amount of funds

SPECIAL CONSIDERATIONS
Research involving:
 Children
 Pregnant and lactating women
 Vulnerable participants, and
 Those with diminished autonomy
 Issues pertaining to commercialisation of research
 International collaboration
Observations and suggestions of IEC should be given in

writing in unambiguous terms in such instances.
 Informed Consent Form Template for
Clinical Studies
CONCLUSION
Success of an IRB depends on:
 The quality and engagement of members
 Procedures
 Documentation, and
 Institutional commitment -financial resources, degree of

autonomy and investigator adherence to norms.
REFERENCES
 ICH –GCP, E6 (R1) (1996), Section 3 (1996) (
www.ich.org/LOB/media/MEDIA482.pdf)
 ICMR Guidelines for Biomedical Research on Human Subjects (Sep 2000)
(http://www.icmr.nic.in/ethical_guidelines.pdf)
 World Medical Association Declaration of Helsinki (1964, last amended in
October 2000), Section B.13 (http://www.wma.net/e/policy/b3.htm)
 CIOMS International Ethical Guidelines for Biomedical Research involving
Human Subjects (2002), Guidelines 2 and 3
(www.cioms.ch/frame_guidelines_nov_2002.htm)
 U.S. Food and Drug Administration (US FDA), 21 CFR Part 56
(www.fda.gov/cber/ind/ind.htm)
 Code of Federal Regulations, Title 45, Part 46, Subpart A, Section 46.102
(1991) (www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
THANK YOU
“Knowing is not enough; we must apply.

Willing is not enough; we must do.”
—Goethe
follow up schedule & study flow
chart
Study flow chart
Gantt chart
. The chart is named after Henry Gantt (1861–1919), who designed his

chart around the years 1910–1915.[3][4]
In the following table there are seven tasks, labeled A through G. Some
tasks can be done concurrently (A and B) while others cannot be done
until their predecessor task is complete (C and D cannot begin
until A is complete). Additionally, each task has three time estimates:
the optimistic time estimate (O), the most likely or normal time estimate
(M), and the pessimistic time estimate (P). The expected time (TE) is
estimated using the beta probability distribution for the time estimates,
using the formula (O + 4M + P) ÷ 6.
Once this step is complete, one can draw a Gantt chart or a network
diagram.
Gnatt chartIn the following table there are seven tasks, labeled A through G. Some
tasks can be done concurrently (A and B) while others cannot be done until their
predecessor task is complete (C and D cannot begin until A is complete).
Additionally, each task has three time estimates: the optimistic time estimate (O),
the most likely or normal time estimate (M), and the pessimistic time estimate (P).
The expected time (TE) is estimated using the beta probability distribution for the
time estimates, using the formula (O + 4M + P) ÷ 6.
Time estimates
Predecess Expected
Activity
or Opt. (O) Normal (M) Pess. (P) time
A — 2 4 6 4.00
B — 3 5 9 5.33
C A 4 5 7 5.17
D A 4 6 10 6.33
E B, C 4 5 7 5.17
F D 3 4 8 4.50
G E 3 5 8 5.17
Gnatt chart
Gnatt chart

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INSTITUTIONAL REVIEW

Ethics is not definable, is not implementable, because

Any board, committee or other group

 Approve the initiation of and

 Conduct periodic review of biomedical

 An objective review of research

 To protect the study subjects’

 Scope for making independent decisions

 Functioning independent of the institution (head

 Democratic functioning (all members should

 Submission of application  Special considerations

 Decision making process

 Safeguard the rights, safety, and well-being of all

 Ensure and verify that universal ethical values and

 Help in the development and the education of

 A reasonable number of members

 Independence and Competence –two hallmarks

 Number of persons: 8 -12(Maximum of 15 members recommended)

 Chairperson –outside the Institution

 Member Secretary –same institution

 Others –mix of medical/non-medical, scientific and non-scientific persons, lay

 Adequate representation of age and gender

 Subject experts, if needed

 Specify these in the SOP

 SOP to be made available to each member

 Written SOPs –to be updated periodically based on the changing

 Extension of membership for another term

 Preferable to appoint persons trained in bioethics or persons conversant

 Nomination of substitute member in case of continuous missing of

 Registration of all IECs under a Biomedical

 Ensure scientific evaluation has been completed

 Evaluate the possible risks, expected benefits, privacy,

 Screening of proposals by Member-Secretary/Secretariat

 Proposals to be categorized into three types –Exemption from

 Plan to withdraw or withhold standard therapies in the course of the

 Probable ethical issues

 Agreement to comply with national and international GCP protocols for

 Periodic meetings at frequent intervals

 Review of new proposals

 Annual progress of ongoing studies

 Review SAE reports

 Assess final reports

 Meetings to be minuted, approved and signed by Chairperson/alternate

Decisions to be based on broad consensus.

 SOP to clarify whether review to be done by all

 Review to be done in formal meetings

 No decision through circulation of proposals

 Meetings at regular intervals

Six months to one year

For continuation, new information, adverse event

 Re-examination of proposal already examined by

 Need for oversight mechanism

 Actual site visits

 Periodic status reports

 Reports of monitoring by sponsor and recommendations by

 Strict confidentiality during access and retrieval

 Records for: composition of IEC, CV of IEC

 Records to be maintained for 3 years after

 Full time secretariat