IRB REVIEW

1. IRB/IEC REVIEW AND APPROVAL
PROCESS AND ONGOING
MONITORING OF SAFETY DATA
-AARTI VATSA

2. TABLE OF CONTENT:
• Introduction
• Background
• Review Process
• Procedure
• Conclusion

3. INTRODUCTION
• IRB/IEC serves as an independent body that reviews, evaluates,
approves and decides on the scientific and ethical aspects of
the clinical trial protocol as well as the benefits and risks to the
study participants.
• Main purpose of IRB/IEC is to protect the rights, safety, and
well-being of the subjects who participate in a trial.

4. BACKGROUND
• National research Act passed by congress on July 12, 1974,
mandated establishment of IRB/IEC.
• Act provided national commission for protection of human
subjects of Biomedical and behavioral research and lead to
publication of The Belmont Report in 1979.
• Private practitioners conducting trials were exempted from IRB
and informed consent regulation required.
• Submissions of NDA’s approval of IRB is necessary.

5. REVIEW PROCESS
• Researchers are required to submit a request for review to the IRB if
their research involves human participants or their data.
• The IRB will determine if the research meets the requirements for
oversight, according to the Code of federal regulations (45CFR46).
• The request must be reviewed by the IRB prior to collecting data or
contacting participants.
• For continuing or modifying a current protocol, use the appropriate
form located on the IRB Forms page.

6. REVIEW PROCESS…
Complete IRB
Request for
Review
Submit
Request,
Documents,
and CITI to
irb@ualr.edu
Receive IRB
Reviewers
Feedback in
10 Business
Days
Possible
Decisions:
• Approved
• NHPR
• Further Review
• Full Board
IRB Decision is Required Prior to Contacting Participants or
Collecting data

7. 1. PROTOCOL COMPLETION
• Complete the Request for Review, Continuation, or Modification form, with
an expected start date at least 10 business days in the future.
• Attach your Human Research CITI Completion for all persons involved with
the research and other supporting documentation (consent/assent forms,
site letter of permission or support, recruiting materials, questionnaire/
survey, flyers, email or phone scripts, etc.)

8. 2. SUBMIT PROTOCOL TO IRB
• Submit ONE PDF ATTACHMENT of your completed protocol to
irb@ualr.edu.
• Please do not sent multiple attachments or a hard copy. Also, do not
send your protocol to the IRB Chair.
• When your protocol has been forwarded for review, you should receive
an email stating that your protocol has been submitted for review with
the estimated decision date.

9. 3. ESTIMATED DECISION DATE
• The IRB should have feedback or a decision back to you within 10
days from the date your protocol was accepted and issued a protocol
number.
• And in case you do not receive feedback or a decision within 10
business days, please contact at irb@ualr.edu

10. 4. DECISIONS
• Decisions are based on the definition provided by the 45CFR46.
• The decisions reached could be-
1. Approved
2. NHPR (Not Human Participant Research)
3. Further Review (need to provide clarifications or corrections to
your submitted materials)
4. Needs Full Board Review

11. The IEC’s member secretary shall screen the proposals for their completeness and
depending on the risk involved categorize them into:
• Expedited review- Those with no more than minimal risk to research
participants may be subjected to this review Ex: clinical studies of drugs and
medical devices. The research involves already approved drugs. When a
adverse event or unexpected adverse reaction is reported.
• Full review- All research proposals presenting with more than minimal
risk. Projects that involve vulnerable population (children, psychiatric
patients etc.,) Full review is carried out in cases involving: (a) collection of
blood samples (b) Prospective collection of biological specimens eg. Skin
appendages, excreta saliva, placenta, amniotic fluid, sputum etc.
• Exempted from review- Proposals with less than minimal risk Ex: research
on educational practice, instructional technics, curricula, classroom
management methods

12. Following parameters are considered for ethical review:
• Scientific design and conduct of study
• Recruitment of Research Participants
• Care and Protection of Research Participants
• Protection of research participant confidentiality
• Informed Consent Process

13. The IRB should review a proposed clinical trial within a reasonable time
and document its views in writing, clearly identifying the trial, the
documents reviewed and the dates for the following :
• Approval / favorable opinion
• Modifications required prior to its approval / favorable opinion;
• disapproval / negative opinion
• Termination / suspension of any prior approval / favorable opinion
• The IRB should consider the qualifications of the investigator for the
proposed trial, as documented by a current curriculum vitae and / or by
any other relevant documentation the IRB requests

14. TYPES OF REVIEW
• Periodic Review: Ongoing research may be reviewed at regular
intervals of six months to one year
• Continuing Review: The IEC has the responsibility to continue
reviewing approved projects for continuation, new information, adverse
event monitoring, follow up.
• Interim Review: Interim Review decide special circumstances for
review by sub-committee – re-examination of proposal already
examined by IEC.

15. STEPS IN IEC REVIEW
IEC date fixed
Submission
made by
researchers
Decide primary
and secondary
reviewers
Review
The IEC
meeting
The
Discussions
The
Decision
Documenting
the
discussions
and decisions
Communicat
e the
decisions to
researchers
Revisions/
Resubmissions
/ Cleared.

16. PROCEDURES
The IRB/IEC should establish, document in writing, and follow its
procedures, which should include:
• Determining its composition (names and qualifications of the members)
and the authority under which it is established.
• Scheduling, notifying its members of, and conducting its meetings.
• Conducting initial and continuing review of trials.
• Determining the frequency of continuing review, as appropriate.

17. • Providing, according to the applicable regulatory requirements, expedited
review and approval/favorable opinion of minor change(s) in ongoing trials
that have the approval/favorable opinion of the IRB/IEC.
• Specifying that no subject should be admitted to a trial before the IRB/IEC
issues its written approval/favorable opinion of the trial.
• Specifying that no deviations from, or changes of, the protocol should be
initiated without prior written IRB/IEC approval/favorable opinion of an
appropriate amendment, except when necessary to eliminate immediate
hazards to the subjects or when the change(s) involves only logistical or
administrative aspects of the trial (e.g., change of monitor(s), telephone
number(s).

18. • Specifying that the investigator should promptly report to the IRB/IEC:
(a)Deviations from, or changes of, the protocol to eliminate immediate
hazards to the trial subjects
(b)Changes increasing the risk to subjects and/or affecting significantly
the conduct of the trial
(c)All adverse drug reactions (ADRs) that are both serious and
unexpected.
(d)New information that may affect adversely the safety of the subjects or
the conduct of the trial

19. • Ensuring that the IRB/IEC promptly notify in writing the
investigator/institution concerning:
(a) Its trial-related decisions/opinions.
(b) The reasons for its decisions/opinions.
(c) Procedures for appeal of its decisions/opinions.

20. RECORDS
• The IRB/IEC should retain all relevant records (e.g., written procedures,
membership lists, lists of occupations/affiliations of members, submitted
documents, minutes of meetings, and correspondence) for a period of at
least 3-years after completion of the trial and make them available upon
request from the regulatory authority(ies). The IRB/IEC may be asked by
investigators, sponsors or regulatory authorities to provide its written
procedures and membership lists.

21. CONCLUSION
• An Institutional Ethics Committee is a mandatory requirement as per
the ICMR which is the over–seeing body of medical research in India.
• It is an Independent body constituted of medical, non- 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 the trial.

22. THANK YOU