regulatory affairs

2. • 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

3. • 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 exmpted
from IRB and informed consent regulation required.

4. • The amended regulation on july 27,1981 requires IRB
review and approval of all research increased need of
establishing IRB that would review and approve research
proposal tha might affilited with major research centre ,
hospital , universities
• Submissions of NDA’s approval of IRB is necessary.

5. • The goal of IRB/IRC is protection of the rights , safety
and welfare oh human subjects involved in clinical
research investigations.
• Reviews a proposed clinical trial within a reasonable time
and document its views in writing
• Conducts continuing review of each ongoing trial at least
once per year

6. • Provide advice to the researchers on all aspects of welfare and
safety of research participants Responsibilities of IRB/IEC
• Ensures that information regarding payment to subjects
(including the methods, amounts, schedule of payment) is set
forth in the written informed consent form and any other
written information is provided to the subjects
• If the all the things are not sufficient may either dissapprove
the investigation or may suggest modifications
• The sponsor must secure the investigator’s agreement to fulfill
obligations by obtaining signed and dated before initiating a
trial

7. • Consists of members, who collectively have the
qualifications and experience to review and evaluate the
science, medical aspects, and ethics of the proposed
trials
• Includes at least five members, of which at least one
member whose primary area of interest is nonscientific,
and at least one member who is independent of the
institution/trial site MEMBERS OF IEC

8. • Chair person
• 1-2 basic medical scientists
• 1-2 clinicians from various institutes
• One legal expert or retired judge
• One social scientist
• One philosopher/ethicist
• One lay person
• Member Secretary

9. • IRB’s must maintain written procedures of all operations.
All activities associated with the following operations
must be recorded.
 Conducting initial review and conducting review/
approval of research
 Conducting expedited review/ approval of research
 Ensuring that changes in research activites are reported

10.  Ensuring that changes in previously approved research
are not implemented without review and approval
 Reporting of serious risk
 Reporting of serious findings
 All IRB’s are required to maintain records of meetings
and documents for at least three years after completion
of study
 IRB’s are responsible for reporting's investigators
noncompliance

11. • All information submitted to an IRB review of a research
protocol is provided by clinical investigator
• The standard document provided are research protocol ,
sample of intended informed consents , Investigators
Brochure.
• It has become important to provide patient information
or instruction guidelines.

12. • FDA information sheets suggesting that they be provided
has served as guidelines / refrences for common
practices that facilitate regulated activites
• In ICH GCP guidelines its specially stated that certain
document be obtained for review as part of responsibility
of IRB/IEC
• Review of the protocol ensures adequate selection
criteria and procedure to protect vulnerable study
population

13. • The informed consent regulations (21 CFR, part 50) apply to
all clinical investigations regulated by FDA that include
applications for research or marketing permits for products
the FDA regulates.
• General requirements for informed consent (IF) are
• Subject participating in trial should not only inform about
project but procedures n followed by risks and benefits
associated with it.
• The IF requires written contest from each participant that
they are satisfied with all terms and conditions.

14. • FDA implemented regulation in regarding case histories to
specify that case histories must document that IF was
obtained before a subject participated in study.
• According to IF clinical investigators should allot sufficient
time for patients to review and ask questions regarding it
• IF overall documentations must be done in simple and
easy language that is easily understood by layperson .
• All technical, medical , legal terminology should be
explained to a prospective subject.

15. • Statement should be prepared which shall involve
purpose of research ,expected duration ,schedule and
events to be followed.
• Descriptions of any reasonable risk or discomfort.
• Descriptions of benefits that may be expected as result
of research.
• Disclosure of appropriate procedures or course of
treatment

16. • A statement that the particular treatment or procedure
involve currently risk
• Circumstances under which subjects involvement may be
terminated by investigator.
• Consequences that may result from the subjects decision
to withdraw from research.
• The approximate no. Of subjects involved in study

17. • It's a short-form written consent document starting that
the elements of IF have been presented orally to the
subject or authorized representative .
• Following are requirements necessarily implemented to
use oral consent
 A witness to oral presentation must be present.

18.  The IRB must approve written summary of what will be
said to subject.
 The oral consent must be signed by
subject/representative and by witness

19. • In an emergency use situation where an investigator has
determined that there is not sufficient time to obtain IF
from subject but he or she is required to have
determination reviewed by physician but a written
certification of following IF requirements before use
which are as follows

20. • The subject is confronted by a life threatening situation
necessitating use of test article
• Time is not sufficient to obtain effective consent from
subject
• No alternative method of therapy is available.