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Guidelines
INSTITUTIONAL ETHICS COMMITTEE (IEC)
Responsibilities
IEC should safeguard the rights, safety, and well-being of all trial
subjects. Special attention should be given to trials that include
vulnerable subjects.
IEC should obtain the following documents for each study proposal
under consideration:
Study protocol with amendments, if any.
Written informed consent forms and consent form updates.. Consent
should be obtained from the subject or the subject's legally acceptable
representative.
Case recruitment procedures.
Copy of the written information to be provided to the study subjects.
Bio-data of the investigators.
Available safety information in case of drug trials or device trials
or surgical procedures.
Any other documents the Committee may need to fulfill its
responsibilities.
IEC should consider the qualification and experience of the
investigator, as evidenced by the curriculum vitae or any other relevant
documents.
IEC should review the proposed study within a reasonable time and
document its views in writing, clearly identifying the trial, the
documents reviewed and the dates for the following:
Approval of the study.
Modifications required prior to its approval.
Disapproval of the study.
Termination/suspension of any prior approval.
IEC should review each ongoing study at periodic intervals
(appropriate to the risk to human subjects).
IEC may request additional information from the investigator that
would add meaningfully to the protection of the rights, safety and/or
well being of the subjects.
Functions and Operations
Only those IEC members who are independent of the investigator and the
sponsor of the study should vote/provide opinion on a study-related
matter.
IEC should perform its functions according to written operating
procedures, should maintain records of its activities and minutes of its
meetings, and should comply with locally applicable regulatory
requirements.
A quorum of at least five members with not more than two from Care
Foundation and Care Hospital should be present for the IEC to make its
decisions. Only members who participate in the IEC review and discussion
should vote/provide their opinion and/or advise.
The investigator should provide information on aspects related to the
study, but should not participate in the deliberations of the meeting or
in the vote/opinion of the IEC.
Wherever felt necessary, IEC may invite special invitees for
assistance.
Procedures
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 (copy of the Care
Foundation Board Resolution).
Scheduling, notifying its members of, and conducting its meetings.
Conducting initial and continuing review of research studies.
Determining the frequency of continuing review, as appropriate. The
Committee should meet as frequently as possible to avoid undue delays in
initiating research studies and also to review the ongoing studies to
monitor the interests of the trial subjects.
Providing approval (or disapproval as the case may be) of minor
changes in ongoing studies that have already been approved by the
Committee.
Specifying that no subject should be recruited to a study before the
IEC issues its written approval.
Specifying that no deviations from, or changes of, the protocol should
be initiated without prior written approval, except when necessary to
eliminate immediate hazards to the subjects or when the logistical or
administrative aspects of the study (eg. Change of monitor(s), telephone
numbers).
Specifying that the investigator should promptly report to the IEC:
Deviations from, or changes of, the protocol to eliminate immediate
hazards to the study subjects.
Changes increasing the risk to subjects and/or affecting significantly
the conduct of the study.
All adverse reactions that are both serious and unexpected (in case of
drug trials). IEC may ask the Investigator, based up on the findings of
interim analysis, to terminate the study.
New information that may affect adversely the safety of the subjects
or the conduct of the study.
Ensuring that the IEC promptly notify in writing the
investigator/Institution concerning:
Its study related decisions/opinions.
The reasons for its decisions/opinions.
Procedures for appeal of its decisions/opinions.
Records
IEC should retain all relevant records for a period of at least 3
years after completion of the study and make them available upon request
from the regulatory authorities.
IEC may be asked by investigators, sponsors or regulatory authorities
to provide its written procedures and membership lists.
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