The document discusses institutional review boards (IRBs) and independent ethics committees (IECs), which are groups that review clinical trials to protect participant rights and safety. IRBs/IECs review trial protocols, risks/benefits, informed consent documents, and monitor trials. They must have at least five members with varying backgrounds, including a lay person and independent member. The principal investigator is responsible for ensuring compliance with IRB/IEC requirements. The document also provides information on IRBs/IECs in India and an example IEC in Mumbai.
2. IRB/EC in Clinical Trials
◦ The International Council on Harmonization (ICH) defines an
institutional review board (IRB)as a group formally designated to
protect the rights, safety and well-being of humans involved in a
clinical trial by reviewing all aspects of the trial and approving its
startup. IRBscan also be called independent ethics committees
(IECs).
◦ An IRB/IEC reviews the appropriateness of the clinical trial
protocol as well as the risks and benefits to study participants. It
ensures that clinical trial participants are exposed to minimal risks
in relation to any benefits that might result from the research.
3. ◦An IRB/IEC:
◦ Reviews all study-related materials before and during the trial
◦ Must operate in accordance with national and/or local regulations, as well as with ICH
good clinical practices(GCPs) guidelines
◦IRB/IEC Membership
◦ IRB/IEC members should be collectively qualified to review the scientific, medical and
ethical aspects of the trial.
◦ An IRB/IEC should have:
◦ At least five members
◦ Members with varying backgrounds
◦ At least one member must represent a non-scientific area (a lay member)
◦ At least one member must not be affiliated with the institution or the trial site (an
independent member)
◦ Competent members who are able to review and evaluate the science, medical
aspect and ethics of the proposed trial
4. IRB/IECResponsibilities Before, During and After a Trial
Before a site is allowed to start enrolling patients in a clinical trial,
the IRB/IEC must review all study-related materials in an initial
review. T
he I
RB/I
EC also performs periodic reviews –called
continuing reviews –throughout the trial’s duration. Continuing
reviews may take place at least once a year and include the
entire trial, not just changes.
The IRB/IEC may also ask for additional information regarding
payments and compensation to study participants, as well as
the informed consent process.
Investigator Responsibilities for Ensuring Compliance
The principal investigator (PI) is responsible for ensuring
compliance with any IRB/IEC procedures or requirements. He or
she may deviate from the study protocol without prior IRB/IEC
approval only to eliminate immediate safety hazard to a study
participant.
6. What is the Institutional Review Board
(IRB)?
◦ The Institutional Review Board (IRB) is an administrative body established to protect the
rights and welfare of human research subjects recruited to participate in research
activities conducted under the auspices of the institution with which it is affiliated.
◦ The IRBis charged with the responsibility of reviewing, prior to its initiation, all research
(whether funded or not) involving human participants. The IRBis concerned with
protecting the welfare, rights, and privacy of human subjects. The IRBhas the authority
to approve, disapprove, monitor, and require modifications in all research activities
that fall within its jurisdiction as specified by both the federal regulations and
institutional policy. The IRBshall have at least five members of varying backgrounds in
order to provide complete and adequate review of human research and its
institutional, legal, scientific, and social implications. The Board will also include at least
one member who is not affiliated with the institution and one member who is not a
scientist. The IRBhas several consultants who advise the Board and are periodically
involved in protocol review.
7. FDA Guidance for Institutional Review
Boards
◦ Under FDA regulations, an IRBis an appropriately constituted group that has been
formally designated to review and monitor biomedical research involving human
subjects. Inaccordance with FDA regulations, an IRBhas the authority to approve,
require modifications in (to secure approval), or disapprove research. This group review
serves an important role in the protection of the rights and welfare of human research
subjects.
◦ The purpose of IRBreview is to assure, both in advance and by periodic review, that
appropriate steps are taken to protect the rights and welfare of humans participating
as subjects in the research. To accomplish this purpose, IRBsuse a group process to
review research protocols and related materials (e.g., informed consent documents
and investigator brochures) to ensure protection of the rights and welfare of human
subjects of research.
8. FDA Guidance for Institutional Review
Boards (CONTD)
◦ As published in the Federal Register on January 15, 2009, (74 FR 2358), 21 CFR Part 56,
Institutional Review Boards, was amended with regard to IRBregistration (21 CFR
56.106). This amendment requires each IRB in the United States (U.S.) that reviews FDA-
regulated studies to register. IRBregistration information is entered into an Internet-
based registration system maintained by the Department of Health and Human
Services (HHS)
◦ The fundamental purpose of IRBreview of informed consent is to assure that the rights
and welfare of subjects are protected. A signed informed consent document is
evidence that the document has been provided to a prospective subject (and
presumably, explained) and that the subject has agreed to participate in the research.
IRBreview of informed consent documents also ensures that the institution has
complied with applicable regulations.
9. Indian I
R
B
◦ The Central Drug Standards and Control Organization (CDSCO), amended the
Schedule Y, by issuing three amendments to introduce new compensation rules and
registration of IRBs functioning in the country.
◦ Central Drug Standards and Control Organization (CDSCO) has granted registration to
565 IRBsin the country, this means that at least on paper these IRBsare compliant to
the norms as of 2013.
◦ IRBsin India must have at least seven members in place of five members required in the
International Conference on Harmonization (ICH) region.
13. Four Basic Ethical Principles
◦Respect for Persons Application: Informed Consent
◦Beneficence Application:Assessment of Harms and
Benefits
◦Justice Application:Selection of Participants in
Research
◦Respect for Communities Application:Community
involvement and participation
14. R
E
SP
ON
SIB
ILIT
IE
SOF IEC
1.To protect the dignity , rights & well being of
patients.
2.Ensure a competent review of the protocol.
3. Advise on all aspects of welfare & safety.
4. Ensure scientific soundness of the proposal.
15. IEC
MUMBAI
DATA
Sr. No. IEC assigned No. Title Name of PI Location
1. IEC/1/2000 A phase II study of Gemitabine, Paclitaxel and cisplatin in
chemotherapy naïve FIGO stage III B and IV ovarian
cancer
Dr. Purvish M.
Parikh
Tata Memorial
Hospital,
Mumbai
2. IEC/2/2000 An open non comparative study of efficacy and safety of
ketoprofen IV in the treatment of cancer pain
Dr. Purvish M.
Parikh
Dr. L.J.D'Souza
Tata Memorial
Hospital,
Mumbai
3. IEC/4/2001 A study of gynaecological morbidity and common mental
disorders in Goa
Dr. Vikram Patel Goa
