INSTITUTIONAL REVIEW BOARD (IRB)/ INDEPENDENT ETHICS COMMITTEE (IEC)
DEFINITION:
An independent group made up of members with backgrounds in medicine, science, and non-science, whose job is to ensure the rights, safety, and well-being of people taking part in clinical trials. They do this by reviewing, approving, and providing an ongoing review of the trial protocol and any amendments. The review procedures should comply with the Declaration of Helsinki and all other applicable international biomedical research norms.
To clarify its duties, each IRB/IEC Panel has its own set of written operational protocols. It should ensure that each subject during a clinical test receives appropriate and adequate care, to protect the confidentiality of subjects, and ensure the payment or compensation procedures.
BACKGROUND:
In the 1960s, the first ECs for research were developed. An independent committee must be consulted before conducting any experiment involving humans, according to the first amendment of the Declaration of Helsinki (DOH), which was published in 1975. The requirement for EC approval of all clinical trials was once again highlighted in the US-drafted Belmont report in 1979. International ethical standards for biomedical research involving human subjects were developed by the Council for International Organization of Medical Sciences (CIOMS) in 2002. A new set of CT rules for 2019 has been published by DCGI.
A "Policy Statement on Ethical Considerations involved in Research on Human Subjects" was published in India by the Indian Council of Medical Research (ICMR) in February 1980. The guidelines were revised in 2006, and 2013 and the latest version was released in 2018.
RESPONSIBILITIES OF IRB/IEC:
To protect the welfare, safety, and rights of test subject
To review protocols within time.
Should communicate their opinions in writing.
Should conduct the continuous reviewing process.
Special care should be taken for the trials that include vulnerable subjects.
Address the necessity of informed consent
- About written materials and documentation.
- Compliance with regulatory requirements.
- Communication with LAR.
- Should enquire for more details.
- About the amount and payment methods.
COMPOSITION OF IRB/IEC:
An IEC is made up of the
institutional head and is a multidisciplinary, autonomous body. The number of
people is limited (8 – 12). The IRB/IEC picks a chairperson from among its
members who should not be the head of an analogous institution and should be
from outside the institution. As a result, the committee's business is handled
by the Member Secretary of an equivalent institution.
There must be a minimum of five people
present to form a quorum or to conduct a meeting. According to the 2005
amendment to the 2005 revision of Schedule Y of the 1940 Medicine and Cosmetics
Act, they should include a fundamental medical expert (pharmacologist), a
doctor, one retired judge or a legal professional, one social scientist, one
NGO representative, one philosopher, one ethicist, one theologian, or an
identical person, and one layperson.
Members of IRB/IEC:
PROCEDURES OF IRB/IEC:
The IRB/IEC should adopt, formally
record, and adhere to its policies, which ought to include:
1. Establishing its members
(members' identities and qualifications) and the legal framework that founded
it.
2. The planning,
announcement, and conduct of its meetings.
3. Doing a preliminary and
ongoing analysis of studies.
4. Stating that no subject
should be allowed to participate in a trial until the IRB/IEC has given their
formal approval or favorable assessment of the trial.
5. Specifying that the
following should be immediately reported by the investigator to the IRB/IEC:
(a)
Deviations from the protocol or adjustments made to it to remove any urgent
risks to the trial patients.
(b)
Modifications that make individuals more at risk and/or materially impact how
the experiment is conducted
(c) All severe and unanticipated adverse drug reactions (ADRs).
MAINTAINANCE OF RECORDS:
After the trial is finished, the IRB/IEC must keep all pertinent records (such as written procedures, membership lists, lists of members' occupations and affiliations, submitted documents, meeting minutes, and correspondence) for at least three years and make them available to regulatory authorities upon request.
CONCLUSION:
This blog mainly focuses on the
IRB/IEC composition, its responsibilities, and its procedures. IRB/IEC
effectiveness is dependent on- the quality and dedication of members;
procedures; design documents; institutional commitment, financial resources,
degree of independence, and investigator adherence to standards.
REFERENCES:
2.http://www.jirb.org.tw/DB/File/Download/970127-08_Role%20of%20IRB_Cristina%20Torres.pdf
3. https://globalresearchonline.net/journalcontents/v63-2/03.pdf
SUBMITTED BY:
B. AKSHITHA REDDY
PHARM-D
CSRPL_INT_OFL_WKD_154/0822
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