Submitted by: Ms. Kalpana Peyyeti, BAMS, PGDCR – JLI Global Clinical Research Academy, Lakdi-ka-pul, Hyderabad
As per the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome.
Ethics are concerned with the distinction between Right and Wrong, with moral choices, duties and obligations.
The four main principles of Biomedical Ethics are:
Institutional Ethics Committee (IEC) is the committee formed of a group of people who go through the research protocol / proposal and state whether or not it is ethically acceptable.
Looking into the history, ethics in medical practice were addressed in Charaka Samhita in 1600 BC which mentions the code of ethical conduct and also by Hippocrates in 600 AD. In first half of 20th century many medicines, vaccines were developed, based on trials on captive groups and prisoners without their consent with no concern for their health & welfare. Several unfortunate things occurred throughout the world like Nazi War Crimes during World War II where studies were done on prisoners at Nazi Concentration camps. After that in 1946 all Nazi doctors were trialed before international tribunal and also mishaps like the Tuskegee Syphilis Experiment 1932-1972 by U.S. Public Health Service where 399 African-American men in Alabama were experimented for Syphilis necessitated the need for and numerous codes of ethics which were:
1947– Nuremberg Code of Medical Ethics.
1948– Universal Human Rights – United Nations.
1956– Code of Medical ethics-Medical Council of India
1964– Declaration of Helsinki. Last revision in 2008 at Seoul, Korea by WMA.
1974– Belmont Report by National Commission by US, PHS.
1980– Policy Statement on Ethical Consideration involved in Research on HumanSubjects ICMR.
1982– Proposed International guidelines for Biomedical Research involving Human Subjects-WHO & CIOMS
1991– International Guidelines for Ethical Review in Epidemiological Studies by CIOMS.
1996– ICH – GCP Guidelines.
2001– Directorate of Health Services, Government of India published GCP.
2001– European Union Directive, 2004- revised.
2006– Ethical Guidelines for Biomedical Research on Human Participants published by ICMR.
ICMR Code is the statement of Ethical Guidelines for Biomedical Research on Human Participants. These Statements of General and Specific Principles may be varied, amended, substituted and added from time to time.
To safeguard the welfare and the rights of the participants it is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Ethics Committee (IEC). This is also referred to as Institutional Review Board (IRB).
Composition and responsibilities of IEC:
Institutional Head constitutes an IEC and it is independent, competent and multidisciplinary unit. The number of persons are fairly small (8 – 12).
The IEC appoints from among its members a chairperson who should be from outside the Institution and not head of the same Institution, and the Member Secretary from the same Institution who conducts the business of the committee. Members of IEC are:
2. One to two persons from basic medical science.
3. One to two clinicians from various Institutes.
4. One legal expert or retired judge.
5. One social scientist/ representative of non-governmental voluntary agency.
6. One philosopher/ ethicist/ theologian.
7. One lay person from the community.
8. Member Secretary.
The Quorum (i.e. the minimum number of people required to conduct a meeting) has 5 persons minimum. As per revised Schedule Y of Drugs & Cosmetics Act, 1940 which is amended in 2005, they should be as :
1. One basic medical scientist (pharmacologist).
2. One clinician.
3. One legal expert or retired judge.
4. One social scientist/ representative of non-governmental organization/Philosopher/ ethicist/ theologian or a similar person.
5. One lay person from the community.
The members work to safeguard the interests and welfare of all sections of the community. If required, subject experts could be invited to offer their views like a pediatrician for pediatric conditions, a cardiologist for cardiac disorders etc.
IEC has its own Standard Operating Procedures (SOPs) according to which it functions. These SOPs are updated periodically and these ensure smooth functioning also. An IEC must preferably be registered at the National Biomedical Research Authority as per the Bill passed in 2007.
Responsibilities of IEC are to protect the dignity, rights and well-being of the potential research participants, to ensure that universal ethical values and international scientific standards are expressed and to assist in the development and the education of a research community responsive to local health care requirements
Functions of IEC:
The IEC’s member-secretary screens the research proposals for their completeness and depending on the risk involved categorize them into 3 types:
1) Exemption from review for proposals that involve less than minimal risk.
2) Expedited review for more than minimal risk proposals, minor protocol amendments, research on disaster management, and research on material collected during routine patient care like CT scans.
3) Full review for more than minimal risk and that involve vulnerable subjects.
The ethical review should be done in formal meetings by all primary reviewers and decision is made only when quorum complete.
The committee should meet at regular intervals and should not keep a decision pending for more than 3 – 6 months. Periodic reviews are done as per the SOPs.
All the decisions are communicated in writing to the principal investigator (PI). Members should be encouraged to attend trainings so that they are aware of all new guidelines and developments.
Elements of review are:
• Scientific design, conduct of the study and approval of review committees.
• Examination of predictable risks and potential benefits.
• Procedure for selection of subjects including inclusion/ exclusion, withdrawal criteria and other issues like advertisement details.
• Management of research related injuries, adverse events and compensation.
• Justification for placebo and availability of products after the study.
• Patient information sheet and informed consent form in local language.
• Protection of privacy and confidentiality.
• Plans for data analysis and reporting.
• Adherence to all regulatory requirements and applicable guidelines.
• Competence of investigators, research and supporting staff, and facilities.
• Criteria for withdrawal of patients, suspending or terminating the study.
Record keeping & Archiving:
All documentation & communication of an IEC are dated, filed and preserved up to minimum of three years after completion/termination of the study and strict confidentiality maintained during access and retrieval procedures.
All institutions which carry out any form of biomedical research involving human beings should establish an appropriate IEC that is consistent with international and local guidelines and regulations. They must follow ICMR guidelines in India to protect safety and well-being of all participants and should prevent unethical research.