it is advisable that ethics committee should be constituted with the
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ICMR GuidelineETHICAL REVIEW PROCEDURES
[SALIENT POINTS REFLECTED FROM THE ICMR GUIDELINES]
The need for evaluation of research proposals has been emphasized under the Statement of General Principles at item no. 5 (http://icmr.nic.in/human_ethics.htm#Guidelines) pertaining to precaution and risk minimisation. It is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Ethics Committee (IEC), also referred to as Institutional Review Board (IRB), Ethics Review Board (ERB) and Research Ethics Board (REB) in other countries, to safeguard the welfare and the rights of the participants. There are also independent ethics committees [IEC(Ind)] functioning outside institutions for those researchers who have no institutional attachments or work in institutions with no ethics committee. The Ethics Committees are entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring of the approved programmes to foresee the compliance of the ethics during the period of the project. Such an ongoing review shall be in accordance with the international guidelines wherever applicable and the Standard Operating Procedures (SOP) of the WHO available at http://www.who.int/ethics/topics/en/BASIC RESPONSIBILITIES
The basic responsibility of an Institutional Ethics Committee (IEC) is to ensure a competent review of all ethical aspects of the project proposals received by it in an objective manner. IECs should provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research through appropriate Scientific Review Committee. In institutions where this is lacking, the IEC may take up the dual responsibility of review of both, the scientific content and ethical aspects of the proposal. It is advisable to have separate Committees for each, taking care that the scientific review precedes the scrutiny for ethical issues. The scientific evaluation should ensure technical appropriateness of the proposed study. The IECs should specify in writing the authority under which the Committee is established.
Small institutions could form alliance with other IECs or approach registered IEC(ind). Large institutions/Universities with large number of proposals can have more than one suitably constituted IECs for different research areas for which large number of research proposals are submitted. However, the institutional policy should be same for all these IECs to safeguard the research participant's rights.
The main IEC may review proposals submitted by undergraduate or post-graduate students or if necessary, a committee may be separately constituted for the purpose, which will review proposals in the same manner as described above. The responsibilities of an IEC can be defined as follows:-
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 in terms of local community values and customs.
To assist in the development and the education of a research community responsive to local health care requirements.COMPOSITION
The IECs should be multidisciplinary and multisectorial in composition. Independence and competence are the two hallmarks of an IEC. The number of persons in an ethics committee should be kept fairly small (8 - 12 members). It is generally accepted that a minimum of five persons is required to form the quorum without which a decision regarding the research should not be taken. The members should be a mix of medical/ non-medical, scientific and non-scientific persons including lay persons to represent the differed points of view.
The composition may be as follows:-
2. One - two persons from basic medical science area
3. One - 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
As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics committee approving drug trials should have in the quorum at least one representative from the following groups:
1. One basic medical scientist (preferably one 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 Ethics Committee (EC) can have as its members, individuals from other institutions or communities with adequate representation of age and gender to safeguard the interests and welfare of all sections of the community/society. If required, subject experts could be invited to offer their views, for instance, a pediatrician for pediatric conditions, a cardiologist for cardiac disorders etc. Similarly, based on the requirement of research area, for example HIV, genetic disorders etc. it is desirable to include a member from specific patient groups in the Committee.
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Ethics Committees in India: Past, present and future
Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, ...
Perspect Clin Res. 2017 Jan-Mar; 8(1): 22–30.
PMCID: PMC5299801 PMID: 28194334
Ethics Committees in India: Past, present and future
Urmila M. Thatte and Padmaja A. Marathe1
Author information Copyright and License information Disclaimer
Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward.
The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency.
A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen.
A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future.
Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.Keywords: Accreditation of Ethics Committee, Ethics Committee Registration, research participant, Schedule Y
With a population of over 1.3 billion and a high disease burden, India must engage in clinical research relevant to its health-care needs to build evidence that drives policy. Yet, this was not so in the past. The National Health Policy of India observed that “In our country, where the aggregate annual health expenditure is of the order of Rs. 80,000 crores, the expenditure in 1998–99 on research, both public and private sectors, was only of the order of Rs. 1150 crores. It would be reasonable to infer that with such low research expenditure, it is virtually impossible to make any dramatic breakthrough within the country, by way of new molecules and vaccines.”
However, the last decade saw a marked and dramatic change in the landscape. Following watershed amendments in Schedule Y, India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. The country's contribution to global clinical trials grew from 0.9% in 2008 to 5% in 2013. This led to both optimistic forecasts that India could attract up to 10% of the global market of clinical trials, and morose, sometimes crusty observations that India was being colonized again. Reality was somewhere in between as always.
Just as dramatic as the rise was the fall of this empire. At its peak in 2010, the clinical trial industry started floundering with the global economic meltdown and then more perilously in 2013 following the slew of regulatory changes brought about following Supreme Court orders and observations of the Parliamentary Standing Committee Reports.[6,7]
Against this background, it is pertinent to review the status of Ethics committees (EC) that are established primarily to protect a research participant's rights, dignity and ensure her/his well-being. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country, and suggests the way forward. For the purpose of this article, we have divided the decade (2005–2015) into three sections: The past which covers 2005–2013, the present running from 2013 to 2015, and the future after that.
THE PAST (2005–2013)
It was as far back as 1975 when the second revision of the Declaration of Helsinki adopted at the 29th World Medical Association General Assembly in Tokyo recommended, “The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment, and guidance.” The Belmont Report issued in 1979 further emphasized the need for review of all clinical research by ECs.
In India, the requirement for an EC to oversee clinical research was first made in the Indian Council of Medical Research (ICMR) Policy Statement for Ethics published in 1980 and then again in the original version of the Schedule Y issued in 1988. Schedule Y (1988) mentioned said, “It is desirable that protocols for clinical trials be reviewed and approved by the Institution's Ethical Committee. Since such committees at present do not exist in all institutions, the approval granted to a protocol by the Ethical Committee of one institution will be applicable to the use of that protocol in other institution, which do not have an Ethical Committee. In case none of the trial centres/institutions has an Ethical Committee, the acceptance of the protocol by the investigator and its approval by the Drugs Controller (India) or any officer as authorized by him to do so will be adequate to initiate the trials.”
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