It is said that those who don't learn from the mistakes of the past are destined to repeat them. It seems that the Coca-Cola has not learnt any lessons from Plachimada - a village in the state of Kerala in India where the community-led campaign has shut down its plant since March
This article has been cited by other articles in PMC. Abstract The past few years have seen a tremendous rise in the number of clinical trials conducted in India.
This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees EC.
The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research.
Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs.
This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions.
Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. As clinical research involves human participants, researchers are ethically obligated to protect them.
The two principal protections offered to an individual taking part in clinical research are Written Informed Consent and Ethics Committee EC review. The purpose of an EC review of biomedical research is to safeguard the dignity, rights, safety, and well-being of the research participants.
The EC review comprises of ethical principles and decision-making to solve actual or anticipated dilemmas in the conduct of human research. The biopharmaceutical majors world over are turning toward India, given its rich technical resource pool, ease of patient recruitment, and sheer diversity inherent in our country's genetic texture.
These guidelines included recommendations for membership criteria and ethical standards for review, which laid down the foundation for the establishment of ECs in India.
This was followed by release of the ICMR guidelines in bioethics, which was a guidance document for research in medical, epidemiology, and public health, in the yearwhich was further revised in However, despite the establishment of ethical guidelines since a long time, the ECs in our country are still grappling with basic issues like, inadequate or no standard operating procedures SOPs and noncompliance with the Schedule Y recommendations.
The EC has the prime responsibility of regulating clinical research and safeguarding the rights and safety of research participants, however, the institutions and hospitals that focus on enhancing their research facilities tend to ignore the EC, which approves their research.
ECs have to deal with basic issues such as lack of trained manpower, heavy workload, inadequate space allocated for EC operations, lack of administrative support, and inadequate remuneration offered to members serving on EC boards.
These issues culminate into reluctance of trained individuals to serve as members of the EC. In a study conducted by ICMR it was observed that there were no legal experts on most of the ECs and a lack of clarity in the appointment procedures of EC members. The study also noted that record keeping was poor, and the independence and competence of EC questionable.
It is seen that most often the Head of the Institution's function as chairperson of its EC, thus compromising its independent status. However, many of the existent ECs do not have their standard operating procedures in place and are not constituted as per Schedule Y recommendations.
It is also seen that ECs do not have adequate representation of members during their meetings, which is likely to generate a biased opinion.
This is an important issue given the increasing number of privately owned hospitals participating in clinical research. The presence of members with conflicting interests is likely to limit the ability of an impartial review by the EC. It is also observed that many EC members are ambiguous about their roles and responsibilities, during a review process.
ECs members comprise of highly educated and experienced representatives from non-scientific communities, but most of them are silent observers during meeting proceedings and do not participate in scientific or ethical deliberations in the review procedures.
EC members see their responsibilities limited to providing approval to research proposals submitted for review and are oblivious to the need for a continuous review. Very rarely do ECs undertake detailed monitoring of studies and scrutinize the informed consent process.
This also advocates the need for an oversight mechanism to be in place during the operations of the EC. To date there is no central registration system for ECs functioning in our country, raising concerns about accountability.
Due to lack of visible oversight by the regulatory authorities, there is noncompliance with the recommended ethical standards noted among ECs. The introduction of the Clinical Trial Registry - India CTRI is considered as an ethical imperative for research conducted in India, but this needs to be coupled with a central oversight for ECs approving research studies.
The Drug Controller of India DCGI has released guidelines for inspection of investigator sites, but there are no recommendations for regulatory inspections to be conducted on ECs. Centralized registration of ECs is a longtime plan, yet to be implemented. The ethical guidelines released by the ICMR are elaborate and give a sound direction to biomedical research conducted in the country.
FERCAP is a forum of bioethicists and medical experts who have come together with the objective of fostering an improved understanding and better implementation of the ethical review of biomedical research in Asia and the western Pacific region.
FERCAP works towards facilitating research and education opportunities by acting as a regional collaborator for ECs and various stakeholders in health research. This national conference was a pioneering step toward improving the functioning of ECs in India and getting them together.
However, these initiatives need to be coupled with strong implementation plans, to ensure stringent regulatory controls to safeguard subject rights. The DCGI designates the EC as an important regulator of ethical research; however, both the bodies seem to work in isolation.® Academy o/ Management Executive.
Vol. No. 2 Business ethics and customer stakeholders Federal Trade Commission stepped in when KFC promoted the health benefits and low carbohy- Ethical issues that have the support of the gov-. PROBLEMS FACED BY KFC IN INDIA:The case highlights the ethical issues involved in Kentucky Fried Chicken's (KFC) business operations in India.
KFC entered India in and has been in midst of controversies since then/5(3). Ethical Approach to Fast Food Product Contents and Their Advertisement Strategies Mustafa SOBA Assistant Prof. Dr. go in for international marketing, increased.
Ethical issues are not suitable for all over the world.
They have not certain rules as a t-shirt. Because of this reason we faced international marketing. King, McDonalds, KFC. KFC in India Case Study Assignment (Ethical Issue) Since the late sass, KEF faced severe protests by People for Ethical Treatment of Animals (PETA), n animal rights protection organization.
Case Study 1 KFC in India – Ethical Issues 1. Since its entry into India in , KFC has been facing protests by cultural and economic activists and farmers. Augustana College Augustana Digital Commons Ethics Essay Contest Prizewinners The Ethical Issues of Dumping Electronic Waste in India Krista E.