Clinical Trials Ethics and Regulations

This assignment delves into the ethical considerations and regulatory framework surrounding clinical trials in India. It outlines the key responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) in ensuring ethical conduct and patient safety. The document emphasizes compliance with applicable laws, guidelines, and international standards such as the Declaration of Helsinki. Specific attention is paid to vulnerable subject protection, informed consent procedures, investigator qualifications, and data management practices.

Surname The Declaration of Helsinki
The Declaration of Helsinki (DoH)
Student’s name
Course
University
Date
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Surname The Declaration of Helsinki
The Declaration of Helsinki
Introduction:
The World Medical Association made a concerted effort to establish an ethical
principle to guide the medical researchers dealing with human subjects like those involving
identifying human data and materials. The Declaration of Helsinki is an ethical statement
guiding the human medical experimentation. The ethics guide the medical community to
conduct human experimentation and research. Although this declaration is not considered as
a binding instrument legally, it draws its authority from regional, national, and state
legislation and regulations (Carlson, Boyd, & Webb 2004). This document needs to form the
international law thus becomes a property of humanity. Without a doubt, determining the
optimal relationship between individual health and public health has established a major
ethical challenge for different health provider and health systems. However, the situation is
never simple because conflicts emerge from various issues including treatment, funding,
rights, duties, and preferences (WMA 2013). The World Medical Association recognized
these conflicts between public and individual health in researching human materials. The
DoH has demonstrated the significance of the concern thus redressing the imbalance.
The Declaration of Helsinki
The WMA developed the ethical principle to guide physicians and other researchers
engaging in medical research regarding human subjects. According to this statement, the
medical research involves human subjects like identifiable data or identifiable human
materials (WMA 2013). The physician has the duty to safeguard and promote the health of
the patients. To this effect, the physicians have to dedicate their conscious and knowledge on
fulfilling this duty. Importantly, the DoH binds the physicians with their words. For instance,
the physicians are guided by “the international code of medical ethics” (WHO 2001: 1) that
compels them to consider the health of patients. This implies that physicians need to work in
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Surname The Declaration of Helsinki
the interests of patients when offering medical care that sometimes can weaken the mental
and physical conditions of patients.
The WMA expects the physicians to consider regulatory, legal, and ethical standards
and norms for researching human subjects based on the legislation and regulations of the host
country. The physicians must also consider the applicable international standards and norms
when conducting research on human materials. Indisputably, medical research regarding
human data or subject can only be undertaken when the benefits outweigh the burden and
risks to the subject (Carlson et al. 2004). However, whenever the risks and burden outweigh
the benefits and definitive outcomes, the physician has the power to modify, or stop the study
based on the assessment. Medical research involving vulnerable group is justifiable where the
study is responsive to the needs, expectations, and priority of the group. It is impossible to
conduct a research in the non-vulnerable group when priorities and health needs are not
justifiable.
The vulnerable group would benefit from the physician’s interventions, practices, and
knowledge resulting in a positive outcome. The physician should justify and describe the
performance and design of research associated with human subjects in the research protocol.
The research protocol should have an ethical considerations statement demonstrating how the
principle is addressing the Declaration (WMA 2013). The research protocol should
encompass information regarding incentives for subjects, potential conflicts of interest,
institutional affiliations, sponsors, funding, and information. The protocol also contains the
provisions on compensating and treating subjects, especially to the victims of the harm
associated with the research study (Carlson et al. 2004). The physician needs to take
precaution to protect the research subjects’ privacy and the confidentiality of patient’s
personal information.
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Surname The Declaration of Helsinki
It is prudent for the physician to consider the individuals participating in the research
to give informed consent. This makes the medical research voluntary. The potential subject
should be informed regarding sources of funding, aims, methods, institutional affiliations,
and possible. The medical research should further acknowledge the potential benefits, risks,
post-study provisions, discomfort, and related aspects of the study (WMA 2013). For an
advanced clinical trial, researchers, host country government, and sponsors have to make
relevant provisions regarding the participants’ post-trial access who require interventions
beneficial to in the advanced clinical trials.
The IRB/IEC for Clinical Trials
Institutional Review Board (IRB) is mandated to protect and safeguard the safety,
rights, and welfare of the trial subjects. Based on the deliberations of the IRB, it is important
for the IEC to consider the design, content, and nature of the clinical trial thus ensure there is
compliance with the ethical principles as provided by the DoH, Belmont Report, and “Ethical
Principles of Biomedical research” (Tripathi 2013: 17). The clinical researchers must further
comply with the applicable and regulatory provisions in India. The researchers are compelled
to pay special attention to the clinical trials related to vulnerable subjects. The IRB/IEC
documents should contain consent form updates, trial protocols, and informed consent forms.
The investigators have to use the Investigator’s Brochure bearing the use of the trials, written
information and the subject recruitment procedures (Tripathi 2013). The investigators must
also pay attention to the information about compensation, payments, and safety information.
The IRB/IEC must fulfil its responsibilities regarding the available subjects. The
investigators are required to submit their documentation evidencing qualifications and current
curriculum (Tripathi 2013). The investigators’ qualifications need to be approved by the
IRB/IEC to conduct the proposed clinical trials. The investigators must meet the IRB/IEC’s
requests by submitting relevant documents like the CVs. The IRB/IEC is required to review
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Surname The Declaration of Helsinki
the payment method and amount to subjects. This would control any aspects of undue
influence or coercion during the clinical trials (Tripathi 2013). The payments have to be
prorated by the subject. The sponsors are compelled to maintain and implement quality
control systems and quality assurance based on the written SOPs thus ensures the clinical
trials conducted, generated, recorded, and reported depending on the protocol, applicable
regulatory requirements, and GCP. With the sponsors, it is possible to secure agreements with
involved parties and stakeholders thus allow for direct access to clinical trials, reports, source
data, and documents (Tripathi 2013). The sponsors of these medical trials are expected to
audit, monitor and inspect the regulatory authorities.
Conclusion:
The investigators and sponsors must enter into agreements to facilitate the clinical
trials. Such agreements are written and form part of the research protocol. The investigators
can only conduct clinical trials depending on their qualifications as experience, training, and
education thus assume responsibility for trials. The investigators should meet the
qualifications as specified under the applicable regulatory requirements by continuously
updating their qualifications and CVs as expected by the regulatory authorities, the IRB/IEC,
and the sponsor. Therefore, the investigators must be familiar with investigational products as
demonstrated in the investigator’s brochure and protocol. The investigators need to permit the
sponsor and appropriate regulatory authorities to monitor, audit and inspect the significant
clinical trials.
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Surname The Declaration of Helsinki
References:
Carlson, R V, Boyd, KM, & Webb, DJ 2004, ‘The revision of the Declaration of Helsinki:
past, present, and future’, British Journal of Clinical Pharmacology, vol. 57, no. 6, pp. 695-
713.
Tripathi, R 2013, ‘Ethics committee member: reviewing the ‘Ethics’ in clinical research’,
Perspectives in Clinical Research, vol. 4, no. 1, pp. 17-20, viewed 20 October 2017,
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601697/>.
WHO 2001, ‘Declaration of Helsinki’, Bulletin of the World Health Organization, vol. 79,
no. 4, pp. 373-374, viewed 19 October 2017,
<http://www.who.int/bulletin/archives/79%284%29373.pdf>.
WMA 2013, ‘WMA Declaration of Helsinki- Ethical principles for medical research
involving human subjects’, WMA Net, October 13, viewed 18 October 2017,
<https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-subjects/>.
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