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Declaration Of Helsinki Add in library

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Question:

Describe about the Description of ‘Declaration of Helsinki’ and Major Functions of Sponsor, Monitor and Investigation?
 
 

Answer:

Introduction:

This assignment deals with some ethical principles of medical community. This assignment discusses about responsibilities of medical research for preventing the life of patients. The monitoring process and concept of clinical trial has been described briefly. Functions of sponsor, monitor and investigator has been discussed with proper definition.

Description of Declaration of Helsinki:

As stated by, Gross and Carrick (2013) Declaration of Helsinki can be referred as guidelines of various types of principles those are related to the human experimentation. Declaration of Helsinki has been developed by World Medical Association. For the ethics of human research, this declaration has been considered truly by the medical personalities among all over the world.

This declaration has been developed as an effective statement of various types of ethical principles of the medical issues. This declaration mainly has been delivered to the physicians. However, Hurst (2014) argued that, other participants of medical research have also been included in the declaration of the guidelines. Declaration of Helsinki states that every medical personality should fulfill the duty to the patients of them. Every physician needs to promote as well as safeguard the health of patients. Apart from the physicians, personalities of medical research should also be included in the process of safeguarding and protecting patients from the illness and problems (Fda.gov, 2015).

Therefore, Harr (2013) stated that, knowledge and experience as well as expertise have fulfilled the need of a patient. Declaration of Helsinki provides various guidelines to the process of medical research. Main and primary purpose of medical research involves various subjects of human in order to understand the cause, effects and development of the diseases. Interventions must be evaluated through continuous medical research for providing the safety, efficiency, quality and accessibility of the patient.

On the other hand, Gurgan (2014) argued that, Declaration of Helsinki states that every subject of medical research is treated under risk and careful practice. Participants of medical research have the duty of providing protection to the health of the people. Life, heath, privacy, dignity as well as confidentiality of various types of personal information should be kept private due to the declaration of Helsinki. Process of clinical trial must be conducted with some principles of ethics that has been described in Declaration of Helsinki.

 

Major functions of Sponsor, monitor and investigation:

As stated by, Blessing and Forister (2013) sponsor refers to an individual, organization or institution who generally delivers responsibility and duty in order to initiate as well as manage a trial for clinical issues.

On the other hand, Investigator means who generally initiates and conducts a process of clinical trial with the help of others or alone. Investigator therefore directs and instructs the investigational products that has administered for the purpose of clinical emergency. However, this term is not related with any individual or organization or agency (Council of Science Editors, 2015).

However, Arie (2013) stated that, monitoring is the process of overseeing the whole trial of clinical activity. Process of monitoring helps to ensure that the whole clinical trial is conducted and recorded by maintaining the standard and protocol of medical regulation.

A monitoring report refers to a written report by a monitor. This report is sent to the sponsor of the clinical trial. This report consists of all types of trial related communication in accordance with the SOP (Standard Operating Procedure) of Sponsor. This report is also written after the visit of each site of clinical activities.

As stated by, Emanuel (2013) the sponsor of a clinical trial is responsible for the process of maintaining and implementing the system of quality control and assurance of quality in accordance with the SOP. Sponsor is responsible in order to ensure that the trial has been conducted by maintaining the clinical protocol and applicable Regulatory Requirements. On the other hand, Gurgan (2014) stated that, sponsor helps to secure the agreement of all parties who are involved in the process of clinical trial.

Investigator is fully responsible for giving the instruction of the whole process of clinical trial. Apart from this, rights and duties of human being are protected in order to do effective clinical process. A trained monitor always looks after the clinical trial with proper and effective knowledge and experience. He/she should familiar with the products of investigation. A monitor acts as the communicator between the investigator and sponsor.

Conclusion:

This assignment has discussed that the process of clinical trial has been conducted with proper knowledge and guidelines of the investor, monitor and sponsor. Clinical research always should be done under severe risk.

 

Reference list

Books

Gross, M. and Carrick, D. (2013). Military medical ethics for the 21st century Farnham, Surrey, England: Ashgate.

Harr, R. (2013). Medical laboratory science review Philadelphia: F.A. Davis.

Blessing, J. and Forister, J. (2013) Introduction to research and medical literature for health professionals Burlington, MA: Jones & Bartlett Learning.

Journals

Gurgan, M. (2014) Changes in The 2013 Version of The Declaration of Helsinki. Turkish Journal of Bioethics, 1(2), pp.100-104

Hurst, S. (2014). Declaration of Helsinki and Protection for Vulnerable Research Participants JAMA, 311(12), p.1252

Arie, S. (2013). Revision of Helsinki declaration aims to prevent exploitation of study participants. BMJ, 347(oct22 6), pp.f6401-f6401.

Emanuel, E. (2013). Reconsidering the Declaration of Helsinki – Author' s reply. The Lancet, 382(9900), pp.1247-1248.

Gurgan, M. (2014). Changes in The 2013 Version of The Declaration of Helsinki. Turkish Journal of Bioethics, 1(2), pp.100-104.

Websites

Council of Science Editors, (2015) Home - Council of Science Editors [online] Available at: https://www.councilscienceeditors.org [Accessed 28 Feb. 2015].

Fda.gov, (2015) U S Food and Drug Administration Home Page [online] Available at: https://www.fda.gov [Accessed 28 Feb. 2015].

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