Question

How is the Belmont report which is the  Ethical Principles and Guidelines for the Protection of Human Research relevant in relation to First-in-human clinical trials (as in patient’s company’s and medical authority's perspective) and potential conclusions that can be drawn?

Answer 1

BELMONT REPORT

It was written by NATIONAL COMMISION FOR PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH. This is created on the basis of National Research Act 1974.It is the ethical principles and guidelines for the protection of human research.

Relevence of Belmont report

Now a days substantial social benefits are produced by sceintific research. During this research some troubling ethical questions are raised.During the time of second world war reported abuses of human subjects in biomedical experiments.Due to this public attention raised and the importance of ethical issues were noticed.

Here comes the importance and relevance of Belmont reports.It conclude the ethical principles and guidelines for human research by protecting human subjects.

In Belmonts reports 3 priciples includes

1. Respect for persons

2. Beneficence

3. Justice

Belomonts reports on patients perspective

• It assures Respect for persons.person can voluntarly parcipate or not in the research.person must be provided all the information regarding the research in a comprehensible form.after this informed concent should be signed by the person voluntarly.Person has right to withdraw the concent.By this principle of the Belmont report person has full freedom and getting respect to his personality
• Second thing about the beneficence.Based on belmonts report there is assessment of probable harm or potential risk to the anticipated benefits that is promotion of health,well being are monitored.And investigations are done to reduce the risks and maximise the benfits.By this persons involved in the research are getting beneficial effects by the research over the probable risk.
• Fair distribution of the benefits and risk over persons undergoing research are the another important thing.Third principle of belmont report offers this to persons undergoing research.It will help in forbiding of exploitation of vulnerable people.

Belmonts report on medical authorities and company's perspectives

• Medical authority should thoroughly asses the probable risk to anticipatory benefits.Risks and benefits are accurately identified,evaluvated and described.investigations should be conducted so that persons get reduced harm and maximal benefit.Risk should be studied in terms of physical,psychological,social or economic situations.Informed written concent is necessary and its renewed regularly.
• Medical conditions of the persons are throughly examined and monitored.
• All the procedures are conducted and reviewed by Institutional review board so that corrections are made accordingly.IRB should check risk benefit ratio has shifted or not.
• Justice should be strictly maintained.because the Belmonts report giving importance to it.Authorities should be careful about fairness in distribution.By this sharing of risks and sharing of anticipatory benefits getting balanced.
• The knowledge acuired in research and research activity itself can be a source of tremendous benefits.so that researchers should valuue the person undergoing research trial.Justice,respect and beneficence are maintained according to Belmonts principle.

CONCLUSIONS

BELMONTS REPORT PROVIDE PROTECTION TO HUMAN RESEARCH BY PROVIDING ETHICAL PRINCIPLES AND GUIDELINES.IT INCLUDE RESPECT,JUSTICE AND BENEFICENCE.

BY FOLLOWING THIS REPORT EXPLOITATION OF THE VULNERABLE GROUP CAN BE PREVENTED,PERSONS GET MAXIMAL BENEFITS AND MINIMAL RISK,PERSONS HAVING THE FREEDOM TO PARTICIPATE OR NOT,FAIR DISTRIBUTION OF RISKS AND BENEFITS ARE MAINTAINED.

BELMONTS REPORT THERE MY REMAINING AS THE REAL PROTECTOR OF HUMAN BEING WHO BECOMING A PART OF BIO RESEARCH FOR THE TREMENDOUS BENEFITS OF THE SOCIETY.