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Discuss The Regulatory Measures For Research Involving Human

Participants

Dr. Nancy Agens, Head,

Technical Operations, Pubrica

sales@pubrica.com

In Brief

The bio medicos conducting researches

using humans as their subjects is one of

the greatest challenges in clinical medicine

research. The research report should have

basic principles that give the ethical

foundation for the performance of research

using human participants. Scientific

writing helps to understand the regulations

to be followed using a human research

subject was discussed in Pubrica, clinical

research services.

Keywords: Scientific Medical Writing

Companies, Medical Writing In Clinical

Research, scientific research paper writing,

Medical Writing for Clinical Trials,

Medical Writing in Clinical Trials, Clinical

Research Services, Medical Writing CRO,

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I. INTRODUCTION

The human subject’s protection used for

research purposes was outlined by

Nuremberg in Germany under the Nazi

government. He outlines that humans

undergoing research experiments should be

treated with ethical principles considering

their safety purposes. However, many

countries accepted and followed his code of

ethics in human subject protection. The

National Commission for the Protection of

Human Subjects of Biomedical and

Behavioral Research found and circulated

recommendations that were titled

the Belmont Report. Scientific medical

writing companies should have a clear idea

about it while writing medical writing for

clinical trials.

II. BASIC PRINCIPLES FOR HUMAN

RESEARCH SUBJECTS

Biomedical researchers involving

humans as their subjects must check the

generally approve principles of research

and should be based on sufficiently

performed laboratory protocols with

animal experimentations.

Experiments involving humans should be

formulated with a protocol. The protocol

is then forwarded to a committee and

verified.

The biomedical researchers involving

humans should be performed by

scientifically qualified persons and under

the supervision of a clinically competent

medical person

The responsibility for the human subject

goes with a medically qualified person

and never depends on the subject of the

research.

Biomedical research involving human

subjects cannot legally be carried out

until or unless the objective of the

research should look after the risk to the

subject.

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The risk factor is more important than the

foreseeable benefits in research involving

humans.

Privacy of the subjects is as important as

the objective of the research. Their

physical and mental integrity should not

be studied.

Doctors should desist from engaging in

research projects involving human

subjects until they are happy that the

toxic injected are believed to be

measurable. Doctors should abstain the

investigation if the hazards are found to

be higher than the potential benefits.

During publication, the doctors should

preserve with accurate results. The results

should be following the principles.

In every project, the subject should be

informed with the aim, objectives and

procedures of the research and they must

declare it with a document signed.

The subject's family must also accept the

rules and regulations.

The legal procedures are mandatory. The

subject and the doctors must complete all

the formalities and in case of any legal

incompetence, there will be difficulties in

continuing the research.

The research protocol should always have

a statement of ethical considerations of

subject to it.

III. IRB INVESTIGATIONS

Any biomedical researchers using humans as

their subjects should get an approval from

the IRB. The purpose of IRB is to check all

the safeguards for humans as per the federal

regulations. IRB consists of five

professionally qualified and well-experienced

persons. The IRB has a right to modify the

experiments in case if they find it hazardous

to humans. If the biomedical investigator is a

member of IRB, The respected person should

not participte in the approval of the project.

Members of IRB should be unbiased of race,

gender, religion.

IRB members should focus on the following

contents

Risk-benefit analysis

Selection of subjects must be

appropriate

Risk estimation

Risk evaluation

The main objective of the research

Failure modes

Future studies

IV. FWA( FEDERAL WIDE

ASSURANCE) ASSURANCE

The investigators get funding from the

federal agencies, was supported by a

common rule federal agency, the

investigator must sign an FWA.

The Key features of FWA are,

Identifying the information about the

investigations and filing it.

Listing the legal components of the

institutions that operate under various

names

Stating the ethical principles for the

protection of human research subjects

Indicating that the FWA can take actions

on violating the regulations for research

purposes

Demanding an assurance from the

insurance

Getting a written agreement between the

organization and FWA

V. CONCLUSION

Human protection is the most important

challenge during research work. There are

many regulations drafted by different

countries for human safeguard. Biomedical

investigators and research scientists should

follow those regulations and work

accordingly. The medical research

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companies should focus on it with the help

of Pubrica

REFERENCES

1. World Medical Association. (2001). World Medical

Association Declaration of Helsinki. Ethical

principles for medical research involving human

subjects. Bulletin of the World Health

Organization, 79(4), 373.

2. Emanuel, E. J., Wood, A., Fleischman, A., Bowen,

A., Getz, K. A., Grady, C.,& Muse, C. T. (2004).

Oversight of human participant’s research:

identifying problems to evaluate reform proposals.

3. Gray, B. H., Cooke, R. A., & Tannenbaum, A. S.

(1978). Research involving human

subjects. Science, 201(4361), 1094-1101.

4. King, K. M. (1998). A proposal for the effective

international regulation of biomedical research

involving human subjects. Stan. J. Int'l L., 34, 163.

5. Pritchard, I. A. (2001). Searching for" Research

Involving Human Subjects": What Is Examined?

What Is Exempt? What Is Exasperating?. IRB:

Ethics & Human Research, 23(3), 5-13.