Discuss the regulatory measures for research involving human participants - Pubrica
                     DISCUSS THE 
REGULATORY  
MEASURES FOR 
RESEARCH  INVOLVING 
HUMAN  PARTICIPANTS
An Academic presentation by
Dr. Nancy Agens, Head, Technical Operations, 
Pubrica  Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline In Brief
Introduction
Basic Principles for Human Research 
Subjects  IRB Investigations
FWA( Federal Wide Assurance) Assurance
Conclusion
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, c 
linical   r esearch services.
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.
Contd.
.
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.
Basic  
Biomedical researchers involving humans as their  
Principles  subjects must check the generally approve principles of 
for Human  research and should be based on sufficiently 
performed  laboratory protocols with animal 
 Research  experimentations.
Subjects Experiments involving humans should be formulated with 
 a protocol. The protocol is then forwarded to a  
committee and verified.
The b iomedical researchers involving humans should 
be  performed by scientifically qualified persons and 
under  the supervision of a clinically competent medical 
person.
Contd..
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.
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.
Contd..
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.
Contd..
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 r esearch protocol should always have a statement of ethical considerations 
of  subject to it.
IRB
Any b iomedical researchers using humans as 
Investigations their  subjects should get an approval from the  
IRB(Institutional Review Board).
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.
Contd..
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 The main objective of the research 
Selection of subjects must be appropriate  Failure modes
Risk estimation Future studies
 Risk 
evaluation
Contd.
.
FWA The investigators get funding from the federal agencies, was 
( Federal   supported by a common rule federal agency, the investigator 
Wide   must sign an FWA.
Assurance) 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 h 
uman  r esearch subjects
Contd..
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
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 companies should focus on it with the 
 help of Pubrica
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