Discuss the regulatory measures for research involving human participants - Pubrica

1. DISCUSS THEREGULATORY MEASURES FOR RESEARCH INVOLVING HUMAN PARTICIPANTS An Academic presentationby Dr.NancyAgens,Head,TechnicalOperations,Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline InBrief Introduction BasicPrinciplesforHumanResearchSubjects IRBInvestigations FWA(FederalWideAssurance)Assurance Conclusion

3. InBrief The bio medicos conducting researches using humans as their subjects is one of the greatest challenges in clinical medicineresearch. The research report should have basic principles that give theethical foundation for the performance of research using humanparticipants. Scientific writinghelpsto understand the regulations to be followed using a human research subject was discussed in Pubrica,clinical researchservices.

4. Introduction The human subject’s protection used forresearch purposes was outlined by Nuremberg in Germany under the Nazigovernment. He outlines that humans undergoingresearch experiments should be treated with ethical principles considering their safetypurposes. However, many countries accepted and followedhis code of ethics in human subjectprotection. Contd..

5. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research found and circulated recommendations that were titled the BelmontReport. Scientific medical writingcompaniesshould have a clear idea about it while writing medical writingfor clinicaltrials.

6. Basic Principles forHuman Research Subjects Biomedical researchers involving humans as their subjects must check the generally approve principles of research and should be based on sufficientlyperformed laboratory protocols with animalexperimentations. Experiments involving humans should be formulatedwith a protocol. The protocol is then forwarded to a committee andverified. The biomedical researchersinvolving humans should be performed by scientifically qualified persons andunder the supervision of a clinically competent medicalperson. Contd..

7. The responsibility for the human subject goes with a medically qualified personand never depends on the subject of theresearch. Biomedical researchinvolving human subjects cannot legally be carried outuntil or unless the objective of the research should look after the risk to thesubject. The risk factor is more important than the foreseeable benefits inresearch involvinghumans. Privacy of the subjects is as important as the objective of the research.Their physical and mental integrity should not bestudied. Contd..

8. Doctors should desist from engaging in research projects involving humansubjects until they are happy that the toxic injected are believed to bemeasurable. Doctors should abstain the investigation if the hazards are found to be higherthan the potentialbenefits. During publication, the doctors should preserve with accurate results. Theresults should be following theprinciples. In every project, the subject should be informed with the aim, objectives and procedures of the researchand they must declare it with a documentsigned. Contd..

9. The subject's family must also accept the rules andregulations. The legal procedures aremandatory. The subject and the doctors must complete all the formalities and in case of anylegal incompetence, there will be difficulties in continuing theresearch. The research protocolshould always have a statement of ethical considerationsof subject toit.

10. IRB Investigations Any biomedical researchersusing humans astheir subjects should get an approval from the IRB(Institutional ReviewBoard). The purpose of IRB is to check all the safeguardsfor humans as per the federalregulations. IRB consists of five professionally qualifiedand well-experiencedpersons. The IRB has a right to modify the experimentsin case if they find it hazardous tohumans. Contd..

11. If the biomedical investigator is a member of IRB, The respected person shouldnot participte in the approval of theproject. Members of IRB should be unbiased of race, gender,religion. IRB members should focus on the followingcontents Risk-benefitanalysis Selection of subjects must beappropriate Riskestimation Riskevaluation The main objective of theresearch Failuremodes Futurestudies Contd..

12. FWA (Federal Wide Assurance) The investigators get funding from the federal agencies,was supported by a common rule federal agency, the investigator must sign anFWA. The Key features of FWAare, Identifying the information about the investigationsand filingit. Listing the legal components of the institutionsthat operate under variousnames Stating the ethical principles for the protection ofhuman research subjects Contd..

13. Indicating that the FWA can take actions on violating the regulationsfor researchpurposes Demanding an assurance from theinsurance Getting a written agreement between the organization andFWA

14. Conclusion Human protection is the most important challengeduring research work. There are many regulations drafted by differentcountries for humansafeguard. Biomedical investigators and research scientistsshould follow those regulations and workaccordingly. Themedical research companiesshould focus on it withthe help ofPubrica

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