Approvals required for a medical research project

Any medical research expects three things to be followed. One is respect for the human race, the benefits of research and the third is justice. Justice is to protect the subjects who enjoy the fruits of research, while at the same time sharing the burden of it. To ensure justice there are a number of agencies in the country and abroad which have some policy related, statuary and regulatory tools under a defined framework.

All medical research work needs to comply with some rules set by the Editorial Board of the Agencies. Every medical article needs a declaration on the details of the ethics approval they have got. It should state the Ethics committee, Institution review Board and the approval number or ID. The agency should be given the contact details of the Ethics committee for future reference.

In case approval from the Ethics committee is not got, the authors should justify to the Board the following points:

  • How does their research differ from normal clinical investigations or trials?
  • What are the risks to their subjects of research and the burden they have to undertake?
  • The actual advantage of research for their subjects.

In case the Agency finds that the research work is unethical it could advise the authors for corrections or call for investigations. The Agency would then contact the concerned department where research was conducted and voice their concerns.

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