Why Ethics Committee Reviews Research Proposal ?

Institutional Review Board is there in place for  reviewing, approving and providing favorable opinion on research proposal submitted by investigator or sponsor. Purpose and Intention behind all is scientific validity of study and safety of the study participants as research subjects. Members of ethics committee have full authority to probe researcher at any time regardless of progress of study, even they terminate study if continuation of such study found to be more detrimental to the subjects and science. Since, any research activities start after approval from IRB or IEC (independent ethics committee), lot of investigations about the study itself happens at the earliest before providing nod to conduct it. Judgments are made basically on the basis of following factors: 

• Qualification of Investigator in terms of his education and experience. 
• Scientific and safety appraisal of study protocol and other supportive documents
• Informed consent form and Patient information sheets designed to provide to the participants to observe how researchers are providing room for voluntariness over the decision of participants
• Compensation and other benefits provided to the participants
• Advertisement method adopted by the researcher to see if any claims are being made or not. 

 Documents to be Submitted before Study Initiations                  

1. A current curriculum vitae (CV) that includes qualification of investigator and sub-investigator, including education, training and experience.
2. Protocol of  study, which basically describes purpose of study, expected benefits, scientific background for research 
3. Investigators brochure which basically describes about clinical and non- clinical finding on the investigational medicine which is going to be studied
4. Proposed informed consent form which contains all appropriate element
5. Subject advertisement and recruitment method
6. statement of investigator form 1572, which includes all FDA- regulated studies conducted under an investigational New Drug Application (IND) 
7. Grant applications if the study is federally funded
8. Any other specific form or material required by IRB, such as application form

Once application is received  with attached necessary documets, members of IRB/IEC should review them within a reasonable time, make appraisals after enough discussions and final verdict should be  documented in the form of written document. This written statement should clearly mention about the details of the study, documents received and decision taken along with rationality behind it and date of decisions made. Generally decisions of ethics committee can be summerised as follows: 

• Approval to conduct study as per the documents submitted
• Any changes deemed necessary to take the project forward in the form of favorable opinions
• Objection to conduct the study by defining rationale behind the decision
• Termination/ suspension of any previously approved ongoing study

It's always the duty of Investigators and Sponsor to make sure ethics committee that their study is needed for the science and the public in the form of appropriate documents as well as way of conducting it. 

                                                                                            Thank You !!!