Application Process for Getting IRB Approval without hassle
1
Basic DATA
Name of Applicant (PI or CO-PI) Applicant should be PI or Co-PI, and Indian resident to whom the approval will be issued PI/CO-PI should submit application from their registered email id. Only one name should be given here    Name of Organisation    Address for correspondence: (With email ID and phone number) Permanent address for future correspondence: GST Number    Study Title Principal Investigator (PI)   Co-PI   Address and contact details of PI   Overseas Collaborator (If any)   Sponsoring Organization/ Funding Agency   Expected date of start of the study Expected date of completion of the study @   Geographical area of the study   Is this study a behavioral study or clinical study or mix of both?   Behavioral  1   Clinical  2  Mix of both  3 Are you seeking/have you applied for IRB approval from any other external/ internal agency? If yes please submit the copy of the same   Expected date of start of the study Expected date of completion of the study @  Date of application
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Objective of The Study
Aims Hypothesis or research question:Â Overall Aim:Â Specific Aims:
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Background
Give (in 100-200 words) background information to explain why your study needs to be done or  its relevance.
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Study Design
In 1-2 pages, describe how you plan to conduct your research study. Briefly describe the population groups/ target groups included in the study (example: male/female, age group adolescent/adult etc. who are the respondents and who will interview them? Who will do these interviews and how do they carry out these interviews Briefly describe how the participants will be recruited to be part of the study
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Sampling
What sample size calculations were done to determine the sample size and what would be the sampling approach to be adopted?
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Risk, Benefits, Confidentiality & Consent
Please ensure that the following are done 1.Seeking informed consent from the participants- written consent preferably 2.The language and literacy level of consent sought appropriate for the participants 3Assent is also obtained in case minors (below 18 years) are the study participants? 4. The following components are mentioned in the informed consent: a.Purpose of study b.Voluntary nature of participation in the study c.Benefits and risks of study to participant? Yes/No d.About compensation to study participants? Yes/No e.Measures to protect confidentiality of data and identity of study participants during data collection f.Measures to protect confidentiality of data and identity of study participants during data analysis and reporting g.Contact information for questions/problems about the study and about ethical aspects? Yes/No 7. Avoid taking photos/ video of the study participants 8. Avoid distributing any products to the participants 9. Mention about back-checks if planned the same for quality assurance 10. Mention about presence of note taker if using the same 11. Mention about audio recording if applicable
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Dissemination
How will the results be disseminated? What information will be fed back to the subjects and/or participating organisation?
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Signature Of Applicant
Signature of Applicant………………… Designation and Organisation………… Please contact The Member Secretary Sigma IRB (irb.sigma@sigma-india.in) for any clarifications or additional information. Please ENCLOSE: Study protocol with details about study area, target groups, sampling procedure, inclusion/exclusion criteria for respondents, risks anticipated and mitigation plan, data sharing policy etc. Consent / assent form to be used for data collection - English and translated version Study tools – English and translated version Translation certificate CV of PI CV of Co-PI, if any Mandatory: Please insert version number, page numbers and date on all the documents, otherwise the IRB application form will not be considered.
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Process Completion
After all Documents are submitted. Our panel will review your application. Shall anything more information be required our team will get in touch with you.