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The word IRB refers to Institutional Review Board that is established to protect the rights and welfare of human participant in research activities. The Board is responsible for reviewing the research protocols and methodology with a view to protect human participants from any type of ethical harm (social, psychological and economical). The IRB has the authority to approve, disapprove, monitor, and request modifications in research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policies.
If your study meets the definition of a research and includes human subjects then your study needs an IRB review.
An integral step before starting a human centered data collection exercise, an IRB approval is required. If you begin your research and start collecting data without a prior approval you risk losing all of the collected data under ethical constraints and after obtaining an IRB approval it is to start again.
RADS-IRB has provided all required information in its Application Form on the website. This application entails all the relevant information for instance; detailed information about the Principal Investigator, consent procedure, study methodology, confidentiality maintenance and inclusion/exclusion criteria etc.
Along with the provided IRB application form, you are required to submit the following documents:
RADS-IRB reviews there search involving human subjects including, the purpose and procedures of the study, policies to minimize risk to the participants and benefits that may result from research. Furthermore, IRB considers the consent procedure, inclusion/exclusion criteria, measure to safeguard rights and welfare of the participants, and how the data will be handled after the completion of the study.
Since the essential requirement for research involving human participants is that people participate voluntarily, the consent process is one of the most important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study
In the case of minors, an assent form is to be used in addition to the consent form from a parent or guardian.
Yes, any changes to a previously approved study must be reviewed and approved by RADS-IRB prior to its implementation. Applicants will have to submit the updated protocols and relevant documents within seven working days along with the Study Amendment Form.
Serious adverse events must be reported to RADS-IRB through Adverse Events Reporting Form immediately, with a written report by the PI within 3 days of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant.