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Prior to any involvement of human subjects, all human subject research must be reviewed and approved by the HSRB. The HSRB reviews a proposal by first assessing the risks and benefits of research participation. After determining that the research benefit outweighs the risks involved, the HSRB turns to the consent process to ensure that participants are fully aware of the risks and benefits and that they understand that their participation is voluntary. The consent process and form is a key element in this review.
For all projects, an application with relevant attachments must be submitted to the HSRB for review. The application asks for information about the investigator(s), the nature of the research, the funding source, targeted subject groups, how subjects will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research.
Upon completion of the review, a letter will be emailed to the responsible project investigator authorizing initiation of the project or containing stipulations that must be met before approval is granted. When the investigator revises a project, the HSRB reviews it again to see whether the concerns have been adequately addressed. A project may undergo several reviews.
The involvement of human subjects, including recruitment, may begin only after stipulations have been satisfactorily addressed and formal, written approval is given.
In most cases, the initial review will occur within two weeks of submission if the application is complete. All HSRB actions are communicated to the responsible project investigator through IRBNet.org. Approval is good for one year. The HSRB conducts continuing reviews of non-exempt research at intervals appropriate to the degree of risk, but at least once per year. A research completion report should be filed with the HSRB within 2 months of the completion of all research activities.