Initial Review
Minimal Risk Wagering Strategy
'You can never get a cup of tea large enough or a book long enough to suit me.' For research that involves more than minimal risk of harm to the subjects, the investigator must assure that the amount of benefit clearly outweighs.
The review process of every research application begins with a complete submission to the Office of Research Compliance (ORC). In preparation for IRB review, the ORC staff works closely with the Principal Investigator to prepare the required IRB documents for their research project.
Minimal Risk protocol applications include:
- A Complete Minimal Risk IRB Applicationwith ALL required signatures (Dean, Department Chair, Faculty Advisor)
- Informed Assent Form(s) - for research involving minors
- Evidence of approval by another IRB or Institution (Documentation of Permission to use patient data or student data from the appropriate institution’s administration)*
- Data Collection Instruments (questionnaires, interviews, online surveys, etc.)
- Advertisement/Recruitment Materials
*Any non-Mercer affiliated investigator seeking student information (including emails) MUST complete a Request for Student Information Form to be submitted with the application and forwarded to the Registrar’s Office upon approval by the faculty sponsor.
Go to Mercer Protocol Forms and Applications for instructions on completing the forms
Once an application is determined to be complete, the ORC formally accepts it and the IRB review process begins.
Upon receipt of all required paperwork, the submitted documentation will be logged, scanned, and uploaded to the InfoEd electronic data management system. From there the application is assigned a protocol number and reviewed for completeness. After being assigned a protocol number, Primary Reviewers are assigned to the application and it is placed on the agenda for the next IRB meeting.
If the application does not require Expedited or Convened Review, the Associate Director of Human Research Protection Programs (HRPP) will indicate in a letter to the Principal Investigator that the study is exempt from further review. It is necessary to submit all non-funded applications to the ORC for review. If the study receives funding, the Office of Grants and Contracts receives a copy of the IRB letter sent to the Principal Investigator for inclusion into Office of Grants and Contracts' files.
Minimal Risk Betting
If the application requires an Expedited Review, the Associate Director (HRPP) forwards the application to the IRB Chair or his/her designee. The IRB Chair or his/her designee conducts the Expedited Review.
If the application requires a Convened Review, the Associate Director (HRPP) assigns two Primary Reviewers to evaluate the application, discuss concerns with the Principal Investigator, and serve as advocates during the Convened Review. The principal investigator receives all information or revision requests from the Primary Reviewers through email and the ORC receives copied notes of the verbal and email communications. All IRB Board Members have access to the application and communications between the Primary Reviewers and the Principal Investigator via InfoEd. Upon completion of IRB review, the Associate Director (HRPP) notifies the Principal Investigator in writing of the application's status.
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