May 26, 2011
In our ongoing effort to increase efficiency and improve customer service to the Indiana University research community, the Research Compliance Office will be implementing new and streamlined updates to the study submission and review prioritization process.
Single Email address for all submissions
Currently there are multiple email addresses for submissions to the Institutional Review Board (IRB) and/or the Human Subjects Office. These addresses were separated by IRB Board or submission type. Effective as of May 31, 2011, all submissions to the IU Human Subjects Office should be sent to one email address, regardless of type or campus. For an interim period, all emails received in the older inboxes will be forwarded to this new email address.
The new email address is: firstname.lastname@example.org
Updated Prioritization Process
Many of the submissions to the Human Subjects Office contain all the necessary information to be presented to an IRB reviewer or at a full board meeting. However, there are submissions which do not have all of the minimum items necessary for approval by the IRB. In an effort to avoid delay of submissions that are considered initially complete, new prioritization criteria have been established to help expedite these submissions. For example, previously, a submission would have been expected to be discussed at a Full Board meeting if it was submitted by the meeting deadline. However, this did not take into consideration whether the submission included all of the necessary information. Thus, in an effort to better serve the research community and to more accurately prioritize submissions, the Human Subjects Office will no longer utilize IRB meeting deadlines, and incomplete submissions will be prioritized lower than complete submissions.
Instead, under the updated process, study submissions will first be reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," submissions will be sent to the next available IRB Full Board meeting with the appropriate expertise. Expedited and Exempt studies will also need to meet these two criteria before being sent to an IRB reviewer or designee for approval. In the event a submission is deemed "incomplete," the Human Subjects Office will contact the Principal Investigator and identified study contact person to notify him/her as to what is needed and how to proceed.
This priority determination will be based on two major factors:
1) Are all of the documents necessary for review included?
- A complete submission will include the following:
- Conflict of Interest Disclosure for all investigators
- Documented Acknowledgement of Participation for all investigators
- Completion of the required CITI modules by each investigator
- All pertinent required submission documents for the type of action being submitted
- (for more information regarding what documents are required, please see:
2) Urgency and risk related to the study protocol.
- High priority items will include special attention to:
- Expiration dates of continuing reviews
- Research being conducted by students
- Time sensitive funding or sponsor requirements
- Responses to study actions that have been provisionally approved or tabled
- High risk items such as serious adverse events
Focused Team Approach
Once received, and deemed to be a complete initial submission, submissions will be prioritized and processed by teams in the IU Human Subjects Office. Teams and their workload will be divided by a school, research area and/or department-based approach for all IRB submissions. Thus, a researcher from one research area should have the same team processing all of his or her research submissions, and the IU Human Subjects Office can offer skilled, personal attention to each department and researcher. For more information regarding the division of departments in relation to these teams and the personnel structure of the teams, please visit: http://researchadmin.iu.edu/HumanSubjects/hsdocs/Communication_ET.pdf
The Research Compliance Office of ORA continues to strive to provide the best service possible to the Indiana University research community. We are encouraged and hopeful that these enhancements will contribute to this ongoing endeavor.
More Information on the impact of these updates
Educational sessions will be held on the Bloomington and Indianapolis campuses in the Summer and Fall to elaborate on these changes, and address any questions or concerns. These sessions will be scheduled shortly and you will be notified of the dates and times.
If you have any questions, please direct them to: email@example.com