EXEMPT REVIEW
ANNOUNCEMENT: IMPORTANT CHANGES TO THE OVERSIGHT PROCESS FOR EXEMPT STUDIES.CHANGE TO OFFICE NAME
The Office of Human Research Protection Programs (OHRPP) is the new name of the Human Subjects Committee. This change reflects a focus in the profession emphasizing human research participants, and to differentiate between the Office per se, and the Institutional Review Board which is the entity responsible for reviewing and approving reserach protocol.HUMAN SUBJECTS PROTECTION TEST REQUIREMENT
IUB began requiring that all researchers pass the IU Human Subjects Protection Test in July 2002. At that time it was intended that passing the test would certify the individual for a certain amount of time. That time is now up for most researchers.A newest tutorial for non-biomedical research and a newest version of the Human Subjects Protection Test have been available since December 19, 2005. These can be found at http://www.indiana.edu/~rcr/index.php.
IUB is now requiring that everyone who took the test prior to December 19, 2005 (or those who have never taken the test but are still working on active OHRPP approved projects) take and pass the new test before October 13, 2006. Once you have passed the new test you will be certified again for 5 years.
It is the researcher's responsibility to let OHRPP know if they have again passed the test. This also applies to sponsors and co-investigators listed on the IRB application. When you log on to take the test you can indicate you want your test score sent to us by placing our e-mail address (iub_hsc@indiana.edu) in the appropriate box.
If you have any questions about the requirement, contact the office at 855-3067 or by e-mail.
BROWN BAG DISCUSSION/Q&A SESSIONS
These sessions are being held again during academic year 2007-2008. Researchers using human subjects will hear a short presentation about a topic related to the application and/or review process with plenty of time for questions on that topic, or any other, that those in attendance might have.
We welcome any suggestions that you may have for monthly topics. Send your suggestions to iub_hsc@indiana.edu with “brown bag topic” in the subject line. We will provide updates on this site when topics are assigned to a specific date.
NEW INTERACTIVE FORMS AVAILABLE
The Documentation of Review and Approval page (cover/signature page) of the main application and the Study Amendment Form are now in interactive PDF format. They can be filled in on-line for printing. They cannot be saved, so be sure to make copies of the printed version. This should help with formatting problems researchers have had in the past. Please use these new versions. Old versions are likely to be returned which will result in delayed review times. If you have questions, contact the office at 855-3067. These new forms can be accessed at this link
PROCEDURES FOR CONTINUING REVIEW APPLICATIONS
As of January 2005, continuing review notices are now sent by e-mail. The first notice goes to the named PI. If there is no response from that person, the reminder notice will be sent to the faculty sponsor if there is one. Otherwise the PI will receive one reminder. If OHRPP does not receive the continuing review application for processing before approval expires, approval to work on the project will expire and no work may be done until a current approval has been obtained. If the project has external funding, C&G will be notified to freeze the funding until approval is once again current. Any questions about this procedure may be directed to the office at 855-3067.
If a study is terminated by the investigator (or approval lapses), it may be reactivated within 30 days without having to submit a complete application to the HSC as a new study. If it is beyond the 30 days, or a significant number of changes have been made, a new application will be required.
While the OHRPP makes every effort to notify the PI of the need to renew the approval, ultimate responsibility lies with the researcher to make sure the approval does not expire for their projects that are ongoing.
POLICY FOR WHERE APPLICATIONS ARE TO BE REVIEWED
Effective May 2004 applications are to be reviewed according to the location of the research as well as where the researcher is located. If a project will take place solely on an IU campus other than the researcher's own campus, the application must be reviewed on the campus where the project will take place. Please see the policy for details. If you have questions, contact the office at 855-3067.
CHANGE FOR SOME DISSERTATION APPLICATIONS
OHRPP has changed its policy regarding the type of application required for a dissertation that will use only data gathered from the student's advisor's already OHRPP approved project. An abbreviated application may be submitted in this type of situation now. The student must be listed as a co-investigator on the advisor's project and must complete a brief form with one attachment. Please see the policy at Student Research Policy. The "Dissertation Form" with directions included can be downloaded at forms.REVIEW SCHEDULES
Review schedules are listed in the operations section of this site. They are also provided with the application available for downloading. Researchers are cautioned that these printed dates are subject to change on short notice. We advise checking with the office, 855-3067, for any changes to the schedule.
Only the 3/06 version of the packet will be accepted. Applications submitted on older versions of the packet will be returned to the investigator. Current forms in paper version can be obtained from the Committee's office in Carmichael Center L03, 530 E. Kirkwood Ave., 855-3067, or by clicking here.
The electronic version is available in MSWord and Acrobat Reader.
