Sponsorship of Applications

Some research involving human participants / subjects must be sponsored by a responsible investigator. Investigators whose appointments carry the approved rank codes do not require sponsorship (primarily, tenured or tenure-track faculty, with or without administrative titles; tenure or tenure-track librarians; full-time salaried clinical rank appointees; and full-time research rank appointees and senior level lecturers). See the end of this section for a list of rank titles and their codes. All other investigators, including students, research associates, postdoctoral fellows, non-salaried clinical rank appointees, non-tenure track faculty and librarians, visiting and part-time appointees must be sponsored by one or more full-time IUB faculty, librarian, salaried clinical rank, or research rank appointee whose primary appointment carries one of the below-listed rank codes.

Sponsorship is more than simply a signature, and carries two responsibilities: (1) supervision of the research, and (2) assistance in preparing the application for IRB approval. While the IRB is able to offer assistance in how to complete the the applications, it cannot take the place of the sponsor.

When a student is working on a project that already has IRB approval and is active with a current approval, and that student will use some of that data to fulfill a course or degree requirement, such as honor's thesis, first-year project, or master's degree, or dissertation, the original principal investigator must submit an amendment to OHRPP requesting the student to be added as a co-investigator on his/her project for the stated purpose. Any student working in this capacity on a dissertation must also submit a separate application to OHRPP describing the project and the data to be used. The "Dissertation Form" that includes directions for this type of submission is available for downloading at http://www.research.indiana.edu/rschcomp/instruct.html. Like our other forms, it is available in three formats. You have to choose the format first, then the form you want.

In all other situations student-initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol. All IUB student research projects being done on the IUB campus or away from any IU campus must be sponsored by one or more full-time IUB faculty, librarian, salaried clinical rank, or research rank appointee.

Applications are now to be reviewed according to where the research is to take place, as well as according the "home campus" of the student. If a project will take place solely on another IU campus, the project must be reviewed on that campus. Please see the "IRB Policy for Studies Conducted on Multiple Campuses" for more details.

Persons with the following ranks are approved to submit, or sponsor, an application to use human subjects in a research project.

FT1 - Professor
FT2 - Associate Professor
FT3 - Assistant Professor
FT5 - Lecturer convertible to tenure-track
FL5 - Lecturer
FLS - Senior Lecturer
EF1-3 - Emeritus Professor, Associate and Assistant
FC1 - Clinical Professor
FC2 - Clinical Associate Professor
FC3 - Clinical Assistant Professor
FC5 - Clinical Lecturer
FCS - Senior Clinical Lecturer
EC1-3 - Emeritus Clinical Professor, Associate and Assistant
LT1 - Librarian
LT2 - Associate Librarian
LT3 - Assistant Librarian
EL1-3 - Emeritus Librarian, Associate and Assistant
RS1 - Senior Scholar/Scientist
RS2 - Associate Scholar/Scientist
RS3 - Assistant Scholar/Scientist
AAA - President
AAB - Vice President
AAC - Associate Vice President
AAD - Assistant Vice President
AAE - Chancellor
AAF - Vice Chancellor
AAG - Associate Vice Chancellor
AAH - Assistant Vice Chancellor
AAI - Dean
AAJ - Associate Dean
AAK - Assistant Dean
AAL - Chairperson
AAM - Director
HAI-HAM - Acting I-M

Follow-Up

OHRPP suggests that researchers be aware that materials can get lost in the mails. If an investigator has submitted an application but hasn't heard from the office within two weeks, the investigator should contact the office by email or phone. If the investigator has provided an e-mail address, OHRPP will use that means to convey any questions to the investigator. If no e-mail address is provided, a written memo will be sent to the address the investigator provides. However, communication from a Full Board Rreview will, in most cases, be by written letter sent via campus or U.S. mail, depending upon the address provided by the investigator. For applications with a sponsor, the sponsor will be copied on all communication with the investigator.

The IRB allows approximately one month from the time it sends questions to the investigator before it will recontact the investigator as follow-up. If the Committee does not receive a response from the investigator by the end of 2 months, the application will be considered not approved/withdrawn.

File Maintenance

It is important for investigators to KEEP A COPY of every document related to the research project which is submitted to OHRPP. For audit purposes, these documents, and signed consent forms, must be kept for at least three (3) years after terminating the study. OHRPP will not be responsible for duplicating any information submitted for Full Board Review.

Research files involving investigational drugs used in the United States must be maintained for two (2) years after the FDA's approval or denial of a New Drug Application (NDA) or two (2) years after a sponsor withdraws an NDA submission. Research files involving investigational drugs used in global trials must be maintained for at least fifteen (15) years after the date of the termination of the study.

On this page:

Sponsorship of Applications

Follow-Up

File Maintenance