Do I need to submit an IRB application for my research study?
You need to submit an IRB application if you are conducting research with human subjects (online or in person). Please see definitions of ‘research’, ‘human subjects’ and other related terms on page 2 of the IIMB IRB Policy document on Venus/Intranet (http://hrm.iimb.ernet.in/iimb/IRB/index.htm).
What do I need to have before I submit the IRB application to IRB for review?
You need to get certification from Collaborative Institutional Training Initiative (CITI).
You can register for CITI training through the following link: https://www.citiprogram.org/index.cfm?pageID=154&icat=0&clear=1
You can register for CITI training through the following link: https://www.citiprogram.org/index.cfm?pageID=154&icat=0&clear=1
What are the steps to register and take the courses listed by CITI?
After you click on the CITI training link (mentioned above), you will need to enter “Indian Institute of Management Bangalore (IIMB)” as your organization affiliation. Please use your IIMB email address (with @iimb.ac.in). Once you log in, you will see “View Courses” corresponding to IIMB. When you click on it, it will lead you to the page where the option of “Courses ready to begin” are there. You can click on this and proceed further.
How many modules are needed for CITI certification?
There are 13 required modules and one elective module that you can choose from a list of five. These modules are needed to get CITI certification, which is valid for 3 years.
Where are the documents that I need to fill for the IRB application procedure?
All the documents related to the IRB process are available on Venus/Intranet. To begin with, you can download the Guide to the IIMB IRB ethics application to know the steps involved in this process. Then you can download the IRB Ethics Application (fillable version) from Venus (http://hrm.iimb.ernet.in/iimb/IRB/index.htm) and fill it out.
Why are there two options of Informed Consent Form- one in the IRB Ethics Application and one as a separate document (Consent form template) on Venus?
You need to fill out only ONE of these Informed Consent Form templates. The separate Consent Form template document on Venus allows for more flexibility in terms of the wordings and is not in a fillable version like the one in the IRB Ethics Application.
How do I know which level of review is needed for my research study- exempt/excused OR expedited OR full?
The level of review depends on the amount of risk involved in participation in the research. Please note the definition of minimal risk and other related details in the IIMB IRB policy document (pages 4 to 6 - http://hrm.iimb.ernet.in/iimb/IRB/9.%20IIMB%20IRB%20Policy%20document.pdf) for these three levels of review. If you are still not sure, please email irb@iimb.ac.in for clarification.
Does excused/exempt level of research mean that I do not have to submit the IRB application at all?
No. Exempt DOES NOT mean the study is exempt from IRB review. You still must submit the IRB application and it will also be reviewed. The IRB will make the final decision about the level of review, even though the applicant can pick one of the levels of review depending on their understanding of the level of risk involved in participation in their respective research.
Can I recruit participants from the IIMB community (students from different programs, faculty, and staff members)?
Please note the document on Venus/Intranet titled, “Rules for recruiting subjects from IIMB community”( http://hrm.iimb.ernet.in/iimb/IRB/Rules%20for%20recruiting%20subjects%20from%20IIMB %20Community.pdf). Special permission is needed from program chairs and Administrative Officers to recruit participants from different programs. Please see the afore-mentioned document for more details.
Can I offer cash as compensation for participation in research?
No cash incentive is allowed for any research study conducted on IIMB campus or off IIMB campus with IIMB students, Executive Education participants, faculty, and full-time and contract staff. Gift cards or coupons can be given as compensation in such cases. Cash incentives may be allowed for studies conducted outside IIMB campus for individuals not affiliated with IIMB.
How long will the entire IRB process take, starting from the submission of the application and the final response of the IRB?
This time period could vary depending on the level of review requested and availability of IRB reviewers. The general rule is that higher the risk involved, longer the time period for review. Usually it will be the shortest for exempt/excused level of review (provided it is ascertained to be at this level), longer for expedited and the longest for full review.
What is the average time taken to review IRB applications? How long a wait should I expect?
You can expect a total period of at least 30 days. It could be between 7 and 30 days. In rare cases, it could be more than 30 days.
What can I do to ensure that there are no delays in the processing of the IRB application?
You can make sure that you have provided all the details in the IRB Ethics Application, especially related to the methodology section on page 8, including the informed consent and the study procedure as well. Also make sure that you have attached all the related questionnaires and study stimuli (as applicable) that will be given to the participants in your study. If you are unsure about any question in the IRB Ethics Application and related documents, send an email to irb@iimb.ac.in for clarification.
What do I need to note after my IRB application is approved?
You can collect data within the time period specified in the approval letter and follow the same protocol that has been approved by the IRB.
What should I remember near the end of the period allotted for data collection by the IRB?
Before the end of your data collection, you should fill out the Research Status Form (downloadable from Venus/Intranet) and send it to irb@iimb.ac.in to provide the status of your application. If you want to extend the time period of data collection, you can request an extension in this form. If it is completed or terminated, you should provide this information in the same form.
I need to make changes in my IRB application which has already been approved. What do I need to do?
You will need to download the Amendment Form from Venus/Intranet and fill in the information about the change (which could be major or minor) and send it to irb@iimb.ac.in. Examples of major and minor amendments are given on page 1 of this Amendment Form. You cannot engage in any data collection until your amendment is approved by the IRB.
How long will the IRB take to respond to my request for amendment?
It may vary depending on the type of change requested (major or minor). Usually it takes less time compared to the original application review.
Does IRB review applications submitted by people affiliated with IIMB only or does it review outside research as well?
IRB reviews only applications submitted by people affiliated with IIMB.
Do case studies require IRB approval?
Case studies may not require IRB approval. Please contact irb@iimb.ac.in for further clarification, if any.
I have a class project for which I am collecting data from people. Do I need to get IRB approval?
A class project does not qualify as research and therefore it does not need IRB approval.
If my research collaborators have approval from their respective institutions in the US (or other locations), do I need to get IRB approval from IIMB as well?
No, you do not need IRB approval from IIMB unless you plan to recruit participants from the IIMB community.
Who can I contact for any further questions regarding the IRB process?
You can send an email to the following address: irb@iimb.ac.in. You will get a response in a timely manner.