About the IRB
What is the Institutional Review Board?
The Institutional Review Board (IRB) works with researchers at Minnesota State Univerisity, Mankato to ensure the protection of human participants in research and related activities that are conducted at, sponsored, or co-sponsored by the university.
Where does the IRB get is authority?
Authority for the IRB is granted through the federal regulations that require institutions that receive federal money for research to establish Institutional Review Boards.
What are the responsibilities of student IRB members?
Responsibilities of all members can be found in the section regarding membership in the IRB Manual.
When do I need IRB approval?
The researcher’s intention determines if IRB approval is needed. IRB approval is usually required when human participants are involved in the research. Some exceptions may apply. For the most accurate guidance, contact the IRB Director at firstname.lastname@example.org and consult these graphic aids published by the Office for Human Research Protections. Do not make the decision on your own. Ask the IRB for their guidance.
I am doing research on starting a new program at Minnesota State University, Mankato. Do I need to submit this research for review?
You will most likely not need IRB approval for your project. Studies used solely to facilitate the management of the university (e.g. program assessment) do not require IRB review. In some instances, the main purpose of the research is to facilitate management of the university, but the data is also being used for research that falls under the purview of the IRB. Please discuss your plans with the IRB Director at email@example.com .
Do I have to submit an IRB proposal if I am just interviewing people?
The researcher’s intention determines if IRB approval is needed. IRB approval is usually required when human participants are involved in research, but some exceptions may apply. For the most accurate guidance, consult the Director at firstname.lastname@example.org and these graphic aids published by the Office for Human Research Protections. If the interview is an oral history intended to stand alone or be archival, then no IRB approval is needed. If, however, the interview's purpose is to compare or contrast, with the intention of generalizing the results to other people, and may subsequently be presented or published outside the classroom it will most likely need IRB approval.
What are vulnerable populations?
See the IRB Manual and search the Table of Contents for “Vulnerable Populations.”
What do I need to include in the consent and proposal if I am recording people (e.g? audio, visual, pictures, or a combination, etc.)
Please review the Informed Consent Check List & Instructions for information regarding this question and consent in general.
Can I ask the students in my class to participate in my research as participants?
Yes, but since you are in a position of authority with respect to your students, you must assure IRB that no coercion or undue influence is exerted in recruitment. Please contact the IRB Director to discuss ways to do the research you wish and still meet federal guidelines. e-mail: email@example.com
I am a professor and my entire research class is administering the procedures. Do I have to list all 85 of them as Co-Investigators?
No, just note the class as student Co-Investigators. Remember that you will have to load CITI training Completion Certificates for all members of the class.
Can students sign and submit proposals?
Yes, but a faculty member must be the Principal Investigator (PI) and sign the
proposal as PI before it is submitted. Students do not sign the submission and should indicate any roll other than PI.
I am a student researcher; why can’t I be the Principal Investigator (PI)?
Only faculty can serve as PIs since they are responsible for all aspects of research that requires IRB approval.
Do I really have to use the application form provided? I have my own way of submitting proposals.
Yes, the application template makes it easier for reviewers because they know the
template, allowing for faster review.
Is it possible to know who reviewed my project?
If an investigator would like to discuss concerns with an IRB reviewer, the request
should be directed to the IRB Director, who will contact the reviewer. With
the permission of the reviewer, the name may be released; however, reviewer
confidentiality must be protected. Sometimes reviewers will call the Principal
Investigator on their own to ask questions about the research/proposal.
What should I do if I must change my procedures/consent after my proposal has been approved?
You will need to submit a Revision form to the IRB.
IRB Approval Timeline
What type of turnaround time should I expect for my proposal?
I’m running behind schedule and need to get my proposal reviewed quickly. How can I get the fastest review?
Proposals are processed in the order in which they are received. The type of review is determined by federal guidelines and whether it is a Level I, II, or III (see turnaround time above). Investigators should plan ahead when doing research and submit to the IRB so there is adequate time for review and approval before data collection can begin.
Can I start my research project while I wait for IRB approval?
No. Data collection may not begin until written approval is received from the IRB.
Utilization of Non-Institutional Resources
I am planning to do my research with an outside agency; what type of support documentation do I need and when do I need it?
If the outside agency has its own IRB approval from that IRB will be required. The alternative is to enter into a Reliance Agreement. For information about Reliance Agreements, contact the IRB Director at firstname.lastname@example.org
In the event you are doing research with an agency that does not have their own IRB, you will need Minnesota State University, Mankato IRB approval before asking permission to do research from the outside agency. Approval from the outside agency should be a signed letter by an appropriate administrator on agency letterhead. For a template letter that could be used see Letter.
What do I do if I am working with another school and I already have IRB approval from them?
You will need to submit a copy of their IRB approval with your application. You will need approval from IRB at Minnesota State University, Mankato. Talk to the Director at email@example.com
How do I find Public Information?
Access to Public Data
Can I use Google Drive to store IRB related documents?
IRB will not approve of IRB related documents being stored on Google Drive. Google has access to anything stored there. Please store your electronic documents encrypted on a password protected device or storage site. For example, you could use your university OneDrive account as part of Office 365. It basically functions the same way as Google but is secure.
Are all Qualtrics surveys, etc. anonymous?
Qualtrics is not as anonymous as many researchers think. The following link explains how to make Qualtrics surveys anonymous. Qualtrics surveys anonymous. Find “What’s on This Page:” and in the list below that heading find, “Anonymizing Responses.
- Principal Investigator: Faculty member or professional employee.
- Co-Investigator: Those who will be collaborating with the Principal Investigator conducting the research (e.g., Minnesota State University, Mankato employees, students, collaborating faculty)
- Administrative Review: This term is used for all reviews until the submission is approved.
- Level I Review: Minnesota State University, Mankato label. The Federal label is Exempt Review.
- Level II Review: Minnesota State University, Mankato label. The Federal label is Expedited Review.
- Level III Review: Minnesota State University, Mankato label. The Federal Label is Full Board Review.
- New Proposal: The first submission of a research proposal.
- Amendment/Modification: Changes in the original (not-yet-approved) submission recommended by the IRB.
- New Package: Submission type used when provided changes to documents requested by the reviewers.
- Revision: Changes in an approved proposal initiated by the Investigator(s).
- Continuation: Extension of an approved proposal that should be initiated by the Investigators 1-3 months prior to date in which approval terminates.
- Withdrawal: Closure of a file for technical reasons (e.g., 'accidental' submission of the proposal before Investigators intended to do so, failure of investigators to sign proposal following requests from IRB Director, duplicate proposals, missing documentation, and more).
Withdrawal can be initiated by IRB Director or the Investigators; however, Investigators cannot withdraw a proposal; they must request the IRB Director to do so.
- Deletion: Closure of a proposal that is labeled 'Work in Progress' by the Deletions must occur prior to submission.
- Informed Consent: The process of describing the research to participants including the purpose, expected duration, procedures to be used, foreseeable risks, benefits, disclosure of alternative treatment, confidentiality, compensation, contacts, and a statement that the research is voluntary and the participant can quit at any time without penalty or loss of benefits. See Check List for a checklist of all the required elements in informed consent.