When do I need IRB approval?
Whenever human participants are involved in research. The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S.
Do I have to submit an IRB proposal if I am just interviewing people?
The researcher’s intention determines if IRB approval is needed. If the interview is an oral history intended to stand alone or be archival, then no IRB approval is needed. If the interview purpose is of contrasting/comparing with intention of generalizing the results to other people, and is published/presented outside the classroom, it will most likely need IRB approval.
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: firstname.lastname@example.org or phone: 507-389-5102
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.
What if I am doing a project in the classroom? Does that need IRB approval?
It depends; if human participants are involved and the results will be presented outside the classroom you will need IRB approval.
What do I need to include in the consent and proposal if I am recording people?
Participants must be advised that participation will include recording. They must be informed of current and planned use of the materials including storage, transcription procedures, access by persons other than the researcher, and how/when the recordings will be destroyed.
What type of turnaround time should I expect for my proposal?
Allow 5-7 working days for Level I submissions; 10-13 working days for Level II submissions. Level III proposals will require full board approval the first Friday of each month and need to be submitted at least 5 full working days prior to the IRB meeting.
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.
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 email@example.com
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.
What are vulnerable populations?
Participants who, because of state and federal regulations, must be provided extra protection. These participants include, but are not limited to, minors, prisoners, fetuses, pregnant women, elderly, and cognitively impaired.
I am a student researcher; why can’t I be the Principal Investigator (PI)?
Only faculty can serve as PIs. This provides students with the legal advisement and legal protection due them.
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 other roll but PI.
I am doing research on starting a new program at Minnesota State University, Mankato. Do I need to submit this research for review?
Probably not. Studies used to facilitate the management of the university (i.e., program assessment) solely do not need to be reviewed by the IRB.
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. This link IRB provides directions for making changes in previously approved proposals.
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.
Where does the IRB get its authority?
Authority for the IRB is granted through the federal regulations that require any institution that receives federal money for research to establish Institutional Review Boards.
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.
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.
What are the responsibilities of student IRB members?
o Preview meeting agenda before meetings
o Read all attachments
o Review assigned proposals and comment on them by the review due date
How do our labels match up with federal labels?
o Exempt Review - we have named these Level I
o Expedited Review - we have named these Level II
o Full Board Review - we have named these Level III
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.
Are all Qualtrics surveys, etc. anonymous?
Qualtrics is not as anonymous as many researchers think. The following the link explains how to make Qualtrics surveys anonymous. Qualtrics
Please define the following:
o Principal Investigator - Faculty member or professional employee
o Co- Investigator: Faculty - Faculty member working on the research with the PI
o Co-Investigator: Student - Students who will be collaborating with the Principal Investigator conducting the research (e.g., Minnesota State University, Mankato employees, graduate students, collaborating faculty)
o Administrative Review - Federal label that is the same as Level I review or Exempt review
o Exempt Review - Same as administrative review or Level I review
o Expedited Review - Federal label that is the same as Level II review
o Level I Review -Minnesota State University, Mankato label that is the same as Exempt Review
o Level II Review - Minnesota State University, Mankato label that is the same as Expedited Review
o Level III Review - Minnesota State University, Mankato label that is the same as Full Board Review
o Full Board Review - Federal label that is the same as Level III review
o New Proposal - An original submission
o Amendment/Modification - Changes in the original (not-yet-approved) submission recommended by the IRB
o Revision - Changes in an approved proposal initiated by the Investigator(s)
o Continuation - Extension of an approved proposal that should be initiated by the Investigators 1-3 months prior to date in which approval terminates
o 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). 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.
o Deletion - Closure of a proposal that is labeled 'Work in Progress' by the Investigator. Deletions must occur prior to submission.
o 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