Frequently Asked Questions

These FAQs represent many of the questions that SAU researchers have about human subject research. When in doubt as to the meaning of the answer or the correct action to be taken, ask the IRB Chair!

1. If I am an SAU student or faculty member collecting data in affiliation with another institutions, does my project have to be approved by their IRB?
2. When acquiring approval to collect data at a facility or organization, is there specific information that the SAU IRB wants included in the letter of agreement with those facilities?
3. What is the difference between confidentiality and anonymity?
4. Students in my classroom-related project already have an Individualized Educational Plan (IEP) that has been agreed upon and signed by their parent(s). Do I still need them to sign an IRB Informed Consent Form for my project?
5. What happens if I do not comply with SAU policy and Federal regulations concerning human subjects research?
6. Where can I get assistance with the SAU IRB forms?
7. What aspects of my research project are reviewed by the Board?
8. How far in advance of my starting date should I submit my project for IRB approval?
9. I am just talking with people for my project … I'm not doing anything to them. There are no experiments, clinical trials, etc. Do I still need IRB approval?
10. My research falls into the "exempt" classification. Do I have to submit my project to the IRB?
11. What do I do with the signed consent forms after the project is completed?
12. When do I need to submit a continuing review form?
13. What is "minimum risk"?
14. How do I handle informed consent with children?
15. What are "protected populations"?
16. Where and when do I submit my IRB forms?
17. My subjects (and/or their parents/guardians) have already signed an IEP (Individualized Education Program) - do I also need them to sign an informed consent form?

1. If I am an SAU student or faculty member collecting data in affiliation with another institutions, does my project have to be approved by their IRB?
   
   YES - if the research participants are affiliated with another institution, you must get approval from the appropriate persons at that institution. Also, if you are affiliated with another institution (i.e. as a student and are faculty/staff at SAU) and the institution has an IRB, you must get approval from their IRB.
2. When acquiring approval to collect data at a facility or organization, is there specific information that the SAU IRB wants included in the letter of agreement with those facilities?
   
   Approval letter by the appropriate facility or institution supervisor or officer containing a statement that they have reviewed and approved the project, and that they foresee no or little potential risk to the participants, or that sufficient safeguards are in place to protect research participants. View an agency approval letter example.
3. What is the difference between confidentiality and anonymity?
   
   Anonymity refers to responses obtained from research participants when there is no way to link responses to the participants. If the investigator cannot, in any way, link the subjects with their responses or other recorded data, then anonymity can be assured.
   
   Confidentiality refers to responses/information obtained from research participants that could be linked to the individual participants. Research investigators must assure that the responses provided by the participants will be kept confidential so that no one other than the investigator can connect the information to specific subjects
4. Students in my classroom-related project already have an Individualized Educational Plan (IEP) that has been agreed upon and signed by their parent(s). Do I still need them to sign an IRB Informed Consent Form for my project?
   
   YES.
   
   The IEP is specific to the child's educational needs. "Classroom-related projects" that are conducted for any reason other than meeting the child's educational needs (i.e. a Master's thesis) are beyond the original intent of the IEP. Thus, guardians have not given consent to such projects or research.
5. What happens if I do not comply with SAU policy and Federal regulations concerning human subjects research?
   
   If non-compliance is alleged, the IRB Chair will initiate an investigation. The researcher will be informed of the allegations and given ample time to respond. The IRB Chair will then review the relevant information and make a report to the Institutional Official (the current Ex Officio Member of the SAU IRB), including recommendations. The Institutional Official will take the appropriate legal and administrative actions to insure that institutional policy and federal regulations are in compliance. Approval for the project may be terminated, and documentation of the non-compliance may be sent to the appropriate administrative offices and/or faculty/university committees (PTS, Board of Studies, etc.). If the Institutional Official determines that the non-compliance to be either serious or continuing, it must be reported to OHRP and to any sponsoring agencies.
   
   Non-compliance can have serious consequences for both the researcher and the University. The University (and researcher) could be placed at risk for losing Federal or other funding related to research activities.
   
   (Note: the SAU IRB gratefully acknowledges the University of Chicago IRB for the use of this FAQ and the general format of the answer.)
6. Where can I get assistance with the SAU IRB forms?
   
   Contact the IRB chair, Dr. Lynn Kilburg at 333-6352 or KilburgLynnJ@sau.edu .
7. What aspects of my research project are reviewed by the Board?
   
   The IRB review of human subjects research is confined solely to procedures affecting the ethical treatment of human subjects. The review focuses on such issues as minimizing risks to subjects, ensuring voluntary participation, and protecting privacy and confidentiality.
   
   
   (Note: the SAU IRB gratefully acknowledges the University of Chicago IRB for the general format of this question and answer.)
8. How far in advance of my starting date should I submit my project for IRB approval?
   
   To be sure that you can meet your proposed start date, we recommend you submit your project one month in advance. Remember that for your project to be considered at one of the IRB meetings, it must be submitted one week in advance of that meeting date. This gives the committee members time to review your proposal before the meeting.
9. I am just talking with people for my project … I'm not doing anything to them. There are no experiments, clinical trials, etc. Do I still need IRB approval?
   
   YES. Federal regulations define "human subject research" such that interactions between subject and researcher are included as well as interventions.
   
   Research that includes surveys, questionnaires, interviews and other such interactions requires IRB approval. Please see this document if you are conducting an oral history.
   
   (Note: the SAU IRB gratefully acknowledges the Indiana University (South Bend) IRB for the general format of this question and answer.)
10. My research falls into the "exempt" classification. Do I have to submit my project to the IRB?
    
    YES.
    
    "Exempt" in this context means "exempt from full committee review."
    
    "Exempt" classed proposals are evaluated by an IRB sub-committee instead of the full committee.
    
    Learn more about "Exempt" and "Non-exempt" proposals.
    
    (Note: the SAU IRB gratefully acknowledges the Indiana University (South Bend) IRB for the general format of this question and answer.)
11. What do I do with the signed consent forms after the project is completed?
    
    Keep them! The signed consent forms should be retained by the researcher for at least 3 years after termination of the research project.
    
    (Note: the SAU IRB gratefully acknowledges the Indiana University (South Bend) IRB for the general format of this question and answer.)
12. When do I need to submit a continuing review form?
    
    On an annual basis, or sooner if any major changes in your project occur.
    
    (Note: the SAU IRB gratefully acknowledges the Indiana University (South Bend) IRB for the general format of this question and answer.)
13. What is "minimum risk"?
    
    Please refer to our project review page.
14. How do I handle informed consent with children?
    
    Health and Human Services (HHS) will allow research with children that involves more than minimal risk only in those cases where there is the prospect of direct benefit to the individual participant. The anticipated benefit must be at least as favorable to the child as other available alternate approaches, and adequate provisions must be made for soliciting the assent of the children and permission of their parents or guardians.
    
    When old enough (age 7 or older), the SAU IRB requires a separate consent form for the child, written at a level so as to be understandable by the child, and signed by both child and parent/guardian.
    
    More information about research involving children.
15. What are "protected populations"?
    
    According to Federal law (45 CFR, part 46, subparts B, C and D), "protected populations" include those groups where special rules apply: Fetuses, Pregnant Women, Prisoners, and Children. Human in Vitro Fertilization also has special considerations.
16. Where and when do I submit my IRB forms?
    
    Proposals for review should be submitted to Maryann Striegel in the Assessment and Institutional Research Office (located on the north side of Ambrose Hall, under the brick archway) at least one week prior to the IRB meeting date.
17. My subjects (and/or their parents/guardians) have already signed an IEP (Individualized Education Program) - do I also need them to sign an informed consent form?
    
    YES. The IEP meets certain educational requirements, but the informed consent meets notification requirements for your research study, which is not a part of any IEP.