These FAQs represent many of the questions that SAU researchers have about human participant research. When in doubt as to the meaning of the answer or the correct action to be taken, ask the IRB Chair.
Note: The SAU IRB gratefully acknowledges the University of Chicago IRB and Indiana University (South Bend) IRB for the use of this FAQ and the general format of some of the answers.
What happens if I don't comply with SAU policy and federal regulations concerning human participants 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 is 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. Please see the SAU IRB Policy for more specific information.
I'm 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" as such that interactions between participant and researcher are included as well as interventions. Research that includes surveys, questionnaires, interviews and other such interactions requires IRB approval. A document to help you conduct an oral history will be posted soon.
Where can I get assistance with the SAU IRB application?
Contact the IRB chair, Dr. Carol DeVolder at 333-6482.
Where and when do I submit my IRB forms?
Research proposals for review should be submitted electronically to the IRB Chair at least two weeks prior to the IRB meeting date. For more information on this process please see Research Procedures.
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 electronically to the IRB Chair at least two weeks in advance of that meeting date. This gives the committee members time to review your proposal before the meeting.
What aspects of my research project are reviewed by the Board?
The IRB review of human participant research is confined solely to procedures affecting the ethical treatment of human participants. The review focuses on issues such as: minimizing risks to participants, ensuring voluntary participation, and protecting privacy and confidentiality.
What is "minimum risk"?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (Code of Federal Regulations, Title 45, Part 46.102 (i))
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 participants 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 participants.
I am an SAU student or faculty member collecting data in affiliation with another institution. Does my project have to be approved by the other institution's IRB?
YES. If the research participants are affiliated with another institution, you must get approval from the appropriate persons at that institution.
Conversely, if you are affiliated with another institution (e.g. as a student and are faculty/staff at SAU) and the institution has an IRB, you must get approval from their IRB.
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?
The board requires an approval letter by the appropriate facility or institution supervisor/officer containing a statement that they have reviewed and approved the project. The letter must also indicate that they foresee little or no potential risk to the participants, or that sufficient safeguards are in place to protect research participants. An Agency Approval Letter example will be posted soon.
What are "protected populations"?
According to Federal law (45 CFR, part 46, subparts B, C and D), "protected populations" include these groups where special rules apply: fetuses, pregnant women, prisoners, and children. Human in vitro fertilization also has special considerations.
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 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. Additionally, adequate provisions must be made for soliciting approval of child(ren) and permission of their parents or guardians.
When the child(ren) are at least 5-years-old, 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. The Child Consent Form will be posted soon.
I want to conduct research for my master's degree. 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 conducted for any reason other than meeting the child's educational needs (i.e. Master's thesis) are beyond the original intent of the IEP. Thus, guardians have not given consent to such projects or research.
My participants (and/or their parents/guardians) have already signed an IEP. 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 part of any IEP.
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 three years after termination of the research project.