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Frequently Asked Questions (FAQ)
What if my study includes individuals from vulnerable populations, such as prisoners, children, economically or educationally disadvantaged persons, or individuals with impaired decision making capacity?
ISU faculty, students, and staff must obtain approval from Iowa State University's Institutional Review Board (IRB) before research involving humans may be initiated, including recruitment, data collection, and obtaining informed consent. Specific examples of activities requiring IRB review are surveys, interviews, exercise studies, use of student records, and taste tests.
Unaffiliated investigators who wish to conduct research that takes place on the ISU campus or that involves ISU faculty, students, or staff, must submit a copy of the application and the letter for approval from their institution's IRB to the Office of Research Ethics (ORE). ORE staff will review the proposed research to determine whether approval from the ISU IRB is needed.
What does "exempt" mean?
“Exempt” or “exempt review” is a special category of IRB review allowable for certain types of research. Federal regulations designate certain types of research as “exempt” from many of the requirements governing human subjects research, and thus subject to fewer IRB requirements. These projects require submission of an application to the IRB office for a formal determination of exemption. Some exempt research is also subject to “limited IRB review” by an IRB member to assess privacy and confidentiality protections. In all cases, human subjects research activities may not commence until a formal written determination of exemption is received by the principal investigator.
Information about Exempt Research provides details about when research may be eligible for exempt review, submission requirements for exempt research, and key ethical responsibilities of investigators (e.g., informed consent, promoting voluntariness, and protecting privacy and confidentiality).
Nearly all IRB processes are managed through the IRBManager System. New applications and amendments (Continuing Reviews, Modifications, and Personnel Changes) must be made through this electronic protocol management system. In addition, you should use IRBManager if you need to report an adverse event or request that ISU rely on an external IRB for review of a project. Paper forms for these will not be accepted, however, if you need to request a Preliminary IRB Determination, the related form can be found on the IRB Forms web page.
New applications and amendments (Continuing Reviews, Modifications, and Personnel Changes) must be submitted through the IRBManager System. Protocols must be submitted two full weeks prior to the scheduled IRB meeting if the study will be reviewed by the full committee.
Many ISU studies do not require full committee review. Studies that qualify for expedited review are reviewed by the IRB Chair/Co-Chair; studies eligible for exempt status are reviewed by IRB staff. There are no deadlines for submission of exempt and expedited studies; they are reviewed in the order received.
How does the Office of Research Ethics (ORE) help ensure efficient review of the IRB applications for approval?
To help ensure efficient review, the ORE conducts preliminary review of all submitted protocols to identify any problems with the application. The ORE staff provides guidance to the PI regarding common questions and/or concerns of the IRB during protocol reviews, provides guidance on regulations and other information that the committee may expect to see, and conducts review of protocols eligible for exempt and expedited review.
The ORE also provides feedback to the PI before sending the protocol for committee review to allow the PI to address any concerns. This often speeds up review as the commonly encountered mistakes and/or questions are addressed before IRB review. For guidance on whom to contact regarding specific questions, please see our Staff Information page.
Whom should I contact if I have problems or questions while filling out the application forms on IRBManager or during the review process?
For problems or questions concerning IRBManager, forms or processes, contact an IRB Administrator at 294-4215 (Roxanne), 294-4566 (Raeann), or 294-1329 (Deirdre), or email the IRB team at IRB@iastate.edu.
What happens to my application after it is submitted to the IRB?
Step 1: The IRB Administrators screen the protocol to verify that all materials have been submitted and that the application is complete. IRB Administrators will correspond with the PI to obtain additional information or clarification as needed.
Step 2: Once a complete application is submitted, the IRB Administrator determines the level of review required (exempt, expedited, or full-board), and conducts preliminary review to ensure any outstanding issues are addressed prior to review by the full-board or IRB Chair/Co-Chair. The IRB Administrator also completes review for studies eligible for exempt status.
Step 3: An IRB Administrator will correspond with the PI to obtain additional information or clarification as needed by the IRB Co-chair or full committee. The results of the review (i.e., approval, exemption, or disapproval) will be communicated in writing to the investigator. Supervising Investigators also receive notifications when additional information is needed or when the project is approved.
For a more detailed overview of the IRB review process, see IRB Basics.
What is the average time before IRB approval is received?
On average, IRB approval is received within four to six weeks of protocol submission. Approval times vary depending on the completeness of the application and corresponding materials, the efficiency of the PI in addressing the committee's questions regarding the submission, and the volume of protocols under review. The IRB experiences peak times for several weeks around the middle of each semester. To be safe, investigators should allow four to six weeks for approval of their study, regardless of the time of the year.
IRB approval can be delayed when the IRB application has these common problems:
- All sections on the application are not completed.
- Responses to questions in the application are incomplete or lack sufficient detail.
- Study materials (recruitment items, consent forms, data collection materials, etc.) are not submitted with the application.
- Inconsistent information is provided throughout the application and study materials. For example, information appears in the informed consent document but is not mentioned or explained in the application for approval.
How can I learn more about the IRB review process?
The Office of Research Ethics has launched a training program that involves in-person sessions with a member of the IRB team. Training sessions are offered at various times throughout the year. Topics include determining whether IRB approval is required, navigating the IRB submission process, protecting human subjects, informed consent, and best practices for a successful IRB submission. More information about session topics, dates, and times can be found on the IRB Process Training webpage.
Anyone listed as key personnel on the IRB protocol must take human subjects training using the CITI training modules. IRBManager automatically verifies human subjects training, provided researchers have used their ISU email address to register with CITI. Exceptions may be made for researchers who are not affiliated with ISU (see below); in that case, copies of training verification must be entered into IRBManager. Applications may not be submitted in IRBManager unless training is complete for all study personnel.
If you have not done so already, we strongly encourage you (and any research staff involved on your projects) to complete the CITI training modules now which will make the switch to IRBManager much smoother. Remember – you must register with CITI using your ISU email address and affiliate with ISU to allow automatic checks of training.
IRBManager cannot automatically check training for researchers who do not have ISU email addresses. Researchers working with unaffiliated colleagues will have the option to add these individuals as “contacts” and upload copies of their completed training certificates into IRBManager when completing an application. Guidance on this process will be located within the application in IRBManager. Information about who must be listed as key personnel and how to complete human subjects training can be found on the IRB Training page.
When are letters of cooperation/approval needed from outside institutions in which ISU research is conducted?
Investigators are responsible for ensuring that adequate permission is obtained from each institution in which research will occur, in accordance with that institution's policies and procedures. Investigators are encouraged to maintain documentation of permission in their files. Documentation of permission will be required during IRB review when research is conducted in prisons or in other situations when the IRB determines that obtaining permission is needed to ensure participants are protected. These "other situations" will vary based on study-specific issues and are expected to be infrequent.
Subjects who do not speak English should be presented with a consent document written in a language understandable to them.
An English version of the informed consent document and a translated version must be included in the application for approval. Investigators must also provide certification regarding the qualifications of the individual who performed the translation by including that individual's name and their qualifications for translating documents. This certification should be provided in the application for approval. The IRB will then review the qualifications of the translator to assess whether they are qualified to translate the informed consent document. This certification is requested in order to avoid requiring "back translation" of documents.
What if my study includes individuals from vulnerable populations, such as prisoners, children, or persons who are cognitively impaired?
Federal regulations require additional safeguards for participants who may be vulnerable to coercion or undue influence. Appropriate safeguards vary depending on the study population and context of the research. For example, parent/guardian consent must be obtained before including children in research, unless this requirement is waived by the IRB. Consent from a legally authorized representative is needed for persons who are unable to fully understand the research or who cannot provide legally effective consent. For research involving prisoners, assurances that participation will not impact an individual’s parole status or treatment in the prison must be obtained from the prison warden. In some cases, vulnerability is situational. For example, adult students or employees may be vulnerable when the researcher is also their teacher or supervisor. If your study includes vulnerable populations, the IRB application must describe safeguards to protect vulnerable participants.
The use of existing records requires IRB approval when the records are private and identifiable. "Identifiable" includes direct identifiers, such as names, addresses, dates of birth, SSN, etc., and indirect identifiers, such as ID codes (e.g., student ID, case numbers, etc.). Depending on the records to be obtained, other regulations may apply. For example, the Family Educational Rights and Privacy Act (FERPA) provides protections for student educational records; the Health Insurance Portability and Accountability Act (HIPAA) relates to privacy of medical records. The IRB must consider requirements of these regulations for research using educational or medical records.
In the primary reviewer system, each IRB member is assigned as a special reviewer of a protocol to be reviewed at the full committee meeting; generally the reviewer is from the same department or area of research as the investigator. Although each IRB member must review all of the materials and be prepared for discussion, the primary reviewer is responsible for presenting a brief summary of the assigned study at the meeting. Prior to the meeting, the primary reviewer will review the assigned study in detail, contact the investigator with any questions regarding the study, and respond to questions raised by other IRB members.
One of the main goals of a primary reviewer system is to ensure that any information and/or clarifications required in order for the IRB to grant approval are obtained from the PI prior to the full committee meeting; fewer proposals will be tabled because additional information is needed from PIs.
Can a student be penalized for failing to show up for a scheduled appointment to participate in a research study?
No. According to a January 8, 2010, memorandum posted on the website of the Office for Human Research Protections (OHRP), penalizing students by deducting credits violates federal regulatory requirements that participation in research must be voluntary and that refusal to participate will involve no penalty. Under the provisions of the regulations, students must be free to choose not to participate in research they have signed up for at any time prior to the start of their involvement and to communicate their decisions not to participate in research in whatever way they choose, including by simply not showing up.
First, you must specify in your IRB application that you will be sending advertisements via email to all faculty and staff. After you obtain IRB approval for your study, you can request a copy of the ISU faculty and staff email list by contacting Human Resource Services at firstname.lastname@example.org. See the ISU Information Technology Knowledge Base article Mass E-Mail: Practice Effective Electronic Communication for more information.
Federal human subject regulations defer to state law when defining a minor. According to Iowa law, an adult is an individual who is married or a person who is 18 years old or older. So, a married minor can consent to participate in research studies. Definitions of a minor vary by state, and investigators should check the applicable state laws if they are recruiting individuals from another state to participate in research, particularly college freshmen.
Do oral history projects require IRB approval?
There has been long-standing confusion of when oral history projects require IRB oversight. Current regulatory wording indicates that oral history projects are deemed not research (and thus do not require IRB approval) when the focus of the project is directly on the individuals about whom the information is collected.
When oral history interviews are obtained for purposes of analyses to draw broadly applicable conclusions (i.e., generalizing to other individuals beyond those who are interviewed), then the project meets the federal definition of research and IRB oversight is required.
How do I handle IRB review if I am collaborating with researchers at other institutions?
In general, human subjects research activities conducted by employees of an external site fall under the jurisdiction of that site’s Institutional Review Board (IRB). When researchers collaborate, that can mean that IRB approval by multiple IRBs is required.
To avoid duplicate review, the IRBs at each site may be willing to enter into formal agreements called Reliance Agreements or IRB Authorization Agreements (IAA), allowing one IRB to serve as IRB of Record—that is, to be the IRB that assumes responsibilities for review of research activities conducted by researchers at multiple institutions.
Research collaboration arrangements vary, and thus the “best” option for IRB oversight depends on the specific situation for each project. The best option also depends on funding agency requirements, and whether a study qualifies for exemption.
Effective January 20, 2020, nearly all federally-funded non-exempt multi-site projects must utilize a single IRB of Record (sIRB). Most NIH-funded research required use of an sIRB as of January 25, 2018. For more information about the sIRB mandate and ISU’s plans for implementation see Multi-Site Research and sIRB.