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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, obtaining informed consent, or analysis of private and identifiable information.
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 IRB application and the letter of approval/exemption from their institution's IRB to IRB@iastate.edu IRB 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).
All IRB processes are managed electronically in IRBManager, including submission of new applications and amendments, reporting adverse events/unanticipated problems, requesting reliance on an external IRB, and requesting a Preliminary IRB Determination. Paper forms are not accepted. Instructions for various IRB submission types can be found here.
Applications must be submitted two full weeks prior to the scheduled IRB meeting if the study will be reviewed by the full committee. However, many ISU studies do not require full-board review. There are no submission deadlines for exempt and expedited studies—applications are reviewed in the order received..
Whom should I contact if I have questions?
Questions about IRB processes, IRBManager, or IRB applications under review can be directed to the IRB team at firstname.lastname@example.org or an IRB Administrator at 515-294-4215 (Roxanne), 515-294-4566 (Raeann), or 515-294-1329 (Deirdre).
For questions about IRB training opportunities or the IRB Post-Approval Monitoring Program, contact the IRB Post-Approval Monitor, Jennifer Ensley Gorshe, email@example.com or 515-294-7792.
For questions about IRB reliance agreements, IRB-related federal requirements (certifications, privacy certificates, etc.), or data use agreements involving human subjects data, contact Kerry Agnitsch, Assistant Director of ORE at firstname.lastname@example.org or 515-294-427
What happens after my application is submitted?
Step 1: Applicable key personnel receive notification to log into IRBManager to complete a Conflict of Interest (COI) Check. After all applicable personnel have completed the COI check, the application is automatically routed to the Chair of the department overseeing the research for approval. Department chairs may return the application to the investigator if they have questions. After department chair review is complete, the application is routed to the IRB office.
Step 2: Once a complete application is received by the IRB office, the IRB Administrator handling review of the application determines the level of review required (exempt, expedited, or full-board). If the project is eligible for exempt or expedited review, the IRB Administrator completes review. If the project requires review by the full-board, the IRB Administrator conducts preliminary review to address outstanding issues prior to scheduling the application for review by the convened IRB.
Step 3: Results of review and any additional information or clarification needed are communicated to the Principal Investigator (and Supervising Investigator, when applicable).
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 established a training program that involves in-person or virtual 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.
IRB team members also provide ad hoc training sessions upon request (e.g., guest lecture in a course, departmental or college seminar, presentation at faculty or graduate student orientation, etc.). To request an ad hoc training session, contact Jen Ensley Gorshe (email@example.com) or Kerry Agnitsch (firstname.lastname@example.org).
- What training is required to conduct Human Subjects research at ISU?
Anyone listed as key personnel on the IRB protocol must take human subjects protection training using the CITI training modules. IRBManager automatically verifies 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.
IRBManager cannot automatically verify 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 is 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 is 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" vary based on study-specific issues and are expected to be infrequent.
Subjects who do not speak English must be provided information about the study in a language understandable to them. Thus, recruitment and informed consent materials must be translated to facilitate understanding. IRB applications should include versions in English and copies of translated materials. Investigators must select qualified translators, and provide the name and qualifications of the individual who performed the translation as a method of certifying translated information is accurate. In some instances, it may be necessary to have translation accuracy independently verified (e.g. research that involves high risk, complex and technical procedures, etc.).
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 record
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 email@example.com. 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. See Guidance for Oral History Projects for more details.
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 Reviewing IRB—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 Reviewing IRB (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.