Institutional Review Board FAQ

The IRB accepts applications on a year-round basis. The only deadlines are for protocols receiving full reviews. PIs need to submit full protocols by the deadline listed on the  IRB Meeting Schedule in order for their application to be reviewed at the next meeting.

Yes. Even if you decide that your research is exempt from the IRB oversight, only the IRB can officially determine whether the research project is, indeed, exempt.

All human subjects research must be submitted for IRB review, even if exempt.

Please call (812) 237-3088 or e-mail your question to IRB@indstate.edu

If the intended use of the data collected is solely for reporting back to the funding agency as a basis for evaluating the project, then the associated data collection activities typically do not require IRB review and approval (keep in mind that there are some federal agencies, such as the Centers for Disease Control (CDC), that may require evaluative data collection activities to receive IRB review and approval).

However, the IRB recognizes that there may be situations where you want to use the evaluation data for research purposes or to collect additional data from your project participants strictly for research purposes. In these situations, IRB review and approval of the research-related aspects are required. In either case (use of evaluation data for research or collection of additional data strictly for research) your consent document(s) should clearly differentiate the evaluation components (for which participation is generally mandatory) from the research related components (for which participation in or use of collected evaluation data is voluntary).

A human subjects research project conducted in a foreign country still requires approval though our IRB. The federal Office for Human Research Protections (OHRP) has developed an International Compilation of Human Subject Research Protections. This compilation lists the laws, regulations, and guidelines of over 50 countries. The compilation can be accessed on the OHRP website at: http://www.hhs.gov/.

To use the Compilation, go to page 3 of the document and then click on the country of interest.

Typically, the IRB approves a research study or continuation request for one year. However, approval may be granted for less than one year in some circumstances, which may include, but are not limited to, high-risk protocols, projects involving unusual risk to subjects, projects involving vulnerable subjects (e.g., prisoners), and projects conducted by a PI who has previously failed to comply with IRB requirements.

Continuation reviews are not required for studies determined to be exempt.

If your study originally was approved following an expedited or full review, you must submit Form D (found in the IRBNet "Forms and Templates" library) and obtain IRB approval via IRBNet prior to implementing any changes to the research project's protocol, informed consent, or assent forms. See IRB Policy and Procedures Manual section F.1.2.2 and F.1.3.2 for more information.

Some changes to exempt protocols, depending on the level of risk, may require IRB approval.

ISU does not normally allow students to participate in a research study conducted by a PI from whom they are currently taking classes except under the exemption categories {45 CFR 46.101 (b) (1)}. If the nature of the study or other circumstances makes it impossible to conduct the study without using one's own students, the IRB may consider exceptions on an individual basis. The preferred method is to have data collected by an independent third party (e.g., colleague in own or other department), in such a way that the instructor does not know the identity of the participants and does not have access to identifiable data until final course grades have been assigned and entered.

In addition, the researcher will need to complete the form titled "Form S" (found in the IRBNet "Forms and Templates") and upload it into the IRBNet system along with the other required application documents. Refer to Section P, "Students as Research Subjects", of the ISU IRB Policies and Procedures manual for more requirements on using students.

Noncompliance is defined in Section G.2 of the ISU IRB Policies and Procedures Manual as:

• Misuse or nonuse of approved informed consent forms or procedures
• Failure to submit protocols in a timely manner
• Breaking confidentiality, unless required by law (e.g. child abuse)
• Unapproved subject recruitment activities
• Failure to secure confidential records in the required manner
• Failure to report problems involving physical or psychological injury to subjects or others
• Failure to report risks to subjects or others that exceed the protocol as approved
• Report from a subject of abuse by the PI or research staff
• Conducting research involving human subjects that has never been approved by the IRB
• Initiating changes to research protocols involving human subjects without prior IRB approval
• Continuing research activities beyond the IRB approval expiration date

You cannot begin recruitment until after the date that an official letter from the IRB is posted within IRBNet. If you begin your recruitment prior to an official letter from the IRB being is posted within IRBNet (either approval or exempt determination), then you will be in noncompliance with IRB Policy.

While there is no specific timeline, you are supposed to receive information regarding the status of your application within 10 business days (two work weeks) of submitting a complete application within IRBNet. That does not mean that your application will be approved or determined to be exempt within that time frame, as sometimes the IRB may request clarification or revisions.

After you have successfully submitted your application via IRBNet, a Submission Confirmation page will appear. If your application is incomplete, signatures from the appropriate faculty/staff sponsor and/or administrator were not provided electronically through the IRBNet system, or key personnel have not met the IRB's training requirements, you will receive a message through IRBNet that states that your application cannot be reviewed by the IRB until the issues are resolved.

When Indiana State is considered to be "engaged in research" (see OHRP guidance document "Engagement of Institutions in Research," October 16, 2008) but the PI is not associated with Indiana State, the PI must submit the following for review by the IRB: an application (Form A, and B or C, if applicable), a letter of support from a faculty member or EAP staff member at Indiana State who will sponsor the project, and a letter of approval from IRB of the institution where the individual is at, unless the individual's institution does not have an IRB. The IRB will then complete the appropriate review of the PI's IRB, in which case both institutions would need to complete the IRB authorization agreement.

When Indiana State is not "engaged in the research," the unaffiliated PI needs to obtain IRB approval at his or her institution and secure permission from Indiana State to conduct research at this university. The researcher should contact Indiana State’s IRB administrator at (812)237-3088 or IRB@indstate.edu.

• Exempt: Research activities in which the involvement of human subjects constitutes no more than minimal risk and falls within one or more of the exemption categories described in 45 CFR 46 101 (see Form B in the "Form and Templates" library in IRBNet) may be eligible for exemption certification. A designated IRB member determines exemption certification.
• Expedited: Research activities in which the involvement of human subjects involves no more than minimal risk and falls within one or more of the expedited review categories (see Form C in the "Form and Templates" library in IRBNet) may be eligible for expedited review. An expedited review is conducted by the IRB Chairperson or Vice Chairperson and a designated IRB member.
• Full: Research activities in which the involvement of human subjects involves more than minimal risk and does not fall within one or more of the exemption categories ((see Form B in the "Form and Templates" library in IRBNet) or expedited review categories (see Form C in the "Form and Templates" library in IRBNet), or involves certain vulnerable populations (e.g. prisoners) must undergo a review. A full review is conducted by entire IRB committee.

As a condition of ISU's IRB Registration and Federal-wide Assurance (FWA) through the U.S. Department of Health and Human Services, all individuals conducting human subjects research must complete training. ISU has contracted with the University of Miami to make this training available on-line.

The University of Miami training consists of two research tracks (Biomedical and Social & Behavioral). IRB members, Principal Investigators, and co-PIs may select the track most appropriate to their research role and complete the required modules for the chosen track.

To begin training go to http://www.citiprogram.org/

Depending on the scope of research, the IRB may require that you take additional modules relevant to the proposed work.

For training to be complete, the entire module sequence must be completed with a combined score of at least 70%. You can register for and complete the training at http://www.citiprogram.org/

Please note that you will need to upload a copy of your CITI training certificate into the IRBNet submission system as part of your application. Instructions for obtaining a copy of your certificate can be found in the IRBNet "Forms and Templates" library. If you have technical difficulties with the on-line training, please contact the Office of Sponsored Programs at (812) 237-3088.

Informed consent assures that potential subjects understand the nature of the research and their participation and can make an informed, voluntary decision about participating or not participating in the research project. Informed consent is an ongoing process, not just a form that is signed.

Consent documents must be clearly written in second person (e.g., you are asked to participate...) and at a reading level appropriate for your potential subjects. Any scientific or technical terms must be plainly defined using nontechnical language.

A checklist of required informed consent elements can be found in the IRBNet "Forms and Templates" library in IRBNet.

As of August 25, 2010, all research studies needing IRB review MUST be submitted via IRBNet, which can be accessed at www.irbnet.org. Visit the IRB Web site for instructions for registering and using IRBNet to submit your study. Please refer to the checklists, provided in the IRBNet "Forms and Templates" library, for a list of items to be submitted with your application. You will also need to complete the required training in human subjects protections prior to submitting your application.

You will also need to complete the required training in human subjects protections prior to submitting your application. For instructions on how to register and complete the training, please see the Training Requirements for Researchers document located in the “Forms and Templates” library in IRBNet.

If your project involves research with human subjects, it needs to be reviewed by the IRB. Often investigators only consider traditional biomedical research studies as needing IRB review, however, legal requirements to protect human subjects apply to a much broader range of research. Examples include:

• Data collected through intervention or interaction with individuals.

  • Intervention and interaction includes not only physical procedures (like drawing blood) but also interviews, observations, surveys, tests, manipulation of a subject's environment, and taste test options.
• Data collected to gain generalizable knowledge about categories or classes of people.
• Existing data or records of individuals, even if the information was not collected specifically for the study in question.
• Bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if you did not collect these materials.

As stated in the federal regulations (45 CFR 46.102)

Research-means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject-means a living individual about whom an investigator (whether professional or student) conducting research obtains:

• Data through intervention or interaction with the individual, or
• Identifiable private information.

If you are unsure if your project meets the definition of research or human subject, please contact the IRB Administrator at IRB@indstate.edu

The Institutional Review Board (IRB) is a campus committee empowered by federal regulations to oversee research activities involving human subjects. The IRB is responsible for the review and monitoring of research involving human subjects in order to assure the protection of the rights and welfare of the subjects participating in research. The IRB is dedicated to facilitating the ethical conduct of research.

The IRB is comprised of faculty and community members. The current list of IRB members may be found on the IRB website. As of August 25, 2010, all applications to the IRB must be submitted via IRBNet. Please consult our home page to obtain instructions.