91社区

The Institutional Review Board, or IRB, is聽a standing university committee established under federal regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the partnership of the 91社区. It oversees institutional compliance with all federal, state, and University guidelines relating to research with human subjects.

The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.

Research is defined as a systematic investigation, inquiry, or analysis鈥攕uch as scholarly or critical study or inquiry or scientific investigation, development, testing, or evaluation鈥攄esigned to develop or contribute to generalizable knowledge. Research includes activities that aim to test a hypothesis, discover or collate facts, principles, or effects, reach new conclusions, or reexamine information by the critical study of a subject or by a course of scientific inquiry.聽Under the purview of the IRB,聽Human Subjects Research, sometimes abbreviated as HSR, is聽considered to be any activity that matches the above description and involves human participants as part of the data collection process.聽Examples may include surveys, interviews, medical tests, or physical fitness/exercise.

Not all research-related projects will require IRB review. The most common type of project we see that does not require IRB review are quality improvement (QI) projects, but for a more exhaustive list of projects that may not require IRB review please visit our page on this topic,聽Research That May Not Require IRB Review.

If you are still unsure whether your project requires IRB review, we recommend that you submit a聽Human Subjects Research Determination Form. This form can be found in the IRBNet library and should be submitted through IRBNet. Upon receipt of your HSR Determination Form, it will be forwarded to one of our IRB members who will review it* and determine whether or not your project meets the definition of Human Subjects Research. If your project is determined to NOT meet the definition of HSR, you will receive a letter confirming this determination.聽

*NOTE: Reviewers have up to 7 business days to review HSR Determination Forms; Please keep this in mind in deciding when to submit your form.聽

Please see IRB Application Form Description for details. Here's an overview.

• IRB Application Form A聽should be used when conducting Type 1 Research* (Exempt from Review)
• IRB Application Form B聽should be used when conducting Type 2 Research* (Expedited Review) or Type 3 Research* (Full Board/Convened Review)
• IRB Application Form C聽should be used when you want to make a modification to an already approved study
• IRB Continuing Review Form聽should be used when you are ready to conclude (close) your project or when you need to renew an already approved study for an additional amount of time

All of the above forms are available in聽聽under the "Forms and Templates" tab.

Yes. Even if聽you聽weren't the one to collect the data through intervention or interaction with human subjects and you have no intention for additional intervention or interaction with those individuals, you must still submit your project for IRB review. Depending on the nature of the data and the reason for initial collection, studies using secondary data* are either submitted for聽Exempt听辞谤听Expedited聽IRB review.

It depends.聽

The IRB only reviews complete applications. To be considered complete, a submission should:

• be signed by both the PI (Principal Investigator) and faculty sponsor (if applicable).
• have the completed and appropriate application form attached.
• have all supporting documents attached (e.g.,聽data collection tools such as surveys or interview questions, informed consent documents, assent documents, site permission letters, a copy of the grant application or contract).
• have CITI training certification documents attached or available through user profiles for聽all聽project team members, including the faculty sponsor(s).

If your submission is not complete, you will receive a notification that there is "Information Required" along with an "Acknowledgment Not Complete" letter outlining what is needed. These items must be addressed before your application can be considered complete and move forward to review.

A complete application will be sent to an IRB member or members for review. The review periods vary based on the type of research category the application falls under:

• Type 1 Research (Exempt) Applications have a review period of 7 business days.
• Type 2 Research (Expedited) Applications have a review period of 10 business days.
• Type 3 Research (Full Board) Applications must be reviewed during a monthly, scheduled IRB meeting during the fall or spring semester. (NOTE: Complete Type 3 Research Applications must be received by the IRB聽at least聽4 weeks聽before the IRB is scheduled to meet* in order to be reviewed at that meeting.)

Once the reviewers have completed their review, you will be notified that your application has been approved OR that your application requires modifications.聽Most applications will require at least some minor modifications, and some will require major modifications. Once you submit your modifications, our office will review your application to ensure that all required modifications have been completed, at which point your application will be approved.聽

The IRB can only approve in one-year increments.聽Projects that extend over more than one year must submit a Continuing Review form via IRBNet towards the end of the initial approval period to renew the project for additional time.聽The continuing review form must be submitted before the initial approval period is over. Any applications that need to be renewed but do not submit a continuing review form before the project expiration date must submit a new application and begin the review process.

Please note that the length of approval will not automatically be one full year.聽If you have requested an earlier end date in your application, the IRB will approve your project through that date. Additionally, if the CITI training of any project team member, including the faculty sponsor(s), expires prior to the one-year mark from approval or before the requested end date, the IRB will only be able to approve through the expiration date of that team member's CITI training.聽

Once your application has been reviewed, our office will contact you through IRBNet to notify you of any required revisions/modification or approval.

The principal investigator (PI), faculty sponsor(s), and any project team members with whom the project has been shared on IRBNet can check the status of the application any time by logging into IRBNet and selecting the "My Projects" tab. If you are still unsure about or have questions regarding the status of your application, you can contact our office by email at聽聽or by phone at 812-465-7000.聽

Investigators are responsible for obtaining IRB approval before beginning any human subjects research. Investigators must provide the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents, ethics training certifications) so that the IRB may conduct an appropriate level review of the proposed research. Along with meeting the specific requirements of a particular research study, investigators are responsible for meeting ongoing requirements in the conduct of approved research that include: obtaining and documenting informed consent of subjects prior to participation in the research, obtaining prior approval from the IRB for any modifications of the previously approved research, providing the IRB prompt reports of any unanticipated problems involving risks to subjects or others and proper storage and disposal of all collected data.

The University requires that the faculty sponsor assume meaningful supervision for each student researcher listed on the application form. The faculty sponsor must be reasonably available to assist in the resolution of and reporting of any problems that may arise during the course of the research. Faculty sponsors are responsible for imparting to students an understanding of the ethical principles of human research to which the University adheres. If a student is conducting research or a class activity that falls within the IRB鈥檚 purview, the faculty sponsor must ensure that the student completes appropriate training and secures IRB approval before beginning the study or activity. The faculty sponsor also has primary responsibility for overseeing the conduct of the research in its entirety and for ensuring that student adheres to the approved protocol. The duty of the faculty member is to assess, and, if prudent, veto, activities proposed by a student to fulfill a class assignment should more than minimal risk for harm to either the participants or the student exist.

Informed consent is the process by which a fully informed research subject can determine whether they wish to enroll in a research study. It is based on the legal and ethical rights of humans to make voluntary and autonomous decisions about whether they wish to be a research subject. Informed consent can only be obtained from individuals over the age of 18. Minors (age 7-17) must complete an assent document AND have a parent or guardian complete an informed consent document.

Informed consent is required for all research studies involving human subjects unless the investigator specifically requests a waiver or alteration of informed consent, which must be approved by the IRB.聽In order to participate in a research study, human subjects must understand that they are part of a research project, that participation is voluntary, and that they may withdraw at any time without penalty. They must also understand the procedures involved, time commitment, benefits and risks, and the extent to which confidentiality is maintained. This information is presented to prospective subjects in consent forms.

Investigators are required to keep all signed informed consent documents.

NOTE: The 91社区 IRB requests that all informed consent and assent documents follow the templates provided in the IRBNet Library.

When conducting research online, we recommend using the updated Informed Consent Template for Online Surveys, which is available in the IRBNet library.

• Some researchers choose to require participants to select an "I consent" option before they can proceed to the survey questions.
• When conducting online surveys, it is sometimes appropriate to use implied informed consent. In these situations, the participants are presented with the informed consent document at the beginning of the survey and informed that by proceeding and/or submitting the survey they are providing their implied consent.聽

If your survey will be distributed by email/completed online as part of your research study:

• It is required that the survey be created in Qualtrics,
• A PDF copy of this survey should be attached to the package in IRBNet, and
• The Informed Consent information should be displayed at the beginning of the survey.

To create a PDF of the Qualtrics survey: 1) Create the survey in Qualtrics, 2) select "Tools", 3) select "Import/Export", 4) select "Print Survey", and 5) "save as PDF." Then, attach this PDF document to the project in IRBNet.聽

• Please refer to 91社区 Qualtrics from Institutional Analytics (IAO) for helpful tips and tutorials and to request a Qualtrics account.聽
• (Columbia University, 2022)

The Collaborative Institutional Training Initiative (CITI) is a high-quality, peer-reviewed, web-based educational program which provides efficient and effective training for the protection of human subjects in research. The CITI Program was developed by experts and is used by many research, healthcare, technology, and educational institutions to train individuals in areas such as聽ethics, research, meeting regulatory requirements, responsible conduct of research, and research administration.

All 91社区-affiliated personnel (faculty, staff, and students) conducting human subject research projects are required to complete CITI training to ensure investigators are well educated on the ethical conduct of, and the regulations regarding, research with human subjects.聽Approval will not be granted for IRB applications until this training has been completed and training certifications are submitted on IRBNet.聽

More 91社区 CITI Training

Completion of any one of the 91社区 CITI courses below satisfy the CITI training requirement for聽Type 1 Research (Exempt) Applications:

• Exempt
• Expedited/Convened
• IRB Members

Completion of any one of the 91社区 CITI courses below satisfy the CITI training requirement for聽Type 2/Type 3 Research (Expedited/Full Board) Applications:

• Expedited/Convened
• IRB Members

NOTE: Responsible Conduct of Research (RCR) training is not accepted for IRB applications.

The 91社区 IRB carefully selected specific CITI training modules for our institution's CITI courses. If you have completed these modules for your CITI training at another institution, the 91社区 IRB will accept that CITI training.* If you have not completed the necessary modules, you will be required to before your CITI training will be accepted. Please contact our office at聽聽for a list of the required training modules for each of our CITI courses.聽

*Please note that 91社区's CITI courses are good for 3 years. If you are using CITI training completed under another institution, the 91社区 IRB will consider your training expired 3 years after the completion date, even if the certification states otherwise.聽

If you need to make any modifications to your ongoing study, no matter how small, you must submit an Amendment form (IRB Application Form C) via IRBNet. Your amendment will be reviewed, after which you will be notified that your amendment has been approved or requires modifications. (The modifications process for amendments is the same as with new submissions.) Once your amendment has been approved, you may implement the changes to your study.

If you have questions about聽how to submit an amendment in IRBNet, please consult the portion of the IRBNet User's Manual.

If you want to renew your study for additional time, you will need to submit a Continuing Review form via IRBNet.聽The continuing review form must be submitted before the initial approval period is over/the current expiration date. (Continuing Review forms also subject to IRB review, so please allow time for the review process.) Any applications that need to be renewed but do not submit a continuing review form before the project expiration date must submit a new application and begin the review process over.

Engaging in human subject research without IRB approval has serious ethical implications and violates university and federal policies. Students, faculty, and staff are required to submit IRB applications before embarking on any data collection. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted.

If it is discovered that research is being conducted without IRB approval, the investigator must immediately stop, appropriately discard/destroy all collected data and submit an application for IRB approval through IRBNet.

NOTE: Most academic journals now require proof of IRB approval before an article can be accepted for publication.