IRB Contact: Sena Lim, Human Research Protection Program Manager

COVID-19 Resources for Research

Find information and resources for research during COVID-19.

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The Institutional Review Board (IRB) is a peer-review committee charged with the responsibility of protecting the rights and welfare of humans involved in research. Ball State follows the ethical principles laid out by the Belmont Report (PDF). Ball State University's IRB subscribes to the "Common Rule" for the protection of human subjects found in 45 CFR 46.

The IRB reviews and approves all of Ball State's research protocols involving human subjects in order to ensure compliance with laws and national standards regarding the ethical treatment of human subjects. The researcher must attain IRB approval before conducting a study involving human subjects. Annual resubmission must be completed for projects of more than 12 months duration. IRB protocols are submitted using IRBNet

UPDATE: CHANGES TO PRINCIPLE INVESTIGATOR (PI) OF RECORD ELIGIBILITY

Beginning July 1, 2021, all PIs on IRB protocols must be BSU faculty and professional staff members. Click here for more information or download (PDF).

UPDATE: NEW APPLICATION SYSTEM -- IRBNeT WIZARD (SMART) APPLICATION

The BSU IRB is pleased to announce that it will be implementing an IRBNET Wizard (SMART) form, an electronic-based application form for new projects. The Wizard application form will replace the current IRB Application form. The Wizard Application form will go live on the IRBNet on July 12, 2021 and will be available for researchers on July 15, 2021. The transition period between the old and new application will last until September 30, 2021. Starting October 1st, only the new application form will be accepted. For more information view the new Wizard Submission Form and IRB Submission Checklist.

COVID-19 INFORMATION FOR HSR

Levels of Review

There are three risk levels at which the IRB reviews research:

  • Exempt (studies posing less than minimal risk)
  • Expedited (studies posing minimal risk)
  • Full Board (studies posing greater than minimal risk)

The amount of potential risk to participants and the participant population determine the type of review. The IRB at Ball State University is the only entity that can determine which kind of review is necessary for your research proposal. 

Since researchers are not able to determine which kind of review is necessary for themselves, we recommend researchers submit their protocols via IRBNet at least one month before the research project will begin. This gives adequate time for review. 

For one-on-one help with research design, be sure to check out BSU's Research Design Studio. The graduate students and faculty there can help you design a sound research project, as well as provide advice on proper qualitative and quantitative methodologies. For one-one-one help with submitting an IRB protocol, visit our office during the graduate assistants' Peer Mentoring hours. 

If you have any questions, please contact Sena Lim, Human Research Protection Program Manager or Sandra Currie, Research Integrity Administrative Coordinator.

Preparing a Proposal

Before submitting your proposal to Ball State University's Institutional Review Board, please make sure you complete the following steps:

  1. Complete CITI Training.
  2. Register on IRBNet.
  3. Review submission deadlines for the Institutional Review Board.
  4. Complete all pieces of the application. This will include the Human Subjects Research Application form, along with any additional relevant documents.
  5. Upload your project to IRBNet.
  6. Share your project with your advisor and team members (if applicable).
  7. The Principal Investigator and Faculty Advisor (if PI is student) must electronically sign off on the project before it is submitted for review.

You can access all documents related to IRB research at the IRBNet Library

About Revisions

Following the initial submission of your protocol, you may be asked to make some revisions before your project will be reviewed. If these pre-review revisions are not made and submitted within 30 days, your project will be withdrawn and must be re-submitted as a new project.

The Office of Research Integrity recommends submitting research proposals at least one month prior to the date when a researcher would like to begin the project. This allows plenty of time for any possible revisions and board discussion.

Please familiarize yourself with the steps to take when submitting a project for IRB review:

  1. Complete the Collaborative Institutional Training Institute (CITI) program.
  2. Register on IRBNet.
  3. Download the IRB application form and all other necessary documents located in “Forms and Templates” on IRBNet.
  4. Upload your finished project by 3 p.m. on the Wednesday before the next meeting for the ORI to pre-review.
  5. Revise project as needed and relock your project by 3 p.m. on the Friday before the next meeting for the IRB to review.

Why you should submit early

Please note that certain times of the year are very busy and we cannot ensure you will receive your pre-review feedback from the ORI in time for you to revise your project by the Friday deadline. Because of this, we highly recommend submitting your project prior to the Wednesday deadline.

The IRB will categorize it based on the amount of potential risk to research subjects. The three categories are:

If an initial review of your project results in an exempt decision, your study will be reviewed on a rolling basis.

Please note that this schedule is subject to revision. Additionally, submitting a protocol by the listed deadline does not guarantee that your protocol will be reviewed on the associated meeting date.

Turnaround time will vary based on protocol volume at the time of submission. Therefore, we strongly encourage that protocols be submitted at least one month prior to the desired review date to allow plenty of time for board discussion and possible revisions.

You must submit your complete proposal two weeks prior to the meeting date.

The following dates are Expedited meetings set for the 2021-2022 academic year (please note that dates are subject to change):

2021-2022 EXPEDITED Meetings
SUBMISSION DEADLINE IRB REVIEW DATE
August 18, 2021 September 1, 2021
August 25, 2021 September 8, 2021
September 1, 2021 September 15, 2021
September 8, 2021 September 22, 2021
September 15, 2021 September 29, 2021
September 22, 2021 October 6, 2021
September 29, 2021 October 13, 2021
October 6, 2021 October 20, 2021
October 13, 2021 October 27, 2021
October 20, 2021 November 3, 2021
October 27, 2021 November 10, 2021
November 3, 2021 November 17, 2021
November 17, 2021
December 1, 2021
November 23, 2021 December 8, 2021
December 1, 2021 December 15, 2021
December 29, 2021 January 12, 2022
January 5, 2022 January 19, 2022
January 12, 2022 January 26, 2022
January 19, 2022 February 2, 2022
January 26, 2022 February 9, 2022
February 2, 2022 February 16, 2022
February 9, 2022 February 23, 2022
February 16, 2022 March 2, 2022
February 23, 2022 March 16, 2022
March 9, 2022 March 23, 2022
March 16, 2022 March 30, 2022
March 23, 2022 April 6, 2022
March 30, 2022 April 13, 2022
April 6, 2022 April 20, 2022
April 13, 2022 April 27, 2022
April 20, 2022 May 4, 2022
May 4, 2022 May 18, 2022
May 18, 2022 June 1, 2022
June 1, 2022 June 15, 2022
June 15, 2022 June 29, 2022
June 22, 2022 July 6, 2022
July 6, 2022 July 20, 2022

*August meetings before the school year starts are held when needed.

Please note that this schedule is subject to revision. Additionally, submitting a protocol by the listed deadline does not guarantee that your protocol will be reviewed on the associated meeting date. Turnaround time will vary based on protocol volume at the time of submission. Therefore, we strongly encourage that protocols be submitted at least one month prior to the desired review date to allow plenty of time for board discussion and possible revisions.

You must submit your complete proposal two weeks prior to the meeting date, no later than 3PM.

The following dates are meetings set for the 2021-2022 school year (please note that dates are subject to change):

2021-2022 FULL BOARD Meetings
IRB REVIEW DATE
SUBMISSION DEADLINE
September 1, 2021
August 18, 2021
October 6, 2021
September 22, 2021
November 3, 2021
October 20, 2021

December 1, 2021

November 17, 2021
January 12, 2022
December 17, 2021
February 2, 2022
January 19, 2022
March 2, 2022
February 16, 2022
April 6, 2022
March 23, 2022
May 4, 2022
April 20, 2022
June 1, 2022
May 18, 2022
July 6, 2022

June 22, 2022

*August scheduled as needed

In support of Ball State University's dedication to the protection of human participants in research, BSU holds a current Federalwide Assurance with the Office of Human Research Protections (OHRP) and has a duly registered Institutional Review Board (IRB).

Our assurance and registration numbers are:

  • FederalWide Assurance: FWA00000797
  • IRB Registration: IRB00001527

Getting Started

The Institutional Review Board (IRB) is a compliance committee responsible for protecting the rights and welfare of individuals who participate as subjects in research conducted by members or affiliates of a given institution (in this case, Ball State University). The IRB is responsible for reviewing and approving all projects (submitted through IRBnet) that involve human subjects. A researcher may not begin working on any research project involving human subjects without IRB approval.

Research, as defined by the federal regulations, is the systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • Systematic investigation – a plan for collecting data consistently and reliably.
  • Generalizable – the impact of the research reaches beyond the research population, adds to a body of knowledge; a common test is whether the researcher plans to present or publish the data in a professional platform.

A human subject is defined as a living individual about whom an investigator (whether faculty or student) obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information.

  • Note: Studies considering deceased individuals do not usually count as HSR. However, they may if information about a deceased individual can identify a living individual and put the living individual at risk.

The Office for Protection from Research Risks provides decision trees to help explain what constitutes HSR.

IRB does not just address experimental protocols. If your study meets the definition of HSR, it must be submitted for IRB review and approval. For more information regarding secondary data use, click here

No; the IRB cannot give retrospective approval for research conducted in the past. IRB approval to conduct research must be obtained prior to any interaction with research subjects. This includes the recruitment of subjects to participate in the research.

If a project is going to be used in the classroom with the intention of teaching research methods, the project may not be considered human subject research. However, this means that at no point during or after the conclusion of the course can the results or data of the class-related project be used for “legitimate” research purposes (i.e., reported in a manuscript or conference presentation). Students should discuss these limitations with their instructor or faculty advisor prior to beginning the project to determine if IRB approval is needed.  To view the policy, click here.

“Exempt” is simply a category of risk. All HSR must be submitted for IRB review and approval regardless of the category of risk it falls into. Consent information will still need to be provided to the participant(s) through a cover letter or verbal script.

Yes. As long as your study meets the definition of Human Subjects Research, it will need BSU IRB approval. Because different locations have different policies and standards of practice, each study will come with its own unique considerations. You may need approval from organizations in the country that your research takes place in as well. Contact our office with any questions particular to your study.

Yes. As a faculty member or student of Ball State, you are legally covered by our IRB. We may agree with another IRB’s determination, but you still need to talk with our office about your project. You will either need a “Institutional Authorization Agreement” or an approval letter from Ball State before you can begin your research. For more information on collaborative studies with non Ball State researchers, click here.

No, journalists are not required to go through the IRB review process because information is not typically being gathered with an eventual goal of being “generalized”. Rather, information is typically gathered to be reported on a very specific person(s), event(s), etc. with the intention of remaining that specific.

No; you may not begin any portion of your research until you have IRB approval. It is important to consider the IRB timeline when building your research schedule to avoid any delays.

Preparing a Submission

Protocols are to be submitted via IRBNet.org.

Learn how to create, modify, and/or submit a study using the new Wizard Submission Guide.

Every protocol submission will look a little different, as necessary materials will be particular to each individual study. The IRB needs to see, hear, or watch anything that your participant will experience from the recruitment process, all the way through to the end of the study. You can expect to be asked to provide the following:

  1. The IRB Human Subjects Application Form (can be found on the Study Designer page within IRBNet from the Forms and Reference Library drop-down menu).
  2. The CITI Completion Certificates of the researcher and any additional key personnel (faculty mentor; any person who interacts with the research subject or the data).
  3. Informed Consent/Assent form(s).
  4. Additionally (if appropriate):
    • All instruments (surveys, questionnaires, test instruments, etc.).
    • A list of interview questions.
    • Letters of permission to conduct the study.
    • Any other documents relevant to the research project.

If a study is determined as exempt, the study will be reviewed on a rolling basis. During the regular academic year, IRB meets weekly to review expedited protocols and monthly to review full-board protocols. Please note that this schedule may be affected by holidays and other occurrences. It is strongly recommended that protocols be submitted at least one month prior to the desired deadline.

Before a protocol can be approved, all researchers and key personnel must complete the required CITI Training modules and provide a Completion Certificate for IRB to have on file.

Learn more about CITI Training.

All IRBNet submissions must be signed by both the student researcher and the faculty advisor before they can be approved. See page 9 of the IRBNet User Manual (PDF) for instructions on how to share a submission, and page 12 for instructions on how to sign a submission. It is also recommended that CITI Completion Certificates of any faculty directly involved in the project be included in the submission package. If the protocol being submitted is a thesis or dissertation, there is no need to include all members of the committee—just those of the faculty who are actively a part of the project.

“Category of risk” refers to the way IRB groups and reviews protocols based on the potential level of risk they may pose to the participants. There are three categories of risk:

  • Exempt: study poses less than minimal risk
  • Expedited: study poses no more than minimal risk
  • Full-board: study poses more than minimal risk

Federally, “minimal risk” is defined as the “probability and magnitude of harm [resulting from participating in a given study] is not greater in and of itself than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” In other words, if participating in a given study will not introduce more risk or danger to the participant than would engaging in regular daily activities or than what would be expected from the given task(s), the study does not pose more than minimal risk.

Informed consent (IC) may be waived under very specific circumstances, such as if a researcher is observing hundreds of people in a busy public area, in which case obtaining IC would be impractical. However, it is extremely important that, whenever possible, research participants have the opportunity to know that they are participating in research and to be able to withdraw participation at any time. To this end, the waiving of the IC requirement is reviewed very carefully on a case-by-case basis.

  • Something that is truly anonymous has no known identity or source. For research data to be considered anonymous, no identifiers of any kind (e.g., name, identification number, code, etc.) are used that can potentially link the data or information to the individual participant who provided it. In other words, the researcher does not know who any of the participants are.
  • Confidential data or information does have identifiers that link individual participants to their private information (this includes pseudonyms, codes, etc.). Researchers have a responsibility to safeguard such data as well as to inform participants of its storage, use, destruction, etc.
  • In the context of research, a “benefit” is something that, through participation, a person gains because it is inherent to (built into) the study. For example, a benefit of participating in a study testing new reading strategies would be that the participant leaves having learned new reading strategies.
  • In the context of research, “compensation” refers to something additional that a person gains by participating in a given study. Examples include money, gift cards, and extra credit for class.

A “conflict of interest” exists “when two or more contradictory interests relate to an activity by an individual or an institution.'' The conflict lies in the situation, not in any behavior or lack of behavior of the individual. A conflict of interest is not intrinsically a bad thing; however it is important that researchers disclose any that may exist.

Learn about conflicts of interest.

People of “special” or “protected” populations are individuals who are especially vulnerable to harm, given present physical/mental conditions, their (in)abilities to give consent, and/or having rights that are different from those of typical adult-aged people. Such populations include:

  • Children/Minors (under age 18 per Indiana law).
  • Prisoners.
  • Pregnant women (depending on the nature of the study).
  • People with diminished capacity to give consent.
  • Mentally or physically challenged individuals.

Please note that these criteria may differ based on the geographical location in which research is being conducted, especially internationally. It is the researcher’s responsibility to learn of and adhere to appropriate laws and ethical guidelines.

The first thing to consider is whether using that particular population is absolutely necessary (i.e., is the study looking at that population for a specific, scientific reason or is the population being used out of convenience?). If it is decided that a special or protected population must be used, be aware that some elements of the study, especially the details of obtaining consent (or assent), will require additional precautions or steps not found in typical protocols per law and ethical policies. Make sure that the protected population under study is the population that will benefit from the research being completed.

Yes, you may provide compensation to your participants. However, things to consider are (but not limited to):

  • Whether the compensation will cause the participants to partake in a study they would otherwise not be comfortable participating in (i.e., coercion).
  • If/how compensation will be affected if the participants do not complete the study (i.e., will partial compensation be awarded for partial study completion?).
  • If the compensation includes extra credit for class, is an alternative option to obtain the extra credit also available?
  • The language by which the compensation is presented (i.e., the avoidance of gambling language such as “drawing”, “enter to win”, etc. per Indiana laws--please clarify that participants have an equal opportunity to receive the compensation).

Contact our office for more information.

Deception is allowed with caution. It is important to remember that deception should only be used if the investigator believes that participants’ knowledge of the study’s true purpose will influence the participant recruitment process or the data that will be collected. A debrief form explaining the study’s true purpose following the conclusion of participation will be required. During the debrief, participants must be given the option to no longer have their data used once they know the true purpose of the study. Any study that involves deception will automatically be reviewed at the Expedited level or higher.

A debriefing from is provided to participants at the conclusion of a study using deception, though it is allowed for any study should the researcher(s) choose to provide one. The form should explain the study’s true purpose, especially the details that the deceptive measures were designed to conceal. Participants should leave the study with a full understanding of what they just experienced. During the debrief, participants must be given the option to no longer have their data used once they know the true purpose of the study.

A debriefing form will be required if a study uses deception. Contact our office for more information.

  • The start date of the project is the anticipated date that the research will begin AFTER IT HAS RECEIVED IRB APPROVAL. The start date should not be a date prior to the approval of the research project by the IRB. A suggestion for the start date is that you indicate "Upon approval of the IRB".
  • The end date is the date that the investigator anticipates completing the research AND the analysis of the data. Because the privacy issues remain until the data analysis is complete or the data have been de-identified, the investigator must maintain the approval of the project until the analysis is complete.

IRB operates on a predetermined schedule. This means that exceptions cannot be made for individual protocols. We strongly encourage that protocols be submitted at least one month prior to the IRB meeting at which you hope your protocol be reviewed.

Frequently, protocols are approved during the initial IRB review. When protocols do not receive approval, however, it is usually because the IRB needs clarification and/or additional information.

Some of the more common issues are listed below.

  • Not following the guidelines for writing the protocol – Bear in mind that some of the members of the IRB may not be familiar with the area of your research. Therefore, the protocol should be written with sufficient clarity and detail that a person with no background in your field would understand the research. Do not assume that "everyone knows that…"
  • Not proofreading the protocol.
  • Missing PI and/or Faculty Sponsor signatures - All new studies and their revisions must be signed by the PI (and their Faculty Sponsor if the PI is a student or not affiliated with Ball State University).
  • Not providing questionnaires (if applicable).
  • Not providing the recruitment materials – including recruitment flyers, posters, advertisements (e.g., for newspapers, radio, television), emails or letters, etc. Make sure all recruitment materials contain your IRBNet number.
  • Not providing the general interview questions (if applicable) – Note, it is understood that follow-up questions are often necessary. Such questions, as long as they remain within the scope of the general topic, often cannot be anticipated and therefore do not need to be included.
  • Not providing the introductory script – i.e., an introductory script (whether read or written) or an introductory letter used to introduce the study and its purpose.
  • Not providing a letter of permission to conduct the research for an institution outside of Ball State – When conducting research at an institution or organization other than Ball State, the investigator must obtain the written permission of the appropriately authorized official from the institution or organization. The permission letter must be on the letterhead of the institution or organization and have the original signature of the authorized official. The majority of problems in a protocol can be detected by proofreading.
  • Not providing a complete informed consent form

If the research is to be conducted at another university or at an institution such as a hospital, the researcher must contact the institution's IRB to determine whether that IRB must review and approve the research.

You will receive an e-mail directly from IRBNet indicating that your study has been approved. Your approval letter can be found on IRBNet. You can check the status of your submission at any time by clicking on “My Projects” on the left-hand menu, followed by “Project History”.

Once a Study Has Been Approved

Unless a change needs to be made immediately for safety reasons (for which a report would need to be made), researchers are to submit a modification/amendment form (Form I) via IRBNet for IRB approval before changes can be made to an already-approved protocol.

If the data collection and analysis of a given study will exceed the original approval period, the researcher will need to request a “Continuing Review” of the project for an additional period (not exceeding twelve months). To maintain the continuous approval of the project, the Continuing Review must be submitted to the IRB in sufficient time (usually one month prior to the expiration date) to allow for the review and approval by the IRB of the Continuing Review.

To report an unexpected problem that has occurred during a study, the researcher will need to complete the Adverse Event form (Form K) via IRBNet within five working days of the event.

Additional Support

You can contact the Office of Research Integrity via phone ((765) 285-5052), email (View Email), or stop by our office in West Quad, room 100.

The Peer Mentoring Program offers researchers the opportunity to meet one-on-one with Office of Research Integrity graduate assistants and solicit whatever assistance is needed.

To set up a phone or in-person appointment with a GA, send us an e-mail at View Email or call our direct GA line at 765-285-5088.

To schedule a training session, please complete a training request form.

Below are direct links to many of our available guides. They, along with many other resources, can also be found within our website.

The Office of Research Integrity has created this resource page to provide additional help and guidance for research using human subjects.

If you are a researcher on a Ball State University project and you are conducting research at Indiana University Health Ball Memorial Hospital, please contact Sena Lim before you submit your application. 

Read Ball State’s IRBNet User Manual (PDF; last updated 2021).

This guide will connect you with Ball State University Libraries resources and services that will help you complete a successful proposal for research projects.

See the guide.

Policies: 

  • To access the Human Research Protection Program Policies and Procedures document, click here or download (PDF).
  • To access the Eligibility of Principal Investigators document, click here or download (PDF). 
  • To access the Faculty Recruitment of Students in Research and Use of FERPA Protected Information document, click here or download
  • (PDF).
  • To access the IRB Review of Class Research Projects document, click here or download (PDF).
  • To access the Recruiting, Recruitment Materials, and Participant Compensation document, click here or download (PDF).
  • To access the Use of Deception in Research document, click here or download (PDF).

Guidance and Guidelines: 

Note: Revised Policies are being added as completed.