Human Subject Participation

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 2020-2021 academic year (please note that dates are subject to change):

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 2020-2021 school year (please note that dates are subject to change):

You might need a reliance agreement.

Do you want all the institutions to review your project individually?

• Yes: If you want all institutions to review the project independently of each other, please mark this on your application. No agreement is required. Please not that you CANNOT do this with federally funded research.
• No: You want one institution to review the project and others to abide by their decision. Do you want Ball State to review the project?
• Yes: Submit to Ball State as normal. Email Sena Lim so that she can reach out to the cooperating institution to document the agreement.
• No: Apply with the other institution’s IRB. Give the other institution Sena Lim’s contact information and advise them to reach out to her. Please notify Sena to expect an email from the other institution's IRB about your project.

You will need an individual investigator agreement. Please download it from IRBNet (Form X) and provide documentation of the researcher’s applicable training in the protection of human subjects.

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.

Yes. If a study being conducted meets the definition of HSR, it requires IRB review and approval.

IRB does not just address experimental protocols. If your study meets the definition of HSR, it must be submitted for IRB review and approval.

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.

“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.

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.

Protocols are to be submitted via IRBNet.org.

Learn how to create, modify, and/or submit a study.

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”.

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.

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.

• Handbook for Researchers (PDF)
• CITI Program User Manual (PDF)
• IRBNet User Manual (PDF)
• Graduate Student Research Handbook (PDF)
• Forms pertaining to protocol submissions and other actions can be found on IRBnet under “Forms and Templates” in the “Ball State University IRB Documents for Researchers” library.

If you are a researcher on a Ball State University project and you are conducting research at Indiana University Health Ball Memorial Hospital, you will need to have your proposal approved by two separate IRBs.

First, fulfill all the steps needed for approval from Ball State University's IRB.

Second, fulfill all the steps needed for approval from Indiana University Health Ball Memorial Hospital's IRB.

Read Ball State’s IRBNet User Manual (PDF).

Check out Ball State’s Research Design Studio.

Some research may involve protected population groups.

This includes people who are:

• prisoners
• minors (younger than 18)
• experiencing diminished capacity
• mentally or physically challenged
• pregnant (particularly for those projects where physical procedures, exercises, etc., will be performed).

The IRB must ensure the research involving these population groups is ethical and legal.

Additional information is available at the US Department of Health and Human Services' Vulnerable Populations page and in this "Research Involving Vulnerable Populations" video.

Using social media in research can be a cost-effective and rapid method to gather project data. However, there are several issues you must consider before proposing to use social media in a research project. Remember, all projects, no matter how data are collected, must adhere to the legal and ethical guidelines governing research with human subjects.

The links on this page are included for researcher information purposes only. These links direct users to the privacy policy pages of commonly used social networking sites. This is not intended to be a comprehensive list. The BSU IRB does not specifically endorse any of these sites nor recommend any one over another for use. Researchers need to review each of the policies, terms of service (TOS)/terms of use (TOU) for each social media site they are considering using for human subjects research (HSR).

Social Media Platform and Online Survey Sites

Are you collecting data from a specific social media platform (such as Facebook, Twitter, etc.)? You must review the terms and conditions and user agreements. You need to determine whether or not you are allowed to use the platform to conduct research.

The links on this page are included for research purposes only and direct users to the privacy policy pages of commonly used social networking sites. This is not intended to be a comprehensive list.

• Facebook - terms and privacy policy
• Skype - terms of use and privacy policy
• Twitter - terms of service and privacy policy
• Reddit - user agreement and privacy policy
• LinkedIn - user agreement and privacy policy

The following are Online Survey Sites that you may want to use to conduct online surveys. The advantage of using Qualtrics over other third-party vendors is that the university has a contract with Qualtrics that ensures survey information is secure. Using other third-party vendors may result in your survey information being used for other purposes without your knowledge. Please read the terms of use and privacy policies carefully:

• Qualtrics - terms of service and privacy statement
• Amazon Mechanical Turk - user agreement and privacy policy
• Survey Monkey - terms of use and privacy policy

Data Storage

While you may be collecting and analyzing data for a short time, data might be stored for a much longer time period on a server somewhere far removed from you.

Data Access

Using social media means you may have less control over the anonymity or confidentiality of the data. Have you minimized risks to your research participants? Have you determined whether the social media content should be considered public or private? Will someone else be able to view your data without your knowledge? Will any data mining occur?

Presenting Your Findings

Using direct quotations, even when author identification is removed, can lead to a breach of confidentiality or anonymity. Online searching for a specific phrase could mean your subjects are re-identified much more easily than you anticipated.

Interaction with Online Communities

Discussion boards, blogs, and online social networks of friends or associates are all forms of online communities. Your research project may involve collecting social media data passively or you may be asking people to answer specific questions. In either case, you want to be sure to interact with online communities the same way you interact with an offline community.

Beneficence, Respect for persons, and Justice

All projects, no matter how data are collected, must adhere to the legal and ethical guidelines governing research with human subjects.

The Office for Human Research Protections (OHRP), Health and Human Services (HHS) has compiled a summary of the relevant regulatory requirements and guidance issued routinely over the past several years. OHRP has not developed a model written IRB procedures document for institutions to adapt because procedures appropriately can vary significantly among institutions as the result of differences in institution size, the type of research activities, institutional administrative practices, number of IRBs, and local and state laws and regulations. For each required element, the written IRB procedures should provide sufficient step-by-step operational details so that an independent observer can understand how an IRB operates and conducts its major functions.

Pursuant to guidance from OHRP, HHS regulations at 45 CFR 46.103(b)(4) and (5) require that institutions have written IRB procedures for each of the following areas:

1. the procedures which the IRB will follow for conducting its initial review of research;
2. the procedures which the IRB will follow for conducting its continuing review of research;
3. the procedures which the IRB will follow for reporting its findings and actions to investigators and the institution;
4. the procedures which the IRB will follow for determining which projects require review more often than annually;
5. the procedures which the IRB will follow for determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review;
6. the procedures which the IRB will follow for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject; and
7. the procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, any Department or Agency head, and OHRP of:
• any unanticipated problems involving risks to subjects or others;
• any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB; and
• any suspension or termination of IRB approval

Our IRB updated their Standard Operating Procedures in January, 2019. Download the SOP (Word).

Questions regarding these SOPs may be made of the Director of Research Integrity at 765-285-5070. For more information on IRB and human subject regulatory requirements, visit the Office for Human Research Protections.

Your application is an important piece of any research proposal and is required for all protocols. We created this guide to provide helpful tips on preparing an application for those researchers working with human subjects. All protocol submissions must be submitted using the Human Subjects Research Application and Protocol Form. This form can be found on IRBNet in the Document Library.

Remember to be as complete as possible when filling out the Human Subjects Research Application Form. The information provided for each section should be complete and should not refer to another section of the protocol.

Your application should be written for a general audience so that anyone without a working knowledge of your field of research can understand what you are researching and how you plan to complete your research project.

Purpose of the Study

State the objectives of the research, and, when appropriate, any hypothesis you have developed for the research.

Rationale

Explain the need for your research. Describe the data that the project is expected to provide and how the data will contribute to existing information in the field. Provide a concise description of the previous work in the field.

References and Citations

List all references and/or citations on which you will base your research in the 'Research References/Citations' section of the IRB Human Subjects Research Application and Protocol form. All forms are available through IRBNet.

Are references cited according to a standard format? (APA, MLA, etc.)

Methods and Procedures

Describe the methods and procedures to be used in your study. Describe the study design and all activities in which the subject(s) will be asked to participate. Be sure to include a complete description of "the who, what, when, where, and how" of the study design. For example, if you are administering a survey, how will the survey be returned to the researcher? If your research does involve a survey, questionnaire, or interview, include these documents as an attachment in IRBNet.

Some questions to consider:

• How will your data be returned to you?
• Are these sent in the mail or electronically?
• Is the data anonymous or confidential?
• Direct interviews or observations?
• Is your writing clear and concise?

Other forms and Documents

List all attachments related to or referenced in this section of the Human Subject Research Application and Narrative form. In addition to this list, make sure to upload all attachments to your protocol in IRBNet.

Some questions to consider:

Have you included all attachments, including introductory letters, informed consent forms, survey/questionnaires, and any other documents that you discussed in either within the application form or elsewhere in your package?

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.

Read the procedure (PDF).