IRB / Human Subjects Research FAQs

On this page, you will find answers to some of our most frequently asked questions on getting started, preparing a protocol submission, matters that may apply following IRB approval, and additional resources we have available.

 

Getting started...

  1. What is the IRB?
    1. 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.

  2. What constitutes “research” and “human subject research” (HSR)?
    1. 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.
      1.  Systematic investigation – a plan for collecting data consistently and reliably
      2.  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
    2. 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.
      1. 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.
    3. The Office for Protection from Research Risks provides decision trees to help explain what constitutes HSR.

  3. Do studies being conducted by Ball State student researchers need IRB approval?
    1. Yes. If a study being conducted meets the definition of HSR, it requires IRB review and approval.

  4. Do I need IRB approval even if I am not doing an “experiment”, but am only conducting interviews, surveys, observations, or using secondary or archival data?
    1. IRB does not just address experimental protocols. If your study meets the definition of HSR, it must be submitted for IRB review and approval.

  5. Can I get retrospective approval for data collection I have already done?
    1. 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.

  6. Can “data” initially collected/intended for a class project be turned into a legitimate research study and used in publications, conference presentations, etc.?
    1. 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.

  7. I believe my study falls into the “exempt” category of risk. Does this mean it is exempt from needing IRB approval and obtainment of informed consent?
    1. “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.

  8. My study will be conducted in another state or country. Do I need Ball State IRB approval?
    1. 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.

  9. If I have approval to conduct research using human subjects from another IRB, do I still need approval from Ball State?
    1. 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.

  10. Are journalists required to go through the IRB review process?
    1. 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.

  11. Can I begin data collection before receiving IRB approval?
    1. 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...

  1. Where do I submit my protocol?
    1. Protocols are to be submitted via IRBNet.org. Click here for more information.
    2. Click here for more instructions on how to create, modify, and/or submit a study.

  2. What needs to be included in my protocol submission?
    1. 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):
        1. All instruments (surveys, questionnaires, test instruments, etc.)
        2. A list of interview questions
        3. Letters of permission to conduct the study
        4. Any other documents relevant to the research project
    2. Click here for more information.

  3. When does the IRB meet to review protocols? How far in advance of my desired data collection start date should I submit my protocol for review?
    1. 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. Click here for a detailed schedule of IRB meeting dates, deadlines, and cancellations.

  4. What training do I need to complete before conducting my research?
    1. 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. Click here for more information.

  5. I am a student researcher. What is needed from my faculty advisor/sponsor?
    1. 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 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.

  6. What exactly is meant by the term “category of risk”?
    1. “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:
      1. Exempt: study poses less than minimal risk
      2. Expedited: study poses no more than minimal risk
      3. Full-board: study poses more than minimal risk

  7. What is “minimal risk”?
    1. 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.

  8. Can the requirement for informed consent be waived?
    1. 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.

  9. What is the difference between “anonymity” and “confidentiality”?
    1. 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.
    2. 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.

  10. What is the difference between a “benefit” and “compensation”?
    1. 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.
    2. 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.

  11. What is considered a “conflict of interest”?
    1. 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. Click here to find more information on conflicts of interest as well as related forms.

  12. Who is considered to be of a “special” or “protected” population?
    1. 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:
      1. Children/Minors (under age 18 per Indiana law)
      2. Prisoners
      3. Pregnant women (depending on the nature of the study)
      4. People with diminished capacity to give consent
      5. Mentally or physically challenged individuals
    2. 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.

  13. What are some things to consider when conducting studies using a special or protected population?
    1. 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. Click here for more information.

  14. Can I provide compensation to my participants? What do I need to consider?
    1. Yes, you may provide compensation to your participants. However, things to consider are (but not limited to):
      1. Whether the compensation will cause the participants to partake in a study they would otherwise not be comfortable participating in (i.e., coercion)
      2. 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?)
      3. If the compensation includes extra credit for class, is an alternative option to obtain the extra credit also available?
      4. 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).
    2. Contact our office for more information.

  15. I want to conduct a study using deception. Is this allowed? What do I need to consider?
    1. 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.

  16. What exactly is a debriefing form? How is it different from an informed consent form?
    1. 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.

  17. How do I know if I need a debriefing form?
    1. A debriefing form will be required if a study uses deception. Contact our office for more information.

  18. What should I indicate as my project’s start and end dates?
    1. 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".
    2. 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.

  19. I want my study approved before the next IRB meeting date. Is there a way to speed up the review process?
    1. 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.

  20. What are some common submission issues/errors that I should be sure to avoid?
    1.  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.
      1. 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…"
      2. Not proofreading the protocol
      3. 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)
      4. Not providing questionnaires (if applicable)
      5. 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.
      6. 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.
      7. 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
      8. 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.
      9. Not providing a complete informed consent form
    2. 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.

  21. How will I know when my study has been approved?
    1. 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...

  1. I want to make changes to a study that has already been approved. Does IRB need to approve the changes?
    1. 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.  

  2. What do I do if my study needs continuing review?
    1. 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.

  3. An unexpected problem (adverse event; unanticipated problem) has occurred in my study. What do I do now?
    1. 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...

  1. Who should I contact for additional help?
    1. You can contact the Office of Research Integrity via phone ((765) 285-5052), email (orihelp@bsu.edu), or stop by our office in West Quad, room 100.

  2. What is the peer mentoring program?
    1. 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. More information can be found here.  

  3. How do I request a training session for a class?
    1. To schedule a training session, please complete a training request form.

  4. Are there any guide- or handbooks I can reference?
    1. Below are direct links to many of our available guides. They, along with many other resources, can also be found within our website.
      1. Handbook for Researchers
      2. CITI Program User Manual
      3. IRBNet User Manual
      4. Graduate Student Research Handbook
      5. 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.