Research Integrity

Human Subject FAQ

Q: What is the IRB?

A: The Institutional Review Board (IRB) is a compliance committee responsible for the protection of the rights and welfare of individuals who participate as subjects in research conducted under the auspices of the Ball State University. The IRB is responsible for reviewing and approving all projects which involve human subjects, which are submitted through IRBnet. A researcher cannot begin working on any research project involving human subjects without IRB approval.

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Q: What constitutes human subject research?

A: As defined by the federal regulations, research 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

• designed – is the intent of the investigation to examine hypothesis or to support a research claim

• 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.

• Living individual – dead people do not usually count; they do count if information about a dead person can identify a living person and put the living person at risk

• Intervention – physical procedures by which data are gathered (e.g. blood or tissue samples) or a manipulation of the subject or the subject's environment preformed for research purposes

• Identifiable private information – may include secondary subject if the identifiable private information can identify a family member or some other person close to the subject

The Office for Protection from Research Risks (OPRR) provides decision trees to help explain what constitutes research with human subjects.

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Q: When am I required to submit a proposal to the IRB for a project involving human subjects?

A: All research that involves human subjects must be submitted to the IRB for review and approval before the investigator can begin the study.

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Q: Do I need IRB approval to begin the collection of data?

A: Yes. You cannot 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.

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Q: Do research projects conducted by Ball State students require IRB approval?

A: If the project meets the definition of “research” and “human subjects” it requires IRB approval. If the project is going to be used in the classroom only to teach 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 be used for research purposes (i.e., reported in a manuscript or conference presentation). Students should discuss these limitations with their instructor or faculty advisor to determine if IRB approval is needed.

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Q. Are there different categories of review?

A. There are three categories of review depending on the amount of risk to the subject:

• Exempt review – Exempt review is a category of review, it does not mean exempt from review. There is essentially no risk to the subject.

• Expedited review – There is minimal risk to the subject.

• Full review – There is more than minimal risk to the subject.

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Q: What constitutes an “exempt” protocol?

A: Research activities in which the only involvement of human subjects will be in one or more specific categories may be exempt from further IRB review once the pre-review has been conducted by a designated member of the IRB. Determination of exemption must be based on regulatory and institutional criteria and documented.

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Q: If my project qualifies as an exempt protocol, does this mean that I don’t have to submit the protocol for review?

A: No. “Exempt review” is a category of review, and does not mean exempt from review. In an exempt study there is essentially no risk to the subject.

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Q. What is minimal risk?

A. According to the federal regulations, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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Q: Can the requirement for a signed consent be waived?

A: Yes. If the research is exempt, the signature requirement for consent may be waived. If expedited or full board then the board would have to decide whether or not to waive the signature requirement, on a case-by-case basis, based on the level of risk to the subject(s). Consent information must still be provided to the subject(s) through a cover letter or verbal script, only the signature portion is waived.

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Q. What should I indicate as the project begin and end dates?

A. The begin date of the project is the anticipated date that the research will begin AFTER IT HAS RECEIVED IRB APPROVAL. The begin date should not be a date prior to the approval of the research project by the IRB. A suggestion for the begin date is that you use "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. If the data collection and analysis will exceed the original approval period, the researcher will need to request a Continuing Review of the project for an additional period as not to exceed 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.

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Q: I don’t know where to start to submit a proposal for review, what needs to be included?

A: If you are creating a new study, you must 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 researcher and all key personnel (the faculty mentor, any person who interacts with the research subject or the data) must have on file with the IRB a copy of the CITI Completion Certificate for the online tutorial before the IRB can approve an application to conduct research.

If appropriate:

1. The consent form

2. All non-standardized instruments (surveys, questionnaires, test instruments, etc.)

3. A list of interview questions

4. Letters of permission to conduct the research

5. Any other documents relevant to the research project

Forms for submitting your proposal can be found in IRBnet under “Forms and Templates” in the “Ball State University IRB Documents for Researchers” library. For additional, more detailed instructions and resources on how to submit your proposal, visit the guidance pages for How to Submit a Research Proposal.

Click here for instructions on how to create, modify, submit, etc. a study.

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Q: What information needs to be included in the Informed Consent document?

A: The Consent Form May be Either of the Following:

A.  A written consent document that embodies the elements of informed consent described in 21 CFR 50.25 and 45 CFR 46.116(a). This form may be read to the subject or the subject's legally authorized representative, but, in any event, the Investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.  The subject must also be given a copy of the signed form.

B.  A "short form" written consent document stating that the elements of informed consent as required above have been presented orally to the subject or the subject's legally authorized representative.  When this method is used, there shall be an impartial witness to the oral presentation.  The IRB must approve a written summary of what is to be said to the subject or representative. The subject or the representative signs only the short form itself.  However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Sample informed consent forms are available in the Study Designer page within IRBNet from the Forms and Reference Library drop-down menu. Click here for a complete list of required and additional elements of the informed consent document.

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Q: How long should it take for my project to be reviewed and approved?

A:The Office of Research Integrity recommends submitting research proposals one month prior to the date when a researcher would like to begin the project to allow plenty of time for board discussion and review.

Projects should be submitted no later than 3:00 P.M. on the Wednesday prior to the board meeting.



If an initial review of your project results in exempt status, the study will be reviewed on a rolling basis. If the initial review of your project results in an expedited or full board decision, your study will be reviewed at the next expedited or full board meeting. The IRB Expedited Committee meetings are held to review and approve protocols once a week during the school year and every two weeks during the summer, and the Full Board meetings are held once a month during the school year and as needed during the summer. The IRB does not meeting during semester breaks or spring break. Projects must be submitted by the deadline in order to be reviewed at the next meeting. Researchers will be notified of the IRB findings within a week of the meeting through an email generated by IRBNet.

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Q. When can I start my research?

A. You can begin your project AFTER IT HAS RECEIVED IRB APPROVAL. You cannot begin collecting data prior to the approval of the research project by the IRB.

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. If the data collection and analysis will exceed the original approval period, the researcher will need to request a Continuing Review of the project for an additional period as not to exceed 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.

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Q. What may delay the review and/or approval of a research protocol?

A. 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 omissions are listed below.

• Not following the guidelines for writing the protocol – The guidelines provide guidance as to the basic information required in the protocol. The application/narrative template and guidelines can be found in the Study Designer page within IRBNet from the Forms and Reference Library drop-down menu. 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 – The majority of problems in a protocol can be detected by proofreading.

• Missing PI and/or Faculty Sponsor signatures - According to the Chair of the IRB, 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) before it is scheduled for review.

• Not providing the questionnaire – If you have developed a questionnaire or a survey (this includes the demographic sheet), you must include this instrument in the protocol for review. If you are using a standardized instrument that is not well known or if there is a possibility that the IRB may not be familiar with the instrument, you should include the instrument with the protocol.

• Not providing the recruitment materials – Any document used to recruit participants for their research must be reviewed by the IRB. This includes recruitment flyers, posters, advertisements (e.g., for newspapers, radio, television, etc.), emails or letters, etc.

• Not providing the general questions used in an interview or focus group – When the research involves interviews with the participants, a list of the general questions that will be used must be included as a part of the protocol. The list of questions is to provide a feel for the direction the interview or focus group will follow. It is understood that follow up questions on the topic 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 in the list of general questions.

• Not providing the introductory script – An introductory script (whether read or written) or an introductory letter used to introduce the study and its purpose must be reviewed by the IRB.

• 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 -sample informed consent forms for adults, parents, and children can be found in the Study Designer page within IRBNet from the Forms and Reference Library drop-down menu. It is important to include all of the required information in the 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.

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Q. Can I get retrospective approval for data collection I have already carried out?

A. 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.

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Q. What is archival data?

A. Archival data are data that were collected in the past, usually for a purpose other than research. The complete data set must exist prior to the initiation of a research project using the data.