Why does Indiana Tech have an institutional review board?
Since there are legal implications for failing to protect subjects that can affect the investigator and the university, oversight by an institutional review board (IRB) is required to ensure that research projects that are university-affiliated include appropriate safeguards to protect human subjects. Federal regulations 45 CFR 46 and 21 CFR describe the protections that form the basis for our policy.
Who needs to get IRB approval?
Any university-affiliated research that uses humans, human tissue, or surveys of human subjects require IRB review. IRB approval is required for any research involving human participants that includes one or more of the following:
- is conducted by university faculty, staff, or students;
- is performed on the premises of the university;
- is performed with or involves the use of facilities or equipment belonging to the university;
- involves university students, staff, or faculty;
- satisfies a requirement imposed by the university for a degree program or for completion of a course of study;
- and/or is certified by an institutional official to satisfy an obligation of a faculty appointment at the university, including clinical or adjunct appointments.
Who submits the IRB application?
Undergraduate students doing an independent senior thesis and undergraduate research studies/projects (including projects/studies for a course) must submit an Application for IRB Approval to the IRB as a co-investigator. Similarly, master’s students doing a master’s thesis or research studies/projects (including projects/studies for a course) must independently submit an Application for IRB Approval to the IRB as a co-investigator. The instructor (or supervising faculty) should be listed as the principal investigator. Students should complete the application, save it, and send the link to the instructor (or supervising faculty) to review and approve before submission. The instructor (or supervising faculty) assumes full responsibility for monitoring the protection of human subjects, student training, and keeping the project in the confines of the IRB guidelines. In particular, students should
- understand the elements of informed consent;
- develop a readable, user-friendly consent form;
- plan appropriate recruitment strategies for identifying subjects;
- establish and maintain strict guidelines for protecting anonymity and confidentiality;
- and allow sufficient time for IRB review and completion of the project.
As assurance that the university’s guidelines will be followed, the instructor (or supervising faculty) is required to sign the student’s application for IRB approval as the principal investigator. After IRB approval, the instructor (or supervising faculty) should take an active role to ensure that projects are in accordance with the IRB’s requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.
Doctoral students doing research for a dissertation or studies/projects (including projects/studies for a course) must independently submit an Application for IRB Approval to the IRB as the principal investigator. These students may list supervising faculty (or committee members) as the co-investigator(s). The doctoral student assumes full responsibility for monitoring the protection of human subjects, training, and keeping the project in the confines of the IRB guidelines.
Are there criteria for IRB review of a protocol?
Yes, the IRB must address all of the following:
- Minimization of Risk: Risks to participants are minimized (a) by using procedures that are consistent with sound research design and do not unnecessarily expose participants to risk and whenever appropriate and/or (b) by using procedures already being performed on the participants for diagnostic or treatment purposes. Additional safeguards must be included to protect the rights and welfare of participants who may be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally-disabled persons, economically-disadvantaged persons, and educationally-disadvantaged persons.
- Reasonable Risk-to-Benefits: The risks to participants are reasonable in relation to anticipated benefits and the importance of the knowledge that can be expected as a result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may, reasonably, result from the research itself. The IRB should not consider potential long-range effects of applying the knowledge obtained in the research.
- Equitable Subject Selection: The IRB should take into account the purposes of the research and the setting in which the research will be conducted. It should be particularly mindful of the special problems associated with involving vulnerable populations. These populations include children, prisoners, pregnant women, mentally-disabled persons, economically-disadvantaged persons, or educationally-disadvantaged persons.
- Informed Consent: This will be sought from each participant (and organizational representative) or their legally authorized representative, in accordance with, and to the extent required by §46.116 and documented, in accordance with, and to the extent required by §46.117;
- Monitoring: The research plan makes adequate provision for monitoring the data collected to ensure the welfare and safety of participants.
- Confidentiality: There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
Are there different types of IRB review?
Yes, there are panel reviews and full board reviews. Each type of review depends on the status of exemption, the need for an expedited review, or the need for a full review.
What are the differences among exemption, expedited review, and full review?
Exemption involves protocols that present extremely low levels of risk to participants and include only procedures described in the Exempt Categories of research. These will be reviewed by a panel of IRB members. Expedited reviews address protocols presenting no more than minimal risk to subjects and include only procedures described in the Expedited Categories of research. Expedited reviews are conducted by a panel of IRB members. Full reviews are conducted by the entire IRB and address protocols that do not meet the criteria for either an exemption or expedited review.
What are the differences between a panel review and a full board review?
A panel review occurs when the research is deemed exempt or expedited. A panel consists of three IRB members, and there are three panels on Indiana Tech’s IRB. The panels review applications on a rotation and must unanimously approve an application. A full board review is necessary for applications that are neither exempt or expedited. A quorum of members meet to discuss the application, and a majority vote must determine an approval of the application.
What is required when a research project cannot be completed by the approved expiration date?
Once an approval has been rendered, research must be completed within a 12-month period. If a project cannot be completed by the originally approved IRB expiration date, the investigator must complete a Post-Approval Change Form. In order to avoid possible interruption, renewal applications will need to be submitted to the IRB at least one month prior to the original expiration date to avoid the expiration of the research project.
Enrollment of new participants cannot occur on a project if it expires. In addition, research intervention or interaction with already enrolled subjects must stop if a project is expired. If a protocol expires, submission of a new Application for IRB Approval will be required.
When an investigator changes a protocol after it has been approved, what needs to be done to obtain IRB approval of any change?
Any changes to research protocol must be reviewed by the IRB prior to implementation of those changes. Investigators can submit an amendment to research protocol by submitting a Post-Approval Change Form. This form requires a description of the change or addition, rationale for the modification, unmarked copy of new documents (e.g., consent form, study instrument, advertisement), and the revised documents (noting all changes by bolding additions and deletions via strike through; or via the track-changes feature in MSWord). After IRB review, a decision regarding the changes will be emailed to the investigator. Changes to approved protocols may not be implemented until the change is approved by the IRB.
If an adverse or unexpected event occurs on an approved protocol, what is an investigator required to do?
An adverse or unexpected event is considered to be (1) any medical, psychological, or behavioral event that is undesirable and unintended although not necessarily unexpected; (2) an event in which the outcome is fatal or life threatening, causes permanent disability, causes hospitalization or prolongation of hospitalization; (3) an overdose; (4) or a complaint by a research subject or family member of a research subject concerning the research or the protocol. If an adverse or unexpected event occurs on an approved protocol, the investigator is required to submit an Adverse or Unexpected Event Report to the IRB in a timely manner. Investigators must notify the IRB of adverse or unexpected events within 48 hours of the event.
How is minimal risk defined?
Minimal risk occurs when the probability and magnitude of harm or discomfort is not anticipated to be greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or test [Federal Policy 45 CFR 46.102(i)]. However, the definition of minimal risk for research involving prisoners differs from that given for non-institutionalized adults. When prisoners are participants in research, minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
What does informed consent mean?
Informed consent is one of the primary ethical requirements underpinning research with human subjects, reflecting the basic principle of respect for persons. Informed consent is an ongoing process — not a piece of paper or at specific moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate at any time. The prospective subject should be presented with the information, given an opportunity to ask questions and have them answered, prior to signing the consent document.
Are there different types of informed consent?
Yes, there are different types of informed consent for quantitative research, qualitative research, and organizations. Quantitative research does not require participants to read and sign a form for consent. However, investigators must provide consent language on recruiting materials as well as at the beginning of the questionnaire that is distributed to participants.
Qualitative research, on the other hand, must include a form that is signed by the participants. This informed consent provides details on the study, risks to participants, and consent language. See the Individual Informed Consent form as a template to use for informed consent in qualitative research.
Indiana Tech’s IRB requires that investigators obtain consent of an organizational representative in addition to participants’ informed consent when the investigator intends to conduct research at that specific location. This organizational informed consent should provide details on the study, risks to participants, and consent language. The organizational representative must include a supervisor or officer who has the authority to give the investigator permission to conduct his/her research at the location. See the Organization Informed Consent form as a template to use for informed consent when conducting research at a specific location. It is important to remember, though, that the investigator must also obtain individual informed consent from the participants even though the organization has given consent to the research.
What is the definition of assent?
Assent is defined as, “A child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent” [45 CFR 46.402(b)]. While children may be legally incapable of giving informed consent, they may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research (1) does not involve interventions likely to be of benefit to the subjects and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol, depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects, whether all or some of the children are capable of assenting to participation. Where appropriate, the IRB may choose to review whether assent should be sought from given individual subjects on a case-by-case basis. Investigators seeking assent from children should obtain permission from the parent(s) and/or guardian(s) as well as use the assent forms below for the appropriate ages:
- Parent/Guardian Permission Form
- Assent Form for Children Ages 7-12
- Assent Form for Children Ages 13-17
Can informed consent be waived?
Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. Otherwise, written informed consent must be obtained. Written documentation of informed consent may be waived if the IRB finds and documents either (1) that signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality or (2) that the research presents no more than minimal risk and involves procedures for which consent wouldn’t normally be obtained outside of the research context. In these cases, the IRB requires that investigators present a Waiver of Informed Consent in the IRB application. However, the IRB also requires that investigators include an individual informed consent form in the IRB application that will be distributed and read to the research participants; this letter will not need to be signed by the participants.
You may review the applicable federal regulation at 45 CFR 46.116 for additional information.
For collaborative research at outside facilities, is IRB approval from both Indiana Tech and the IRB of the outside facility required?
Yes, investigators who propose to conduct research at an outside facility must submit documentation to both Indiana Tech’s IRB and the IRB for the outside facility.
What if research is taking place in the military?
The U.S. military has specific guidelines that investigators must follow when conducting research in DoD-sponsored organizations. Indiana Tech’s IRB adheres to the guidelines issued by the military and follows all protocols outlined by this organization. For more information on research being conducted in the military, please review the DoD Instruction on the protection of human subjects and adherence to ethical standards in DoD-supported research.
What if the research requires deception and/or manipulation?
A research project may require deception and/or manipulation of the participants because 1) the participants may deliberately behave to provide the results that they think the researcher wants and/or 2) the participants may deliberately behave to provide the opposite results that they think the researcher wants. Either way, the researcher will not obtain a clear result that reflects everyday life. In situations that require deception and/or manipulation, the researcher must debrief every participant at the conclusion of the study prior to data analysis. Using the Debriefing Form, researchers must follow these guidelines when deception and/or manipulation occurs:
- The researcher must present and explain the complete research purpose, the deception that was used, and why the deception was necessary before the participants leave the researcher’s presence.
- The researcher must obtain the participants’ signatures, agreeing that they were debriefed of the study.
- All participants must agree to have their data included in the study after being debriefed by signing the form. If they do not want their data included in the study, their data cannot be included.
- There cannot be a “passive re-consent,” which means that a researcher cannot use the participant’s data if a definite response is not obtained.
When is a Certificate of Confidentiality required?
A Certificate of Confidentiality is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the Certificate of Confidentiality information on the federal Department of Health and Human Services (DHHS) page. Investigators who are considering submitting an application for a Certificate of Confidentiality should plan in advance since the process can be lengthy. If participation in research is likely to place an individual at risk of criminal liability, the IRB will require that a certificate be obtained and included as an attachment in the IRB application.
Is training required in order to receive approval and, if so, where can I take certified training that would enable me to conduct research with human subjects?
As of January 1, 2020, all investigators must obtain a CITI certification for research ethics and compliance training. This certificate must be included as an attachment in the Application for IRB Approval. All Indiana Tech students, faculty, and staff may obtain the CITI Institutional Training free of charge through the Let Me In one-click apps.
When identifying the specific course to take to obtain the required certification, select “Biomedical Researchers” or “Social-Behavioral-Educational Researchers” under Question 1. Researchers can ignore Question 2 but may opt to take additional courses under Questions 3-8. However, the IRB only requires that researchers complete a training from Question 1. For more guidance on courses, please email IRB@IndianaTech.edu.
Where can I learn more about human subject research?
For additional information on human subject research, links are posted under the Links tab at the IRB web page. Additionally, the forms necessary for IRB applications can be found on the Procedures and Forms tab at the IRB web page. You may also contact Indiana Tech’s IRB directly at IRB@IndianaTech.edu.