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 associated with the university includes 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, surveys of human subjects, or human subjects’ records requires IRB review. IRB approval is required for any research involving human participants that:
- 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;
- involves Indiana Institute of Technology data;
- satisfies a requirement imposed by the university for a degree program or for completion of a course of study, or
- is certified by an institutional official to satisfy an obligation of a faculty appointment at the university, including clinical or adjunct appointments.
How is IRB applicable to class-related projects?
For research done for an undergraduate class as a class project, the instructor should submit an Application for the Review of Human Subjects Research with Dean approval for a course in which students commonly do research (rather than students submitting independently for approval). The instructor assumes full responsibility for monitoring the protection of human subjects, student training, and keeping the project in the bounds of the IRB guidelines.
Undergraduate students doing independent senior theses, undergraduate research studies/projects, graduate students doing a master’s research studies, and similar exercises must independently submit an Application for the Review of Human Subjects Research to the IRB as a student-researcher. Ultimately, the supervising faculty member is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. During the design of a project, the supervising faculty member should instruct students on the ethical conduct of research, help the student prepare the application for IRB approval, and review the application prior to submission. 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 supervising faculty member is required to sign the student’s application for IRB approval and obtain the dean’s signature prior to submission. After IRB approval, the supervising faculty member 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.
Are there criteria for IRB review of a protocol?
Yes, the IRB must address 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, (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 to 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 disable persons, economically disadvantaged persons, or educationally disadvantaged persons;
- Informed Consent: This will be sought from each participant 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, and;
- 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 three types of IRB review which are exemption, expedited review, and 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 six specific categories of research. These will be reviewed administratively. Expedited reviews address protocols presenting no more than minimal risk to subjects and include only procedures described in nine specific categories of research. Expedited reviews are conducted by a limited number of assigned board 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.
When does the IRB meet and when should application packets be submitted to the IRB for review or exemption?
Investigators should review the IRB schedule posted on the IRB web page for meeting dates. Investigators requesting full or expedited review of a protocol should submit an Application for the Review of Human Subjects Research and all attachments to the IRB by the 1st of the month preceding the IRB meeting at which it will be reviewed. If an investigator seeks an expedited or full review during the board’s March meeting, the investigator is required to submit his or her application by March 1st. Applications received after the first day of any given month will be reviewed by the IRB at its meeting held in the following month. For example, if an application is received on March 2nd or later that month, the IRB will review it during its April meeting. Applications that meet the criteria for exemption are accepted throughout the month, and reviewed on a rolling basis and there is no disruption of the exemption review process during the summer.
What is required when a research project cannot be complete by the approved expiration date?
All non-exempt protocols involving human participants must be reviewed by the IRB annually. If any project cannot be completed by the originally approved IRB expiration date, the investigator must complete a renewal application and submit it to the IRB. In order to avoid possible interruption, renewal applications will need to be submitted to the IRB at least two months prior to the original expiration date to avoid the inactivation of the research project. Exempted research does not have expiration dates, so continuing review is not required.
Enrollment of new participants cannot occur on a project if it becomes inactive. In addition, research intervention or interaction with already enrolled subjects must stop if a project becomes inactive. If a protocol becomes inactive, submission of a new Application for the Review of Human Subjects Research 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 the exempted or approved research protocol must be reviewed by the IRB prior to implementation of those changes. Investigators can find the university’s amendment request with the forms posted on the IRB web page. 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 strikethrough; or via the track-changes feature in MSWord). Completed forms should be sent to IRB@IndianaTech.edu. After IRB review, a Notice of Approval or revised Notice of Exemption will be emailed to the investigator. Changes to approved protocols may not be implemented until the change is approved by the IRB. Amendments to non-exempt protocols must be submitted by the 1st of the month for review at that month’s IRB meeting.
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, or; (4) 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.
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 nevertheless 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.
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 university requires that investigators present an informed consent letter in the IRB application in addition to providing a copy to their research participants; however, 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 Tech IRB and the IRB for the outside facility.
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 information posted by the federal Department of Health and Human Services (DHHS). 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 may require that a certificate be obtained.
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?
Tech-affiliated investigators and researchers must supply proof of recognized ethics training with their Application for the Review of Human Subjects Research. You can learn more about training and enroll in relevant courses at CITI. Indiana Tech covers the cost of CITI ethics training, so there is no charge to university-affiliated investigators for CITI courses. A link to CITI training is posted on the IRB web page under the Links tab.
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. You may also contact Indiana Tech’s IRB chairperson at IRB@IndianaTech.edu.