Institutional Review Board (IRB)

Number:

4.15

Policy Name:

Institutional Review Board (IRB)

Sponsor:

Dr. Christine Kelly-Kleese
Vice President, Chief Strategy Officer
(Revision)

Dr. Melanie Riester
Director, Institutional Research and Evaluation

Custodian:

Strategy

Effective Date:

June 8, 2021; July 7, 2021 (Revision);
March 4, 2022 (Revision); July 8, 2022 (Revision);
August 1, 2022 (Revision)

Last Reviewed:

2022-2023

Location:

durhamtech.edu/policies-and-procedures/institutional-review-board

Citations:

45 CFR 46 (Protection of Human Subjects Policy)
The Belmont Report
The Nuremberg Code

 

Policy Statement

Durham Technical Community College is committed to ensuring that all research involving human participants follows the ethical principles and requirements set forth in the federal Protection of Human Subjects policy (45 CFR 46), the Belmont Report, and the Nuremberg Code.

Contact Information

IRB@durhamtech.edu

Procedure

Durham Technical Community College (Durham Tech) encourages and supports the scholarly endeavors of its students and employees, as well as other educational institutions and reputable community organizations. The pursuit of scholarly work and research sometimes involves human subject participation where subjects’ data is collected and analyzed. When research conducted involves human subjects, it is necessary to ensure that the rights and welfare of the subjects are considered and protected; that risks have been considered and minimized; that the potential for benefit has been identified and maximized; that all subjects only volunteer to participate in research after being provided with legally effective informed consent; and that any research is conducted in an ethical manner and in compliance with established standards. Individuals under the age of eighteen (18) are unable to give informed consent and cannot participate in human subjects research without the consent of a parent or legal guardian.

To support these principles, Durham Tech has established an Institutional Review Board (IRB), a specially formed review body established to protect the welfare of human subjects in research. Durham Tech’s IRB reports to the Vice President, Chief Academic Officer (Chief Academic Officer), who serves as the Institutional Official and appoints the IRB Chair and the IRB Administrator. The Chief Academic Officer ensures the provision of sufficient resources and personnel in accordance with 45 CFR 46.103(b). 

Authority of the IRB

The IRB will begin accepting research proposals in Fall 2022. The IRB will review all research proposals and will determine whether the study is human subjects research and whether the proposal should undergo Exempt Review, Expedited Review, or Full Board Review. If a study does not meet the federal definition of human subjects research as outlined in 45 CFR 46.102, the IRB will confirm this designation in writing, and no additional IRB oversight will be required. 

The IRB will determine the risk level of a study as minimal risk or greater than minimal risk. A study is considered minimal risk if the probability and magnitude of harm or discomfort anticipated in the research is no greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Researchers may provide their own description of perceived risk factors. However, the final determination of risk level is made by the IRB.

Studies found to meet the federal definition of human subjects research will be subject to one of the following types of IRB review:

  • Exempt Review – A review conducted by one reviewer, typically the IRB Chair or their designee, rather than by the full IRB. Please Note: There are six (6) categories of minimal risk research that are exempt from federal oversight: education research; surveys, interviews, educational tests, and public observations that do not include children; benign behavioral interventions; analysis of previously collected, identifiable information; federal research projects; and taste and food evaluation studies. These categories are not exempt from review by Durham Tech’s IRB. 
     
  • Expedited Review – A review conducted by the IRB Chair or their designee rather than by the full IRB; or 
     
  • Full Board Review – A review conducted during a convened meeting with a majority of the IRB membership present, with at least one member whose primary concerns are in nonscientific areas.

The IRB has the authority to review and approve, require modifications to, or deny research covered by 45 CFR 46. In accordance with 45 CFR 46.112, research approved by the IRB may be subject to additional review by College officials. These officials may approve or disapprove the research after an IRB approval, but they may not approve the research if it was first disapproved by the IRB. In accordance with 45 CFR 46.113, the IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with IRB requirements or that has resulted in unanticipated harm to subjects. 

Institutional Research and Course-Based Projects

To meet the definition of research with human subjects and require IRB review, the research must meet the federal definitions of “research” and “human subjects”:

  • Research – A systematic investigation designed to develop or contribute to generalizable (widely applicable) knowledge
     
  • Human Subjects – Living individuals about whom an investigator (whether professional or student) conducting research:
    • Obtains information or biospecimens through intervention or interaction with the individuals, and uses, studies, or analyzes the information or biospecimens; or
       
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following types of institutional research do not require IRB review unless the data are intended for publication or to contribute to generalizable knowledge:

  • Internal research to evaluate institutional programs or determine institutional effectiveness; 
     
  • Data collection and analysis for accreditation purposes; and 
     
  • Course and instructor evaluations. 

All dissertation research must be submitted to the IRB for review.

Classroom Research

Durham Tech students working on course projects that are solely pedagogical and not designed to contribute to generalizable knowledge are not required to submit to the IRB as these projects are not considered research proposals. Classroom research is outside of the federal definition of human subjects research. As such, classroom research projects do not require formal IRB approval and thus may be presented at local, state, national, or international conferences; published; or used for thesis/dissertation projects. If a student wishes to present or publish the work in the future, the student, with faculty assistance, should seek prior approval from the IRB. 

Classroom research must be supervised by a faculty member; may not include research subjects under the age of eighteen (18); and must not involve sensitive, personal, or incriminating topics. Employees who teach research methods and/or oversee student research projects are expected to: 

  • Understand the philosophy, ethics, and practice of protecting human subjects in research; 
     
  • Adhere to these principles during the conduction and supervision of classroom research projects; and 
     
  • Teach these practices and principles to students.
     

Unsupported Research

The following types of research proposals will not be supported or approved by the IRB:

  • Research involving human subjects that is not in accordance with the ethical principles and requirements set forth in 45 CFR 46, The Belmont Report, and The Nuremberg Code;
     
  • Research consisting of the implementation of behavioral, clinical, or medical interventions designed to alleviate a medical or mental health symptom or illness, if the researcher does not have a clinical license and does not have supervised training in patient care;
    • If a researcher has a clinical license, the proposal can be considered for approval provided adequate safeguards, as determined by the IRB, are in place to protect participants;
       
    • If a researcher does not have a clinical license but the researcher has completed an adequate number of supervised hours with a relevant clinical population, the proposal can be considered for approval provided adequate safeguards, as determined by the IRB, are in place to protect participants. The IRB may require a licensed clinician to be present on-site or to perform the clinical interactions with participants;
       
  • U.S. Food and Drug Administration (FDA) studies (e.g., studies related to medical devices, drugs, and food testing);
     
  • Research conducted with fetuses or neonates (i.e., newborn children);
     
  • Research conducted with minors, of greater than minimal risk, with no potential for direct benefit to the minor;
     
  • Research conducted with pregnant women, if it involves greater than minimal risk or unknown risk to the participant or fetus.
     

Researcher Responsibilities

Researchers are responsible for the following:

  • Researchers must comply with this policy and any other applicable College policies, procedures, and guidelines.
     
  • Researchers must complete the Durham Tech required training modules. These modules review rules, regulations, and the ethical practice of research. Researchers must ensure that every required and completed module within the course is current (not more than two (2) years old) for research submitted to the IRB for approval. The IRB may require specific modules relevant to the research topic. 
     
  • Researchers must submit the current Durham Tech IRB application. The IRB will return without review applications that are outdated or otherwise improperly submitted. Researchers may, without prior approval of the IRB, make changes to an approved application when necessary to eliminate apparent immediate hazards to the human subjects.
     
  • Researchers may not obtain data for the purpose of conducting research without IRB review and approval. Researchers may not access identifiable private or legally protected information unless the IRB has approved a process to obtain appropriate authorization from each participant. Researchers must provide evidence to the IRB that the information will be obtained in compliance with all applicable local, state, and federal laws; policies; and regulations related to the privacy and confidentiality of legally protected information.
     
  • Researchers may not contact potential participants about the research prior to IRB approval. For example, researchers may not advertise the study, may not discuss possible future interest with participants, and may not ask a third party to perform either of these actions on their behalf.
     
  • Researchers may not conduct pilot tests without IRB approval. A pilot test involves data collection from human subjects; therefore, researchers must have prior IRB approval. Researchers may conduct expert reviews of questions (or field tests) prior to IRB approval. In an expert review or field test, the researcher can ask for feedback on the clarity or applicability of data collection instruments or interview questions, but the researcher cannot ask individuals to complete the instrument or answer interview questions. If any data will be collected, even if those data will not be used in the final analyses, the study is considered a pilot test, and the IRB must review and approve the research before it begins.
     
  • Researchers may not perform any procedure, intervention, or data collection for future research purposes and then retroactively deem those data archival and not in need of appropriate participant safeguards (including consent).
     
  • Researchers must submit an IRB application if they intend to change or modify an approved application. The modification request must be approved by the IRB before any changes are implemented. Researchers must contact the IRB at IRB@durhamtech.edu to report any injuries, problems, or complaints from participants within twenty-four (24) hours of occurrence.
     
  • Researchers must fully disclose dual roles with sites or participants in their research application.  This information is required for adequate risk assessment. When performing research with participants who live outside of the United States, it is the researcher’s responsibility to know and comply with local laws, research regulations, and requirements to obtain approval from the appropriate in-country ethics board. The IRB may request additional documentation as evidence of adequate compliance.
     
  • The IRB will only approve the inclusion of Durham Tech employees, students, and alumni as research participants if the population of interest is Durham Tech itself (not online learning in general, for example). The focus must be on an internal process, and the researcher must be a Durham Tech employee who has been granted written permission by an appropriate College official. Even when these criteria are met, the IRB reserves the right to require adherence to additional guidelines to ensure participants are protected. Furthermore, even with written permission from a College official, employees must contact the IRB before initiating their research.
     
  • Researchers must submit an updated IRB application for continuing review of an approved protocol if they intend to continue recruitment and/or data collection beyond the approved expiration date. The updated application must be submitted prior to the expiration date noted in the initial IRB approval letter. If the IRB has not approved the continuing review by the approved expiration date, the researcher must confirm in writing that all study procedures have ceased and must document their understanding that study procedures may not resume until the IRB has completed the continuing review, approved the application and extension, and provided a new expiration date.
     
  • Researchers must submit an IRB study closure form as soon as data collection is complete, all participant contact has ceased, and identifiers have been removed or separated from the data set.
     

IRB Administrator Responsibilities

The IRB Administrator is responsible for the following:

IRB Chair Responsibilities

The IRB Chair is responsible for the following:

  • Compliance with all College policies and procedures;
     
  • Scheduling and facilitating meetings of the Full Board;
     
  • Overseeing the recording and maintenance of Full Board meeting minutes;
     
  • Collaborating with the IRB Administrator to communicate Full Board determinations to researchers;
     
  • Coordinating review of resubmissions to verify conditions are met when the Full Board’s determination is “approval with conditions”; and
     
  • Assisting with the expedited review of minor modifications to studies previously approved by the Full Board in accordance with IRB SOPs.
     
  • Communicate IRB determinations to the Chief Academic Officer.

The IRB Chair is also responsible for meeting the expectations set forth for all IRB members.

IRB Member Responsibilities

IRB members are responsible for the following:

  • Compliance with all College policies and procedures;
     
  • Maintaining awareness of community attitudes and promoting respect for the IRB’s advice and counsel in safeguarding the rights and welfare of human subjects;
     
  • Possessing professional competence in research, except in the case of non-scientist member(s);
     
  • Remaining knowledgeable about institutional commitments and regulations, applicable laws, and standards of professional conduct and practice;
     
  • Recusing themselves from the initial or continuing review of any project in which there is a conflict of interest, except to provide information as requested by the IRB;
     
  • Maintaining working knowledge of 45 CFR 46 and approving studies only when requirements are met; and
     
  • Ensuring that their required, elective, and supplemental training modules are current (not more than two (2) years old).
     

Employee Responsibilities

Durham Tech employees are responsible for complying with College policies and procedures and ensuring that all student research projects are conducted in accordance with federal regulations and principles regarding the protection of human subjects in research. Employees involved with designing course projects related to research are strongly encouraged to contact the IRB to verify that the projects do not require IRB oversight.

Faculty members who are supervising research are responsible for the following:

  • Ensuring that required, elective, and supplemental training modules that apply to their own research or research they supervise are current (not more than two (2) years old);
     
  • Reviewing students’ IRB applications for clarity and accuracy;
     
  • Emphasizing student awareness of, and compliance with, all aspects of this policy; and
     
  • Reviewing and signing students’ IRB applications and attesting to awareness of their supervisory responsibilities.
     

Appeals Process

If a researcher believes that an IRB requirement is unduly restrictive and will greatly interfere with the feasibility of their research, the researcher should first informally discuss their concern with the IRB Administrator. If an informal resolution cannot be reached, the researcher should submit a formal appeal letter to the IRB Administrator. The formal appeal letter must detail the rationale for the researcher’s concerns and offer support for proposed alternatives by referencing applicable policies and federal regulations. Appeals of expedited and exempt reviews will be reviewed and decided upon by the IRB Chair. Appeals of Full Board reviews will be reviewed by the Full Board and decided upon by a majority vote of the Full Board. IRB appeal determinations are final and are not subject to further appeal.

Policy Violations

Suspected violations of this policy should be reported to the IRB Administrator immediately. The IRB Administrator will determine if a non-compliance investigation is warranted and will initiate an investigation and corrective action plan when necessary. The IRB Administrator will provide written notification of the investigation, findings, and/or corrective action plan to the researcher, the IRB Chair, and the Chief Academic Officer. The IRB Administrator will also notify the appropriate College officials if they are made aware of violations of other College policies or local, state, or federal laws or regulations. 

The IRB may impose any of the following corrective actions for non-compliance: 

  • Establishment of more frequent continuing reviews of IRB-approved research;
     
  • Suspension or termination of IRB-approved research;
     
  • Referral for a suspected College policy violation (students and employees will be subject to disciplinary action in accordance with the Student Code of Conduct and the Disciplinary Actions, Suspension, and Termination of Employment policy, respectively);
     
  • Restriction of access to sites or participant groups affected by non-compliance; and/or
     
  • Other appropriate actions as determined by the IRB Administrator and/or Full Board.
     

Definitions

The Belmont Report – A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

Closure Form – An electronic form used to close a protocol.

College Official – A College employee who serves in one of the following roles: President, Chief of Staff to the President, Vice President, or Chief of Police.

Confidentiality – Confidentiality pertains to the treatment of information/data that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. 

Identifiable – The investigator can determine or associate the information with individuals’ identities. Some examples of identifiers would be names, social security numbers, or student identification numbers. 

Informed Consent – Voluntary agreement, based on relevant information and adequate knowledge to participate in research. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. 

Legally Effective Informed Consent – A process and consent form that follows human subjects regulations; follows applicable federal, state, or local laws; and is correctly obtained from the subject or the subject's legally authorized representative. Legally effective informed consent minimizes the possibility of coercion and undue influence, is free of exculpatory language, emphasizes that the research is voluntary, and is properly documented.

The Nuremberg Code – The Nuremberg Code is a set of research ethics principles for human experimentation created as a result of the Nuremberg trials at the end of the Second World War.

Pedagogical – Relating to the methods, practices, and theory of teaching.

Privacy – Respecting an individual’s right to be free from unauthorized or unreasonable intrusion, including control over the extent, timing, and circumstances of obtaining personal information from or about them. For example, individuals may not want to conduct the consent process in an open area or may not want to be seen entering a study site for fear of stigmatization. 

Protocol – The portion of the IRB application that describes how the Principal Investigator (PI) will conduct the study; the formal design or plan of an experiment or research activity that is described in the IRB initial review application; how the investigator will carry out the research.

Risks – The discomforts, hazards, or inconveniences to subjects related to their participation in the research. The probability, magnitude, duration, and reversibility of the risks should be described in the IRB application and should include physical, psychological, social, legal, and economic risks.

Voluntary – Free of coercion, duress, or undue inducement; refers to a subject's decision to participate (or to continue to participate) in a research activity.