Thank you for visiting the University of Lynchburg IRB policies page. Please use the link below to access the policy and procedure manual.

Policy and Procedure Manual

The manual contains all policies and procedures; items selected for inclusion on this page reflect some of the most frequently used policies. Please refer to the policy and procedure manual for more details on policies included on this page or for information on less frequently used policies. Contact the IRB Director with inquiries about these policies and the policy and procedure manual: [email protected].

The University of Lynchburg affirms that, in the pursuit of knowledge, individual rights must be preserved and human rights protected. The following policies and procedures are designed to comply with the federal and state law protection for human subjects involved in research.

All systematic biomedical, health science, behavioral, or social research involving human subjects that is associated with this University must comply with the policies and procedures set forth below and must be properly reviewed and approved by the Institutional Review Board (IRB) before the research begins. These policies apply not only to research done in academic departments, but to all systematic biomedical, health sciences, behavioral, and social research executed by any individual, office, or department at the University of Lynchburg. Individuals from outside the University of Lynchburg community who wish to involve or engage members of the Lynchburg community, or the institution as an entity, in their research activity must also comply with the policies and procedures for review outlined by the Lynchburg IRB. Contact the IRB Director with any questions: [email protected].

Research Misconduct Policy

All faculty, staff, and students seeking approval from the LC IRB (Human Subjects Research) for research proposals must pass a basic training course on research ethics offered by the Collaborative Institutional Training Initiative (CITI).

Successful completion of this training is required to ensure that all members of the University of Lynchburg community who plan to conduct research are familiar with ethical research practices given the fact that the IRB is now registered with and has established an assurance policy with the federal government.

The IRB will only review proposals submitted by those who have passed the training as evidenced by the receipt of a training certificate on file with CITI and accessible by the IRB Director committee.

• Instructions for completing the CITI training for faculty/staff.
• Instructions for completing the CITI training for students.

Please follow the instructions carefully to ensure completion of the correct modules.

It is common for instructors, especially those teaching courses in research methods, to design class assignments that utilize questionnaires, interviews, and other interactions with human subjects. Novel and imaginative classroom exercises help students learn and are, therefore, integral to high-quality teaching. All teaching assignments, however, must respect the rights and welfare of all individuals involved. The IRB distinguishes between student research projects, which require IRB approval, and class assignments, which often do not. Student research projects require review and approval by the IRB, whereas class assignments, in general, do not. Class assignments do, however, require a waiver of IRB review application, which may be found on the IRB webpage under Forms and Templates. There are two categories of class assignments that require IRB oversight—those that lead to the dissemination of data or findings outside of class and those that involve more than minimal risk to human subjects.

Faculty members may design assignments that engage students in interaction with individuals or data about individuals to teach research methods or to help students understand concepts covered in their courses. Such required class assignments often involve University of Lynchburg students beyond those on the class roster as well as other participants. These assignments are not intended to create new generalizable knowledge or lead to scholarly publication. Therefore, class assignments, as a general rule, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of “research.” Such assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight but do require a class project waiver form. There are two exceptions for in-class assignments that require IRB review:

Exception 1: When class assignments are intended to contribute to generalizable knowledge (e.g., publish findings, presentations at research conferences inside or outside of the University of Lynchburg, etc.), the assignments are, indeed, “research” and fall under the jurisdiction of the IRB. Instructors and students wishing to use such assignments for presentation outside of class must apply to the IRB for review and approval of these assignments before they begin.

Exception 2: When class assignments extend to human subjects beyond queries of University of Lynchburg students to minors or other vulnerable populations, or involve more than minimal risk to participants, such assignments fall under the jurisdiction of the IRB. Class assignments that involve more than minimal risk are assignments that ask students to survey, interview, or interact with the following populations:

• Minors (i.e., persons under the age of 18);
• Vulnerable individuals (e.g. those whose capacity to freely give consent may be compromised because of socio-economic, educational, or linguistic disadvantage; cognitive impairment; advanced age; or terminal illness);
• Individuals involved in potentially stigmatizing behaviors which, when anonymity cannot be sustained, place participants at more than minimal risk physically, socially, or economically or for civil or criminal liability;
• Other individuals who, by the nature of the class assignment, are placed at more than minimal risk (e.g. research on sensitive topics such as rape, abuse, criminal behavior, etc.).

In such cases, the class assignment requires IRB review and approval.

It is the instructor’s responsibility to ensure that her/his students understand the importance of protecting human subjects. Although many class assignments are designed as instructive measures and are not the type of activities typically reviewed by the IRB, there are instances when the nature of these projects is such that participants could be put at risk of harm, and IRB approval is required. For example, if a student proposes to ask peers about their safe-sex habits, names and responses could circulate, and the questions themselves could create emotional distress since they pertain to potentially stigmatizing behavior. Research on topics such as these would require IRB review. In all cases, instructors are responsible for minimizing risks to participants in-class assignments. The IRB strongly encourages instructors to ensure that their students are educated about risks and how to minimize them. If a faculty member is unsure as to whether a planned project requires IRB review, the faculty member or student may submit a research determination form to be reviewed by the IRB so that a determination can be made as to whether the project requires IRB review and oversight.

*If an instructor is unsure as to whether the design or topic for a particular study qualifies for a class project waiver, please contact the IRB Director for guidance.

Note: Content in the policy for class project waivers is largely taken, with permission, from the Sacred Heart University IRB.

(This policy is consistent with the guidance provided by the OHRP in their resource “Quality Improvement Activities FAQ”.)

Research activities conducted solely for academic assessment data purposes, including quality improvement activities, and intended only for internal dissemination (within the University of Lynchburg and potentially with accrediting bodies) are not subject to oversight by the IRB. This includes items such as student opinion surveys (“course evaluations”); focus groups/interviews/surveys for the development of courses, programs, and services; and other assessment research tasks that are focused solely on improving and refining the delivery of curricular and extra-curricular services and are only intended for internal audiences. Plans for the external dissemination of academic assessment data shall necessitate that IRB approval take place.

The IRB suggests that researchers conducting institutional assessment research ask the following question before collecting data: “If I/we learn something very interesting or extremely helpful, would I/we wish to disseminate it externally to non-LC audiences?” If the answer is “yes,” then your research study does need to go through the IRB approval process.

This policy applies only to academic assessment research conducted by individuals on the department, school, or college level. Individual faculty researchers and student researchers who wish to research these sorts of topics but who are not officially doing so at the behest of an academic or administrative unit must go through the IRB for approval.

If data have already been collected and a researcher, academic, or administrative unit wishes to re-analyze the data for dissemination to external audiences, then the research study proposal does need to go through the IRB approval process and would be treated as secondary data analysis through the procedures for verification of exempt status.

Protection against harm

Researchers are responsible for identifying, justifying, and minimizing the risks of real or potential harm accruing to human subjects involved in their proposed research; such risks include physical, psychological, and social harm.

Physical harm may range from unnecessary discomfort or inconvenience to physical pain or disfigurement. Psychological harm includes emotional distress, loss of self-esteem, and impairment of the subject’s ability to judge behaviors or make decisions. Social harm includes damage to reputation and social or legal standing.

Protection against coercion and deceit

Researchers must respect a subject’s right to autonomy and guard against unnecessary deception. Therefore, researchers are required to obtain in writing the informed consent of their subjects, except as otherwise approved in advance by the IRB.

In obtaining “informed consent” researchers must meet the following conditions: (l) before agreeing to participate in the study, prospective subjects must be given the most detailed and accurate description of the study as the research design will allow; (2) consent and subsequent participation cannot be coerced and prospective subjects must be provided with written and oral reassurance that they are free to refuse to participate or to withdraw from the study at any time; (3) if parties other than the researchers identified with the study are to have access to the individual contributions of the participants, prospective subjects must be provided with a written statement identifying these parties; (4) under no circumstances may prospective subjects be misled or uninformed as to any risks associated with the study; (5) when the design of the study necessitates concealment or deception on other matters, researchers are ultimately required to reveal to participants the reasons for the actions; and (6) any other items required by law.

The IRB is legally required to determine whether the proposed “informed consent” contains the necessary types of information. Ideally, prospective subjects should understand all features of the research that reasonably might be expected to influence willingness to participate. Furthermore, after the study researchers should freely provide to participants upon request information explaining the purposes of the study, the genuine nature of the design, and the results. This access to information should be clearly stated in writing on the consent form that participants sign.

If a prospective subject is less than 18 years of age, then the prior informed consent of a parent or legal guardian is required and the conditions prescribed herein pertain also to the parent or guardian.

Protection against violations of privacy and personal integrity

Researchers must respect the privacy and human dignity of subjects. Research participants possess the right to decide how much of themselves to share with others.

When possible, subjects should participate anonymously. If the research design precludes the anonymity of research participants, then information that may lead to the identification of the individual subjects or their contributions to the study must be treated with strict confidentiality. Once obtained, personal data about subjects may not be revealed to any third parties or the public in such a way as to make possible the identification of individual participants.

A statement explaining the anonymity or confidentiality of information associated with the individual participants and their contributions to the research must be presented in writing to the proposed subjects before their participation.

Researchers should make every effort to preserve the personal integrity and dignity of human subjects, including refraining from research that could conceivably humiliate or belittle participants.

Any change to an approved research project, including research plan, consent/assent process and form, co-investigators, other research personnel, and/or methods of subject recruitment, requires submission of a Research Modification Form along with all supporting documents as outlined on the form. The form is found on our Submission Instructions and Forms page. Modifications to research projects may not be initiated until IRB approval has been obtained.

All research that has been approved by the IRB must be reviewed annually (if the study has not been completed), and closed once the study has been completed. The LC IRB considers a study to be completed once the Principal Investigator (PI) determines that there will be no further contact with human subjects – for many studies, this means that the study is completed once data are collected.

The renewal review requirement at LC includes studies approved at all levels of review (exempt, expedited, and full board review status). The Renewal Request Form is the form to use for annual renewal review, and this form must be submitted to the IRB Director following the instructions provided on the form at least 30 days before the end date of the approval period as stated in the most recent approval letter for the study.

The study closure requirement at LC includes studies approved at all levels of review (exempt, expedited, and full board review status). The Research Study Closure Form is the form to use for study closure, and this form must be submitted to the IRB Director following the instructions provided on the form within 30 days of the end of data collection OR at least 30 days before the end of the one year approval period as stated in the most recent approval letter for the study.

While the LC IRB makes an effort to send reminder correspondence 60-90 days before the end of the approval period, it is ultimately the responsibility of the PI and research team, not the LC IRB, to ensure that this deadline is met. This deadline will allow adequate time for the IRB to review the form so that a decision can be made before the research proposal approval expires. Research studies approved at the exempt status level will be reviewed by the IRB Director, expedited level either by the IRB Director or members of the Board, and full board level by the full Board.

The Renewal Request Form and the Study Closure Form are found on our Submission Instructions and Forms page.

Failure to complete the Renewal Form or the Closure Form in the stated time frame will result in the automatic closure of the study due to noncompliance with the stated policy and the IRB will no longer accept any responsibility for the research; noncompliance with the stated policy will serve as a barrier for approval of future research at LC as it is a violation of the Research Integrity & Misconduct Policy.

Per IRB policy, any adverse events must be reported to the IRB in writing immediately following any such occurrence and should not be held for notification until the renewal review. This form requires the reporting of all adverse events; the information provided here will be compared to previously submitted written reports.

Researchers are responsible for ensuring that the research activities associated with their studies are conducted in a way that is consistent with the procedures approved by the IRB and in compliance with the stated human subjects research protection policies.

Research misconduct falls into three major categories:

1. An action or inaction on the part of the lead researcher (Principal Investigator) or a member of the research team that is a deviation from the accepted research procedures approved by the IRB.
2. Fabrication, falsification, or other misrepresentation of data; plagiarism in the course of the research process (including proposal and dissemination processes); and violations of human subjects protection policies.
3. Conducting research under the auspices of and/or in affiliation with the University of Lynchburg without gaining approval for the research project (including exempt review status approval) from the IRB committee.

This is not an exhaustive list of potential infractions of the policy on research integrity and misconduct.

While the IRB may discuss concerns related to and provide education around the topic of research misconduct, the IRB does not investigate accusations of research misconduct. Accusations of research misconduct will be investigated per the policy and procedures outlined in the Research Integrity & Misconduct Policy.

Student research projects involving human subjects must comply with the policies and procedures prescribed in the IRB policies and must be properly reviewed. Faculty research sponsors guiding such research share with their students the responsibility of compliance. Faculty research sponsors must serve as the Principal Investigator (PI) for a student’s research study if the student is classified as an undergraduate student; faculty research sponsor may serve as Co-Principal Investigator (Co-PI) along with a graduate student or may choose to serve as the only PI. Faculty research sponsors are responsible for ensuring that the student research follows all policies and procedures prescribed in the IRB policies. Students are not permitted to submit materials directly to the IRB on behalf of the research team. Only LC faculty/staff serving as PIs may submit completed IRB forms for review. Accusations of research misconduct will be investigated per the policy and procedures outlined in the Research Integrity & Misconduct Policy.

A special note for biographers, historians, journalists, and humanities scholars: Most activities conducted by these scholars (and students of these disciplines) are not considered “human subjects research” by the federal and state regulations, and as such also by the LC IRB. While these disciplines may refer to an activity as “research,” the LC IRB recommends that a distinction be made between these activities and human subjects research. Methods employed in journalism enjoy constitutional protection from censorship and restraint under the First Amendment (and thus do not qualify as human subjects research). Contact the IRB director for more information.

The federal government defines research as “systematic investigations designed to develop or contribute to generalizable knowledge” (45CFS46, 102(d)). The LC IRB does not require that research contribute to generalizable knowledge in the sense of generalization to a large-scale population for it to be reviewable; reviewability is discussed further in this policy.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

If such research involves obtaining information about “a living individual” (45CFR46, 102(f)), then the activity is human subjects research. This definition follows:

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Most human subjects research at the University of Lynchburg is “social and behavioral research” (SBR) which occurs in the social and behavioral sciences and sometimes in the humanities; and biomedical and health science research which occurs in the health sciences. Per federal regulations, all such human subjects research must be reviewed and approved or exempted by the IRB before the initiation of the research.

Many investigators know that their research activity necessitates review by the LC IRB. Sometimes, there are elements of a proposed activity that lead the investigator to question whether the activity necessitates review by the LC IRB. Only the LC IRB has the authority to determine the reviewability of an activity. A person engaging in an activity that she or he believes is not reviewable research can receive a written determination on the matter from the IRB by submitting a written summary in the form of a letter or email to the IRB in which they explain the project and justify why review by the IRB should not be required. In some cases, the IRB may ask for the submission of additional materials or information including a research proposal. Generally, investigators should not themselves determine as to whether or not a project constitutes human subject research. If the IRB determines that an activity/project does not meet the criteria for human subject research and is therefore not reviewable, then a letter of determination will be provided by the IRB. This will mean that the activity has been classified as “non-reviewable” status.

At times researchers choose to compensate research participants for completing a study. Any form of compensation must be clearly stated in the informed consent form and in the protocol proposal form that is submitted for IRB review. In addition, the business office at the University of Lynchburg will need to access personally identifiable information for each participant earning compensation per federal tax law. If money is being provided, a W-9 form will need to be completed by each participant receiving funds (name, address, social security number, or tax ID number) for those not affiliated with the University of Lynchburg. A Pay Authorization form from human resources will need to be completed for all participants receiving compensation who are members of the faculty, staff, or student body at the University of Lynchburg. If participants are being compensated with gift cards, please contact the business office at 434-544-8213 to obtain the required form to track distribution. A signature acknowledging receipt of the gift card must be obtained from each participant on the distribution tracking form or an email must be obtained and saved verifying receipt of each gift card. A copy of the consent form and the IRB approval letter must be provided to the University of Lynchburg business office for all compensation requests (cash or gift cards). After compensation is provided, all materials need to be provided to the business office for verification.

Researchers are required to inform participants in the informed consent form that their personally identifiable information, and what specific information, will be viewed by the University of Lynchburg business office to process payment. It must be clearly stated in the confidentiality section of the informed consent form who will have access to compensation documents. If participants do not want their personally identifiable information to be viewed by business office personnel, they can waive their right to receive compensation for research participation. Research participants cannot be compensated if they do not want to complete a W-9 form or sign for acceptance of a gift card.

Ethical practices when providing research participation compensation are vital. Compensation should not be unduly influential but be used to balance the time, effort, or other specific reasons based on the engagement of the participants in the research study. Gift cards that are provided to participants cannot be reused or have any additional funds added to them. Data obtained from the research study should never be shared with business office personnel, only the required documentation to allow them to track the receipt of compensation. Research team members should not keep any copies of W-9 forms past the period required to process payment. After payment is processed, research team members must shred and/or delete any copies of W-9 forms. The human resources and business office administration will maintain the confidentiality of personal information by allowing only essential staff to view completed W-9 forms.