LC IRB Policies for Human Subjects Research
Lynchburg College affirms that, in the pursuit of knowledge, individual rights must be preserved. 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, behavioral, or social research directly involving human subjects which is associated with this College 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. This policy applies not only to research done in academic departments, but to all systematic biomedical, behavioral, or social research executed by any office or department at Lynchburg College.
These policies do not apply to nonscientific polls, surveys, and other methods employed in journalism, which enjoys constitutional protection from censorship and restraint under the First Amendment.
All faculty, staff, and students seeking IRB approval for research proposals requiring full or expedited review 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 Lynchburg College community who plan to conduct research are familiar with ethical research practices given the fact that the IRB is now registered with and is working to establish 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 chair of the IRB committee.
Instructions for completing the CITI training can be found on the following pages. Please make sure to follow the instructions that pertain specifically to you as either a faculty/staff researcher or a student researcher.
(This policy is consistent with the guidance provided by the OHRP in their resource “Quality Improvement Activities FAQ” found online at www.hhs.gov/ohrp/policy/qualityfaqsmar2011.pdf.)
Research activities conducted solely for academic assessment data purposes, including quality enhancement activities, and intended only for internal dissemination (within Lynchburg College and potentially with accrediting bodies) are not subject to oversight by the Human Subjects IRB. This includes items such as student opinion surveys ("course evaluations"); focus groups/interviews/surveys for development of courses, programs, and service; 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 the IRB approval take place.
The IRB suggests that researchers conducting institutional assessment research ask the following question prior to collecting data: "If I/we learn something very interesting or extremely helpful, would I/we wish to disseminate 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 conduct research on 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 the purpose of 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 & 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 perspective 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, at the conclusion of 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 which 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.
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 is traceable to the individual subjects or to 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 proposed subjects prior to their participation.
Researchers should make every effort to preserve the personal integrity and dignity of human subjects, including refraining from research which 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 (modified from a document provided by Claremont Graduate University).
You will also need to include a detailed explanation of the reason(s) you are seeking to modify your previously approved research project. In addition, you must also include any revised instruments, questionnaires, letters of cooperation, informed consent/assent forms, etc.
Modifications to research projects may not be initiated until IRB approval has been obtained.
All research that has been approved by the IRB as expedited or full board must be reviewed annually if the study has not been completed. Exempt research does not need annual renewal.
A Renewal or Closure Form (modified from a document provided by Claremont Graduate University) must be submitted via email to firstname.lastname@example.org requesting renewal of the research study. A Renewal or Closure Form must be submitted for IRB review at least one month before the end date of the approval period as stated in the most recent approval letter.
This deadline will allow adequate time for the IRB to review the form so that a renewal decision can be made before the research proposal approval expires. If your research proposal approval expires before the application for the Renewal or Closure is approved by the IRB, then you must resubmit your entire proposal for the review and approval process.
Failure to complete the Renewal or Closure Form in the stated time frame will result in the closure of the study due to noncompliance and the IRB will no longer accept any responsibility for the research. Any adverse events must be reported to the IRB in writing immediately following any such occurrence.
In addition, on completion of a research study a Renewal or Closure Form must be submitted indicating closure of the study.
The Renewal or Closure Form is found on our Submission Instructions and Forms page.
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:
- An action or inaction on the part of the lead researcher (Principal Investigator) or a member of the research team which is a deviation from the accepted research procedures approved by the IRB.
- 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.
- Conducting research under the auspices of and/or in affiliation with Lynchburg College 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 in accordance with the policy and procedures outlined in the LC Research 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, and as such they are also responsible for submitting research materials to the IRB. The IRB recommends that the PI indicate the role of student researchers clearly in the proposal materials and disclose the research activities being carried out by the student researcher.