LC IRB Policies for Human Subjects Research

Thank you for visiting the LC IRB policies page.  This page will be updated regularly during the 2014-2015 academic year – the Board is currently updating and revising the policy and procedure manual; the manual will be posted on this page once it is completely updated.  The manual contains all policies and procedures; items selected for inclusion on this page reflect the most frequently used policies, and the Submission Instructions and Forms page contains the most frequently engaged in procedures.  Contact the IRB Director with inquiries about these policies and the policy and procedure manual:  IRB-HS@lynchburg.edu.

 

Lynchburg College 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. Federal and state regulations are to be seen as a “floor” and not a “ceiling” for the protection of human subjects in research.

All systematic biomedical, health science, behavioral, or social research 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. 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 Lynchburg College. Individuals from outside the LC community who wish to involve or engage members of the LC community, or the institution as an entity, in their research activity must also comply with the policies and procedures for review outlined by the LC IRB. Contact the IRB Director with any questions: IRB-HS@lynchburg.edu.

Jump ahead to a specific policy:

Ethical Research Practices Policy

Internal Assessment and Evaluation Research Policy

Protection of Human Subjects Policies

Research Modification Policy

Research Renewal or Closure Policy

Research Integrity & Misconduct Policy

Student Research Policy

Policy on Assessment of Reviewability and Key Definitions

 

Ethical Research Practices 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 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.

Internal Assessment and Evaluation Research Policy

(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 of Human Subjects Policies

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.

Protection against violations of privacy & 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 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.

Research Modification Policy

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.

Research Renewal or Closure Policy

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 prior to 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; 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 stated policy and the IRB will no longer accept any responsibility for the research; noncompliance with 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.

Research Integrity & Misconduct Policy

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 which 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 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 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. While students are permitted to submit materials directly to the IRB on behalf of the entire research study team, it is a requirement that the PI be carbon copied on all correspondence. Accusations of research misconduct will be investigated in accordance with the policy and procedures outlined in the LC Research Misconduct Policy.

Policy on Assessment of Reviewability and Key Definitions

A special note for biographers, historians, journalists, and humanities scholars:  A policy update is pending for this section regarding activities in these areas of scholarship including biographies, historical research (including oral histories), journalism, etc. 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. Oral history recently became a category that is not reviewable. While the 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 Dr. Sharon Foreman-Kready 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 which meet this definition consitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other puproses. 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 Lynchburg College 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. In accordance with federal regulations, all such human subjects research must be reviewed and approved or exempted by the IRB prior to 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 in not reviewable research can receive a written determination on the matter from the IRB Director by submitting a written summary in the form of a letter or email to the IRB Directorin which they explain the project. In some cases, the IRB may ask for the submission of additional materials or information including a research proposal. Generally, investigators should not themselves make the determination as to whether or not a project constitutes human subject research. If the IRB Director 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 Director. This will mean that an activity has been classified as “non-reviewable” status.

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