Human Subjects Policy
Institutional Review Board at Lynchburg College
Policy for the Protection of Human Subjects Involved in 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. This policy does not apply to nonscientific polls, surveys, and other methods employed in journalism, which enjoys constitutional protection from censorship and restraint under the First Amendment.
Institutional Review Board (IRB)
The Board consists of five members as follows: At least three faculty members, preferably one from psychology, and including one whose primary concerns are in the scientific areas (any discipline may have more than one member represented on the Board); and two additional members; a community person who is not affiliated with the College, and who is not part of the immediate family of a person who is affiliated with the College; and one who may or may not be affiliated with College. At least one of the IRB members must be someone whose primary concern is in nonscientific areas. All terms are for three years, staggered, so that no more than two new members must be appointed in any one year.
Members will be recommended by the Faculty Steering Committee, in consultation with the chair of the IRB, and appointed by the president or dean of the College. The chair, who is preferably a faculty member, shall be appointed by the Faculty Steering Committee. The Board reports to the dean of the College.
The function of the Board is to review all proposed research which involves the use of human subjects. Full reviews require action by the entire board and may necessitate the convening of meetings at which a majority of the members of the Board are present, including at least one member whose primary concerns are in nonscientific areas. Expedited reviews may be conducted by phone or through the mail, or may only require the attention of the chair.
The Board approves or rejects research proposals and notifies the investigators and the dean of the College in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure Board approval.
The Board also submits an annual report of its activities to the dean of the College.
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 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 eighteen 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 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.
Student research
Student research projects involving human subjects must comply with the policies and procedures prescribed in this document and must be properly reviewed. Faculty members guiding such research share with their students the responsibility of compliance.