Institutional Review Board at VMI
Statement of General Principles
VMI is committed to the pursuit of excellence in teaching, research, and public service. Members of the Institute community, while upholding the highest standards of freedom of inquiry and communication, accept the responsibility this freedom entails: for competence, for objectivity, for consideration of the best interests of the Institute and society, and for the welfare of every participant in a project. The IRB is primarily concerned with the welfare and consideration of the best interests of all subjects participating in research, the Institute, and society.
The Institute gives assurance that it will comply with the Department of Health and Human Services (HHS) regulations for the Protection of Human Research Subjects (45 CFR 46, as amended). Thus, the following principles are affirmed and should be interpreted in the broad context provided by the code of medical and general ethics promulgated by the World Medical Association as the Declaration of Helsinki and by the Ethical Principles in the Conduct of Research with Human Participants of the American Psychological Association. Copies of all documents, including VMI's Assurance of Compliance with HHS Regulations, are on file in the office of the Assistant Dean for Research.
- Because participation of humans in research and training projects raises fundamental ethical and civil rights questions, no distinctions in the monitoring of projects will be drawn between funded and unfunded projects, sponsored and unsponsored projects, or among projects carried out by students, faculty, or other Institute employees, on-campus or off-campus. Furthermore, approval by an agency that will be used to obtain subjects is necessary to obtain final IRB approval for the project. Review by another IRB, however, does not replace that of the VMI Board for studies conducted under the aegis of the Institute.
- All activities involving humans as subjects must provide for the safety, health, and welfare of every individual. Rights, including the right of privacy, must not be infringed.
- The direct or potential benefits to the subject, or the importance of the knowledge to be gained, must outweigh the inherent risks to the individual.
- Participation in projects must be voluntary, and informed consent must be obtained from all subjects, unless this requirement is specifically waived by the IRB. Investigators may establish a process consistent with guidelines for the process of documenting informed consent (guidelines as stated in Section X, beginning on page 18). Methods that are in accordance with the requirements of 45 CFR 46.116 and 45 CFR 46.117 and are adequate and appropriate to the risks of the project must be used to obtain the subject's informed consent.
- Consent should be obtained whenever appropriate from the participants themselves. If a subject is adjudicated to be not legally capable of giving informed consent, a legally authorized representative may do so. Any process by which informed consent is secured must consider the ability of the potential participant to comprehend the information and competently respond. Careful consideration shall be given to the representative's depth of interest and concern with the subject's rights and welfare. Informed consent must be secured for every project in which a person might participate.
- An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to withdraw from a research project at any time or can refuse to participate without loss of benefits to which the subject would otherwise be entitled. Further, a subject has the right to receive appropriate professional care,to enjoy privacy and confidentiality in the use of personal information and to be free from undue embarrassment, discomfort, anxiety, and/or harassment.
- Safeguarding information about an individual that has been obtained in the course of an investigation is a primary obligation of the investigator. The faculty sponsor is always responsible for the monitoring of procedures. Such information shall not be communicated to others unless the following conditions are met:
- Explicit written permission for the release of identifying data is given by the individual. The consent form to release information must be independent of the Informed Consent Form and must specify the name(s) of the person(s) or agencies to whom the data will be released.
- Information about individuals may be discussed only for professional purposes and only with persons clearly involved in the project. Written and oral reports should present only data germane to the purposes of the project, and every effort should be made to avoid invasion of privacy.
- Provisions must also be made for the maintenance of confidentiality in the preservation and ultimate disposition of any data collected. Adequate security measures must be described to the IRB and carried out by the principal investigator until the records are destroyed.Information in the records which contain personal information that could permit another person to identify a subject should be destroyed as soon as possible in keeping with the long-range goals of the project and federal regulations requiring the maintenance of primary data for a period of three years.
- Projects will be given initial and continuing review by the IRB as set forth in the description of Review Procedures and Criteria for Approval (Section VII, beginning on page 12).All members of the Institute community involved in investigation and training are responsible for continual monitoring to assure compliance of their research with these principles.
- No individual involved in the conduct and/or supervision of a specific project shall participate in IRB review of his/her project, except to provide information.
- A second review may be required:
if six months has elapsed between IRB review and project initiation;
if natural or unforeseen circumstances warrant a change in procedure; or
- if the principal investigator intends to change procedures after the proposed project has been approved by the IRB.
- In all cases, the investigator should show practical regard for the VMI community, recognizing thatviolations of the ethical and legal standards incorporated in this statement of principles (for example, concerning confidentiality, informed consent, and regard for the health, safety and welfare of all human subjects) could impugn the investigator's own name and the reputation of the Institute. Furthermore, the investigator should ensure that the research staff is reasonably protected from harm.
- The investigator does not abdicate ethical and legal responsibility merely by complying with this protocol.It is always the responsibility of the investigator to obtain clearance from the IRB prior to the initiation of any research activity involving the use of human subjects. Failure to do so may result in personal restrictions on the research activities of such individuals, as well as potential endangerment of all federal funding to the Institute.