CFR: Code of Federal Regulations – This is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal government. The Code is divided into 50 titles that represent broad areas subject to Federal regulation. For research conducted at the VA, the titles that would most frequently apply are:
38 CFR – Department of Veterans Affairs
45 CFR – Department of Health and Human Services
21 CFR – Food and Drug Administration
Children: Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
Coercion: Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research. This would be considered coercion.
Common Rule: The common federal policy for protecting human subjects, promulgated in regulation and contained in the CFR, that outlines the provisions regarding the review and approval of research, is generally referred to as the “Common Rule”. It was signed by 17 federal agencies, including the VA, which are thus bound by it.The “Common Rule” for VA is in 38 CFR 16. Comparable regulations for DHHS are 45 CFR 46 Subpart A & for FDA are 21 CR 50 and 56.
Compassionate Use: The provision of investigational drugs outside of an ongoing clinical trial to a limited number of patients who are desperately ill and for whom no standard alternative therapies are available.
Confidentiality: A condition in which information is shared or released in a controlled manner so that information is not made available or disclosed to unauthorized individuals, entities or processes.
Conflict of Interest: Any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. Conflicts of interest may arise because of the intellectual property involved in many research discoveries or industry-academic partnerships, from financial incentives pharmaceutical or biotech companies may offer researchers or physicians for conducting trials or enrolling subjects, or due to particular role relationships.
Continuing Review: The IRB is required to review all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year.