VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Covered Entity: This is the term that the HIPAA regulations use to describe the businesses in the health care industry that are subject to HIPAA regulations. Specifically, covered entities are health plans, health care clearinghouses and health care providers who transmit any health information in electronic form in connection with the following transactions: health care claims or encounter information, health care payment and remittance advice, coordination of benefits, health care claim status, enrollment or disenrollment or eligibility information, health plan premium payments, referral certification and authorization, first report of injury or health claims attachments. Emergency Use: The use of a test article on a human subject in a life-threatening situation which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21CFR56.102(D)]. Exempt Review: Federal regulations describe eight categories of research that may be exempt from IRB review. As a term of VCOM’s FWA, the College has a mechanism for review and verification of exempt status by someone other than the investigator. Because the person making this determination needs sufficient knowledge of the federal regulations on exempt status, the IRB Chair and IRB Coordinator will together make the decision to exempt a study from IRB review. Exemptions do not necessarily apply to research conducted on vulnerable groups. Expedited Review: The proposed research is reviewed by the IRB Chair or a designated voting member or group of voting members of the IRB rather than by the entire IRB. Federal regulations permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Family Member: Any one of the following legally competent persons: spouse, parents, children (including adopted children), brothers and sisters, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship [21CFR50.3(m)]. Federal Department or Agency: Refers to a Federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that take appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). Fetus: The product of conception from the time of implantation (as evidenced by any of the presumptive signs of pregnancy, such as missed menses, or a medically acceptable pregnancy test), until a determination is made, following expulsion or extraction of the fetus, that is viable [45CFR46.202(c)]. Neonate: A newborn [45CFR46.202(d)]. Viable as It Pertains to Neonates: Being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a fetus is viable for purposes of the subpart. If a fetus is viable after delivery, it is a premature infant [45CFR46.202(h)]. Nonviable Neonate: A neonate ex utero which, although living, is not viable [45CFR46.202(e)]. Dead Fetus: A neonate ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of umbilical cord (if still attached) [45CFR46.203(a)].

VCOM Institutional Review Board Policies and Procedures

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