Adverse Event - any adverse experience occurring during the course of the study or during planned follow-up.
Authorization -- Authorization is written permission required prior to disclosing a patient’s PHI when the use or disclosure is for a purpose other than for treatment, payment, or operations. A valid authorization must contain all of the elements listed in the Privacy Standards for the specific type of disclosure and entity.
CFR – Code of Federal Regulations
CPHS - Committee for the Protection of Human Subjects, the Institutional Review Board at UTHSCH.
Dead fetus - A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
De-identified -- De-identified describes the status of information that does not identify an individual and there is no reasonable basis to believe that the information can be used to identify an individual. Information that has been de-identified according to the methodology described in 45 C.F.R. § 164.514 is not subject to the Privacy Standards.
Delivery - Complete separation of the fetus from the woman by expulsion or extraction or any other means.
Designated Record Set -- A designated record set is a group of records maintained by or for UTHSC-H that consists of the medical records and billing records about individuals maintained by or for a covered health care provider; the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or used, in whole or in part, by or for the covered entity to make decisions about individuals. A record is any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.
Disclosure -- Disclosure means the release, transfer, provision of access to, or divulging in any other manner of information outside UTHSC-H holding the information. See also Use.
FDA – Food and Drug Administration
FWA – Federalwide Assurance
Fetus - Product of conception from implantation until delivery
HHS – Health and Human Services
IEC – Independent Ethics Committee
IND- Investigational New Drug
iRIS – Integrated Research Information System. An online application for research protocols for submission to CPHS.
IRB -- IRB is an acronym for Institutional Review Board. An IRB has the authority to decide whether to waive individual authorization for the use or disclosure of PHI for research purposes. The IRB for UTHCS-H is the Committee For the Protection of Human Subjects (CPHS).
Limited Data Set -- A limited data set is PHI that excludes the following direct identifiers of the individuals or of relatives, employers, or household members of the individuals:
names;
postal address information other than town or city, state, and zip code;
telephone numbers;
fax numbers;
e-mail addresses;
Social Security numbers;
medical record numbers;
health plan beneficiary numbers;
account numbers;
certificate/license numbers;
vehicle identifiers and serial numbers, including license plate numbers;
device identifiers and serial numbers;
Web Universal Resource Locators (“URLs”);
Internet Protocol (“IP”) address numbers;
biometric identifiers, including finger and voice prints; and
full face photographic images and any comparable images.
Identifiable information that may remain in a limited data set includes dates relating to a patient (dates of service, admission, or discharge; date of birth; date of death) and information relating to the town or city, state, and five-digit zip code of the patient, his or her employer, and the patient’s household members.
Minimum Necessary Standard -- The minimum necessary standard is a limitation placed on uses, disclosures, and requests for PHI. It applies when using or disclosing PHI or when requesting PHI from another covered entity. UTHSC-H must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request. The minimum necessary standard does not apply to certain disclosures or requests.
Neonate - A newborn.
Nonviable neonates - Neonate after delivery that, although living, is not viable.
OHRP – Office for Human Research Protections
Pregnancy - Encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if of reproductive potential and exhibiting any signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
Protected Health Information (“PHI”)--PHI or protected health information is individually identifiable health information that is transmitted or maintained in any medium or form. PHI excludes individually identifiable health information in education records covered by the Family Educational Rights and Privacy Act, as amended; in records described at 20 U.S.C. § 1232g(a)(4)(B)(iv) (student treatment records excepted from FERPA); and in employment records held by a covered entity in its role as an employer. Individually identifiable health information is information that is created or received by a health care provider, health plan, employer, or health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and that identifies the individual; or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
Treatment--Treatment means the provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of health care by a health care provider with a third party, consultation between health care providers relating to a patient, or the referral of a patient for health care from one health care provider to another.
Use -- Use means, with respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within UTHSC-H, which maintains the information.
Viable - As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary of Health and Human services, may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.
Office of Research Support Committees (713) 500-7942
