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RULE §414.753Definitions
Texas Register

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

  (1) Assent--Affirmative agreement of a prospective human subject to participate in research, which is obtained when the subject does not have capacity or legal authority to consent.

  (2) Authorization--The written permission given by an individual who is participating in a research study or the individual's LAR to use or disclose certain protected health information related to the research study.

  (3) Central Office--TDMHMR's administrative offices in Austin.

  (4) Designated institutional review board (IRB)--The IRB, chosen by the facility and approved by the Office of Research Administration in accordance with this subchapter, that will review, approve, and monitor all research to be conducted at the facility.

  (5) Facility--A state mental health facility, a state mental retardation facility, or Central Office.

  (6) Human subject--Consistent with 45 CFR §46.102(f), referenced as Exhibit A in §414.763 of this title (relating to Exhibits), a living individual about whom a key researcher conducting research obtains:

    (A) data through intervention or interaction with the individual; or

    (B) identifiable private information.

  (7) Individual--A person who has received or is receiving mental health or mental retardation services from a facility.

  (8) Informed consent--The knowing approval of an individual or an individual's legally authorized representative (LAR) to participate in a research study, given under the individual's or LAR's ability to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

  (9) Institutional review board (IRB)--A board whose membership meets the requirements of §414.755(d) of this title (relating to Designated Institutional Review Board (IRB)), and whose purpose is to review and approve proposed research as well as oversee the conduct of approved research.

  (10) Investigation (of misconduct in science)--The formal examination and evaluation of all relevant facts to determine if misconduct in science has occurred.

  (11) Investigational medication or device--Any drug, biological product, or medical device under investigation for human use that is not currently approved by the Food and Drug Administration for the indication being studied.

  (12) Key researcher--A principal investigator, a co-investigator, or a person who has direct and ongoing contact with human subjects participating in a research study or with prospective human subjects.

  (13) Legally authorized representative (LAR)--A person or entity authorized under applicable law to consent on behalf of a prospective human subject to the subject's participation in a research study and to authorize the use or disclosure of protected health information.

  (14) Limited data set--Protected health information that excludes the following direct identifiers of an individual or of relatives, employers, or household members of an individual:

    (A) names;

    (B) postal address information, other than town or city, state, and zip code;

    (C) telephone numbers;

    (D) fax numbers;

    (E) electronic mail addresses;

    (F) social security numbers;

    (G) medical record numbers;

    (H) health plan beneficiary numbers;

    (I) account numbers;

    (J) certificate/license numbers;

    (K) vehicle identifiers and serial numbers;

    (L) device identifiers and serial numbers;

    (M) Web Universal Resource Locators (URLs);

    (N) Internet Protocol (IP) address numbers;

    (O) biometric identifiers, including finger and voice prints; and

    (P) full face photographic images and comparable images.

  (15) Mental health priority population--Persons with mental illness, including severe emotional disturbance, identified in TDMHMR's current strategic plan as being most in need of mental health services.

  (16) Mental retardation priority population--Persons with mental retardation identified in TDMHMR's current strategic plan as being most in need of mental retardation services.

  (17) Minimal risk--The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine psychical or psychological examination or tests.

  (18) Misconduct in science--The fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

  (19) Notice of Privacy Practices--A written notice describing:

    (A) the uses and disclosures of protected health information that may be made by a facility; and

    (B) individuals' rights and the facility's legal duties with respect to protected health information.

  (20) Office of Research Administration (ORA)--The Central Office department that is responsible for the duties described in §414.762 of this title (relating to Responsibilities of the Office of Research Administration (ORA)).

  (21) Principal investigator--The person identified as responsible for conducting a research study.

  (22) Privacy coordinator--A member of the workforce of a facility who is responsible for working with the TDMHMR Central Office Privacy Official in developing and implementing the facility's policies and procedures relating to state and federal medical privacy laws.

  (23) Protected health information (PHI)--

    (A) Any information that identifies or could be used to identify an individual, whether oral or recorded in any form, that relates to:

      (i) the past, present, or future physical or mental health or condition of the individual;

      (ii) the provision of health care to the individual; or

      (iii) the payment for the provision of health care to the individual.

    (B) The term includes, but is not limited to:

      (i) an individual's name, address, date of birth, or Social Security number;

      (ii) an individual's medical record or case number;

      (iii) a photograph or recording of an individual;

      (iv) statements made by an individual, either orally or in writing, while seeking or receiving services from or through a facility;

      (v) any acknowledgment that an individual is seeking or receiving or has sought or received services from or through a facility;

      (vi) direct identifiers of relatives, employers, or household members of the individual; and

      (vii) any information by which the identity of an individual can be determined either directly or by reference to other publicly available information.

    (C) The term does not include:

      (i) health information that has been de-identified in accordance with 45 CFR §164.514(b); and

      (ii) employment records held by a facility as an employer.

  (24) Research--A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this subchapter whether or not they are conducted or supported under a program which is considered research for other purposes. For example, certain demonstration and service programs may include research activities.

  (25) Rights officer--An employee appointed by a facility CEO to protect and advocate for the rights of persons receiving services from the facility.

  (26) State mental health facility--A state hospital or a state center with an inpatient component that is operated by TDMHMR.

  (27) State mental retardation facility--A state school or a state center with a mental retardation residential component that is operated by TDMHMR.

  (28) TDMHMR--The Texas Department of Mental Health and Mental Retardation.

Source Note: The provisions of this §414.753 adopted to be effective July 5, 2004, 29 TexReg 6093

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