SECTION 925.3. Definitions

The following words and terms have the following meanings when used in this chapter.

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

(2) Children--Consistent with 45 Code of Federal Regulations §46.402(a), individuals 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.

(3) Code of Federal Regulations (CFR)--The codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government.

(4) Designated institutional review board--The institutional review board whose purpose is to review, approve, and monitor proposed research studies as well as oversee the conduct of approved research, which includes:

(A) an external institutional review board established and operated by a non-Texas Health and Human Services Commission organization with an active Federalwide Assurance (see, 48 C.F.R. Subpart §370.3 Acquisitions Involving Human Subjects) approved by the Office for Human Research Protection (OHRP); and

(B) IRB2.

(5) HHSC--Texas Health and Human Services Commission.

(6) HHSC services--Services provided by HHSC or an HHSC-contracted provider. For purposes of this chapter, HHSC services are:

(A) services delivered in state psychiatric hospitals;

(B) services delivered in state supported living centers;

(C) community-based mental health services;

(D) intellectual or developmental disabilities services;

(E) substance use prevention, intervention, and treatment services; and

(F) services delivered by other HHSC-contracted behavioral health providers required to submit data and information to HHSC.

(7) HHSC services authorized person--A person with the authority to allow research at the proposed research site where HHSC services are delivered (i.e., superintendent, director, or chief executive officer).

(8) Human subject--Consistent with 45 CFR §46.102(e)(1), a living individual about whom an investigator (whether professional or student) conducting research:

(A) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(B) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(9) Individual--A person who previously received, or is currently receiving, HHSC services.

(10) Informed consent--The knowing approval by an individual or an individual's legally authorized representative to participate in a research study, given under the individual's or legally authorized representative's decision without undue influence or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

(11) Institutional review board (IRB)--A board that reviews and approves proposed research, as well as oversees the conduct of approved research.

(12) Intellectual or developmental disability (IDD)--Intellectual disability consistent with Texas Health and Safety Code §591.003 or a disability that meets the criteria described in the definition of "persons with related conditions" in 42 CFR §435.1010.

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

(14) Investigator--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.

(15) IRB2--The Mental Health, Substance Use and Intellectual or Developmental Disabilities Institutional Review Board, which is established and operated by the Texas State Hospital Central Administration.

(16) Legally authorized representative (LAR)--Consistent with 45 CFR §46.102(i), an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure or procedures involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject's participation in the procedure or procedures involved in the research.

(17) Limited data set--Consistent with 45 CFR §164.514(e), protected health information of an individual or of relatives, employers, or household members of an individual that excludes the following direct identifiers:

(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 or 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.

(18) 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 physical or psychological examination or tests.

(19) 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.

(20) Notice of privacy practices--A written notice describing:

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

(B) the individual's rights and the legal duties of the HHSC service with respect to protected health information.

(21) Office for Human Research Protection (OHRP)--The office that provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.

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

(23) Privacy coordinator--An HHSC staff member who is responsible for working with the Texas Health and Human Services Privacy Division to implement the policies and procedures relating to state and federal privacy laws.

(24) 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:

(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 HHSC services;

(v) any acknowledgment that an individual is seeking or receiving or has sought or received HHSC services;

(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.

(25) Research--Consistent with 45 CFR §46.102(l), 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 chapter, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this chapter, the following activities are not deemed as research.

(A) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(B) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters).

(C) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(D) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

(26) Rights officer--A person who oversees the research site to protect and advocate for the rights of individuals receiving HHSC services.

(27) State Hospital Central Administration--The HHSC office that is responsible for the management and oversight of the state hospital system.

(28) Texas Health and Human Services Commission Privacy Division--The HHSC workforce responsible for creating and maintaining privacy policies and procedures and investigating potential unauthorized disclosures of protected health information, personally identifiable information, and sensitive personal information. The Privacy Division is responsible for declaring whether an incident is a breach of information and notifying or recommending notification to affected individuals. The Privacy Division acts as a resource and subject matter experts to HHSC.

Source Note: The provisions of this §925.3 adopted to be effective November 27, 2022, 47 TexReg 7731