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:
Cont'd... |
