121075. Research records, in a personally identifying form,
developed or acquired by any person in the course of conducting
research or a research study relating to HIV or AIDS shall be
confidential, and these confidential research records shall not be
disclosed by any person in possession of the research record, nor
shall these confidential research records be discoverable, nor shall
any person be compelled to produce any confidential research record,
except as provided by this chapter.
121080. Confidential research records may be disclosed in
accordance with the prior written consent of the research subject
with respect to whom the research record is maintained, but only to
the extent, under the circumstances, to the persons, and for the
purposes the written consent authorizes. Any disclosure authorized by
a research subject shall be accompanied by a written statement
containing substantially the same language as follows:
"This information has been disclosed to you from a confidential
research record the confidentiality of which is protected by state
law and any further disclosure of it without specific prior written
consent of the person to whom it pertains is prohibited. Violation of
these confidentiality guarantees may subject you to civil or
criminal liabilities."
121085. (a) Confidential research records shall be protected in the
course of conducting financial audits or program evaluations, and
audit personnel shall not directly or indirectly identify any
individual research subject in any report of a financial audit or
program evaluation. To the extent it is necessary for audit personnel
to know the identity of individual research subjects, authorized
disclosure of confidential research records shall be made on a
case-by-case basis, and every prudent effort shall be exercised to
safeguard the confidentiality of these research records in accordance
with this chapter. Information disclosed for audit or evaluation
purposes should be used only for audit and evaluation purposes and
may not be redisclosed or used in any other way.
(b) Nothing in this section imposes liability or criminal sanction
for disclosure of confidential research records in accordance with
any reporting requirement for a case of HIV, including AIDS, by the
department or the Centers for Disease Control and Prevention under
the United States Public Health Services.
121090. Notwithstanding Section 121080, whether or not the research
subject, with respect to whom any confidential research record is
maintained, gives prior written consent, the content of the
confidential research record may be disclosed in any of the following
situations:
(a) To medical personnel to the extent it is necessary to meet a
bona fide medical emergency of a research subject.
(b) To the department to the extent necessary for the conduct of a
special investigation pursuant to Section 100325, in which case the
confidentiality provisions of Chapter 8 (commencing with Section
121025) shall apply.
121095. The content of any confidential research record shall be
disclosed to the research subject, the legal representative of the
research subject if the research subject is a minor, or the personal
representative of a deceased research subject to whom the record
pertains, thirty (30) days after written request therefor by the
research subject, the legal representative or the personal
representative.
121100. (a) No confidential research record may be compelled to be
produced in any state, county, city or other proceeding in order to
initiate or substantiate any criminal charge or charges against a
research subject, or to conduct an investigation of a research
subject, unless a court finds there is reasonable likelihood that the
records in question will disclose material information or evidence
of substantial value in connection with the criminal charge or
charges or investigation, and there is no other practicable way of
obtaining the information or evidence.
In addition, no confidential research record shall be disclosed,
discoverable, or compelled to be produced in order to initiate or
substantiate any criminal charge or charges against a research
subject until after a showing of good cause. In assessing good cause,
the court shall weigh the public interest and need for disclosure
against the injury to the research subject and the harm to the
research being undertaken. Upon the granting of an order to produce,
the court, in determining the extent to which disclosure of all or
any part of a confidential research record is necessary, shall impose
appropriate safeguards against unauthorized disclosure, that shall
include, but not necessarily be limited to, the individuals or bodies
that may have access to the data, the purposes for which the data
shall be used, prohibitions on further disclosure and protection of
the identities of other research subjects.
(b) No confidential research record may be compelled to be
produced in any state, county, city or other civil proceeding, except
as expressly provided in this chapter.
121105. Prior to participation of an individual in a research study
relating to HIV or AIDS, both of the following requirements shall be
met:
(a) The informed consent of each research subject shall be
obtained in the method and manner required by Section 46.116, (a) and
(b), of Part 46 of Title 45 of the Code of Federal Regulations and
be documented in accordance with Section 46.117 of that part.
(b) Each research subject shall be provided with an explanation in
writing, in language understandable to the research subject, of the
rights and responsibilities of researchers and research subjects
under this chapter.
121110. (a) Any person who negligently discloses the content of any
confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not to exceed two
thousand five hundred dollars ($2,500), plus court costs, as
determined by the court, which penalty and costs shall be paid to the
subject of the test.
(b) Any person who willfully or maliciously discloses the content
of any confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not less than five
thousand dollars ($5,000) and not more than ten thousand dollars
($10,000), plus court costs, as determined by the court, which
penalty and costs shall be paid to the subject of the test.
(c) Any person who willfully, maliciously, or negligently
discloses the content of any confidential research record, as defined
in subdivision (c) of Section 121125, to a third party, except
pursuant to this chapter, that results in economic, bodily, or
psychological harm to the research subject, is guilty of a
misdemeanor, punishable by imprisonment in the county jail for a
period not to exceed one year, or a fine of not to exceed twenty-five
thousand dollars ($25,000), or both.
(d) Any person who commits any act described in subdivision (a) or
(b) shall be liable to the subject for all actual damages for
economic, bodily, or psychological harm that is a proximate result of
the act.
(e) Any person who negligently or willfully violates Section
121105 is guilty of an infraction punishable by a fine of twenty-five
dollars ($25).
(f) Each violation of this chapter is a separate and actionable
offense.
(g) Nothing in this section limits or expands the right of an
injured research subject to recover damages under any other
applicable law.
121115. In the event that the participation of an individual in a
research study is disclosed, the information shall not be used to
determine the employability or insurability of the research subject.
121120. Nothing in this chapter shall preclude disclosure of
information in order to further research efforts, including, but not
limited to, the publication, dissemination, or sharing of raw data,
statistics, or case studies, so long as no confidential research
records concerning any research subject are disclosed.
121125. For purposes of this chapter:
(a) "AIDS" means acquired immunodeficiency syndrome.
(b) "Disclosed" means to disclose, release, transfer, disseminate,
or otherwise communicate all or any part of any confidential
research record orally, in writing, or by electronic means to any
person or entity, or to provide the means for obtaining the records.
(c) "Confidential research record or records" means any data or
information in a personally identifying form, including name, social
security number, address, employer, or other information that could,
directly or indirectly, in part or in sum, lead to the identification
of the individual research subject, developed or acquired by any
person in the course of conducting research or a research study
relating to HIV or AIDS.
(d) "HIV" means human immunodeficiency virus.
121075. Research records, in a personally identifying form,
developed or acquired by any person in the course of conducting
research or a research study relating to HIV or AIDS shall be
confidential, and these confidential research records shall not be
disclosed by any person in possession of the research record, nor
shall these confidential research records be discoverable, nor shall
any person be compelled to produce any confidential research record,
except as provided by this chapter.
121080. Confidential research records may be disclosed in
accordance with the prior written consent of the research subject
with respect to whom the research record is maintained, but only to
the extent, under the circumstances, to the persons, and for the
purposes the written consent authorizes. Any disclosure authorized by
a research subject shall be accompanied by a written statement
containing substantially the same language as follows:
"This information has been disclosed to you from a confidential
research record the confidentiality of which is protected by state
law and any further disclosure of it without specific prior written
consent of the person to whom it pertains is prohibited. Violation of
these confidentiality guarantees may subject you to civil or
criminal liabilities."
121085. (a) Confidential research records shall be protected in the
course of conducting financial audits or program evaluations, and
audit personnel shall not directly or indirectly identify any
individual research subject in any report of a financial audit or
program evaluation. To the extent it is necessary for audit personnel
to know the identity of individual research subjects, authorized
disclosure of confidential research records shall be made on a
case-by-case basis, and every prudent effort shall be exercised to
safeguard the confidentiality of these research records in accordance
with this chapter. Information disclosed for audit or evaluation
purposes should be used only for audit and evaluation purposes and
may not be redisclosed or used in any other way.
(b) Nothing in this section imposes liability or criminal sanction
for disclosure of confidential research records in accordance with
any reporting requirement for a case of HIV, including AIDS, by the
department or the Centers for Disease Control and Prevention under
the United States Public Health Services.
121090. Notwithstanding Section 121080, whether or not the research
subject, with respect to whom any confidential research record is
maintained, gives prior written consent, the content of the
confidential research record may be disclosed in any of the following
situations:
(a) To medical personnel to the extent it is necessary to meet a
bona fide medical emergency of a research subject.
(b) To the department to the extent necessary for the conduct of a
special investigation pursuant to Section 100325, in which case the
confidentiality provisions of Chapter 8 (commencing with Section
121025) shall apply.
121095. The content of any confidential research record shall be
disclosed to the research subject, the legal representative of the
research subject if the research subject is a minor, or the personal
representative of a deceased research subject to whom the record
pertains, thirty (30) days after written request therefor by the
research subject, the legal representative or the personal
representative.
121100. (a) No confidential research record may be compelled to be
produced in any state, county, city or other proceeding in order to
initiate or substantiate any criminal charge or charges against a
research subject, or to conduct an investigation of a research
subject, unless a court finds there is reasonable likelihood that the
records in question will disclose material information or evidence
of substantial value in connection with the criminal charge or
charges or investigation, and there is no other practicable way of
obtaining the information or evidence.
In addition, no confidential research record shall be disclosed,
discoverable, or compelled to be produced in order to initiate or
substantiate any criminal charge or charges against a research
subject until after a showing of good cause. In assessing good cause,
the court shall weigh the public interest and need for disclosure
against the injury to the research subject and the harm to the
research being undertaken. Upon the granting of an order to produce,
the court, in determining the extent to which disclosure of all or
any part of a confidential research record is necessary, shall impose
appropriate safeguards against unauthorized disclosure, that shall
include, but not necessarily be limited to, the individuals or bodies
that may have access to the data, the purposes for which the data
shall be used, prohibitions on further disclosure and protection of
the identities of other research subjects.
(b) No confidential research record may be compelled to be
produced in any state, county, city or other civil proceeding, except
as expressly provided in this chapter.
121105. Prior to participation of an individual in a research study
relating to HIV or AIDS, both of the following requirements shall be
met:
(a) The informed consent of each research subject shall be
obtained in the method and manner required by Section 46.116, (a) and
(b), of Part 46 of Title 45 of the Code of Federal Regulations and
be documented in accordance with Section 46.117 of that part.
(b) Each research subject shall be provided with an explanation in
writing, in language understandable to the research subject, of the
rights and responsibilities of researchers and research subjects
under this chapter.
121110. (a) Any person who negligently discloses the content of any
confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not to exceed two
thousand five hundred dollars ($2,500), plus court costs, as
determined by the court, which penalty and costs shall be paid to the
subject of the test.
(b) Any person who willfully or maliciously discloses the content
of any confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not less than five
thousand dollars ($5,000) and not more than ten thousand dollars
($10,000), plus court costs, as determined by the court, which
penalty and costs shall be paid to the subject of the test.
(c) Any person who willfully, maliciously, or negligently
discloses the content of any confidential research record, as defined
in subdivision (c) of Section 121125, to a third party, except
pursuant to this chapter, that results in economic, bodily, or
psychological harm to the research subject, is guilty of a
misdemeanor, punishable by imprisonment in the county jail for a
period not to exceed one year, or a fine of not to exceed twenty-five
thousand dollars ($25,000), or both.
(d) Any person who commits any act described in subdivision (a) or
(b) shall be liable to the subject for all actual damages for
economic, bodily, or psychological harm that is a proximate result of
the act.
(e) Any person who negligently or willfully violates Section
121105 is guilty of an infraction punishable by a fine of twenty-five
dollars ($25).
(f) Each violation of this chapter is a separate and actionable
offense.
(g) Nothing in this section limits or expands the right of an
injured research subject to recover damages under any other
applicable law.
121115. In the event that the participation of an individual in a
research study is disclosed, the information shall not be used to
determine the employability or insurability of the research subject.
121120. Nothing in this chapter shall preclude disclosure of
information in order to further research efforts, including, but not
limited to, the publication, dissemination, or sharing of raw data,
statistics, or case studies, so long as no confidential research
records concerning any research subject are disclosed.
121125. For purposes of this chapter:
(a) "AIDS" means acquired immunodeficiency syndrome.
(b) "Disclosed" means to disclose, release, transfer, disseminate,
or otherwise communicate all or any part of any confidential
research record orally, in writing, or by electronic means to any
person or entity, or to provide the means for obtaining the records.
(c) "Confidential research record or records" means any data or
information in a personally identifying form, including name, social
security number, address, employer, or other information that could,
directly or indirectly, in part or in sum, lead to the identification
of the individual research subject, developed or acquired by any
person in the course of conducting research or a research study
relating to HIV or AIDS.
(d) "HIV" means human immunodeficiency virus.
121075. Research records, in a personally identifying form,
developed or acquired by any person in the course of conducting
research or a research study relating to HIV or AIDS shall be
confidential, and these confidential research records shall not be
disclosed by any person in possession of the research record, nor
shall these confidential research records be discoverable, nor shall
any person be compelled to produce any confidential research record,
except as provided by this chapter.
121080. Confidential research records may be disclosed in
accordance with the prior written consent of the research subject
with respect to whom the research record is maintained, but only to
the extent, under the circumstances, to the persons, and for the
purposes the written consent authorizes. Any disclosure authorized by
a research subject shall be accompanied by a written statement
containing substantially the same language as follows:
"This information has been disclosed to you from a confidential
research record the confidentiality of which is protected by state
law and any further disclosure of it without specific prior written
consent of the person to whom it pertains is prohibited. Violation of
these confidentiality guarantees may subject you to civil or
criminal liabilities."
121085. (a) Confidential research records shall be protected in the
course of conducting financial audits or program evaluations, and
audit personnel shall not directly or indirectly identify any
individual research subject in any report of a financial audit or
program evaluation. To the extent it is necessary for audit personnel
to know the identity of individual research subjects, authorized
disclosure of confidential research records shall be made on a
case-by-case basis, and every prudent effort shall be exercised to
safeguard the confidentiality of these research records in accordance
with this chapter. Information disclosed for audit or evaluation
purposes should be used only for audit and evaluation purposes and
may not be redisclosed or used in any other way.
(b) Nothing in this section imposes liability or criminal sanction
for disclosure of confidential research records in accordance with
any reporting requirement for a case of HIV, including AIDS, by the
department or the Centers for Disease Control and Prevention under
the United States Public Health Services.
121090. Notwithstanding Section 121080, whether or not the research
subject, with respect to whom any confidential research record is
maintained, gives prior written consent, the content of the
confidential research record may be disclosed in any of the following
situations:
(a) To medical personnel to the extent it is necessary to meet a
bona fide medical emergency of a research subject.
(b) To the department to the extent necessary for the conduct of a
special investigation pursuant to Section 100325, in which case the
confidentiality provisions of Chapter 8 (commencing with Section
121025) shall apply.
121095. The content of any confidential research record shall be
disclosed to the research subject, the legal representative of the
research subject if the research subject is a minor, or the personal
representative of a deceased research subject to whom the record
pertains, thirty (30) days after written request therefor by the
research subject, the legal representative or the personal
representative.
121100. (a) No confidential research record may be compelled to be
produced in any state, county, city or other proceeding in order to
initiate or substantiate any criminal charge or charges against a
research subject, or to conduct an investigation of a research
subject, unless a court finds there is reasonable likelihood that the
records in question will disclose material information or evidence
of substantial value in connection with the criminal charge or
charges or investigation, and there is no other practicable way of
obtaining the information or evidence.
In addition, no confidential research record shall be disclosed,
discoverable, or compelled to be produced in order to initiate or
substantiate any criminal charge or charges against a research
subject until after a showing of good cause. In assessing good cause,
the court shall weigh the public interest and need for disclosure
against the injury to the research subject and the harm to the
research being undertaken. Upon the granting of an order to produce,
the court, in determining the extent to which disclosure of all or
any part of a confidential research record is necessary, shall impose
appropriate safeguards against unauthorized disclosure, that shall
include, but not necessarily be limited to, the individuals or bodies
that may have access to the data, the purposes for which the data
shall be used, prohibitions on further disclosure and protection of
the identities of other research subjects.
(b) No confidential research record may be compelled to be
produced in any state, county, city or other civil proceeding, except
as expressly provided in this chapter.
121105. Prior to participation of an individual in a research study
relating to HIV or AIDS, both of the following requirements shall be
met:
(a) The informed consent of each research subject shall be
obtained in the method and manner required by Section 46.116, (a) and
(b), of Part 46 of Title 45 of the Code of Federal Regulations and
be documented in accordance with Section 46.117 of that part.
(b) Each research subject shall be provided with an explanation in
writing, in language understandable to the research subject, of the
rights and responsibilities of researchers and research subjects
under this chapter.
121110. (a) Any person who negligently discloses the content of any
confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not to exceed two
thousand five hundred dollars ($2,500), plus court costs, as
determined by the court, which penalty and costs shall be paid to the
subject of the test.
(b) Any person who willfully or maliciously discloses the content
of any confidential research record, as defined in subdivision (c) of
Section 121125, to any third party, except pursuant to this chapter,
shall be assessed a civil penalty in an amount not less than five
thousand dollars ($5,000) and not more than ten thousand dollars
($10,000), plus court costs, as determined by the court, which
penalty and costs shall be paid to the subject of the test.
(c) Any person who willfully, maliciously, or negligently
discloses the content of any confidential research record, as defined
in subdivision (c) of Section 121125, to a third party, except
pursuant to this chapter, that results in economic, bodily, or
psychological harm to the research subject, is guilty of a
misdemeanor, punishable by imprisonment in the county jail for a
period not to exceed one year, or a fine of not to exceed twenty-five
thousand dollars ($25,000), or both.
(d) Any person who commits any act described in subdivision (a) or
(b) shall be liable to the subject for all actual damages for
economic, bodily, or psychological harm that is a proximate result of
the act.
(e) Any person who negligently or willfully violates Section
121105 is guilty of an infraction punishable by a fine of twenty-five
dollars ($25).
(f) Each violation of this chapter is a separate and actionable
offense.
(g) Nothing in this section limits or expands the right of an
injured research subject to recover damages under any other
applicable law.
121115. In the event that the participation of an individual in a
research study is disclosed, the information shall not be used to
determine the employability or insurability of the research subject.
121120. Nothing in this chapter shall preclude disclosure of
information in order to further research efforts, including, but not
limited to, the publication, dissemination, or sharing of raw data,
statistics, or case studies, so long as no confidential research
records concerning any research subject are disclosed.
121125. For purposes of this chapter:
(a) "AIDS" means acquired immunodeficiency syndrome.
(b) "Disclosed" means to disclose, release, transfer, disseminate,
or otherwise communicate all or any part of any confidential
research record orally, in writing, or by electronic means to any
person or entity, or to provide the means for obtaining the records.
(c) "Confidential research record or records" means any data or
information in a personally identifying form, including name, social
security number, address, employer, or other information that could,
directly or indirectly, in part or in sum, lead to the identification
of the individual research subject, developed or acquired by any
person in the course of conducting research or a research study
relating to HIV or AIDS.
(d) "HIV" means human immunodeficiency virus.
