Title 24, Chapter 9, Section 40.2
( 24-9-40.2)
(a) The General Assembly finds and declares that protecting the
confidentiality of research data from disclosure in administrative
proceedings, civil and criminal judicial proceedings, and
quasi-judicial proceedings is essential to safeguarding the
integrity of research in this state, guaranteeing the privacy of
individuals who participate in research projects, and ensuring the
continuation of research in science, medicine, and other fields that
benefits the citizens and institutions of Georgia and other states.
The protection of such research data has more than local
significance, is of equal importance to all citizens of the state,
is of state-wide concern, and consequently is properly a matter for
regulation under the police power of the state. (b) As used in this Code section, the term "confidential raw
research data" means medical information, interview responses,
reports, statements, memoranda, or other data relating to the
condition, treatment, or characteristics of any person which is
gathered by or provided to a researcher: (1) In support of a research study approved by an appropriate
research oversight committee of a hospital, health care facility,
or educational institution; and (2) With the objective to develop, study, or report aggregate or
anonymous information not intended to be used in any way in which
the identity of an individual is material to the results. The term does not include published compilations of the raw research
data created by the researcher or the researcher's published
summaries, findings, analyses, or conclusions related to the
research study. (c) Confidential raw research data in a researcher's possession
shall not be subject to subpoena, otherwise discoverable, or deemed
admissible as evidence in any administrative, civil, criminal, or
other judicial proceeding in any court except as otherwise provided
in subsection (d) of this Code section. (d) Confidential raw research data may be released, disclosed,
subject to subpoena, otherwise discoverable, or deemed admissible as
evidence in a judicial or quasi-judicial proceeding as follows: (1) Confidential raw research data related to a person may be
disclosed to that person or to another person on such person's
behalf where the authority is otherwise specifically provided by
law; (2) Confidential raw research data related to a person may be
disclosed to any person or legal entity designated to receive that
information when that designation is made in writing by the
research participant or where a designation is made in writing by
a person authorized by law to act for the participant; (3) Confidential raw research data related to a person may be
disclosed to any agency or department of the federal government,
this state, or any political subdivision of this state if those
data are required by law or regulation to be reported to that
agency or department;
(4) Confidential raw research data may be disclosed in any
proceeding in which a party was a participant, researcher, or
sponsor in the underlying research study, including but not
limited to any judicial or quasi-judicial proceeding in which a
research participant places his or her care, treatment, injuries,
insurance coverage, or benefit plan coverage at issue; provided,
however, that the identity of any research participant other than
the party to the judicial or quasi-judicial proceeding shall not
be disclosed, unless the researcher or sponsor is a defendant in
the case; (5) Confidential raw research data may be disclosed in any
proceeding in which the researcher has either volunteered to
testify or has been hired to testify as an expert by one of the
parties to the proceeding; and (6) In a criminal proceeding, the court shall order the production
of confidential raw research data if the data are relevant to any
issue in the proceeding, impose appropriate safeguards against
unauthorized disclosure of the data, and admit confidential raw
research data into evidence if the data are material to the
defense or prosecution. (e) Nothing in this Code section shall be construed to permit,
require, or prohibit the disclosure of confidential raw research
data in any setting other than an administrative, judicial, or
quasi-judicial proceeding that is governed by the requirements of
this title. (f) Any disclosure of confidential raw research data authorized or
required by this Code section or any other law shall in no way
destroy the confidential nature of that data except for the purpose
for which the authorized or required disclosure is made. |