§ Sec. 24-9-40.2. Confidentiality of raw research data

§ 24-9-40.2. Confidentiality of raw research data

 

(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.