La. Admin. Code tit. 48 § V-11709

Current through Register Vol. 50, No. 11, November 20, 2024

Section V-11709 - Use of Vital Records in Research

A. Definitions

Department-Department of Health and Hospitals

Human Subject-A person to whom the record pertains or his next of kin as described in R.S. 40:41(C).

Limited Research-The investigator or researcher provides the name, date and place of birth/death for all requests and assures that no contact with the subjects or subjects' families will occur.

Panel-Refers to Vital Records Review Panel consisting of the state health officer, the state registrar of vital records and the tumor registry administrator as described in R.S. 40:41(D), along with a representative from Louisiana State University Medical School-New Orleans and a representative from Tulane University Medical School.

Research-A systematic epidemiological and/or public health investigation designed to develop or contribute to medical knowledge.

B. Panel

1. Panel Members. The state health officer, the state registrar, and the tumor registry administrator form the nucleus of the panel and shall be called "Class A" members. One representative each from Louisiana State University, New Orleans and Tulane Medical Schools will be appointed for two-year terms by medical schools and shall be called "Class B" members. The state health officer may also appoint resource persons, who are not necessarily employed by the department to attend panel meetings and review proposals. These resource persons shall be called "Class C" members.

2. Panel Quorum. A quorum shall require the presence of two Class A members and one additional member from either Class A or Class B. Only Class A and Class B members may vote. A majority of the voting members present must concur via roll call vote for the panel to take action on the approval or disapproval of any application.

C. Public Health Research

1. Panel Records. Adequate documentation of the panel activities shall be maintained including the following:

a. copies of all research proposals reviewed, including attachments;

b. minutes of all panel meetings shall be in sufficient detail to show attendance at meetings, actions taken by the panel, the vote on the actions including the number of members voting for, against or abstaining, the basis for requiring changes in or disapproving research, and a written summary of controversial issues and their resolution;

c. copies of all correspondence;

d. the records required by these rules shall be retained for at least three years after completion of the research.

2. Application. A request for the use of vital records for research shall be in writing and shall be addressed to the State Registrar of Vital Records. The data request must include:

a. a complete experimental protocol including public health objectives, rationale for the study, design detail and scientific basis for selection of subjects;

b. a summary of the protocol;

c. a copy of the informed consent form and an outline of the consent process which meets the consent requirements described in these rules, as provided in Paragraph C.4;

d. provisions to protect the confidentiality of the data and the privacy of the subjects and their families;

e. resumes of all investigations, listing educational degrees and societies, certifying boards and academic institutions which have recognized their competence by granting membership, diplomate, or title, previous work in the subject area and employment;

f. approval from an institutional review board for this study or approval from and educational department chairman where the applicant is employed by or associated with an institution which requires such approval;

g. affirmation that a report of the findings resulting from the sue of the records shall be provided to the state health officer;

h. a signed agreement to indemnify and hold the department and its employees harmless from any liability arising out of authorized or unauthorized access to the vital records.

3. Confidentiality. The researcher must establish reasonable administrative, technical and physical safeguards to prevent unauthorized use or disclosure of the records. Information that allows the individual to be indentified must be removed or destroyed at the earliest time which is consistent with the purpose of the project.

4. Informed Consent

a. The following elements of informed consent must be provided to each subject when the research design calls for personal contact or other follow-up:

i. a statement that the study involves research, an explanation of the purpose of the research, the expected duration of the subject's participation, and a description of the procedure to be followed;

ii. a statement describing the extent to which confidentiality of records identifying the subject will be maintained;

iii. a statement describing the extent to which confidentiality of records identifying the subject will be maintained;

iv. an explanation of whom to contact for answers to pertinent questions about the research and the rights of the subject;

v. a statement that participation is voluntary. Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. The subject may discontinue participation at any time without penalty.

b. An investigator shall seek the consent of the subject under circumstances that provide sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

c. The information that is given shall be in language understandable to the subject.

d. In obtaining informed consent, no exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator or the sponsor from liability for negligence shall be used.

e. A written document embodying the elements of informed consent as described above must be signed by each subject. The original shall be retained by the investigator's research.

5. Criteria for Approval of Research. The following shall be the criteria for the approval of research.

a. The study objective and design reflect that the proposal is in the best interest of the public health.

b. The selection of subjects is made on a scientific basis.

c. The investigators/researchers are deemed qualified based on their past research, employment and education.

d. Where appropriate, as provided in Subparagraph C.2.f, approval of an institutional review board has been obtained.

e. Provisions to protect the confidentiality of the data and the subjects comply with Paragraph C.4.

f. The informed consent process and forms, follow the guidelines required in these rules and will be appropriately documented as required.

6. Notification. The panel shall notify requestors in writing of the decision to approve or disapprove the proposed study or of modifications required to secure approval of the research activity. If the committee disapproves a request, it shall include in its written notification a statement of the reasons for tits decision and give the investigator/researcher and opportunity to request reconsideration in writing.

7. Requests for Reconsideration. Requests for reconsideration must be field within 30 days of the date appearing on the notification. The principal investigator/researcher may be invited to appear at the hearing. The decision of the committee after reconsideration is final.

8. Fees. Fess for copies of certificates will be the same as those set forth in R.S. 40:40. The cost per reel for computer tape with no accompanying certificates will be $100.

9. Exception to Approval Process. Requests for vital records information may be approved by the state health officer or a duly authorized representative without being presented to the panel if the request is for a limited research and the investigator/researcher provides the name, date, and place of birth/death for all requests. An affidavit stating that no family members will be contacted and that stringent confidentiality procedures will be followed to protect the data and the privacy of the subject must be submitted. A signed hold harmless agreement and a description of the research design must be submitted. A signed hold harmless agreement and a description of the research design must be submitted.

La. Admin. Code tit. 48, § V-11709

Promulgated by the Department of Health and Human Resources, Office of Preventive and Health Services, LR 10:465 (June 1984), amended in the repromulgation by the Department of Health and Human Resource, Office of Preventive and Health Services, LR 13:246 (April 1987), revised and repromulgated by the Department of Health and Hospitals, LR 15:475 (June 1989).

AUTHORITY NOTE: Promulgate in accordance with R.S. 40:33(C) and 40:41(D)(1).