Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 25 - Departmental Research › Section I-2509 - Policies and Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A. Policy
				  Basis. Research conducted and authorized by the DHH will meet all applicable
				  federal and state laws and regulations, accreditation standards, and
				  professional codes of ethics. These policies derive primarily from 45 CFR, Part
				  46, Protection of Human Subjects and are also consonant with 21 CFR, Parts 50
				  and 56, adopted by the Food and Drug Administration. (Both sets of regulations
				  were effective on August 19, 1991.)  45 CFR, Part 46  is applicable to other DHHS
				  components, including the Health Care Financing Authority (Medical Assistance
				  Programs).
B. Establishment of
				  Institutional Review Board (IRB). There is hereby established a DHH IRB to
				  review and evaluate all proposed research projects.
1. Twenty-four hour facilities may either
				  utilize these policies as written or amend them to provide for an in-house IRB
				  for initial assessment of research projects prior to submission to the DHH IRB
				  for final review.
2. All research
				  involving DHH consumers, employees, or services in the community and in
				  institutions will be reviewed by the DHH IRB before it is submitted to the
				  secretary or designee for final approval.
3. The IRB is a permanent standing committee
				  which meets quarterly or as needed.
4. The membership shall consist of at least
				  seven members, appointed by the secretary, partly from recommendations by the
				  assistant secretaries and the director of the BHSF:
a. the director of research and development
				  or his/her designee shall serve as permanent chairperson of the IRB. In the
				  event of an extended absence from duty of the permanent chair, the secretary
				  shall appoint a temporary replacement to serve during that period;
b. each office and the BHSF shall have at
				  least one member;
c. relevant
				  professional disciplines shall be represented in the membership;
d. at least one member shall be a direct
				  service provider;
e. one member
				  shall not be employed by the DHH. If possible, this member should be an
				  ethicist (specialist in ethics) or an attorney;
f. at least one member shall be either a
				  primary consumer, or a family member, or an advocate;
g. at least one member's primary concerns
				  shall be in science areas and at least one member's primary concerns shall be
				  in nonscientific areas. If not selected under §2509. B.4 e, an attorney or
				  ethicist should fill the latter slot;
5. The IRB may, in its discretion, invite
				  individuals with competence in special areas to assist in the review of issues
				  which require expertise beyond or in addition to that available to the IRB.
				  Such individuals shall not vote with the IRB.
6. IRB members should have appropriate
				  research training, experience or interest. Membership should also sufficiently
				  represent the cultural, ethnic, and gender diversity of the state and be
				  sensitive to diverse community attitudes.
7. Except for the chair, members shall be
				  appointed for one-year terms and may be reappointed.
8. No IRB member may participate in the
				  initial or continuing review of any project in which the member has a
				  conflicting interest, except to provide information requested by the
				  IRB.
9. Once constituted, the IRB
				  shall adopt written bylaws and guidelines/application materials for conducting
				  research in DHH operated/funded programs or facilities.
10. Research approved by the Office of Public
				  Health's (OPH) IRB prior to the adoption of these policies does not require DHH
				  IRB approval. However, copies of proposals approved by the OPH IRB shall be
				  provided to the chair of the DHH IRB.