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HUMAN SUBJECTS RESEARCH DEVELOPMENT PROGRAM

HUMAN SUBJECTS RESEARCH DEVELOPMENT PROGRAM. THE REGULATIONS AND HOW WE IMPLEMENT THEM AT LSU HEALTH . LEGALLY AUTHORIZED REPRESENTATIVE (L.A.R.).

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HUMAN SUBJECTS RESEARCH DEVELOPMENT PROGRAM

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  1. HUMAN SUBJECTS RESEARCH DEVELOPMENT PROGRAM THE REGULATIONS AND HOW WE IMPLEMENT THEM AT LSU HEALTH

  2. LEGALLY AUTHORIZED REPRESENTATIVE (L.A.R.) • A legally authorized representative is an individual or body authorized under Louisiana law to provide permission on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (HRPP AND IRB SOP SECTION 5.2)

  3. NECESSITY OF L.A.R. Informed consent may only be obtained from subjects who have the legal and mental capacity to give consent. L.A.R. is necessary for: 1. Persons without Mental Capacity 2. Minors (under 18 years of age) (HRPP AND IRB SOP SECTION 5.5.1)

  4. EXCEPTIONS: WHEN MINORS MAY CONSENT • Treatment for Venereal Disease (La. R.S. 40:1065.1) • When minor is or believes himself to be afflicted with illness or disease (La. R.S. 40:1065.1) • Treatment to alleviate pain during labor/childbirth (La. R.S. 40:1065.1) • Treatment for Drug Abuse (La. R.S. 40:1065.1) • 17 year old may donate blood w/o compensation (La. R.S. 40:1065.1) • Preventive alcohol and addiction counseling provided by schools (La. R.S. 40:1065.1)

  5. L.A.R. CATEGORIES The following person(s) may consent to medical treatment for another individual: • Any adult, for himself. • The judicially appointed tutor or curator of the patient, if one has been appointed. • An agent acting pursuant to a valid mandate, specifically authorizing the agent to make health care decisions. • The patient's spouse not judicially separated.

  6. L.A.R. CATEGORIES (CONT’D) • A person chosen by the interdisciplinary team, as defined in R.S. 28:451.2, to make recommendations on behalf of an individual with a developmental disability, as defined in R.S. 28:451.2. The interdisciplinary team shall exercise discretion in choosing, by majority vote, the family member, friend, or other person most familiar with the individual or most capable of making the decision at issue. • A person chosen by an ad hoc team assembled by any interested person for the purpose of addressing the medical decision at issue for an individual with a developmental disability. (La. R. S. 40:1299.53)

  7. PRIORITY OF PERSON(S) • The foregoing list is in order of priority • If there is no person(s) in the prior class who are reasonably available, willing and competent to act, person(s) in the next class may act i.e. give consent. • If there is more than person in the class authorized to consent, not including the person chosen by the interdisciplinary or ad hoc team, consent may be given by a majority of the class members available for consultation

  8. LEGAL GUARDIANSHIP • Legal Guardian: A person appointed by a court of appropriate jurisdiction. (HRPP AND IRB SOP SECTION 5.2) • “Guardianship” means the judicial placement of a child under the duty and authority of a guardian to make decisions in matters having a permanent effect on the life and development of the child as set forth in Article 719. (La. Ch C. Art 116 (12.1)).

  9. CONCLUSION • QUESTIONS/DISCUSSION

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