IRB Meeting
Investigator's Handbook  

SCOPE AND PURPOSE OF THE IRB

IRB MEMBERSHIP
INSTITUTIONAL REVIEW BOARD OFFICE
WHAT NEEDS IRB REVIEW
WHO NEEDS IRB REVIEW
TYPES OF IRB REVIEW
RESEARCH ETHICS EDUCATION POLICY
SUBMISSION DEADLINES AND APPROVAL PROCEDURES
PREPARING AN APPLICATION FOR IRB REVIEW
INFORMED CONSENT
RECRUITMENT AND SELECTION OF SUBJECTS
FOOD AND DRUG ADMINISTRATION REGULATIONS
RESPONSIBILITIES OF THE PI FOR RESEARCH IN PROGRESS
EMERGENCY USE OF EXPERIMENTAL DRUGS OR DEVICES
HUMAN SUBJECT RESEARCH WITHOUT PRIOR IRB REVIEW

IRB Members

IRB members are appointed by the President of the UTHSCSA from the various sections of the medical center, other institutions that rely on the IRBs and from the community at large to ensure that the committee:

1) is sufficiently qualified to safeguard the rights and welfare of human research subjects; and

2) possesses the professional competence necessary to review a specific research activity, and to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

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The IRB-1 consists of a Chair and twenty-two members, alternates who attend meetings in their absence and  various ex-officio members (see below)  The Chair is appointed to a three-year term and may be appointed additional terms in part based on guidance by the IRB Steering Committee.  Members are appointed to three-year terms and may be appointed to additional terms in part based on guidance by the IRB Steering Committee.  Terms of alternate members vary.  IRB-1 reviews new research protocol applications.  There are various ex-officio members.  The Director of the IRB is an ex-officio voting member.  Mental Health Advocates are sought to represent family members of persons affected by mental illness as ex-officio voting members, along with a Prisoner Representative.  Other ex-officio members include an at-large faculty representative, and the representative of the UTHSCSA administration who serves as legal counsel to the IRB. Changes are under way to merge the duties of IRB-1 and IRB-3 as of October 2007 (See home page).

The IRB-2 consists of a Chair, eight members, a deputy chair and alternates who attend meetings in the members’ absence, and an ex-officio voting member who is a prisoner representative.  The Chair is appointed to a three-year term.  Members are appointed to three-year terms.  Terms of alternate members vary.  The Chair and the members may be appointed to additional terms.  IRB-2 performs continuing review of all studies originally approved by IRB-1 and IRB-3.

The IRB-3 consists of a Chair and eleven members, a deputy chair and alternates who attend meetings in their absence, and an ex-officio member who is a prisoner representative.  The Chair is appointed to a three year term.  Members are appointed to three-year terms.  Terms of alternate members vary.  Both the Chair and the members may be appointed to additional terms in part based on guidance by the IRB Steering Committee.  IRB-3 reviews new Oncology research protocol applications, including those which are NCI funded Multicenter Oncology Cooperative Group studies, such as those of Southwest Oncology Group, Children’s Oncology Group, Radiation Therapy Oncology Group and the National Surgical Adjuvant Bowel & Breast Project.  Protocol amendments for active Oncology research studies are also reviewed by IRB-3. Changes are under way to merge the duties of IRB-1 and IRB-3 as of October 2007 (See home page).

The IRB Steering Committee provides guidance on policies and procedures for the IRBs in consultation with the UTHSCSA Institutional Official.  The IRB Director chairs the committee, which is made up of the IRB Chairs and other representatives of the faculty and the UTHSCSA administration.

 

  
 

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