West Texas A&M University

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WTAMU Research: Institutional Review Board Resource Toolbox

Institutional Review Board (IRB)

Resource Toolbox

The resource toolbox contains a listing of regulations, reports, documents, and websites that researchers may need when conducting human subjects research.

FWA - Federalwide Assurance

The FWA (Federalwide Assurance) is the agreement between West Texas A&M University and the federal government. The WTAMU identification number is FWA 000012607 and is approved until 12/2013. The WTAMU IRB is also registered with the federal government and identified as IRB 00002071 and IORG00001611. These identification numbers can be used to search for more details on the Office for Human Research Protections (OHRP) website.

WTAMU Policies and Procedures for Protection of Human Subjects in Research:

West Texas A&M University has specific policies and procedures for the establishment and operation of the WTAMU IRB. The WTAMU IRB institutional official is Dr. J.Patrick O’Brien, President of the University. Dr. Angela Spaulding is the Dean of the Graduate School and the Vice President of Research and Compliance for the University and supervises the operations of the IRB. Dr. Gary Bigham is Chair of the IRB and is broadly engaged with the IRB members and staff. The IRB is directly accountable to the Office of Human Research Protections of the Department of Health and Human Services federal agency.

 

Based on United States Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(b)(4) and (5) require that institutions have written IRB procedures for each of the following:

(1) the procedures which the IRB will follow for conducting its initial review of research; See SOP 15.99.05.W1.08AR Institutional Review Board for Human Subjects – Initial Review of Research Procedure

(2) the procedures which the IRB will follow for conducting its continuing review of research; See SOP 15.99.05.W1.09AR Institutional Review Board for Human Subjects – Continuing Review of Research Procedure 

(3) the procedures which the IRB will follow for reporting its findings and actions to investigators and the institution; See SOP 15.99.05.W1.05AR Potential Non-Compliance in the Course of Human Subjects Research  

(4) the procedures which the IRB will follow for determining which projects require review more often than annually; See SOP 15.99.05.W1.12AR Institutional Review Board for Human Subjects – Determining Which Projects Require More Often Than Annually Procedure 

(5) the procedures which the IRB will follow for determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; See SOP 15.99.05.W1.11AR Institutional Review Board for Human Subjects – Post Approval Monitoring Procedure 

(6) the procedures which the IRB will follow for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject; and See SOP 15.99.05.W1.10AR Institutional Review Board for Human Subjects – Amendment of Research Procedure 

(7) the procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, any Department or Agency head, and OHRP of

(a) any unanticipated problems involving risks to subjects or others (hereinafter referred to as unanticipated problems);

(b) any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB; and

(c) any suspension or termination of IRB approval.

See SOP 15.99.05.W1.13AR Institutional Review Board for Human Subjects – Unanticipated Problems & Serious Adverse Events

Standard Operating Procedure for Potential Non-Compliance in the Course of Human Subjects Research

 
This procedure, which applies to all faculty, staff and students, affiliated researchers, or other affiliated individuals involved in human subjects research, describes the process, reporting requirements, and obligations in the case of reports of potential non-compliance in the course of human subjects research.
 

Federal Regulations: 45 CFR 46

Federal regulations mandate how research with human subjects is conducted. The Code of Federal Regulations (CFR) provides the definition of research and human subjects. These definitions determine if IRB review is needed. The IRB itself also is defined in the federal regulations.

Office of Human Subjects Research

The Office of Human Subjects Research (OHSR) operates within the Office of the Deputy Director for Intramural Research (DDIR), National Institutes of Health (NIH). The NIH is part of the U.S. Public Health Service (PHS) which is an agency within the Department of Health and Human Services (DHHS).

Belmont Report

The Belmont Report provides guidelines to researchers as they design and conduct their research studies. The three principles highlighted include respect for persons, beneficence, and justice.

Declaration of Helsinki

The Declaration of Helsinki provides outlines ethical principles for medical research involving human subjects.

Nuremberg Code

The Nuremberg Code provides directives to researchers for human experimentation.

OHRP: Office for Human Research Protections

The Office of Human Research Protections (OHRP) is the leadership body within the U.S. Department of Health and Human Services that ensures the rights, welfare, and well-being of human subjects participating in research. The OHRP provides clarification and guidance, education, regulatory oversight, and ethical advice on biomedical and behavioral research.

American Psychological Association: Ethical Principles of Psychologists and Code of Conduct

The American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct.

American Anthropological Association: Code of Ethics

Guidelines for making ethical choices in the conduct of their anthropological work.

American Sociological Association: Code of Ethics

Principles and ethical standards that underlie sociologists' professional responsibilities and conduct.

Society for Research in Child Development: Ethical Standards

Ethical standards for research with children.