HUMAN SUBJECTS APPROVAL PACKET TO: Deans, Research Directors, and Department Heads FROM: Barbara Talbot, Office of University Research firstname.lastname@example.org 257-5075 phone 257-5079 fax http://research.latech.edu/ SUBJECT: Human Use Committee Forms, Procedure, and Policy The Human Use Committee is pleased to serve the University by striving to ensure that research projects involving human subjects comply with governmental, legal and University guidelines. As you know, this compliance protects the researcher and the University as well as the research participants. In an effort to facilitate Committee approval, the Human Use Committee adopted new standardized forms to assist researchers. The use of these new forms will make submission of projects to the Committee easier, faster and more likely to meet speedy approval. Attached please find some information for your use. Please duplicate them, as necessary, and distribute them to your faculty, staff and anyone doing research projects. 1) Study/Project Information for Human Subjects Committee. This provides the suggested outline for the abstract of the project. The researchers are encouraged to retype the outline, using as much space for each section as their project requires. 2) Human Subjects Consent Form. This provides the recommended format for the Consent Form. Once again, please retype using as much space as your project requires. Also include samples of any questionnaire or form you intend to use. 3) Sample Approved Form A sample of the review form has been provided as an example. 4) Educational Resource/Training A publication issued by the U. S. Department of Energy entitled "Protecting Human Research Subjects" has also been included as a handy general reference guide. This same brochure can be found online at http://www.science.doe.gov/ober/humsubj/brochure/brindex.html An educational video featuring three programs can be checked out from UR. This video includes Evolving Concern: Protection for Human Subjects, Balancing Society’s Mandates: Criteria for Protocol Review, and The Belmont Report: Basic Ethical Principles and their Application. For more information, read the Belmont Report at the following link: http://ohrp.osophs.dhhs.gov/irb/irb_introduction.htm This entire IRB packet is available online at the University Research website under Campus Forms as well as Proposal Preparation (Institutional Review Boards). 5) Human Use IRB Committee The Committee encourages submission at least two weeks before the research begins and annually hereafter. Contact Dr. Les Guice (257-3056), Dr. Mary Margaret Livingston (257-2292 or 257-4315) to answer any questions you may have regarding review process. 7) Policy 7108 Use of Human Subjects Revision Date: Spring 1995 Responsible Office: Vice President for Research and Development Reference: Department of Health and Human Services USE OF HUMAN SUBJECTS Louisiana Tech University has filed an Assurance of Compliance with the Department of Health and Human Services regarding its implementation of the provisions of the regulations for the protection of human research subjects. All research projects involving human subjects, both sponsored and non-sponsored projects, must be reviewed and approved by the Institutional Review Board for Use of Human Research Subjects before the research project is initiated as well as periodically during the conduct of the research project. A faculty member planning to conduct a research project or to supervise a student's research project that will involve the use of human subjects should contact the Chair of the Human Use Committee and the Dean of the Graduate School and University Research to secure the criteria to which he/she must adhere. DEPARTMENT HEAD APPROVAL FORM TO: Project Directors FROM: Barbara Talbot, Office of University Research email@example.com 318-257-5075 phone 318-257-5079 fax http://research.latech.edu/ SUBJECT: HUMAN USE COMMITTEE REVIEW DATE: Please submit this page signed by your Department Head or Dean when submitting a proposal to the Human Use Committee for expedited approval. Their signature is stating that they are aware of this proposal and/or survey that is being conducted. (print or type below) Department _______________________________ Department Head Name _______________________________ __________________________ Signature Date (Actual original signature required) Do you plan to publish this study? □YES □NO Will this study be published by a national organization? □YES □NO COMMENTS: STUDY/PROJECT INFORMATION FOR HUMAN SUBJECTS COMMITTEE Describe your study/project in detail for the Human Subjects Committee. Please include the following information. TITLE: PROJECT DIRECTOR(S): EMAIL: PHONE: DEPARTMENT(S): PURPOSE OF STUDY/PROJECT: SUBJECTS: PROCEDURE: INSTRUMENTS AND MEASURES TO INSURE PROTECTION OF CONFIDENTIALITY, ANONYMITY: RISKS/ALTERNATIVE TREATMENTS: BENEFITS/COMPENSATION: SAFEGUARDS OF PHYSICAL AND EMOTIONAL WELL-BEING: Note: Use the Human Subjects Consent form to briefly summarize information about the study/project to participants and obtain their permission to participate. HUMAN SUBJECTS CONSENT FORM The following is a brief summary of the project in which you are asked to participate. Please read this information before signing the statement below. TITLE OF PROJECT: PURPOSE OF STUDY/PROJECT: PROCEDURE: INSTRUMENTS: RISKS/ALTERNATIVE TREATMENTS: The participant understands that Louisiana Tech is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. The following disclosure applies to all participants using online survey tools: This server may collect information and your IP address indirectly and automatically via “cookies”. BENEFITS/COMPENSATION: I, ___________________, attest with my signature that I have read and understood the following description of the study, "________________________", and its purposes and methods. I understand that my participation in this research is strictly voluntary and my participation or refusal to participate in this study will not affect my relationship with Louisiana Tech University or my grades in any way. Further, I understand that I may withdraw at any time or refuse to answer any questions without penalty. Upon completion of the study, I understand that the results will be freely available to me upon request. I understand that the results of my survey will be confidential, accessible only to the principal investigators, myself, or a legally appointed representative. I have not been requested to waive nor do I waive any of my rights related to participating in this study. ________________________________ _____________ Signature of Participant or Guardian Date CONTACT INFORMATION: The principal experimenters listed below may be reached to answer questions about the research, subjects' rights, or related matters. Members of the Human Use Committee of Louisiana Tech University may also be contacted if a problem cannot be discussed with the experimenters: Dr. Les Guice (257-3056) Dr. Mary M. Livingston (257-2292 or 257-4315) STUDY/PROJECT INFORMATION FOR HUMAN SUBJECTS COMMITTEE Describe your study/project in detail for the Human Subjects Committee. Please include the following information. TITLE: An exploration of personality characteristics and mood state. PROJECT DIRECTOR(S): Professor XYZ EMAIL: xxx PHONE: xxx DEPARTMENT(S): Behavioral Sciences PURPOSE OF STUDY/PROJECT: To determine the relationship, if any, between socialized personality characteristics and mood state. SUBJECTS: Louisiana Tech University students selected from psychology classes. PROCEDURE: Approximately 200 students from introductory psychology classes will voluntarily complete a packet of self-report inventories, including a sex role questionnaire, a depression inventory, and a self-efficacy survey. Data will then be analyzed to determine the relationship among these variables. INSTRUMENTS AND MEASURES TO INSURE PROTECTION OF CONFIDENTIALITY, ANONYMITY: The 21 items Beck Depression Inventory (BDI) developed by Aaron T. Beck will be used to assess mood. The Bem Sex-Role Inventory (BSRI), a 60 item inventory developed by Sandra Bem, will be utilized to assess sex-role. The 27 item Self-Efficacy Scale (SES) developed by Robert Tipton and Everett Worthington will be used to measure self-efficacy. Additionally, a brief self- report instrument developed by the researchers will be used to collect demographic information and additional characteristics. All collected information will be held confidential and only viewed by the researchers RISKS/ALTERNATIVE TREATMENTS: The participant understands that Louisiana Tech is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. BENEFITS/COMPENSATION: None SAFEGUARDS OF PHYSICAL AND EMOTIONAL WELL-BEING: This study involves no treatment or physical contact. All information collected from the survey will be held strictly confidential. No one will be allowed access to the survey other than the researchers. Note: Use the Human Subjects Consent form to briefly summarize information about the study/project to participants and obtain their permission to participate.
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