HUMAN SUBJECTS APPROVAL PACKET by ylc12017

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									                       HUMAN SUBJECTS APPROVAL PACKET


TO:                 Deans, Research Directors, and Department Heads

FROM:               Barbara Talbot, Office of University Research
                    btalbot@latech.edu
                    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
               btalbot@latech.edu
               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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