version 8.26.02 for web HSC# ________________(leave blank)

CENTRAL CONNECTICUT STATE UNIVERSITY

HUMAN STUDIES COUNCIL (HSC)

PLEASE TYPE

PRINCIPAL INVESTIGATOR:__________________________________PHONE:_________

INVESTIGATOR'S MAILING ADDRESS_________________________________________

TITLE OF PRINCIPAL INVESTIGATOR:____________________________EMAIL____________

TITLE OF PROJECT:_______________________________________________________

________________________________________________________________________

· If this research is for thesis/graduate work or other student project, your supervising professor must sign below indicating approval for submission of proposal to HSC. (If you are submitting this electronically, then your supervising professor should submit a separate e-mail or letter indicating approval of your project).

CCSU

DEPT/CLASS:___________PROFESSOR'S SIGNATURE*__________________________

SPONSORING AGENCY (if applicable)_______________________________________

PROJECT START DATE:______________________CONTINUATION___________________

NEW PROPOSAL_____ OLD PROPOSAL WITH CHANGES_____ OLD PROPOSAL W/OUT CHANGES_____

IF OLD PROPOSAL, PREVIOUS HSC #______

PLEASE COMPLETE ALL PARTS OF THIS FORM

1. SUMMARIZE YOUR PROPOSED RESEARCH; OUTLINE OBJECTIVES AND METHODS

(Do not exceed 150 words) See #2 on Checklist.

2. SUMMARIZE ALL INVOLVEMENT OF HUMANS IN THIS PROJECT: (WHO, HOW MANY,

AGE, SEX, LENGTH OF INVOLVEMENT, FREQUENCY, ETC.)

3. INDICATE WHETHER ANY SUBJECT OF YOUR RESEARCH WILL BE SELECTED FROM THE

FOLLOWING CATEGORIES:

( ) Minors ( ) Pregnant women ( ) Mentally retarded

( ) Mentally disabled ( ) Physically disabled ( ) Prisoners

( ) Addicts ( ) Parolees ( ) Fetuses ( ) none of the above

4. CHECK ALL RISKS TO HUMANS INVOLVED IN YOUR PROJECT: (See #3C Checklist)

____ No risks

____ Deception

____ Personal material (interviews, opinions, test scores)

____ Stress or emotional arousal

____ Loss of privacy

____ Embarrassment, disappointment, or other disagreeable emotion

____ Alteration of self-concept (e.g., through knowledge of test scores)

____ Physical or psychological trauma or pain

____ Loss of legal rights

____ Experimental diagnostic procedures

____ Side effects of medications

____ Experimental treatment procedures

____ Contraction of disease

____ Worsening of illness

BRIEFLY EXPLAIN ANY OF THE ABOVE YOU CHECKED

5. INDICATE PROCEDURES TO PROTECT HUMAN PARTICIPANTS FROM RISKS

(Check all appropriate):

_____ Precautions in uses of stressors or emotional material

(explain below)

_____ When deception used, subjects full informed as to the nature of the

research at a feasible time (explain below)

_____ Procedures to minimize changes in self concept (explain below)

_____ Data from protected sources

_____ Code numbers will be used

_____ Individual data submerged in results

_____ No unauthorized use of data

_____ Data confidentiality will be used

_____ Debriefing on experimental purposes

_____ Clinical trial (describe data monitoring below)

_____ Sterile equipment

_____ M.D. or other appropriately trained individual in attendance

OTHER AND EXPLANATIONS

6. INDICATE HOW YOU WILL OBTAIN INFORMED CONSENT (see sample CONSENT FORM)

___ Subject or parent/guardian reads information on consent form and signs

(Please attach a copy of the consent form used)

___ Subject receives ORAL briefing (from principal investigator or project

personnel) and then gives ORAL consent.

(Please attach copy of the text of briefing and consent)

___ Other (please explain)

7. BRIEFLY DESCRIBE THE SOCIAL AND SCIENTIFIC BENEFITS THAT WILL ACCRUE TO

EACH HUMAN SUBJECT, OR TO HUMAN BEINGS IN GENERAL, AS A RESULT OF THE

INDIVIDUAL'S PARTICIPATION IN THE PROJECT:

DRUG FREE CERTIFICATION

As a condition of approval of this research, I certify that I will not

engage in the unlawful manufacturing, distribution, dispensing, possession

or use of a controlled substance in conducting any activity associated with

this research. (45 CFR 620, subpart F, Appendix C)

SCIENTIFIC MISCONDUCT STATEMENT

I certify that I am aware that Central Connecticut State University

does not tolerate scientific misconduct. The following PHS definition

(NPRM) is accepted by the University: "'Misconduct' or 'misconduct in

science' as used herein is defined as plagiarism, deception or other

practices that seriously deviate from those that are commonly accepted

within the scientific community for proposing, conducting or reporting

research; or (2) material failure to comply with federal requirements that

uniquely relate to the conduct of research."

________________________________________

Signature of Investigator

Date_____________________

*If you are submitting this form electronically check here______ and read section B below. Please note that you should also print one hard copy of this form and send it with your signature via mail to: Office of Sponsored Programs, Barnard Hall, Room 102. We must have a signed copy on file before we can approve the project.

A. If submitting paper copies: SUBMIT TEN (10) COPIES OF THIS FORM WITH THE FOLLOWING ATTACHED TO EACH COPY:

1. Copies of each consent form (written and/or verbal text)

2. Copies of all questionnaires, surveys, tests and other relevant material used

SEND OR DELIVER ALL COMPLETED FORMS TO:

Office of Sponsored Programs and Research Services, Barnard Hall, Room 102.

B. If submitting electronically: Submit a copy of this form, a copy of each consent form (written and/or verbal text), and a copy of all questionnaires, surveys, tests and other relevant material used attached as MS-Word (or similar standard file type) documents. E-mail to Kaplan@ccsu.edu.

Where to direct questions: Please call Ms. Mimi Kaplan, Assistant Director, Office of Sponsored Programs at 832-2366 or Dr. Bradley Waite, Chair, Human Studies Council at 832-3115, if you have questions about submissions.

Be sure that you also click on the HSC Sample Consent Form and the HSC Information Appendices that will help to guide you through this process. The following information is contained there:

The sample consent form is intended for your use as a “boilerplate” consent instrument. You will need to fashion your actual consent instrument in a format that is appropriate for and specific to your study and research participants.

Appendix A: Documentation of Informed Consent Checklist that was adapted from the Office for Human Research Protections, U. S. Department of Health and Human Services.

Appendix B: Contains information on who must use this form.

Appendix C: Contains an HSC APPROVAL CHECK LIST. The checklist is included to help guide you in the completion of the HSC Human Research Approval Form. Please refer to it as necessary.