Application for Exemption from Human Studies Council Research Review

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Submit completed form as attachment to waite@mail.ccsu.edu and to Kaplan@mail.ccsu.edu or submit 2 paper copies to:

 

Mimi Kaplan, Office of Sponsored Programs, Room 102 Barnard Hall

Phone: 832-2366

 

PLEASE TYPE into bracket areas.  Use as much space as you need.

 

PRINCIPAL INVESTIGATOR (your name): [                   ]  PHONE:[             ]

 

INVESTIGATOR'S MAILING ADDRESS:[                        ]

 

TITLE OF PRINCIPAL INVESTIGATOR:[                    ]    E-MAIL:[               ]

 

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:[           ]

 

  1. See the listing of exemption categories attached at the end of this form.  In which of these exemption categories do you believe your project falls? ______ (insert  the specific number here)
  2. Please check Yes or No for each of the following items.

 

                ___Yes    ___No   1.   My research deals with sensitive topics (i.e., those dealing with behaviors, which, if publicly

                                                disclosed, could be damaging to participants or place them at risk of criminal or civil

prosecution.

           

___Yes    ___No   2.   My research participants may experience physical, emotional, or mental stress, discomfort

                                    or harm as a consequence of their participation (e.g., includes embarrassment, etc).

 

___Yes    ___No   3.  My research will include hospitalized, institutionalized, or mentally retarded persons;

                                    prisoners;  pregnant women or fetuses; or other members of a vulnerable population). 

 

If you answered “yes” to any of the above questions STOP HERE, your project does not qualify for exempt status;  you should apply for an expedited or full review.  See www.psychology.ccsu.edu/waite/human_studies_council.htm  to get the HSC form and to get further information (or call 832-2366).  Otherwise go on to items 4 and 5.

 

            ___Yes    ___No   4.  My research participants will include children under the age of 18 years.

 

            ___Yes    ___No   5.  My research will be conducted in a normal classroom setting and will involve only normal

           educational practices. 

If you answered “yes” to Item 4 and “no” to Item 5 STOP HERE, your project does not qualify for exempt status; you should apply for an expedited or full review.  See www.psychology.ccsu.edu/waite/human_studies_council.htm to get the HSC form and to get further information (or call 832-2366).  Otherwise, type a brief answer to each of the following :

 

1.   Describe the nature and purpose of your research. Be sure to describe your methods here (Do not exceed 150 words).

 

2.   Summarize all involvement of humans in this project.  (who, how many, age, sex, length of involvement, etc).

 

3.   Describe the procedures you will use to assure participants that their involvement in the project is voluntary and that there is no penalty for not participating.  Include verbatim instructions or text, as appropriate.

 

4.  Will the information you collect include identifiers of any kind?  Yes___          No___    

      If yes, describe the procedures you will use to inform your participants of this and to insure the confidentiality of their information.

 

 

PRINCIPAL INVESTIGATOR’S SIGNATURE*_______________________________________

      ·         Your signature indicates your belief that this study is exempt from review.

If you are submitting this electronically, check here ___ if you believe your study is exempt from review.

 

(below is for HSC use only)

 

____I certify that this project is exempt from review by the CCSU Human Studies Council.

 

____ I certify that this project is NOT exempt from review by the CCSU Human Studies Council.

 

___________________________________          __________

         Signature of HSC Chair or designate                                              date

 

 

BMW: 8-26-02. 

 

 

Exemption Categories

Research activities in which the only involvement of human participants will be in one or more of the following categories are exempt from review:

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

 Thanks to CSUSM for the foundations of this exemption form.