HSC APPROVAL CHECKLIST

 

THE FOLLOWING CHECKLIST IS INCLUDED TO HELP GUIDE YOU IN THE COMPLETION OF THE HSC HUMAN RESEARCH APPROVAL FORM.  PLEASE REFER TO IT AS NECESSARY.

 

  1. Administrative
    1. Are the appropriate number of copies submitted? 
    2. Are copies of each informed consent form submitted (see further information below about consent forms)?
    3. Are copies of each questionnaire and/or example stimuli submitted?
    4. Have you attached a “gatekeeper” letter, if necessary.   For example, if you are conducting a study in a school, have you attached written permission from the principal or superintendent?

      

  1. Scientific Aspects
    1. Is the hypothesis stated?
    2. Is the research design appropriate?
    3. Does the information to be collected provide a means to answer the hypothesis?
    4. Is a sample size calculation performed?  If not, is it necessary?

 

  1. Human Subjects Issues
    1. Is the study population defined?
    2. Are there any anticipated problems from using this study population?  Is it appropriate for the hypothesis to be tested?  Are subject  recruitment procedures documented?  Will the study be advertised? Is subject  compensation addressed?
    3. Are the risks adequately defined?
    4. Are the potential benefits clearly defined to the subjects and to society?
    5. Do the benefits outweigh the risks?
    6. How are the subjects protected from risks?

 

  1. Consent Form
    1. Is the study title on each page of the consent form with the investigator's name and contact phone numbers and e-mail addresses? Be sure to include all CCSU contact information (phone & e-mail) for Human Studies contacts: Ms. Kaplan and Dr. Waite  (see sample consent form for model)
    2. Is there a clear description of the study goals, design and implementation?
    3. Is there a clear description of potential risks?
    4. Is there a clear description of what is expected of the subject such as extra visits, extra tests, and the duration of the subject's participation?
    5. Are all of the standard University statements included, such as confidentiality, withdrawal, subject rights, and compensation provided, if any? (see sample consent form for model)
    6. Is the consent form readable and in clear, easy to understand lay terms?  Are there spelling, typographical, or grammatical errors?
    7. If your study involves children (e.g., minors under the age of 18 years) have you provided a copy of the consent letter/form that you will use with parents or guardians and the assent form that you will use with the minors.

Each HSC Form and supporting materials can submitted in either of two ways:

 

Preferred mode of submission: You can copy and paste the form into a word document, fill it out, and send as an e-mail attachment (saved as a Word document or .pdf file). We strongly prefer e-mailed submissions with all supporting documents (e.g., consent forms, instruments) saved into the same single file as the form.  Emailed forms should be sent to Ms. Mimi Kaplan (kaplan@ccsu.edu) and to Dr. Bradley Waite (Waite@ccsu.edu).

Alternate mode of submission:  You can copy and paste the form into a word document, fill it out, print it, and send the correct number of hard copies with all supporting documents (e.g., consent forms, instruments), as specified on the form.   Hard copies should be sent to Mimi Kaplan, Sponsored Programs, Barnard 102.

(important note: Before you submit your form and supporting materials, please check to ensure that your submission is complete, is consistent with relevant ethical principles and procedures, is free of typographical and other errors, and that the quality of the material is deemed to be suitable for human studies review and distribution to potential participants, as appropriate.)

 

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v. 1-2005