Check List by CLO4YG0


									                                 Texas A&M University-Commerce
                                     Pre-submission Checklist

General Review

   1. Have you completed the Protection of Human Subjects
      training or Responsible Conduct of Research training?            Y N N/A Unclear

   2. Does your protocol have signatures of three: the
      researcher, the advisor, and the departmental/college
      IRB representative?                                              Y N N/A Unclear

   3. Is your description of the study consistent throughout
      the protocol?                                                    Y N N/A Unclear

   4. In Research Team Roles, item #6, have you described
      the role of each member of the research team and indicated
      which research activities will be carried out by whom?           Y N N/A Unclear

   5. In Study Purpose, item #7, have you clearly stated what
      the purpose of the study is?                                     Y N N/A Unclear

   6. In Study Locations, item #14, if you will obtain data from
      other schools, or community organizations, is the research
      site letter attached?                                            Y N N/A Unclear

   7. In Recruitment Method, item #15, if you will use materials such
      as advertisements, flyers, telephone scripts, etc. to recruit
      participants, is a copy of material attached?                  Y N N/A Unclear

   8. In Protection of Confidentiality, item #19, have you included
      statement of where all data will be stored and who will have
      access them to ensure confidentiality?                           Y N N/A Unclear

   9. In Risk/Benefit Analysis, item #20, if the research falls into
      “minimal risk” category have you stated “There are minimal
      risks to participants, no more than expected in daily life”?     Y N N/A Unclear

   10. Are data collection materials attached? (e.g., instruments,
      interview questions, demographic forms)                          Y N N/A Unclear

   11. In the Informed Consent, did you use third person language
      rather than first person language?                               Y N N/A Unclear

   12. In the Informed Consent, did you make sure that you did
       not refer that this is for your thesis or dissertation?         Y N N/A Unclear

   13. Did you follow the informed consent template listed
       in the Graduate School website?                                 Y N N/A Unclear
Research Design
   14. Is the potential subject population appropriate given the
       research questions?                                            Y N N/A Unclear

   15. Is a copy of each data collection form included, unless it
       is a well accepted tool?                                       Y N N/A Unclear

Selection and Recruitment of Subjects
   16. Are especially vulnerable subjects being recruited? If yes
       please specify                                                 Y N N/A Unclear

   17. Are there additional safeguards planned to protect the
       rights and welfare of potentially vulnerable subjects?         Y N N/A Unclear

Privacy and Confidentiality
   18. Are methods used to obtain information about subjects
       identified and appropriate?                                    Y N N/A Unclear

   19. Is the use of personally identifiable information
       protected?                                                     Y N N/A Unclear

   20. Are methods identified to protect the confidentiality of
       research data? (i.e. coding, removal of identifying
       information, limiting access to data, etc.)                    Y N N/A Unclear

Risk/Benefit Analysis:
   21. Are reasonably foreseeable risks described?                    Y N N/A Unclear

   22. Are risks addressed?
       Physical                                                       Y   N   N/A   Unclear
       Psychological                                                  Y   N   N/A   Unclear
       Social                                                         Y   N   N/A   Unclear
       Economic                                                       Y   N   N/A   Unclear

   23. Are risks to subjects minimized through one of the following
       (a) sound research design and/or (b) procedures to protect
       the subject from unnecessary risks?                            Y N N/A Unclear

   24. Are there any undue burdens on potential
       subjects or guardians?                                         Y N N/A Unclear

   25. Have probable benefits of research to subjects
       and others been identified?                                    Y N N/A Unclear

   26. Are risks to subjects reasonable in relation to the benefits
       to subjects, if any; and the importance of knowledge
       to be gained?                                                  Y N N/A Unclear

   27. Are risks of research activities distinguished from
       the risks of therapy (when applicable)?                        Y N N/A Unclear
Informed Consent
   28. A statement that the study involves research                Y N N/A Unclear

   29. An explanation of the purposes of the research              Y N N/A Unclear

   30. An expected duration of the subject’s participation         Y N N/A Unclear

   31. A description of the procedures to be followed              Y N N/A Unclear

   32. A description of any reasonably foreseeable risks
       or discomforts to the subject                               Y N N/A Unclear

   33. A description of any benefits to the subject or to others
      which may reasonably be expected from the research           Y N N/A Unclear

   34. Financial or other compensation                             Y N N/A Unclear

   35. A statement describing the extent, if any, to which
      confidentiality of records identifying the subject will be
      maintained.                                                  Y N N/A Unclear

   36. Whom to contact for answers to pertinent questions
      about the research                                           Y N N/A Unclear

   37. A statement that participation is voluntary                 Y N N/A Unclear

   38. A statement that refusal to participate will involve no
       penalty or loss of benefits to which the subject is
       otherwise entitled                                          Y N N/A Unclear

   39. A statement that the subject may discontinue
       participation at anytime without penalty or loss of
       benefits, to which the subject is otherwise entitled        Y N N/A Unclear

   40. Written in plain, non-technical language                    Y N N/A Unclear

To top