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IRBForm.rtfUNIVERSITY OF DAYTON INSTITUTIONAL REVIEW BOARD
APPLICATION FOR APPROVAL TO USE HUMAN RESEARCH PARTICIPANTS
Please type all information. HANDWRITTEN FORMS WILL NOT BE ACCEPTED . Move through the document using TAB or Mouse. Do not use the enter Key. To mark a box, click with the mouse.
Project Title:
PART I: Please answer the following by checking the correct response:
Yes No 1. Will participants be identifiable to anyone other than the researchers through records, responses or identifiers linked to the participants?
Yes No 2. Could participants be at risk of criminal or civil liability, damage to employability or to financial standing, or undue embarrassment, if responses became known outside this research project?
Yes No 3. Does research deal with sensitive aspects of participants' behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol?
Yes No 4. Does research involve the collection or study of existing data from sources not publicly available? (existing data can be documents, records, pathological specimens or diagnostic specimens)
Yes No 5. Will participants be videotaped, audio taped or photographed?
Yes No 6. Are participants free to withdraw at any time without penalty?
Yes No 7. Is there deception of participants? (If so, answer questions #23-33 on page 5.)
Yes No 8. Does research deal with participants who are children under eighteen years? (If so, answer question #18 on page 4).
Yes No 9. Will identifiable medical information be collected?
- 10. Does research deal with participants who are:
Yes No___ not-legally-competent adults
Yes No ___ mentally disabled
Yes No___ physically challenged
Yes No___ pregnant women
Yes No___ prisoners
11. Does the project involve:
Yes No___ administering drugs
Yes No___ administering alcohol
Yes No___ administering nutritional supplements
Yes No___ drawing blood
Yes No___ taking tissue samples
Yes No___ giving injections
(If yes, answer question #16 on page 6).
PART II: Summarize proposed project including goals of present project, purpose of present study, and procedures to which humans will be subjected. (DO NOT WRITE "SEE ATTACHED")
Context
In this section include the back ground information about your study so it can be easily understood by a lay person.
Definition of Problem
Here you will discuss what you are trying to find out about by doing this research. Why is this study important?
Procedure
Finally, describe in detail what it is you will be doing in this study.
PART III: Please answer all of the following items. Spaces will expand to accommodate your descriptions.
Participants
11. Briefly describe the characteristics of your population(s) and your participant selection procedures. Describe the size of your sample, the ethnic background, sex, age, state of health and the criteria for inclusion or exclusion of participants. (Include rationale for use of special classes of participants such as pregnant women, children, institutionalized mentally disabled, prisoners, or those whose ability to give voluntary informed consent may be in question.) If your population is all one gender or ethnic group, please explain.
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12. Who makes the initial contact with the participants? (If you want to use patients/clients of another professional, the initial contact must be made by the other professional, to protect patient confidentiality).
Risks/Benefits
13. Identify any risks (here and in the consent form) -- physical, psychological, and/or social -- to which your participants may be exposed as a result of participation in your project (beyond the risks normally encountered in everyday life).
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a). What safeguards will you use to protect the participants from these risks, as well as to protect their rights, welfare and privacy? (Never answer "NA".)
b). Participants will be informed of the risks through:
consent form (include copy)
verbal (include script)
assent (for children 12 years of age and under) and consent from the childrens’ parents/guardians.
14. Describe any form of compensation to participants. (i.e., money, grade, extra credit, etc.)
15. Were alternative procedures considered?
Yes No Explain:
16. Describe the qualifications of the person administering drugs, alcohol, or nutritional supplements, or drawing blood, taking tissue samples or giving injections. (Note: 1) persons doing venipuncture must provide a copy of their certification to draw blood and proof they completed a blood-borne pathogens training course. 2) Indwelling venous catheters and lines can only be done by licensed/registered/certified medical personnel such as physicians, RNs, and EMTs. Proof of certification is required. 3) Arterial blood sampling can only be carried out in an appropriate medical facility such as a hospital or clinic. The procedure can only be carried out by qualified personnel under the direct supervision of a licensed physician.)
17. Describe the benefits expected to be gained from this project. (This should include any direct benefits to the participants as well as any general gain in knowledge.)
Children
18. If you will be using children under 18, explain in detail how you will obtain parental consent and assent (for children under 12; see page 8) or consent (for children 12 to 18). If assent/consent will be obtained orally, supply a script of what you will say and how you will give the children the opportunity to say "yes" or "no".
Records
19. What do you intend to do with the data collected? (i.e., publish data, present paper, erase tapes, etc.)
20. a). If the participants' personal files (school, medical, etc.) will be read, where are the files kept (name the place, e.g. doctor’s office, hospital, clinic, etc.) and who will gather the information?
b). Has permission been obtained to gather this information? (Attach documentation)
c). Do the participants (and/or their parents or guardians) know that these files will be read? If no, explain.
21. a). Will test results be disseminated to the participants (and/or their parents or guardians)?
b). If so, explain the qualifications of the person(s) interpreting the results.
22. Does the proposed study involve deception?
Yes If yes, fill out deception page.
No
