42.1. IRB Questionaire
C. DECEPTION - If any deception (withholding of complete information) is required for the validity of this activity, explain why this is necessary and attach debriefing statement.
1. Approximate number and ages How Many Subjects: Age Range of Subjects: How Many Normal/Control: Age Range of Normal/Control: 2. Criteria for selection:
3. Criteria for exclusion:
4. Source of Subjects (including patients):
5. Who will approach subjects and how? Explain steps taken to avoid coercion.
6. Will subjects receive payments, service without charge, or extra course credit?
Yes or No (If yes, what amount and how? Are there other ways to receive similar benefits?)
7. Location(s) where procedures will be carried out.
E. RISKS AND BENEFITS (ADVERSE EFFECTS)
1. Describe nature and amount of risk and/or adverse effects (including side effects), substantial stress, discomfort, or invasion of privacy involved.
2. Will this study preclude standard procedures (e.g., medical or psychological care, school attendance, etc.)? If yes, explain.
3. Describe the expected benefits for individual subjects and/or society.
F. ADVERSE EFFECTS
1. How will possible adverse effects be handled? By investigator(s):
Referred by investigator(s) to appropriate care: Other (explain):
2. Are facilities/equipment adequate to handle possible adverse effects? Yes or No (If no, explain.)
3. Describe arrangements for financial responsibility for any possible adverse effects. Bacone College compensation (explain): Sponsoring agency insurance: Subject is responsible: Other (explain):
G. CONFIDENTIALITY OF RESEARCH DATA
1. Will data be coded? Yes or No 2. Will master code be kept separate from data?
Yes or No 3. Will any other agency have access to identifiable data?
Yes or No (If yes, explain.) 4. How will documents, data be stored and protected? Locked file: Computer with restricted password: Other (explain): VIII. Checklist to be completed by Investigator(s)
A. Will any group, agency, or organization be involved? Yes or No (If yes, please confirm that appropriate permissions have been obtained.)
B. Will materials with potential radiation risk be used (e.g. x-rays, radioisotopes)? Yes or No 1.
Status of annual review by BACONE COLLEGE Radiation Sources Committee (RSC). Pending or Approved (If approved, attach one copy of approval notice.) 67
2. Title of application submitted to BACONE COLLEGE RSC (if different).
C. Will human blood be utilized in your proposal? Yes or No (If yes, please answer the following)
1. Will blood be drawn? Yes or No (If yes, who will draw the blood and how is the individual qualified to draw blood? What procedure will be utilized?)
2. Will the blood be tested for HIV? Yes or No
3. What disposition will be made of unused blood?
4. Has the Bacone College designated Occupational Health Officer been contacted? Yes or No
D. Will non-investigational drugs or other substances be used for purposes of the research?
Yes or No Name: Dose: Source: How Administered:
E. Will any investigational new drug or other investigational substance be used?
Yes or No [If yes, provide information requested below and one copy of:
1) available toxicity data;
2) reports of animal studies;
3) description of studies done in humans;
4) concise review of the literature prepared by the investigator(s); and
5) the drug protocol.] Name: Dose: Source: How Administered: IND Number:
Phase of Testing: F. Will an investigational device be used? Yes or No (If yes, provide name, source description of purpose, how used, and status with the U.S. Food and Drug Administration FDA).
Include a statement as to whether or not device poses a significant risk.
Attach any relevant material.)
G. Will academic records be used? Yes or No H.
Will this research involve the use of: Medical, psychiatric and/or psychological records Yes or No
Health insurance records Yes or No
Any other records containing information regarding personal health and illness Yes or No
If you answered "Yes" to any of the items under "H.", you must complete the HIPAA worksheet.
I. Will audio-visual or tape recordings or photographs be made? Yes or No
J. Will written consent form(s) be used? (Yes or No. If no, explain.) (Please use accepted format from
our website. Be sure to indicate that participation is voluntary. Provide a stand-alone copy; do not
include the form here.)