-
Section I.
-
-
-
-
-
-
-
-
-
3. Funding Source
-
-
-
B. Will the research be conducted at external sites under the oversight of an external IRB? *
-
Will PSC investigators or staff interact with subjects, collect data or solicit consent at those external sites? *
-
-
C. Does PSC serve as the lead site with responsibility for data and/or safety monitoring? *
-
D. Does this study involve any international sites where the PI will either; 1) conduct 2) supervise or 3) receive data?
(If yes, you will need to fill out the International Research Addendum in addition to this application) *
-
-
Section II
PURPOSE OF THE STUDY AND BACKGROUND
-
-
B. What will be done with the information generated from this research once it is collected and analyzed? (check all that apply) *
-
-
CHARACTERISTICS OF THE SUBJECT POPULATION
-
-
-
4. Gender of the Subjects
Are there any enrollment restrictions based on gender? *
-
-
-
C. Will children (18 years of age or younger) be included in this research *
-
6. Race and Ethnicity
Are there any subject enrollment restrictions based upon race or ethnic origin? *
-
-
METHODS AND PROCEDURES
-
-
B. Does the research involve review of identifiable private information? *
-
-
-
RISK/BENEFIT ASSESSMENT
-
11. Potential Risks
A. Are there any potential risks associated with the research procedures, interventions or tests? *
-
-
C. Will the research involve the collection of identifiable private information? *
-
12. Potential Benefits to the Subject
Are there potential benefits to the subjects that may reasonably be expected from participation in the research? *
-
-
-
FINANCIAL COMPENSATION
-
14. Compensation to the Subject for Participation
Will the subject receive any compensation for participation? *
-
-
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT
-
-
-
-
16. Informed Consent
Describe the process of obtaining and documenting informed consent from subjects? Choose all that apply. *
-
-
SUBMISSION CHECKLIST
Check all that apply
-
-
-
-
-
-
-
-
I understand this is a legal representation of my signature.
Clear
-
General Information
Research activities in which the only involvement of human subjects will be in one or more of the categories specified by HHS Regulations at 45 CFR 46.101(b) or 21 CFR 56.104(d) may be exempt from the requirements of the regulations.
In accordance with PSC IRB policy, certain types of research activities are either not exempt or, depending upon the nature of the study, may not be exempt. Therefore, investigators should review this policy before submitting an application for exemption.
In order for research to qualify for exempt status, the attached Exemption Application must be submitted and certified as exempt by the PSC IRB.
EXEMPT REVIEW: Applications that qualify for exempt review have no submission deadline and can be reviewed independent of the IRB meeting schedule. The PSC IRB reserves the right to reclassify applications and/or refer those applications for either expedited review or full board review as appropriate. In some cases, investigators may be asked to resubmit the project using the IRB Application for Behavioral and Social Science Research.
Research personnel should notify the PSC IRB Office that exempt research is complete with the submission of the Study Closeout Report using MachForms.
-