IRB Exempt Eligibility Determination Form

IRB EXEMPT ELIGIBILITY DETERMINATION FORM

Instructions: Complete all questions regarding this research activity. Use as much space as necessary. See IRB Exempt Submission Checklist for required submission documents. Exemptions will not be permitted for research that uses a consent document, involves genetic research, or involves vulnerable subjects.
IMPORTANT: NO ACTIVITY MAY BEGIN ON THIS PROJECT UNTIL THE PRINCIPAL INVESTIGATOR HAS RECEIVED FORMAL NOTIFICATION THAT AN EXEMPTION HAS BEEN GRANTED BY THE IRB AND R&D COMMITTEE APPROVAL HAS BEEN OBTAINED.
PRINCIPAL INVESTIGATOR (Last, First, M.I., Degree) / HEALTH CARE GROUP, PHONE #
,
PROJECT TITLE AND MIRB NUMBER
PROPOSED STARTING DATE OF RESEARCH ACTIVITY / EXPECTED DURATION OF RESEARCH ACTIVITY
CO-INVESTIGATOR(S) NAME AND DEGREE(S) (Maximum of 2)
1. / 2.
BRIEF SUMMARY DESCRIPTION OF RESEARCH ACTIVITY
1. (a) Are you contributing to the design or conduct of the study or expect to coauthor a publication resulting from this study? Please describe your role in this research activity: / YES NO
2. Where are the subjects of this research activity (or their samples or data) located?
3. If the research activity is taking place elsewhere (not at VALBHCS), will you have direct contact or intervention with the human subjects? (Examples: as subject’s physician; in obtaining samples directly from the subject; by interviewing the subject?) / YES NO
4. Has the activity been reviewed and approved by an Institutional Review Board (IRB) elsewhere? If “Yes”, specify which IRB, when reviewed, name and contact for P.I., and attach approval memo from that IRB. / YES NO
5. What kind of human samples (e.g., tissue, blood) or data (e.g., private information, chart review, questionnaires) will be involved?
6. What is the source of the samples or data
7. Will you be: Collecting Receiving Sending these samples or data?
If “Yes”, are the samples or data you expect to collect, receive or send anonymous?
NOTE: The IRB must review and approve the use of existing samples or data that are coded and may be linked in any way to an individual, or that contain personal identifiers. The use of samples or data that are anonymous may be considered for exemption from IRB review and approval. / YES NO
YES NO
8. If you will be sending data or samples off site, do those samples or data contain personal identifiers or are coded and can be linked in any way to subjects?
If “Yes”, please describe where and to whom the samples or data will be sent, and how confidentiality will be protected. / YES NO N/A
9. (a) Do the samples or data already exist?
(b) Are the samples or data being collected for the express purpose of this study? (may check both)
If “Yes”, please describe: / YES NO
YES NO
10. Do the samples or data come from individuals who may need special safeguards (e.g., individuals less than 18 years of age, pregnant women, or prisoners)? If “Yes”, please specify: / YES NO
11. Use this checklist to determine which exemption category can be declared based upon the protocol:
Category 1 (Both boxes must be checked for the research to qualify for this exemption):
Research conducted in established or commonly accepted educational settings.
The research involves normal educational practices, such as
-Research on regular and special education instructional strategies or
-Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
The research is NOT subject to FDA regulation.
Category 2 ( One box under each subheading must be checked in order for the research to qualify for this exemption):
Research involves the use of one or more of the following:
Educational tests (cognitive, diagnostic, aptitude, achievement)
Survey procedures
Interview procedures
Observation of public behavior
Information obtained is recorded in such a manner that either:
Participants CANNOT be identified, directly or through identifiers linked to the participants
Participants CAN be identified, directly or through identifiers linked to the participants, however, any disclosure of the participants’ responses outside the research could NOT reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, or reputation
The research is NOT subject to FDA regulation.
Category 3 (All subheadings must be checked and at least one box under the second and third subheading must be checked in order for the research to qualify for this exemption.
The research is NOT exempt under category 2 above.
The research involves the use of one or more of the following:
Educational tests (cognitive, diagnostic, aptitude, achievement)
Survey procedures
Interview procedures
Observation of public behavior
Either of the following is true:
The participants are elected or appointed public officials or candidates for public office.
Federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
The research is NOT subject to FDA regulation.
Category 4 (Both subheadings and one box under the second subheading must be checked in order for the research to qualify for this exemption):
The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens (The reviewed materials currently exist and are NOT prospectively collected.)
At least one of the following are true:
These sources are publicly available.
Information is recorded by the investigator in such a manner that both of the following are true: (The investigator should describe what information will be recorded and how it will be recorded.)
-Participants cannot be directly identified.
-Participants cannot be identified through identifiers linked to them.
The research is NOT subject to FDA regulation.
Category 5 (All subheadings must be checked in order for the research to qualify for this exemption.)
The project is a research or demonstration project.
The project is conducted by or subject to the approval of Department or Agency heads
The project is designated to study, evaluate, or otherwise examine:
-Public benefit or service programs;
-Procedures for obtaining benefits or services under those programs;
-Possible changes in or alternatives to those programs or procedures; or
-Possible changes in methods or levels of payment for benefits or services under those programs.
The program under study delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).
The project is conducted pursuant to specific federal statutory authority.
There is no statutory requirement that an IRB review the project.
The project does not involve significant physical invasions or intrusions upon the privacy of participants.
The research is NOT subject to FDA regulation.
Category 6 (The first subheading plus one additional subheading must be checked in order for the research to qualify for this exemption):
The research involves a taste and food quality evaluation and consumer acceptance studies if one of the following is true.
Wholesome foods without additives will be consumed.
A food will be consumed that contains a food ingredient at or below the level to be safe and for a use found to be safe
A food will be consumed that contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
12.SIGNATURE OF INVESTIGATOR / DATE
13. Review of organization’s ethical standards by IRB Chair:
The research holds out no more than minimal risk to subjects
Selection of subjects is equitable
If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data
If there are interactions with subjects:
There will be a consent process that will disclose the following information:
That the activities involve research
The procedures to be performed
The time it will take to complete the research procedures
That participation is voluntary
Name and contact information for the investigator
There are adequate provisions to maintain the privacy interests of subjects
14. The project has been reviewed by the Chair, IRB. Action taken:
PROJECT EXEMPT FROM IRB REVIEW
Exemption #______above applies
Does not involve human subjects or associable private data
Involves only existing publicly available or anonymous samples/data
Project is not research
PROJECT NOT EXEMPT, QUALIFIES FOR: EXPEDITED FULL IRB REVIEW NOT HUMAN SUBJECTS RESEARCH
COMMENTS
14. SIGNATURE OF CHAIRPERSON, IRB / DATE

VALBHCS Version Date: 12/14/2007

Replaces Version Date: 7/12/2007