Exempt Eligibility Determination Form

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					                  Department of Veterans Affairs

                             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                  YES              NO
the subject; by interviewing the subject?)
4. Has the activity been reviewed and approved by an Institutional Review Board (IRB) elsewhere? If “Yes”,
                                                                                                                             YES              NO
specify which IRB, when reviewed, name and contact for P.I., and attach approval memo from that IRB.


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?                             YES               NO


If “Yes”, are the samples or data you expect to collect, receive or send anonymous?                                   YES               NO
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.
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?                                                                   YES          NO        N/A
If “Yes”, please describe where and to whom the samples or data will be sent, and how confidentiality will
be protected.
9. (a) Do the samples or data already exist?                                                                               YES           NO
    (b) Are the samples or data being collected for the express purpose of this study? (may check both)                    YES           NO
   If “Yes”, please describe:
10. Do the samples or data come from individuals who may need special safeguards (e.g., individuals less
                                                                                                                           YES           NO
than 18 years of age, pregnant women, or prisoners)? If “Yes”, please specify:

   VALBHCS Version Date: 12/14/2007
   Replaces Version Date: 7/12/2007
VALBHCS Version Date: 12/14/2007
Replaces Version Date: 7/12/2007
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.


  VALBHCS Version Date: 12/14/2007
  Replaces Version Date: 7/12/2007
  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

  VALBHCS Version Date: 12/14/2007
  Replaces Version Date: 7/12/2007
  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

				
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