Institutional Review Board

Claim of Exemption

DO NOT USE THIS FORM FORCATEGORY 4 EXEMPTION: Research involving the collection or study of already existing data, documents, records, pathological specimens, or diagnostic specimens. Use Claim of Exemption-Category 4 form.
Study Information
1.IRBNumber: / (assigned by the IRB staff)
2.Protocol Title:
3.Principal Investigator:
Department:
Address:
Phone: / () -
Fax: / () -
E-Mail:
4.Co-Investigator:
Department:
Address:
Phone: / () -
Fax: / () -
E-Mail:
8.Primary Contact:
Phone:
Fax: / () -
E-Mail: / () -

Statement of Financial Interests

By the signatures below, each investigator is certifying that either no financial interest exists or a complete listing of all financial interests related to the proposed project is provided. All individuals named below further acknowledge their responsibility to disclose any new reportable financial interest obtained during the term of the project. The Principal Investigator’s signature also certifies that all individuals required to make disclosures have been listed below:

Do you, your spouse, or dependent children have a financial interest in the work to be conducted under the proposed project?
1.NoYes: Attach Financial Disclosure Form
Signature of Principal InvestigatorDate
2.NoYes: Attach Financial Disclosure Form
Signature of Co-InvestigatorDate
Exemption Categories
Check the appropriate categories that apply to your research project. See Exemption Categories for details.
1.Research conducted in established or commonly accepted educational settings involving normal educational practices.
2.Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the following two conditions exist:
a) information is recorded in such a manner that the human subjects can be identified directly, or through identifiers linked to the subjects; and
b) any disclosure of the subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Note: This exemption applies to research with children or individuals with mental handicaps as follows:
i) research involving the use of educational tests is exempt; ii) research involving survey or interview procedures is not exempt; iii) research involving observations of public behavior is exempt only when the investigator does not participate in the observed activities.
3.Research that is not exempt under category 2 above (involving elected or appointed public officials or candidates for public office, etc.)
5.Research to study, evaluate, or otherwise examine: a) public benefit or service programs; b) procedures for obtaining benefits or services under these programs, etc. Examples are Medicare, food stamps, and welfare benefits.
6.Taste and food quality evaluation and consumer acceptance studies.
Summary Information
1.Please describe the study population(s).
2.Please indicate the number of subjects to be involved. Age range:
Research involving survey or interview procedures involving minors is not exempt (see Category 2 above)
3.What is (are) the source(s) of the subjects?
4.Briefly describe the purpose of the project and attach a copy of the research protocol and any other study related materials (consent documents, questionnaires, etc.).
5.Will subjects be identifiable either by name or through demographic data?
If yes, please describe how the confidentiality of subjects’ identities will be maintained and plans for maintaining or destroying identifying links to subjects after the study is completed. / YesNo
6.Will data be recorded by audiotape or videotape?
If yes, please describe how subjects' identity will be protected in the study records/taped responses, and plans for maintaining or destroying tapes. / YesNo
7.If survey instruments will be used, describe the time that it will take subjects to complete them, the frequency of administration, and the setting in which they will be administered. Please submit a copy of all instruments for this study, including all surveys, questionnaires, focus group questions, etc.
Note: Exploration of sensitive or private topics is not an exempt activity. N/A
8.To insure voluntary participation, briefly describe the recruitment procedures. Attach a copy of any material (verbal or written) used to recruit subjects (flyers, cover letters, telephone scripts, etc.).
9.Informed Consent: An appropriate consent document can consist of a consent form to be signed by the subject and/or parent/guardian, information sheet, survey cover letter, verbal consent script, or a letter tothe subjects. If requesting a waiver or alteration of the requirements for informed consent this should be justified by completing either section A or B below. (indicate below)
Consent document(s) attached.
A. Waiver of Consent Requested B. Waiver of Documentation of Consent Requested

A. APPLICATION FOR WAIVER OF INFORMED CONSENT

1.Explain why the proposed study presents no more than minimal risk(including minimal risk to privacy) to the subject.
2.Describe why the research could not practicably be performed without the waiver or alteration of informed consent.
3.Explain why a waiver or alteration of informed consent will not adversely affect the rights/welfare of the subjects.
4.Will subjects be provided with additional pertinent information after their participation? / No Yes
5.If "Yes," describe the process and submit any post-enrollment information sheets or consent forms for review. If "No," explain why it is not appropriate to do so.

B. APPLICATION FOR WAIVER OF DOCUMENTATION OF INFORMED CONSENT

45 CFR §46.117(c): An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) the only record linking the subject and the research would be the consent document; or (2) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
A waiver of the documentation of consent is requested because:
The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
The IRB may require the investigator to provide subjects with a written statement regarding the research.
HIPAA APPLICABILITY
If you will have access to (see or review) protected health information (PHI) as any part of this study, including identifying subjects for recruitment, even if no PHI will be collected (recorded),you must obtain a HIPAA Authorization or an IRB Waiver of HIPAA Authorization. To qualify for Exemption under Category 2 you must not record any information concerning any subject that has any of the following "Identifiers" or is coded so that subjects can be identified. Will you record any of the following identifiers to complete your research?
  • Names (including names of other individuals connected to the subject, e.g. relatives, employers)
  • Addresses (include any that are in any way associated with the subject, e.g. relatives, employers)
  • Telephone & Fax numbers
  • All geographic designators
  • E-mail addresses
  • Social Security numbers
  • Medical record numbers
  • Health plan beneficiary numbers
  • URLs & IP numbers
  • Device identifiers, such as pacemaker serial numbers
/
  • Biometric identifiers, including finger and voice prints
  • Any and all account numbers
  • Any Certificate/license numbers
  • Vehicle identifiers, such as serial numbers and license plate numbers
  • All elements of dates, with the exception of the year, including birth date, admission dates, discharge dates, date of death.
    All ages > 89 must be reported as age 90
  • Full face photographic images
  • Any other unique identifying number, characteristic or code
/ Yes
Not Exempt under Category 2.
Do not use this form.
No
Continue with this form.

ACCESS TO PROTECTED HEALTH INFORMATION

1.What is the sourceof health information?
2.Will you require access to a patient’s entire medical record?
Yes: for identification of eligible subjects for recruitment.
for conduct of protocol. / No
3.If Yes, please explain why such access is necessary.

APPLICATION FOR WAIVER OF HIPAA AUTHORIZATION

1.The research cannot be practicably conducted without the waiver because: / The data records used are inactive.
Subjects are no longer at the institution and site is not required to track individuals once discharged.
Data records are part of an enormous registry, and it would be impractical to contact subjects.
Explain:
Other (explain):
2.The research is (i) no more than minimal risk to the privacy of the subject and (ii) the research cannot be practicably conducted without access to and use of PHIbecause: / PHI is needed to identify subjects who are eligible for study participation.
PHI is needed to answer the research question. Explain:
Other (explain):

IRB USE ONLY

Your request for a Waiver of Informed Consent been reviewed and approved pursuant to
45 CFR §46.116(d).
Your request for a Waiver ofwritten documentation of informed consent has been reviewed and approved pursuant to 45 CFR §46.117(c). The investigator must:
provide subjects with a written statement regarding the research.; and/or

read to subjects from a prepared script regarding the research.

Your request for a Waiver of HIPAA Authorization has been reviewed and approved. All criteria for Waiver of HIPAA Authorization andhave been met.
Institutional Review Board Chair, Vice-Chair or Designee
Signature / Approval Date

Claim of Exemption – 03-16Page 1 of 7