1

Date of Preparation:
WIUIRB #: (Include, if known)

Human Subjects in Research

Request for Claim of Exemption from Board Review[1]
Project Title:
Principal Investigator/Faculty Sponsor:
Address:
Telephone Number: / Fax Number:

E-Mail Address:

Co-PI or Student Investigator

Address

Telephone Number: /

Fax Number:

E-mail Address:

Primary Contact Person:

II. Funding

External Funding Agency (Name)
Internal Grant Program None
Contract or Grant Title if applicable*:
Contract or Grant if applicable #:

III. Principal Investigator’s Assurance

Signature certifies that the Principal Investigator understands and accepts the following obligations to protect the rights and welfare of research subjects in this study.
I recognize that as the Principal Investigator it is my responsibility to ensure that this research and the actions of all project personnel involved in conducting the study will conform to the IRB approved protocol, IRB requirements/policies, and all applicable Health and Human Services (HHS)/Family Education Rights and Privacy Act (FERPA)/Protection of Pupils Rights Amendment (PPRA)/Health Insurance Portability and Accountability Act (HIPAA) regulations.
I recognize that it is my responsibility to ensure that the study has been reviewed for scientific merit.
I recognize that it is my responsibility to ensure that the study has been reviewed for ethical content.
I recognize that it is my responsibility to ensure that there is constant open dialogue between myself and the co-investigators to ensure that the study is conducted correctly, and the safety and protection of the subjects are ensured.
I recognize that it is my responsibility to ensure that valid informed consent/assent has been obtained from all research subjects or their legally authorized representatives. I will ensure that all project personnel involved in the process of consent/assent are trained properly and are fully aware of their responsibilities relative to the obtainment of informed consent/assent according to the IRB guidelines and applicable federal regulations. I will use only the currently approved, IRB stamped informed consent form or script for recruiting subjects.
I will inform the IRB of any unanticipated adverse event or injury no later than two (2) business days following the time it becomes known that a subject suffered an adverse event/injury.
I will not initiate any change in protocol without IRB approval except when it is necessary to reduce or eliminate a risk to the subject in which case the IRB will be notified as soon as possible.
I will maintain all required research records and recognize the IRB is authorized to inspect these records.
I will inform the IRB immediately of any significant negative change in the risk/benefit relationship of the research as originally presented in the protocol and approved by the IRB.
I understand that IRB approval is valid for a maximum period of one year with continuing review by the IRB required at least annually in order to maintain approval status. I will not enter subjects on the study before IRB approval or if IRB approval expires. In the latter case, I will immediately contact the IRB to obtain permission to continue subjects in the research study.
I will inform the IRB immediately if I become aware of any violations of HHS regulations (45 CFR 46), FERPA regulations (34 CFR 99), PPRA regulations (34 CFR 98), HIPAA regulations (45 CFR 164.530), or IRB Policies and Procedures for the protection of human subjects.
I understand that failure to comply with all applicable HHS/FERPA/PPRA/HIPAA regulations, IRB Policies and Procedures and the provisions of the protocol as approved by the IRB may result in suspension or termination of my research project, notification of appropriate governmental agencies by the IRB, and/or suspension of my freedom to present or publish results.
I certify that as faculty sponsor that the student investigator is knowledgeable about the IRB Policies and applicable federal regulations governing research with human subjects and has sufficient training and experience to conduct this study in accord with the approved protocol. In addition I will meet with the student investigator on a regular basis to monitor study progress. Should problems arise I agree to be available personally to supervise the student investigator in solving them. If I will be away, I will arrange for an alternate faculty sponsor to assume my responsibilities.
I certify that all study personnel have completed the IRB education program and are certified, if applicable.
I certify that all study personnel have completed the HIPAA education program and are certified, if applicable.
I understand that, per Office of Human Research Protection/Federal Drug Administration guidelines, the IRB will be monitoring adherence to approved research protocols. The oversight process does not end with approval of a proposal. I understand that I am part of the collaborative effort to maintain the integrity of the human subjects’ research approval process and procedures to ensure continuous quality improvement and academic excellence at WIU.
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PRINCIPAL INVESTIGATOR (FACULTY SPONSOR) Print Name, Signature & Date
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CO-PRINCIPAL INVESTIGATOR Print Name, Signature & Date
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DESIGNATED REVIEWER (Chair/IRB Administrator) Print Name, Signature & Date

IV. Student Investigator’s Assurance (if applicable)

Student Investigator’s (Co-Principal Investigator’s) Assurance: By my signature as student investigator, I certify the above applicable assurances and that I will meet with my faculty sponsor on a regular basis to monitor study progress. If my faculty sponsor is away, I will meet with his/her arranged alternate faculty sponsor who will assume his/her responsibilities.
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CO-PRINCIPAL INVESTIGATOR (STUDENT) Print Name, Signature & Date
Exemption Categories Checklist
Exempt status applies to research activities in which the only involvement of human subjects will fall in one or more of the categories listed below. Please check-off the appropriate categories that apply to your research project. Note: These exemptions do not apply to research: a) involving minors, prisoners, fetuses, pregnant women, human in vitro fertilization; b) when there is additional involvement of human subjects beyond the categories listed below; c) when deception of subjects may be an element of research; or d) when the activity might expose the subject to discomfort or harassment beyond levels encountered in daily life.
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Exemption Categories
  1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as i) research on regular and special educational instructional strategies, or ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Note: This exemption is applicable to individuals who are mentally disabled only if research involved no change in the content, location, or procedures of instruction from those normally experienced by the subject.

  1. 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: i) information is recorded in such a manner that the human subjects can be identified directly, or through identifiers linked to the subjects; and ii) any disclosure of the subjects’ responses outside the research could reasonable 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 who are mentally disabled, 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.

  1. All research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures or observation of public behavior that is not exempt under category 2 above, i) if the human subjects are elected or appointed public officials or candidates for public office; or ii) federal statue(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter. Coding of records, statistical techniques, and physical or computerized methods for maintaining the security of stored data are among the available methods for ensuring confidentiality.

  1. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Note: this category is applicable to data, specimens, etc. that are already existing at the time that the research is proposed. If a link exists anywhere including, but not limited to the source material, this study will not qualify for exemption, but may qualify for expedited review.

  1. Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services (DHHS), and which are designed to study, evaluate, or otherwise examine: i) public benefit or service programs; ii) procedures for obtaining benefits or services under these programs; iii) possible changes in or alternatives to those programs or procedures; or iv) possible changes in methods or levels of payment for benefits or services under these programs.

  1. Taste and food quality evaluation and consumer acceptance studies, i) if wholesome foods without additives are consumed or ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Other: Not human subject research (e.g., research with cells from cadavers); please specify in the application.
Summary Information
1. Please describe the study population(s).
2. Please indicate the number of subjects:
3. What is (are) the source(s) of the subjects?
4. Briefly describe the purpose of the project.
Complete this section if you are requesting permission to study existing data, documents, records and/or biological specimens (Exemption category #4).
If you are requesting permission to study products of in-vitro fertilization or human fetuses, please do not complete this form. Submit an application to the Health Sciences IRB.
5. Will only currently existing or archived data, documents, records, or biological
specimens be used? Yes No
(If yes, please answer the following questions)
a. What is (are) the type(s) of specimens that will be used?
b. Were the data/biological specimens originally collected solely for research purposes?
(If “yes” is checked, please attach a copy of the IRB notice and approved consent form for the research responsible for the original data collection.) / Yes No
c. What is the source of the existing or archived data/biological specimens?
d. Is the source publicly available?
“Publicly available” means that the general public can obtain the data/biological specimens. Sources are not considered “publicly available” if access is limited to researchers. / Yes No
e. How are data/biological specimens identified when they are made available to your study team?
i. Direct Identifier (e.g., subject name, address, social security number, medical record number, etc.)
ii. Indirect Identifier (e.g., an assigned code used to track specimens )
iii. No Identifier (neither the researcher nor the source providing the data/biological specimens can identify
a subject based upon information provided with the data/biological specimens)
NOTE: If (i) or (ii) is checked above your study will not qualify for an exemption.
Please complete this section if you are requesting
Exemption under categories #1, 2, 3, 5, or 6.
  1. In order to ensure voluntary participation, describe the recruitment procedures. Attach a copy of any material (verbal or written) used to recruit subjects (e.g., flyers, cover letters, verbal recruitment, etc.) Please list the attached documents:

8. Describe in detail the research procedures in which subjects will participate. Include any supporting documents relevant to the research procedures (e.g., grant applications, dissertation proposals, protocols, etc.). 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, surveys, etc. Note: exploration of sensitive or private topics is not an exempt activity and Expidited/Full Review forms need to be filled out.
9. Will subjects be identifiable either by name or through demographic data? Yes No
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.
10. Will data be recorded by audiotape or videotape? Yes No
Please note that if subjects are identifiable by audio-tapes or video-tapes, the study may not qualify for exemption. Please submit a Section II application for expedited review. In addition, include the appropriate check boxes in the consent documents (see Informed Consent Template).
11. Informed Consent - Yes No
If yes, please attach an appropriate informed consent document[2] to this application. If subject participation is anonymous, an information sheet is recommended. If subject participation is not anonymous, please attach a consent form to this application or provide justification for a waiver of informed consent.

WIUIRB Claim of Exemption Form

Rev. 06/09/05

[1] This form is designed to be filled out on the computer; please submit forms electronically.

[2] An appropriate consent document can consist of a consent form, information sheet, survey cover letter, verbal consent script, or a letter to the subjects.