PROTOCOL REQUEST FORM
FOR WSU IRB APPROVAL
I. BACKGROUND INFORMATION
A. Principal Investigator / PhoneDepartment
PI Status / Faculty / Student / Staff / Other (specify)
B. Faculty Sponsor / Phone
C. Co-Investigator(s) Name(s) / Email / Phone
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Include additional names in a separate uploaded document if necessary.
D. Project Title (Include Proposal Title for externally-funded activities if different.)
E. Type of Review – See following page for definitions. Check only one box.
Full IRB ReviewExpedited Review
Exempt
Administrative (Only for approval of minor protocol adjustments)
F. Estimated dates of the project: / Start date / End date / \
II. SIGNATURES
Electronically signing this package indicates the following individuals (as applicable)
principal investigator,
faculty sponsor,
co-investigators and
any other individual responsible for the design and conduct of the study
agree to the following certification:
I certify that the information furnished concerning the procedures to be taken for the protection of human subjects is correct. I understand the IRB may inquire about the project at any time and a Project Status Report is required annually for multi-year projects. I will seek and obtain prior approval for a substantive modification in the protocol and will report promptly any unexpected or otherwise significant adverse effects encountered during the study.
III. TYPE OF REVIEW
Check the type of review you believe is most appropriate for this request. Only one check mark should appear on this page. On the cover page, also check the type of review required in I. E.
A. Full IRB Review –Review by Full IRB Required
1. Research supported by an external agency.2. Other research (not supported by external agencies) subject to regulation which does not fall under the Expedited or Exempt categories below.
B. Expedited Review – Review by Chair or Designee Required (See Regulation 3-7, VII.B.3., for list of expedited categories.
1. Projects involving research in those categories identified by the federal government as involving no more than minimal risk.2. Projects involving minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
C. Exempt from Full IRB Review – Review by Chair or Designee Required
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to subjects’ financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior that is not exempt under (2) above, if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. 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 through identifiers linked to the subjects.
5. Research and demonstration projects, which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payments for benefits or services under those programs.
6. 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 US Department of Agriculture.
IV. RESEARCH PROPOSAL INFORMATION
A. Description of the Research
Provide a 2-3 sentence description of the research project.
B. Purpose of the Research
Provide a 2-3 sentence description of the purpose of or scientific rationale for the research.
C. Subject Population – Note: If your project involves children (minors), prisoners, pregnant women, fetuses or human in vitro fertilization, contact the Human Protections Administrator for additional regulatory information before completing your protocol request.
1. Specify total number of adults and minors. Identify numbers in all other categories, as appropriate.
AdultsMinors (up to 18 years)
Total number of subjects
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minority groups (specify) / pregnant women
economically disadvantaged / Fetuses
educationally disadvantaged / human ova
mentally disabled / other vulnerable group (specify)
prisoners
2. How are subjects chosen (records, classes, referral, canvassing, etc.)? If subjects are chosen from records, indicate who gave approval for use of the records.
3. How are subjects initially contacted (ads, telephone, letter, etc :)?
4. Will subjects receive inducements to participate in the study or receive any benefits from participating in the study? If yes, explain.
5. Will the subjects be charged for any research-related procedures? If yes, explain.
D. Research Procedures (Check as many as are applicable.)
Observation of people in public placesObservational study that involves intervention or manipulation of the subjects’ environment
Review of existing privately held records
Surveys, questionnaires, interviews
Epidemiological study (identifying disease risk factors)
Case control study
Prospective study (observing events over time after subjects’ identification)
Clinical trial
Therapy, behavior modifications, etc.
Physical training, exercise, etc.
Other (Describe below)
E. Risks
Subjects may be “at risk” if exposed to physical, psychological, social or economic harm. Does this project involve:
Yes No
1. Use of privately held records containing confidential information, such as medical, mental health or educational records?2. Intrusion or observation of people in public places where privacy can be reasonably expected?
3. Any physical manipulation of subjects, such as changing dietary habits, requiring physical exertion, medical procedures or clinical trials?
4. Any manipulations of psychological or social variables, such as sensory deprivation, social isolation, or psychological stresses?
5. Use of a deceptive technique, (placebo, double-blind, etc.)? Note: Use of deception requires inclusion of a debriefing procedure in the protocol request.
6. Recording of responses to surveys, questionnaires and interviews in such a way that the subjects could be identified.
7. Collection of data that could place the subjects at risk of criminal or civil liability?
8. Collection of data that could be damaging to the subjects’ financial standing, employability or reputation?
9. Presentation of materials which subjects might consider offensive, threatening, or degrading?
10. Collection of sensitive information, such as information related to sexual practices, substance abuse, illegal behavior, medical conditions, psychological well-being or mental health?
11. Other: (Describe)
If the answer to any of the above was yes, what precautions have been taken to safeguard subjects’ welfare?
F. Confidentiality of Data
1. Will any data be made part of a permanent record that can be identified with the subject?
2. Will whether or not a subject participated in the study be made a part of any record available to other than the investigator(s) and their research staff? If so, who?
3. What steps will be taken to ensure confidentiality of the data during the study and over an extended period (if applicable)?
G. Informed Consent
Important: Use the Consent Guidelines and Consent Samples in the document library.
Informed consent is necessary for all research and other activities which involve human subjects. The requirement of obtaining a consent form signed by the subject or the subject's legally authorized representative(s) may be waived only by the IRB. (Note: Informed consent must always be documented in some manner.)
1. Describe the procedures used to obtain informed consent and attach copies of the consent form. (Use the Consent Guidelines and Consent Samples in the document library.)
2. If it appears necessary to use consent procedures different than those normally required, describe the procedures to be used and justify their use. NOTE: If you will not be securing any type informed consent, complete and submit a Consent Waiver Request form.
3. If the project involves vulnerable populations, what precautions will be taken to document their informed consent?
4. If a cooperating institution is involved, in terms of providing access to data or facilities, please provide evidence of their adherence to human subject regulations and, if appropriate, copies of the informed consent forms used by the cooperating institution.
5. Does the consent form include:
Yes NA (not applicable)
a. A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;b. A description of any reasonably foreseeable risks or discomforts to the subject;
c. A description of any benefits to the subject or to others which may reasonably be expected from the research;
d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
e. A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained;
f. For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained;
g. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research related injury to the subject; and
h. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.
6. If appropriate, does the consent form include:
Yes NA (not applicable)
a. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable;b. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
c. Any additional costs to the subject that may result from participation in the research;
d. The consequences of a subject’s decision to withdraw from the research, and procedures for orderly termination of participation by the subject;
e. A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject; and,
f. The approximate number of subjects involved in the study.
V. FINANCIAL INFORMATION
A. External Funding
1. For projects which involve (or may involve) external funding:
a. Date proposal was (will be) submitted to funding agency:b. If this project will be funded under a grant to another investigator, identify the source of funds, the title of the grant, and the investigator’s name and address.
SourceTitle
Name
Address
2. Name and address of person at funding agency and/or other cooperating institution(s) who should receive notice of WSU IRB approval (other than investigator).
B. Financial Conflicts of Interest
Financial conflicts of interests may have an impact on the protection of human subjects. If an investigator or co-investigator responds affirmatively to any of the following, the IRB may require modifications in the protocol or seek the advice of the Conflict Review Committee established by WSU Regulation 3-27, Conflicts of Significant Financial Interests Policy as Related to Grants and Sponsored Projects.
1. Are you or your spouses or dependents (dependent children or other relatives living at the same address) an officer, director, partner, trustee, employee, advisory board member, or agent of the external organization funding this sponsored project or of any organization from which goods and services will be obtained under the sponsored project?
Yes / No2. Are you or your spouse or dependents the actual or beneficial owner of more than five percent (5%) of the voting stock or controlling interest of the external organization funding this sponsored project or any external organization from which goods and services will be obtained under this sponsored project?
Yes / No3. Have you or your spouse or dependents derived income within the past year or do you or any member of your immediate family anticipate deriving income exceeding $10,000 per year from the external organization funding this sponsored project or any external organization from which goods and services will be obtained under the sponsored project?
Yes / No1/11/11