Western Oregon University - IRB Application - Editable Form

Institutional Review Board Application

Western Oregon University


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PART I

To receive approval from the WOU Institutional Review Board (IRB) for the use of human participants in a study, submit the following packet of materials to the current IRB Chair if you predict a full board review will be necessary or any IRB Committee member, if you predict your project will be exempt or expidited. When your packet has been received by the IRB it will be checked for completeness. If the application is not complete, it will be returned with a request for additional materials necessary for the review. The current IRB Commitee Members are:

Hank Bersani, Committee Chair, Chair/Professor, Special Education, ED 143A
503-838-8687, bersanh@wou.edu

Peter Callero, Professor, Sociology, HS 220
503-838-8352, callerp@wou.edu

Mark Girod, Assistant Professor, Teacher Education, ED 114D
503-838-8518, girodm@wou.edu

Bob Ayres, Professor, Teaching Research Institute, TO 225
503-838-8749, ayresr@wou.edu

Chehalis Strapp, Associate Professor, Psychology, TO 309
503-838-8316, strappc@wou.edu

Mike Ward, Professor, Mathematics, AA 205
503-838-8443, wardm@wou.edu

Please Note: Classroom curriculum projects, workshop evaluations, and administrative review projects need not be reviewed by the IRB if they are not research (i.e., the results will not be distributed outside the classroom or institutional setting) or will be used to evaluate or review a program in order to build a better program. If, however, the results of the project will be published or otherwise distributed, the project must be reviewed by the IRB. Additionally, it is the request of the IRB that all surveys be filed (without review) with the IRB office. Moreover, all surveys, questionnaires, or other research that does not qualify as exempt or expedited must be reviewed by the full IRB Committee. This may include special populations such as subjects under the age of 18, criminal populations, and subjects who may not be legally competent. Western Oregon University’s IRB encourages all project to be submitted for review if there is any doubt about classification or the possibility of future publication.

To determine the level of review needed for your protocol turn to Section 2.

PACKET CHECKLIST

EVERY PACKET MUST INCLUDE THE FOLLOWING MATERIALS

Item:

1. Completed and Signed WOU Human Participants Forms (Sections 1, 2 and 3, Pages 1-7).

2. Documentation of Consent Procedures (one or more of the following):

          a. Consent Form, or
          b. Verbal Consent Script, or
          c. Letter indicating why consent is not needed

3. Any survey instruments or questionnaires to be used.

4. A list of interview questions or topics, in as much detail as possible.

5. Protocols:

          Exempt Protocols: (Section 2, Page 6) Signed original and 2 copies of items 1-4. or
          Expedited Protocols: (Section 3, Page 7) Signed original and 2 copies of items 1-4. or
          Full Board Protocols: (Section 4, Page 7) Signed original and 7 copies of items 1-4

6. Original must be single-sided and not stapled. Copies may be stapled and double-sided.

REVIEW TIMETABLE

Exempt projects are reviewed as the packets are received and will take no more than 10 working days for approval once they are received by an IRB member.

Expedited projects are reviewed as the packets are received and will take about 10 working days for approval once they are received by an IRB member.

Full Board reviews will be reviewed at the next arranged meeting of the IRB, usually within 4 weeks of receipt.

HOW TO CONTACT THE IRB

Contact any of the above members by mail at: (Name of IRB Committee Member), Western Oregon University, 345 N. Monmouth, Monmouth, Oregon 97361

or call (503) 838-8000 and you can be transferred to any of the above committee members.

In addition, you can direct questions to the Provost Office.

Phone: (503) 838-8271, Provost’s Office

Campus Mail: Ad 202

Fax: 8-8116

Mail: HSIRB, c/o Provost’s Office, Western Oregon University, 345 N Monmouth, Monmouth, Oregon 97361

SECTION 1

TYPE OR WRITE NEATLY. If you use an electronic version of this form, use a different font for your responses. DO NOT leave a question blank. If a question does not apply to your protocol write "n/a."

Principal Investigator(s) (PI): #1

#2 #3

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Status:

          Faculty
          Adjunct Faculty
          Staff
          Graduate Student
          Undergraduate

Contact Phone Number: Contact Email Address:

Mail Correspondence To (Street Address):
          City:
          State:     Zip:

Project Title:

INVESTIGATOR PREDICTION OF TYPE OF REVIEW:

          EXEMPT
          EXPEDITED
          FULL BOARD

Estimated data collection completion date:

Is there, or will there be extramural funding that directly supports this research?

          YES
          NO

If yes, funding agency (s):
                     PI(s) on grant:

Renewal Date:

PURPOSE: Describe the purpose of the study.

DESIGN: Describe the research design and procedures. Clearly specify what the participants will do.

DATA COLLECTION

A. Check the method(s) to be used:

          Survey, administered by:
                    investigator
                    subject
                    mail
                    phone
                    in person

          Interview:
                    one-on-one
                    focus group
                    oral history
                    other

Note: If you are using a survey or doing interviews, submit a copy of the survey items/interview questions.

          Observation of Public Behavior:
                    in classroom
                    at public meetings
                    other

          Examination of Archived Data or Records:
                    academic
                    medical
                    legal
                    other

          Taste/Sensory Evaluation:
                    food tasting
                    olfactory
                    auditory
                    visual

          Examination of Tissue Specimens

          Therapeutic:
                    biomedical
                    psychological
                    physical therapy

          Experimental:
                    biomedical
                    psychological
                    other

          Other: Briefly Describe

 

B.     Data:
          Anonymous
          Confidential
          Intentionally identified

If participants will be identified, describe how permission to use data in connection with participants’ identities are obtained. If anonymous or confidential, describe how anonymity or confidentiality will be maintained (e.g., coded to a master list and separated from data, locked cabinet, office, restricted computer, etc.). Who will have access to the data?

 

C. Will

          video tapes
          audio tapes
          photographs

be taken?

If checked, where will tapes or photographs be stored? When will this material be destroyed (e.g., within 5 years of a published paper)? How will confidentiality be maintained?

 

 

DESCRIPTION OF THE POPULATION (see Definitions: www.wou.edu/psych/winningham/definitions)

A. Approximate number: Age Range:

B. How will participants be selected or recruited?

 

 

C. Will participants be compensated (include extra credit)? YES NO

If yes, how much, when and how. Must they complete the project to be paid?

 

 

D. What form of consent will be obtained? In most situations a written informed consent is required. (see Frequently Asked Questions about the Consent process: www.wou.edu/psych/winningham/consent_questions)

a. Implied (Please attach cover letter or describe terms.)

b. Verbal (Please attach consent script.)

c. Written (Please attach consent form.)

d. Seeking Waiver of Consent (Contact the IRB for further information.)

e. Consent Not Applicable (e.g., archived data; On a separate page explain why not.)

E. Are any participants not legally competent (minor and/or under care of guardian) to give consent?

YES NO

If yes, please describe how consent will be obtained. Please note a parent or guardian needs to sign and return an informed consent form for participants who are under 18 years of age. In addition, it is reccommended that consent is obtained from the minor.

 

F. Will any ethnic group or gender be excluded from the study pool?

YES NO

If yes, please justify the exclusion.

 

 

G. Is this study by design likely to involve any participants who are not native users of English?

YES NO

If yes, please submit both the English and translated versions of consent forms and surveys, if applicable.

 

H. Does this study involve participants located outside of the United States?

YES NO

If yes, on an attached page, please explain exactly "who the participants are," and the identities (if possible) and responsibilities of any additional investigators.

DECEPTION (see Definitions: www.wou.edu/psych/winningham/definitions)

If any deception is required for the validity of this activity, explain why this is necessary. Please include a description of when and how participants will be debriefed regarding the deception.

 

 

RISKS AND BENEFITS (see Definitions: www.wou.edu/psych/winningham/definitions)

A. Describe any potential risks to the participants, and describe how you will minimize these risks. These include stress, discomfort, social risks (e.g., embarrassment), legal risks, invasion of privacy, and side effects.

 

 

B. In the event that any of these potential risks occur, how will it be handled (e.g., compensation, counseling, etc.)?

 

 

C. Will this study interfere with any participants’ normal routine (e.g., prevent them from going to class and/or work)?

YES NO If YES, explain.

 

 

D. Describe the expected benefits to the individual participants and to other members of society.

 

 

E. If blood or other biological specimens will be taken please address the following.

Brief Description of Sampled Tissue(s):

Describe the personnel involved and procedure(s) for obtaining the specimen(s). Note that the IRB requires that only trained certified or licensed persons may draw blood. Contact the IRB for more details on this topic.

 

 

PROJECT CHECKLIST (Attach additional pages as necessary.)

A. Will any investigational new drug (IND) be used? YES NO

B. Will any other drugs be used? YES NO

If yes to A or B, on a separate page, list for each drug:

1. the name of the drug,

1. the manufacturer of the drug,

2. the IND number,

3. the dosage,

4. any side effects or toxicity, and

5. how and by whom it will be administered.

C. Will alcohol be ingested by the participants?

YES NO

If yes, on a separate page, describe what type and how will it be administered. Refer to the guidelines for

administration of ethyl alcohol in human experimentation (OGRD Memo No. 18 available at OGRD).

 

 

 

INVESTIGATOR’S ASSURANCES

This investigation involves the use of human participants. I understand the university’s policy concerning research involving human participants and I agree:

1. to obtain voluntary and informed consent of persons who will participate in this study, as required by the IRB.

2. to report to the IRB any adverse effects on participants which become apparent during the course of, or as a result of, the activities of the investigators.

3. to cooperate with members of the IRB charged with review of this project, and to give progress reports as required by the IRB.

4. to obtain prior approval from the IRB before amending or altering the project or before implementing changes in the approved consent form (i.e., changes that would alter what is required of the participant).

5. to maintain documentation of IRB approval, consent forms and/or procedures together with the data for at least three years after the project has been completed or paper has been published--whichever is later.

6. to treat participants in the manner specified on this form.

Principal Investigator(s): The information provided in this form is accurate and the project will be conducted in accordance with the above assurances.

Signature _______________________________ Print Name _____________________________ Date __________

Signature _______________________________ Print Name _____________________________ Date __________

Faculty Sponsor: (If P.I. is a student.) The information provided in this form is accurate and the project will be conducted in accordance with the above assurances.

Signature _______________________________ Print Name _____________________________ Date __________

When Section 1 is filled out and fully signed, review the Packet Checklist (Page 1) to complete the packet for review and submission.

 

Institutional Review Board: These assurances are acceptable and this project has adequate protections for participants. This project has been properly reviewed and filed, and is in compliance with federal, state, and university regulations.

Signature _______________________________ Print Name _____________________________ Date __________

 

 

IRB ONLY: This protocol has been given- Exempt ___ Expedited ___ Full Board ___ status

 

SECTION 2

Is your project EXEMPT?

Exempt Reviews

Federal regulations specify that certain types of research pose very low risks to participants, and therefore requires minimal review from the IRB. To determine if your project is exempt, answer the following questions.

1. Will participants be asked to report their own or others’ sexual experiences, alcohol or drug use, and will their identities be known to you?

YES NO

2. Will the participants’ data be directly or indirectly identifiable, and could these data place participants at risk (criminal or civil liability), or might they be damaging to participants’ financial standing, employability or reputation?

YES NO

3. Will any participants be confined in a correctional or detention facility?

YES NO

4. Will adult participants be used who may not be legally competent?

YES NO

5. Will personal records (e.g., medical, academic, etc.) be used with identifiers and without written consent?

YES NO

6. Will alcohol or drugs be administered?

YES NO

7. Will blood/body fluids be drawn?

YES NO

8. Will specimens obtained from an autopsy be used?

YES NO

9. Will you be using pregnant women by design?

YES NO

10. Are live fetuses participants in this research?

YES NO

11. Will participants be videotaped?

YES NO

If you answered YES to any of the questions above, then your project is NOT exempt, but may still qualify for expedited review (see Section 3, Page 7).

If you answered NO to all of the above questions, your research might be EXEMPT if it fits into one of the following categories. (Check below all that apply)

  • Educational Research: Research conducted in established or commonly accepted educational settings, involving normal educational practices. This is the research that is concerned with improving educational practice.
  • Surveys, Questionnaires, Interviews, or Observation of Public Behavior: To meet this exemption, the subject matter must not involve "sensitive" topics, such as criminal or sexual behavior, alcohol or drug use on the part of the participants, unless they are conducted in a manner that guarantees anonymity for the participants.
  • Surveys, Questionnaires, Interviews, or Observation of Public Behavior: Surveys that involve sensitive information and participants’ identities are known to the researcher may still be exempt if (1) the participants are elected to appointed public officials or candidates for public office; or (2) federal statute(s) specify without exception that confidentiality will be maintained throughout the research and thereafter.
  • Archival Research: Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. These data/samples must be preexisting, which means they were collected prior to the current project.
  • Research Examining Public Benefit or Public Service Programs: To qualify for this exemption, the research must also be conducted by or subject to review by an authorized representative of the program in question. Studies in this category are still exempt if they use pregnant women by design and their purpose is to examine benefit programs specifically for pregnant women.
  • Taste Evaluation Research: Studies of taste and food quality evaluation. Studies of taste evaluation qualify for this exemption only if (1) wholesome foods without additives are consumed; or (2) if a food is consumed that contains a food ingredient at or below the level of and for a use found to be safe.

If any participants will be under 18 years of age and your study could be considered a normal educational experience (e.g., a classroom curriculum project), then your project may be exempt if you answered no to all of the above questions and your study fits into one of the above categories. If any participants will be under 18 years of age and your study does not meet the above guidelines then the IRB Application will need to go before a full board review.

If it appears that your study is exempt, then complete and submit Sections 1 and 2 to an IRB member. In addition, be sure that all the materials in the check list (e.g., questionnaires, tests, informed consent forms) are included in your application. Finally, be sure that the principle investigator(s) and faculty sponsor (if applicable) have signed the application.

 

 

--SECTION 3 --Does your study qualify for expedited review?

SECTION 3

Does your study qualify for EXPEDITED review?

Expedited Reviews

Expedited reviews are for studies involving no more than minimal risk or for minor changes in previously approved protocols. To meet expedited review criteria your protocol must meet the following conditions: no more than minimal risk to the participants, participants must not be confined in a correctional or detention facility, and one or more of the following types of participation on the part of participants.

(Check any that apply to your project)

  • Collection of excreta and external secretions: sweat, saliva, placenta, and/or amniotic fluid. None of these may be collected by "invasive" procedures, such as those that use cannulae or hypodermic needles, such as in amniocentesis.
  • Recording of data using noninvasive procedures routinely employed in clinical practice. This includes but is not limited to the use of "contact" recording electrodes, weighing, tests of sensory acuity, electrocardiography and electroencephalography, and measures of naturally occurring radioactivity. Participants must be at least 18 years of age for the research to qualify for expedited review. This does NOT include procedures which: a) impart matter or significant amounts of energy to the participants, b) invade the participants’ privacy, or c) expose participants to significant electromagnetic radiation outside the visible range (e.g. Ultraviolet light from tanning beds).
  • Collection of hair or nail clippings, teeth from patients whose care requires the extraction or collection of plaque and/or calculus using routine procedures for the cleaning of teeth.
  • Voice recordings made for research purposes such as investigations of speech defects and speech pathology.
  • Moderate exercise by healthy volunteers.
  • Experimental research on individual or group behavior or on the characteristics of individuals, such as studies of perception, cognition, game theory or test development. This does NOT include studies that involve significant stress to the participants or that are intended to produce a relatively lasting change in behavior.
  • Studies of archived data, records or diagnostic specimens that are not exempt.
  • Studies involving the collection of blood samples by venipuncture, in amounts not exceeding 450 ml (about a pint) in an eight week period and no more often two times per week, from participants 18 years of age or older and who are in good health and not pregnant.

If your study fits into one of the eight types of participation and required criteria, then your project should be EXPIDITED. Now complete Section 1.

 

SECTION 4

If your study does not meet exempt or expedited review criteria, then it qualifies for FULL BOARD review.

Full Board Reviews

Protocols that require full board review have the potential for high risks to participants (physical, psychological or social) or those that have special population consent considerations (research on prisoners, children, or persons who are not legally competent, ethnic considerations). Allow 4 weeks for review.

Now Complete Section 1.

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