IRB Application

Application for Use of Human Participants in Research Request for Protocol Review and Approval

The Committee on Human Research Participation (CHRP) and Institutional Review Board (IRB) is an administrative body established under federal requirements to protect the dignity, rights, and welfare of human participants involved in research conducted by any University of Western States (UWS) faculty, staff or student.

The IRB has the authority to approve, require changes to, or disprove all research activities that fall within its jurisdiction as specified by both federal regulations (45 CFR 46) and UWS policy (policies 8002 and 8003).

The university accepts the responsibilities for research as described in the UWS Policy Handbook only if appropriate policies are followed, including approval of research by the UWS IRB. However, it is still the responsibility of the principal investigator to establish and maintain acceptable ethical practices in research.

Research is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d))

Human Subject, as it pertains to research involving human subjects in the Department of Health and Human Services (DHHS) regulations (45 CFR 46.102(f)), is defined as “a living individual about whom an investigator conducting research obtains

data through intervention or interaction with the individual, or
identifiable
private information”

Other important human subjects information can be found at https://humansubjects.nih.gov/.

Levels of Review

There are three levels of review for UWS/IRB applications:

1. Exempt from review
2. Expedited review
3. Full board review

Exempt means review by the IRB chair, sometimes in consultation with others. Research activities may be determined exempt if the only involvement of human subjects fall in one or more of the following categories (45 CFR 46.101(b)):

Research conducted in established or commonly accepted educational settings, involving normal educational practices
Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior
Research involving the collection or study of existing data

Expedited means review by the IRB chair and one or more experienced reviewers. Research activities may be determined expedited if it is determined to involve only minimal risk, does not include intentional deception, does not engage sensitive populations or topics, and includes appropriate informed consent procedures (45 CFR 46.110).

Full Board Review is required for research that is not eligible for exempt or expedited review. Research that is determined to involve more than minimal risk and/or involves protected populations must undergo a full IRB review.

The level of review is determined by the UWS IRB based on the amount of risk to the human participants in accordance with University Policies. Further guidelines for the protection of human participants may be found in 45 CFR 46, which is available at https://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.

Important Note: The use of human participants may commence only after this approved, signed application is returned to the principal investigator including your approval letter from the Chair of the UWS IRB. UWS IRB approval is good for the specified time stated on your approval letter through the approval expiration date. Should the use of human participants, the use of identifiable data, or data analysis be required past the approval period, the application must be renewed using the IRB Annual Renewal Form. Once the use of human participants is completed, the protocol must be closed with the Study Closure and Final Report Form that can be obtained from the UWS IRB.

Investigators are not permitted to make changes to the research without IRB review.

You must notify the IRB to any changes in your study by completing the Study Modification Form before any changes can be implemented. For personnel changes, please submit a Personnel Change Form.

Before completing the application, please be aware that you must finish the whole form in one sitting. There is not an opportunity to save your progress and return at a later date.

Submission Checklist and Instructions

Please provide the following required documents to the IRB when submitting a new study for review and approval.

Submit the following forms and documents:

Application for Use of Human Participants in Research/Request for Protocol Review and Approval (this form).

Complete sections A – P. Please provide answers to all applicable questions. Incomplete applications will be returned without review.

Conflict of Interest Statement (completed, signed and dated by the principal investigator)

Proposed Informed Consent(s) or Signed Waiver of Informed Consent Form – Refer to Informed Consent Templates or Waiver of Informed Consent Form – all documents are available in Udocs

Investigator Assurance Form (completed, signed and dated by the principal investigator)

Certificate of completion for CITI Training (EdD students only)

Entire study protocol/proposal

Signatures via SignNow – Upon receipt of your IRB application and supporting documents, you and your co-investigators (as applicable) will be sent a document to review and sign via SignNow.

The written protocol/proposal should include: study title, population design, sample size, duration, primary objective, secondary objectives, background and significance including literature review with complete citations, statistical analysis plan, consent process and documentation, costs and compensation, risks and benefits, privacy and confidentiality, and data safety monitoring. Reading level should be included for any documents aimed at human subjects; identify the scale used for ascertaining reading level.

When applicable, you must also include the following:

Proposed advertisements/recruitment materials

Questionnaires, letters, educational materials, diaries, or any document the participant will view or use

Appropriate Vulnerable Population Worksheet

Funding worksheet with grant/contract documentation

If the study involves institutional data from UWS, include a letter from the campus provider of the data, approving use of data and timeline need.

Questions regarding the UWS IRB Application for Use of Human Participants in Research and Request for Protocol Review and Approval can be sent to:

General IRB inquiries: [email protected]

Marni Goodman Academic Affairs Coordinator/IRB Administrator [email protected] 503-847-2551

Rian Debner, MA, MLIS, AHIP, Chair of the University of Western States Committee on Human Research Participation [email protected] 503-251-5757

Application for Use of Human Participants in Research Request for Protocol Review and Approval

Section A: Project Information

Title of project:(Required)

Anticipated start date (pending IRB approval which may take longer than 1 week):(Required)

Duration of the study:(Required)

Years/Months

This research is for:(Required)

Section B: Principal Investigator Information

Principal Investigator (PI):(Required)

First Last

Is the PI faculty, student (EdD students only), or staff?(Required)

Faculty

Student

Staff

Upload your CITI Training Completion Certificate:

Max. file size: 50 MB.

Campus

Department

Mailing Address(Required)

Street Address City State / Province / Region ZIP / Postal Code Country

Phone

Email(Required)

Section C: Co-Principal Investigator Information

Is there a Co-Principal Investigator?(Required)

Yes

If the Principal Investigator is a student (EdD students only), the Faculty Sponsor/Advisor must be listed as a Co-Principal Investigator. For Dissertation research, the Co-Principal Investigator should be the Dissertation Committee Chair.

Co-Principal Investigator #1 Name(Required)

First Last

Co-Principal Investigator is:(Required)

Faculty

Staff

Student

Alumni

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Is there a Co-Principal Investigator #2?

Yes

Co-Principal Investigator #2 Name(Required)

First Last

Co-Principal Investigator is:(Required)

Faculty

Staff

Student

Alumni

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Section D: Co-Investigator Information

Is there a Co-Investigator?(Required)

Yes

Co-Investigator #1 Name(Required)

First Last

Co-Investigator is:(Required)

Faculty

Staff

Student

Alumni

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Is there a Co-Investigator #2?

Yes

Co-Investigator #2 Name(Required)

First Last

Co-Investigator is:(Required)

Faculty

Staff

Student

Alumni

Campus(Required)

Department(Required)

Maling Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Is there a Co-Investigator #3?

Yes

Co-Investigator #3 Name(Required)

First Last

Co-Investigator is:(Required)

Faculty

Staff

Student

Alumni

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Section E: Additional Roles (e.g., study coordinator, data analyst, outside reader)

Are there additional personnel involved in the study?(Required)

Yes

Additional Personnel #1 Name(Required)

First Last

This person is:(Required)

Role(Required)

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Are there more additional personnel involved in this study?(Required)

Yes

Additional Personnel #2 Name(Required)

First Last

This person is:(Required)

Role(Required)

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Are there more additional personnel involved in this study?(Required)

Yes

Additional Personnel #3 Name(Required)

First Last

This person is:(Required)

Role(Required)

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Are there more additional personnel involved in this study?(Required)

Yes

Additional Personnel #4 Name(Required)

First Last

This person is:(Required)

Role(Required)

Campus(Required)

Department(Required)

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Phone(Required)

Email(Required)

Section F: Level of Review

Are there other institutions involved in this project?(Required)

Yes

If yes, please list:

Has another IRB reviewed and given approval or exemption for this research project?(Required)

Yes

Hidden

If yes, please list and attach documents:

Max. file size: 50 MB.

If yes, please list and attach documents:

Drop files here or

Max. file size: 50 MB.

Section G: Purpose and Significance

Explain the purpose of your research (including your research question(s):(Required)

Explain the scientific rationale and the significance of the knowledge to be gained from your study:(Required)

Section H: Project Information

Setting for Contact:(Required)

(List each site where the research procedures will be performed. Be specific – simply indicating UWS campus is not detailed enough. For sites other than UWS, please attach information about that site (address, type of business/institution, etc.) If a cooperating institution (school, hospital, prison, etc.) is involved, append letters that have been prepared on the official letterhead of the cooperating institution and signed by an authorized representative allowing the study and the adjudication to the UWS IRB.)

Methods:(Required)

(Describe the procedures and methodology that involve human participants. Please elaborate on the procedures that ensure confidentiality will be maintained. Remember that the UWS/IRB committee members have diverse backgrounds and are most likely not from your discipline).

Section I: Data Collection and Participant Population

Anticipated inclusive start date for use of participants and the use of all identifiable data (pending IRB approval which may take longer than 1 week):(Required)

Please provide the anticipated number of study participants.(Required)

Please provide the anticipated age range of study participants.(Required)

Please provide the anticipated gender identity of study participants.(Required)

Are participants all University of Western States faculty/staff/students:(Required)

Yes

Characteristics of research participants:(Required)

Please check all that apply. Note: Studies involving vulnerable populations may require full review.

If other, please explain:

Describe how potential participants will be identified and selected:(Required)

If you will be using social media to recruit participants, please review the IRB Guidance for UWS Researchers document in UDocs for guidance in creating your posts and your recruitment strategy.

Hidden

Attach a copy of letters, advertisements, transcripts, etc if applicable.

Max. file size: 50 MB.

Attach a copy of letters, advertisements, transcripts, etc if applicable.

Drop files here or

Max. file size: 50 MB.

Explain why participants might be excluded from your study:(Required)

Section J: Funding Information

Has funding been awarded for this project?(Required)

Yes

If yes, please explain:

Will funding be requested for this project?(Required)

Yes

Source of Funding:(Required)

Check all that apply.

Internal

External

Sources Used:(Required)

Check all that apply

Department funds

Personal funds

Awarding agency

Other

If other, please explain:

Source of external funding:

Please provide: source, awarding agency, account/fund # and PI of award.

Section K: Confidentiality

Please check all that apply.(Required)

Note: Studies involving vulnerable populations may require full review.

Data is collected anonymously

Data will be recorded without possibility of identification

Data will be recorded with a code replacing identifiers

Data will be recorded with identifying information (e.g., name, SSN, student ID, etc.)

Nature of data makes it potentially identifiable (e.g., photographs, material with DNA, etc.)

Who will have access to the data?(Required)

If data is stored with identifiers, please provide details of how will data be stored securely?(Required)

If not applicable, please enter “N/A.”

Will research data be shared with anyone outside the immediate research team (e.g., data analyst)?(Required)

Yes

If yes, describe:

How will the data be destroyed and at what point in time?(Required)

Section L: Benefits and Risks

Check yes or no to the following questions. If yes, please explain.

Will any apparatus be applied externally or internally to the participants?(Required)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Will any drugs or special diet be administered to the participant?(Required)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Will the participants be exposed to any stimuli that may be physically or mentally harmful?(Required)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Might the participants experience any risk, stress, or discomfort (mental or physical)?(Required)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Might the information gathered expose participants to liability, discrimination, or embarrassment if revealed?(Required)

(e.g. concerning child abuse sexual behavior, drug abuse, etc.)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Will the participants be involved with any physical activity?(Required)

Yes

Specific risks:(Required)

Corresponding safeguards:(Required)

Section M: Informed Consent Process

Select one of the following options:(Required)

I am obtaining signed informed consent for this study (attach copies of all consent documents) – Informed Consent Templates are available in Udocs. Select the form that meets your needs.

I am requesting a waiver of informed consent

If requesting a waiver of informed consent, complete the waiver of informed consent form.

Attach consent documents(Required)

Drop files here or

Max. file size: 50 MB.

Are you anticipating enrollment of non-English speaking participants?(Required)

Yes – Include translated informed consent document

How and where will the consent process occur?(Required)

Where will the informed consent documents be stored? Please explain.(Required)

Who will be obtaining the informed consent from the participant?(Required)

Please include name(s) and role in study.

Where will the informed consent documents be stored? Please explain.(Required)

Will participants be deceived or incompletely informed regarding any aspect of the study?(Required)

Yes

Identify which of the following components are included in the informed consent form or script

Note: All questions checked “yes” must be addresses in the informed consent.

Was there a waiver of informed consent requested?(Required)

Yes

The purpose of the project, procedures to be followed, and expected duration of the research subject's participation.(Required)

Yes

Any reasonably foreseeable risks, stress, or discomforts.(Required)

Yes

Any benefits that can be reasonably expected.(Required)

Yes

Any alternative procedures or course of treatment (if any) that might be advantageous.(Required)

Yes

The manner in which confidentiality of the records that identifies the subject will be maintained.(Required)

Yes

Whom to contact if injury occurs, and whether any compensation or medical treatment is available.(Required)

Yes

That participation is voluntary, that the subject may discontinue participation at any time or skip any question, and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.(Required)

ALL ELEMENTS must be in the consent form/cover letter.

Yes

The investigator will be available to answer any questions the participants may have about risks or the informed consent form.(Required)

Yes

The following statement: If you have questions regarding your rights as a research participant, contact Rian Debner, MA, MLIS, AHIP, Chair of the University of Western States Committee on Human Research Participation, at [email protected] or 503-251-5757.(Required)

Yes

Section N: Instruments

List all questionnaires, instruments, standardized tests below with a brief description. You must provide copies with this application.

Hidden

Copies of the above mentioned:

Max. file size: 10 MB.

Copies of the above mentioned:

Drop files here or

Max. file size: 50 MB.

Section O: Assurance

1. I certify that the information provided in this application is complete and accurate and consistent with any proposal(s) submitted to external funding agencies. Misrepresentation of the research described in this or any other institutional review board application may constitute non-compliance with federal regulations and/or academic misconduct.

2. I agree to provide proper surveillance of this project to ensure that the rights and welfare of the human subjects. are protected. I will report any problems to the institutional review board.

3. I agree that the modifications to the approved project will not take place without prior review and approval by the institutional review board.

4. I agree that the research will not take place without the receipt of permission from any cooperating institutions when applicable.

5. I understand that approval of this project by the institutional review board does not grant access to any facilities, materials, or data on which my research may depend. Such access must be granted but the unit with the relevant custodial authority.

6. I agree that all activities will be performed in accordance with all applicable federal, state, local, and University of Western States policies.

Upon receipt of your IRB application and supporting documents, you and your co-investigators (as applicable) will be sent a document to review and sign via SignNow. Please note this is different from the Investigator Assurance Form.