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Application: Human Subjects Research

Principal Investigator and Faculty Advisor Responsibilities Agreement

A. Conduct of the Research

1. I accept responsibility for the ethical conduct of this research and protection of participants as set forth in the Belmont Report, Declaration of Helsinki, the Nuremberg Code, the Common Rule, and the policies and procedures of Western Washington University.

2. I accept responsibility for ensuring this research is conducted according to:

i. the protocol approved by the IRB;

ii. the applicable terms of the grant, contract, or signed funding agreements; and

iii. applicable laws and regulations.

3. I certify that I (or my faculty advisor) is sufficiently qualified to assume responsibility for the proper conduct of this research.

4. I accept responsibility for ensuring that members of this research team are appropriately trained and supervised.

B. Ensuring and Maintaining Compliance

1. I will comply with relevant regulatory and institutional requirements, including those relating to conflicts of interest, responsible conduct of research, and research misconduct.

2. I will ensure that informed consent is obtained as approved by the IRB and that a copy of the consent form is provided to participants, unless the IRB waives this requirement.

3. I confirm that I will follow all applicable retention requirements for research and data. This includes WWU’s retention requirement for signed consent forms to be maintained for 6 years after study completion.

4. I will obtain initial approve before beginning any research interaction or intervention or data collection with human subjects.

5. I will obtain prior approval for any modifications to this research.

6. If my research is considered to be expedited or full board, I will notify the IRB of the study closure promptly.

7. If my research is considered to be expedited or full board, I am responsible to requesting an extension of my research project prior to my study expiration date, allowing sufficient time for IRB review.

8. I will promptly report any instances of noncompliance or unanticipated problems.

C. Investigator Records, Reports, and Documentation

1. I will maintain research records, all protocol materials, and any other documents associated with this research for at least 3 years after this research ends or for the length of time specified in applicable regulations or institutional or sponsor requirements, whichever is longer.

2. I will ensure safe and secure storage of research data according to the agreed upon security procedures.

Application Approval Signatures

Principal Investigator Agreement

I have read and agree to uphold with the responsibilities of the Principal Investigator as outlined on page 3 of this application. I attest that the materials provided in support of this application are an accurate reflection of the proposed research.

Jo Ann Arinder

Principal

Investigator Name

5/14/2018

Principal

Investigator Signature

Date

Faculty Advisor Agreement

I have read and approve the attached application submitted for review. I agree to provide appropriate education and supervision of the student investigator and share the Principal Investigator responsibilities as stated above.

Sondra Cuban

Faculty Advisor Name

5/14/18

Faculty Advisor Signature Date

Department Chair Agreement

I certify that I have reviewed this research protocol and that I attest:

· to the competency of the investigator(s) to conduct the research;

· that facility, equipment, and personnel are adequate to conduct the research; and - that continued guidance will be provided to the investigator as appropriate.

Raine Dozier

Department Chair Name

5/16/18

Department Chair Signature Date

Application: Human Subjects Research

RECEIVED STAMP APPROVAL STAMP IRB Use Only: Protocol Number: ______________ Review Status: Exempt Category: _____ Expedited Full Approval Period: ______________ to ______________ Reviewer: _____________________________________________ Reviewed Date: _______________

1. Investigator Information

Principal Investigator (One per application is allowed)
First Name:	Jo Ann	Last Name:	Arinder
Degrees:	BA History	Department:	AHE
Home Institution:	WWU	Address/Mail stop:	2132 Franklin St Bellingham WA 98225
Phone:	3602141907	Email:	[email protected]
Status:	☐ Faculty ☐ Staff ☒ Graduate student ☐ Undergraduate Student

Faculty Advisor (Required for Undergraduate & Graduate Students)
	Sondra		Cuban
Home Institution:	WWU	Department:	AHE
		Address/Mail stop:	MH417D
Phone:	360) 650-2977	Email:	[email protected]

IRB contact (If different from the Principal Investigator)
First Name:		Position:		Phone:
Last Name:		Address/Mail stop:		Email:

2. Study Information

Graduate Writing Centers

2.1 Short Study Title:

2.2. Funding: Is this research supported in whole or in part by a grant or contract?

☒ No

☐ Yes ➔ If yes:

	Grant Award Term:

Funding Agency:

Grant/Contract Title:

Grant Number#

2.3. Co-Investigators and Key Personnel involved in the research: Please list the names of any individuals other than the Principal Investigator, Faculty Advisor, or IRB contact who will have contact with subjects or have access to identifiable data.

Insert additional rows into the table if additional lines are needed. Type NA in the first line if there are no additional personnel other than the Principal Investigator, Faculty Advisor, and IRB Contact.

Note: Everyone in this list should complete training in human subjects protections and submit their certificates with this application. If you do not have the certificate for an individual, do not include them on this application at this time. Submit a modification at a later point, including their certification.

If you are unable to list the individuals, or submit these individuals’ training certifications, you will need to attach a separate document with justification and any alternative training plans.

Name	Role on Study (Co-PI, Research Coordinator, etc)	Email	Institution
NA

2.4. Research Sites: Please list the sites where data will be collected from subjects, stored/archived, or analyzed. Insert additional rows into the table if additional lines are needed.

If you are conducting research in a WWU classroom, list this as a site individually (ex. “WWU, Psychology 101, Dr. Professor) or collectively (ex. WWU STEM classrooms).

Site Name/Location	Activity at this Site (Recruitment, data collection, intervention, analysis, etc.)
Western Washington University	Recruitment, data collection, and analysis

2.5. IRB of Record: If your study has multiple sites, will the WWU IRB be the IRB of Record?

☒	NA
☐	No ➔ If no, will any research interaction or intervention with human subjects occur on Western Campus or with Western staff, faculty, or students?
	☐ Yes ➔ Complete the rest of this application and submit.
	☐ No ➔ Stop completing this application and contact a Research Compliance Officer. The WWU IRB will likely be able to sign a reliance agreement with the IRB of Record.
☐	Yes If yes → Please describe your plan for coordination between sites.

The study’s other IRB(s) will need to sign documentation of deferral to or reliance on the WWU’s review and approval.

2.6. Multiple IRBs: Does this research require an International IRB/Ethics Committee or First Nations/Tribal review?

☒ No

☐ Yes ➔ If yes:

Name of IRB/Committee:

FWA or equivalent #:

Do you have this IRB’s ☐ Yes Please attach a copy of your IRB’s approval memo or similar

approval? documentation.

☐ No ➔ What is the status of receiving approval from your outside IRB?

2.7. Financial Conflict of Interest: Does the PI, Co-PI, Faculty Advisor or any other individual on the study have a financial conflict of interest with the proposed research? Investigators who receive federal funds must have Financial Conflict of Interest training every 4 years.

☒ No

☐ Yes ➔ If yes, explain:

3. Study Design

3.1. Intent: Please check all of the options below that apply to your research.

Research conducted in established or commonly accepted educational settings involving normal educational practices.

☒

Examples: Research on regular or special instructional strategies; Research on the effectiveness of instructional techniques, curricula, or classroom management methods.

If checked: Will these practices adversely impact students’ opportunity to learn required educational content

or the assessment of educators who provide instruction?

This project will consist of a digital survey and a volunteer focus group. Students will not be affected in any way from participating or refusing to participate.

☒ No → if No, describe why not:

☐ Yes → If Yes, explain:

Research with adults involving surveys, interviews, observation of public behavior, or non-classroom based

☒ educational tests (cognitive, diagnostic, aptitude, achieved). This category does not apply if the research includes tasks or interventions.

Research involving a benign behavioral intervention where data is collected from an adult subject through verbal or written responses or video recording. The intervention must be brief in duration, harmless, painless, not physical invasive, not likely to have a significant adverse lasting impact, and not likely to be considered offensive ☐ or embarrassing by the subject.

Examples: Subjects solving a puzzle under various noise conditions, testing the effect of the noise level on their ability to complete the puzzle. Subjects are given a nominal amount of cash and are asked to allocate it between themselves and someone else.

Research involving an intervention that cannot be considered benign and/or behavioral.

☐ Examples: Subjects are asked to wear an activity monitor (this is not in the category above because of the method of data collection). Subjects are asked to drink alcohol while playing a driving simulator, testing the effect of alcohol on driving ability. Subjects are randomly assigned to take a placebo or a drug.

☐ Research re-using identifiable private information or identifiable specimens which are already publicly available.

☐ Research re-using using data already collected for non-research purposes or from research studies other than the proposed research.

☐ Research re-using data where the information is recorded in a manner where the identity of the subjects cannot be readily ascertained directly or indirectly through a code and subjects will not be contacted or re-identified.

☐ Research for the purposes of health care operations or public health activities and purposes.

☐ Research that is conducted by, or on behalf of, a Federal department or agency using government generated or government collected information obtained for non-research activities.

☐ Research on taste and food quality (on wholesome foods or foods with additives, ingredients, agricultural chemicals, or environmental contaminants are at or below the level for a use found to be safe)

☐ Part of an institution, organization, or program’s own internal operational monitoring.

☐ Research for a WWU undergraduate or graduate thesis or capstone project.

Class project or other activity whose purpose is to provide an educational experience for the researcher (for

☐ example, to learn about the process or methods of doing research), not for publication or presentation. If checked, do not complete this application. Your project is not considered research.

Focus directly on the specific individuals about whom the information or biospecimens are collected through oral

☐ history, journalism, biography, or historical scholarship activities, to provide an accurate and evidence-based portrayal of the individuals.

☐ An activity initiated with the goal of only improving the performance of an institutional practice or program.

Public health surveillance activities conducted, requested, or authorized by a public health authority for the sole

☐ purpose of identifying or investigating potential public health signals or timely awareness and priority setting during a situation that threatens public health.

An activity designed to determine whether aspects of medical practice are being performed in line with

☐ established standards.

☐ Other

3.2. Purpose: Briefly describe the purpose, specific aims, or objectives that will be met by this project. Use lay language, avoid technical terms, and please spell out acronyms the first time they are used. Do not describe your specific procedures here – you will be asked in a later section.

The purpose of this project is to determine why graduate students use or do not use writing centers, and how they determine their satisfaction when they use writing centers. Understanding how students determine their satisfaction will assist in creating student satisfaction surveys that will provide accurate data.

3.3. Background: Describe how your study design and instruments are appropriate to examine your question or hypothesis. Please keep this section brief. If your study is based on similar studies in your field, please provide literature citations.

Survey information will provide a broad picture of graduate student attitudes regarding writing centers. Focus groups will provide additional understanding of the survey results.

3.4. Related Applications/Studies: Are there any related IRB applications either approved or also under review that provide context for or impact this study?

☒ No

☐ Yes ➔ If yes, provide the application number:

4. Participants

4.1. Participants: Describe the general characteristics of your research subjects, including age range, sex and/or gender, race, ethnicity, any other relevant characteristics. If you are not sure about some demographics of your population, list what you do know. If your study has specific inclusion and exclusion criteria, list the criteria here.

Participants are graduate level students currently enrolled at Western Washington University. Subjects will be at least 18 years old. The survey includes a screening question to screen out subjects under 18. There is a signature block in Qualtrics for participants to sign for consent.

4.2. Participants with special considerations: Check any of the following populations that you will be working with and complete any necessary supplements.

☒	Students
☐	People lacking fluency or literacy in English → Complete the Non - English Speaking Supplement
☐	American Indian/Native Americans or indigenous peoples → Complete the Indigenous Populations Supplement
☐	Neonates/Fetuses → Contact ORSP for Additional Guidance
☐	Minors/Children (any individual under 18 years old) → Complete the Minors in Research Supplement
☐	Prisoners → Complete the Prisoners Supplement

☐ People with Impaired Decision Making → Complete the Impaired Decision Making Supplement

☐ None of the above

4.3. Number of Subjects: What is the maximum number of subjects (or subject groups, such as families) that will be enrolled? If you have separate subject groups, such as cases and controls, tell us the estimated number per group. If you cannot estimate the number of subjects, tell us as much information as possible.

Please keep in mind that if your study is determined to be non-exempt, going above this maximum number would be considered non-compliance. You would need to submit a modification to increase your total number of subjects prior to over-enrolling.

728 for the survey, 16 for focus groups (2 groups 5-8 each group).

4.4. Third Party Subjects: Will you collect private identifiable information about individuals other than your direct subjects?

For example: Recording classroom discussions to evaluate professors, who are the subjects of the research, but student conversations are also included. Collecting medical history information or contact information about family members of subjects.

☒ No

☐ Yes ➔ If yes, describe:

4.5. Local Context or Laws: If applicable, describe any site-specific cultural issues, customs, beliefs, values, or laws that may affect your research or how it is conducted.

5. Recruitment

5.1. Recruitment Methods: Describe how you will recruit your subjects. Include how you will identify subjects, the method of outreach (phone, email, media advertising, events, class announcement), and who will be contacting them or giving the announcement. We encourage researchers to think broadly.

If your research involves the use of schools (pre-kindergarten to university level) a clearance letter will be required from an administrator at the site, giving permission to conduct the research. This requirement is waived if you are recruiting from a scheduled class at Western.

I will send a recruitment letter, via email, to the entire current graduate student population.

5.2. Recruitment Materials: List the recruitment materials or software that you will use. Please attach recruitment documents to your application. Do not insert the recruitment text here. If recruitment text is inserted here we will return your application as incomplete.

For example: Recruitment Letter 1, Recruitment Letter 2, Flyer

Recruitment letter, email

5.3. Dual Role with Subjects: Do any of the researchers listed on the application have a dual role with the subject population? For example: A professor conducting research in their classroom has a dual role as a professor and a researcher.

☒ No

☐ Yes ➔ If yes, describe the dual role:

➔ Describe how you will prevent

the possibility or appearance of coercion.

6. Consent: Adults

For research with minors (anyone under the age of consent according to the laws of the country where research is conducted), write NA for this section and complete the Minors Supplement.

Consent is a process. A consent form/information statement is documentation of the end of the process. See our guidance on consent for more information about this process.

6.1. Consent Process: Describe how you will obtain consent. Include who will be obtaining consent (their role(s) not the specific individual), in what location/setting, the process for describing the research (discussing the form one-on-one, describing the research to a class, an information statement on paper or online, etc), how you will provide the opportunity to ask questions, and how you will document consent.

Methods of Obtaining Consent

· Written: the subject signs a paper consent form or provides a legally accepted electronic signature → This is the default accepted method for non-exempt research.

· Verbal: the subject verbally agrees to participate, but does not sign a form. You must request a waiver of written documentation of consent from the IRB to use this method.

· Electronic consent: the subject consents electronically by reading an information statement and clicking a button agreeing to continue to participate. You must request a waiver of written documentation of consent to use this method.

· Implied consent: the subject provides unwritten consent by taking action to participate. You must request a waiver of documentation of consent to use this method.

· No consent: the subject does not provide consent. You must request a waiver of informed consent to use this method.

See WWU’s guidance on consent forms , including templates for use. You will need to attach final consent forms/information statements to your application for submission.

The WWU consent form will be inserted into the Qualtrics survey. I am using an information template from the WWU compliance page to conduct written consent. Participants will be asked to read the consent and sign before they are able to enter the survey. This is embedded in the Qualtrics survey.

6.2. Waivers: Are you requesting any waivers related to consent or elements of consent (such as a signature)?

☒ No

☐ Yes ➔ If yes, complete the Waivers Supplement .

6.3. Influence & Coercion: Even if you don’t pressure subjects to participate, would it be difficult based on your role or any other factor for subjects to opt out of participating?

For example: Professors conducting research in their classrooms may unintentionally cause students to feel pressured to participate.

☒	No
☐	Yes	If yes, describe what steps you will take to prevent against this:

Examples: Someone other than the professor will obtain consent from their students/subjects; Professors will leave the room after providing consent forms, which are collected by a third party and sealed in an envelope – not to be opened until after grades have been submitted to the Registrar’s Office

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6.4. Deception & Delayed Disclosure: Will you withhold information, provide false information, or delay disclosure of information to any subjects?

☒ No

☐ Yes If yes, describe what information you will withhold, your rationale for withholding, and whether/how you will disclose this information at a later time (debriefing).

7. Procedures

7.1. Procedures: Using lay language, describe the procedures for this study. Include the overall sequence of the procedures. Tell us the setting/location of the procedure(s). For each task include the time required.

A Qualtrics survey will be emailed to all currently enrolled graduate level students. Students who would like to volunteer to participate in focus groups will provide their Western email. The survey will take approximately ten minutes to complete and will be available until June 4th, 2018. Self-selected focus group participants will be contacted through their Western email to schedule focus group sessions and provide their numerical designation. Focus groups will be one time, for 30 minutes. With consent, these will be audio recorded. There will be two focus groups, one for participants who have never used a writing center, and one for participants who have used a writing center. Focus groups will be held on campus between June 4th, 2018 and June 14th, 2018. Participants will be contacted via their Western email to notify them that they have won their focus groups gift card. All email addresses of focus group participants will be destroyed after compensation has occurred.

7.2. Communication: Describe the types of communication (if any) that you will have with enrolled subjects during the study, outside of conducting the study procedures listed above. This would include scheduling or follow-up communication.

Communication will be via Western email accounts.

7.3. Devices: Does your study use a device as defined by the U.S. Federal Drug Administration (FDA)?

☒	No
☐	Yes	➔ If yes, is an Investigational Device Exemption (IDE) required?
		☐ No
		☐ Yes

8. Data Security Protections

Please see the IRB’s guidelines for data security and protection .

8.1. Identifiers: Will you be collecting any identifying information at any point (including recruitment)? Identifiers include: name, contact information, date of birth (with the exception of just the year or someone’s exact age, unless the subject is over 89 years old), Western ID number, social security number, medical record number, IP address, photographic image, audio, or any other characteristic that could uniquely identify the individual.

☐ No

☒ Yes ➔ If yes, list the identifiers you will be collecting.

Contact information will be collected for participants who self-select to participate in focus groups.

8.2. Protected Health Information (PHI): Will you access, obtain, use, or disclose subject identifiable PHI?

PHI is individually identifiable health care information or clinical specimens from an organization considered a “covered entity” by federal Health Insurance Portability and Accountability Act (HIPAA) regulations. University health clinics voluntarily extend HIPAA protections to their patients, so if you will be accessing PHI through university clinics then HIPAA regulations apply.

☒ No

☐ Yes ➔ If yes, will obtain HIPAA authorization from the subject before obtaining and using the PHI?

8.3. Research Collaboration: Will any of the individuals who provide you with coded information or specimens also collaborate on other activities for this research?

For example, an individual providing you with names of eligible patients from a clinic is also a researcher on the study.

☒ NA

☐ No

☐ Yes ➔ If yes, who are your research collaborators and what activities will they engage in?

8.4. Washington State Department of Corrections Data (DOC): Will you be requesting data from the DOC?

☒ No

☐ Yes ➔ The DOC will only accept IRB approval from the Washington State IRB (WSIRB) for data requests. You will need to seek separate approval for the use of their data.

8.5. Family Educational Rights and Privacy Act (FERPA) Data: Will you access, obtain, use, or disclose elements of WWU student education records?

☒ No

☐ Yes ➔ If yes, please confirm that you will follow the regulations for protection and disclosure of FERPA data.

☐ Confirmed.

8.6. Data Identifiability: Check the options that apply to your data.

☐	Public	Subjects are identifiable when data is collected and published.
☒	Data is Never Linked	The researcher will never know, or have any possible way of knowing, the identity of the subjects OR there is no link between the subject’s data and their identifiable information.
☒	Data is Linked	There is a link (at any point in the study) between the subject’s data and their identifiable information, either directly or indirectly. ➔ If Checked:
		☐ Directly: Subject’s data will be labeled with or inherently contains their contact information or other identifying information. Example: labeling a survey with a subject’s name; audio recordings
		☒ Indirectly: Subjects will be assigned a code, which will be used to label the data. This code will link to the subject’s contact information.
		☒ Random unique ID: Subjects are assigned a random ID number that does not correlate with the subject.

☐ Logical unique ID: Subjects are assigned a non-random unique ID number that is a

combination of elements related to the subject (but that would not be considered identifiable).

8.7. Publications: Do you plan to use potentially identifiable information about subjects in publications and presentations, or is it possible that individual identities could be inferred from what you plan to publish or present? Example: Using direct quotes from an interview or questionnaire; using video or images of subjects

☒	No
☐	Yes	➔ If yes, will you obtain consent for this use?
		☐ Yes
		☐ No → If yes, complete the Waivers Supplement .

8.8. State Mandatory Reporting: Each state has reporting laws that require some types of individuals to report some kinds of abuse, and medical conditions that are under public health surveillance. These include:

· Child abuse

· Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult

· Sexual assault

· Serious physical assault

· Medical conditions subject to mandatory reporting (notification) for public health surveillance.

Are you or a member of your research team likely to learn of any of the above events or circumstances while conducting your research AND are obligated to report it to state authorities?

☒ No

☐ Yes ➔ If yes, which events/circumstances are you likely to learn about and what is your plan for reporting?

8.9. Methods of Data Protection: Please see our guidelines on research data and security protections . Identify the classification of the data you will collect and the minimum requirements that are expected for that level. Please write here what level of protections will be applied to the data/specimens. If you will use more than one level, describe which level applies to which data/specimens.

The classification of the data I collect will be level 2 data. This data in motion (level 2-4) will be protected through SSL settings in Outlook when the survey recruitment letter is emailed, through Qualtrics TLS encryption for surveys, through SSL in Outlook to set up focus groups, and only the survey data and written consent form will be saved at completion. Identifiable data will only be collected from self-selecting participants. No other participants will have identifiable data. Focus group participants will be given a participant numerical designation, which will link to their data until compensation, has been completed. Survey data will be linked. Focus group data will be linked to the participants’ provided contact email address, which will be assigned a random code.

8.10. Data Retention: Please describe whether you will retain identifiers (if collected) and how long data will be retained (until the study ends, indefinitely, etc).

Identifiers will be retained only until focus group participants have been compensated.

8.11. Withdrawal: Describe what will be done with data in the event that a participant withdraws from the study.

If a participant withdrawals from the study their data will be removed and destroyed, using AVG shred.

8.12. Future Contact: Do you plan to retain contact information for subjects in order to re-contact them in the future?

☒ No

☐ Yes → If yes, this information must be included in the consent form.

9. Compensation or Reimbursement

9.1. Compensation: Please describe any compensation (monetary, extra credit, course credit, non-monetary) or reimbursement that will be provided to subjects. Include the amount and if payment will be pro-rated for the completion of certain tasks. For course credit, you can provide an estimated range. Include whether subjects will still receive compensation if they withdraw early from the study.

Participants who self-select to participate in focus groups will be entered for a random chance to win an Amazon gift card for $25. One card will be offered per focus group.

9.2. Alternative Provided: If you are providing course credit as compensation, you must have an alternative assignment worth equal amounts of course credit and requiring the same effort for subjects who choose not to participate. Please provide a very general description of the alternative available. You do not need to provide an alternative for offers of extra credit.

9.3. Request to Deviate from the Default Compensation Type: Please see our guidelines on providing research incentives . For cash or cash equivalent incentives funded by or administered through Western, the preferred incentive format is Amazon gift cards. Other methods are allowable if the researcher can demonstrate that the integrity of the research will be affected in a material, negative way by using the preferred method. If this applies to your research, please briefly describe your reasoning.

10. Risks & Benefits

10.1. Anticipated Risks: Please describe any reasonably foreseeable risks. This can include a risk of emotional or physical discomfort or harm. Include how you will reduce the possibility of these risks.

Examples: Subjects may feel uncomfortable answering questions about their feelings; Subjects may experience physical discomfort from exercising; If accidentally identified, subjects may experience a change in reputation or employability.

Participants may experience discomfort answering questions about their experiences in a writing center, if they had a negative experience, which cannot be ascertained in advance.

11. Attachments

Please attach all of your final supporting documents to your email submission.

☒ Recruitment Documents (letters, emails, scripts)

☒ Consent Form or Information Statement

☐ Assent Form (if applicable) – for minors participating in research

☒ Study instruments (questionnaires, interview questions, task descriptions/pictures)

☐ Clearance Letter(s) – permission for access to subjects or their data through schools

☐ CITI or NIH Training in human subject research protections

☐ Other IRB Approval Notice (if applicable) – for a study with multiple sites and IRBs

☒ Other: https://wwu.az1.qualtrics.com/jfe/form/SV_dg2VQTm1xRy2IUR

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