Human Subjects Research

Application:

Human Subjects Research

Before completing this form:

Step 1: Ask yourself these two questions:
Is my project a systematic investigation designed to develop or contribute to generalizable knowledge?
Are the human subjects, from which I am collecting information or data, living individuals?

If you answered NO to either question, stop here. No review is required, so it is not necessary to submit this form. You will need to document your responses to these questions for your records.

Step 2: Ask yourself these two questions:
Will I obtain information or biospecimens through intervention or interaction with these individuals?
“Intervention” includes both:
physical procedures by which information or biospecimens are gathered (for example, measurement of heart rate or venipuncture)
manipulations of the subject or the subject’s environment that are performed for research purposes.
“Interaction” includes communication or interpersonal contact between the investigator and subject (for example, surveying or interviewing)
Will I obtain, use, study, analyze, or generate identifiable private information or biospecimens?
"Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, or information which the individual can reasonably expect will not be made public (e.g., a medical record)
"Identifiable" means that the identity of the subject may be ascertained by the investigator or associated with the information (e.g., by name, code number, pattern of answers, etc.).

If you answered NO to BOTH questions, stop here. No review is required, so it is not necessary to submit this form. You will need to document your decision process for your records. If you answered YES to either question, continue.

Instructions:

Please read all the instructions carefully.
This form is not compatible with versions of Microsoft Word 2003 or older. Please contact us if you’re having trouble with compatibility and formatting, so that we can figure out a solution together.
To receive a copy of a web disability accessible version of this form, please call the Office of Research and Sponsored Programs at (360) 650-2146 or email .
Do not edit or delete any portion of this form, except to delete these initial instructions pages for submission or to add rows to tables as needed. Applications with sections removed or instructions edited will be returned.
Answer all questions. If a question is not applicable to your research, type “NA.” If you leave the question blank the IRB has no way of knowing whether that question was skipped or accidentally overlooked. Incomplete applications will delay the review process.
To add text, click on the grey box and begin typing. To select a check box, click on the checkbox.
Please try to target your response to the question and avoid repeating information between sections. Rather than repeating information, you may reference an answer in another section of the application by question number.
Use non-technical language as much as possible, spelling out all new acronyms and explaining any field-specific jargon. Assume that the IRB is not familiar with your field of research.
Materials should be typed, not handwritten, with the exception of application signatures.
When complete, submit your application by with the subject line “New Application.”Attach all documents to your email, including your recruitment materials, consent form, and study instruments. This application can be submitted as a PDF or as a Word document.
Each application should have one Principal Investigator, though your research may have several co-investigators.
You can specify an IRB contact if someone other than the Principal Investigator or Faculty Advisor will be responsible for correspondence with the IRB.
Undergraduate and graduate students can be Principal Investigators on projects. A Faculty Advisor is required.
Please review the guidance on our website related to:
Informed consent
Requirements and recommendations for data security and protections
Compensation procedures
Please note where supplements are required in addition to this application. These should be downloaded, completed, and sent along with your application as a PDF or a Word document.

DO NOT SUBMIT THESE INSTRUCTIONS PAGES

Application: Human Subjects Research

Principal Investigator and Faculty Advisor Responsibilities Agreement

Conduct of the Research
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.
I accept responsibility for ensuring this research is conducted according to:
the protocol approved by the IRB;
the applicable terms of the grant, contract, or signed funding agreements; and
applicable laws and regulations.
I certify that I (or my faculty advisor) is sufficiently qualified to assume responsibility for the proper conduct of this research.
I accept responsibility for ensuring that members of this research team are appropriately trained and supervised.
Ensuring and Maintaining Compliance
I will comply with relevant regulatory and institutional requirements, including those relating to conflicts of interest, responsible conduct of research, and research misconduct.
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.
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.
I will obtain initial approve before beginning any research interaction or intervention or data collection with human subjects.
I will obtain prior approval for any modifications to this research.
If my research is considered to be expedited or full board, I will notify the IRB of the study closure promptly.
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.
I will promptly report any instances of noncompliance or unanticipated problems.
Investigator Records, Reports, and Documentation
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.
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.

Principal Investigator Name
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.

Faculty Advisor Name
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.

Department Chair Name
Department Chair Signature / Date

Application: Human Subjects Research

Investigator Information

Principal Investigator(One per application is allowed)
First Name: / Last Name:
Degrees: / Department:
Home Institution: / Address/Mail stop:
Phone: / Email:
Status: / ☐ Faculty ☐Staff ☐Graduate student ☐Undergraduate Student
Faculty Advisor (Required for Undergraduate & Graduate Students)
First Name: / Last Name:
Home Institution: / Department:
Position: / Address/Mail stop:
Phone: / Email:
IRB contact (If different from the Principal Investigator)
First Name: / Position: / Phone:
Last Name: / Address/Mail stop: / Email:

2. Study Information

2.1 ShortStudy Title:
2.2. Funding: Is this research supported in whole or in part by a grant or contract?
☐ / No
☐ / Yes / If yes:
Funding Agency:
Grant/Contract Title:
Grant Number# / Grant Award Term:
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
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.)
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 approval? / ☐ / Yes / Please attach a copy of your IRB’s approval memo or similar 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?
☐ / 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/orbehavioral.
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 datawhere 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 ofonlyimproving 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.
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.
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.
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.
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.
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
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