Other TCU, Tribal, or Health Board IRBs may use this form,
and modify/edit it to meet their needs.
The NWIC IRB encourages student researchers and their faculty advisors to discuss the content of their application with NWIC IRB staff before submitting this formal Application.
þ = (copy and paste check mark where needed)
Student Principal Investigator (PI)/Researcher:
Major: Expected Graduation Date:
College/Site:
Faculty Advisor/Instructor:
Course/Capstone Project:
Capstone Committee members (if applicable):
Student Address: .
Student Telephone #: _____-______-______Fax #: _____-______-______
Student E-mail(s):_
Project Title:
_
Expected dates of entire project. Start: ______End: ___ _
q A. No other IRB is involved or reviews your research project and plan (“protocol”).
q B. Other IRB[s] has/have reviewed, is/are reviewing, or will review, your protocol:
(Please include a copy of all correspondence from that/those IRB[s].)
Name(s):
e-mail: phone:
Discuss with NWIC IRB staff; box completed by NWIC staff
What is deadline date by which you must have NWIC IRB complete its review and approval?
q A. No deadline.
q B. By (date):
q C. Other approval(s) necessary before research begins (i.e.: LIBC, Cultural Commission, etc.):
General Instructions
If your research involves human participants (interviewing, specimen testing, records search) you must submit this application. The IRB reviews research protocol for ethical conduct to ensure that the research does not harm individuals or tribal communities through identification or unnecessary research procedures. Involving Tribal individuals or community requires approval from the Tribal government through the Council, and/or the Cultural Commission, and/or other committees that may be impacted by the research.
1. Please attach your proposal and indicate here the page numbers where the following topics can be found in the proposal:
Background (What do you already know about this topic? Why is this research an important topic?)
Purpose of your research project (What do you plan to accomplish or do?)
Procedures of your research project (What do you plan to do?)
What will you ask research participants to do (include interview questions if used)
Study population (Whom will you study: age range, gender, characteristics [e.g., elders, students, people working in …]?)
Timeline of your research project (start date, recruit and interview dates, end date)
Source of data or specimens you will obtain
Future use of data and specimens
Future disposal of data and specimens
Procedure to maintain privacy of each individual and of Tribe[s]
Procedure to maintain data confidentiality
Dissemination of research results (Will you present your research? If yes, to who?)
(NOTE: It is especially important to discuss this Section with IRB staff before filling it out. Please see additional worksheet titled “How to assess harms and benefits in your research.”)
2. Describe potential harms and benefits.
A. Broad types of potential harms (risks), Think about how your research could impact your research participants: examples could include information that causes embarrassment or discomfort, or information that may involve private and/or sensitive cultural information. Please discuss with NWIC IRB staff.
B. Broad types of potential benefits, examples could include research participants providing information that may help others or their community, or they themselves will benefit from the results of your research. Please discuss with NWIC IRB staff.
C. Minimizing potential harms and maximizing potential benefits.
What methods or techniques will you use to assure that your participants are protected from potential negative data, AND how will you emphasize the benefits and the Tribal community?
3. Process of recruitment:
What recruitment materials will be used and who will conduct recruitment process (i.e.: posters, handouts, script of phone calls, etc.)?
Please attach all recruiting materials.
4. Number of people to be enrolled in your research.
Please give the expected or planned Numbers of Participants to be enrolled, and/or to give specimens, and/or that will have their medical records reviewed. (Please state if specimens or record review will also be involved.)
q Group 1: . #
q Group 2: . #
q Group 3: . #
q Group 4: . #
q Group 5: . #
5. Process of consent. Please discuss with NWIC IRB staff.
A. Process(es) of Informed Consent (adults), Permission (guardian for minor), and/or Assent (minor’s agreement) Describe the process(es) used to ask for informed consent/permission/assent. Describe your procedures to avoid possible coercion or appearance of coercion.
Consents should include:
· Summary sentence of research (the term “research” should be included in the title and description)
· What participants are expected to do
· Contact information for researcher
A standard NWIC IRB clause: “If you have grievances or complaints about this project, you can call the Northwest Indian College IRB at (360) 392-4224 or email ”
· What potential harms and benefits there is to participating
· Time commitment required by participant
· If compensated for time, what would that be
· How will identities be protected (or not)
· How the data will be used, disseminated, and stored (or not)
· Statement about participant getting a copy of the (written) signed consent document
· Signature block for participant’s signature and date. (NOTE: If you will interview Elders, please discuss with IRB staff. Some elders may choose to NOT sign a consent document for cultural reasons.)
6. Additional documents. (NWIC IRB strongly prefers electronic files.) Please include:
A. The current Consent documents (as editable files).
B. Recruitment letters, flyers, etc. and similar documents.
C. Resolutions of approval by the government (usually by the Tribal Council) of every tribe involved.
D. Letter[s] from CEO or Executive Director, and (if applicable) Clinical Director of every agency or institution upon which the project relies (e.g., CHRs will read medical records, recruit people in the waiting room, or survey school students).
E. Letters of Support from college faculty/instructor and other people key to the success of the project.
7. Please BRIEFLY list all activities in or with tribal communities related to the project that you have already done. These activities may include (for example): * informal presentations; * discussions with Tribal Council and/or Health Commission or Culture Commission; and * written or oral formal proposals or reports to participating tribal communities or funders. List only the type of activity, the date, by whom, with whom, and approximate number attending. Please attach all relevant documents (e.g., handouts, summaries).
q A. No activities in or with tribal communities.
q B. Activities as follows (listed briefly):
8. Please describe the development of any planned dissemination (poster presentation, publication, etc.). The reason is that this IRB protects Tribes and Tribal-based institutions from potential stigmatization during the dissemination process. The IRB reviews and verifies that the dissemination process is followed in the research plan approved by the NWIC IRB. (
Signature of PI: Date:
Please send this signed form electronically to the NWIC IRB.
Northwest Indian College Center for Health
2522 Kwina Road
Bellingham, WA 98226-9217
360-392-4224 fax 360-392-4349
NWIC IRB Student Application Checklist
q This application
Completed and signed. Please see NWIC Center for Health (Building 10) for assistance in completing the form, or contact , 360-392-4224.
q Your complete, entire, research plan (“protocol”).
For instance, if you are doing a Capstone Project, your entire written Capstone Plan is your protocol. Please include your current version, even if it may change in the future as you work with your advisor[s].
q Consent document
Please be sure that all the bullets outlined in this application are included in your document, that it is grade 8 reading level (simple language), and has YOUR contact information.
q Applications completed to other IRBs
If other IRBs are reviewing your protocol (research project), we need to know who they are and contact information which would be on applications that you completed for them.
q Data dissemination plan
If you are planning on presenting the information that you gathered from your research, the NWIC IRB needs to know BEFORE the information is disseminated. What, where, who, when and how (Public presentation or poster presentation of research, intention to publish research).
q Letter of Approval from appropriate Tribal Committee, Board or Commission, or TCU
Examples: Cultural Committee, Education Board, Law & Justice Board, Health Board, and Fish Commission
q Resolution of Tribal approval (may not be required)
If you are involving Tribal participants, approval must be provided by an entity of the Tribe (Council, Clinical director, Cultural committee, etc.)
Rev: 7/8/13 page XXX Student Application, NWIC IRB