Institutional Review Board (IRB)

Welcome to the Navajo Technical University research site for researchers. If you are a student about to embark on a research initiative, please read all of the following information so you can be well informed about your project.

1. Have your faculty advisor review and approve your project
2. Determine the type of review required: exempt, expedited or full review
3. Download an Application for Research for your project.
4. Complete the application and submit to a member of the CIR
5. Use the application checklist below to insure your documents are complete before submission.

Application for Research
All applications should be in type-written form, written in non-technical terms, and response placed directly under each question. It is the investigator's responsibility to provide information about research procedures so that the CIR has a clear understanding of what the research entails. It is important that you answer every question to ensure that all of the necessary information is included in your application.

Data collection may not begin until researchers have received approval to conduct the research, and research related activity shall not continue beyond the date stated on the approval letter. Research projects involving human subjects can be approved for up to one year in accordance with Federal Regulations. A study is considered complete when data collection and data analysis are complete.

Application Checklist
The following is provided to assist you with your application. Be sure your completed application includes these documents:

1. A title page with contact information for all investigators and sponsors.
2. A completed application form that includes:
   • - A description of any potential financial or professional interest by a funding source in the outcome of the research.
   • - A description of the setting or location(s) of where the research will be conducted.
   • - An estimate of how the amount of time that will be requested of each participant.
   • - A description of any potential benefits to participants for participating in this research (including incentives of any type).
   • - A description of instances in which participant confidentiality would be broken.
   • - Disclosure of any additional or non-institutional funding sources.
3. Attach letters of support or agreement showing permission to conduct research at this location.
4. Copies of advertisements, recruitment letter(s), scripts, instructions given to participants.
5. Forms that will be used: Informed Consent, Confidentiality Statement, and Project Renewal.
6. Copies of surveys, instruments or measures, questionnaires, interview schedules, focus group questions, screening instruments, and/or other materials used to collect data.
7. Certification of back-translation for any materials that were translated into a language other than English as well as copies of materials in that language.
8. CV or bio sketch for Principal Investigator
9. Submit two complete application packet to the Chair or Co-Chair of the CIR

Faculty Responsibility for Student Projects
All research involving human subjects conducted by students are to be supervised by a faculty member and be reviewed and approved by the Committee on Institution Research prior to initiation. Investigators may not solicit subject participation or begin data collection until they have received written approval from the CIR.

The faculty advisor has the responsibility for (1) making the decision whether student research activities involving human participants meet eligibility for CIR review; (2) overseeing all research related activities; and (3) assuring that ethical principles are adhered to in the conduct of the project.

An example: consider a student who undertakes an individual or class project that does not involve a vulnerable population and involves no risk to the subjects of the study. The student delivers a presentation on campus (e.g., poster or showcase session or an oral presentation before faculty and peers.) This project would not require CIR review. However, if the results of this otherwise "no or low-risk" project may/might be disseminated at a professional conference, submitted for publication, or published on the World Wide Web, government regulations require prior review by CIR.

Generally, student research involving human subjects falls into one of two categories, only one of which requires CIR Review:

• Independent research
• Research methods training
• Curriculum Projects

Regulations:
Title 45 Code of Federal Regulations Part 46 (45 CFR 46) Protection of Human Subjects specifies federal regulations for the conduct of research involving human subjects. All human subjects research at Navajo Technical University must be conducted in accordance with 45CFR46. Regulations are available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

(Ref: 21 CFR Part 312, 812, 45 CFR 46.101(b)(4), (b)(3), 45 CFR 46.402(a), 63 FR 60364-60367, November 9, 1998.)