NAU IRB - INITIAL APPLICATION FOR APPROVAL OF RESEARCH

** This form is for drafting purposes only. Please DO NOT turn this in to IRB!

  1. Project Title:
  2. Name of Principal Investigator/Lead Investigator and email address:
  3. Are you applying as a student?Yes No

3a. If yes, faculty sponsor name, email address, and department:

*Graduate and undergraduate students are required to conduct research under the guidance of a faculty sponsor, advisor, or mentor.

  1. Primary NAU College:
  2. Primary departmental or school affiliation within your college:
  3. If not College affiliated, NAU department or office:
  4. Names of any collaborators, co-PI’s, key personnel, etc. Please state the names, email addresses, and roles of these people:
  5. Conflict of Interest: Do you or your spouse, domestic partner, or dependent child (as defined by the IRS) have any significant financial interest greater than US $5,000.00 that is or could potentially be affected by this research project? Yes No
  6. Conflict of Interest: Do any of your collaborators or their spouse, domestic partner, or dependent child (as defined by the IRS) have any significant financial interest greater than US $5,000.00 that is or could potentially be affected by this research project? Yes No
  7. What is the purpose of the project?
  8. What is the status regarding funding for this project? If there is no funding, say “None.”
  9. What situation, special circumstances, or unique qualifications does the researcher have that will enable or facilitate carrying out this research? If none, answer “None.”
  10. Please provide a brief overall description of the research project. Include information about the background and rationale for the study, its purpose, and objectives.

Population

1. Will any participants be less than 18 years of age? Yes No

*If you are including participants under 18, you will likely need to include an Informed Assent Form for Minors (ages 13 to 17), Assent Form for Children (under 13), and a Parental Consent Form. You can find templates for these forms on the NAU IRB website.

2. What is the age range for the participants? Minimum: Maximum:

*If you are unsure of the exact age ranges of the participants, provide an estimate.

3. What is the anticipated number of participants in the research?

4. What special or vulnerable groups will be involved? Note: children, prisoners, pregnant women and their fetuses are considered vulnerable groups by the federal government. Research involving these groups may prompt additional safeguards.

5. Describe the population under study:

Recruitment and Consent

  1. How will prospective participants be selected, enlisted, or recruited?
  2. Are you requesting a waiver of the requirement for a signed consent form? Yes No

*Most projects do not qualify for a waiver of signed consent. However, if your project can be described by one of the two statements below, you can request a waiver of SIGNED informed consent. If you believe that your project qualifies, place and X in the “yes” box.

  1. The only record linking the participant and your research would be the consent form, and the principal risk would be the potential harm resulting from a breach of confidentiality. If the IRB approves your request for a waiver of the requirement for a signed consent based on this condition, you must ask each participant whether they want documentation (the signed consent form) linking them to the research.
  2. The research presents no more than minimal risk of harm to participants, and involves no procedures for which written consent is normally required outside of research context.
  1. How will potential participants receive informed consent? Describe the informed consent process.

Methodology and Data Collection

  1. What type of data collection will be employed? Please select all that apply.
  1. Describe research methods and procedures for data collection.
  1. Where will the project be conducted? *If off-campus, describe where off-campus, and if appropriate provide a statement of authorization for the site(s).
  1. Is this project part of a multicenter (more than one site) or a collaborative study? Yes No

4a. If you answered “Yes,” please describe your plan for communicating information between the groups including: unexpected problems, protocol modifications, results of the study; security/protection of the data, and how confidentiality or anonymity will be maintained. Will NAU be the primary IRB? If not provide a copy of the approval form from the primary IRB.

Confidentiality

*Signed consent forms and data, with the exception of transcribed or analyzed recordings, must be stored securely for at least three years after completion of the study.

  1. Describe the procedures to ensure that information collected for the study will be kept secure.
  1. Do you plan to maintain personal identifiers (names, addresses, birth dates, phone numbers, etc.) after your project is completed? Yes No

2a. If YES, describe your plans for maintaining personal identifiers securely.

2b. If NO, describe your plans for the destruction of linkages to personal identifiers and the time frame.

  1. If you plan to take photographs or audio or video recordings of participants, describe whether you will maintain, destroy, or return them to participants.
  1. If personal identifiers will be revealed in your study (i.e., not kept confidential), provide justification and describe how the participants are informed. If personal identifiers will be kept confidential, type N/A.
  2. Will your study involve the collection of data that might produce a regulatory mandate or duty to inform authorities about potentially harmful or illegal activities? If so, what is your plan for dealing with this information? *If your study will not likely reveal such information, respond to this question with N/A .
  3. Will a Certificate of Confidentiality be obtained? *Most researchers will answer “no” to this question.

Benefits and Risks

  1. Describe any potential direct benefits to the participants.
  2. Describe any potential benefits to society, the field of study, or discipline.
  3. Describe any potential costs to the participants.
  4. Will the participants be compensated for the study? *If so, please describe how they will be compensated.
  5. Describe any potential risks that the participants could encounter through their participation in this study.
  6. Describe efforts to minimize risks to participants.

Upload Additional Documents

Upload informed consent forms, assent forms, funding proposals, letters of support, data collection measures, recruitment flyers and scripts, and any other documents related to your project

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