Nairbe Application Template

NAIRBe Application Template

Use this template to develop answers to the questions asked on the NAIRBe online IRB application system. Do not turn in this document to the IRB. Use it to draft your answers for the online application. You can pass it around among your co-investigators, faculty sponsors, or other collaborators to revise your answers before transferring them to the online application.

The questions and phrases in bold are the items requested verbatim on the online application. Clarification and guidance on how to answer immediately follows each question. The open text fields (grey boxes) are provided for you to draft your answers prior to filling out the online application.

Page 1 Main Application

Project Title:Choose a title that is descriptive and succinct. Try to limit your title to 100 characters.

MY ANSWER:

Are you applying as a student?Yes No

If you are doing a research project under the guidance of a faculty sponsor, advisor, or mentor, then you should answer “yes” to this question.

What is the primary NAU department/institution/other sponsor?Select from a drop-down box listing schools, departments, research centers, and administrative offices at NAU.

MY ANSWER:

What is the purpose of the project?Choose from among Class Project, Dissertation, Research, Thesis, or Other (please specify). “Other” can be evaluation projects, database collection projects, or any other type of project that does not fall within the other categories listed. If you are doing a class project, you will need to specify the class and course number.

MY ANSWER:

Proposed Project Start Date: Select a date that is at least 1 month from the time you expect your application to be submitted to the IRB. The date should be formatted as MM/DD/YYYY.

MY ANSWER:

Proposed Project End Date: The end date should not be more than 1 year from the proposed start date. If your application is accepted under expedited or full board review, the approval is good for 1 year only. If your project will extend beyond 1 year, you can apply for a continuation by using the short form on our website.

MY ANSWER:

What is the status regarding external funding for this project?If your project is supported by a grant or other funding source, you will need to identify it in the open text box.

MY ANSWER:

Page 2 Researchers

First, add yourself and click Add Researcher. Include the date on which you took the IRB required tutorial. Select a role for yourself from among Principal Investigator (PI), Lead Investigator (LI), or Co-Investigator. Students should assign themselves as Principal Investigator if they are doing a dissertation or thesis only; all other students who are the main researchers should assign themselves as Lead Investigator. Faculty and staff can be Principal Investigator, Co-Investigator, Faculty Sponsor, or Key Personnel. Key Personnel is used for any other members of the research team who will have access to data. Be sure to click “Add Researcher” before going on or quitting.

Please note: if your project includes a Faculty Sponsor/Advisor or Co-Investigator, or a PI or LI other than yourself, your application will be forwarded to that person PRIOR TO coming in to the IRB. That person will then have to “Accept the Application” and answer the “Conflict of Interest” question with a “Yes” or “No” in order for your application to be submitted to the IRB.

If that person makes comments on the application and returns it you for corrections, the application will go back to you. After you make your corrections and submit your application, your application will go back to that person for approval. That person then clicks “Accept the Application” for your application to come to the IRB.

Researchers and RolesMY ANSWER:

Page 3 Abstract

Please provide a brief overall description of the research project. Include information about the background and rationale for the study; the purpose, hypothesis, or research question and objectives; and the research methods. Your abstract should include a non-scientific description of the study and why you doing it. What will the outcome of the study be used for? Who will want to know the results? What methods and instruments will be used? Try to be succinct (less than 250 words) and to-the-point. Extensive citing of the literature and background information is not necessary. You only need to provide that information which will help the IRB in determining the reason for your research and who will be affected by it.

MY ANSWER:

Page 4 Population

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. You can attach these forms to Page 9 of your online application.

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.

Will any participants be NAU students?Yes No

What is the anticipated number of participants in the research? MY ANSWER:

What special or vulnerable groups will be involved?Select “yes” or “no” from among children, prisoners, pregnant women, cognitively impaired, Native Americans living on reservations, undocumented persons, or economically or educationally disadvantaged persons. If your study specifically targets participants who fall under these categories, then click “yes.” If you think that people who fall under these categories may become part of your participant pool by chance, then click “no.”

Your application may be selected for Full Board review (discussed at the next IRB Board meeting) if you select any one of the special or vulnerable groups. If this happens, you will be notified by the IRB Director and invited to attend that meeting. The Board may then make special requests for additional safeguards to be included in your application.

MY ANSWER:

Describe the population under study:Try to include as much demographic information as possible, even if you are not sure at this point. Be sure to describe ALL participants groups that will be part of your study. For instance, if you are looking at a classroom, be sure to describe the students AND the teacher. If using an intact university class, describe the participants as graduate or undergraduate students, the subject area, and why you are using this group.

MY ANSWER:

Page 5 Recruitment and Consent

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, in some cases, a breach in confidentiality can be especially risky to certain groups of participants, such as gang members, illegal border crossers, teen runaways, etc. Because of this, there is the option of requesting a waiver of signed informed consent. If you believe that your project qualifies, click “yes.” You will then be presented with two statements:

1. The only record linking the subject 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 subject 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 subjects, and involves no procedures for which written consent is normally required outside of research context.

Select the second option if you are collecting data via the internet.You will still need to provide informed consent information to your participants, either verbally or in writing, but you won’t be collecting signed copies if you request this waiver. Please note that your study will not qualify for this waiver if it involves audio or video recording, photographing, or the naming of participants in your written report.

If you answer “no” to this question, you will need to include the appropriate Informed Consent forms for your participant pool. Templates are available on the NAU IRB website. Spanish language versions are also available.

MY ANSWER:

Briefly describe how the participants will be selected, enlisted, or recruited.How will prospective participants be identified? Who and how will they be contacted (by email, phone, flyer, class announcement, etc.)? What information will be provided to them? How will potential participants contact you? Include the wording that will be used in the recruitment and screening of potential participants. Recruitment material should be straightforward and honest and specify that that this is research, the purpose of the research, benefits and risks, eligibility criteria, any compensation, contact person, and institutional affiliation.

MY ANSWER:

Describe the informed consent process. Your response should include a description of the presentation of informed consent information and the process for guiding potential participants through the informed consent process. DO NOT SIMPLY COPY AND PASTE YOUR INFORMED CONSENT FORM. Who will be presenting the information to the participants? Will participants have a chance to ask questions and make a decision about participating? For participants with literacy issues, the researcher should read the informed consent form aloud, providing time for questions; in second language situations, translations of documents may be required. For internet research, the online instrument should include a checkbox question where participants verify that they have read and understood the informed consent information.

MY ANSWER:

Page 6 Methodology and Data Collection

What type of data collection and recording will be employed? CHECK ALL THAT APPLY AND SUBMIT COPIES OF DATA COLLECTION INSTRUMENTS. Select from questionnaires/surveys, photography, observations, participant observation, video recordings, interviews/focus groups, audio recordings, records review, and other (please describe).Please note that additional safeguards may be requested by the IRB if you select audio or video recordings or photography. Be sure to include all instruments (survey questions, observation tools, etc.), including drafts of those in progress, as attachments on page 9 of your online application.

MY ANSWER:

Describe research methods and procedures for data collection. Describe how you will collect data including who will be involved, when and where it will take place, how long each data collection session will take, and where data will be stored securely as it’s collected. Be sure to describe how you will employ each of the items you have checked in the previous question.

MY ANSWER:

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).Data collected through phone interviews, internet surveys, or by mail are not considered off-campus. If data will be collected at another site, such as at a public school or place of business, describe that location and provide a written statement from the person in charge of that site stating that you have been granted permission to conduct your study there. This may be as informal as an email or a typed letter.

MY ANSWER:

Is this project part of a multicenter (more than one site) or a collaborative study? Yes No

Click “yes” if your project involves collaborations with researchers who are collecting or analyzing data at an off-campus or non-NAU-affiliated site. If you click “yes,” you will also need to answer the question below. Don’t forget to include letters or emails of support from your collaborators.

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.Please include the location of the other site(s). If your project involves collaborations with researchers who are collecting data at an off-campus site, describe how you will communicate with those researchers regarding unforeseen problems, concerns, changes, etc. on a regular basis. Include how the data will be secured and confidentiality maintained if multiple sites are involved in the project.

MY ANSWER:

Page 7 Confidentiality

Describe the procedures to ensure that information collected for the study will be kept secure.ALL DATA MUST BE SECURELY STORED FOR 3 YEARS AFTER COMPLETION OF THE STUDY. What is your plan for maintaining the confidentiality of your participants and the data they provide? Where will data (either hard copy or electronic) be stored? Who will have access to the data? Who will know the identity of participants? If participants will be de-identified either through pseudonyms or subject numbers, explain how this will work? What will be the disposition of any identifying data (i.e., will it be preserved or destroyed)? If you will be using aggregated data sets, or other de-identified data, explain it as such here.

Researchers are required by law to keep all data securely stored for at least three years after completion of the study. State where the data will be stored and what will happen to it once the three years are up, i.e., how it will be destroyed. If data will be kept longer than three years, describe how it will be kept secure and provide a justification for keeping it longer than three years.

MY ANSWER:

Do you plan to maintain personal identifiers (names, addresses, birth dates, phone numbers, etc.) after your project is completed? Yes/No

In most cases, personal identifiers (names, addresses, birth dates, phone numbers, etc.) are destroyed after the all the data are collected. However, some projects,such as longitudinal studies, maintain the identities of participants for long periods of time so that participants can be contacted in the future.

MY ANSWER:

If yes:

Describe your plans for maintaining personal identifiers securely. Research projects falling under this category should describe where and how data and personal identifiers will be kept securely. When participant identification is maintained indefinitely, researchers must have explicit permission from the participants, usually done in the informed consent process.

MY ANSWER:

If no:

Describe your plans for the destruction of linkages to personal identifiers and the time frame. Linkages between personal identifiers and collected data should be destroyed after all the data are collected. Provide details about how long information identifying participants will be kept and where. At what point will the linkages to personal identifiers be destroyed and how?

MY ANSWER:

If you plan to take photographs or audio or video recordings of participants, describe whether you will maintain, destroy, or return them to participants. Photographs and audio/video recordings are special types of data that can reveal participant’s identities. For this reason, you must provide an explanation of what will become of photographs and recordings after the data has been collected. Will they be destroyed? If so, how? Will they be maintained? If so, how will be they be maintained securely, by whom, where, and for how long? Another option is to return the photographs or recordings to the participants so that they can do with them what they wish. Whatever your plan is, you will need to explain it to participants in your informed consent form and include a question explicitly asking permission using a yes/no checkbox. For example: “I agree to be photographed for this project and wish to have my photo returned to me upon completion of the study. ___yes ___ no”

MY ANSWER:

If personal identifiers will be revealed in your study (i.e., not kept confidential), provide justification and describe how the subjects are informed.If personal identifiers will be kept confidential, type N/A. Very few research projects involve the disclosure of participant identification. If your study will reveal participants’ identities, provide a justification for doing so and describe how you will secure participant permission to reveal their identities and in what capacity. Usually, this involves getting explicit permission on the informed consent process.

MY ANSWER:

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?

In some cases, research may involve participants disclosing information that the researcher would be compelled to report to authorities, such as child or elder abuse or mistreatment, suicidal ideation, or threats of serious harm to self or other individual(s) such as date rape. Researchers are obligated by law to report such cases to the appropriate authorities. If your study will not likely reveal such information, respond to this question with N/A .If you think your study might reveal such information about your participants, what is your plan for dealing with it?