Research Proposal Narrative, a template to help develop your IRB Application

[In these brackets are General Instructions that can be deleted, since this is instructional:

Before you fill out this Research Proposal Narrative, you must have done the following:  CITI Human Subjects Protection Training. If you have not had this, sign up at www.citiprogram.org and complete this assigned SBE course. This will take up to five hours to complete.  Research Description Form emailed to [email protected] . If you have not done this, look at the last page of this document. Email the IRB if you need a blank Research Description Form (RDF). Please complete and email this. Within one week, the CU IRB will tell you if you need to complete a full IRB Application (this proposal is part of the full IRB Application). If you do not receive a letter of exemption, then you proceed to create this narrative. Below begins your Research Proposal Narrative Template (model to guide you). You keep the heading (outline) text to show A, B, C … and so on until H. But you can delete the descriptor/guidance text. For example, delete this text!]

A. Purpose 1. Provide a clear statement of the question(s) being asked, or hypothesis(es) being tested, and supporting rationale. Explain why you selected this research. What are the potential benefits of the research? Note that a complete literature review is not necessary. Please do not copy and paste thesis/dissertation proposal chapters. Most statements of purpose can be adequately explained in less than a page.

B. Methods – Be specific when addressing the following items. 1. Participants

A good way to present sampling procedures from the IRB perspective is to complete a TARGETED ENROLLMENT TABLE. We suggest that you fill-out the CU IRB Targeted Enrollment Table Standard Form (THIS IS THE TABLE USED FOR MOST STUDY DESIGNS) Or the CU IRB Targeted Enrollment Table Two Population Form (THIS IS USED FOR CASE-CONTROL STUDIES). You will have to submit this form as a separate document. By filling this out early in your Proposal Narrative development, you will be able to focus your narrative in a clear and specific way.

Describe sampling procedures, sample size, and the characteristics of your sample.

Be sure to address the age(s) of participants; whether or not participants come from a vulnerable population (e.g., children or adolescents, individuals with cognitive disabilities, pregnant women, and prisoners); the exact source(s) for all participants; how participants will be initially contacted.

2. Institutions If you are going to do recruitment or data collection at an institution that is external to CU Portland, you need to describe the institution and how or why you plan to have permission from that institution.

C. Data Collection Procedures Provide a step by step protocol of what participants will be asked to do in your study.

Stipulate the nature of all data to be collected: what will be observed, what questions specifically (write out the questions) will be asked, and why this is important to the study.

You use this section to develop your consent form. The difference is that in the consent form, you use extremely basic and easy to understand language. In this “Data Collection Procedures” section, you can use more detail and take more space to describe why procedures are undertaken and exactly what the participants will do, the risks, the benefits, and the needs for any special processes such as deception or payment for participation. If any form of deception is to be used, it must be thoroughly justified and procedures for debriefing must be included. If there is deception, you must debrief – later tell you participants.

1. Data Analysis Procedures Describe what will be done to the data after it has been collected. How will you address your questions/hypotheses? A brief explanation of the statistical design may be helpful to reviewers.

2. Data Plan

Describe where data will be stored, who will have access to data, how the identity of participants will be protected (e.g., data will be recorded by geographical area or group rather than by individuals, numeric identifiers will be used for interview or field data, records will be stored in locked file cabinets etc.), when data will be destroyed (e.g., in the case of test scores of interview recordings). If the lead investigator is a student, please bear in mind that consent forms must be retained by the Research Advisor for a period of three years.

If subjects are to be anonymous (i.e., no one, including the researchers, knows their identity), explain how this will be accomplished. Explain whether or not the data can be traced back to the original source from identifiers used in the records.

Remember that it is impossible to guarantee confidentiality. Information submitted electronically or in a group setting cannot be considered secure, and there is a legal obligation to report suspected mistreatment of children and serious threats against self or others. It is also possible that a court might order the release of data or a list of subjects. Again, focus on the steps you will take to maximize confidentiality.

Describe any special arrangements to protect the safety of atypical populations, if applicable (e.g., hospital patients, developmentally disabled, young children, prisoners, etc.).

D. Risks, Discomforts and Benefits

The IRB is required to insure that the potential risks to participants (however minimal) are clearly justified by the potential benefits of the research. You have already provided the rationale for the research in Section A of the narrative. Here you must delineate any risks to subjects. You must be specific and identify the risks specifically.

A statement that “there are no foreseeable risks” is acceptable and is likely to be the case for some research. Another acceptable form for the risks statement is referring to the comparability of participants’ experiences in the research to activities in everyday life (e.g., “the risks inherent in this study are no greater than those normally encountered during regular classroom participation”). On the other hand, foreseeable risks must be fully disclosed, for example the discomfort of having your views challenged by others in a focus group, the stress one may encounter when completing an exam-like instrument, the discomfort associated with negative feedback about a learning assessment, or the physical fatigue and discomfort associated with exercise.

It is possible that participants will benefit directly from their participation by gaining knowledge or skills; however, if the subjects do not stand to benefit directly from their participation, say so plainly. Indirect benefits should also be mentioned (e.g., benefits to the discipline as a result of what is learned from the research project).

E. Costs and Compensations

Any costs and compensation must be identified. Compensation might include extra credit in a class. If this is the case, be sure to stipulate here that an alternative form of extra credit of comparable effort and equal value is also available. In other words, extra credit must be available to all students, whether they volunteer for a given research study or not. Other compensation might be refreshments, gifts, money, raffle tickets, or an educational debriefing. If compensation is provided, it must not be so great as to coerce participation.

Costs might include missed instructional time, expense associated with transportation to and from the data collection site or the loss of artifacts (e.g., artwork, homework) to the researcher.

F. Grant Information (if applicable)

If the study is, or will be, funded by a grant, please explain fully. Explain any restrictions imposed by the grantor. Evidence of ethics training is required of all researchers conducting human subject research. For research sponsored by grants, there may be other restrictions and/or requirements. [Delete this and the next pages: These next pages are only shown for your information. NOW that you have completed your research proposal narrative, HERE IS WHAT YOU DO NEXT:

The Research Proposal Narrative is a key component within your IRBNet Project Using www.IRBNet.org, your IRB Application will be compiled and submitted as a Project under your IRBNet user profile. After you sign up for your account, you will see on the left side a tab that says “CREATE NEW PROJECT.” Click there. After you fill out your name, project title, and such, you will see a tab that says “DESIGNER.” In the DESIGNER, you will be able to pull down document templates, save them to your computer, fill them in, save them to your computer, and then go to STEP 2, which is to load the document. If you happen to have a template already filled out and saved to your computer (such as your STEP 1 Research Description Form) then you just skip to STEP 2 and upload that document.

TABLE 1. THE CONTENTS FOR A FULL (COMPLETE) IRB APPLICATION, available at IRBNet.org: The following documents need to be uploaded. The table below shows the document needed and a description of the document type you might use (shown as a drop down list to choose from). You can give your own title however you wish, but it would be good to be descriptive of the content; for example, “Research Description Form” or “Cover Letter.” Do not worry about the document type – that is, whatever document you load will be visible and described by your title, but the table below shows the best type of description wording to choose for each document.

Document to upload (saved to your Document type Notes computer) 1 Research Proposal Narrative Template Proposal The template gives you detailed instructions. 2 Cover Letter Cover Letter 3 Investigator Assurance Investigator Assurance If you cannot get your department officials to sign on the same form as you, this is okay. You will then have two uploads: for example “investigator assurance 1” and “investigator assurance 2” 4 Targeted Enrollment Table Protocol You pick either 5a or 5b. Use the standard form for most studies – the two population is used for case-control types of study designs 5 Consent Form …. Consent Form You can use the downloads available to help you construct your consent form. The 5a document gives an example for a minimum risk social science study. There are other documents to help you. If you need more help, or consultation on developing an assent form, contact the IRB Director at obranch@cu- portland.edu 6 Institutional Permission Letter for off Letter If you enter into an institution that is not campus research Concordia University, then you need permission. If this is standard research in a United States Institution, a simple letter from the director or other authorized individual is okay. If this is an international study, we will need the letter to say that the work has been reviewed by their institutional review board or equivalent. As in all cases, studies with vulnerable subjects and/or sensitive questions will need higher level of authorization and review before the research will be approved. 7 Project Specific Research Tools [name this as you wish to be descriptive] You can add as many as you want. For example, you can say “Recruitment Brochure,” “Tool1,” and/or “Tool2” .. and just continue uploading until all important/pertinent documents are loaded. Likely documents include:  Recruitment material  Survey Instruments – Copies of widely used standardized tests are not necessary.  Questionnaires  Interview Questions/Potential Questions/Protocols/Range of Topics  Debriefing Materials (if applicable)

If you have any questions, please consult your faculty advisor (do this first if you have a faculty advisor or department advisor) and/or contact the CU IRB Director at [email protected] . You can schedule a telephone call and/or a Skype session, if you wish.

DELETE THIS and the preceding 2 pages – that is the text within this bracket. Delete this because this was just for your instruction – to give you the above check-off list (TABLE 1) of your complete application.]