[In these brackets are General Instructions:
Your IRB Application consists of a minimum of 7 documents that you write utilizing forms we have designed to guide you. This Research Proposal Narrative is one of the 7. See table at the end for the complete list. Start by completing this Research Proposal Narrative and sharing it with your colleagues and advisors.
Before you fill out this Research Proposal Narrative, you must have done the following:
· CITI Human Subjects Protection Training (www.citiprogram.org).
· Research Description Form emailed to .
You can get more information on procedures and research ethics theory by reading material at www.cu-portland.edu/IRB .
Below begins your Research Proposal Narrative Form (a template model to guide you).
You keep the heading (outline) black text to show A, B, C … and so on until H.
You delete the descriptor/guidance blue text. For example, delete this text!
Your research proposal Narrative should be concise and clear. If you are a student, it should be apparent that you consulted with your advisor in order to condense from what you might have presented in a longer form to your advisor to create this concise and clear research proposal narrative, which focuses on critical things needed for the IRB to evaluate the risks, protections, justifications, and benefits of your research proposal. This research proposal narrative is usually 3-5 pages long, depending on the complexity and needs of your research.
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Research Proposal Narrative
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.
2. Write how your research method (survey/questionnaire/procedure) will help you answer the question(s) you are asking or test your hypothesis.
Most statements of purpose can be adequately explained in less than a page.
B. Methods
1. Potential participant population: Who is your population of study, geographic location and/or target population group and/or recruitment organization?
2. Relationship/role with the participants: Why do you have access to the people you want to recruit? Write if you are the instructor of student participants, supervisor of employee participants, or contractor of customer participants.
3. Recruited population included/excluded: Reference the Targeted Enrollment Table that will be attached as a separate document.
What is the exact source(s) for all participants? How participants will be initially contacted? What is the specific method of advertising, and why do you think this will work?
A good way to help you with clearly showing who you intend to recruit and why you will enroll is by completing a
TARGETED ENROLLMENT TABLE. You must fill-out a Targeted Enrollment Table, and we provide two templates:
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.
4. Inclusion and exclusion criteria, and justification to purposely include or exclude vulnerable population groups:
5. Sampling Procedures to obtain appropriate number of sampled individuals (Sample Size):
Describe sampling procedures, sample size, and the characteristics of your sample.
What is the sample size you hope for? Is this based on a calculation that told you how many people you must enroll in order to firmly test your hypothesis: see informational sheet about Type I and Type 2 error and Samle Size Calculations. Can you justify your study if you have a less than optimal sample size? What will enable you to obtain valid results from the sample that you enroll?
C. Data Collection Procedures
1. Setting for data collection
Where are you going to conduct the research? Is this multi-site or single site data collection? Describe the scene.
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. You do not need final approval to have your IRB Application reviewed by the CU IRB. But, write brief text here describing the institution and what will occur on the property of that institution.
2. Study 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 must attach the literal STUDY TOOLS: questionnaire, interview script, research tools as part of your IRB Application (this will be loaded as Document Type #7, see table on the last page).
This section will help you when you go on to completing your permission and consent forms (that will be a separate document, as described in #5 in the table on the last page). Unlike the very simple language you will use in the consent form, here you can use more technical and detailed language.
If this is a multi-procedure study, a diagram will help to show the flow of participants from procedure (phase) 1 on to procedure (phase) 2, and so on. Are there certain risks and the benefits distributed through the procedures?
If you need special processes, such as deception* or payment for participation. Describe this and justify this. If any form of deception is to be used, it must be thoroughly justified and only last for the amount of time absolutely required. Procedures on how to debrief the participant, once the true reason/rational of the study, must be written in detail.
3. Plan to deal with withdraw, “loss-to-follow-up,” or some reason to stop the study:
How will you protect the integrity of your data while protecting the safety of the participants -- what happens if a participant needs to withdraw from the study? Is this a longitudinal study? What happens if the person doesn’t participant in the 2nd or other phases? Will you throw out the whole follow-up of this participant or include the participant for the data that they did end up contributing? [as an FYI: be certain to include language in the consent form that explains they can withdraw and if they need to contact you if they want to retract their data.]
D. Declaration of Conflicts of Interest, or statement that you do not anticipate any Conflict of Interest
A conflict of Interest is not just when financial interests are involved, but rather any circumstance that could result in perception of undue influence or coercion. If this research could impact your financial arrangement for consultation or a contract that involves this research (other salary for your primary role as a professor), then please describe this here. If you want to ask a student to enroll in a study which they might not do if they did not think they were being graded or being asked by a person of authority over them, then please describe this here.
E. Data Analysis Procedures
How will you get the data from your study tool? If this is qualitative, how will you code the data?
How does the data you collect address your questions/hypotheses? Is there some evidence that this method will result in valid data? Provide a brief explanation of the statistical design. If the sample size is low, how can you justify this? What benefits will be derived from your study?
F. Data Protection and Security 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, not even 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. In contrast to the word “anonymous,” the word “confidential” means that the research could identify the participant, but that the information will be protected and kept in confidence by using codes and by protecting data.
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.).
If you are collecting data that includes Sensitive Private Data, then you need to include a more detailed Data Protection and Security Plan. Sensitive Private Data includes the following, but this is not an exhaustive list: financial-identifying information, FERPA-protected information, health-related information, and any information that – if released – could have serious negative consequences, such as serious social, employment (firing or loss of promotion ability), financial, healthcare, or judicial (victim or perpetrator) consequences. If you collect this information please read the informational sheet called “Data Plan for PII” located as a tab at www.cu-portland.edu/IRB (see tab on left hand side of this webpage) and adhere to the section titled “The minimum requirements for Type 3 and Type 4 data.”
G. Risks and Discomforts
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.
H. Benefits
Benefits must be stated as it relates to the participant. 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).
Your study needs to provide some benefit. The IRB needs to balance any risk or discomfort against the potential of benefit. For a benefit to be gained in most cases, the research has to have some validity or outcome that can be realized. Therefore, it is important that the researcher and Faculty Advisor, if the researcher is a student, consider methods that will at a minimum justify the time that the participants will contribute to the study.
I. 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.
J. 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 writing in brackets and the next pages: This is just information to help you and provide a CHECK LIST (Table 1, on next page). This will tell you the next steps and help you understand that this Research Proposal is only 1 of several components that together make your IRB Application.