UMO IRB Application · Web view4.2 Population and Sample Qualitative Proposals: Describe the characteristics of the larger population from which the sample (study participants) will

UMO IRB Application

IRB Use Only - IRB Study Number:

Institutional Review Board (IRB) Application

PROTECTING HUMAN SUBJECTS

The IRB reviews research projects that involve human subjects to uphold two broad standards:

1. That subjects are not placed at undue risk; and

2. That they give uncoerced, informed consent to their participation.

With representation from a wide range of scientific disciplines and from outside the academic community, the IRB gives prompt but individualized attention to the numerous research projects at the University.

A project is first reviewed in its proposal stage - even before subjects are recruited. Each approved project is reevaluated at least annually. The IRB works with investigators to modify projects to ensure adequate protection for its subjects' welfare and right of self-determination.

The University's process for protecting human research subjects reflects federal regulations developed by the Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP) oversees the operation of the IRB.

Basic Criteria of IRB Review

In assessing the adequacy of human subjects’ protections in research, the IRB considers a number of basic criteria – specifically whether:

· risks to subjects are minimized;

· risks to subjects are reasonable in relation to anticipated benefits;

· selection of subjects is equitable;

· informed consent is sought from each prospective participant or legally authorized representative, and properly documented;

· adequate preparation is taken to protect the privacy and confidentiality of subjects; and

· adequate provisions are made for the ongoing monitoring of the subjects' welfare.

The assessment also includes additional factors important in the context of the individual proposal.

Note that once a study has been reviewed initially by the IRB, every effort is made to send all subsequent correspondence and requests regarding that study back to the same reviewers, for review. The reviewers are most familiar with the research and can best assess new information in the context of the study as a whole.

Submit this application, along with all required appendices and supplemental documents to the University of Mount Olive IRB Chair: [email protected]

Research Proposal Title:

Principle Investigator or PI

Name:

Email address:

Phone number:

Affiliation to UMO:

Conflict of Interest

Federal Guidelines emphasize the importance of assuring there are no conflicts of interest in research projects that could affect the welfare of human subjects. Reporting of financial interests is required from all individuals responsible for the design, conduct or reporting of the research. If this study involves or presents a potential conflict of interest, additional information will need to be provided to the IRB.

Does the PI have a conflict of interest?

Required CITI Program social and Behavioral Research Investigator Training https://about.citiprogram.org/en/homepage/

The UMO IRB requires researchers to complete the CITI Program training course every two years.

Date CITI Program training completed (submit proof of completion):

As Principal Investigator of this study, I assure the UMO IRB that the following statements are true:

· The information provided in this form is correct.

· I have evaluated this research protocol and determined that I have the resources necessary to protect participants, such as adequate funding, appropriately trained staff, and necessary facilities and equipment.

· I will seek and obtain prior written approval from the UMO IRB for any substantive modifications in the research proposal, including changes in procedures, co-investigators, funding agencies, etc.

· I will promptly report any unexpected, or otherwise significant adverse events, or unanticipated problems, or incidents that may occur in the course of this study.

· I will report in writing any significant new findings, which develop during the course of this study, which may affect the risks and benefits to participation.

· I will not begin my research until I have received written notification of final UMO IRB approval.

· I will comply with all UMO IRB requests to report on the status of the study.

· I will maintain records of this research according to UMO IRB guidelines.

· If applicable: The grant that I have submitted to my funding agency, which is submitted with this UMO IRB application, accurately and completely reflects what is contained in this application.

If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of PI:

Email Address of PI:

Date of IRB Submission:

Faculty Advisor for Student Research

Name:

Email address:

Phone number:

Affiliation to UMO:



Does the Faculty Advisor have a conflict of interest?




Faculty Advisor must be cc’ed on emailed submissions to the UMO IRB. Copying the Faculty Advisor fulfills the signature requirement. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of Faculty Advisor:

Email Address of Faculty Advisor:


Additional Study Personnel – Co-Investigator #1

Co-Investigators, responsible for knowing and following the research plan, should be listed below. Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up.

Name:

Email address:

Phone number:

Affiliation to UMO:



Does the Co-Investigator have a conflict of interest?




Co-Investigators must be cc’ed on emailed submissions to the UMO IRB. Copying the Co-Investigator fulfills the signature requirement. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of Co-Investigator #1:

Email Address of Co-Investigator #1:


Additional Study Personnel – Co-Investigator #2

Name:

Email address:

Phone number:

Affiliation to UMO:



Does the Co-Investigator have a conflict of interest?




Co-Investigators must be cc’ed on emailed submissions to the UMO IRB. Copying the Co-Investigator fulfills the signature requirement. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of Co-Investigator #2:

Email Address of Co-Investigator #2:


Research Staff #1

Research staff, including study coordinators, responsible for knowing and following the research plan, should be listed below. Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up.

Name:

Email address:

Phone number:

Affiliation to UMO:



Does the Research Staff have a conflict of interest?




Research Staff must be cc’ed on emailed submissions to the UMO IRB. Copying the Research Staff fulfills the signature requirement. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of Research Staff #1:

Email Address of Research Staff #1:


Research Staff #2

Name:

Email address:

Phone number:

Affiliation to UMO:



Does the Research Staff have a conflict of interest?




Research Staff must be cc’ed on emailed submissions to the UMO IRB. Copying the Research Staff fulfills the signature requirement. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Name of Research Staff #2:

Email Address of Research Staff #2:


Outline of Proposed Research Activity

Please, answer in lay language or language understood by a person unfamiliar with your area of research. Please, single space using 12 pt font throughout the form. The boxes will expand as you input text.

Section 1: Topic Endorsement

1.1 Research Topic

(2 paragraphs only)

FIRST PARAGRAPH: Describe the specific topic to be studied.

SECOND PARAGRAPH: describe the significance of this topic to your specialization

The research topic should be cover:

· The relationships between/among the concepts should be clearly specified (e.g., correlation).

· The target population should be named.

1.2 Research Problem

(1 Paragraph only)

Write a brief statement regarding the need for the study that fully describes the problem or need being addressed. The “need for the study” is what we often refer to as the research problem.

Section 2: Research Overview

2.1 Research Problem Background

(3 paragraphs only)

Provide a brief SUMMARY of your review of the research literature on the topic.

2.2 Research Question

List the primary research question and any sub-questions that the proposed study will address.

2.3 Purpose of the Study

State the purpose of the study, which will be to answer the research question to solve the research problem, and to contribute information about the problem to a specific audience.

2.4 Methodology and Basic Design Overview

Qualitative Proposals:

· Provide an overview of the basic research methodology.

· State how this methodology is a good fit for the question being asked and the phenomena being studied.

Quantitative Proposals:

· State your rationale for studying the research problem with a quantitative research methodology.

· State your study’s research design (non-experimental, experimental, quasi-experimental, etc.), and the rationale for selecting that design (why the design is appropriate for answering the research question).

· Briefly describe the data collection, statistical models, and analysis that will be used to conduct the study.

Section 3: Research Theory

3.1 Advancing Scientific Knowledge


Demonstrate how the study (a) will advance the scientific knowledge base; (b) is grounded in your field, and (c) addresses something that is not known, something that is new or different from prior research, something that extends prior research, or something that fills a gap in the existing literature.


1. Theoretical Foundations

Briefly describe the primary theoretical basis for the study. Describe the major theory (or theories) that will serve as the lens through which you will view the research problem and research questions and provide any corresponding citations.

NOTE: The theoretical foundation should be a theory from your discipline that supports your topic. In doing so, certain constructs (explanatory ideas) from that theory would be used to support the research focus.

2. Contributions to Theory

Describe how your study will contribute to theory in your field by meeting one or more of these four criteria:

1. The study should generate new theory.

2. The study should refine or add to an existing theory.

3. The study should test to confirm or refute a theory.

4. The study should expand theory by telling us something new about application or processes.

3.2 Theoretical Implications


Describe any theoretical implications that the proposed study may have for understanding phenomena. For example, will the study generate new theory, provide a description of the lived experience of the participants, or provide a description of a cultural phenomenon?


Describe the theoretical implications you believe your study could have for your specialization area. This will be the theoretical framework(s) to be used in conceptualizing the study and analyzing the data.

3.3 Practical Implications

Describe the practical implications that may result from your research.

Section 4: Research Methodology

4.1 Research Design


1. Describe the qualitative design (for example grounded theory) and research model (for example Strauss and Corbin, or Charmaz – constructivist grounded theory) you propose to use, supported and referenced by primary sources.

2. Describe in detail the method(s) will you use to collect the data, such as: Structured, unstructured, and semi-structured interviews, journaling, letters, pictures, observations, field notes, focus groups.

3. Describe the philosophy underlying the methodology and model.

4. Briefly describe how the study will be conducted. (Describe how you are going to carry out the study.)


1. Describe the research design you will use. Start by specifically stating the type of quantitative research design you will use (non-experimental, quasi-experimental, experimental), include the exact name or type of design to be used, and describe the exact method(s) (archival, survey, observations) you will use to collect the data.

2. Briefly describe how the study will be conducted.

3. Briefly describe the research philosophy underlying your study and the ontological, epistemological, axiological, and methodological assumptions of your design.

4.2 Population and Sample


1. Describe the characteristics of the larger population from which the sample (study participants) will be drawn. Include sampling strategy, such as purposeful.

2. State the estimated sample size needed for the study. Justify the sample size with support from the literature.


1. Describe the characteristics of the larger population from which the sample (study participants) will be drawn. Include specific data/statistics.

2. State the estimated sample size and your method of determining the sample size needed for the study.

3. State the sampling strategy (probability or non-probability), the specific method (random, purposive, convenience, etc.), then describe the sample inclusion and exclusion criteria.

4.3 Ethical Considerations

Describe any ethical considerations given the sample, population, and/or topic. Please explain as fully as possible (i.e., How do you plan to protect human participants while identifying the sample, while collecting the data, while analyzing the data, after data are collected, and during data storage?).

Section 5: Research Data

5.1 Data Collection - Sampling Procedures

Describe in detail each step that you will take from the beginning of recruitment to consent for the participants to participate. You must provide specific details and present the details in the order in which they will occur. Be sure to include all the necessary details so that someone else could follow this to replicate the study. You must include all of the following (if applicable):

· The recruitment site(s), acknowledgement of any permissions needed from the sites, and if there is an IRB at any of the sites.

· All of the means by which recruitment will occur (i.e., flyers, e-mails, social media)

· How potential participants will contact you.

· How the potential participants will be screened, and how you will proceed if they do or do not qualify for the study.

QUANTITATIVE PROPOSALS ONLY (5.2 through 5.9)

Qualitative Proposals complete to 5.10 Through 5.14 then 6.0

5.2 Constructs

Quantitative Proposals ONLY:

A construct is an idea - an intangible concept that we want to measure. We must then define the construct in terms of a variable (something which can be measured), and then we must provide an operational definition as to how that variable will be measured for this particular study. For example:

Construct: Intelligence

Variable: IQ

Operational definition: WAIS-IV score

Define each construct required by the research question and title.

5.3 Variables (Definitions of Constructs as Variables)


Define each construct (in Item 5.2) as a variable.

5.4 Operational Definitions


1. Present an operational definition for each construct you will measure

2. How will this variable be measured in this study?

5.5 Measures/Instruments


Describe in detail all data collection instruments and measures (tests, questionnaires, scales, interview protocols, and so forth). Also include any demographic information you plan to collect.

For each measure include:

A. Citation for published measure/instrument

B. Description of the measure/instrument

C. Data type(s)/levels of measurement for variable(s) measured by the instrument

D. Available psychometric information (including normative data and validity and reliability coefficients for each measure or instrument.)

Attach a copy of each instrument you plan to use as an Appendix to your IRB Application. If permission is required to use the instrument, please attach a copy of documentation showing that you have permission to use the instrument.

5.6 Research Hypotheses


1. For each quantitative question and sub-question in Item 2.2, list hypotheses for their investigation.

2. Give nulls and alternates for each sub-question.

3. Use appropriate nomenclature for the hypotheses.

5.7 Type(s) of Data


Complete the table rows for each Research Question (RQ), indicating the variables, whether they are Independent Variables (IV) or Dependent Variables (DV), and what data type they are (i.e., Ordinal, Ratio).

RQ

Variables

IV/DV

Data Type

1

2

3

4

5.8 Data Analyses


1. List the research question and sub-questions, followed by the null and alternative or research hypotheses for each research question.

2. Then describe all methods and all procedures for data analysis including:

a. Types of data to be analyzed

b. Organizing raw data

c. Managing and processing data

d. Preparation of data for analysis (transforming, recoding, etc.)

e. The actual data analyses to be conducted to answer each of the research questions and/or to test each hypothesis, including descriptive statistics, any hypothesis tests and any post-hoc analyses (complete the table),

f. Storage and protection of data

a.

b.

c.

d.

e.

RQ#

Type of Analysis

Descriptive Stats

Hypothesis Testing

Posthoc Analysis

f.

5.9 Expected Findings


1. Describe the expected results of the data analysis.

2. Discuss the expected outcome of each of the hypotheses and discuss whether or not your expectations are consistent with the research literature on the topic.

QUALITATIVE PROPOSALS ONLY (5.10 through 5.14)

Quantitative Proposals complete to 5.2 Through 5.9 then 6.0

5.10 Data Collection Procedures

Qualitative Proposals ONLY:

Describe where and how will you get the data and describe the exact procedure(s) that will be used to collect the data. This is a step-by-step description of exactly how the research will be conducted. This should read like a recipe for the data collection procedures to be followed in your study. Be sure to include all the necessary details so that someone else can clearly understand how you will obtain your data.

5.11 Guiding Interview Questions


1. Describe the interview method will you use and how you will conduct the interviews.

2. List the guiding interview questions to be used in the qualitative interviews with the participants.

3. Provide a rationale for how and why you are using the interview technique you will use to address the primary research question.

4. Be sure to discuss the results of any field test that was conducted as a part of the process of developing the final version of the guiding interview questions.

5.12 Data Analyses


1. Provide a step-by-step description of the procedures to be used to conduct the data analysis.

2. Support this process by identification and reference to primary descriptive sources, such as Moustakas, Giorgi, Stake Yin, Charmaz, or Braun et al.

3. Check that that the data analysis process is consistent with the accepted analytical steps for the specific qualitative methodology chosen to conduct this study.

4. If you plan to use qualitative data analysis software, list the software you will use and describe how it will be used.

5.13 Role of the Researcher


Provide a description of the researcher’s pre-understandings, preconceptions, and biases about the topic and about how the researcher will set them aside?

5.14 Credibility, Dependability and Transferability


1. Present a strategy to ensure credibility, dependability, and transferability in the proposed study.

2. Because the researcher is the primary instrument of research in qualitative studies, describe how you will establish credibility for the research.

3. Describe the training and experience you have in regard to your methods for collecting and for analyzing your data.

4. Describe how you will demonstrate your expertise in regard to your research design.

Credibility refers to confidence in the accuracy of the data as reported as well as a systematic and thorough interpretation by the researcher.

Credibility involves carrying out the study in a way that enhances the believability of the findings of the data over time and over conditions.

Credibility is assessed by how well you demonstrate your understanding of your research methodology and how well you apply the methodology to data collection and data analysis.

Transferability is demonstrated by showing that the sample fairly represents the target population, as well as by showing that the sample participants have the knowledge, experience, or expertise necessary to provide information that the discipline or field and the target population would find meaningful regarding the topic.

Dependability is demonstrated by providing clear, detailed, and sequential descriptions of all procedures and methods, such that another researcher could repeat each of them faithfully.

Section 6: References

In the field below, provide your references for the research about your topic, and key theorists/researchers associated with the selected methodology.

Section 7: Expedited Review Eligibility

Federal criteria for risk assessment make some studies eligible for expedited Review (see 45 CFR46.110 and 21 CFR 56.110). Studies eligible for expedited review must meet the federal definition of minimal risk which is:

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

What is the level of risk to subjects in this research study? Write “Yes” in the appropriate box.

Greater than minimal risk

(Full UMO IRB review required)

Not greater than minimal risk

(Final expedited review eligibility decisions are made by the UMO IRB after initial review of the application).

Section 8: Informed Consent

It is the responsibility of the investigator to assess comprehension of the risks and benefits of participation in the research and only enroll subjects who can demonstrate understanding of the research study (45 CFR 46.116). The federal regulations require that consent be in language understandable to the subject. If subjects do not comprehend English, translated consent forms are required, or the use of short forms with an oral explanation can be accepted.

Consent and assent forms must be submitted for UMO IRB review. It is highly recommended that researchers use the sample consent form template available on the UMO IRB page. Do not submit sponsor prepared forms without editing the form to include UMO IRB standard language and all essential elements of informed consent.

Who will conduct the consent process?

What questions will be asked to assess the subjects’ understanding? Questions should be open-ended and go beyond requiring a yes/no response.

Participation in research must be voluntary. Describe the steps taken to minimize the possibility of undue influence on potential subjects.

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UMO IRB Application (revised 2016; 2017; 2018; 2019 jk)

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UMO IRB Application · Web view4.2 Population and Sample Qualitative Proposals: Describe the characteristics of the larger population from which the sample (study participants) will