DSRT-839: Advanced Research Methods : Week 1 - IRB/Research Proposal Draft - Part I

If Exempt study, which category describes your study?

☐ Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (§46.104(d)(1)).

☐ Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) when at least one of the following criteria is met (§46.104(d)(2)): See (i), (ii), (iii).

☐ Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: §46.104(d)(3)(i) and A, B, C.

☐ Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met §46.104(d)(4): See (i), (ii), (iii). (iv).

☐ Study involves no recruitment of human subjects and involves only deidentified data.)

If Expedited study, which category describes your study?

☐ Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

☐ Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

☐ Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

☐ Category 8: Continuing review of research previously approved by the convened IRB as follows:

a. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or

b. Where no subjects have been enrolled and no additional risks have been identified; or

c. Where the remaining research activities are limited to data analysis.

☐ Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

6. Assent Process: Describe procedures for soliciting the assent of the children, following permission from the parents/guardians.

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7. Understandable Language: Describe what efforts have been made to present information about the study in a language that is understandable to the children who will be recruited (i.e, informational documents, recruitment flyers, assent forms, data collection instruments).

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8. Wards as Subjects: Will the study involve children who are wards of the State or any other agency, institution, or entity?

☐ No ☐ Yes (respond to 8.A. and 8.B. below)

A. Research Classification: The use of wards as subjects in research is permissible in only the following two situations. Indicate which classification below applies to the proposed research.

☐ The proposed research is related to the subjects’ status as wards of the state.

☐ The proposed research is to be conducted in schools, hospitals, or similar settings in which the majority of children involved in the study are not wards.

B. Ward Advocate: An advocate must be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as an advocate for more than one child. The advocate(s) must have the background and experience to act in, and agree to act in, the best interests of the child for the duration of the child's participation in the research and may not be associated in any way with the research, the investigator(s), or the guardian organization. Please explain how these ward advocate requirements will be met.

FULL APPLICATION- Research Involving Persons with Impaired Decision-Making Capacity

When a prospective research participant lacks the ability necessary to understand and use information relevant to an informed consent process, additional precautions and protections are required.

1. Will the study involve subjects who have impaired decision-making capacity?

☐ No (skip remainder of this section)

☐ Yes (respond to all items in this section)

2. Suitability of Subjects: Individuals with impaired decision-making capacity should be used as research subjects only in situations where they are the only population who can provide the data needed for the study and only when the potential risks are balanced with expected benefits. Explain why individuals with impaired decision-making capacity are suitable subjects for this research.

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3. Subject Advocate: What procedures are in place to allow an advocate to assist subjects in navigating the research process?

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4. Competency to Consent: Describe who will determine individuals’ competency to consent and the criteria to be used in determining competency (i.e., use of standardized measurements, consultation with qualified professionals, etc.)

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5. Consent for Individuals Incapable of Consenting on Their Own Behalf: Explain how you will identify who is authorized to give legally valid consent on behalf of any individual(s) determined to be incapable of consenting on their own behalf.

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6. Expectations, Obligations, and Authority of Legally Authorized Representatives: Explain the expectations, obligations, and authority of the legally authorized representative for each subject and describe how this information will be conveyed to the representative (i.e., through a written information sheet).

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7. Assent: Explain the criteria you will use to determine when assent is required for subjects who are not competent and describe the assent process to be used with these subjects.

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8. Evaluating Dissent: Explain the methods to be used for evaluating dissent (i.e., description of behaviors that would indicate that an individual does not want to participate, such as moving away or displaying certain facial expressions or head movements).

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9. Re-Consent/Re-Assent: Explain procedures to be followed for periodic re-consent and/or re-assent and define the documentation interval.

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10. Monitoring Capacity to Consent: Describe the process for monitoring capacity to consent and describe procedures for protecting the subjects’ rights in the event they lose their capacity to consent or their capacity to withdraw during the course of the research (i.e., use of legally authorized representative).

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11. Use of Institutionalized Individuals: Does the proposed research involve individuals who are institutionalized?

☐ No

☐ Yes (Respond to item below and attach approval from an authorized representative at the institution).

· Provide a justification for the use of institutionalized individuals and explain why individuals who are not institutionalized cannot be substituted.

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FULL APPLICATION- Research Involving Prisoners

1. Category of Research: 45 CFR 46.303(c) defines prisoner as any individual involuntarily confined or detained in a penal institution. Prisoners may be subjects in research only in the specific situations defined below. Please indicate which of the following categories apply to this study:

☐ A. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects

☐ B. Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects

☐ C. Research on conditions particularly affecting prisoners as a class (i.e., vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to approve such research

☐ D. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to approve such research.

2. Advantages and Choice: Any possible advantages accruing to the prisoners through their participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, must not be of such magnitude that the ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired. Provide a description of the possible advantages that prisoners can expect from their participation and the impact of these advantages on their choices regarding voluntary participation.

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3. Appropriate Risks: The risks involved in the research must be commensurate with risks that would be accepted by non-prisoner volunteers. Provide a description of possible risks to the participants and justify how those risks are the same as they would be for non-prisoners.

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4. Fair Selection: The procedures for the selection of subjects within the prison must be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the investigator provides justification for following other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for a particular research project. Describe how prisoners will be selected and what measures will be taken to prevent intervention by prison authorities or prisoners in the selection process.

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5. Understandable Language: All information regarding the study must be presented in language that is understandable to the subject population. Describe what efforts have been made to present information about the study in a language that is understandable to the prisoner population being recruited (i.e, informational documents, recruitment flyers, informed consent forms, data collection instruments, etc.).

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6. Parole Board Consideration: Adequate assurance that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole is required, and each prisoner must be clearly informed in advance that participation in the research will have no effect on his or her parole. Describe measures in place to ensure that parole boards are not influenced by prisoners’ participation in the research and how prisoners will be informed that their participation (or refusal or withdrawal from) will not impact their parole status. Parole board considerations must also be addressed in both the informed consent form and the letter of support for off-campus research provided by the correctional institution.

FULL APPLICATION- Research Involving Indigenous Populations

Research with/in Indigenous communities, including sovereign tribal nations, requires permissions and considerations that are different from (and in addition to) those required when conducting human subjects research in other contexts. Indigenous tribes are sovereign nations. Many Indigenous communities have created IRBs and have generated guidelines for researchers. The method and detail of research requirements vary among communities according to their resources and experience with researchers. Even if an Indigenous population has not created research guidelines or an IRB, investigators are required to talk directly to the tribal leadership and secure permission through tribal decision-making processes (e.g., via tribal council meetings and securing tribal resolutions). Proof of approval from a tribal IRB, a tribally-specific government office, a tribally-run non-profit organization, or a regional IRB with whom the community collaborates must be submitted with the IRB application when proposing research with/in Indigenous communities.

All researchers who plan to conduct studies with Indigenous populations must comply with the following research principles:

· Advise Indigenous populations who will be affected by the study of the purpose, goals and timeframe of the research, the data gathering techniques, the positive and negative implications and impacts of the research.

· Obtain informed consent from the appropriate governing body.

· Protect the sacred knowledge and cultural/intellectual property of the Indigenous population.

· Use Native languages whenever English is the second language.

· Ensure confidentiality of data and sensitive material.

· Include Native viewpoints in the final study.

· Acknowledge the contributions of Native resource people.

· Inform the Native Research Committee in a summary and in nontechnical language of the major findings of the study.

· Provide copies of the study to the local people. 

The U.S. Census Bureau defines Indigenous populations as individuals who have origins in any of the original peoples of North and South America and who maintain tribal affiliation or community attachment.

1. Will this study involve an Indigenous population as subjects?

☐ No (skip remainder of this section)

☐ Yes (complete all items in this section)

2. Suitability of Subjects: Explain why an Indigenous population is suitable for this research.

3. Number of Subjects: Provide a justification for the number of subjects proposed for enrollment in the project.

4. Advise Indigenous populations: Describe procedures for advising Indigenous populations who will be affected by the study of the purpose, goals, and timeframe of the research, the data gathering techniques, and the positive and negative implications and impacts of the research.

5. Informed Consent: Please attach your obtained informed consent from the appropriate governing body.

6. Protection: Describe how you will protect the sacred knowledge and cultural/intellectual property of the

Indigenous population.

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7. Understandable Language: Describe efforts made to present information about the study in the primary language of the Indigenous participants who will be recruited (i.e, informational documents, recruitment flyers, assent forms, data collection instruments). Attach documents.

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8. Confidentiality: Explain how you will ensure confidentiality of data and sensitive material.

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9. Native Viewpoints: Explain how you will include Native viewpoints in the final study.

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10. Contributions: Explain how you will acknowledge the contributions of Native resource people.

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11. Findings: Explain how you will inform the Native Research Committee in a summary and in nontechnical language of

the major findings of the study.

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12. Copies of Study: Explain how you will provide copies of the study to the local people. 

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22. Principal Investigator Statement

I certify that this application fully discloses the involvement of human subjects, or any data gathered from human subjects in this research study, and that participants will not be involved in any other way. I agree to follow the approved protocol in the conduct of this study and to abide by the protection of human subjects in research.

I understand that I am responsible for maintaining IRB study records in a secure manner while the study is active and for a period of three (3) years following closure, termination, or expiration of IRB approval, then destroy using appropriate techniques based on the storage method, protecting participants’ confidentiality throughout the process.

I understand that changing any of these procedures will require an IRB modification submitted to the IRB for review prior to the implementation of any changes to study protocols.

I understand that I should complete the IRB Close-Out form after the research study is completed to notify the IRB that the study has concluded.

Typing your name below serves as your official signature.

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Back to Application

The research questions are where you articulate exactly what your study is attempting to measure. Do not submit descriptive questions and avoid shallow questions that do not fully explain your dependent variable.  All questions should have a unified focus based on the problem statement.

Examples of Qualitative Research Questions:

1. In the absence of top-level procurement positions, how do procurement management actions mediate power to drive interorganizational efficiency and vendor performance?

2. In the absence of top management procurement roles, which procurement management actions are most efficient in mediating power to increase interorganizational efficiency and supply chain performance?

Note: In a qualitative study, you are searching for the how or the why behind a particular research phenomenon. 

Examples of Quantitative Research Questions:

1. Is there a significant correlation between students living in poverty and student achievement in reading and vocabulary development according to the Kentucky’s K-Prep assessment for grades three, four, and five?

Note: In a quantitative study, you are seeking to measure an independent variable (students living in poverty) against a dependent variable (student achievement) for a fixed population (grades three, four, and five). 

Back to Application

Research Procedures

Describe the procedures that will be used. How will data be collected? Pilot study?

Example for Qualitative Interviews:

Each prospective participant will complete a short demographic form to collect contact information and gauge criteria for participation in the study. The researcher will conduct interviews one-to-one via Zoom with each participant using a semi-structured interview protocol (please see attached). The interviews will last approximately 45 to 90 minutes. Each participant will be provided with a transcript of the interview and will be given the opportunity to amend or add to their statements. If needed, the researcher may request an additional short interview (no more than 20 minutes) to clarify points or seek additional information.

Example for Quantitative Archival Data:

Non-identifying data will be collected through John Doe Community College’s Institutional Planning & Research Department. Approval has already been obtained for this research through the institution’s Chief Academic Officer and Executive Vice President (attached) who also serves as the Chief Officer of the community college’s IRB. The independent variable of this research is course delivery modality. This includes two categories of modalities: online course delivery and traditional course delivery. The dependent variables in this research include, student success rate, course GPA, and the course retention rate.

Data Collection and Data Analysis

Specify the data collection process that will be used and the data that will be collected from subjects. CITE surveys. Attach all instruments to be used, such as survey instruments, interview guide, assessment tools, and data collection form for existing data. How will you analyze your data?

Example for Quantitative Archival Data:

Data to be collected will be at the course level, and return a count of letter grades A, B, C, D, F, I, and Withdrawal. Initially, section numbers will be used to determine the format of the course (online, hybrid, or traditional) for calculations. From that point Course Retention and Course Success Rates can be calculated and separated by delivery type. In addition, identifying information such as course section number will be eliminated and totals will be used in the reporting of course delivery type only. A sample of a specific class (CIS-110) can be found below. The “Verified Grade” columns will be pulled from the data sets, and the other columns will be calculated in Excel based upon these numbers. For this causal comparative study, the researcher will examine success rates of a sample of community college students in applied science degree programs. Analysis to determine if a statistically significant difference exists by performing the following statistical analysis: t test using α = 0.05, and chi-square using α = 0.05, power of 0.80 and df = 5 to determine sample sizes large enough to produce statistically significant results.

Example for Quantitative Survey Data:

RQ1 Procedure:

The independent variable for RQ1 is the grade level of each teacher for the 2021-2022 school year which will be answered in question one of the demographic portion of the survey. The dependent variable for RQ1 is the survey data collected from the School Climate Survey questions from the Office of Special Education Policy (OSEP) distributed through Survey Monkey as a four-point Likert scale (1= Strongly Disagree, 4 = Strongly Agree). The statistical test used to measure RQ1 is an Analysis of Variance (ANOVA) test to determine if a statistical difference between the independent variable and the dependent variable exists.

RQ2 Procedure:

The independent variable for RQ2 is the years of experience of each teacher which will be answered in question two of the demographic portion of the survey. The independent variable for RQ2 is the grade level of each teacher for the 2021-2022 school year. The dependent variable for RQ2 is the survey data collected from the School Climate Survey from the Office of Special Education Policy (OSEP) distributed through Survey Monkey as a four-point Likert scale (1= Strongly Disagree, 4 = Strongly Agree). The statistical test used to measure RQ2 is an Analysis of Variance (ANOVA) test to determine if a statistical difference between the independent variable and the dependent variable exists.

RQ3 Procedure:

The independent variable for RQ3 is the number of years PBIS has been implemented in the teacher’s current school. The independent variable for RQ3 is the grade level of each teacher for the 2021-2022 school year. The dependent variable for RQ3 is the survey data collected from the School Climate Survey from the Office of Special Education Policy (OSEP) distributed through Survey Monkey as a four-point Likert scale (1= Strongly Disagree, 4 = Strongly Agree). The statistical test used to measure RQ3 is an Analysis of Variance (ANOVA) test to determine if a statistical difference between the independent variable and the dependent variable exists.

Link to survey SurveyMonkey.com

Example for Qualitative:

The data collected for this study will begin with an examination of academic research publications published between 2005 and 2021. Three bibliographic databases, including ProQuest, will be used to collect peer-reviewed literature on the primary and secondary activities of HRO procurement management. The second phase will review citations using RefWorks or a comparable tool to eliminate duplication and text that is irrelevant to the humanitarian supply chain. Additionally, the data will be divided into other categories based on the findings to enable evaluation of the purchase impact across the supply chain (e.g., inventory, distribution). The study's objective is to avoid redundancy and to incorporate the larger implications of research findings. Four steps will be taken to code the data and answer the research questions:

Data Analysis Strategy

Step 1: Categorize supply chain area (e.g., distribution)

Step 2: Identify all associated factor(s) influencing supply chain performance (from a list of nine)

Step 3: Use Likert scale to rank impact of each primary and support activity power base

Step 4: Calculate powerbase rating to determine areas high impact procurement areas across the supply chain

Back to Application

Describe any potential risks that the study poses to subjects, whether seen or unforeseen, including physical, social, psychological, legal, or other risks.

Example for Quantitative Archival Data:

There are no risks as no identifiable data will be used or reported.

Example for Quantitative Survey Data:

There are no foreseen risks associated with this research study. 

Example for Qualitative Data:

There are no foreseen risks associated with this research study. 

Resources to help with Section 7: Potential Risks

Back to Application

Describe the demographic characteristics of the study population, including the sampling method, minimum sample size, and how you determined adequate sample size.

Per the doctoral research handbook, a quantitative dissertation must utilize a G*Power Analysis (see Appendix F of the Doctoral Research Handbook).  

Please use the following guidance to establish the minimum sample size for your study.  

G*Power statistical analysis is required for the minimum sample size. Link for G*Power3