Application to Use Human Subjects in - Research Proposal Example

Before completing this application, please review Procedures for Obtaining al Approval for the Use of Human Participants, available at http://www.callutheran.edu/irb/ Instructions: Complete all sections below. Incomplete applications will not be reviewed Be sure to attach all relevant material in appendices, including informed consent documents, instruments, interview protocols, and letters of approval from sites, as applicable. List all appendices by both label and title (e.g. Appendix A Interview Protocol). ______________________________________________________________________________ A. REVIEW TYPE: Include justification for Exempt Status or Expedited Review. (See Procedures for Obtaining Institutional Approval for Research, available at http://www.callutheran.edu/irb/, for a discussion of the criteria for each category). Exempt Expedited Full Board B. PRINCIPAL INVESTIGATOR: Name (s) Department Affiliation (Student, Faculty, Staff, Other) Mailing Address Telephone Number Email Address NIH Training Certificate Number (Please also attach electronic copy) C. FACULTY SPONSOR: Not Applicable Faculty Sponsor’s Name Department Phone Email Address D. TITLE OF PROPOSED RESEARCH PROJECT: Program Improvement Status and Standardized Math Scores in Elementary Schools E. CATEGORY OF RESEARCH: Institutional Research, Intended for Possible Publication Proposal Already Approved by Another Institution (attach documentation) Modification of a Proposal Already Approved by CLU IRB All-inclusive Application* for Research Conducted by Students in a Graduate Course NOT to include Masters theses or Doctoral dissertations (specify title)________________________________ All-inclusive Application* for Research Conducted by Students in an Undergraduate Course (title)__________________________________ Doctoral Dissertation Master’s Thesis, Honors Thesis, or Capstone Project Student Individualized (Independent) Study Project Action Research Project Other____________________________________________________ *Instructor must collect Class Project Approval Form from each student for his/her records. F. BACKGROUND, RESEARCH OBJECTIVES, AND METHODOLOGY: Describe and justify the proposed methodology: Sections should include; (1) Background: cite related literature that roots the study in unanswered conceptual, theoretical, or practical issues; (2) Research objectives: describe what you hope to accomplish with this study and list the research question(s) and hypothesis(es), if applicable.; (3) Methods: describe the proposed methodology. Be sure that the methodology will permit the research/educational objectives to be met. DO NOT paste elements of a thesis proposal. This section should be brief but clear, allowing the committee to understand the why, what, and how of your project. Program improvement status stems from the No Child Left Behind Act. It is an initiative designed, in essence, to force underperforming schools throughout America to offer more quality educational service and to improve the academic standards in the school. In Los Angeles, there are a significant number of elementary schools within the school that have been placed on program improvement status in recent years, primarily as a result of much lower than average scores on state mandated math exams. The objective of this research study will be to determine if the program improvement status concept is working to raise the overall math standards within the Los Angeles Unified School District, as would be represented by an increase in math scores across the board. This is primarily measured by examining annual yearly progress, which is a requirement for being removed from program improvement status. The methodology will be a qualitative study. There will be in in-depth literature review conducted to determine the effectiveness, or lack thereof, of new programs within the LAUSD that are designed to increase that academic standards in low performing elementary schools. In addition, an in-depth interview will be utilized to gain the expert perspective and insight of professionals within the district to determine if program improvement status is truly making the impact that it was designed to have. G. PROPOSED RISK: Please respond to the following questions: G1. In your opinion, does the research involve more than minimal risk to participants? Minimal risk means that “the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Yes No - There is no perceived risk to any of the participants that will possibly help out with this proposed research project. G2. Are any emergencies or adverse reactions (physical, psychological, social, legal, or emotional) foreseeable as a result of the research? Yes No - No, there are not any potential physical, psychological, social, legal, or emotions adverse reactions that might arise from participating in this study. G3. Is there any conflict of interest or dual role that needs to be explained? No, there is not any potential conflict of interest or dual role on either the part of the research or possible participants in this study. H. PROTECTING AGAINST OR MINIMIZNG RISK: If yes to the above question, indicate the form the risk(s) will take, a justification for its necessity, and the procedures you will take to ensure the protection of participants. There is no perceived risk to participating in this study. I. HUMAN SUBJECTS CHARACTERISTICS: Gender Number Age Range Male 12 21-60 Female 8 21-60 J. VULNERABLE POPULATIONS: Vulnerable populations include minors, elderly, physically or mentally disabled, economically or educationally disadvantaged, victims, institutionalized people, or those who can easily be victimized. Will any vulnerable populations be included in your study? Yes No - There are no members of a vulnerable population that will asked to participate in this study. If so, please explain the population and describe how they will be protected. K. OTHER HUMAN SUBJECTS CHARACTERISTICS: Describe any other characteristic common to your potential human subjects population or research question. Each of the participants that will be asked to serve on the research panel are either an administrator, teacher, or support personnel currently employed in an elementary school in the Los Angeles Unified School District. Each of the schools represented were also currently on program improvement status. L. RECRUITING SOURCES: Identify the sources (e.g., schools sites, hospitals, prisons, CLU classes, etc.) where participants will be recruited from for the research. Where participants are sampled from agencies or other schools, letters of informed consent from these sites must also be attached. Any requests for waiver of these requirements must be justified. All participants will be stakeholder in the Los Angeles Unified School District. Specifically, each participant will be currently involved with an elementary school that is on program improvement status. Schools will be randomly selected by first locating them via the Los Angeles Public School District website, as they list all schools that are on PI status. They will be given a letter of informed consent, such as the one below: California Lutheran University Informed Consent: Participants 18 years of age and older Dear Participant, My name is __________ and I am a student at theCalifornia University working on a graduate degree in Education. I am conducting a research study, entitled Program Improvement Status and Math Scores in Los Angeles Elementary Schools: A Qualitative Study. The purpose of this proposed qualitative research study is to obtain an in-depth understanding of how educators think the concept of program improvement status is working to help raise academic standards in the elementary schools within the district, particularly in the area of raising scores on state mandated math exams. Your voluntary participation will involve answering questions related to personal experiences with your work environment. If you choose not to participate you may withdraw from the study at any time, you can do so without penalty or loss of benefit to yourself. By not returning the Informed Consent form you have successfully withdrawn from the study. While completing the interview you may also withdraw by informing the researcher to remove all responses. The results of the research study may be published, but your identity will remain confidential as data taken from this survey will be coded and held for a period of three years, and then destroyed. The questionnaire will ask some general demographic questions. The entire interview is expected to take between 30 and 60 minutes to complete. In this research, there are no foreseeable risks to you. “By typing your name and clicking on the radio button you acknowledge that you understand the nature of the study, the potential risks to you as a participant, and the means by which your identity will be kept confidential. Your acceptance of this form also indicates that you are 18 years old or older and that you give your permission to voluntarily serve as a participant in the study described.” Best Regards, M. RECRUITMENT PROCESS: Clearly explain in chronological order how participants will be identified, selected and recruited to participate in your study. Include the complete, step-by-step series of events from initial approach to informed consent. Include incentives and samples of any advertisements that will be posted or scripts that will be read for recruitment in your appendices. This proposed research study would take place entirely within the Los Angeles Unified School District. The population of this study is slated to include selected elementary schools that are on program improvement status during the 2013-2014 academic school year. Various administrators, teachers, and parents will be contacted to provide insight and solicit opinions to help answer the research questions previously outlined. By using the above guidelines, the following types of individuals will be approached to become a part of the final research panel: elementary school administrators, teachers, staff, parents, and adult stakeholders within the community. A minimum of twenty and maximum of fifty students involved with the slated type of elementary school in the Los Angeles Unified School District will be interviewed. Once a school is located for possible inclusion, the administration of that school will be contacted by telephone to gain permission to email teachers. Teachers and other stakeholders will then be emailed an informed consent letter to determine if they wish to participate. Once that is returned, then a time for an interview will be set. N. INFORMED CONSENT: Include a copy of the proposed Informed Consent form(s) in your appendices. See Elements of Informed Consent, available at http://www.callutheran.edu/irb/, for the necessary elements for informed consent. Where participants are minors, informed consent must be obtained from their legal guardians and “assent” should be obtained from the minor on a separate form. Please see CLU child assent policy on the IRB Website. California Lutheran University Informed Consent: Participants 18 years of age and older Dear Participant, My name is __________ and I am a student at theCalifornia University working on a graduate degree in Education. I am conducting a research study, entitled Program Improvement Status and Math Scores in Los Angeles Elementary Schools: A Qualitative Study. The purpose of this proposed qualitative research study is to obtain an in-depth understanding of how educators think the concept of program improvement status is working to help raise academic standards in the elementary schools within the district, particularly in the area of raising scores on state mandated math exams. Your voluntary participation will involve answering questions related to personal experiences with your work environment. If you choose not to participate you may withdraw from the study at any time, you can do so without penalty or loss of benefit to yourself. By not returning the Informed Consent form you have successfully withdrawn from the study. While completing the interview you may also withdraw by informing the researcher to remove all responses. The results of the research study may be published, but your identity will remain confidential as data taken from this survey will be coded and held for a period of three years, and then destroyed. The questionnaire will ask some general demographic questions. The entire interview is expected to take between 30 and 60 minutes to complete. In this research, there are no foreseeable risks to you. “By typing your name and clicking on the radio button you acknowledge that you understand the nature of the study, the potential risks to you as a participant, and the means by which your identity will be kept confidential. Your acceptance of this form also indicates that you are 18 years old or older and that you give your permission to voluntarily serve as a participant in the study described.” Best Regards, Clearly describe the process of obtaining informed consent (i.e. when, where and how consent will be obtained). This is an ESSENTIAL element of the review. Do not leave blank. Participation in this proposed study will be entirely voluntary, and will be stated as such from the onset of first contact with any potential panel member. Permission will first be obtained from the Los Angeles Unified School District to conduct this study. Further, permission will be sought from all administrators at individual schools where teachers or support staff will be asked to participate in the study. As mentioned previously, various community stakeholders and parents will also be contacted for inclusion on the panel, and their permission to participate in the qualitative study will be sought via email. The purpose in their inclusion in the study will be solicit their opinions and ideas about what can be done to improve the academic performance of students attending elementary schools currently on program improvement status. The informed consent letter will be sent via email to possible participants. O. DEBRIEFING PROCEDURE: O1. Will any deception be used in your study and/or in its description to participants? Yes No - No deception whatsoever will be used at any time in this study. All of the topics to be covered in the scope of the study will be open and transparent. If yes, describe and explain the reason and rationale, and scientific merits of deception. O2. Will the results of the study be shared with the participants? Yes - Participants will be able to see the final published dissertation, although their name will not mentioned in the study at any time. No If so, what process will you follow to share your results? I will inform each participant when the final study is published an inform them how they can receive a copy. O3. Describe the process that will ensure that participants have access to the researcher(s) to ask questions about all and any aspect of the research project. The information you provide here should parallel what participants are provided in the informed consent document. Each participant will have the email address of the researcher and will be encouraged at every step of the process that they can contact myself with any questions that they may have. At several points along the way, participants will be reminded that they can withdraw from participating in the study, even if that were to happen during the actual interview itself. P. PROCEDURES FOR ENSURING CONFIDENTIALITY: How will anonymity and or confidentiality of data be ensured? Give specific information on your process for ensuring confidentiality. You should include a statement of how long and where data will be kept following completion of the study. Federal guidelines require data and informed consent documents to be retained for at least three years. Anonymity has to be differentiated from confidentiality. Below are definitions for both constructs. Carefully describe how confidentiality will be protected and the place that anonymity has in your study, if any. Anonymity: in human subjects research is when data cannot be traced back to any particular research participant, not even to the principal investigator. In research that is anonymous, collected data and human subjects are entirely uncoupled or delinked. Online surveys are not considered anonymous, as IP addresses maintain personally identifiable information that can be traced back to the participant. Confidentiality: in human subjects research is when data/information may potentially be traced back to a participant with whom the data was collected. Thus, interviews and observations are in the category of confidential as opposed to anonymous. In this case, the principal investigator asserts that he or she will hold information confidential. Risks associated with confidentiality are minimized in this study. This can be stated because there is no identifiable information that will be released in the final report, and all responses given by the participants will be coded by the following titles: administrator, teacher, support staff, parent, or community member. The informed consent letter that is agreed to electronically, or in print, will be stored online via a secure server, where it still stay for a period of three years. The student conducting this research is the only person who will have access to this file. After three years, all data associated from the study will be eliminated from the server. Individuals participating in this study will be notified of the confidentiality procedures previously mentioned through the informed consent letter. This letter will document will detail how the information provided by participants will be handled. First and foremost, the information gathered during the interview stage will always be confidential and anonymous. The researcher will go to great lengths to clearly state that all panel members need to use confidential methods when completing the online portion of the interview. Participants will complete the interview on a voluntary basis, no compensation will implied or given, and at no time will the information shared be released or identified by name in the final published study, or in any organizational records. In most cases, the interview/survey will be sent to individual email accounts. The anonymity of participants will be further assured because the interview design is such that it should not be completed at work during business hours. In addition, all participants are clearly notified that they are free to withdraw from the study at any time, and they will be given detailed information about how to do so. To further guarantee participant anonymity, personal interviews that are completed and any corresponding materials will be categorized, coded, and stored in a secure online location that only the researcher has access to. Whenever possible, all data will be stored in such a secure environment, with no need for hard paper copies. Some participants may choose for the interview to take place either via telephone or in-person. In such cases, notes will still be taken online by the researcher, coded by participant number, thus assuring that no personal information is associated with interview responses. Q. ANALYSIS OF RISK/BENEFIT RATIO First, describe any benefits to the participants and/or the field, etc. anticipated from your study. Second, describe any short-term or long-term risks to participants that could be anticipated by participating in the study (even the loss of time is a risk). Describe how such risks will be minimized and precautions taken to protect participants. Benefits and risks are ESSENTIAL elements of the review. Do not leave blank. The benefits to the participants is that possible conclusions drawn from this study can be used to assist elementary schools in the Los Angeles area develop more effective programs aimed at improving the math level of children in underperforming schools. As this study is solely designed to be exploratory in nature, and no personal information is to be divulged (including school names), there are no risks that participants should anticipate from taking part. R. HAZARDOUS MATERIALS Will drugs or hazardous substances be used as a part of this study? Yes No - No drugs or hazardous substances will be used as a part of this study. If yes, please read and complete the Hazardous Materials Use Form from the Federal Government and attach with this application. S. PROJECT MATERIALS Attach as appendices copies of all materials (e.g., surveys, observation protocols) used in this study and information about the sources of these instruments (e.g., who developed the instruments, reference for where additional information about the instrument’s reliability and validity can be found, etc.). List all appendices by both label and title (e.g., Appendix A Interview Protocol). Appendix A: Pre-Screening Interview (To Determine Qualified Participants) 1. Are you an administrator, educator, or support staff in a Los Angeles Unified School District elementary school? 2. What is the highest degree you have completed? a. Secondary School b. Bachelor’s c. Master’s d. Doctorate 3. How long have you been involved directly with your current school? Appendix B: Personal Interview Questions (to be conducted in-person or via telephone) 1. In your opinion, what are some of the main reasons that your elementary school continues to find itself on Program Improvement Status? 2. What improvements have you noted in terms of math achievement in the past few years on the part of students in your school? 3. What are some of the areas currently lacking from the math program in your school and what do you feel can be done to correct these? 4. In your estimation, what is the ideal method by which to teach math to elementary students? How is this different than the methodology employed by many of the teachers in your school? 5. What will it take to improve the math scores on state mandated tests, as earned by your students? 6. If you could implement five new pieces of technology or supplies into the classroom, what would they be and why? 7. Do you think it is ‘fair’ that your school in placed on program achievement status? Do you see them be removed from this list at anytime in the next four school years? Explain. T. CERTIFICATION FOR RESEARCH OR TEACHING I certify that to the best of my knowledge the information provided above is complete and accurate. I agree to obtain approval from the IRB for any modifications of the above protocol as described. I accept responsibility for ensuring that the rights, welfare, and dignity of the participants in this study have been protected and are in accordance with applicable federal/state laws and regulations and the University’s Institutional Guidelines for the Treatment of Human Participants in Research (see Procedures for Obtaining Institutional Approval for Research, available at http://www.callutheran.edu/irb/). I certify that this research or instruction does not unnecessarily duplicate research already published or previous student instruction. I ensure that all personnel conducting the work of this protocol have or will receive appropriate training in the use of human participants in experimentation. I accept responsibility for submitting a Continuing Review form, if the study continues longer than one year from the date of approval, and/or a Final Report form, at the completion of the study. Signature_______________________________________ Date_______________ (Principal Investigator) Signature_______________________________________ Date_______________ (Faculty Sponsor, if different from above) CLU IRB CHECKLIST I HAVE REVIEWED THE INSTRUCTIONS I HAVE PROVIDED THE FOLLOWING: REVIEW TYPE PRINCIPAL INVESTIGATOR FACULTY SPONSOR (If applicable) TITLE OF PROPOSED RESEARCH PROJECT CATEGORY OF RESEARCH BACKGROUND, RESEARCH OBJECTIVES, AND METHODOLOGY PROPOSED RISK PROTECTING AGAINST OR MINIMIZNG RISK HUMAN SUBJECTS CHARACTERISTICS VULNERABLE POPULATIONS OTHER HUMAN SUBJECTS CHARACTERISTICS RECRUITING SOURCES RECRUITMENT PROCESS INFORMED CONSENT DEBRIEFING PROCEDURE PROCEDURES FOR ENSURING CONFIDENTIALITY ANALYSIS OF RISK/BENEFIT RATIO HAZARDOUS MATERIALS PROJECT MATERIALS CERTIFICATION FOR RESEARCH OR TEACHING APPENDICES Read More