Research Paperwork


Please use the prior paper completed to complete this proposal. I submitted for 15 pages it may not be that much but its ok.

Please create the doc from the paper created on comparing perceptions of school climate between parents, students, and teachers.

2.1 Abstract
On a separate sheet, include an abstract of the project of no more than 500 words. The abstract should address the following:
• Purpose of the research project;

• Type of research design employed in the project;

• Subjects, if any, involved;

• Procedures for data collection;

• Measurement instruments to be employed in the project;

• Anticipated type of data analysis to be employed;

• Relevance of the research project.

2.2 Narrative Description
A narrative description of the proposed research project should be brief (no more than ten (10) pages), but should provide sufficient information to permit the IRB re-viewers to judge if the problem chosen is significant or important, if the research question and design are adequate to address the problem, and whether the investiga-tors have the knowledge, funding, and access to any equipment and/or subject popu-lations necessary to complete the proposed project.
The narrative description shall be prepared in accordance with the following outline (except as noted in the opening paragraph of this document):
2.2.1 Purpose
State the overall purpose of the research project and, if appropriate, hypoth-eses to be tested. Briefly explain what you feel is the potential significance of the research project.
2.2.2 Duration
Provide an estimate of the duration of the entire research project. The start-ing date is when the research proposal is finalized (including IRB approval) and sample selection and data collection may begin. The ending date is the anticipated date of completion of the research project – SEPT to DECEMBER
2.2.3 Location
Provide the specific name and location of any and all facilities at which data collection will take place. – I WILL TAKE CARE OF THIS SECTION
2.2.4 Background
Briefly review the most significant previous work done in the topic area and the specific problem area and describe the current status of work in this top-ic and problem area. Document this review with appropriate references us-ing the AMA style. Describe any preliminary work that the principle inves-tigator, additional investigators, or others have done which led to this re-search project.
2.2.5 Methods
The methods section of the proposal should describe the:
• Type of study or research design that will be employed in conduct-ing the project;

• Methods and instrumentation to be used for sample selection and for data collection;

• Data to be collected;

• Procedures used for data collection and analysis;

• Projected timetable of the study (all major steps in the study with approximate dates for initiation and completion).

2.2.6 Resources
• Describe the facilities, special equipment, consultative services, and other relevant resources available for the project. If any of the-se are to be secured through collaborative arrangements with insti-tutions other than that which might be indicated in the address(es) of the investigator(s), attach letters from each such source confirm-ing their willingness to provide these resources.

• Identify any supplies, equipment, or other resources that are re-quired for completion of the project.

2.2.7 Subject Recruitment and Selection
• Summarize the process of obtaining subjects for the proposed re-search project. Specify the sample size needed for the level of significance desired in your proposed data analysis. If a larger sample is desired because attrition is expected, so state and state the additional number of subjects desired. If your design uses experimental and control groups, specify the number of subjects to be assigned to each experimental group and each control group. If your sample is to be generated by inviting m persons to participate, from which you shall select a sample of size n (n < m), specify the number m. – 2 HIGH SCHOOLS RANDOM SELECTION At least 50 of each group (parent, Student, Teacher) NO EXCLUSIONS NO INDUCEMNTS

• If potential subjects are to be excluded because of age, gender, economic status, or race, the reasons for the exclusion must be documented.

• Describe any inducements that will be offered to subjects, such as cash payments, free hospitalization, medication, treatments, test-ing, etc.

• For research projects using patient populations, attending or refer-ring physicians must have a reasonable opportunity to affect the manner in which their patients are invited to participate. If a pa-tient has not previously given consent to the disclosure of his/her name as a candidate for research, the patient should first be con-tacted by his/her physician with the investigator’s request.

• Include sample copies of all correspondence that will be presented or sent to subjects or prospective subjects, and any intermediaries involved.

• Indicate all special categories of subjects to be included in the re-search project, e.g. mentally retarded or disabled, minors, pregnant women, prisoners, etc.

2.2.8 Potential Risks
Describe and assess any potential risksphysical, psychological, social, economic, monetary, legal, or otherto the subjects involved in the re-search project and assess the likelihood and seriousness of such risks. If the research methods proposed create potential risks, describe other methods, if any, that were considered and provide the reasons why they were rejected.
2.2.9 Consent Procedures
Describe the procedures to be followed in obtaining informed consent from subjects, including how, when, where, and by whom informed consent shall be obtained. – INFORMED CONCENT LETTER
2.2.10 Protection of Subjects
Describe the procedures, including confidentiality safeguards, that will be employed to protect against or minimize potential risks to subjects, and provide an assessment of the likely effectiveness of these procedures.
The following issues must also be addressed:
• If there is a point at which the collection of data from subjects may be discontinued prior to the end of the data collection phase of the research project, state how monitoring of the data collection is to be performed and the criteria for determining the discontinuation point.

• Include a description of any measures that will be taken to handle side effects or problems identified during the research that are associated with or resulted from the procedures used.

• Include one (1) copy of any questionnaires or rating scales that will be employed in the research project.
• If drugs are to be administered or devices are to be used in the re-search project, the packaging brochure or other informational liter-ature regarding the drug or device must be attached to the re-

search proposal and the following questions must be answered:
What is the name of the drug or device?
Does the drug or device have FDA approval?
What is the name of the manufacturer of the drug or device?
If drug or device is investigational, does it have an FDA in-
vestigational new drug or device exemption?
What is the exemption number?
• Proposals for research projects involving clinical drug or medical device trials should have a copy of an indemnification clause, signed by appropriate parties, attached to them. An indemnifica-tion form is usually available at the institution where the trials will take place.

2.2.11 Potential Benefits
Assess any potential benefits that may be gained by individual subjects involved in the research project and any benefits that may accrue to society in general as a result of the proposed research.
2.2.12 The Risk/Benefit Ratio
Analyze the possible benefits that may be gained by the subjects involved in the proposed research in light of the risks involved. Minimal risk means that the risks of harm anticipated in the proposed research are not greater than, with respect to both probability and magnitude, the risks encountered in daily life or during the performance of routine physical or psychological examinations or tests.
2.3 Informed Consent
Any research project that involves the use of human subjects requires implementation of procedures for obtaining the informed consent of the subjects. The research proposal must address how informed consent will be obtained and must provide cop-ies of the actual consent form(s) that will be employed by the researchers. LETTER INCLUDED in Upload
Consent forms must be prepared in accordance with Section 3 of this document

2.5 Budget
Each proposal must contain a budget summary page which provides a breakdown of expenses in the following categories: – Expenses are only Copies of the survey.
• Equipment purchase/rental;

• Supplies;

• Clinical site fees;

• Personnel/consultant fees;

• Participant support costs;

• Other.

The IRB is interested in budget information that has the potential to affect the safe-guarding of human subjects involved in the research.

3. Consent Forms
The consent form should be a succinct statement (no more than three pages) providing in-formation about the research project including (but not limited to) its purpose, proce-dures, benefits, risks, duration, and (where applicable) alternative therapies that are avail-able. The document should bear the title Consent Form and immediately beneath the ti-tle should bear the title of the research project, the name and address of the principal in-vestigator, and the names of any additional investigators. The consent form should iden-tify the institution(s) represented by the investigator(s) and the institution(s) where the re-search project is to be carried out. The document should contain a footer identifying the date of the latest revision; only the form approved by the IRB may be used in the research project.
The consent form should be written in clear, understandable English. If the population to be sampled speaks another language, the investigators may attach to the English language version a certified translation of the consent form and have subjects sign both versions. A certified translation is one that has been approved by the IRB after consistency with the English language version has been certified by an IRB member or consultant to the IRB who is fluent in the language used in the non-English version of the consent form.
The consent form must provide adequate information to enable a prospective subject to decide whether or not to participate in the research project and may not include language by which a subject is made to waive, or appear to waive, any of his/her legal rights or to release the investigator(s), or the sponsoring institution(s) or its (their) agents, from liabil-ity for negligence. Each adult subject and each legal guardian who signs consent for a subject who is a minor must receive a copy of the signed consent form. The principal in-vestigator must retain in his/her confidential files copies of consent forms signed by each subject in the study for at least five years after completion of the research project or such longer period as may be specified by program requirements. In the case of subjects who are minors, the above rule on retaining copies of signed consent forms applies or the signed copies must be retained until the subject reaches his/her majority, whichever peri-od is longer.
In preparing the consent form, it is recommended that the document be written in the same person throughout, that scientific terminology be defined in plain language, and the document be carefully edited for errors in fact, grammar, spelling, and typing.
The following information must be included in the consent form:
• Invitation to Participate: Provide a brief statement inviting participation as a subject in the research project. Basically, this section should state, “You are in-vited to participate in a research study ” and continue with an amplification of the title of the research project.

• Basis of Subject Selection: Provide a brief explanation of how the sampled population was determined, i.e. explain the defining criteria that determined who was invited to participate. For example, individuals with a certain specific condition were sought for an experimental group while those without the condition were sought as controls. POulation are 9-12th grade students randomly selcted

• Purpose: The purpose of the research project, and the potential significance of the research, should be explained without using jargon or undefined technical terms.

• Procedure: All subjects must be informed of what, exactly, their participation in the study will involve. All tests and procedures should be explained, and any that are experimental in nature should be clearly identified as such.

• Potential Risks and Discomfort: It should be clearly stated that participation in the study may involve risks or discomfort, and the known risks and discomforts should be clearly delineated. Participants should also be apprised of the potential for unknown or unforeseeable risks or discomforts. The disclosure of risks in-cludes the implications of randomization procedures and of the experimental de-signsuch as in a double blind experiment neither the investigator nor the sub-ject knows who is receiving genuine treatment and who is receiving a placebo.

• Potential Benefits: The benefits of the research to the subject or to society in general are to be explained. If no benefit to the subject is foreseeable, this should be clearly stated.

• Inducements: Any inducements being offered to subjects, such as cash pay-ments, free hospitalization, medication, treatments, testing, etc. must be clearly explained as well as the mechanism for obtaining or availing oneself of the in-ducement.

• Financial Obligations: In addition to any inducements offered, prospective sub-jects should be told which expenses involved in participation are the investiga-tor’s or sponsoring institution’s responsibility and which expenses are the partic-ipant’s responsibility. For example, the investigators are responsible for the cost of all tests and procedures performed and the only cost to the participant is trans-portation to the facility where testing and treatment takes place.

• Alternatives: In therapeutic studies, alternative treatments, including their risks and benefits, should be described.

• Confidentiality: When the research project involves the acquisition or use of personal information, subjects must be informed of the steps that will be taken to safeguard that information and assure confidentiality. A subject must consent to the investigator(s) using secondary sources to obtain personal or confidential in-

formation concerning the subject. Subjects must be informed of who will receive information derived from the study. Research subjects involved in clinical trials involving drugs or devices under the jurisdiction of the FDA must be told in the consent form that representatives of the manufacturer of the drug or device and representatives of the FDA may review data collected during the study and that the information will be kept confidential except as may be required by law.

• Non-participation or Withdrawal: It must be made clear that those invited to participate are free to consent or decline. In the case of those consenting to par-ticipate, assurance must be given that they are free to withdraw from the study at any time. Assurance must be given that a decision not to participate in, or a deci-sion to withdraw from, the research project will not prejudice future interactions between the person involved and the investigator(s) or the sponsoring institution(s).

• Complications or Injuries: Prospective subjects should be advised of the avail-ability or non-availability of medical treatment or compensation for complica-tions or injuries incurred as a result of participating in biomedical or behavioral research.

• Subjects’ Questions and Rights: Subjects must be provided with an opportuni-ty to ask questions regarding the study and their participation in the study, or to request an elaboration of any of their rights as subjects of research. Subjects must be provided with the name and method of contacting a person who can an-swer their questions or requests for additional information.

• Consent: An affirmation should appear at the end of the consent form immediately above the line for the subject’s signature and should read,

“I have read and received a copy of this consent form. I voluntarily consent to participate in the research project described herein. My rights as a subject of this research have been explained to me