IRB

You have to create a study for example like the effect of weight loss on happiness for a college student. An excellent 3-5 page paper You will complete a project proposal detailing an outlined plan, methods, and hypotheses. The plan can be related to an experiment, a survey, or a systematic review (or meta-analysis). The length of the final paper will depend on the magnitude of your study, but should be somewhere between 3-5 pages and will include the typical structure of a study proposal (introduction, method). This project is worth 100 points.

fill out this application to while making up your study then write a 3-5 page paper and follow the outline below and there will be another document attached as the example

20 points

1-3 specific aims are clear, concise, and good rationale is provided and backed-up by relevant and up to date literature review. A clear prediction is detailed with a hypothesis or hypotheses.

Background and Significance

20 points

Excellent and up to date literature review demonstrating rationale for the study, starting broad and then narrowing in on the study question.

20 points

Choice of methods for summarizing and analyzing data is ideal for the dependent variable(s) and for answering the research question and methods are clearly justified.

APA style and writing 20 points

Excellent

1

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Correct usage of APA style

Correct in-text citation, reference section has hanging indent and is in APA style, heading levels are correct.

fill out this application to while making up your study then write a 3-5 page paper and follow the outline below and there will be another document attached as the example

Application for the Use of Human Subjects ( can make information up about the person or put n/a and do nt put a name or number or address, just say a student.

Part A Application Information

1.  Title of the Study:

2.  Principal Investigator:

3.  Contact Person:

(if different from PI):

Title:

Dept:

Title:

Dept:

Address (+ ZIP):

Address (+ Zip):

Phone:

Email:

Phone:

Email:

4.  Co-Investigator(s):

(Name & Affiliation)

5.  Research Originated By:   (Check One)             Faculty               Student                Staff

6.  Research Purpose (Check All that Apply):         Grant           Dissertation         Thesis

 Honors Thesis      Course Project: Which Course?

7.  Correspondence Request:          N/A

Part B Research Study Synopsis

1.  Brief Study Description (Include Purpose of the Research):

2.  Study Length

     What is the duration of the study?

3.  Location of Research

   a. Where will the research take place?

   b. Will the PI be conducting and/or supervising research activity off-campus?

      Yes            No         If Yes, please list sites:

4.  Subject Information:

   a.  Number of Subjects:

   b.  Sex of Subjects:

   c.  Ages of  Subjects:

5.  Potentially Vulnerable Populations: (Check All that Apply)

    Children        Pregnant Women         Cognitively Impaired       Prisoners         Institutionalized

    Faculty’s Own Students        Other.  Please describe:

6.  Non-English Speaking Subjects

   a.  Will subjects who do not understand English participate in the research:     Yes           No

   b.  If yes, describe your resources to communicate with the subjects:

   c.  Into what language(s) will the consent form be translated:

7.  Additional Subject Concerns

   a. Are there cultural attitudes/beliefs that may affect subjects in this study?       Yes            No

   b. If yes, please describe attitudes and how they may affect subjects

8.  Dissemination of Research Findings

   a. Will the research be published?    Yes            No       If yes, where if known?

   b. Will the research be presented?    Yes           No       If yes, where if known?

9.  External Funding

   a.   Are you seeking external funding?    Yes         No      What agency?

   b.   Have you received funding?    Yes         No         c.   Dollar amount?

10.  Method of Recruitment:  (Check All that Apply)

    Flyer      Classroom Announcement         Letter to Subjects        Third Party      Random

   Other:

11.  Payment to Subjects

   a. Will subjects be compensated for participation?    Yes        No      If yes, please indicate amount:

   b.  Form of Payment:   Cash      Check       Gift Certificate       Voucher          Other

   c. Will Payment be prorated?     Yes          No      If yes, please explain:

   d. When will the subject be paid?      Each Visit         Study Completion      Other

12.  Extra Credit

   a. Will subjects be offered extra credit?       Yes      No

   b. If yes, describe the alternative:

13.  Risks:  Identify all potential risks/discomforts to subjects.

14.  Benefits:

   a. Are there direct benefits to participants?   Yes     No   If yes, please list.

   b. Are there potential benefits to society?     Yes     No    If yes, please list.

15.  Study Procedures:

   a. What will be the duration of the subjects’ participation?

   b. Will the subjects be followed after their participation ends?  Yes     No    If yes, please describe:

  1. Describe the number, duration and nature of visits/encounters.

  2. Is the study    Therapeutic?     Non-therapeutic?

  1. List all procedures that will be performed to generate data for the research.

  2. List all procedures/questionnaires done solely for the purpose of the research study.

  1. List all procedures/questionnaires participants already do regardless of research.

16.  Informed Consent:

   a. Are you requesting Waiver or Alteration of Informed Consent?   Yes     No   If yes, please fill out the waiver of informed consent and attach it.

   b. Briefly describe your process to obtain consent:

17.  Confidentiality:

   a. Are the subject’s social security number or any identifier (other than study number and initials) being sent off site?    Yes     No   If yes, describe and explain reasons:

  1. Will any entity other than the investigative staff have access to medical, health or psychological information about the subject?     Yes     No    If yes, please indicate who:

  1. Briefly describe provisions made to maintain confidentiality of data, including who will have access to raw data, what will be done with the tapes, where data will be stored, how long data will be stored, etc.

  1. Will raw data be made available to anyone other than the PI and immediate study personnel?

Yes     No

         If yes, describe the procedure for sharing data. Include with whom it will be shared, how and why.

Part C

The attached investigation involves the use of human subjects.  I understand the university’s policy concerning research involving human subjects and I agree:

  1.    Yes     No   To obtain voluntary and informed consent of subjects who are to                                                                                                participate in this project.

  2.    Yes     No   To report to the IRB any unanticipated effects on subjects which become apparent during the course of, or as a result of, the experimentation and the actions taken.

  3.    Yes     No   To cooperate with members of the committee charged with continuing review of this project.

  4.    Yes    No   To obtain prior approval from the committee before amending or altering the scope of the project or implementing changes in the approved consent document.

  5.    Yes    No   To maintain the documentation of consent forms and progress reports as required by institutional policy.

  6.    Yes    No   To safeguard the confidentiality of research subjects and the data collected when the approved level of research requires it.

    1. Yes   No   all investigators on this project have completed CITI training related to ethical practices in the use of human subjects in research.

Signature of the Principal Investigator:  Date:

Part D Synopsis of the Proposal

  1. Specific Aims

  2. Hypothesis

  3. Background and Significance

  4. Description of Subjects

  5. Confidentiality

  6. Method or Procedures

  7. Data Analysis

  8. Risks

  9. Benefits

  10. Compensation

  11. References

  12. Qualifications

then write  An excellent 3-5 page paper You will complete a project proposal detailing an outlined plan, methods, and hypotheses. The plan can be related to an experiment, a survey, or a systematic review (or meta-analysis). The length of the final paper will depend on the magnitude of your study, but should be somewhere between 3-5 pages and will include the typical structure of a study proposal (introduction, method). This project is worth 100 points. there will be 2 files attached to tell you how to do so look at both

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