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psy335_r1_uopx_irb_week4teamassignment_1.docx

UOPX logo with bird and name 2011 Institutional Review Board Application FOR HUMAN SUBJECTS Research

The University of Phoenix Institutional Review Board (IRB) exists to ensure university compliance with federal regulations regarding research involving human subjects. This application is used to facilitate and document this compliance review. Research projects which meet the federal definition for research and the federal definition of human subjects must be approved by the University of Phoenix IRB before any data collection begins. If an IRB application is approved by the IRB and, later, the nature of the research design, requirements, or site locations change, a revised application describing these changes must be submitted for reconsideration and approval by the IRB. This application is intended as a stand alone document, so reference to other documents or appendices of dissertation proposals or other research studies does not substitute for direct provision of that information as part of this application, either as a response within a section or as an addendum. This application pertains to both pilot studies and full studies. Please note that it is the researcher’s responsibility to give complete and accurate information about the nature of the proposed study, particularly in terms of the effects on, and expectations for, subject participants. Please note that you must document currency in CITI certification as part of this application.

Name of Researcher(s)

City, State, and Country / School or College and University

Affiliation

(student, faculty, or staff and id)

Type of Research

(research study, *funded research, or other)

Phoenix Arizona

University of Phoenix

IRN: LEAVE THIS BLANK

Research study

* If research is funded, please complete the following agency information. Otherwise, leave blank.

agency submitted to

submission date

location of project

     

/  /    

     

1. Title of the Research Study/Dissertation: Sunlight increases suicide rate.

2. Classification of the Study:

a) Will primary data collection from human subjects be done in this study?

(|_|) Yes, original data only is collected from human subjects and no archival data will be used.

(|_|) Yes, both original data from human subjects and archival data will be collected and used.

(|X|) No, only archival data will be used.

b) Are the research study results generalizable or relevant to a larger population or only relevant to one

organization or entity?

(|X|) Results are generalizable to a larger population.

(|_|) Results are relevant only to one organization or entity.

3. Purpose and Anticipated Study Goal(s) and Benefits: Briefly describe the following:

The purpose of the study: The purpose of this study is to prove to society that when people are exposed to sunlight there are changes in mood, and there is also an increase in suicide rate.

The anticipated study goal(s):To prove that our hypotheses is correct. That it is true that in fact there is an increase in suicide rate when people are exposed to sunlight.

The benefits of the study to the subjects, to the organization, and to society: Once the study is completed and this is proven then something can be done in order to reduce the suicide rate in places where there is an elevated rate. It is for the benefit of society because finding out the statistics can actually help save more people’s lives.

3.1 Data Usage and Ownership: If your research involves access to, and/or use of, a pre-existing private or restricted database (one that is not open access/publically available), please briefly describe the type of data in the database, the organization or individual owner or controller of the data, how the data will be accessed and how data confidentiality will be ensured.

a) Does this research study involve access to, or use of public, open access databases or

datasets, resources, recruitment lists, contact information for potential subjects or any other pre-

existing public data? (Note that “open access” means free and available to the general public without

restriction or prior permission needed.)

(|_|) No (|X|) Yes (Please describe here)

Yes. In the process of our research, we will be needing access to various records that are indicated in the category of open access databases, whether it be through University Libraries, such as the one provided through University of Phoenix, or from open access online institutions that will allow us to obtain the valued information necessary for comparison in our study. Regarding recruitment lists and existing public data, such as contact information for subjects, these records will need to be obtained once again for a comparison. We need to know whether or not some of the subjects that are involved in past studies, or similar forms of study that fall in line with our subject matter, have had similar outcomes based on our hypothesis. We may also want to be able to recruit certain individuals who may have had personal experiences with the subject matter of this study, as well as collecting those who are considered “blind” in the study as well.

b) Does this research study involve access to, or use of private databases or datasets, private resources or

recruitment lists, contact information for potential subjects or any other pre-existing private data?

(|_|) No (|X|) Yes (Please describe here and document permission granted for access and

use)

Yes. Some private databases may have information needed in order to proceed with our final study. The primary reason for this is because much of what is collected in the private databases, usually is of pertinent value. In many cases that are studied and dictated, they end up in University libraries, as well as Academy’s that may have little to no direct access, without the proper notification. In this study material, we would seek out the information that was gathered form past experiments that closely resemble our own, and form there try to use the analysis and methods they have used, to be sure that our data will not be in too close of correlation as the past study that has already been conducted. Regarding the recruitments, and the subject list, the same thing applies as with the open access. We may hope to contact them with information from our study for comparison, as well as possible recruit those involved in past studies that resemble our own. The subject we may want to involve in our won study, may very well have undergone a similar study, and therefore we may want to compare how they would present their overall behavior during our experiment compared with that of another.

c) During data collection or subject recruitment, will access be needed to any health information created,

received or archived by health care providers, clearinghouses, or health care plans that pertains to the

past, present or future health conditions or provision of health care to an individual living or deceased?

(|X|) Yes (|_|) No

(|X|) HIPAA compliance (if health records are used, please discuss here and address HIPAA compliance)

Yes, HIPAA would be involved in this process and this is due to the extensive research of this particular subject that our experiment tis based on. The fact that the experiment is based on individual’s and the duration of direct sunlight as to how it affects mood and behavior. This means that we are mostly focusing on whether or not that the behavior of an individual could have some form of abnormal behavior, whether it be depression, or even a form of enlightenment or happiness due to the sunlight or lack thereof. Due to this we must evaluate each subject we take in, and know whether or not they have had prior medical history of depression, or if they are currently using medications that may induce stress relief, reduce anxiety, pain relief, or even if they are involved in any form of substance abuse. The access to medical records will then help us to determine whether o not the affects that we see during the experiment are caused by our dependent variables or by the subjects past and present medial background. HIPAA requires that any release of medical history must be consented and granted to a third party. such as the researchers involved in this study or to the school who heads up the study. In order to comply we will need a consent from all subjects involved to obtain medical history information.

d) Will school or student related data be collected in this study?

(|_|) Yes, individual student data (|X|) Yes, aggregate student data (|_|) No

(|X|) FERPA compliance (if student data is used, please explain here and address FERPA compliance)

This study is not based only students alone, and although students will be involved this does not dictate that there will only be students used during the experiment. According to the FERPA guideline’s and regulations, a student of the age 18 or older, may give an informed consent releasing his school records, as well as allowing the student to receive all information gathered form our study if it is pertaining to their education as well.

4. Project Description: Briefly explain and address the following questions as indicated:

a) Who are the subjects of this study and where are they located? (for example, lawyers in private practice in the State of Ohio)

The Subjects in this study are people who are susceptible to depression, pessimistic, and unable to enjoy the things that usually give them pleasure during summer season. Also along with this cluster of symptoms, but not limited to decreased energy, especially in the afternoon hours; difficulty concentrating and accomplishing tasks; withdrawal from friends, family, and social activities. When winter comes, this depressive mood decreases and these symptoms generally resolve. Also, there will be subjects in this study who does not suffer any depression.

b) What are the subjects expected to do as participants in this study and what is the time commitment involved? Please explain. If class time is used, please describe the activities planned for non-participants.

We will be studying, evaluating, and collecting archive and current data from the internet, library and case studies, that when people are exposed to sunlight there are changes in mood, and there is also an increase in suicide rate. Before the initial experiment the volunteer participants will be asked to note their compliance in their trial-diaries. There will be a light treated group on both self-assessment and observer rating scales in patients with a high prevalence of melancholic depression. The subject’s measures are performed: just before the start of light therapy, after completion of three weeks therapy period, and three weeks thereafter. Baseline characteristics across the treatment groups are compared using analysis of variance and statistics. Details about the social support is measured using Social Support Questionnaire, it focuses on: (social support discrepancies, negative interactions, emotional support, informative support, instrumental support, social companionship and esteem support. Eating and drinking any mood altering food, including (coffee, tea, chocolate), and smoking will not be permitted.

c) Will a pilot study be conducted before the primary data collection occurs? (|X|) No (|_|) Yes

d) What is the research method and design? Check all that apply:

(|_|) quantitative analysis (|_|) qualitative analysis (|_|) mixed methods

(|_|) phenomenological (|_|) case study (|_|) experimental (|_|) quasi experimental (|_|) Delphi

(|X|) other (specify) ___________Inferential Study________________________________

e) How will data be collected? Check any that apply:

(|_|) face to face interview (|_|) focus group (|_|) online survey (|_|) mail survey (|_|) telephone survey

(|_|) onsite survey (|_|) email survey (|_|) Skype or related technology

(|X|) other (specify) __________On line data from articles and UOP Library__________________

f) Where will data collection occur? Check any that apply and specify the location(s) below.

(|_|) organizational site (|X|) online (|_|) private premises (|_|) public facility (|_|) open access site

(|_|) other (|_|) not applicable

Location __________________________________________

g) What is the degree or magnitude of risk/stress (physical, psychological, emotional, legal, financial) to the

human subjects because of their participation in this study?

(|X|) minimal risk/stress, not greater than encountered in ordinary daily life/activities or routine tests.

(|_|) greater than minimal risk/stress with potential for direct benefit to the individual subjects

(|_|) greater than minimal risk/stress with little/no potential direct benefit to individual subjects

h) If greater than minimal risk/stress to the human subject is possible, please explain how the risk/stress will be mitigated or lessened.

i) Are any third parties assisting with this study that will have access to the data?

(|X|) No (|_|) Yes (specify) ______________________________________

j) Will any aspect of the study take place outside of the United States?

(|X|) No (|_|) Yes (specify where) _______________________________________

Note that IRB approval may be needed in the country where research is taking place.

PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION

OR EXPLANATION THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING YOUR RESEARCH STUDY

DESIGN OR IMPLEMENTATION.

5. Subject Groups: Will the subjects recruited to participate in this study include any that are in protected groups identified below as specified within the federal human subject guidelines? (The guidelines are defined at www.citiprogram.org)

If any category from this list is checked “yes”, please explain in the “Comments” area below how the subjects will be protected from harm, risk, or stress as a study participant and how stress/risk will be mitigated or lessened.

a. Children/minors under age 18?

Yes (|_|)

No (X)

b. Prisoners?

Yes (|_|)

No (X)

c. Pregnant women?

Yes (|_|)

No (X)

d. Cognitively impaired or mentally

disabled?

Yes (|_|)

No (X)

e. Educationally or economically

disadvantaged?

Yes (|_|)

No (X)

Will the subjects be traumatized, comatose, or terminally ill patients?

Yes (|_|)

No (X)

Will the subjects be elderly or aged persons?

Yes (|_|)

No (X)

Will the subjects be minorities (including women)?

Yes (X)

No (|_|)

Will information be withheld from subjects prior to, or during, participation?

Yes (X)

No (|_|)

Will the subjects be college students?

Yes (|_|)

No (X)

Will the subjects be deceived, misled, or coerced in any way?

Yes (|_|)

No (X)

Will/might the subjects be students of the University of Phoenix?

Yes (X)

No (|_|)

Will/might the subjects be faculty or staff of the University of Phoenix?

Yes (X)

No (|_|)

Will information be requested that is, or may be, personal or sensitive?

Yes (|_|)

No (X)

If the subjects are active duty military, will their supervisors have influence on their participation in this research or will participation be affected at all by the reporting relationship(s)?

Yes (X)

No (|_|)

Will any aspect of this study involve subjects from countries outside of the U.S.? If yes, please specify in the comments section below.

Yes (|_|)

No (X)

Comments:

We will have minorities including women because we want to see the effects on mood on all aspects. Being a woman or in the minority is not something that will affect the research.

We will be holding all information for experimental purpose. We will be looking at all data throughout the experiment. If something would to happen or things get out of hand, we will realest any information to the authorities.

We would want any participants to be involved with this research and being part of University of Phoenix should not interfere with this. It could help us more because we will have a better communication with them.

We would not want a person serving in the military to be involve. The reason for that is because we are researching the effects that the sun has in the person’s mood. The person could be affected and may have problems with their responsibilities in the military.

6. Subject Recruitment and Selection: Briefly explain and address the following:

a) Which of the following will be used to find and recruit subjects? (check all that apply and include copies with

this application)

(|_|) Flyers (|_|) Email Announcement

(|_|) Events, Meetings, Conferences (|_|) Area Canvassing

(|_|) Phone Solicitation (|_|) Registry

(|_|) Newspaper/Radio/Television (|_|) Referrals from Others

(|_|) Institutional “gatekeepers” (|_|) Direct Mail

(|_|) Face to Face Interaction (X) Internet/Websites

(|_|) Bulletin Board Post (|_|) Social Media (e.g. LinkedIn, Facebook, etc.) (please specify

(|_|) Poster below; documented use permission is required)

(|_|) PhoenixConnect (please note if this is used,

separate prior approval through the UOPX

Committee on Research must be documented)

(|_|) Other (please specify)____________________________________________

EXPLAIN AND DESCRIBE HERE IF SOCIAL MEDIA WILL BE USED ____________________________________

b) What is the anticipated sample size?

(X) 10 or less (|_|) 11-20 (|_|) 21-50 (|_|) 51-99 (|_|) 100-199 (|_|) 200 or more

c) Will any external parties (such as editors, translators, interpreters, statisticians, etc.) provide assistance for

recruitment purposes? (This does not pertain to persons who assist recruitment by “snowball sampling”.)

((X) No (|_|) Yes (please identify and explain how they will assist) _____________________________

d) Are any of the research subjects students, employees, or patients of the researcher?

(|_|) Yes (X) No

e) If any potential subjects under the age of 18 years are not selected to participate in this study, what activities

will they be doing during the time the subjects are participating in the study so that they do not feel excluded

or left out? If this scenario does not pertain to the study, please indicate “Not applicable” here.

“Not applicable”

f) Please briefly describe the criteria that will be used to determine the inclusion or exclusion of subjects for

this study.

College students who do not have any depression issues currently.

g) Will any compensation or remuneration be given to subjects for their participation in this study?

(X) No (|_|) Yes (please identify amount and type, and the plan for dissemination.

PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR EXPLANATION CONCERNING THE ABOVE QUESTIONS THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING THE RECRUITMENT OF SUBJECTS FOR YOUR RESEARCH STUDY.

7. Informed Consent: Briefly explain and address the following questions.

a) How will subjects be informed of the study’s purpose, procedures, intent, duration of the study and any

potential risks or discomforts to them? Check all that apply:

(|X|) Informed Consent form (|_|) Email (|_|) Letter (|_|) Meeting (|_|) Phone Call (|_|) Other _______

b) How will subjects be informed of withdrawal procedures? Check all that apply:

(|X|) Informed Consent form (|_|) Email (|_|) Letter (|_|) Meeting (|_|) Phone Call (|_|) Other _______

c) How will the researcher contact information be provided to the subjects? Check all that apply:

(|X|) Informed Consent form (|X|) Email (|_|) Letter (|_|) Meeting (|_|) Phone Call (|_|) Other _______

d) How will subjects withdraw from the study as participants after data collection is completed?

(|X|) Email the researcher (|_|) Phone call to researcher (|_|) Submit withdrawal form

(|_|) Other (please specify) ___________________________________________________________

e) Please explain what subjects must do to withdraw from the study after data is collected and how subject data

will be retrieved and handled to ensure security and confidentiality.

The subject will be required to complete and submit the withdrawal form stating their withdrawal is due to the completion of the study. The participants will be required to provide contact information including name, telephone number, mailing address and email for debriefing and follow-up. Any form of contact or information exchanged between researcher and participants will be considered confidential and secured accordingly by the researcher.

f) If any subjects are under the age of 18 years, parental consent is required. What provision is made to

answer any questions the parents have about this study or to address any individual concerns? (For example,

will there be an informational meeting with the parents, etc.?) If this scenario does not apply to this study,

please indicate “Not applicable” here.

“Not applicable”

PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION

OR EXPLANATION THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING ANY OF THE ABOVE

QUESTIONS OR ABOUT THE INFORMED CONSENT FOR YOUR RESEARCH STUDY.

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOXES BELOW:

|X| I attest that no primary data collection from human subjects will occur without a prior signed Informed

Consent form completed for each subject and that Informed Consent documentation will be retained

separately from study data.

|X| I attest that a process for subject withdrawal will be implemented whereby subjects may withdraw without

penalty before, during and after data collection has been completed and submitted and that the

information they provided will be identified, secured, withdrawn and kept confidential.

8. Confidentiality and Privacy: Briefly explain and address how the identity and privacy of the individual subjects will be protected. Check any of the following that apply:

a) How will subject identity and data be protected?

(|_|) Subject names will not be used or identified

(|_|) Pseudonyms or numbers will be used instead of subject names

(|_|) Data will be coded alphanumerically

(X) Other (please specify) We will be using subject A,B,C and so on, instead of names.

b) Will any audio and/or video tape or other recording of data be done in this study?

(X) Yes (|_|) No

c) How long will the study data be kept after study completion?

(|_|) Three years (please note this is the minimum required retention time)

(X) More than three years

d) Where will the data be stored:

(|_|) In an office or other location at the researcher’s residence

(X) At an office at the researcher’s place of employment

(|_|) At a third party facility (please specify) ________________________________

(|_|) Other (please specify) ______________________________________________

e) How will data be destroyed at the appropriate time?

(X) Shredding (|_|) Burning or incineration (|_|) Smashing (|_|) File Deletion

(X) Other (please specify) If any information is in a computer is will be deleted to its completion.

f) How will the results of this study be disseminated?

(|_|) Publication (X) Presentation (|_|) Other _____________________________

PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR EXPLANATION CONCERNING THE ABOVE THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING CONFIDENTIALITY AND PRIVACY CONCERNS ASSOCIATED WITH YOUR RESEARCH STUDY.

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOX BELOW:

|X| I attest that the data from this research will be kept in a secured location for at least three years following

study completion, and then will be permanently destroyed.

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