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Irb Application

In: Philosophy and Psychology

Submitted By Rudy675
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Internal Review Board

For The Protection
Of Human Subjects In Research

North Carolina Central University
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
Request for Review of Research Involving Human Subjects
COVER SHEET

| | (For Staff Use Only) | |
|1. School/Department/Unit:NCCU/Psychology |REQUEST #____________ |Today's Date February 3, 2005 |

2. Name of Principal Investigator (PI) ______________________________________________ Name of Faculty Advisor (FA), if PI is a student__Dr. Les Brinson _________________________________

Telephone Number (PI): 919*530*4526_ Mailing Address (PI): PO Box 19408 Durham, NC 27707 Telephone Number (FA):919*530*5166 Mailing Address(FA): Taylor Ed. Rm 217A Durham, NC 27707

3. PROJECT TITLE:
____________Organizational Communication and Its Relationship With Job Performance and Job Satisfaction _________

4. PROJECT TYPE: __N__ (Select one: N = New; AR = Annual Renewal; PC = Protocol Change) This is a : _SP__ (Select one: SP = SPECIFIC PROJECT or GP = GRANT PROJECT PROPOSAL)

If Grant Project Proposal, list agency and address to which project is being submitted:
__________________________________________________________________________________________
____________________________________________________________________
5. This project relates to previous Request # ____________________, approved on

6. PI/FA Recommendation (If the PI is a student, the FA must also sign this sheet):

[ ] Exempt from further IRB Review, see Exempt Paragraph # ___________
[ ] Full Review Signature (PI) _____________________________________ Date: ________________

(FA) ____________________________________ Date: ________________

7. IRB Chair Recommendation [ ] Exempt from further IRB Review, see Exempt Paragraph # _________ [ ] Full Review
8. Final Disposition: [ ] Exempted [ ] Approved [ ] With Conditions [ ] Not Approved [ ] See Attachment [ ] Conditions Met ____________ (Chair's Initials)

Signature ___________________________________ __________________________ Chair, IRB Date

NOTE: Project will expire on ___________________. If Exempted, no further review is needed unless the protocol changes. If approved as grant Proposal, PI must resubmit as Specific Project.

NORTH CAROLINA CENTRAL UNIVERSITY
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH Protocol ____________________________ Investigator_Hope Sinclair________ Date_February 3, 2005_____
RESEARCH PROTOCOL CHECKLIST [ One (1) copy to be filled out by investigator; ALL items* must be submitted unless not applicable to your project.] YES N/A [X ] [ ] *1. Summary sheet - one page, in lay terms

[X ] [ ] *2. Informed Consent (For detailed description see IRB Handbook)

[X] [ ] a. Statement that study involves research/clinical investigation

[X] [ ] b. Purpose of research

[X] [ ] c. Duration of subjects' participation

[X] [ ] d. Procedures to be followed

[ ] [X] e. Risks [both foreseeable & unforeseeable]

[X] [ ] f. Anticipated benefits, or lack thereof

[ ] [X] g. Alternative procedures or treatment

[ ] [X] h. Additional cost(s) to subject

[ ] [X] i. Statement of compensation for injury

[X] [ ] j. Statement that participation is voluntary and subject may withdraw without penalty [ ] [X] k. Financial interest statement, if applicable

[X] [ ] l. Statement of whom to contact for questions

[X] [ ] m. Confidentiality of records

[ ] [X] n. Statement regarding pregnancy, if applicable

[ ] [X] 3. Investigational drug data, if pertinent

[X] [ ] *4. Research Protocol [include amendments and sample consent]

[ ] [X] 5. Letters of support, if required

[X] [ ] *6. Six complete packet submitted to IRB Office (160 Alex-Dunn) four weeks before IRB meeting for preliminary review and revision

[ ] [X] 7. Financial Conflict of Interest

[X] [ ] *8. CV - one copy of Primary Investigator(s) for IRB file

[X] [ ] *9. Cover Sheet

[X] [ ] *10. Thesis Plan (Chapters 1 & 2) INSTITUTIONAL REVIEW BOARD NCCU FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH North Carolina Central University NCCU
RESEARCH PROTOCOL
To Principal Investigator: The Institutional Review Board for the Protection of Human Subjects will need 6 copies of this form for distribution to members of the Board. Please include one copy of the complete proposal. The complete proposal includes the research protocol and such items as consent forms, questionnairs, and other documents necessary to conducting the research. Please submit by the 1st working day of the month in which the review results are needed.
The proposal will be retained in the Office of Sponsored Research, 160 Alexander-Dunn, extension 7333. The primary reviewer for this protocol will contact the primary investigator if additional data is needed.
ALL INVESTIGATORS MUST SIGN THE INVESTIGATORS’ ASSURANCE AT THE BOTTOM OF THIS FORM.
All responses must be on this format.
Date: February 3, 2005 1. Tentative research title:
Organizational Communication and Its Relationship With Job Performance and Job Satisfaction

2. List the name and Faculty / Student / Staff status of the person(s) conducting the research. a. Principal Investigator: Hope Sinclair b. Department: Psychology c. Other Key Project Personnel: Dr. Les Brinson, chair of thesis committe

3. Proposed time span of research: From: March, 2005 To: April, 2005 Month/Year Month/Year

(Note: If this project receives external funding, the IRB must be informed of the changes to the funding period.) Funding (If funding is to be requested, indicate the funding agency to which the proposal will be sent, the amount of the request, and the due date of the application): N/A a. Agency: b. Amount to be requested: c. Due date for application:

In a paragraph or two, summarize the objective(s) of the research, including what you hope to learn or demonstrate:

A focal point of the current research is to determine the relationship between academic-faculty and academic-staff__ members’ satisfaction of organizational communication dimensions and their overall job satisfaction and job performance. It is hoped to learn that the usage of the Communication Survey Questionnaire (Downs & Hazen, 1977) is as useful in an academic setting as it is in the business arena. A demonstration of the different communication levels amongst academic-faculty departments and academic-staff departments is hoped to justify job satisfaction and job performance within each department. _______________________________________________________________

6. What is the research design and how will results be analyzed?

A comparison of each department will be measured; for example, the academic-faculty will be compared with the academic-staff, the security compared to the BBRI, and the Science compared with the Business, and so forth and so on. Reliability will be assessed across each department and each person within each department. The relationship between organizational communication, job productivity, and job performance, will be evaluated within and between each group as well.__________________________________________________________________ An ANOVA will be used, as was in abovementioned research, for the purpose of detecting employee’s perceptions of the impact of the CSQ, which tests H1. A 2x3 ANOVA will be used to compare the differences amongst and within academic-faculty and academic-staff, which tests H2. A chi-square will be used to measure the three main dimensions, in reference to the current study, of the CSQ to detect job productivity within and between each department.______________________________________________________________________________

7. Who will be your research participants and how will they be recruited?

Research participants will include academic-faculty and academic-staff members of North Carolina Central University. Three academic-faculty departments and three academic-staff departments will be recruited to participate in the given study. The English, sciences, business, security, athletics, and human resource departments will be selected to complete the CSQ due to the size of each department. These departments total to about 260 faculty and staff members. Out of the 241 participants, at least 150 surveys are expected to be returned for an acceptable response level. 150 surveys allow the researcher a large enough sample to have normal distribution amongst the two groups. _______________________

8. Describe the means through which persons will be informed of the right to participate, not to participate or withdraw at any time. Where students are used as participants, indicate alternatives available to the student in lieu of participation. (A copy of the Informed Consent Form must be included.)

Subjects’ participation in this study is voluntary. You may refuse to participate, or may discontinue your participation at any time without penalty or loss of benefits which you would be otherwise entitled. Please see attached consent form also.

9. Describe the ways in which persons will participate:

Each person will be asked to sign a consent form which will enlighten them of the basis of the research. The consent forms will ask each participant to take 30 – forty-five minutes to complete the survey, as well, it will be expressed that completing the survey is done on an anonymous and volunteer basis and there are no consequences for not turning the survey in. The CSQ will be delivered to each faculty and staff member, along with two drop-boxes in each department. One drop-box will be labeled: ‘CSQ Hope Sinclair’ and each participant will be asked to return his or her completed CSQ in the drop-box, in their departmental office by the end of the third workday. The second drop-box, also located in each departmental office, will be labeled: ‘Consent form Hope Sinclair’ and each participant will be asked to return his or her completed consent form at the same time they turn in the CSQ. The researcher will pick up the drop-boxes from each department at 5:00 p.m. on following week, allowing participants a total of seven days to complete the survey. Participants will also be advised that they will receive an e-mail inviting them to see the researcher present the findings of the study. To facilitate the response rate, on the beginning of the fourth and day, a general email will be sent to public relations, and they will be asked to email the aforementioned departments in regards to completing the survey and turning it in.

What sequence of activities will be followed to conduct the research (e. g., administering a survey or personality inventory)?

E-mail sent to the prospective departments informing them of their possible participation in the study.
Deliver the surveys and consent forms to each faculty and staff member and drop-boxes to each departmental office.
Send an email on the 4th day reminding each participant to turn in their surveys and consent forms in the drop-box.
Collect surveys on the third day
Begin data analysis

10. Attendant risks* (Indicate any physical, psychological, social, or privacy risks which participants may incur):

There are no foreseeable or unforeseeable risks and discomforts involved in this study. There is no likelihood of any serious problem. Your participation is voluntary, and you may refuse to participate or stop your participation at any time for any reason without penalty. Subjects will be instructed NOT to put their name on the questionnaires such that anonymity can be protected (that is, the information will be collected in a manner in which a subject’s individual responses cannot be linked to that subject.)

11. Describe how the procedures reflect respect for privacy, feelings, and dignity of subjects, avoid unwarranted invasion of privacy, and minimize risks as much as possible:

In order to ensure anonymity, participants will be instructed NOT to put identifying information on the CSQ. All data collected will be coded and not have the participant’s name on it. Upon completion of the CSQ participants will place the material in a drop-box; the investigator will provide each department with. This allows participants to turn in the survey anytime between the three days and ensures that the investigator will not be able to identify the individual responses of a given participant. To ensure confidentiality, the signed consent forms will be stored in a locked file in Dr. Les Brinson’s office. No subject will be identified in any report or publication of the study or its results.

12. Describe the procedures to assure confidentiality in the use, storage, and disposal of the primary data. (Copies of participants' signed consent forms for funded projects are to be delivered to the Office of Sponsored Research, 160 Alexander Dunn, for permanent storage.)

To ensure confidentiality, the signed consent forms will be stored in a locked file in Dr. Les Brinson’s office. No subject will be identified in any report or publication of the study or its results.

Would you like to receive editorial comments from the members of the IRB? No Yes [X]

*DHHS regulations define participants ("subject at risk") as "any individual who may be exposed to the possibility of injury including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service."

INVESTIGATOR'S ASSURANCE
I have read the Standards for Research with Human Participants, adapted by permission of the American Psychological Association, plus other principles that may be adopted by my Department/School/Unit, concerning the use of human subjects in research, and agree to abide by them. I also agree to report any significant and relevant changes in the procedures or instruments to the IRB for additional review.

Principal Investigator _______________________ Signature __________________________________Date ___________ (Print Name)

**Advisor Approval ________________________ Signature _________________________________ Date____________ (Print Name) P.O. Box _________________________________ Extension_________
**Advisor Approval is required when the Principal Investigator is a student.

Confidential
CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Title of Study: Organizational Communication and Its Relationship with Job Performance and Job Satisfaction

Principal Investigator: Hope Sinclair Department of Psychology North Carolina Central University(NCCU) P.O. Box 19408 Durham, North Carolina 27707 Telephone: (919) 530-4526

You are being asked to take part in a research study under the direction Hope Sinclair. Approximately 260 subjects will be asked to participate in this research.

Purpose: The purpose of this research is to examine the relationship between organizational communication, job performance, and job satisfaction.

Duration and Location: Participation in this study will occur over a one week period in March, 2005, at North Carolina Central University. Participation will last for approximately thirty to forty-five (30-45) minutes.

Procedure: In this study you will be asked to complete a questionnaire regarding organizational communication, entitled Communication Survey Questionnaire (CSQ) which measures levels of communication satisfaction.

During the course of study the following will occur: The CSQ will be administered by the investigator to your office and it will be explained to you to leave the questionnaire in the drop-box, labeled CSQ Hope Sinclair, and to leave the consent form in the drop box labeled, Consent forms Hope Sinclair, which is located in the departmental office. It will also be explained that you have one week, or seven days, to complete the survey which only takes between 30 – 45 minutes, and an e-mail will be sent on the second day reminding you of the pick-up date for the surveys.

Inclusion and Exclusion Criteria: Participants for this study are being recruited from the English, science, business, security, athletics, and BBRI, faculty and staff departments at North Carolina Central University

You should not participate in this study if you are under the age of 18.

Risks and Discomforts: There are no foreseeable or unforeseeable risks and discomforts involved in this study.

There is no likelihood of any serious problem. Your participation is voluntary, and you may refuse to participate or stop your participation at any time for any reason without penalty.

Subjects will be instructed NOT to put their name on the questionnaires such that anonymity can be protected (that is, the information will be collected in a manner in which a subject’s individual responses cannot be linked to that subject.)

Right to Refuse or Withdraw from the Study: Subjects’ participation in this study is voluntary. You may refuse to participate, or may discontinue your participation at any time without penalty or loss of benefits which you would be otherwise entitled.

Use of Research Results: The data obtained in this study will assist current investigators in understanding organizational communication and its relationship with job performance and job satisfaction, in academic-faculty and academic-staff. Such an understanding will be helpful as future investigators conduct research on organizational communication in an academic setting. Data may be used in publications.

Benefits and Payment: Study participants will be contributing to society’s understanding of organizational communication and its relationship with job performance and job satisfaction in an academic setting. Participants will also receive information regarding an invitation to see the investigator present the results. This study does NOT provide funding to participants for completing the survey.

Confidentiality and Anonymity: In order to ensure anonymity, participants will be instructed NOT to put identifying information on the CSQ. All data collected will be coded and not have the participant’s name on it. Upon completion of the CSQ participants will place the material in a drop-box; the investigator will provide each department with. This allows participants to turn in the survey anytime between the three days and ensures that the investigator will not be able to identify the individual responses of a given participant. To ensure confidentiality, the signed consent forms will be stored in a locked file in Dr. Les Brinson’s office. No subject will be identified in any report or publication of the study or its results.

Institutional Review Board Approval: This research study has been approved by the North Carolina Central University Institutional Review Board (IRB) for the Protection of Human Subjects in Research. If you believe that there is an infringement upon your rights as a participant in this research you may contact the IRB Interim Chair, Dr. Franklin B. Carver, Room 306 Hoey Administration Building, NCCU, Telephone (919) 530-7371.

Subject’s Agreement: I have read the information provided above and voluntarily agree to participate in this research study. If I have any questions or concerns that arise in connection with my participation in this study, I should contact Hope Sinclair (919) 530-4526 or Dr. Les Brinson at (919) 530-5166. I may also contact Dr. Franklin B. Carver, Interim Chair of the Institutional Review Board for the Protection of Human Subjects in Research at Room 306 Hoey Administration Building, NCCU, Telephone (919) 530-7371. I understand that I will be given a copy of this consent form.

____________________________________
Name of Research Participant (Print)

____________________________________ _____________
Signature of Research Participant Date

THE INFORMED CONSENT CHECKLIST AND EXAMPLES OF INFORMED
CONSENT FORMATS

The Consent Form Checklist which follows contains a summary of the points to be addressed for obtaining consent. Unless the research meets the criteria whereby informed consent waivers should be considered, the points labeled B(n) in the first column are BASIC elements and must be addressed. Make copies of the following checklist for use in determining if the informed consent addresses all the required issues.

Exceptions to any of the informed consent requirements are allowed only if: 1. There is no more than minimal risk to the subject. 2. The waiver or alternation will not adversely affect the rights and welfare of the subjects. 3. The research could not be practically carried out without the waiver or alternation. 4. Whenever appropriate, the subjects will be provided additional information after they have participated (see Exceptions, 3-16 of the OPRR Guidebook).

Study Name_Organizational Communication and Its Relationship on Job Performance and Job Satisfaction
Date: February 3, 2005
Project Director Name: Hope Sinclair
CONSENT FORM CHECKLIST
The Process of obtaining informed consent must comply with requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. The following checklist summarizes the points that must be addressed for obtaining consent and its approval by IRBs.

|___.116 |ITEM |COMMENTS |
|Element* | | |

|GENERAL |
|.117(c)(1) |Consent Form documents the basis for consent and is the subject''s reference. | |
| |Requires signature except for waivers or confidentiality and minimal risk research. | |
| |Readability - the form must be understandable to people being asked to | |
| |participate-avoid scientific jargon and "legalese." | |
| |Format - avoid use of first person except for the statement of consent. | |
| |Exclude any language that makes or appears to make the subject waive any legal | |
| |rights. | |
|PURPOSE / DESCRIPTION |
|B1 |State clearly if it is a research study. | |
|B1 |Describe procedures to be followed and which are experimental. | |
|B1 |Prominent discussion of purpose of study. | |
| |Why the subject qualifies for study. | |
|B1 |Duration of subject involvement. | |
| |What treatment is different for the patient if a participant in the study. | |
|A6 |Approximate number of subject's in study. | |
|RISKS AND BENEFITS |
|B2 |Description of risks or discomforts to subject. | |
|B3 |Description of possible benefits to subject or future subject. | |
|B6 |Description of voluntary compensation and treatment if the subject is injured related| |
| |to the research. Applicable for research posing greater than minimal risks. | |
| |
|ALTERNATIVE TREATMENT |
|B4 |Alternative Treatment - What alternative is available if subject elects not to | |
| |Participate | |
|___.116 |ITEM |COMMENTS |
|Element* | | |
|CONDITION OF SUBJECT |
|B6 |For research involving more than minimal risk: availability of medical treatment or | |
| |compensation of injuries occur, what services are available and who pays. | |
|B7 |Contacts (at least two) for questions concerning research subject's rights, research | |
| |project and research-related injury. (Provide local or 800 numbers.) | |
|B8 |State clearly that participation is voluntary and refusal to participate or | |
| |discontinuation results in no loss of benefits to which subject is otherwise | |
| |entitled. | |
|B8 |For studies of prison population: state that the study participation will not effect | |
| |their treatment or consideration for parole. | |
|A2 |Why subject's participation may be terminated by principal investigator. | |
|A4 |Consequences of subject's decision to withdraw from research and procedures, if | |
| |applicable. | |
|A5 |Notification of significant finding(s) that may determine subject's willingness to | |
| |Continue | |
|CONFIDENTIALITY |
|B5 |Describe the extent subject's personally identifiable private data will be held in | |
| |confidence. | |
| |Does study have (or need) Certificate of Confidentiality. | |
| |Will subject be recontacted? Is there potential for use of data in other legitimate | |
| |research? | |
| |If applicable, state that reports of "imminent harm" to the subject will be reported | |
| |to authorities. | |
|FINANCIAL CONSIDERATION |
|B6 |Compensation to subject must not be coercive in amount or method of distribution. | |
|A3 |Disclose any potential costs to subject. | |

*BX references the Basic element of ___.116(a). These elements are required for informed consent. Ax references the Additional element number of ___.116(b). This information must be provided for appropriate studies. FDA indicates an additional requirements for clinical investigations.
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