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Complete and upload your draft IRB forms

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Complete and upload your draft IRB forms. You will find directions on how to complete the forms; an example of a completed IRB form; and a blank IRB form to be used for this assignment in the General Resources for Research Proposal Assignment folder.   

 

FSU-HRRC

Application for the Use of Human Subjects in Research

 

I.   Instructions:

· All materials must be typed;

· A signed original is required;

· Do not staple any part of the application;

· All submitted material must be single sided;

· All questions/statements listed in blue on the application must be answered;

  • If a survey or other instrument is being used, a copy of the actual survey or instrument must be supplied with the application;
  • All researchers, faculty, staff, administration and students who conduct research for or at FSU must complete trainings in: 1) Social and Behavioral Research; and 2) Ethics for Researchers;
  • If references are used, complete citations are required at the end of each section in which the reference appears;
  • Sample forms are included at the end of this application, include in your submission only those that will be used in the study;
  • Omission of any required document(s) will yield an incomplete application and prolong your review process;

· Responses are generally rendered within 14 business day to the Principal Investigator; and

· Questions can be directed to the HRRC Chair prior to the submission of your application.

Text Box: I.   Instructions:
•	All materials must be typed;
•	A signed original is required;
•	Do not staple any part of the application;
•	All submitted material must be single sided;
•	All questions/statements listed in blue on the application must be answered;
•	If a survey or other instrument is being used, a copy of the actual survey or instrument must be supplied with the application;
•	All researchers, faculty, staff, administration and students who conduct research for or at FSU must complete trainings in: 1) Social and Behavioral Research; and 2) Ethics for Researchers;
•	If references are used, complete citations are required at the end of each section in which the reference appears;
•	Sample forms are included at the end of this application, include in your submission only those that will be used in the study;
•	Omission of any required document(s) will yield an incomplete application and prolong your review process;
•	Responses are generally rendered within 14 business day to the Principal Investigator; and
•	Questions can be directed to the HRRC Chair prior to the submission of your application.

 

 

Checklist for application submission:

  • IRB Application with applicable signatures
  • Certificates of All Required CITI Trainings (from PI, all CoI’s and Keys Study Personnel)

 

 

Applicable consent form

ent form (if applicable)

materials (phone script, fliers, ads, etc)

estionnaire(s), focus group or interview questions (if appl

¨
  • Child ass
  • Recruiting
 

Select all that apply to your proposal

 

  • Survey/qu                                                                                                              icable)
  • Conflict of interest/financial interest disclosure (if applicable)
  • Letter(s) of support or agreement (if conducting research at another agency, school, etc)
  • When appropriate, include IRB approved protocol from other involved institution or organizations

Applications should be delivered to:

The Office of Sponsored Research and Programs

Attn: Carla Raineri Padilla, School of Business and Economics, Room 314

 

(HIPAA), where applicable.

subjects research including

This study will be reviewed in accordance with federal regulations governing human

 

those found at 45 CFR 46 (Common Rule), 45 CFR 164

 

Principal Investigator (PI):  State your name here

 

Select this. To select, double click the

box and select check in the pop up!

 

 

PI Status: (check one):        FSU Faculty      FSU Staff      FSU Undergraduate Student       FSU Graduate Student        Visiting Scholar      Non FSU Affiliation (Specify Institution): (Complete appropriate section below)

 

Office Location or Mailing Address: (This is the address to where all IRB correspondence will be sent.) Use NERC 200, FSU

 

Department: Psychology

 

 

Project Title: State the title of your proposal here

 

Phone Number: (       )   use 910.672.1413                                           University Email: State your e?mail here

 

Co?Investigator #1:                                                                                 Department: state Psychology

 

Co Investigator #2:                                                                                 Department:

 

Key Study Personnel: Key personnel are defined as individuals who participate in the design, conduct, or reporting of human subjects’ involvement in the research. At a minimum, these individuals may be involved in conducting procedures and obtainment of legally effective informed consent/assent.  All key personnel must have sufficient knowledge about the protocol to facilitate effective interaction with the subject as well as complete the Human Subjects Training.

Names (or TBD*)                                                             Position                                  Department

 

 

 

 

 

Is internal or external funding being sought for this research?      Yes           No Funding Source(s):

 

 

Select this

 

 

If yes, you must (1)

 

submit a complete copy of that proposal as soon as it is available and (2) provide one copy of the funding announcement and all relevant forms, instructions, etc., with your original copy of this application. Does the funding agency require notification of Institutional Review Board approval?                                                              Yes          No

 

 

 

o

Project period dates     August 2015                                                to                                      December 2015                                          This is required information, must be future dates ? after you have received final IRB approval to conduct your research.

 

 

Other Institutional Review Boards       Does the research involve another institution or site?                                                                Yes                                                                 N

Select

 

Select this

 

?      If yes, please list all institutions and sites:

?      Has any other IRB approved this project?                                                                                 Yes            No If Yes, please provide a copy of the approval letter with this application. If No, will any other IRB be asked for approval?                                                                                 Yes (please specify which IRB)                                                   No

 

Certificates of Training  All Principal Investigators, Faculty Advisors, Co?Investigators, Research Assistants, Graduate Assistants, personnel and volunteers associated with the study must complete the training. NOTE: Only valid certificates from the Collaborative Institutional Training Initiative (CITI) will be accepted.

 

 

 

State your name here

 

State the date here

 

Principal Investigator’s Signature                                                                                                                                          Date

The activity described herein is in conformity with the standards set by our department and I assure that the Principal Investigator has met all departmental requirements for review and approval of this research.

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                    

Department Chair’s or Dean’s Signature                                                                                                                                          Date

 

 

 

II. COMPLETE THIS SECTION IF THE PRINCIPAL INVESTIGATOR IS A GRADUATE STUDENT (NOTE: Graduate Faculty Status is required for all Thesis/Dissertation Chair or Advisors.)

Text Box: II. COMPLETE THIS SECTION IF THE PRINCIPAL INVESTIGATOR IS A GRADUATE STUDENT (NOTE: Graduate Faculty Status is required for all Thesis/Dissertation Chair or Advisors.)

 

 

Check one:           Thesis               Dissertation            Other                              

 

Has the Thesis/Dissertation Committee approved the proposal?   q Yes   Date Approved:                                                                                                                                        /       /      No

 

Name of Thesis/Dissertation Advisor:                                                                                                                                    

 

 

 

Advisor’s Department:

Advisor’s Phone No.:          

III. COMPLETE THIS SECTION IF THE PRINCIPAL INVESTIGATOR IS AN UNDERGRADUATE STUDENT

Check one:

Class Project/Paper

Honors Project

Independent Study

Other

Name of Research Supervisor/Class Instructor:

Complete

this

Department:                                                                                                 

Phone No.:

section

Course Name (if applicable):

 

 

 

IV. INVESTIGATOR ASSURANCES AND AFFIRMATION OF COMPLIANCE:

Text Box: IV. INVESTIGATOR ASSURANCES AND AFFIRMATION OF COMPLIANCE:

 

 

I agree to follow the procedures outlined in the summary description and any attachments to ensure that the rights and welfare of human participants in my project are properly protected. I understand that the study will not commence until I have received approval of these procedures from the IRB: HRRC; I have complied with any required modifications in connection with that approval. I understand that additions to or changes in the procedures involving human participants, or any problems with the rights or welfare of the human participants must be promptly reported to the IRB. I further understand that if the project continues for more than one year from the approval date, it must be re? submitted as a renewal application.

 

*NOTE: You (the investigator/researcher) are required to notify the IRB: HRRC if any substantive changes are made in your research prospectus/protocol, if any unanticipated adverse events are experienced by subjects during your research, and when your project has ended. Important: If your project lasts longer than one year, you (the investigator/researcher) are required to notify the Office of Sponsored Research and Programs in writing of Notice of Project Ending or Request for Continuation at the end of each year. See the OSRP website for the proper form at  http://uncfsu.edu/research Failure to notify the IRB of the above may result in disciplinary action under the FSU campus student and faculty misconduct policy. You are required to keep copies of the informed consent forms and data for at least three years.

*(Required for all Investigators): I affirm the accuracy of this application, and I accept responsibility for the conduct of this research, the supervision of human participants, and maintenance of informed consent documentation as required by the IRB: HRRC.

 

 

 

 

State your name and date here

Investigator’s Signature                                  Date

Co?investigator’s Signature                                      Date

 

 

 

 

V. APPROVAL OF FACULTY ADVISOR/SPONSOR

Text Box: V. APPROVAL OF FACULTY ADVISOR/SPONSOR

 

 

 

*(Required for all faculty advisors) By signing ? you as Faculty Advisor affirm the accuracy of your students application and accept responsibility for the conduct of this research, the supervision of the researcher (student) in ethical conduct of research, and maintenance of informed consent documentation as required by the IRB

 

State my name here

 

Supervisor or Committee Chair Signature (for student investigator)                                                                                                                                                                                        Date

 

  1. DESCRIPTION OF PARTICIPANTS:

 

 

Anticipated number to enroll (if applicable):                Gender:         Males                                                                                          Female

 

Select which is applicable

 

 

Please check all that apply

 

 

Fayetteville State University employees/students

 

State number here

 

 

Prisoners – include authorization from appropriate correctional department(s)

 

 

Minors (17 years of age or younger) ? include child’s assent and parent’s consent forms Pregnant Women

 

Select which is applicable to your proposal.

 

Vulnerable populations, which include, but are not limited to persons with physical or mental disabilities, cognitive impairments (including persons in institutions)

 

Use of Protected Health Information

 

Members of the United States Military or their immediate family members (spouse or dependent children)

 

Non English speaking subjects

 

Persons otherwise dependent on the researcher (such as students of the researchers, etc.)

 

Students in a school system. Name of School/System                                                                                                                               

 

Other populations (explain)                                                                                                                              

 

Existing Data (specify source)                                                                                                                              

       Data already collected for another research study

       Data already collected for administrative purposes (e.g., Medicare data, hospital discharge data)

       Medical records (custodian may also require form, e.g., HD?974 if UNC?Health Care System)

       Electronic information from clinical database (custodian may also require form)

       Patient specimens (tissues, blood, serum, surgical discards, etc.)

       Other (specify):         

 

 

Select this

Which of the following best describes your proposed activity?

 

Program evaluation?                                                       Class projects for educational purposes only?

 

QI/QA for internal purposes?                                          Center or core grants (to establish infrastructure)?

 

Training grants?                                                 Demonstration projects?

 

Other? Explain                                                                                                                         

 

Will the research be conducted on the FSU campus?    Yes                                                                                       No.  If no, please indicate the location(s) of the study and attach an institutional consent letter that details their participation in the researcher’s study.                                                                                                  

 

 

 

 VII. IDENTIFIERS: (check all of the identifiers that will be collected and associated with your study).                                                                                                                              

 

 

    1.    
    2.    
    3.    

 

 

 

    1.    

 

    1.    
    2.    
 

Names

Telephone numbers

Any elements of dates (other than year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death. For ages over 89: all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 and older

Any geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code and their equivalent geocodes, except for the initial three digits of a zip code

Fax numbers

 

 

 

 

 

 

numbers

Electronic mail addresses

 

    1.    
    2.    
    3.    
    4.    
    5.    
    6.    
 

Social security numbers or other ID numbers (including BANNER) Medical record numbers

Health plan beneficiary numbers Account numbers Certificate/license numbers

Vehicle identifiers and serial numbers (VIN), including license plate

 

Select what is applicable to your proposal

 

    1.    
    2.    
    3.    
    4.    
    5.    
    6.    

 

 

    1.    
 

Device identifiers and serial numbers (e.g., implanted medical device) Web universal resource locators (URLs)

Internet protocol (IP) address numbers

Biometric identifiers, including finger and voice prints    Full face photographic images and any comparable images

Any other unique identifying number, code, or characteristic, other than dummy identifiers that are not derived from actual identifiers and for which the re?identification key is maintained by the health care provider and not disclosed to the researcher

NONE of the above

 

 

 

 

VIII. Please answer questions fully and succinctly. Do NOT copy chapters associated with your thesis or dissertation to the application. All information must be incorporated into the application itself.  Use as many separate sheets of paper as needed to respond to minimize delays in your review. Remove all blue statement/questions.

Text Box: VIII. Please answer questions fully and succinctly. Do NOT copy chapters associated with your thesis or dissertation to the application. All information must be incorporated into the application itself.  Use as many separate sheets of paper as needed to respond to minimize delays in your review. Remove all blue statement/questions.

 

 

      1. PURPOSE AND RATIONALE:

 

Provide a summary of the background information, state the research question(s), and explain why the study is needed. Also provide an abbreviated literature review here

 

 

 

      1. RESEARCH SUBJECTS:

Describe your potential participants, recruitment strategies, and how and where you will contact them.

 

Describe the relevant characteristics of the participants including age, ethnic background, sex, institutional

 

status (i.e., patients or prisoners). Clarify if participants will receive any inducements before or rewards after

the research study (stipends, gift cards, reimbursement for travel or parking, value of monetary token, etc.).

     

 

      1. STUDY DESIGN, METHODOLOGY AND PROCEDURES:

 

Provide an abbreviated description of the proposed design (including hypotheses and/or research questions); study procedures; description of what subjects will be asked to do; assignment of subjects to various conditions of the study if applicable. Include information on who will collect the data, who will conduct procedures or measurements.  Indicate the number and duration of contacts with each subject and location; outcome measurements; and follow?up procedures.

 

 

      1. DATA ANALYSIS:

Provide an overview of how the data to be collected will be analyzed to test your research hypothesis(es)

 

      1. CONFIDENTIALITY OF DATA:

Describe you proposed procedures for maintaining confidentiality of the data you will collect or will receive. What procedures do you propose to use to safeguard identifiable records of individuals and protect the confidentiality and privacy of participants? Describe your proposed plan for destroying the data after the study has been conducted

 

      1. RISKS AND BENEFITS:

Provide an overview of the immediate or long?range risks to participants, if any, that may arise from the procedures used in this study.

 

      1. INFORMED CONSENT:

Provide an example of your proposed informed consent form by following the example in the consent form below. You may refer to the consent form at this stage by simply stating [see consent form below]

 

      1. PROTECTED HEALTH INFORMATION (PHI):

If the researcher proposes to access Protected Health Information (PHI) to identify potential subjects who will then be contacted, you will need a limited waiver of HIPAA authorization.  If this applies to your proposal please provide the following information: (a) Under this limited waiver, you are allowed to access and use only the minimum amount of PHI necessary to review eligibility criteria and contact potential subjects; (b)What information you are planning to collect for this purpose? (c) How confidentiality/privacy will be protected prior to ascertaining desire to participate? (d) When and how you will destroy the contact information if an individual declines participation? If none of this applies to your proposal just state N/A

 

      1. DEBRIEFING STATEMENT:

Provide a brief debriefing statement to be given to all potential participants. In the debriefing statement describe your proposed reason(s) for conducting the research, the manipulation that you propose to perform, the results that you propose to obtain and what importance you expect to come out of the proposed study.

 

      1. GENERALIZABLE KNOWLEDGE: Will the proposed activity result in the development of or contribution to generalizable knowledge?                                                                                               yes             no  If no, please explain.  Generalizable knowledge might include information presented to a broader audience or published with the

intent of drawing scientific conclusions or increasing the body of scientific knowledge.

 

 

      1. SUMMARY OF THE RESEARCH/ABSTRACT:

Summarize the proposed research using non?technical language that can be readily understood by someone outside the discipline.

 

      1. USE OF THE RESULTS:

Describe with specificity to whom will the results be presented (class, conference, published article, other, etc).

 

SAMPLE CONSENT FORM

 

[Title of your study]

 

You are invited to participate in a study of [a brief description of your study].

 

 

My name is [put your name in], and I am a [your position with the University, e.g., a faculty member, if a student site the name of the Principal Investigator or Advisor] at Fayetteville State University, Department of [your department].  I hope to gain a better understanding about [a brief description of what you hope to learn from this study]. You will be one of [number] participants chosen to participate in this study.

 

 

If you decide to participate, you may be asked to participate in the following phases of data collection: [list the phases that the subject will be involved with; give a brief description of each task the subject will have to perform]. You may decide not to participate in any task or you may decide to not answer any questions on the questionnaire, inventories, or during the interviews that make you feel uncomfortable or embarrassed [list any other risks that the subject maybe exposed to]; you may stop your participation at any time during the study. There is [no monetary compensation or monetary compensation (chose one). If there is monetary compensation or credit given specify the amount] for participation in this study. I will make all reasonable efforts to accommodate your schedule and time constraints.

 

Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission. Completed questionnaires, and/or scores on test, experiments or inventories (whichever is applicable) will be kept under lock and key. All information will be erased following data collection, analysis, and report development. At no time will your name or institution be identified in reports, papers, or publications.

Your decision whether or not to participate will not affect your future relations with Fayetteville State University. If you decide to participate, you are free to discontinue participation at any time.

 

You are making a decision whether or not to participate. Your signature indicates that you have read the information provided above and that you have decided to participate. You may withdraw at any time after signing this form, should you choose to discontinue your participation in this study.

 

If you have questions, please ask me. If you have additional questions later, I will be happy to answer them. You can reach me at [your phone number and email] or write me at [your name and address]{use Department of Psychology, Fayetteville State University}. If you have questions or concerns, at any time during this study, about your rights as a research subject you may contact:

Dr. Theodore Kaniuka , Chair Human Rights and Research Committee Fayetteville State University

Fayetteville, NC 28301?4298 (910) 672?1636

You may keep a blank copy of this form for your records.

 

 

                                                                                                                                                                                                                                                                                                                               

Signature of Participant                                                                                  Date                                        Signature of Investigator                                                                                                       Date

This project has been approved by the Fayetteville State University Institutional Review Board Human Rights in Research Committee (Phone: 910?672?1569)

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