FSU-HRRC

Application for the Use of Human Subjects in Research

Checklist for application submission:

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

• 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

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

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.

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

Check one:           Thesis               Dissertation            Other                              

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

Name of Thesis/Dissertation Advisor:                                                                                                                                    

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.

*(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

6. 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):         

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).                                                                                                                              

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

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

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

1. 1. 1. PURPOSE AND RATIONALE:

1. 1. 2. RESEARCH SUBJECTS:

1. 1. 3. STUDY DESIGN, METHODOLOGY AND PROCEDURES:

1. 1. 4. DATA ANALYSIS:

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

1. 1. 5. 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. 1. 6. 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. 1. 7. 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. 1. 8. 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. 1. 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. 1. 10. 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. 1. 11. SUMMARY OF THE RESEARCH/ABSTRACT:

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

1. 1. 50. USE OF THE RESULTS:

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