Section Two: Key Personnel

King’s College Institutional Review Board for Research Involving Human Subjects

RESEARCH PROTOCOL REVIEW FORM Section One: General Information Proposed Start Date of Study: Proposed Category (Check one):

Full Board

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Project Title: Principle Investigator: Phone: ( ) Ext: E-mail: Fax: ( ) Mailing Address: Funding Source: Not Applicable

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Internal

Expedited

□ Department: Alternative E-mail:

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External Agency : ___________________________

List any contractors, entities, or IRBs Associated with this project: Not Applicable 1- ________________________________________________________ (add lines as necessary)

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Section Two: Key Personnel Describe the responsibilities of each person, check the box for completion of NIH training , attach all NIH certificates or state “already on IRB file” in Appendix B Principle Investigator:

NIH training completed

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Roles/Responsibilities:

My Signature below indicates the following: 1- I certify that all information provided in this application is complete and correct. 2- I understand that as the Principle Investigator I am responsible to ensure that this study is conducted in an ethical manner and follows the protocol outlined in this proposal. I will also ensure that other research personnel will have access to a competent supervisor during the implementation of this study. 3- I will ensure that other key personnel meet their obligations as outlined in this proposal. 4- I agree to comply with all applicable federal, state, and local laws. 5- I will promptly report any significant adverse events or effects of this research to the IRB in writing within 5 working days of the occurrence. Signature of Principle Investigator: ______________________ Date: ________ (Researchers may use an electronic signature or submit an additional hard copy in addition to the electronic copy that includes an original signature from the Principle Investigator)

Key Personnel (Continued) Faculty Advisor/Sponsor if applicable: e-mail address: Roles/Responsibilities:

NIH training completed

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My Signature below indicates the following: 1- I certify that the student or guest researcher is knowledgeable about the regulations and policies governing human subjects research and has the prerequisite skill set to conduct this research according to ethical guidelines. 2- I agree to meet with the principle investigator on a regular basis to ensure that research standards are being met and the protocol submitted in this form is being followed. 3- I agree to comply with all applicable federal, state, and local laws. Signature of Faculty Advisor/Sponsor: ______________________ Date: ________ (Researches may use an electronic signature or submit an additional hard copy in addition to the electronic copy that includes an original signature from the Principle Investigator) Other Individual Involved in conducting research: e-mail address: Roles/Responsibilities:

NIH training completed

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Other Individual Involved in conducting research: e-mail address: Roles/Responsibilities:

NIH training completed

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Other Individual Involved in conducting research: e-mail address: Roles/Responsibilities:

NIH training completed

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Other Individual Involved in conducting research: e-mail address: Roles/Responsibilities:

NIH training completed

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(Add additional Individuals and lines as necessary)

Section Three: Research Participants Please check all descriptors that apply:

□ Prisoners □ Males

Females

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King’s College Students

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Pregnant Women/Fetuses

Individuals in residential treatment facilities

Children/Adolescents under the age of 18

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Persons with:

□ Intellectual Disabilities □ Economic Disadvantages

Is this an existing data set?

Educational Disadvantages

Yes

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No

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Physical Disabilities

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If Yes: Describe the population from whom data were collected and include the number of participants data was collected from.

Do you plan on compensating your participants?

Yes

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No

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If Yes: Describe the type, amount, and method of compensation

Describe your participant population including sex, age range, and projected number of research participants. Also indicate any special participant characteristics, i.e., undergraduate volunteer students, racial or ethnic minorities, disabilities, etc.

Describe why this sample is appropriate for inclusion in the study:

Describe a step by step process for how you will recruit participants. Include any flyers, e-mails, scripts, or advertisement that will be used in Appendix C.

List all realistic benefits participants might experience by participating in this research.

Section Four: Project Overview Abstract (400 word maximum): Describe the following in terms that are understandable to someone who is not familiar with your field of study:  A summary of relevant research leading to this proposal (Include references as Appendix A),  Expected and/or possible outcomes, and  A statement on the significance/import of this research.

Purpose: State all objectives of this project, how the results will be used, and list any realistic benefits this research may generate for the general population.

Section Five: Methodology Please check all descriptors that best apply to the research methodology.

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Data Source: New Data Existing Data Will recorded data collected contain identifying data (See IRB website for document “what constitutes identifying data”) Failure to select the correct box will delay research approval: What methods of data collection will be utilized?

□ Measures/Specimens □ Survey / Questionnaire

Observation/Interview

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Yes

Physical / Physiological

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No

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Procedures: Describe the following in terms that are understandable to someone who is not familiar with your field of study:  How you will carry out the project?  How you will consent participants (attach the informed consent as Appendix D)?  Describe participants’ time and effort.

Measures: List all tests and measures to be employed. Indicate any copyrighted material. Indicate that copyrighted materials have been purchased or provide a copy of permission letters to edit or post copyrighted material in Appendix E.

Location of Research: List all locations where data will be collected. Attach necessary permission letters in appendix F.

If using the internet to collect data, what confidentiality or security precautions are in place to protect identifiable data?

Section Six: Participant Protection Deception: Does this research study involve deception: If yes, please address the following three questions.  What is the nature of the deception involved?  Why is this deception necessary?  How and when will debriefing take place?

Yes

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No

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Are there any risks to participants (both immediate and long range)? Include those aspects of the procedure that might cause unusual discomfort or inconvenience to the research participants:

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Psychological Coercion Physical Social Breach of Confidentiality* None Other: ___________________________________________________________________________ (*If collecting identifiable data, investigator must endorse this risk).

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If any of the above risks are endorsed, address the following questions for each risk.  What is the nature of this risk?  Why is this risk necessary?  Identify and describe all precautions you have taken to eliminate or reduce risks?

Section Seven: Protection of Data Will data be collected as anonymous: If no, answer the following questions.

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Yes

No

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Will data be collected as confidential:

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If data is collected as confidential, will the participants’ data be coded or linked to identifying information:

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Yes

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No

Yes

No

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Justify your need to link participants’ data to identifying information.

Data Storage and collection.  Where and how will data be stored?  How will data be secured?  How will electronic data be secured?  Who will have access to stored data?  When will the latest date that confidential data will be retained?  How will confidential data be destroyed?  Note if anonymous data will be retained indefinitely.

Section Eight: FOR IRB USE ONLY: Do not write in this section Protocol #: _____________ Date Received: _____________ Date of Review:_____________ Date of Approval: _____________ Project Approval Dates: _______ through ________ If the study extends beyond this date, the researcher must submit a renewal form. Determination of the IRB:

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Approved

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Conditional Approval (Must resubmit protocol with a memo outlining how each concern was addressed. One IRB member insures that concerns were adequately addressed.) 1- ______________________________________________________________________________ ______________________________________________________________________________ 2- ______________________________________________________________________________ ______________________________________________________________________________ 3- ______________________________________________________________________________ ______________________________________________________________________________

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Resubmit (Must resubmit protocol with a memo outlining how each concern was addressed. Requires new IRB review process to take place.) 1- ______________________________________________________________________________ ______________________________________________________________________________ 2- ______________________________________________________________________________ ______________________________________________________________________________ 3- ______________________________________________________________________________ ______________________________________________________________________________ Reviewer Codes: