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Full Protocal Review

A full protocol review is required of any research project that potentially may involve more than minimal risk to human participants, involve children under the age of 15, or that are not eligible for expedited or exempt review. The submitted proposal for such a project must be detailed and organized according to the following outline in general:

Project Title: The title should be descriptive of the project AND the title on the consent form that the human participant must sign should be identical to the project title.

Principal Investigator: The proposal must state the name, office address, home address, office phone number, home phone number, fax number, and email of the principal investigator (PI). Any other investigators must also be listed with at least email and office phone number for each included. If this proposal is for a student research project, the Faculty Advisor to the project will be treated as PI.

Location of Study: All facilities and laboratories where the study is to be carried out must be listed with complete addresses and phone numbers if applicable. If research is to be conducted at other facilities which require similar review, research protocols may be reviewed concurrently by all review boards.

Time Required to Complete Study: The month and year of expected start and termination dates should be clearly indicated. It is understood that these times are estimates only and may vary.

Abstract: A brief summary of the proposed research should be provided; this summary should be written in clear, layman's language and may not exceed one page in length, single spaced. The abstract should indicate the purpose of the study, methods, research design, expected outcomes, and other relevant information. For experimental research, specific statistical justification for the number of participants is recommended.

Review of Literature: The proposal should provide a brief review of the literature in the proposed area of research and the need for the research proposed where practical.
Objectives : The proposal should briefly and clearly state the purpose or hypothesis of the research to be performed.

Study Population: The proposal should include source, age range, gender of participants, and controls for the study where applicable. Also include inclusion or exclusion criteria where appropriate. Describe how participants will be recruited and who will provide consent for the participant.

Experimental Design: The proposed methodology should be included to demonstrate the course of the study. The following information should be included:

• how confidentiality will be protected

• what evaluations of participants prior to entry into the study will be done

• methods or treatment procedures to be used in the course of the study

• data collection methods to be used over the study

• storage, disposition, or destruction of data once the study is completed

• how information from the study will be shared and with whom

10. Risk-Reward Analysis : Include any benefits to the participants of the study, the risks to the participants, and measures to minimize such risks. Identify potential risk frequency, severity, and reversibility and provide a fail-safe measure at which point the study would be terminated owed to unacceptable risk.

11. Costs : The proposal should include estimates of costs associated with the research and how the research is to be funded. Details of funding sources should be provided as possible.

• Use of Personnel: The proposal should include a brief description of the duties of personnel other than the PI and how such personnel will be chosen.

• Completion Report: For all projects, a brief summary of the results of the project in layman's terms is required to be presented to the review board within one month of the completion of the study.

• Adverse Effects: All unexpected or serious adverse effects must be immediately reported to the review board by email or phone call. This initial report must be followed by a written report detailing the occurrence; this written report will be sent to the review board and to the Provost's Office.

• Signature: By signing the proposal, the PI indicates that he or she agrees to abide by the protocol outlined in the proposal.

Applications must be typed. Prior to submitting the full protocol review application to the IRB, please ensure that the following have been completed:

• Does the abstract clearly convey the purpose of the research?

• Does the review of the literature support the need for this research?

• Are the research objectives, subject population, and methods clearly indicated?

• Are the risks and precautions identified in commonly understood language?

• Are measures to ensure confidentiality described?

• Has the entire protocol been written in understandable, non-technical language?

• Has the location of the research been identified?

• If the research is to be done with an outside investigator or in a clinical space off the CSU campus, have appropriate approval signatures been obtained?

• Is coordination with another IRB necessary? If so, what plans have been made to meet with that IRB?

• Has the duration of the study and the subject commitment been identified?

• Are page numbers provided for the entire manuscript and has the cover page clearly indicated that this is a full review?

• Have all the investigators signed the protocol?

• Are the appropriate number of copies of the full protocol application attached, including the subject informed consent forms?

• Are the appropriate number of additional materials, such as impact statements or questionnaires, attached?

• Have the copies been collated into separate packets?

• Has the proposal been submitted in a timely fashion?

• Completion of on-line training tutorial developed by the National Institutes of Health entitled “Human Participation Protection Education for Research Teams” ( http://cme.nci.nih.gov/ ) for each investigation and data collection.

CHARLESTON SOUTHERN UNIVERSITY
INSTITUTIONAL REVIEW BOARD
FULL PROTOCOL REVIEW APPLICATION

Cover Sheet

The entire application should be typed.

Title of Project:

Principal Investigator:

Associate Investigators:

Faculty Sponsor:

Qualification: Please indicate what makes the proposal research require a full protocol review.

 

Full Protocol Review Application

Title of Project:

• General Information:

• Investigators

• Principal Investigator

• Signature of Principal Investigator:

______________________________________

Date:

Phone:

Email:

Fax:

Address:

Qualifications to Perform Research:

• Associate Investigators

None:

Signatures:

1. ___________________

2. ___________________

3. ___________________

4. ___________________

5. ___________________

(c)Faculty Sponsor

Name: ____________________________

Signature: _______________________

• Coordination for use of facilities or medical supervision. Please describe the necessary coordination and provide the name of relevant individuals.

Name of Responsible Individual: ____________________

Signature: _________________________________________

3. Type of Proposal or Activity: ( ) New ( ) Renewal

Date of Last IRB Approval: ____________________

If this proposal is part of a grant, please provide the name of the grant and the principal investigator listed on the grant.

• Cost of Research and Method of Funding

Governmental Agency:

Foundation:

Corporation:

Organization:

Indivdual:

• Location of the Research

Describe the locations where the research will take place.

• Number and Type of Subjects and Controls:

• Number of Subjects and Controls:

• Types of Subjects and Controls:

• Population from which subjects were derived:

• Any of the following categories of subjects to be used?

______ Minors under 14 years of age

______ Mentally retarded individuals

______ Mentally disturbed individuals

______ Pregnant women

______ Other at-risk group. Please specify.

• Subjects from other institutions:

• Will any of the subjects be from the Veterans' Administration Hospital? ________

• Other institutions like hospitals, high school, other universities? _______

• Name of involved institution or school:

______________________________________________

Notice: If subjects are from another institution with an IRB, then an application to that institution's IRB MUST be performed. CSU's IRB findings will be subordinate to the associated institution.

• Duration of the Study:

• Probable duration of the entire study:

• Total average time commitment of each subject involved with this project:

Notice: If this protocol is approved, the approval process is for a period of time NOT TO EXCEED one year from the date of approval. A report requesting an extension is required for all research that exceeds one year.

• Abstract of the Research Plan:

• Provide an overview of the proposed research in lay language. The abstract may be no more than one page.

• Risks and Precautions: List any possible risks, physical, psychological, or social. Describe any special precautions to be taken.

• Confidentiality: Describe procedures to maintain subject confidentiality.

• Provide any other required documentation