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Expedited Review Instructions

Expedited review is for those research activities that involve no more than minimal risk to human subjects and fall into an expedited review category listed on the application form (see attached). If the proposed research falls outside the expedited review categories listed, then a full review is indicated.

To apply for an expedited review, the principal Investigator must submit to the Charleston Southern University Institutional Review Board (IRB) office the following:

Three copies of the completed Expedited Review Application -indicate the category or categories that qualify this study for an expedited review and complete the rest of the application

Three copies of the volunteer agreement affidavit to be used with this research protocol

Three copies of any questionnaires, impact statements or other supporting documentation required to assure the committee that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute questionnaires, etc., at any facility or institution where the research will be conducted).

Deadline for submission of these materials to the IRB Office, is 10 days prior to the 15 th of each month (August – May). Over the summer, special coordination with the Chair of the IRB is required, since many of the IRB members are on leave over this time period. If there are questions, please call the Chair of the IRB.

Sponsorship: For student research proposals as part of an academic program of study, the Expedited Review Application must have a faculty sponsor. The IRB will review the project for protection of human subjects, scientific merit and appropriateness as an expedited review, and rely on the sponsoring faculty member for research design issues.

Expedited Review for Research Involving Children: Expedited review is not allowed for research where children age subjects. Children are defined as persons under 14 years of age. If a research protocol involves this age group, then a full review is required.

Administrative Instructions (NOT PART OF THE APPLICATION)

Summary of minimum responsibilities of the Principal Investigator:

• Promptly report changes or unanticipated problems in a research activity.

• Promptly report by telephone and send information by facsimile to the Chair of the IRB of serious or unexpected adverse effects on human subjects participating in an approved research protocol.

• Promptly report any change of investigators to the IRB.

• Prepare, at a minimum, an annual progress report or final report of the research project.

• Maintain all documents associated with the project, for a period of at least seven years. All signed and witnessed informed consents must be available if requested for review and data protection procedures in evidence.

Charleston Southern University
Expedited Review Application
Cover Sheet

(Entire application should be typed. Provide the highest degree with each investigator's name)

Title of Project:

Principal Investigator:

Associate Investigator (s):

Faculty Sponsor:

Please indicate by checking the appropriate space below the category or categories that you believe qualifies this project for an Expedited Review . If none of these categories are appropriate, then the project should be considered for a Full Review (see the Full Review instructions).

_____ Collection of data from voice, video, digital, or image recordings made for research purposes such as investigations of speech defects or subject's responses to questioning.

_____ Moderate exercise, muscular strength testing, body composition assessment, and flexibility where appropriate given the age, weight, and health of the volunteers (intensity, frequency, duration, type of exercise and mode of monitoring must be specified in the proposal).

_____ Study of existing data, documents, or records that have been collected or will be collected solely for nonresearch purposes.

_____ Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, game theory, or test development, where the investigator does not manipulate subject's behavior and the research will not involve significant stress to the subjects. Research involving sensitive matters such as sexual or political behavior does require a Full Review . Expedited Review is not appropriate if the subject's responses, if known outside of the research process, could place them at risk of civil or criminal liability or damage their financial standing or employability.

_____ Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture, in amounts not exceeding 550 milliliters in an eight week period and no more often than two times per week, from subjects 18 years of age or older who weigh at least 110 pounds, in good health, and not pregnant. Proposed research with subjects under 18 years of age with the above procedures automatically warrants a full review.

_____ Prospective collection of biological specimens for research by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner; excreta and external sections (including seat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; and, sputum collected after saline mist nebulization.

_____ Recording of data from subjects 18 years of age or older using noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice excluding procedures involving x-rays or microwaves. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing; testing sensory acuity; electrocardiography; electroencephalography; echocardiography; thermography; ultrasound; magnetic resonance imaging; electroretinography; diagnostic infrared imaging; Doppler blood flow and detection of naturally occurring radioactivity. Where medical devices are employed, they must be cleared/approved for marketing. Proposed research with subjects under 18 years of age with the above procedures automatically warrants a full review.

Charleston Southern University
Expedited Review
Application for Research Involving Human Subjects

Title of Project:

A. General Information:

• Investigator (s)

• Principal Investigator

Signature of Principal Investigator:

____________________________________________________

Date:

Phone:

E-mail:

Address:

Qualifications to perform research:

• Associate Investigator (s): List all involved

NONE: _____

Signature of Associate Investigator:

____________________________________________________

Signature of Associate Investigator:

____________________________________________________

Signature of Associate Investigator:

____________________________________________________

If more Associate Investigators are involved with this project, electronically insert their names or include on an attached sheet.

• Faculty Sponsor (s): Required for all student research projects.

NAME:

Signature of Faculty Sponsor:

____________________________________________________

2. Coordination for use of facilities or for supervision. If coordination is required for a laboratory, clinical space, supervision, or medical assistance, provide the name and signature of the individual who has the authority to provide the needed assistance or clearance. An impact statement must be attached to the application in all cases where outside coordination is required to perform the requested research.

COORDINATION REQUIRED (describe):

NAME of responsible individual:

Signature of Responsible Individual:

__________________________________________________________

3. Type of Proposal or Activity: ( ) NEW ( ) RENEWAL

Date of last IRB approval:

If this proposal is part of a grant, please indicate the following:

• Name of grant:

• Principal Investigator listed on the grant:

4. Expected cost of the research and method of funding: (state specific name of funding source)
Governmental Agency or Agencies:

Foundation(s):

Corporation(s):

Organization(s):

Individual(s):

5. Location of the research: (where will the research physically be conducted?)

B. Number and Type of Subjects and Controls:

• Name 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 unique group (please specify)

• Subjects from other institutions:

• Will any of the subjects be from other institutions, such as other universities, high schools, or hospitals?

_____ Yes

_____ No

• Name of involved institution/school:

If subjects are from another institution with an IRB, an application to that institution's IRB must be performed. Charleston Southern University's IRB findings will be subordinate to the associated institution.

C. Duration of the Study:

• Probable duration of the entire study:

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

If this protocol is approved, the approval process is for a period of time not to exceed one year from the date of the approval. A report requesting an extension is required for all research that exceeds one year. Additionally, the Principal Investigator is responsible for providing the IRB with findings and/or notification of the status of the research at the completion of the project.

D. Abstract of the research plan:

• Provide an overview of the proposed research in lay language . This abstract should be limited to no more than one page, yet it should clearly identify the need for the study, variables, hypothesis, methods, instrumentation, research design, and anticipated statistics.

• Risks and precautions: List any possible risks – physical, psychological, and social. Describe any special precautions to be taken to avoid these risks.

• Confidentiality: Describe the procedures to be used to maintain confidentiality.

E. Other

• Attach a copy of the Informed Consent to this application. This should be written in lay language at the 5 th or 6 th grade level.

• Attach signed impact statements to this application.

• Attach copy of the certificate/s and approved data collectors verifying completion of the National Institutes of Health (NIH) on-line tutorial course “Human participant protections: education for research teams.” The course is available at http://cme.nci.nih.gov/.

Institutional Review Board: Review's Comments

(This space is for IRB use only)

____________________________________________

Signature of Reviewer Date

Phone Number, if questions:

E-mail address:

Charleston Southern University
Institutional Review Board
Expedited Review Application Checklist

Prior to submitting an Expedited Review application, please insure that the following have been completed:

Abstract clearly conveys the purpose of the research?

Risks and precautions identified in commonly understood language?

Pertinent category/categories for an Expedited Review indicated on the application?

Anticipated costs associated with the research identified and addressed?

Location of the research identified, and if the research is to be done with an outside investigator or in a space off the Charleston Southern University campus, appropriate approvals with signatures obtained?

Duration of the study and the number of subjects expected identified?

Measures to insure confidentiality described?

Page numbers provided for the entire manuscript and cover page clearly indicates that this is an expedited review?

All investigators (principal, associate, and faculty sponsor) signed the protocol?

Subjects, controls, and sample population described?

Coordination with another IRB indicated? If so, what plans have been made to meet with that IRB?

Three complete copies of the expedited application attached, including the subject informed consent form, impact statements, questionnaires, and NIH certificate “Human participant protections: Education for research teams”?

Proposal submitted at least 10 calendar days prior to the next IRB meeting. Proposals arriving at the IRB office after the deadline may not be considered until the following meeting.