Institutional Review Board Links
IRB Fact Sheet
Guidelines
Exempt Review
Expedited Review
Full Protocal Review
User Guidelines
Informed Consent Form (sample)
Informed Consent Form (checklist)
Pre-Institutional Review Board Introduction
Contact IRB Review Board
User Guidelines
GUIDELINES FOR INSTITUTIONAL REVIEW BOARD USE
The Institutional Review Board (IRB) is an administrative, standing university committee established to provide ethical review and protection of the rights and welfare of human research subjects recruited to participate in research activities on or off campus.
The IRB is charged with reviewing all human studies conducted under the auspices of Charleston Southern University. It has the authority to approve, require modifications in, or disapprove all research activities as specified by federal regulations and local institutional policy. Its primary responsibilities are:
a. Protect all human subjects participating in campus-related research with respect to their safety, confidentiality, anonymity, and freedom from undue physical, psychological, social or economic risk.
b. Make recommendations to project researchers for protecting their human subjects in a manner that avoids substantive change to the project itself.
c. Apply sanctions against those project researchers who disregard the ruling of the IRB.
d. Provide an appeals process in the case of unresolved conflict between the researcher and the IRB.
e. Promote research that has scientific merit.
f. Provide dialogue on research design.
Charleston Southern University IRB FAQs
1 . How do I know if I need IRB approval?
2 . What qualifies as human subjects research?
3 . Do student projects need IRB approval?
• What level of review do I need?
• What is informed consent?
• Do I need informed consent for research on friends and colleagues?
• What criteria does the IRB use to review proposals ?
• What should I include with my proposal?
• Can I start my research before I receive approval?
• What happens if I do?
• Why does IRB get in my way?
• When is the deadline for submission to the IRB?
Q1. How do I know if the research I plan to do requires IRB approval or registration?
A. If you will aggregate, analyze, or summarize for publication or presentation human and/or animal data (whether inside or outside the University), you need IRB approval. For an explanation of the different categories of human subjects research and their corresponding requirements for approval, read the following section, "What Level of Review Do I Need?"
Q2. What qualifies as human subjects research?
A. Any systematic investigation (including curricular evaluation), that is designed to develop or contribute to generalizeable knowledge, and which uses living humans or identifiable private information about living humans qualifies as human subjects research. To read the federal regulations defining human subjects research, visit our links to "Regulations, Policies and Procedures."
Q3. Do students' academic research projects require IRB approval?
A. If they use human subjects, then yes. Student research can pose as many dangers to people as faculty research can, and so we must be as cautious with it for the protection of the community as well as other students. Student researchers must obtain a faculty sponsor for each research project. Most student projects will only require forms for "exempted review," and you can visit " What Level of Review Do I Need? " for more information about that.
If you conduct the project within the confines of the classroom and involve members of the class, then you usually won't need full review by the IRB; approval in this case depends on the amount of risk involved to the subjects. Responsibility for compliance with this commitment rests with the course instructor and department head. For example, instructors should pay special attention to student projects involving children or elementary and secondary school students to assure that the children, parents, teachers, and school administrators approve these projects. The IRB must, however, reserve the right to review these projects.
Q4. What Level of Review Do I Need?
A. You will file for one of these three: Exempt, Expedited, or Full. Exempted projects involve no serious risk to human subjects, and your protocol will explain how you avoid risks. Expedited reviews involve minor risks, and F ull reviews are necessary when your research poses substantial risks. For more information on these three forms of review, see our separate page, "Levels of Review."
Q5. What is informed consent?
Informed consent is the attainment of consent from the subject or subject's legally authorized representative to participate in your research. The content of the consent form must provide very specific information to the subject. For specific information on informed consent requirements go to “ Informed Consent . ”
Q6. Do I need informed consent for research on my friends and colleagues?
A. Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived. For more information on informed consent requirements, visit our page on "Informed Consent"
Q7. What criteria does the board use for reviewing research protocols ?
A. Before granting approval, the IRB must be satisfied that the following criteria are met:
• risks to subjects are minimized by using procedures consistent with sound research design, and if possible using procedures already being performed on the subjects for diagnostic or treatment purposes;
• risks to subjects are reasonable in relation to anticipated benefits to subjects, and the importance of the knowledge that may result;
• selection of subjects is equitable in terms of the purposes of the research and the setting in which it will be conducted (in other words, we don't target the same conveniently-located populations over and over for our research);
• informed consent is sought from each prospective subject and documented to include all appropriate information;
• the protocol makes adequate provision for monitoring the data collected to ensure the safety of the subjects;
• adequate provision is made and documented to protect the privacy of subjects and to maintain the confidentiality of the data; and
• where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness; those economically or educationally disadvantaged; or those living in institutions such as nursing homes, schools, or prisons, appropriate safeguards have been included in the study to protect their rights and welfare.
Q8. What should I include with my proposal?
A. For expedited (future link here) or full (future link here) review you should include either three or seven copies, respectively, of the following:
1. Completed and signed Human Subjects form
2. Final version of the study protocol
3. All consent forms
4. Questionnaires
5. Advertisements
6. Any additional information that may help the review process
(journal articles, news reports,etc.)
For exempted research, please just submit the following:
1. Original completed and signed Application for Exemption
2. Final version of the study protocol
3. Any consent forms
4. Questionnaires
5. Advertisements
6. Any additional information that may help the review process(journal articles, news reports, etc.)
Q9. Can I begin my research before I receive IRB approval?
A . No . Research must be approved by the IRB before research can be conducted.
Q10. What happens if I begin my research without IRB approval?
A. If you have external funding for your research, you may jeopardize the funding of the entire university by not gaining IRB approval before beginning. The IRB cannot give approval of a research study once it has begun. Should you begin without approval, you run the risk of being reported to your funding agency.
If your research is not funded, although an external agency is not involved, you still run the risk of reprimand or possibly dismissal if you have willfully endangered the safety of human subjects or the standing of this University without obtaining appropriate guidance and approval or your academic peers via this Institutional Review Board. Again, the IRB cannot approve a study once it has begun. Graduate students who begin human-subject research before IRB approval may be denied permission to graduate as decided by the Graduate Council???
Q11. When is the deadline for submission to the IRB?
A. Submissions to the IRB need to be to be Chair of the IRB by the 15 th of each month, August through May. During the Summer months, prompt replies may not be possible as the members of the IRB may not be available.
