1.  What is the Institutional Review Board (IRB)?

          The IRB is the University of South Carolina committee that reviews and approves protocols for the use of human subjects in research.  The IRB consists of representatives from a variety of scientific disciplines, non-scientists, and community members.  The primary function of the IRB is to protect the rights and welfare of human subjects and to assist investigators in this process.

2.   Does my project involve human subjects?

          Human Subject refers to a living individual about whom an investigator, research personnel or student obtains:

•   Data through intervention or interaction with the individual, or
   

•   Identifiable private information.

            Intervention includes both physical procedures by which data are gathered or manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

            Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

3.  Who determines if human subject research is exempt from review   by the IRB?

          Exemptions are determined by the IRB or a designee of the IRB (i.e. an IRB Liaison).

4.  My research with human subjects is not funded.  Do I Still have to submit an application to the IRB?

          Yes.  ALL research that involves human subjects must be reviewed and approved by the IRB.

5.  Do surveys and questionnaires require IRB approval?

          Surveys and questionnaires used in the course of performing research require IRB approval.

6.  If I am only analyzing existing data, do I need to obtain IRB approval?

          It is likely that your research is exempt, but consultation with the IRB is required to determine the appropriate review category. Some anonymous databases do not meet the definition of "human subjects" while others contain private identifiable information and require some level of review.

7.  Do all student research projects have to be submitted to the IRB?

          Research conducted to fulfill the requirements of a dissertation, thesis, or other University research requirement must receive IRB approval.

          Course related activities (e.g. research methods instruction) that involve the use of human participants, but have no connection with research beyond the instructional function preclude the need for IRB review. However, efforts that lead to presentation outside of the classroom, and/or the publicizing of the student- prepared documents in any manner are considered research. Instructors of research courses are encouraged to consult with their IRB Liaison or Office of Research Compliance staff to determine the appropriate procedures for assuring that student projects conform to ethical guidelines.

8.  May I begin human subject research before I obtain IRB written approval?

          No.  All human subject research must be approved by the IRB before the research may be conducted.

9.  Can the IRB stop me from conducting my experiment?

          Yes. The IRB has the authority to suspend or terminate research that is not carried out in accordance with its requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the IRB's reasons for its action and will be reported promptly to the principal investigator, the Vice President for Research, and the funding agency.

10.  If I do begin my research before I receive IRB approval, what action may be taken against me?

          Research on human subjects without appropriate approval is a violation of University policy and government regulations; as such it can lead to a variety of sanctions and/or disciplinary actions. At a minimum, data gathered without approval must be excluded from the research study.

11.  How long is my IRB approval valid?

          Unless otherwise stated, your approval is valid for twelve (12) months from the date stated on your approval letter.

12.  Must I notify the IRB with changes to my approved project/protocol?

          Any changes in protocol must receive prior approval by the IRB.

          Please note that ALL changes should be reported to the IRB, no matter how insignificant you may think they are. For example, any changes in study personnel, changes in expected participants, new advertising or promotions to recruit participants, changes to incentives offered, or even a one word change to the informed consent document must be submitted to the IRB for approval.

13.  How long am I required to maintain my research documents?

          All documentation relating to research must be maintained by the principal investigator for three years after completion of the research project for which the data were collected, unless a longer retention period is specified by the sponsor. Please see University of South Carolina Policies - Data Access and Retention.

14.  How can an investigator obtain further information or advice regarding the use of human subjects?

          Contact the Office of Research Compliance at(803) 777-7095.

1.  What type of research qualifies as exempt?

          Please see Categories of Exempt Research.

2.  What factors do the IRB consider in reviewing nonexempt research?

          The IRB considers the a) soundness of the research protocol b) recruitment and selection of subjects c) the informed consent process d) assessment of benefits and risks.

3.  What type of research is eligible for expedited review by the IRB?

          Please see Categories of Expedited Review.

4.  What materials should I submit to the IRB?

          Please see Overview of the Submission Process.

5.  How long will it take to obtain IRB approval?
 

•  Exempt research is normally approved within 2 to 4 days.
   

•  Expedited research is normally approved within 2 to 4 days.
   

•  Full convened committee review varies depending on the action of the committee.  If revisions are required, the response by the investigator will determine the ultimate length of time between submission and approval.  Typically, the process can be completed in 3 to 6 weeks depending on the date of application submission and the date of the IRB meeting.

1.  When do projects require informed consent?

          Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent if the project involves no more than minimal risk; the waiver does not adversely affect subjects; the research could not practicably be carried out without the waiver; and, where appropriate, subjects are given information about the project afterwards. Otherwise, consent must be obtained.

2.  Does the project require written consent?

          The IRB may waive written consent if:

•   Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality;  or
   

•  The research presents no more than minimal risk and involves procedures for which consent would not normally be obtained outside of the research context.

3.  What must I include in an informed consent statement?

          Please see the Informed Consent Process.

4.  Can deception or misrepresentation be used in studies with human subjects?

          Yes, if the benefits outweigh the risks to the subjects for participating in such a study, and if the investigator provides a compelling scientific justification for such experimental manipulation. The participants must be informed that some information is being withheld until the end of their participation. If deception or misrepresentation is involved, the subjects must receive an explanation (a debriefing) about the nature of the experiment and why such manipulation was critical to its success. Such an explanation should be included with the materials submitted for IRB review and approval.

5.  What consent material are required for research with minors?

          Human subject research with minors requires completion of a parental consent form and an assent form. Please see The Investigator's Handbook and The Consent Process for more information.

6.  What is assent?

          Assent refers to agreement by a minor, 7 or above, to participate in human subject research. Assent must be accompanied by consent from a parent or guardian. The assent form must be written in the simplest terms possible. Please see The Consent Process for more information.

7.  Is assent always required?

          Assent must be sought from the child unless: 1) the child is incapable of providing assent (due to age or condition), or 2) the intervention holds out the prospect of direct benefit to the child and the intervention is available only in the context of the study. In these two situations, consent from parent(s) is sufficient.

8.  What do I do with the consent forms once they are signed?

          You must keep the signed consent forms in a secure location. These consent forms must be retained for a period of three years after the study is complete. For some disciplines and sponsored projects, the forms and data must be kept longer.

          The research subject must receive a copy of the consent form.