Below are Frequently Asked Questions related to basic policies and procedures that govern the IRB review and approval process.
While we serve a regulatory function, we take a collegial approach to consultation with researchers and their staff. Please feel free to call on us as you navigate the process. We are happy to respond to your inquiries.
FAQ Topic Areas:
- General Questions
- First Steps
- The Review Process
- Informed Consent and Informed Assent
- After Approval – What’s Next
The Review Process
Informed Consent and Informed Assent
After Approval – What’s Next
IRB stands for “Institutional Review Board.” The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
A human subject is a living individual about whom an investigator conducting research obtains data through intervention/interaction with the individual or identifiable private information.
- Research contributes to generalizable knowledge
- Research is designed in advance
- Research utilizes a systematic approach
Examples of generalizable knowledge include but are not limited to:
- Studies being conducted with the intent of publishing journal articles
- Theses, dissertations, or other investigations that will be biographically available
- Research that is presented at conferences or other professional venues
- Pilot studies that form the basis of subsequent research or are conducted with collaborators from other institutions
Investigators are responsible for:
- Obtaining IRB approval before beginning any human subjects research
- Providing the IRB with sufficient information and related materials about the research
- Meeting ongoing requirements in the conduct of approved research that include:
- Obtaining and documenting informed consent of subjects prior to participation in research
- Obtaining prior approved from the IRB for any modifications of the previously approved research
- Providing the IRB prompt reports of any unanticipated problems involving risks to subjects or others
- Proper storage, retention and disposal of all collected data
The University requires that the faculty advisor assume meaningful supervision for each student researcher listed on the protocol. The faculty advisor must be reasonably available to assist in the resolution of and reporting of any problems that may arise during the course of the research.
The faculty advisor is responsible for imparting to students an understanding of the ethical principles of human research to which the university adheres.
If a student is conducting research or a class activity that falls within the IRB’s purview, the faculty advisor must ensure that the student completes appropriate training and secures IRB approval before beginning the study or activity.
The faculty advisor also has primary responsibility for overseeing the conduct of research in its entirety and for ensuring that students adhere to the approved protocol.
The duty of the faculty member is to assess, and, if prudent, veto activities proposed by a student to fulfill a class assignment should more than minimal risk for harm to either the participants or the student exist.
All members listed on the protocol application must successfully complete the WCU Investigator’s training course. This training requirement pertains to all faculty, staff, students, faculty advisors, and unaffiliated investigators.
The training is available online at http://www.citiprogram.org/
The Social/Behavioral Research, Basic Course must be completed and then, every 5 years investigators must complete a renewal course.
All Western Carolina University faculty and staff may submit protocol for review by the IRB.
Enrolled WCU students may submit protocol for review, but the protocol must include a WCU faculty member in the role of faculty advisor.
Individuals unaffiliated with WCU may participate in protocol but they must work in collaboration with a WCU faculty or staff member who is serving in the role of Principal Investigator. The individual not affiliated with the institution must complete an unaffiliated investigator form to attest that they understand our policies and procedures and agree to abide by them in the course of the research project.
Faculty who are collaborating on research with investigators outside WCU must obtain approval for their activities before starting work on the project. The IRB office will work with investigators to determine if a single IRB review is feasible, through a Reliance Agreement.
If a WCU investigator will rely upon the IRB approval of another agency or institution, the investigator should provide all related documentation (i.e. protocol, informed consent, advertisements) approved by the partnering agency or institution. Upon review the IRB representative will determine if it is reasonable to proceed. A formal Reliance Agreement will then be executed by the Chief Research Officer.
The review process typically takes up to 2 weeks. However, during holidays and university breaks the process can take longer.
Your protocol will be received by the IRB administrative office.
- It will be logged into the system and assigned an IRB number. That number should be on all correspondences related to the study.
- The protocol will be forwarded onto your designated reviewer. The reviewer will determine the appropriate level of review for your protocol.
- The designated reviewer will contact you via email to discuss any areas needing clarification, editing, or additional details.
The IRB includes 7 designated reviewers from various backgrounds and areas of expertise. Your protocol is assigned to the reviewer who is familiar with your subject matter.
When the Institutional Review Board receives protocol that require expertise beyond that available on the Board, it seeks assistance from qualified persons outside its membership. While outside experts may inform the IRB’s decision, they do not vote on WCU protocols presented for review.
There are three levels of IRB review:
- Full Board
- High level of risk to participants (above minimal risk)
- Research is identifiable and sensitive
- Research does not fit any of the Expedited categories
- Minimal risk to participants
- Research is identifiable and sensitive and fall within one of the Office of Human Research Protections (OHRP) expedited categories.
- Less than minimal risk to participants
- Research that is identifiable but not sensitive
- Research that is sensitive but not identifiable
- Research that is not sensitive and not identifiable
The determination of the appropriate level of review is made by the IRB
You will receive written notification via email of your approval from your designated reviewer indicating the level of review under which the protocol was approved.
Yes, the IRB may elect to disapprove your protocol. Typically the designated reviewer will work with the investigators to develop an acceptable protocol. However if the reviewer and the investigators are unable to establish a protocol that will be supported by WCU, the project, as proposed, is disapproved and will not move forward.
Consent is a continuing process that starts before any forms are signed and continues until the individual’s participation is complete. It involves meeting with a potential participant, determining whether s/he is capable of giving consent, discussing the purpose, risks, and benefits of participation, etc. Its goal is to assure that prospective participants can knowledgeably and voluntarily, without coercion, decide whether to participate. Consent is required for every participant unless the consent or one of its elements has been waived by the IRB, or the IRB has determined that the research is exempt.
Informed Assent is the consent form for children and must be accompanied by a parent/guardian consent form.
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or others that may be reasonably expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of the records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and/or medic treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a research related injury to the subject, if relevant. Typically questions concerning a research project should be referred to the PI for that project, whereas questions concerning the rights of human subjects should be referred to the IRB;
- A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;
- Other requirements may apply.
The approval period will be for no more than one year, it may be less if the proposed research needs more frequent monitoring. After the initial approval, you may submit an Application for Continuing Review for years 2 and 3 of the research. To begin the 4th year of research, you must submit an Application for Initial Review, as part of de novo review.
After a research study has been reviewed and approved by the IRB, the investigator MUST conduct the study exactly as approved by the IRB. No changes in approved research should be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants (these cases must be reported to the IRB immediately). The Request for Modification form is used to request any changes to your research protocol including changes to approved documents such as consent forms, recruitment materials, or instruments to be used in the study. Changes may not be implemented until approval is received from your IRB reviewer.
Researchers must promptly report to the IRB any serious or continuing non-compliance with federal regulations or university policies, any injuries to subjects, or unanticipated problems.
Researchers must submit a Report of Protocol Deviation or Violation within 10 business days of a protocol deviation or violation:
- A Protocol Deviation is an inadvertent act (from the perspective of the PI and study staff) in which the protocol is not followed. Examples that are reportable to the IRB include the accidental loss of consent forms, or study materials with participant information, or an accidental misread of a laboratory value as being within the reference range when it actually is sufficiently abnormal to preclude study participation by the subject.
- A Protocol Violation is an intentional act (from the perspective of the PI and study staff) in which the protocol is not followed. Examples that are reportable to the IRB include the PI prescribing or administering the wrong drug on the study, or the study subject being scheduled to return for follow-up intervention outside the protocol-dictated window as a convenience to the PI or the study staff.
The Adverse Event Form should be used as you conduct your research study whenever you encounter a problem or event that is both unanticipated and indicates that the research places subjects or others at a great risk of harm (including physical, economic, or social harm) than was previously known or recognized. Unanticipated is defined as: unexpected (in terms of nature, severity, or frequency) given:
- The research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and
- The characteristics of the subject population being studied.
The adverse event should be reported to the IRB within 3 business days of the event.
Do not hesitate to contact your IRB Liaison at any time. Collegial interaction between researchers and IRB members facilitates the IRB review process and research compliance as well as fosters respect for human subject’s protection.
Additionally the IRB website is continually being updated with new resources and information.