What is the Carilion Clinic Institutional Review Board (Carilion Clinic IRB) and when must I use it?
An IRB is a committee established to review and approve research involving human subjects. Its primary purpose is to protect the rights and welfare of human subjects. An IRB assures that human subjects consent to their involvement in research. You must use the CC IRB for any research involving human subjects that is conducted by Carilion Clinic employees, is performed on the premises of Carilion Clinic, is performed with or involves the use of facilities or equipment belonging to Carilion Clinic, and/or involves Carilion Clinic patients, including use of information about Carilion Clinic patients for research purposes. Also, CC IRB must review research conducted by employees and/or students of the Jefferson College of Health Sciences.
What is research?
Federal regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
What is a human subject?
A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What is Quality Assurance (QA) and Quality Improvement (QI)?
QA/QI activities are simply to assure known quality. QA activities present no risk to participants. They are typically observational and unobtrusive, and involve the collection and analysis of data to which the investigators have legitimate access through their institutional roles. They do not prevent or hinder standard practices and they do not impose additional risks or burdens on participants. They do not infringe on privacy or breach confidentiality. QI activities determine quality and improve services or clinical care. They are usually applied within a defined institutional setting, often a single department or division. Their intent is to evaluate and alter processes constituting the delivery of care in the near future, with the expectation that the population of patients usually served in that location will benefit.
What kinds of IRB review are there?
There are three levels of IRB Review: full board, expedited and exempt:
- Full Board Review – any study involving greater than minimal risk requires a review by the convened IRB. This also includes studies with vulnerable populations and sensitive questions. Studies assigned for full board review are reviewed by members ahead of time and then discussed at the meeting. The committee then votes on whether or not to approve the study.
- Expedited Review – used for research involving no more than minimal risk to subjects. An expedited review is conducted by an individual reviewer or a few reviewers rather than going to the full board.
- Exempt Review – research with very minimal risk to human subjects may be exempted from continuing review at the discretion of the IRB.
How do I apply?
You submit the completed IRB Research Application, either by mail, fax or electronically, to the IRB, as indicated on the front page of the form. The IRB will then determine what type of review is required. For a QA/QI project there is a separate QA/QI application.
How long will it take to get my research project approved?
For research that does not require full board review, approvals can usually be granted within one week of receiving all required information. For full board review, please see the IRB Meeting Schedule located in the IRB section of the Carilion web site under General Information. This schedule provides the meeting dates, the deadline for preliminary review of new protocols and the final deadline for all protocol and consent copies and changes. Approval times for full board reviews may vary because of requested changes or modifications to the study.
What are my responsibilities as an investigator?
As an investigator you are responsible for obtaining IRB approval for your study. No subjects may be recruited into your study until you have received written IRB approval. During the course of the study there are several items you may have to report to the IRB, including modifications to the protocol or the consent form, serious deviations from or violations of the protocol, and local serious adverse events. All research must be reviewed by the IRB at least once every year and you are responsible for submitting a continuing review form so the IRB can conduct this review. You must assure that all research staff has completed the required IRB educational training and that all research staff follows all IRB Policies and Procedures and Guidelines as stated on the Carilion Clinic-IRB web site, along with all HHS/FDA regulations. Research records are to be maintained on file and the IRB must be allowed to inspect these records. All confidentiality policies are to be strictly adhered to.
Am I required to have any training in research before starting my research project?
Yes. Investigators, study coordinators and other research staff are required to complete a CITI course before their research will be reviewed by the IRB. There are four different curriculums: one for FDA-regulated/drug/device research, one for non-FDA regulated biomedical research, one for social/behavioral research, and one for IRB board members. Each course consists of a series of required modules and each module has a short quiz. You must pass each quiz with a minimum score of 80%. A running tally is compiled in the Grade Book. If you want to improve a score or quiz, you may repeat any quiz in which you did not score 100% correct. Please call the IRB Administrator at 853-0728 for assistance.
What should I know about subject recruitment?
Recruitment begins with identifying what subjects will be eligible to participate in the study. This is usually accomplished with an inclusion/exclusion list in the protocol. It is important to include a representative population in most research projects. Advertising may be used as a recruitment method, but the IRB will need to approve all advertising tools, whether the venue is TV, radio, newspaper, posters, mailings, internet, etc., prior to their use. Although payment to subjects for participation is acceptable, payment should not present an undue influence to potential subjects. The payment should not be contingent upon the subject’s completing the entire study. While payment to subjects is acceptable, the payment of Finder’s Fees (payment for referring potential subjects to investigators) and Bonus Payments (additional payments to study staff not related to increased trial costs) are prohibited.
Do I have to get consent from study participants?
The standard expectation is that all subjects will participate in the informed consent process, including signing an informed consent document. The informed consent document provides a complete description of the study that is clear enough for the individual to judge whether he or she wants to participate. For all of the required elements of a consent form, and a sample form, see the “Informed Consent” section of this web site.
Are there any exceptions to the informed consent requirements?
The IRB may waive the requirement of written consent if the consent document is the only link between the subject and the research and the principal risk of harm would come from a breach of confidentiality. The IRB may also waive consent if the research involves not more than minimal risk to subjects, the waiver will not adversely affect the rights and welfare of the subjects, and the research could not practicably be carried out without the waiver.
What is HIPAA and how does it affect research?
HIPAA stands for Health Insurance Portability and Accountability Act of 1996. HIPAA regulations focus on the privacy and security protections for an individual’s heath care information, referred to as protected health information (PHI). PHI includes individually identifiable health and health care payment information, including demographic data that is a potential identifier of the individual, maintained in the records of health care providers. If a research study either uses or creates PHI, documentation of the subject’s authorization to use such information is required.
Can HIPAA Authorization be waived?
Yes, when strict confidentiality measures are in place, or when the research could not practicably be conducted without the waiver or without access to the PHI.
What happens after I submit my research application?
The IRB will determine the level of review for your project. After review, one of the following actions will be taken:
- You will receive a written approval to begin your research.
- Minor changes to the consent form or protocol may be requested by the IRB. Once these changes have been made and verified by the IRB, your project will be approved and you will receive an approval letter.
- The IRB, in a full board review, determines that substantive changes must be made to the consent form or protocol before approval may be granted. In this case the IRB will defer action. Once its concerns have been addressed, the full board will again review the research.
- The IRB, in a full board review, disapproves the project. Disapproval determines that the research cannot be conducted at Carilion Clinic or by employees or agents of Carilion Clinic. The research cannot be performed with the involvement or use of Carilion Clinic facilities or equipment. Carilion Clinic patients cannot participate in the research.
- The IRB may determine that your study is not subject to continuing review.
What information must I provide to the Carilion Clinic IRB after I begin my research project?
- Any modifications of the protocol or consent form must receive written approval from the IRB except when necessary to eliminate immediate hazards to the subjects.
- Any serious deviation from or violation of the protocol must be reported to the IRB in writing within ten days of discovery.
- Any local event that is serious, unexpected and related or possibly related to the research must be reported to the IRB within seven business days of the site learning of the event.
- The Carilion Clinic IRB office must be notified within 30 days of a change in the Principal Investigator or of the closure of the study.
Must I ever renew the IRB approval of my research project?
Yes. IRB approval of your protocol and consent form is valid for a maximum of one year from its original review date. At least 30 days before that approval expires, you will be notified that you must submit a completed Continuing Review form to the IRB office.
Where can I get more information about research and the IRB process?
The web is a good source of additional information, providing links to many ethics, research and regulatory sites. Additionally, the IRB section of the Carilion web site offers valuable information with regard to local requirements. Of course, you may always call the Carilion Clinic IRB office and we will be happy to assist you.