IRB Administrative Resources

Here you will find the Standard Operating Guidelines of Carilion Clinic's Human Research Protections Office as well as contact details for HRPO staff. 

IRB Home Page

Standard Operating Guidelines

General Administration

Review of Research

Reviews Requiring Special Consideration

Investigational Drugs, Biologics and Devices

Informed Consent Process

Conduct of Research

IRB Education and Outreach

Frequently Asked Questions (FAQs)

What is Carilion Institutional Review Board and when must I use it?

Carilion's HRPO oversees all human research conducted at Carilion to ensure that it's being conducted ethically and complies with federal, state and institutional requirements. Human subjects research at Carilion is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research).

Carilion has 3 federally mandated Institutional Review Boards (IRBs) that are responsible for reviewing and approving human research studies that require full-board review prior to the conduct of the research. We offer support and guidance for the research community and IRB members through education outreach and quality assurance activities. Carilion's IRB oversees research that is conducted by Carilion employees, involves Carilion patients and/or their data or is conducted in Carilion facilities. Carilion's IRB should be consulted if external collaborators will be involved in the project.

What are the different types of IRB submissions?

IRB submissions are reviewed in 1 of 3 ways:

  • Full-board review
  • Expedited review
  • Exempt review

Full-board review: Research that involves a greater-than-minimal risk to participants requires a review by a convened IRB committee. Some very specialized submissions using drugs or devices don't meet the definition of research; however, they require IRB approval per the U.S. Food and Drug Administration.

Examples of submissions that may require full-board review include:

  • Clinical procedures involving drugs, devices or biologics
  • Studies using vulnerable populations
  • Studies in which information may be disclosed to researchers who could require mandatory legal reporting (e.g., child/elder abuse, drugs)
  • Studies involving deception, which raises the risk level

Expedited review: If the level of risk in a research project is considered to be no greater than minimal and the research meets at least 1 of the expedited categories below, the IRB may review the project at the expedited level.

Expedited review covers the same considerations as a full committee review; however the project can be reviewed and approved by the IRB chair or designated reviewer rather than the whole convened IRB committee.

In reviewing research, expedited reviewers may exercise all of the authorities of the IRB; however, the reviewers may not disapprove the research. In this case, the expedited reviewer must defer review to the full IRB committee. The Code of Federal Regulations (CFR) lists nine expedited categories (45 CFR 46.110).

Exempt review: Exempt research involves research with human subjects; however, it's exempt from the provisions stated in the CFR (e.g., a consent form is not required).

Exempt research projects must be submitted to the IRB for initial review; however they don't require annual re-review by the IRB (continuing review). Changes to exempt research must be submitted to the IRB for review and approval if the project is amended in such a way that it no longer meets the exemption criteria.

The IRB/designee is required to determine whether a research project falls under 1 or more of the 6 exempt categories listed in the CFR (43 CFR 46.101(b)).

What is the determination “Not Human Subjects Research (NHSR)”?

Projects that don't meet the definition of research don't require IRB review unless the investigator requires a determination from the IRB prior to the conduct of the project for publication or presentation purposes. The intention is to obtain information that is not intended to be generalizable to a broader context.

Quality assessment/quality improvement (QA/QI) activities are conducted specifically to assess and/or improve quality of care and processes at Carilion in the near future, with the expectation that the population of patients usually served in that location will benefit. Activities involve the collection and analysis of data to which the investigators have legitimate access through their institutional roles. They don't impose additional risks or burdens on participants, infringe on privacy or breach confidentiality. They're usually applied within a defined institutional setting, often a single department or division.

Case reports also fall into this category. The use of protected health information (PHI) is the primary consideration and institutional requirements must be addressed.

How do I submit an application to the Carilion IRB?

You'll submit the completed Carilion IRB Research Application via the PRIS3M submission system. The HRPO will then determine what type of review is required. All application types should be submitted through PRIS3M, including research submissions, QA/QI, case reports and determination of human subjects applications.

How long will it take to get my research project approved?

It's our intention to conduct preliminary reviews in a timely manner. For research that doesn't require full-board review, submissions are typically reviewed within approximately 10 business days.

The submission may require additional information or clarification (stipulations). When stipulations are returned to the study team, the review timeline becomes dependent on the amount of time it takes for the study team to address the stipulations and return the application to the IRB. Upon return, the 10-day review window opens again. There are times when we handle an increase in submissions and the 10-day window may be extended.

For full-board review, please see the IRB submission schedule located in the IRB section of the Carilion website under Guidelines for Approval. This schedule provides the meeting dates, the deadline for preliminary review of new applications, and the final deadline for all application and applicable document revisions. IRB approval is dependent on the submission being satisfactory and complete with consistent information throughout the research documents. 

What are my responsibilities as an investigator?

As an investigator, you're 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 study, you'll have to report several items to the IRB, including modifications to research procedures, promptly reportable events (serious adverse events, unanticipated problems, protocol deviations) and continuing reviews.

All research must be reviewed by the HRPO at least once every year. You're responsible for submitting a continuing review form for full-board studies and some expedited studies, or an annual check in, so the IRB can conduct this review.

You must ensure that all research staff have completed the required IRB educational training and that all research staff follow all IRB policies, procedures and guidelines as stated on Carilion's IRB website, along with all HHS/FDA regulations.

Research records are to be maintained on file and the IRB must be allowed to inspect these records. Adherence to all confidentiality policies is required.

Am I required to have any training in research before starting my research project?

Yes. Individuals involved in the conduct of research must complete CITI training before their research will be approved by the IRB. The training requirements can be found on the Carilion's IRB webpage under New IRB Submissions: Required Education. Updated CITI training is required every 3 years.

Do I have to get consent from study subjects?

The standard expectation is that subjects will participate in the informed consent process, including signing an informed consent document based on the risk level of the study and the type of interactions/interventions outlined in the IRB application.

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. The consent should be written at or below an 8th grade reading level.

For all of the required elements of consent and sample forms, see the IRB Forms section, Consent Templates button of the Carilion IRB webpage or under the Help button in PRIS3M.

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 won't adversely affect the rights and welfare of the subjects and the research couldn't practicably be carried out without the waiver.

What is HIPAA and how does it affect research?

HIPAA refers to the Health Insurance Portability and Accountability Act of 1996. HIPAA regulations focus on the privacy and security protections for an individual’s healthcare information, referred to as protected health information (PHI). PHI includes individually identifiable health and healthcare payment information, including demographic data that is a potential identifier of the individual, maintained in the healthcare records. If a research study either uses or creates PHI, documentation of the subject’s authorization to use such information is required. Carilion IRB provides HIPAA authorization language in the consent template. 

Can HIPAA authorization be waived?

Yes. HIPAA authorization may be waived when strict confidentiality measures are in place, or when the research could not practicably be conducted without the waiver or without access to PHI.

What happens after I submit my research application?

IRB will determine the level of review for your project. After review, one of the following actions will be taken:

  • You'll receive a written approval to begin your research. Please read all IRB communications carefully.
  • IRB may request stipulations. Once the stipulations have been fully addressed and verified by the IRB, your project will be approved, and you'll receive an approval letter.
  • IRB, in a full-board review, determines that substantive changes must be made to the submission before approval may be granted. In this case, IRB will defer action. Once IRB concerns have been addressed, the full board will again review the research.
  • IRB, in a full-board review, disapproves the project. Disapproval determines that the research can't be conducted at Carilion or by employees or agents of Carilion. The research can't be performed with the involvement or use of Carilion facilities or equipment. Carilion patients can't participate in the research.

What information must I provide to Carilion's IRB after I begin my research project?

  • All modifications of procedures or documents must receive written approval from IRB except when necessary to eliminate immediate hazards to the subjects.
  • Any serious deviation from or violation of the protocol must be reported to IRB in writing within seven business days of discovery.
  • Any local event that is serious, unexpected and related or possibly related to the research must be reported to IRB within seven business days of the site learning of the event.
  • Carilion's IRB office must be notified within 30 days of a change in the Principal Investigator.
  • Study status changes including closure to enrollment and conclusion.

Must I ever renew the IRB approval of my research project?

Yes. IRB approval of your submission is valid for a maximum of 1 year from its original review date. It's the Principal Investigator’s responsibility to submit for continuing approval. Please read the initial IRB approval letter carefully for requirements.

Where can I get more information about research and IRB process?

The IRB section of the Carilion website offers valuable information with regard to local requirements. Please contact Carilion's IRB office at irb@carilionclinic.org, and we'll be happy to assist you.

Industry-Sponsored Review Fees/Carilion IRB of Record

IRB Review Fees for Industry Sponsored Studies When Carilion Is the IRB of Record

The current Carilion IRB review schedule when Carilion is the reviewing IRB of industry/commercial sponsored studies is outlined below:

  • Full Board Initial Review: $2,500
  • Full Board Continuing Review: $1,000
  • Full Board Change Update Submission: $300
  • Expedited Initial Review: $1,000
  • Expedited Continuing Review: $500
  • Expedited Change Update Submission: $100
  • Study Conclusion: $250