IRB Review

How Do I Know if I Need if I Need IRB Approval?

• Is it research as defined by the federal regulations?
• Is it research with human subjects as defined by the federal regulations?
• Is Radford University engaged in research with human subjects as defined by the federal regulations?

Is it Research?

45 CFR 46.102(l) defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Is it Human Subjects Research?

45 CFR 46.102(e)(1) states a human subject is defined as a living individual about whom an investigator conducting research:
• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens (this includes manipulation of the human’s environment)
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Do I need IRB approval through Radford University?

If you are affiliated with Radford University and acting as a researcher for Radford University, you are considered an agent or an employee. As a result, your research project (even if you are a student) will need IRB approval through Radford University. This is done through submitting an IRB application to the Radford University IRB or if completing collaborative research, through requesting a Reliance Agreement/Institutional Authorization Agreement (IAA), where one IRB relies on the review and approval of another IRB.

An institution’s employees or agents refers to individuals who:

• act on behalf of the institution.
• exercise institutional authority or responsibility.
• perform institutionally designated activities.

Employees and agents can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

What does not need IRB Review?

Not Human Subjects Research (NHSR)

Not Human Subjects Research (NHSR) applications are used to determine if a project meets the regulatory definition of human subjects and/or research. When the IRB determines a project does NOT meet the regulatory definitions, a determination letter will be generated which states IRB approval is not required. If the IRB determines the project DOES meet the regulatory definitions, it will be reviewed normally as an IRB study application. NHSR determinations are made by the IRB and do not require a convened committee meeting.

Please submit your IRB application by filling out the IRBManager xForm and selecting "Not Human Subjects Research (NHSR Determination" in the "Type of Study" section of the IRBManager application. 

Quality improvement activities (that are not considered human subjects research)

Human subjects research is reviewed by the IRB according to the following categories:

Exempt or Non-Exempt Review

Research can be approved as “exempt” if it is no more than “minimal risk” and fits into one of the exempt review categories as defined by the Federal regulations 45 CFR 46. All Exempt studies MUST be submitted to the Radford University IRB for review. Exempt reviews are conducted by a member of the IRB committee and do not require a convened committee meeting. These are reviewed individually as they are received. For further information, please contact the IRB Office at 540-831-5290 or irb-iacuc@radford.edu.

The following types of research are commonly processed under exempt review: 

• Research on educational practices or educational curriculums 
• Benign behavioral interventions with adult subjects  
• Anonymous surveys or interviews on non-sensitive topics 
• Passive observation of public behavior without the collection of identifiers 

View exempt categories [PDF]

Not Eligible for Exemption

• Prisoners as subjects - When prisoners are being studied as a population. (The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners)  
• Children as subjects - Only allowed under certain conditions 
• Medical records - With the exception of Limited Data Sets 
• FDA regulated studies - With the exception of Taste and Food Quality and Consumer Acceptance 
• Deception studies 

Expedited Review                                                                                                        

Federal regulations mandating IRB review recognize that not all research rises to the level of full board review. In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited. If the proposed research meets the definition for minimal risk, in addition to one of the federally designated review categories, the IRB can expedite a protocol's review. Expedited reviews are conducted by a member of the IRB committee and do not require a convened meeting. 45 CFR 46.102(j) defines minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine or psychological examinations or tests." 

Certain types of research may be reviewed and approved under an expedited procedure. In order to qualify for expedited review, research activities must present no more than minimal risk to human subjects and involve only procedures listed in one or more of the categories listed below. Learn more about the different levels of IRB review, here.

Summary of Expedited Review Categories 

1. Clinical studies of drugs and medical devices only when certain conditions are met
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
3. Prospective collection of biological specimens for research purposes by noninvasive means
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
6. Collection of data from voice, video, digital, or image recordings made for research purposes
7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
8. Continuing review of research previously approved by the full committee a) Where: i) the research is permanently closed to the enrollment of new subjects, ii) all subjects have completed all research-related interventions; and iii) the research remains active only for long-term follow-up of subjects OR b) Where no subjects have been enrolled and no additional risks have been identified, OR c) Where the remaining research activities are limited to data analysis.

Full Board Review

Research that does not qualify for exempt or expedited review, presenting more than minimal risk to subjects, will receive a review at a fully convened IRB committee meeting. The research requires approval from a majority of those members.

Examples of Full Board Research

Research involving greater than minimal risk procedures and:

• Clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgical procedures 
• Disclosure of information that could require mandatory legal reporting (e.g. child/elder abuse, etc.) 
• Deception 
• Vulnerable populations (Children, prisoner, pregnant women, and neonates, per Federal regulation) 
• The IRB staff, board member, or designee determines risks are greater than minimal  

If your protocol is greater than minimal risk, you will be notified by the IRB Office with any required changes/corrections to the protocol prior to distributing the protocol documents to the committee. Full Board submissions are reviewed at convened meetings of the IRB and must be submitted three (3) weeks in advance of the IRB meeting for all faculty submissions and two (2) weeks in advance for all graduate student protocols.The PI and/or research team is usually encouraged and invited to present and defend their research and to be available for any questions that the Board may have.

Expedited categories one (1) through seven (7) below pertain to both initial and continuing IRB review, while categories (8) and (9) apply in certain cases to research already approved by the full board.

• Clinical studies of drugs and medical devices only when the following conditions are met:
  • Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) AND
  • Research on medical devices for which an investigational device exemption is not required, OR the medical device is cleared/approved for marketing and is being used in accordance with its cleared/approved labeling.
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
  • from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
  • from other adults and children (persons under 18 years old) considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
• Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
  • Hair and nail clippings in a non-disfiguring manner;
  • deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
  • permanent teeth if routine patient care indicates a need for extraction;
  • excreta and external secretions (including sweat);
  • uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue;
  • placenta removed at delivery;
  • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
  • supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
  • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
  • sputum collected after saline mist nebulization.
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
  • Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
  • weighing or testing sensory acuity;
  • magnetic resonance imaging;
  • electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
  • moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
• Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (Note: See section I.A. for similar research that may fall into the exempt category. This listing refers only to research that is not exempt.)
• Collection of data from voice, video, digital, or image recordings made for research purposes.
• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: See section I.A. for similar research that may fall into the exempt category. This listing refers only to research that is not exempt.)
• Continuing review of research previously approved by the full committee as follows where:
  • the research is permanently closed to the enrollment of new subjects;
  • all subjects have completed all research-related interventions; and
  • the research remains active only for long-term follow-up of subjects; or
  • Where no subjects have been enrolled and no additional risks have been identified; or
  • Where the remaining research activities are limited to data analysis.
• Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the Georgia Tech IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

If your IRB application needs to be reviewed by the Full Board at the monthly meeting, the PI and student (if applicable) will be notified and sent an invitation to attend the meeting. While it is not mandatory for the PI and student to attend the IRB meeting, the Board has found it helpful to resolve any outstanding points of clarification to provide an adequate review and assist the researcher in the review and approval process.

If the application is related to a student project and there are conflicts related to the ability of the PI/Radford University faculty member to attend the regularly scheduled IRB meeting, the IRB application may be deferred until the next month's IRB meeting to accommodate schedules. 

We are here to help and ask that you reach out to the Research Compliance Office with any questions you may have.   

The Radford University IRB convenes on the third Monday of each month. Exceptions to this may be in the Summer months and /or the holiday season. For more information about meeting dates and deadlines, please see the Meeting Dates & Deadlines page.

Classroom Exercises

Course projects usually do not lead to generalizable knowledge and are often not undertaken with specific research goals in mind. These projects do not need Radford University IRB approval UNLESS they: 

• Will be presented in any form outside of the immediate Radford University Community (e.g., the Radford University Undergraduate/Graduate Research Forum, Waldron College Symposium, and the Masters of Social Work Poster Presentation. 
• Involve the questioning of children or other vulnerable populations as stipulated in 45 CFR 46; 
• Ask about illegal activities (e.g., underage drinking) that can be subpoenaed by a court of law; 
• Involve socially stigmatizing and/or stigmatizing behavioral and/or attitudes; 
• Involve the use of subject matter which could cause emotional distress; 
• Involve the use of videotaping and/or audio taping. 

Classroom exercises DO NOT include Independent studies or other individualized research activities and does not apply for independent or directed studies, dissertations, theses, honors theses, capstone projects, or any other individualized learning experience. 

Please contact the IRB Office PROMPTLYif you have any questions about your proposed project.

It is the responsibility of the faculty advisors to ensure that course projects are conducted to the standards of their relevant discipline. See the appliable policy prior to implementing a project that may qualify as a Classroom Exercise project. 

Please read and review the optional Classroom Exercise Agreement [PDF] may be used between student and instructor to ensure that the criteria are appropriately discussed and understood.

One of the questions frequently asked of the Radford University IRB office is, “When will my IRB protocol be reviewed?” or “How long will it take for my IRB protocol to be approved?”

Protocols are reviewed on a first-come, first-served basis year-round. While the time for IRB review will vary, it typically takes 4-6 weeks from submission to approval of a protocol to occur. We ask that you plan accordingly. 

Many times, an IRB application will be returned by the IRB office to the PI for revisions following IRB review due to an incomplete response(s) to questions in the IRB application or lack of required documents for the project. It is important to remember to carefully read each question on the IRB application and respond to each question. 

In those cases, the Radford University IRB office will return the protocol to the PI for revisions. Once revisions are submitted, the protocol application is again reviewed in the order it was received. 

If "Expedited" does not mean fast, what is an Expedited review for IRB?

A researcher may contact the Radford University IRB office to request an “expedited” review of their protocol. Please note, that this does not necessarily mean the review is fast.

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research found in 45 CFR 46.110, through an expedited procedure if the research involves no more than minimal risk.  

Under expedited review, the review may be carried out by the IRB Chair or by one or more experienced IRB reviewers designated by the Chair. This review may exercise all of the authorities of the IRB except this reviewer may not disapprove of the research. 

For more information about the different levels of IRB review, take a look under the IRB Review /Levels of Review section of the IRB webpage.

What the researcher may mean to say instead is, “Can you rush my protocol to the front of the review queue?” Unless the request will immediately affect a participant’s well-being, the answer is usually no. It is a matter of justice and equity for your fellow Radford University researchers who are also waiting for their protocol to be reviewed.

Full Board

Full Board protocols must be submitted by the cut-off date listed under Meeting Dates & Deadlines to be considered for review at the next convened IRB meeting, dependent on meeting the requirements for a quorum. Please have your pre-review comments submitted at least 1 week prior to the meeting date so the IRB has an updated protocol to review. Please plan on at least 6 weeks for IRB review of protocols reviewed by the Full Board. 

The Radford University IRB will make every attempt to streamline the approval process while still evaluating and ensuring the protection of human subjects involved in the research.  Researchers are encouraged to contact the Research Compliance Manager with any questions or concerns about the IRB review process. 

Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

45 CFR 46.114(b)(1) states that any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.

Note: Effective January 25, 2018, the National Institutes of Health mandated the use of single IRBs as a contingency for funding of multi-center studies.  

IRB Reliance Agreements 

A reliance agreement (i.e. IAA’s, IIA, etc.) is an agreement between two or more institutions that allows an institution’s IRB to rely on another, unrelated institution’s IRB for review of human subjects’ research. A reliance agreement comes in multiple formats, with the most common being Institutional Authorization Agreements (IAA), Memorandum of Understanding (MOU), and Master Reliance Agreement (MRA). An Investigator working at multiple institutions, each having their own IRB, may decide to have one IRB serve as the IRB of record for some or all participating sites. This practice is commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight.

In some cases, the Radford University IRB will either serve as the reviewing IRB (IRB of Record) or will cede oversight (rely upon) of the research activity to another equally qualified institution’s IRB. Each individual IRB will indicate which agreement format is appropriate for a specific study.

Under a Master Agreement with Carilion Clinic effective Fall 2020, Radford University cedes authority for IRB review for students with IRB projects involving students and/or patients at Carilion Clinic. These human subjects research projects will undergo the Carilion Clinic's IRB review process with a Carilion Clinic faculty member as PI for the project. Following approval of the IRB protocol, a copy of the IRB approved protocol, approval letter, and corresponding documents shall be sent to Radford’s Research Compliance Office for documentation purposes.

For other collaborative projects please contact the Research Compliance Office for the IRB Authorization Agreement (IAA) to be completed. Submission of the completed IAA along with a copy of the IRB-approved protocol, approval letter, and corresponding approved materials from your University's IRB or Exemption letter received is needed. The IRB Office will review the submitted documents and contact you either for any more information that might be required or with approval information that you may begin your project.