Researchers
Steps for IRB Approval:
- Determine whether you need IRB approval (pdf)
- Apply to the IRB by completing the form "Research Protocol.doc" (see below), and review the instructions.
- Wait until you receive an approval letter (via email) before initiating activities involving human subjects (including recruitment).
For those of you who have submitted an application before, please note that we no longer require an Exempt, Expedited, or Full Review form, and the "Research Protocol" replaces the "Initial Review Application." Also, investigators' signatures are no longer required on the application. In lieu of signatures, all investigators must be copied on the submission email. If you are in the middle of completing an application using our old forms, please note that we will still be accepting the old forms during this transition period.
Research Protocol.doc
| Instructions for Submitting a New Project Application
Before applying to the IRB, all of the project's investigators (who must be included as an investigator?) must have completed human subject protections training.
Email (PDFs preferred) the completed Research Protocol and all applicable supporting documents to the IRB via email (irb@vt.edu). Check the following Departmental Reviewer list to determine whether your department requires the IRB application to be approved by a departmental reviewer before being submitted to the IRB.
 Departmental Reviewer
The following departments must send their IRB applications to a departmental reviewer before submitting the application to the IRB. The Research Protocol contains a signature line (on page 1) for departmental reviewers to sign, indicating their approval of the IRB application. The signed form can be sent to the IRB office via email (irb@vt.edu), fax (540-231-0959), or mail.
- Geography (Dr. Lawrence Grossman)
- Human Development (Dr. Joyce Arditti, Dr. Angela Huebner in Northern VA, and Dr. Fred Piercy in the summer)
- Center for Gerontology (Dr. Karen Roberto)
- Industrial Systems Engineering (Dr. Thurmon Lockhart - send application through Teresa Coalson)
- Psychology (Dr. David Harrison)
- Virginia Tech Transportation Institute (Suzie Lee)
How Long Does it Take for Approval?
Most IRB applications can be reviewed and approved by the IRB office (and not by the actual Board/Committee), and typically take 10-14 days for processing and approval. To ensure a speedy review of your application, please review the above instructions carefully, complete the application throroughly, and send all required documents.
Please note that the 10-14 day approval timeframe is not guaranteed. Researchers must plan accordingly and submit IRB applications early. The IRB office reviews applications in order of receipt. Please do not contact the IRB office for at least two weeks after you have submitted an application to inquire about the status. We have a small staff and work hard to provide efficient reviews. In addition, do not contact the IRB office with a request to speed up review of your protocol. The IRB staff has been instructed not to do so because reviewing protocols out of order (of receipt) is not fair to the other researchers who have submitted protocols.
Those applications that require Full Review by the Board/Committee (i.e., studies of higher risk to participants, studies involving vulnerable populations - see Section 7 of the Research Protocol for specifics), may take several months for approval. Review deadlines for Full Review protocols.
What Can I Expect after Submitting an Application?
If the application is approved as submitted, all investigators listed on the Research Protocol will receive an approval letter via email (only).
Often times, IRB applications require modifications before they may be approved. If so, all investigators listed on the Research Protocol will receive an email from the IRB office detailing the required changes.
If the application must undergo Full Review by the Board/Committee (i.e., studies of higher risk to participants, studies involving vulnerable populations - see Section 7 of the Research Protocol for specifics), all investigators listed on the Research Protocol will receive an email indicating during which monthly IRB meeting the application will be reviewed.
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Amendment Request Form.doc
(learn more...)
Amending an Approved IRB Application
Once the IRB has approved a project, it must be carried out as planned/described in the original IRB submission package. Any changes to the IRB application must be approved by the IRB prior to implementation of changes, unless it is in the best interest of research participants.
To submit an amendment request, email the above completed Amendment Request Form and any revised documents (e.g., Research Protocol, survey instruments, recruitment flyer, etc.) to irb@vt.edu.
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Continuing Review Request Form.doc
(learn more...)
Requesting a Continuation of IRB Approval Beyond the Expiration Date
All Expedited and Full Review protocols must either receive Continuing Review approval or be reported as closed prior to the protocol's expiration date (see "When is Continuing Review Required?" to help you decide whether to close or continue your protocol). A protocol's expiration date is located on the IRB approval letter.
If continuing review is not approved by the IRB prior to the expiration date, activities involving human subjects must cease immediately. Human subjects activities may continue on an expired protocol only if it is in the best interest of study participants; however, such a circumstance (including justification) must be reported to the IRB immediately.
To submit a Continuing Review request, email the above completed Continuing Review Request Form and the study's current consent form (if applicable) to irb@vt.edu (PDFs preferred). Unless the protocol was originally approved as Expedited, also email a copy of the current (i.e., incorporating all amendments) Research Protocol / Initial Review Application.
What is Continuing Review?
If an approved IRB protocol is to continue beyond the specified expiration date (see approval letter - typically one year from the approval date), it must receive IRB continuing review approval on or within 30-days prior to the expiration date in order to not be disrupted (see "Allowing a Protocol to Expire" for further information).
When is Continuing Review Required?
Continuing review is not applicable for exempt research. Exempt research does not expire.
Continuing review is required unless data collection at all sites is complete AND data analysis at Virginia Tech is complete. If you are still analyzing or using data for any type of research write-up (e.g., dissertation paper, journal publication, etc.), the study must be re-approved by the IRB.
If data collection at all sites is complete and data analysis at Virginia Tech is complete, you may report the study as "closed" at any time by sending an email to irb@vt.edu. Remember to provide your IRB number or study title.
If, after the study is closed, there is a desire to reanalyze the data, the protocol must be re-opened (see below "How Do I Re-Open a Closed or Expired Protocol" for further information).
Allowing a Protocol to Expire
Failure to report your project as closed or have your study re-approved on or before the study's expiration date will result in the issuance of an expiration letter that will be sent to you along with (if applicable) your Department Head, Dean, OSP, sponsoring agency, and possibly to the Office for Human Research Protections (OHRP).
The expiration letter will serve as notification that subject enrollment, and use of and collection of data from existing subjects must be halted. Researchers are encouraged to contact the IRB office (Carmen Green, ctgreen@vt.edu) immediately upon receipt of an expiration letter.
Federal regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. Data collected in the interim period prior to a new IRB approval will not be approved for analysis or publication purposes.
Issuance of an expiration letter will be tracked by the IRB office as an incident of noncompliance which may result in a compliance audit of all research conducted under the principle investigator and/or further sanctions. For funded projects through OSP, issuance of an expiration letter may result in a halt of funds.
Incomplete re-approval submission packages will be sent back to the Principal Investigator. This may result in a late submission and expired protocol.
How Do I "Re-Open" a Closed or Expired Protocol?
If no longer than one year has passed since the protocol expired or was properly closed, submit a request for continuing review by completing the above form. With your application for continuing review inform the IRB office as to whether any human subjects activities have occured under the protocol during the lapse of IRB approval.
If it has been longer than one year since the protocol expired or was properly closed, submit a new application. If the protocol is being "re-opened" for data analysis purposes only, the new protocol may cover only data analysis activities.
Reminder Emails Sent by the IRB Office
For expedited and full Board research, the IRB office will send 2 reminder emails (one four weeks prior and the other two weeks prior to the study's expiration date). However, obtaining re-approval (i.e., continuing review approval) prior to the study's expiration date is that of the investigators, and not that of the IRB office.
Continuing Review for Expedited Protocols
If the IRB Chair gave “Expedited approval” for the original request, and if there have not been any adverse incidents, and if the level of risk to the subjects has not changed, then the Chair is authorized to provide re-approval of the project.
Continuing Review for Full Review Protocols
The continuing review request must be reviewed by the Full IRB at its monthly meeting unless one of the following applies: 1) 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 2) where no subjects have been enrolled and no additional risks have been identified; or 3) where the remaining research activities are limited to data analysis; or 4) continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories for expedited approval do not apply, but the 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.
Deadline = Two weeks before monthly Board meeting at which the research must be reviewed and approved to not expire (the Board typically meets the second Monday of each month). See approval letter for expiration date and continuing review due date.
Why is Continuing Review Required?
The goals of IRB re-approval are to ensure that the risk/benefit ratio is still acceptable, that the measures taken to safeguard subjects are adequate, that the approved IRB Application/protocol is followed, and that the project reflects any changes that have been made in the regulations for human subjects research since the last approval.
IRB review of proposed research is an ongoing process, not a one-time step. Regular reevaluation ensures that research is conducted responsibly. Even in responsibly conducted studies, a one-time review is inadequate, since the risks can really be understood only after research has begun, and since the regulations for human subjects research are constantly being refined as the risks and benefits are better understood. Unexpected developments in a project can raise questions about the conduct of the research, and new findings can raise questions about the project. Periodic review by researchers and the IRB helps in assessing risks and maintaining a favorable risk/benefit ratio.
The Department of Health and Human Services (DHHS) Regulations, Title 45 Code of Federal Regulations Part 46 (45 CFR 46), require at Section 46.109(e) that "an IRB shall conduct continuing review covered by this policy at intervals appropriate to the degree of risk, but not less than once per year... ." OHRP interprets "not less than once per year" review to mean review on or before the 1-year anniversary date of the previous IRB review required by 45 CFR 46, even though the research activity may not begin until some time after the IRB has given approval. OHRP guidance on Continuing Review.
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Adverse Event Report.doc
(learn more...)
Adverse Event Reporting
To report an adverse event, email the above completed Adverse Event Report form to irb@vt.edu.
If a sponsor funds or supports the study, then the Principal Investigator is responsible for notifying the sponsor of any adverse events.
What Do I Need to Report to the IRB & When?
Unanticipated Problems
When a participant or researcher in a research study experiences an unanticipated problem, the Principal Investigator (PI) must report this incident to the IRB within 5 days. A summary of the unanticipated problem must be submitted to the IRB using the Adverse Event Report form (above).
The University defines an unanticipated problem as new findings or unexpected events whose nature, severity, and frequency are not described in the information provided to the IRB or to study participants.
The University defines an unanticipated problem as any of the following:
- An actual unforeseen harmful or unfavorable occurrence to participants or others that relates or possibly relates to the research protocol (injuries, psychological harm)
- An unforeseen development that potentially increases the likelihood of harm to participants or others in the future
- Breach of confidentiality or privacy
- A participant complaint about research procedures
- Unexpected risk that is not listed in the consent form
Serious Unanticipated or Anticipated Problems
Notify the VT IRB of any serious unanticipated or anticipated problems via email within 24 hours of becoming aware of the occurrence, and follow-up with a detailed summary of the problem using the Adverse Event Report form within 5 days.
Serious = Results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, cancer, overdose or is congenital anomaly/birth defect; reportable event even if identified in current investigator brochure/protocol.
See below section for examples of serious problems.
Deviations from IRB Approved Procedures or Documents
Notify the VT IRB of any deviations from IRB approved study procedures or documents within 5 days of becoming aware of the deviation by emailing the Post Approval Monitoring Officer, Louisa Gay, at lgay@vt.edu.
Minor Anticipated Adverse Events
Minor anticipated adverse events (adverse events described in the risks section of the consent form) are to be reported during the continuing review process.
Potential Responses from the IRB to the Report
The IRB Chair will send a response to the principal investigator regarding possible actions, which could include:
- Acknowledge report, no further action required;
- Request additional information;
- Request a meeting with principal investigator and/or other parties;
- Monitor the study for additional adverse events;
- Recommend a change in the IRB Application/protocol and/or consent form(s);
- Determine if current subjects need to be informed of adverse event;
- Determine if actions taken by the investigator adequately addressed the adverse event or request further actions to be administered by the investigator;
- Temporarily suspend enrollment and/or study treatments pending the collection of additional information;
- Permanently suspend enrollment and/or study treatments.
Examples of Serious Problems
Physical Harm
Exercise Studies:
* Fainting;
* Joint injuries;
* Spinal injuries;
* Stress fractures;
* Heart attack;
* Stroke;
* Miscarriage of pregnancy;
* Any problems requiring intervention by a physician
Ergonomic Studies:
* Joint injuries;
* Stress fractures;
* Prolonged muscle pain (> 3-4 days);
* Injury to head, neck, spine, limbs, hands, or feet;
* Miscarriage of pregnancy;
* Any problems requiring intervention by a physician
DXA Scans:
* Female participants discover after the fact that they were pregnant at the time of the scan;
* Miscarriage of pregnancy;
* Birth of a child with congenital defects subsequent to participation in a study
Transportation / Driving Studies:
* Vehicle accidents resulting in injury to subjects and/or vehicle occupants and/or other individuals;
* Any vehicle accident regardless of initial determination of "no injuries"
Blood Collection:
* Fainting;
* Uncontrolled bleeding after venipuncture;
* Evidence of acute nerve injury/damage
Interpersonal Actions:
* Spousal/partner/child abuse following involvement in a study where these actions might be triggered;
* Peer bullying of children involved in or who decline participation in studies
Psychological Harm
Significant emotional responses/reactions including, but not limited to:
* Inconsolable crying;
* Extreme sadness; depression;
* Rage (directed toward researcher, self, or others);
* Indication of suicidal thoughts;
* Self-mutilation or self-abuse;
* Alteration in family relationships as a result of participating (or deciding to not participate) in studies;
* Inadvertent disclosure of non-paternity;
* Lowered self esteem or other psychological problems related to failure to be selected for a study (after screening);
* Aggravation of psychological condition when placed on a wait list where standard or experimental treatment is not readily provided
Social Harm
Subsequent to participation:
* Ostracism/expulsion from civic, social or religious groups;
* Stigmatization/persecution because personal information revealed or "deduced" (i.e., HIV positive, infection with sexually transmitted diseases [STDs], sexual preference, past crimes/offenses, mental illness);
* Student complaints about pressure to participate or of being penalized for deciding to not participate;
* Damage to the doctor/patient relationship;
* Minor "thrown out" of parent's house;
* Permanent expulsion of minor or adult students from school/educational institution
Economic Harm
Prior to participation: loss of income while being placed on a wait-list
Subsequent to participation:
* Loss of job;
* Loss of business/clientele;
* Loss of state or federal benefits;
* Loss of health benefits or significant increase in health insurance costs post-participation
Legal Harm
Subsequent to participation
* Arrest or incarceration because personal information revealed or "deduced";
* Civil suits directed toward subject because personal information, revealed or "deduced", is claimed to have harmed someone outside of the study (i.e., slander/defamation of character, "discovery" of repressed memories of physical or sexual abuse leading to civil or criminal actions, falsification of job applications alleged if past "history" revealed)
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Interim Request Form.doc
(what is Interim approval?)
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Interim Approval to Release OSP Funds Before Applying to the IRB
(To request Interim approval, email the above completed Interim Request Form to irb@vt.edu.)
The Dilemma
When applying to the IRB, a researcher must have developed his or her study documents to allow thorough review by the IRB. Sometimes, researchers will seek sponsored funding from external organizations with the intent to: (1) develop the research plan using a portion of the funding, then (2) subsequently submit a developed protocol to the IRB for approval. Since an IRB approval letter is required to obtain funds, this presents a serious dilemma - the researcher cannot develop the human subjects research protocol without the funding; however, OSP has been told not to release funding without IRB approval.
The Solution
The IRB may grant interim approval for studies needing the release of funds for study procedures not involving human subjects (e.g., designing survey instruments, developing the study design, etc.).
Granting Interim approval is supported by 45 CFR 46.118 (after clicking on this link, scroll down the new page to 46.118).
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The following items must be included with your IRB application (as applicable):
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For Research Involving:
Additional Information about:
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Definition of Human Subjects Research
Human subjects research (as defined and regulated by federal law and Virginia Tech policies) involves a systematic investigation, including research and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102d).
This is generally interpreted to mean that if the results of the work are meant to be published or disseminated to an unrestricted audience, it is considered as regulated human subjects research. However, the benchmark/goal of 'publishing' is not a part of the federal code. If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research.
Examples of regulated human subjects research include: surveys, interviews, observations of activities or behaviors, exercise tests, blood collections, psychological or medical measurements or intervention, sensory responses to taste, smell, etc., and any research involving responses from people or access to records about people.
Definition of Human Subject
Human Subject is defined as a living individual about whom a research investigator (whether a faculty professional, research staff or student), conducting research, obtains either data through intervention or interaction with the individual, or specific identifiable private information about that individual (45 CFR 46.102f).
Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review, irrespective of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture, electrocardiogram, electroencephalogram, muscle biopsy) and 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
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Who Must be Included as an Investigator?
Internal and external key personnel responsible for the design and conduct of the study, or individuals planning to use the data for publication purposes. The Principal Investigator must be a VT faculty member.
HIPAA: Health Insurance Portability and Accountability Act of 1996
HIPAA resources for research involving the use of individually identifiable health information collected in a setting related to the patient care process:
http://www.hhs.gov/ocr/hipaa/
http://privacyruleandresearch.nih.gov/
Student Researchers
A faculty member must be listed as the principal investigator on student's IRB applications. Principal investigators / faculty members are ultimately responsible for the conduct of the research and compliance with IRB determinations, federal and state regulatory requirements, and human participant protection standards.
Faculty members should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.
The Virginia Tech IRB no longer requires that class research projects be approved by the IRB unless there is intention of publishing or disseminating study results. This includes independent class projects, class assignments, and undergraduate research. This does NOT include senior theses and doctoral dissertation research. Research for senior thesis and doctoral dissertation still require IRB approval.
Conflict of Interest
As it relates to human subjects research, a conflict of interest is defined as a set of conditions in which an investigator's judgment concerening a primary interest (e.g., subject's welfare, integrity of research) may be biased by a secondary interest (e.g., personal gain).
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