Training in the Protection of Human Subjects - Policies

To satisfy Virginia Tech IRB training requirements, investigators may choose one from the following list:

VT IRB Tutorial

The VT IRB Tutorial is entitled "VT Human Subjects Protection Tutorial", and is available online to everyone (not just VT individuals).

Individuals who successfully complete the tutorial (including 10 question quiz) will be presented with a certificate of completion.

ENTER TUTORIAL

In-Class Training by IRB Chair

Groups only (5 or more). Those interested in requesting in-class training for a group may email Dr. David M. Moore, IRB Chair, or contact him by phone at (540) 231-4991.

Note: If you'd like to listen to an audio recording of a previous class session, click here to begin (select "High Speed Audio"). IMPORTANT NOTE! A certificate of completion will not be awarded for listening to this audio clip. In other words, listening to this audio recording does not satisfy VT IRB human subjects protection training requirements.

Training from Outside Institutions

The Virginia Tech IRB accepts the training of any other institution as long as there is sufficient documentation of the completion of such training. Appropriate documentation (e.g., certificate, correspondence from IRB office or institution at which training was completed) must be submitted to the IRB office before a new application or amendment is submitted. NIH's online tutorial is an excellent option for human subject protections training.

STS 5444: Issues in Bioethics

Those who have taken Dr. Doris Zallen's course, STS 5444: Issues in Bioethics have satisfied the IRB's training requirements. The IRB office has on file all students who have completed this course.

Although the human subjects protections training mandate from the HHS applies only to NIH grants and contracts, the VT policy extends this mandate to include all human subjects research under the VT IRB's purview (see Policy No. 2.03: Purview of the VT IRB).

All investigators (including researchers from other institutions and independent researchers), originally listed on an approved IRB application or later added to the project through an amendment, must provide the IRB with documentation of the completion of human subjects protections training, unless the IRB has verification of prior training within its records.

It is the Principal Investigator's responsibility to ensure all members of the research team who interact with research subjects, or collect or handle human subjects data have completed human subjects protection training prior to interacting with subjects, or handling or collecting the data. This includes team members (graduate students, undergraduate students, etc) who code recordings (e.g., video or audio recordings), observe research activities, and/or enter data.

Training need not be renewed unless specifically required by the VT IRB or outside institution.

Completion of appropriate training is verified automatically* by the IRB Protocol Management (PM) system for all investigators listed on new applications and amendments. Note: if the amendment is to a research protocol initially submitted before the implementation of the IRB PM, verification is completed manually by the IRB office using the IRB PM training database.

Investigators who do not complete human subjects protection training and/or submit documentation of their successful completion of appropriate training before an IRB application is submitted to the IRB office will not be an approved investigator on the project. To be added as an investigator after the application has been submitted to the IRB office, an amendment must be submitted only after the initial application receives approval from the VT IRB.

*Automatic verification is performed by cross-checking the IRB PM training database. The IRB PM training database contains a completion date and training type for all previous and current investigators/users. Such dates are pulled automatically for users who complete the online VT Human Subjects Protection Tutorial quiz. All other training data are manually entered into the IRB PM training database by the VT IRB office upon receipt of training documentation.

VT Human Subjects Protection Tutorial (hardocpy and online):

Online quiz version: The date of successful completion is automatically stored in the IRB Protocol Management training database. Quiz results are graded automatically and are not retained. Certificates sent to users are not saved by the IRB office, but can be regenerated upon request.

Manual quiz version: Completed quizzes are retained by the IRB office. Certificates sent to users are not saved by the IRB office, but can be regenerated upon request.

In-Class Training by IRB Chair:

Certificates sent to users are not saved by the IRB office, but can be regenerated upon request. The IRB office retains class rosters.

Training from Outside Institutions:

The IRB retains the documentation submitted by the investigator as verification of successful completion of the training.

STS 5444: Issues in Bioethics:

Certificates sent to users are not retained by the IRB office, but can be regenerated upon request. The IRB office retains class rosters.

As one of the options for human subjects protection training, the VT IRB offers an online or hardcopy tutorial, "Virginia Tech Human Subjects Protection Tutorial", which is accessible to both VT and non-VT individuals. Both VT and non-VT users review the tutorial content beginning at the following link: VT IRB Tutorial. Completion of the tutorial quiz differs for VT and non-VT users in the following manner:

VT Users:

VT users are prompted to login to the online quiz using their VT PID and password. Once submitted, grading and generation of a certificate is automated by the software program. Users will receive their certificate via email. Record of successful completion is retained in the IRB Protocol Management system training database.

Non-VT Users:

Non-VT users are prompted to download a PDF version of the quiz to complete and submit to the IRB office for grading. Once graded, the IRB office enters the date of completion into the IRB Protocol Management system training database. Once entered, a certificate is sent to the user via e-mail.

Successful completion of the tutorial requires a score of 70% or higher on the quiz for both VT and non-VT individuals.

IRB members and staff are provided with training that provides information and copies of, links to, or access to the following information:

1. VT IRB Policies, Procedures, & Guidance Manual
2. VT Human Subjects Protection Tutorial
3. Amdur, R. (2003 or 2007). Institutional Review Board: Member Handbook. Massachusetts: Jones and Bartlett Publishers.
4. Education items distributed with agenda items (not always on a monthly basis)

Attendance at regional and national meetings, such as PRIM&R and AAHRPP are encouraged and supported for staff members, as appropriate.