Human Subjects Research FAQs
Updated: August 21, 2020 at 11:27 a.m.
For researchers who are approved to resume in-person research activities with human participants, please see Scholarly Integrity and Research Compliance documents and forms: (add links)
Yes, please plan timelines accordingly as approvals might be delayed.
Yes, all office hours will continue, but will be virtual via telephone or videoconference.
Yes, for studies that involve face-to-face interaction with participants, consider whether all or parts of the research can be shifted to an on-line format. If so, submit an amendment to alter your protocol.
Yes, any research that requires modifications (personnel changes or procedures changes) will require an amendment. Please submit amendments via protocol management.
Yes, CITI training will remain available and students and staff will be able to access it. We recommend that you check your Duo settings to ensure you can complete two-factor authentication without a device in your office (e.g., your office phone) should you need to complete CITI training remotely.
You can request a waiver for the requirement of documenting informed consent if:
- The only record linking the subject and the research would be the consent document and the primary risk to the participant would be potential harm resulting from a breach of confidentiality; or
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., taking a blood pressure measurement or asking shoppers in a mall about the ambient lighting and temperature).
In cases in which the documentation requirement is waived, the IRB might require the investigator to provide subjects (or the subject’s parents) with a written statement, containing the required elements of the consent.
To request a waiver of documentation of informed consent, submit an amendment through the protocol management system.
Yes, consent or parental permission can be implied. Implied consent is most common in minimal risk research that involves the completion of surveys and questionnaires. When the IRB has approved a waiver of documentation of consent, the researcher may replace the signature line on the consent form with a statement indicating that by responding to the questions and mailing the survey back (or hitting the submit button if the survey is on-line), the recipients have agreed to participate in the research.
Yes, if the relevant laws in the jurisdiction where the research is conducted equates electronic signatures to written signatures.
Yes, a faxed signature is acceptable.
No, if your research study has been determined to be exempt you do not have to obtain documentation of informed consent. You must provide your participants with an information sheet that contains all of the same elements as an informed consent document, but do not need to include a signature line. Since documentation of informed consent is not required for exempt research, there is no need to request a waiver.
If your study is already approved for online remote interactions, please continue according to your approved protocol. If you change an existing in-person study to use remote interactions, please amend your protocol through the Virginia Tech Institutional Review Board Protocol Management System. New protocols that include remote interactions should outline procedures in the appropriate sections. Please contact the Human Research Protection Program staff: email@example.com for guidance specific to your project.
There are a variety of Virginia Tech tools available for remote communication. These include Google Hangouts Meet, Teams, and Zoom (for working with protected health data) among others. Please check with your department IT or the Privacy and Research Data Protection program: firstname.lastname@example.org for guidance on which Virginia Tech tools are appropriate for your project or activity.
It depends on the nature of the interaction and the information discussed. For lower risk studies without sensitive data, the use of personal devices may be an option. For higher risk interactions such as counseling sessions or collecting sensitive behavioral health information, it may be necessary to limit activities to only Virginia Tech managed and approved devices. Please contact: email@example.com for additional guidance.
For some studies, it is permissible to record the interactions. Most of the tools for remote interactions allow both cloud and local recording options. The version of Zoom for working with protected health information does not allow cloud recording. Local recording processes are under development for this version but are not yet available.
- Ensure that you have obtained informed consent according to your Institutional Review Board-approved protocol methods.
- Ensure a quiet, distraction-free environment, with the ability to host a remote meeting (bandwidth, computer, etc.). The door to the environment should be closed to prevent intrusion.
- Individuals not involved in the interview (e.g., roommates, partners, children) may not be in the room during the interaction with the participant. Interactions may not be conducted outside, in any public place, nor while driving.
- Please ensure that others at your location are aware that you will be speaking with participants and that you must speak privately.
- Use headphones to help prevent the participant’s comments from being overheard by others.
- Shut down all other programs (email, browsers, etc.) to prevent notifications, sounds, or other interactions with your device.
- Document that the interaction was conducted virtually and note any abnormalities (including interruptions from other individuals) that occurred.
- If paper-based documentation is to be used for documenting interactions, it must be stored in a locked cabinet that is not accessible by others in the environment.
- If you must call participants using your personal device, block or restrict your number so that participants do not have access to your personal telephone number.
- The participant must have access to an electronic device(s), such as a telephone or a computer with a webcam and/or audio capability, and secure internet access (e.g., not public WiFi) for the interaction.
- The participant should have a location that is private and free from distractions or other intrusions.
- COVID-19 related Institutional Biosafety Committee (IBC) protocol amendments and new applications will be prioritized for review by both the IBC program staff, and the IBC.
- Some COVID-19 related IBC amendments may be able to be processed as minor amendments. These minor amendments will be reviewed by the IBC chair and biosafety officers, after the IBC program staff complete an initial review to check that all required information has been submitted.
- COVID-19 IBC protocol applications that require review at a convened IBC meeting will first be reviewed by the IBC program staff to check that all required information has been submitted. The applications will then be placed onto the agenda for review at a COVID-19 IBC meeting. COVID-19 IBC meetings will be held weekly, as needed.